(Former name, former address and former fiscal year, if changed since last report)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

As previously disclosed in the Current Report on Form 8-K filed by Geron Corporation (the “Company”) with the Securities and Exchange Commission (the “SEC”) on May 8, 2020, the filing of this Quarterly Report on Form 10-Q for the period ended March 31, 2020 (this “Form 10-Q”) was delayed due to circumstances related to the ongoing COVID-19 global pandemic. In compliance with local governmental “shelter in place” measures and to limit the risk of exposure to and transmission of the SARS-CoV-2 virus, which causes COVID-19, access to the Company’s facilities has been restricted since March 17, 2020 and the Company’s employees have a minimal presence in its offices for essential activities. These restrictions caused limited access to the Company’s facilities and disrupted normal interactions among the Company’s accounting personnel and other staff, all of which slowed the completion of the Company’s quarterly review and preparation of the Form 10-Q. Accordingly, the Company’s ability to complete its quarterly review and to prepare and file the Form 10-Q by the original SEC filing deadline had been hampered. As a result, the Company relied on the “Order under Section 36 of the Securities Exchange Act of 1934 Modifying Exemptions From the Reporting and Proxy Delivery Requirements for Public Companies” dated March 25, 2020 (Release No. 34-88465) issued by the SEC to delay the filing of this Form 10-Q.

	JUNE 30,			DECEMBER 31,			MARCH 31,			DECEMBER 31,
	2019			2018			2020			2019
	(UNAUDITED)			(NOTE 1)			(UNAUDITED)			(NOTE 1)
ASSETS
Current assets:
Cash and cash equivalents	$	17,710		$	10,575		$	20,294		$	13,644
Restricted cash		270			269			270			270
Marketable securities		134,778			152,714			111,822			125,681
Interest and other receivables		838			1,168			701			802
Prepaid and other current assets		1,166			1,332			1,068			1,211
Total current assets		154,762			166,058			134,155			141,608
Noncurrent marketable securities		9,497			18,582			1,029			19,651
Property and equipment, net		100			59			749			408
Operating lease, right-of-use asset		402			—
Other assets		1,464			585
Operating leases, right-of-use assets								5,827			2,497
Deposits and other assets								1,129			1,353
	$	166,225		$	185,284		$	142,889		$	165,517

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	1,210		$	982		$	3,376		$	1,181
Accrued compensation and benefits		2,756			2,642			2,674			4,830
Amount due to Janssen Biotech, Inc.		1,576			2,610			1			14,269
Operating lease liability		402			—
Operating lease liabilities								828			354
Accrued liabilities		3,237			1,317			10,037			7,528
Total current liabilities		9,181			7,551			16,916			28,162
Noncurrent operating lease liabilities								5,159			2,200
Commitments and contingencies
Stockholders' equity:
Common stock		187			186			200			200
Additional paid-in capital		1,192,338			1,189,194			1,217,105			1,214,835
Accumulated deficit		(1,035,762	)		(1,011,464	)		(1,096,367	)		(1,080,012	)
Accumulated other comprehensive gain (loss)		281			(183	)
Accumulated other comprehensive (loss) gain								(124	)		132
Total stockholders' equity		157,044			177,733			120,814			135,155
	$	166,225		$	185,284		$	142,889		$	165,517

	THREE MONTHS ENDED						SIX MONTHS ENDED						THREE MONTHS ENDED
	JUNE 30,						JUNE 30,						MARCH 31,
	2019			2018			2019			2018			2020			2019
Revenues:
License fees and royalties	$	101		$	208		$	158		$	526		$	52		$	57

Operating expenses:
Research and development		10,134			3,204			16,040			5,644			10,802			5,906
General and administrative		5,191			4,246			10,643			9,561			6,120			5,452
Total operating expenses		15,325			7,450			26,683			15,205			16,922			11,358
Loss from operations		(15,224	)		(7,242	)		(26,525	)		(14,679	)		(16,870	)		(11,301	)
Interest and other income		1,113			717			2,275			1,111			754			1,162
Change in fair value of equity investment		(98	)		(350	)		—			(475	)		(195	)		98
Other expense		(30	)		(59	)		(48	)		(77	)		(44	)		(18	)
Net loss	$	(14,239	)	$	(6,934	)	$	(24,298	)	$	(14,120	)	$	(16,355	)	$	(10,059	)

Basic and diluted net loss per share	$	(0.08	)	$	(0.04	)	$	(0.13	)	$	(0.08	)	$	(0.08	)	$	(0.05	)

Shares used in computing basic and diluted net loss per share		186,556,082			174,475,244			186,475,055			167,538,530			200,222,092			186,393,128

Accumulated

Additional

Other

Total

Common Stock

Paid-In

Accumulated

Comprehensive

Stockholders'

Shares

Amount

Capital

Deficit

Gain (Loss)

Equity

Balance at December 31, 2018

186,392,682

$
186

$
1,189,194

$
(1,011,464
)

$
(183
)

$
177,733

Net loss

—

—

—

(10,059
)

—

(10,059
)
Other comprehensive income

—

—

—

—

282

282

Stock-based compensation related to
   issuance of common stock and
   options in exchange for services

13,365

—

22

—

—

22

Stock-based compensation for equity-
   based awards to employees and directors

—

—

1,426

—

—

1,426

401(k) contribution

—

—

9

—

—

9

Balance at March 31, 2019

186,406,047

186

1,190,651

(1,021,523
)

99

169,413

Net loss

—

—

—

(14,239
)

—

(14,239
)
Other comprehensive income

—

—

—

—

182

182

Issuance of common stock in connection
   with at market offering, net of
   issuance costs of $73

108,386

—

101

—

—

101

Stock-based compensation related to
   issuance of common stock and options in
   exchange for services

5,097

—

11

—

—

11

Stock-based compensation for equity-
   based awards to employees and directors

—

—

1,434

—

—

1,434

Issuance of common stock under equity plans

118,871

1

141

—

—

142

Balance at June 30, 2019

186,638,401

$
187

$
1,192,338

$
(1,035,762
)

$
281

$
157,044

Accumulated

Additional

Other

Total

Common Stock

Paid-In

Accumulated

Comprehensive

Stockholders'

Shares

Amount

Capital

Deficit

Gain (Loss)

Equity

Balance at December 31, 2017

159,877,239

$
160

$
1,089,684

$
(985,840
)

$
(207
)

$
103,797

Cumulative effect of accounting principle
  change

—

—

—

1,393

—

1,393

Net loss

—

—

—

(7,186
)

—

(7,186
)
Other comprehensive loss

—

—

—

—

(124
)

(124
)
Issuance of common stock in connection
   with at market offering, net of
   issuance costs of $48

776,788

1

1,552

—

—

1,553

Stock-based compensation related to
   issuance of common stock and
   options in exchange for services

8,308

—

71

—

—

71

Stock-based compensation for equity-
   based awards to employees and directors

—

—

1,614

—

—

1,614

401(k) contribution

—

—

10

—

—

10

Balance at March 31, 2018

160,662,335

161

1,092,931

(991,633
)

(331
)

101,128

Net loss

—

—

—

(6,934
)

—

(6,934
)
Other comprehensive income

—

—

—

—

254

254

Issuance of common stock in connection
   with at market offering, net of
   issuance costs of $2,096

21,865,344

22

82,284

—

—

82,306

Stock-based compensation related to
   issuance of common stock and options in
   exchange for services

10,295

—

49

—

—

49

Issuance of common stock under equity plans

9,097

—

14

—

—

14

Stock-based compensation for equity-
   based awards to employees and directors

—

—

1,545

—

—

1,545

Balance at June 30, 2018

182,547,071

$
183

$
1,176,823

$
(998,567
)

$
(77
)

$
178,362

										Accumulated
					Additional					Other			Total
	Common Stock				Paid-In		Accumulated			Comprehensive			Stockholders'
	Shares		Amount		Capital		Deficit			Gain (Loss)			Equity

Balance at December 31, 2019		199,814,581	$	200	$	1,214,835	$	(1,080,012	)	$	132		$	135,155
Net loss		—		—		—		(16,355	)		—			(16,355	)
Other comprehensive loss		—		—		—		—			(256	)		(256	)
Issuance of common stock in connection with at market offering, net of issuance costs of $76		530,228		—		686		—			—			686
Stock-based compensation related to issuance of common stock and options in exchange for services		6,039		—		16		—			—			16
Stock-based compensation for equity- based awards to employees and directors		—		—		1,568		—			—			1,568
Balance at March 31, 2020		200,350,848	$	200	$	1,217,105	$	(1,096,367	)	$	(124	)	$	120,814

										Accumulated
					Additional					Other			Total
	Common Stock				Paid-In		Accumulated			Comprehensive			Stockholders'
	Shares		Amount		Capital		Deficit			Gain (Loss)			Equity

Balance at December 31, 2018		186,392,682	$	186	$	1,189,194	$	(1,011,464	)	$	(183	)	$	177,733
Net loss		—		—		—		(10,059	)		—			(10,059	)
Other comprehensive income		—		—		—		—			282			282
Stock-based compensation related to issuance of common stock and options in exchange for services		13,365		—		22		—			—			22
Stock-based compensation for equity- based awards to employees and directors		—		—		1,426		—			—			1,426
401(k) contribution		—		—		9		—			—			9
Balance at March 31, 2019		186,406,047	$	186	$	1,190,651	$	(1,021,523	)	$	99		$	169,413

	SIX MONTHS ENDED						THREE MONTHS ENDED
	JUNE 30,						MARCH 31,
	2019			2018			2020			2019
Cash flows from operating activities:
Net loss	$	(24,298	)	$	(14,120	)	$	(16,355	)	$	(10,059	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		26			31			27			15
Accretion and amortization on investments, net		(958	)		(111	)		(124	)		(482	)
Change in fair value of equity investment, including foreign currency translation		3			513			220			(103	)
Stock-based compensation for services by non-employees		33			120			16			22
Stock-based compensation for employees and directors		2,860			3,159			1,568			1,426
Amortization related to 401(k) contributions		9			10			—			9
Operating lease expense		334			—
Amortization of right-of-use assets								244			—
Changes in assets and liabilities:
Current and noncurrent assets		(386	)		146			249			(1,532	)
Current liabilities		894			(1,611	)
Current and noncurrent liabilities								(12,039	)		(2,034	)
Net cash used in operating activities		(21,483	)		(11,863	)		(26,194	)		(12,738	)

Cash flows from investing activities:
Purchases of property and equipment		(67	)		—			(191	)		(45	)
Purchases of marketable securities		(66,408	)		(107,067	)		(6,913	)		(44,092	)
Proceeds from maturities of marketable securities		94,851			37,850			39,262			53,101
Net cash provided by (used in) investing activities		28,376			(69,217	)
Net cash provided by investing activities								32,158			8,964

Cash flows from financing activities:
Proceeds from issuances of common stock, net of issuance costs		243			83,873
Proceeds from issuances of common stock from financings								686			—
Net cash provided by financing activities		243			83,873			686			—
Net increase in cash, cash equivalents and restricted cash		7,136			2,793
Net increase (decrease) in cash, cash equivalents and restricted cash								6,650			(3,774	)
Cash, cash equivalents and restricted cash at the beginning of the period		10,844			16,603			13,914			10,844
Cash, cash equivalents and restricted cash at the end of the period	$	17,980		$	19,396		$	20,564		$	7,070

The terms “Geron”, the “Company”, “we” and “us” as used in this report refer to Geron Corporation. The accompanying unaudited condensed financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles, or GAAP, for complete financial statements. In the opinion of management, all adjustments (consisting only of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three ~~and six~~ months ended ~~June 30, 2019~~March 31, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, ~~2019~~2020 or any other period. These financial statements and notes should be read in conjunction with the financial statements for each of the three years ended December 31, ~~2018,~~2019, included in the Company’s Annual Report on Form 10-K. The accompanying condensed balance sheet as of December 31, ~~2018~~2019 has been derived from audited financial statements at that date.

Basic net income (loss) per share is calculated by dividing net income (loss) by the weighted-average number of shares of common stock outstanding during the periods presented, without consideration for potential common shares. Diluted net income per share would be calculated by adjusting the weighted-average number of shares of common stock outstanding for the dilutive effect of potential common shares outstanding for the periods presented, as determined using the treasury-stock method. Potential dilutive securities consist of outstanding stock options and a warrant to purchase our common stock. Diluted net loss per share excludes potential dilutive securities outstanding for all periods presented as their effect would be anti-dilutive. Accordingly, basic and diluted net loss per share is the same for all periods presented in the accompanying condensed statements of operations. Since we incurred a net loss for the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 2019, ~~and 2018,~~ the diluted net loss per share calculation excludes potential dilutive securities of ~~35,795,314~~43,005,837 and ~~26,306,263,~~32,714,257, respectively, related to outstanding stock options and warrant as their effect would have been anti-dilutive.

The accompanying financial statements have been prepared in accordance with ~~U.S. generally accepted accounting principles, or~~ GAAP. The preparation of financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, we evaluate our estimates, including those related to accrued liabilities, ~~revenue recognition,~~ fair value of marketable securities and equity investments, income taxes, and stock-based compensation. We base our estimates on historical experience and on various other market specific and relevant assumptions that we believe to be reasonable under the circumstances. Actual results could differ from those estimates.

We consider all highly liquid investments with an original maturity of three months or less to be cash equivalents. We are subject to credit risk related to our cash equivalents and marketable securities. Our marketable debt securities include government-sponsored enterprise securities, commercial paper and corporate notes.

We classify our marketable debt securities as available-for-sale. We record available-for-sale securities at fair value with unrealized gains and losses reported in accumulated other comprehensive income (loss) in stockholders’ equity. Realized gains and losses are included in interest and other income and are derived using the specific identification method for determining the cost of securities sold and have been insignificant to date. Dividend and interest income are recognized when earned and included in interest and other income in our condensed statements of operations. We recognize a charge when the declines in the fair values below the amortized cost bases of our available-for-sale securities are judged to be other-than-temporary. We consider various factors in determining whether to recognize an other-than-temporary charge, including whether we intend to sell the security or whether it is more likely than not that we would be required to sell the security before recovery of the amortized cost basis. Declines in market value judged as other-than-temporary result in a charge to interest and other income. We have not recorded any other-than-temporary

impairment charges on our available-for-sale securities for the three ~~and six~~ months ended ~~June 30, 2019~~March 31, 2020 and ~~2018.~~2019. See Note 2 on Fair Value Measurements.

With the adoption of ASU No. 2016-01, Financial Instruments - Overall: Recognition and Measurement of Financial Assets and Financial Liabilities, or ASU 2016-01, beginning January 1, 2018, we measure our investment in equity securities at fair value at each reporting date. Changes in fair value resulting from observable price changes are included in change in fair value of equity investment and changes in fair value resulting from foreign currency translation are included in other expense in our condensed statements of operations.

At the inception of an arrangement, we determine whether the arrangement is or contains a lease based on the unique facts and circumstances present. Operating leases are included in operating lease, right-of-use assets and lease liabilities in our condensed balance sheets. Right-of-use assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of remaining lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, to calculate the net present value of lease payments, we apply our incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as of the lease commencement date. We may adjust the right-of-use assets for certain adjustments, such as initial direct costs paid or incentives received. In addition, we include any options to extend or terminate the lease in the expected lease term when it is reasonably certain that we will exercise any such option. Lease expense is recognized on a straight-line basis over the expected lease term.

For lease agreements entered into after January 1, 2019 that include lease and non-lease components, such components are generally accounted for separately. We have also elected not to recognize on our condensed balance sheets leases with terms of one year or less. See “New Accounting Pronouncements – Recently Adopted” in this Note 1 on Summary of Significant Accounting Policies for additional information on the adoption of the new accounting standard for leases.

~~Beginning January 1, 2018, we~~We recognize revenue in accordance with the provisions of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers, or Topic 606. In determining the appropriate amount and timing of revenue to be recognized under this guidance, we perform the following five steps: (i) identify the contract(s) with our customer; (ii) identify the promised goods or services in the agreement and determine whether they are performance obligations, including whether they are distinct in the context of the agreement; (iii) measure the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations based on stand-alone selling prices; and (v) recognize revenue when (or as) we satisfy each performance obligation.

A performance obligation is a promise in an agreement to transfer a distinct good or service to the customer and is the unit of account in Topic 606. Significant management judgment is required to determine the level of effort required and the period over which completion of the performance obligations is expected under an agreement. If reasonable estimates regarding when performance obligations are either complete or substantially complete cannot be made, then revenue recognition is deferred until a reasonable estimate can be made. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method.

We allocate the total transaction price to each performance obligation based on the estimated relative stand-alone selling prices of the promised goods or services underlying each performance obligation. Estimated selling prices for license rights are calculated using an income approach model and include the following key assumptions, judgments and estimates: the development timeline, revenue forecast, commercialization expenses, discount rate and probabilities of technical and regulatory success.

Following is a description of the principal activities from which we generate revenue. License fees and royalty revenue primarily represent amounts earned under agreements that out-license our technology to various companies.

We ~~have~~previously entered into several license agreements with various oncology, diagnostics, research tools and biologics production ~~companies.~~companies, whereby we granted certain rights to our non-imetelstat related technologies. As of March 31, 2020, all license

agreements related to our human telomerase reverse transcriptase, or hTERT, technology have been terminated or expired due to patent expirations on such technology.

The remaining active license agreement is a license related to our specialized oligonucleotide backbone chemistry, as well as patent rights covering the synthesis of monomers, the building blocks of oligonucleotides. Economic terms ~~in these agreements may~~of this agreement include non-refundable ~~upfront license payments in cash or equity securities,~~ annual license maintenance ~~fees, cost sharing arrangements,~~payments, milestone payments upon achievement of certain research, development and regulatory milestones, and royalties on potential future product sales. Also, in connection with the divestiture of Geron’s human embryonic stem cell assets, including intellectual property and proprietary technology, to Lineage Cell Therapeutics, Inc. (formerly BioTime, Inc. which acquired Asterias Biotherapeutics, Inc.), we are entitled to receive royalties on future ~~sales of products, or any combination of these items.~~product sales. Non-refundable upfront fees and annual license maintenance fees ~~and funding of research and development activities~~ are considered fixed consideration, while milestone payments and royalties are identified as variable consideration.

Licenses of Intellectual Property. If we determine that the license to intellectual property is distinct from the other performance obligations identified in ~~the~~an agreement and the licensee can use and benefit from the license, we recognize revenue from non-refundable upfront fees allocated to the license upon the completion of the transfer of the license to the licensee. For such licenses, we recognize revenue from annual license maintenance fees upon the start of the new license period. For licenses that are bundled with other performance obligations, we assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable upfront fees or annual license maintenance fees. At each reporting date, we reassess the progress and, if necessary, adjust the measure of performance and related revenue recognition.

Milestone Payments. At the inception of each agreement that includes milestone payments, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. For milestones that we do not deem to be probable of being achieved, the associated milestone payments are fully constrained and the value of the milestone is excluded from the transaction price with no revenue being recognized. For example, milestone payments that are not within our control, such as regulatory-related accomplishments, are not considered probable of being achieved until those accomplishments have been communicated by the relevant regulatory authority. Once the assessment of probability of achievement becomes probable, we recognize revenue for the milestone payment. At each reporting date, we assess the probability of achievement of each milestone under our current agreements.

Royalties. For agreements with sales-based royalties, including milestone payments based on the level of sales, where the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (a) when the related sales occur, or (b) when the performance obligation, to which some or all of the royalty has been allocated, has been satisfied (or partially satisfied). At each reporting period, we estimate the sales incurred by each licensee during the reporting period based on historical experience and accrue the associated royalty amount.

Cost Sharing Arrangements. Research and development and other expenses being shared by both parties under an agreement are recorded as earned or owed based on the performance obligations by both parties under the respective agreement. For arrangements in which we and our collaboration partner in the agreement are exposed to significant risks and rewards that depend on the commercial success of the activity, we recognize payments between the parties on a net basis and record such amounts as a reduction or addition to research and development expense. For arrangements in which we have agreed to perform certain research and development services for our collaboration partner and are not exposed to significant risks and rewards that depend on the commercial success of the activity, we recognize the respective cost reimbursements as revenue under the collaboration agreement over time in a manner proportionate to the costs we incurred to perform the services using the input method.

Restricted cash consists of funds maintained in a separate certificate of deposit account for credit card purchases.

Research and development expenses consist of expenses incurred in identifying, developing and testing product candidates resulting from our independent efforts as well as efforts associated with collaboration ~~agreements.~~agreements, if any. These expenses include, but are not limited to, in-process research and development acquired in an asset acquisition and deemed to have no alternative future use, payroll and personnel expense, lab supplies, non-clinical studies, clinical trials, including support for investigator-sponsored clinical trials, raw materials to manufacture clinical trial drugs, manufacturing costs for research and clinical trial materials, sponsored research at other labs, consulting, costs to maintain technology licenses, our proportionate share of research and development costs

sharing arrangements with collaborative partners and research-related overhead. Research and development costs are expensed as incurred, including costs incurred under our collaboration and/or license agreements.

~~In May 2019,~~On November 13, 2014, we ~~assumed~~entered into a Collaboration and License Agreement, or the ~~imetelstat investigational new drug, or IND, sponsorship from~~Collaboration Agreement, with Janssen Biotech, Inc., or Janssen, ~~upon~~pursuant to which we ~~became sponsors~~granted Janssen the exclusive rights to develop and commercialize imetelstat worldwide for all indications in oncology, including hematologic myeloid malignancies, and all other human therapeutic uses. Janssen terminated the Collaboration Agreement effective September 28, 2018. Under the termination provisions of the ongoing clinical trials of imetelstat in the United States: Phase 2 trial in relapsed/refractory myelofibrosis, referred to as IMbark and a Phase 2/3 trial in lower risk myelodysplastic syndromes, referred to as IMerge. In the second quarter of 2019, we assumed sponsorship in certain countries outside of the United States. We expect to obtain country-specific health authority and ethics committee approvals for change of sponsorship to us in remaining countries outside of the United States on a country-by-country basisCollaboration Agreement, during ~~the third quarter of 2019. Until full sponsorship responsibilities for imetelstat transfer from Janssen to us, Janssen will continue supporting ongoing clinical trials of imetelstat during the~~ transition of the program to ~~us. For~~us, Janssen was required to provide certain operational support for the imetelstat program through September 28, 2019. Operational support from Janssen included clinical development activities, such as continuing monitoring and treatment of patients in ongoing imetelstat clinical trials. We reimbursed Janssen 100% for the costs of such operational support. As of September 30, 2019, the transition of the imetelstat program to us from Janssen has been completed.

Our current imetelstat clinical trials are being supported by third-party contract research organizations, or CROs, and other vendors. We accrue expenses for clinical trial activities performed by ~~Janssen~~CROs based upon the estimated amount of work completed for each trial. For clinical trial expenses and related expenses associated with the conduct of clinical trials, the significant factors used in estimating accruals include the number of patients enrolled, the number of active clinical sites, and the duration for which the patients have been enrolled in the ~~past and during the transition period under the collaboration and license agreement, or Collaboration Agreement, which was terminated effective September 28, 2018, we~~trial. We monitor patient enrollment levels and related activities to the extent possible through ~~discussions~~internal reviews, review of contractual terms and correspondence with ~~Janssen personnel and~~CROs. We base our estimates ~~of clinical trial costs~~ on the best information available at the time. ~~We conduct a similar process for clinical development activities being performed by us.~~ However, additional information may become available to us which ~~would~~will allow us to make a more accurate estimate in future periods. In ~~this~~that event, we may be required to record adjustments to research and development expenses in future periods when the actual level of activity becomes more certain.

We record property and equipment at cost and calculate depreciation using the straight-line method over the estimated useful lives of the assets, generally four years. Leasehold improvements are amortized over the shorter of the estimated useful life or remaining term of the lease.

We recognize stock-based compensation expense based on grant-date fair values of service-based instruments on a straight-line basis over the requisite service period, which is generally the vesting period. For performance-based stock options with vesting based on the achievement of certain strategic milestones, stock-based compensation expense is recognized over the period from the date the performance condition is determined to be probable of occurring through the date the applicable condition is expected to be met and is reduced for estimated forfeitures, as applicable. If the performance condition is not considered probable of being achieved, no stock-based compensation expense is recognized until such time as the performance condition is considered probable of being met, if at all. If ~~that~~the assessment of probability of the performance condition changes, the impact of the change in estimate would be recognized in the period of the change. The following table summarizes the stock-based compensation expense included in operating expenses on our condensed statements of operations related to stock options and employee stock purchases for the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 2019, ~~and 2018~~ which was allocated as follows:

As stock-based compensation expense recognized in our condensed statements of operations for the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 2019 ~~and 2018~~ is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures, but at a minimum, reflects the grant-date fair value of those awards that actually vested in the period. Forfeitures have been estimated at the time of grant based on historical data and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. We have not recognized any stock-based compensation expense for performance-based stock options in our condensed statements of operations for the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 2019, ~~and 2018,~~ as achievement of the specified strategic milestones was not considered probable at that time.

We grant service-based and performance-based options under our equity plans to employees, non-employee directors and consultants. The service-based vesting period for employee options is generally four years from the date of the option grant. Performance-based options vest upon the achievement of specified strategic milestones. The fair value of service-based and performance-based options granted during the ~~six~~three months ended ~~June 30,~~March 31, 2020 and 2019 ~~and 2018~~ has been estimated at the date of grant using the Black Scholes option-pricing model with the following assumptions:

The fair value of employees’ purchase rights during the ~~six~~three months ended ~~June 30,~~March 31, 2020 and 2019 ~~and 2018~~ has been estimated using the Black Scholes option-pricing model with the following assumptions:

Dividend yield is based on historical cash dividend payments. The expected volatility is based on historical volatilities of our stock since traded options on our common stock do not correspond to option terms and the trading volume of options is limited. The risk-free interest rate range is based on the U.S. Zero Coupon Treasury Strip Yields for the expected term in effect on the date of grant for an award. The expected term of options is derived from actual historical exercise and post-vesting cancellation data and represents the period of time that options granted are expected to be outstanding. The expected term of employees’ purchase rights is equal to the purchase period.

With the adoption of ASU 2018-07, Improvements to Nonemployee Share-Based Payment Accounting, or ASU 2018-07, beginning January 1, 2019, we measure share-based payments to non-employees based on the grant-date fair value of the equity awards to be issued. We recognize stock-based compensation expense for the fair value of the vested portion of non-employee stock-based awards inon our condensed statements of operations.~~See “New Accounting Pronouncements – Recently Adopted” in this Note 1 for additional information on the adoption of ASU 2018-07.~~

Our executive management team represents our chief decision maker. We view our operations as a single segment, the development of therapeutic products for oncology. As a result, the financial information disclosed herein materially represents all of the financial information related to our principal operating segment.

In ~~February 2016,~~August 2018, the Financial Accounting Standards Board, or FASB, issued ASU ~~2016-02,~~2018-13, ~~Leases (Topic 842)~~Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement,, or ASU ~~2016-02. ASU 2016-02 requires an entity to recognize a right-of-use asset and lease liability for all lease arrangements with terms of more than 12 months, measured at~~2018-13, which modifies the ~~present~~disclosure requirements on fair value ~~of the lease payments. Recognition, measurement and presentation of~~

~~expenses will depend on classification as a finance or operating lease. In July 2018, the FASB issued ASU 2018-11,~~ ~~Leases (Topic 842): Targeted Improvements~~, or ASU 2018-11. In issuing ASU 2018-11, the FASB decided to provide another transition method in addition to the existing transition method by allowing entities to initially apply the new leases standard at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption.

measurements. We adopted ~~Topic 842 on January 1, 2019 using the modified retrospective approach as allowed under~~ ASU ~~2018-11, and we elected to utilize the available practical expedients.~~ Financial results for the reporting periods beginning after January 1, 2019 are presented under Topic 842, while prior period amounts have not been adjusted and continue to be reported in accordance with our historical accounting under Accounting Standards Codification Topic 840, ~~Leases, or Topic 840~~.

~~In connection with the adoption of Topic 842~~2018-13 as of January 1, 2019, we recorded an operating lease, right-of-use asset and a corresponding operating lease liability of approximately $736,000 for the net present value of remaining lease payments of our current operating lease for our office space in Menlo Park.2020. The adoption of ~~Topic 842~~this new guidance did not have a material impact on our condensed ~~statements of operations. See Note 4 on Operating Leases for further discussion of our operating lease obligations.~~financial statements.

As of January 1, ~~2019,~~2020, we also adopted ASU ~~2018-07 which simplifies~~2018-18, Collaborative Arrangements (Topic 808): Clarifying the ~~accounting~~Interaction Between Topic 808 and Topic 606, or ASU 2018-18. The amended guidance precludes presenting consideration from a transaction in a collaborative arrangement as revenue from contracts with customers if the counterparty is not a customer for ~~share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions.~~that transaction. The new guidance applies to nonemployee awards issued in exchange for goods or services used or consumed in an entity’s own operations. Since all of our share-based awards to nonemployees were fully vested before the

adoption of ASU ~~2018-07, no cumulative-effect adjustment was recognized to the opening balance of retained earnings on January 1, 2019. The adoption of ASU 2018-07~~2018-18 did not have a material impact on our condensed financial ~~statements.~~

~~In August 2018,~~statements given the ~~Securities and Exchange Commission issued Release No. 33-10532 that amends and clarifies certain financial reporting requirements. The principal change to our financial reporting is the inclusion~~termination of the ~~annual disclosure requirement of changes~~Collaboration Agreement in stockholders’ equity in Rule 3-04 of Regulation S-X to interim periods. With the adoption of this new rule on January 1, 2019, condensed statements of stockholders’ equity for the current and year-to-date reporting periods and the corresponding prior periods are presented.September 2018.

In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments, or ASU 2016-13. The main objective of ASU 2016-13 is to provide financial statement users with more decision-useful information about an entity's expected credit losses on financial instruments and other commitments to extend credit at each reporting date. To achieve this objective, the amendments in this update replace the incurred loss impairment methodology currently used today with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to develop credit loss estimates. Subsequent to issuing ASU 2016-13, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, or ASU 2018-19, for the purpose of clarifying certain aspects of ASU 2016-13. In May 2019, the FASB issued ASU 2019-05, Financial Instruments – Credit Losses (Topic 326): Targeted Transition Relief, or ASU 2019-05, to ~~provides~~provide entities with more flexibility in applying the fair value option on adoption of the credit impairment standard. In November 2019, the FASB issued ASU 2019-11, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, which expands the scope of the practical expedient that allows entities to exclude the accrued interest component of amortized cost from various disclosure. Entities that elect to apply the practical expedient must disclose the total amount of accrued interest that they exclude from their disclosures of amortized cost. ASU 2018-19, ASU 2019-05 and ASU ~~2019-05~~2019-11 have the same effective date and transition requirements as ASU 2016-13. ASU 2016-13 will be effective for fiscal years beginning after December 15, ~~2019,~~2022, using a modified retrospective ~~approach.~~approach, for smaller reporting companies. Early adoption is permitted. We plan to adopt ASU 2016-13 and related updates as of January 1, ~~2020.~~2023. We do not expect the adoption of this standard to have a material impact on our condensed financial statements.

~~In August 2018,~~Other recent accounting pronouncements issued by the FASB ~~issued ASU 2018-13,~~ ~~Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement,~~did not or ASU 2018-13, which modifies the disclosure requirements on fair value measurements. The new standard is effective for fiscal years beginning after December 15, 2019, and early adoption is permitted. We plan to adopt ASU 2018-13 as of January 1, 2020. While we continue to assess the potential impact of this standard, we doare not ~~expect the adoption of this standard~~believed by management to have a material impact on our condensed financial statements.

~~In November 2018, the FASB issued ASU 2018-18,~~ ~~Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606~~, or ASU 2018-18. The amended guidance precludes presenting consideration from a transaction in a collaborative arrangement as revenue from contracts with customers if the counterparty is not a customer for that transaction. The new guidance is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early

adoption is permitted. We plan to adopt ASU 2018-18 as of January 1, 2020. We do not expect the adoption of ASU 2018-18 to have a material impact on our financial statements given the termination of the Collaboration Agreement in September 2018.

Cash equivalents, restricted cash and marketable securities by security type at ~~June 30, 2019~~March 31, 2020 were as follows:

			Gross		Gross							Gross		Gross
	Amortized		Unrealized		Unrealized			Estimated		Amortized		Unrealized		Unrealized			Estimated
(In thousands)	Cost		Gains		Losses			Fair Value		Cost		Gains		Losses			Fair Value
Included in cash and cash equivalents:
Money market funds	$	15,457	$	—	$	—		$	15,457	$	18,370	$	—	$	—		$	18,370

Restricted cash:
Certificate of deposit	$	270	$	—	$	—		$	270	$	270	$	—	$	—		$	270
Marketable securities:
Government-sponsored enterprise securities (due in less than one year)										$	11,504	$	16	$	—		$	11,520
Commercial paper (due in less than one year)	$	42,000	$	83	$	(1	)	$	42,082		29,028		37		—			29,065
Corporate notes (due in less than one year)		92,546		155		(5	)		92,696		71,422		44		(229	)		71,237
Corporate notes (due in one to two years)		9,448		50		(1	)		9,497		1,021		8		—			1,029
	$	143,994	$	288	$	(7	)	$	144,275	$	112,975	$	105	$	(229	)	$	112,851

Cash equivalents, restricted cash and marketable securities by security type at December 31, ~~2018~~2019 were as follows:

			Gross		Gross							Gross		Gross
	Amortized		Unrealized		Unrealized			Estimated		Amortized		Unrealized		Unrealized			Estimated
(In thousands)	Cost		Gains		Losses			Fair Value		Cost		Gains		Losses			Fair Value
Included in cash and cash equivalents:
Money market funds	$	7,003	$	—	$	—		$	7,003	$	6,671	$	—	$	—		$	6,671
Commercial paper											3,990		—		—			3,990
										$	10,661	$	—	$	—		$	10,661
Restricted cash:
Certificate of deposit	$	269	$	—	$	—		$	269	$	270	$	—	$	—		$	270
Marketable securities:
Government-sponsored enterprise securities (due in less than one year)										$	6,506	$	6	$	—		$	6,512
Government-sponsored enterprise securities (due in one to two years)											6,999		1		—			7,000
Commercial paper (due in less than one year)	$	57,594	$	22	$	(29	)	$	57,587		40,110		33		(3	)		40,140
Corporate notes (due in less than one year)		95,238		7		(118	)		95,127		78,926		116		(13	)		79,029
Corporate notes (due in one to two years)		18,647		—		(65	)		18,582		12,659		1		(9	)		12,651
	$	171,479	$	29	$	(212	)	$	171,296	$	145,200	$	157	$	(25	)	$	145,332

Cash equivalents and marketable securities with unrealized losses that have been in a continuous unrealized loss position for less than 12 months and 12 months or longer at ~~June 30, 2019~~March 31, 2020 and December 31, ~~2018~~2019 were as follows:

Less Than 12 Months

12 Months or Longer

Total

Gross

Gross

Gross

Estimated

Unrealized

Estimated

Unrealized

Estimated

Unrealized

(In thousands)

Fair Value

Losses

Fair Value

Losses

Fair Value

Losses

As of June 30, 2019:

Commercial paper (due in less than one year)

$
5,492

$
(1
)

$
—

$
—

$
5,492

$
(1
)
Corporate notes (due in less than one year)

11,318

(4
)

4,400

(1
)

15,718

(5
)
Corporate notes (due in one to two years)

1,053

(1
)

—

—

1,053

(1
)

$
17,863

$
(6
)

$
4,400

$
(1
)

$
22,263

$
(7
)
As of December 31, 2018:

Commercial paper (due in less than one year)

$
22,628

$
(29
)

$
—

$
—

$
22,628

$
(29
)
Corporate notes (due in less than one year)

66,557

(82
)

14,221

(36
)

80,778

(118
)
Corporate notes (due in one to two years)

18,582

(65
)

—

—

18,582

(65
)

$
107,767

$
(176
)

$
14,221

$
(36
)

$
121,988

$
(212
)

	Less Than 12 Months					12 Months or Longer				Total
			Gross					Gross				Gross
	Estimated		Unrealized			Estimated		Unrealized		Estimated		Unrealized
(In thousands)	Fair Value		Losses			Fair Value		Losses		Fair Value		Losses
As of March 31, 2020:
Corporate notes (due in less than one year)	$	49,835	$	(229	)	$	—	$	—	$	49,835	$	(229	)
As of December 31, 2019:
Commercial paper (due in less than one year)	$	8,571	$	(3	)	$	—	$	—	$	8,571	$	(3	)
Corporate notes (due in less than one year)		26,082		(13	)		—		—		26,082		(13	)
Corporate notes (due in one to two years)		11,624		(9	)		—		—		11,624		(9	)
	$	46,277	$	(25	)	$	—	$	—	$	46,277	$	(25	)

The gross unrealized losses related to government-sponsored enterprise securities, commercial paper and corporate notes as of ~~June 30, 2019~~March 31, 2020 and December 31, ~~2018~~2019 were due to changes in interest rates and not credit risk. We determined that the gross unrealized losses on our marketable securities as of ~~June 30, 2019~~March 31, 2020 and December 31, ~~2018~~2019 were temporary in nature. Our exposure to unrealized losses may increase in the future due to the economic pressures or uncertainties associated with local or global economic recessions as a result of the current COVID-19 pandemic. We review our investments quarterly to identify and evaluate whether any investments have indications of possible other-than-temporary impairment. Factors considered in determining whether a loss is temporary include the length of time and extent to which the fair value has been less than the amortized cost basis and whether we intend to sell the security or whether it is more likely than not that we would be required to sell the security before recovery of the amortized cost basis. We currently do not intend to sell these securities before recovery of their amortized cost bases.

We categorize financial instruments recorded at fair value on our condensed balance sheets based upon the level of judgment associated with inputs used to measure their fair value. The categories are as follows:

A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Below is a description of the valuation methodologies used for financial instruments measured at fair value on our condensed balance sheets, including the category for such financial instruments.

Money market funds are categorized as Level 1 within the fair value hierarchy as their fair values are based on quoted prices available in active markets. Commercial paper, government-sponsored enterprise securities, corporate notes and equity investments are categorized as Level 2 within the fair value hierarchy as their fair values are estimated by using pricing models, quoted prices of securities with similar characteristics or discounted cash flows.

The following table presents information about our financial instruments that are measured at fair value on a recurring basis as of ~~June 30, 2019~~March 31, 2020 and December 31, ~~2018~~2019 and indicates the fair value category assigned.

	Fair Value Measurements at Reporting Date Using								Fair Value Measurements at Reporting Date Using
	Quoted Prices in				Significant				Quoted Prices in				Significant
	Active Markets for		Significant Other		Unobservable				Active Markets for		Significant Other		Unobservable
	Identical Assets		Observable Inputs		Inputs				Identical Assets		Observable Inputs		Inputs
(In thousands)	Level 1		Level 2		Level 3		Total		Level 1		Level 2		Level 3		Total
As of June 30, 2019:
As of March 31, 2020:
Money market funds⁽¹⁾	$	15,457	$	—	$	—	$	15,457	$	18,370	$	—	$	—	$	18,370
Government-sponsored enterprise securities⁽²⁾										—		11,520		—		11,520
Commercial paper⁽²⁾		—		42,082		—		42,082		—		29,065		—		29,065
Corporate notes⁽²⁾⁽³⁾		—		102,193		—		102,193		—		72,266		—		72,266
Equity investment⁽⁴⁾		—		582		—		582		—		169		—		169
Total	$	15,457	$	144,857	$	—	$	160,314	$	18,370	$	113,020	$	—	$	131,390
As of December 31, 2018:
As of December 31, 2019:
Money market funds⁽¹⁾	$	7,003	$	—	$	—	$	7,003	$	6,671	$	—	$	—	$	6,671
Commercial paper⁽²⁾		—		57,587		—		57,587
Government-sponsored enterprise securities ⁽²⁾⁽³⁾										—		13,512		—		13,512
Commercial paper⁽¹⁾⁽²⁾										—		44,130		—		44,130
Corporate notes⁽²⁾⁽³⁾		—		113,709		—		113,709		—		91,680		—		91,680
Equity investment⁽⁴⁾		—		585		—		585		—		389		—		389
Total	$	7,003	$	171,881	$	—	$	178,884	$	6,671	$	149,711	$	—	$	156,382

In December 2007, we received 13,842,625 ordinary shares in Sienna Cancer Diagnostics Limited, or Sienna, in connection with a license we granted to Sienna for our human telomerase reverse transcriptase, or hTERT, technology for use in human diagnostics. ~~Upon receipt, the~~The shares, which represented less than 20% ownership, were recorded at a zero cost basis under the cost method of ~~accounting.~~accounting, upon receipt. With the adoption of ASU 2016-01 on January 1, 2018, we reassess the fair value of our equity investment in Sienna ~~must be reported at fair value~~ at each reporting date and any resulting change in fair value is recognized inon our condensed statements of operations. As of ~~June 30, 2019,~~March 31, 2020, the fair value of our shares in Sienna was ~~$582,000.~~$169,000. For the three months ended ~~June 30,~~March 31, 2020 and 2019, ~~and 2018,~~ we recognized a decrease in fair value of equity investment of ~~$98,000~~$195,000 and ~~$350,000,~~an increase in fair value of $98,000, respectively, related to observable price ~~changes. There was no change in the fair value~~changes on our condensed statements of ~~equity investment for the six months ended June 30, 2019, compared to a decrease in fair value of $475,000 for the comparable period in 2018, related to observable price changes.~~operations. For the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 2019, we also recognized a loss of ~~$8,000~~$25,000 and ~~$3,000,~~a gain of $5,000, respectively, ~~compared to a loss of $38,000 for each of the comparable periods in 2018,~~ related to foreign currency translation, which ~~are~~have been included in other expense inon our condensed statements of operations.

On November 13, 2014, we and Janssen entered into the Collaboration Agreement under which we granted to Janssen exclusive worldwide rights to develop and commercialize imetelstat for all human therapeutic uses, including hematologic myeloid malignancies. Under the Collaboration Agreement, Janssen initiated two clinical trials of imetelstat: ~~a Phase 2 trial in relapsed/refractory myelofibrosis, referred to as~~ IMbark and ~~a Phase 2/3 trial in lower risk myelodysplastic syndromes, referred to as~~ IMerge. Under the terms of the Collaboration Agreement, prior to ~~the~~its termination, development costs for IMbark and IMerge were shared between us and Janssen on a 50/50 basis, including costs related to patents licensed to Janssen.

Janssen terminated the Collaboration Agreement effective September 28, 2018. Upon the effective date of termination, we regained the global rights to the imetelstat program and ~~plan to continue~~are continuing development of imetelstat on our own. As a result of the termination of the Collaboration Agreement, we will not receive any ~~further~~ milestone payments or royalties from Janssen for the development or commercialization of imetelstat, including any clinical development or sales milestones, and Janssen has no ~~further~~

obligations to us or any third parties, such as clinical sites or vendors, to fund any potential future imetelstat clinical trials. ~~Under~~Since September 28, 2018, our responsibility for imetelstat development costs incurred by Janssen, including continuing support of ongoing clinical trials of imetelstat, increased from 50% to 100%. As of March 31, 2020, the ~~termination provisions~~amount due to Janssen of $1,000 on our condensed balance sheet represents final costs incurred by Janssen for the three months ended March 31, 2020 for operational support of the ~~Collaboration Agreement, Janssen is required to provide certain operational support for the~~ imetelstat program during transition of the program to us. As of May 14, 2019, we assumed the imetelstat investigational new drug, or IND, sponsorship from Janssen. In the second quarter of 2019, we assumed sponsorship in certain countries outside of the United States. We expect to obtain country-specific health authority and ethics committee approvals for change of sponsorship to us in the remaining countries outside of the United States on a country-by-country basis during the third quarter of 2019. The transition process is expected to be completed by the end of the third quarter of 2019, including transfer of the remaining non-clinical, manufacturing, and ex-U.S. clinical operational responsibilities from Janssen. Each company is responsible for its own costs incurred related to transition activities unless otherwise specified in the Collaboration Agreement. program.

On June 14, 2019, we entered into a Clinical Supply Agreement, or Supply Agreement, with Janssen to purchase certain inventories of drug product, drug substance and raw materials for imetelstat manufacturing. As of December 31, 2019, activities ~~Under~~under the Supply Agreement ~~we will pay Janssen approximately $7,500,000~~ ~~for drug product upon shipment of the product to our specified drug distribution centers, which is expected to occur~~were fully complete, resulting in the third quarter of 2019. We have also agreed to pay up to approximately $6,700,000 for drug substance and raw materials upon testing and confirmation such materials meet certain specifications and expect such testing to occur in the third and fourth quarters of 2019. We are not obligated to purchase materials that do not pass testing and conform to our specifications.

Until the sponsorship responsibilities for imetelstat fully transfer from Janssen to us, Janssen will continue supporting ongoing clinical trials of imetelstat. Since September 28, 2018, our responsibility for imetelstat development costs incurred by Janssen, including continuing support of ongoing clinical trials of imetelstat, increased from 50% to 100%. As of June 30, 2019, thean aggregate amount due to Janssen of ~~$1,576,000~~$14,269,000, which we have paid in full as of March 31, 2020. No amounts remain due to Janssen under the Supply Agreement as of March 31, 2020.

On January 23 and February 14, 2020, two putative securities class action lawsuits were commenced in the United States District Court, or the Court, for the Northern District of California, or the Northern District, naming as defendants us and one of our officers. On March 5, 2020, a third putative securities class action lawsuit was commenced in the United States District Court for the District of New Jersey, naming as defendants us and two of our officers. On March 19, 2020, the New Jersey lawsuit was voluntarily dismissed without prejudice. The remaining putative securities class action lawsuits allege violations of the Securities Exchange Act of 1934 in connection with allegedly false and misleading statements made by us related to IMbark during the period from March 19, 2018 to September 26, 2018. The plaintiffs allege, among other things, that we failed to disclose facts related to the alleged failure by IMbark to meet the two primary endpoints of the trial, spleen response rate and Total Symptom Score, and that our stock price dropped when such information was disclosed. The plaintiffs seek damages and interest, and an award of reasonable costs, including attorneys’ fees. On May 14, 2020, the Court consolidated the remaining putative securities class action lawsuits, appointed a lead plaintiff, and invited applications for lead counsel. It is possible that additional suits will be filed, or allegations made by stockholders, with respect to these same or other matters and also naming us and/or our officers and directors as defendants. We believe that we have meritorious defenses and intend to vigorously defend against the pending lawsuits.

On April 23, 2020, a shareholder derivative lawsuit, or the Derivative Lawsuit, was filed in the Northern District, naming as defendants certain Geron Board members. The plaintiff in the Derivative Lawsuit alleges breach of fiduciary duty, unjust enrichment, and violations of the Exchange Act of 1934 in connection with allegedly false and misleading statements made by the Company regarding IMbark. The plaintiff seeks damages, corporate governance reforms, equitable relief, restitution, and an award of reasonable costs, including attorneys’ fees. On May 13, 2020, the Derivative Lawsuit was determined to be related to the putative securities class

action lawsuits described above. On May 19, 2020, the Court deferred further litigation of the Derivative Lawsuit until after the Court rules on any motion to dismiss to be filed on the putative securities class action lawsuits.

The pending lawsuits and any other related lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors. The outcome of the pending lawsuits and any other related lawsuits is necessarily uncertain. We could be forced to expend significant resources in the defense of the pending lawsuits and any additional lawsuits, and we may not prevail. In addition, we may incur substantial legal fees and costs in connection with such lawsuits. We currently are not able to estimate the possible cost to us from these matters, as the pending lawsuits are currently at an early stage, and we cannot be certain how long it may take to resolve the pending lawsuits or the possible amount of any damages that we may be required to pay. Such amounts could be material to our financial statements if we do not prevail in the defense against the pending lawsuits and any other related lawsuits, or even if we do prevail. We have not established any reserve for any potential liability relating to the pending lawsuits and any other related lawsuits. It is possible that we could, in the future, incur judgments or enter into settlements of claims for monetary damages.

We are subject to risks and uncertainties as a result of the COVID-19 pandemic. As of the date of this filing, the extent of the impact of the COVID-19 pandemic on our ~~condensed balance sheet primarily represents~~business is highly uncertain and difficult to predict, as information continues to evolve rapidly. Due to the ~~amount owed to Janssen for operational support~~evolving effects of the COVID-19 pandemic, we have had and expect to continue to have disruptions and/or delays in our imetelstat development program, including with respect to our ability to initiate trial sites, enroll and assess patients, maintain patient enrollment, ensure patient clinical and lab collection visits, conduct monitoring visits, supply study drug, report trial results, or interact with regulators or other important agencies due to limitations in employee resources or otherwise. Restrictions on travel, availability of site personnel, and diversion of hospital staff and resources to COVID-19 patients, have disrupted our trial operations, as well as patient recruitment in many areas, resulting in a slowdown in patient enrollment and/or deviations from or disruptions in key clinical trial activities, such as clinical trial site initiation and monitoring. If the COVID-19 pandemic continues and persists for an extended period of time, we could experience significant disruptions to our clinical development timelines, continued delays in enrollment and clinical trial site initiation in the ~~three months ended June 30, 2019.~~Phase 3 portion of IMerge, delays in opening the Phase 3 clinical trial in refractory MF for screening and enrollment and other disruptions that could severely impact our business and the imetelstat development program.

~~As described~~In response to the spread of COVID-19 and “shelter in ~~Note 1 on Summary~~place” and similar orders issued by state and local governments, we have temporarily restricted access to our offices in California and New Jersey. Many of ~~Significant Accounting Policies – New Accounting Pronouncements Recently Adopted, we adopted Topic 842~~our employees are conducting their work remotely, and our employees otherwise have minimal presence in our offices for essential activities. The effects of the “shelter in place” and similar orders, as ~~of January 1, 2019. Prior period amounts have not been adjusted~~well as our own policies, may negatively impact productivity, disrupt our business and continue to delay our imetelstat development program and clinical trial timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course. In addition, our increased reliance on personnel working remotely could increase our cybersecurity risk, create data accessibility concerns and make us more susceptible to communication disruptions, any of which could adversely impact our business operations. These and similar, and perhaps more severe, disruptions in our operations could continue to negatively impact our business and business prospects, our financial condition and the future of imetelstat.

The effects of the COVID-19 pandemic have increased market volatility and could result in a significant long-term disruption of global financial markets, reducing or eliminating our ability to raise additional capital, which could negatively affect our liquidity, our ability to conduct and complete our planned Phase 3 clinical trial in refractory myelofibrosis, or MF, and to commence, conduct and complete any other potential future clinical trials of imetelstat. In addition, the global economic slowdown caused by the COVID-19 pandemic could materially and adversely affect our business and the value of our common stock. The extent to which the COVID-19 pandemic impacts our business, our regulatory and clinical development activities, clinical supply chain and other business operations, as well as the value of and market for our common stock, will depend on future developments that are highly uncertain and cannot be ~~reported~~predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in ~~accordance with historical accounting under Topic 840.~~the United States and in other countries, and the effectiveness of actions taken globally to contain and treat COVID-19. Accordingly, we do not yet know the full extent of potential delays or impacts on our business, our regulatory and clinical development activities, clinical supply chain and other business operations or the global economy as a whole. However, these effects could materially and adversely affect our business and business prospects, our financial condition and the future of imetelstat.

We have an operating lease for our office space at 149 Commonwealth Drive, Menlo Park, California, or the Menlo Park Lease, that commenced in February 2018 and ~~expires~~was due to expire in January 2020. ~~We have an option~~On September 10, 2019, we amended this lease agreement to extend the lease ~~for one additional period~~term by two months to the end of ~~two years,~~March 2020. In March 2020, in connection with the “shelter in place” orders issued by the Health Officer of the County of San Mateo and the Governor of the State of California on March 16 and March 19, 2020, respectively, which directed non-essential businesses to cease operations until the orders are rescinded, we ~~did not include~~further amended the Menlo Park Lease to extend the lease term until the 15th day after the later of: a) April 7, 2020; b) the expiration or termination of the “shelter in ~~determining~~place” orders; or c) the ~~right-of-use asset or~~modification of the “shelter in place” orders such that non-essential business operations and non-essential travel are expressly permitted. The amendments to the Menlo Park Lease are treated as modifications to the existing lease liability as we did not consider it reasonably certain that we would exercise such option. Since the operating lease is a net lease, as the non-lease components (i.e., common area maintenance) are paid separately from rent based on actual costs incurred, such non-lease components were not included in theagreement, and the right-of-use asset and ~~liability and are reflected as an expense in the period incurred.~~

~~The components of lease costs included in operating expenses in our condensed statements of operations were as follows:~~

~~The~~corresponding operating lease liability have been remeasured based on ~~the condensed balance sheet reflects~~ the present value of ~~the~~ remaining lease payments over the remaining extended lease ~~term. In determining~~term as of each amendment, using the ~~present value~~same discount rate of ~~lease payments, we~~5% applied ~~our incremental borrowing rate based on the information available~~ as of the ~~January 1, 2019~~ adoption date. ~~As of June 30, 2019, future minimum payments under~~For the ~~operating lease were as follows (in thousands):~~

~~As of~~ ~~June 30, 2019~~,March 2020 extension, the ~~weighted average remaining lease term is 7 months~~right-of-use asset and ~~the weighted average discount rate used to determine the~~corresponding operating lease liability was ~~5%.~~approximately $149,000, assuming the “shelter in place” orders cease at the end of May 2020. Under the Menlo Park Lease, we are also obligated to pay certain variable expenses separately from the base rent, including taxes and common area maintenance. Such costs are considered non-lease components and have been excluded from the calculation of the right-of-use asset and corresponding operating lease liability and are being expensed in the period they are incurred.

In April 2019, we entered into an operating lease agreement for office space located at 3 Sylvan Way, Parsippany, New ~~Jersey.~~Jersey, or the New Jersey Lease. The initial term of the ~~lease~~New Jersey Lease is 11 years with an option to extend for an additional five years and a one-time option to terminate the ~~lease~~New Jersey Lease without cause as of the 103^rd month anniversary of the commencement date of the lease. ~~We have not yet occupied the space as it is being renovated for~~The New Jersey Lease commenced on October 1, 2019, upon our ~~use. The lease term commences upon the earlier of the date of completion of the construction work or the date upon which we occupy and use the space for its intended purpose. Since we do not yet have~~ control of the office space ~~as defined by Topic 842, during the construction period and do not expect to gain control~~on that date. As of the ~~space until on or near~~lease commencement date, the ~~construction completion date, we will not record a~~ right-of-use asset and corresponding operating lease liability ~~until we occupy~~was approximately $2,356,000, which represented the ~~space, which we expect to occur by the end~~present value of ~~the third quarter of 2019. Upon the commencement of the lease, the aggregate minimum future~~remaining lease payments ~~for~~over the initial lease term ~~is approximately $3,700,000,~~of 11 years, net of a seven-month rent abatement ~~period.~~period and, using an incremental borrowing rate of 8%. Under the ~~lease,~~New Jersey Lease, we are also obligated to pay certain variable expenses separately from the base rent, including electricity and common area maintenance. Such costs are considered non-lease components and have been excluded from the calculation of the right-of-use asset and corresponding operating lease liability and are being expensed in the period they are incurred.

In October 2019, we entered into an operating lease agreement for office space located at 919 East Hillsdale Boulevard, Foster City, California, or the Foster City Lease. The purpose of the Foster City Lease is to replace our current leased premises at 149 Commonwealth Drive, Menlo Park, California (see above). The initial term of the Foster City Lease is 87 months with an option to extend for an additional five years.

The Foster City Lease commenced on March 10, 2020, upon the substantial completion of all tenant improvements. As of the lease commencement date, the right-of-use asset and corresponding operating lease liability was approximately $3,426,000, which represented the present value of remaining lease payments using an incremental borrowing rate of 7% over the initial lease term of 87 months, net of a three-month rent abatement period. Under the Foster City Lease, we are also obligated to pay certain variable expenses separately from the base rent, including taxes and common area maintenance. Such costs are considered non-lease components and have been excluded from the calculation of the right-of-use asset and corresponding operating lease liability and will be expensed in the period they are incurred.

~~We have performed an evaluation~~The future non-cancellable lease payments under the Menlo Park Lease, the New Jersey Lease and the Foster City Lease as of our other contracts with vendors in accordance with Topic 842 and have determined that, except for the operating leases described above and a nominal financing lease for office equipment, none of our contracts contain a lease.March 31, 2020 were as follows (in thousands):

On June 6, 2019, we filed a Certificate of Amendment to our Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to increase the number of authorized shares of our common stock from 300,000,000 shares to 450,000,000 shares. The foregoing amendment was approved by our stockholders at our 2019 annual meeting of stockholders held on June 6, 2019.

On August 28, 2015, we entered into an At Market Issuance Sales Agreement, or the 2015 Sales Agreement, with MLV & Co. LLC, or MLV, under which we could elect to issue and sell shares of our common stock having an aggregate offering price of up to $50,000,000. Pursuant to the 2015 Sales Agreement, common stock was sold at market prices prevailing at the time of sale through MLV as our sales agent. We paid MLV an aggregate commission rate equal to up to 3.0% of the gross proceeds of the sales price per share for common stock sold through MLV under the 2015 Sales Agreement. During the six months ended June 30, 2018, we completed the sale of the remaining common stock subject to the 2015 Sales Agreement and issued an aggregate of 13,195,106 shares of our common stock, resulting in net cash proceeds to us of approximately $47,651,000 after deducting sales commissions and other offering expenses payable by us. No further shares of common stock may be sold under the 2015 Sales Agreement.

On May 18, 2018, we entered into an At Market Issuance Sales Agreement, or the 2018 Sales Agreement, with B. Riley FBR, Inc., or B. Riley FBR, pursuant to which we may elect to issue and sell shares of our common stock having an aggregate offering price

of up to $100,000,000 in such quantities and on such minimum price terms as we set from time to time through B. Riley FBR as our sales agent. We pay B. Riley FBR an aggregate commission rate equal to up to 3.0% of the gross proceeds of the sales price per share for common stock sold through B. Riley FBR under the 2018 Sales Agreement. For the three ~~and six~~ months ended ~~June 30, 2019,~~March 31, 2020, we sold an aggregate of ~~108,386~~530,228 shares of our common stock pursuant to the 2018 Sales Agreement, resulting in net cash proceeds to us of approximately ~~$101,000,~~$686,000, after deducting sales commissions and other offering expenses payable by us. For the three and six months ended June 30, 2018, we sold an aggregate of 9,447,026 shares of our common stock pursuant to the 2018 Sales Agreement, resulting in net cash proceeds to us of approximately $36,208,000, after deducting sales commission and other offering expenses payable by us. The 2018 Sales Agreement will expire upon the earlier of: (a) the sale of all common stock subject to the 2018 Sales Agreement, ~~and~~or (b) May 18, 2021. See also Note 7 on Subsequent Events.

In December 2018, our board of directors approved the adoption of the 2018 Inducement Award Plan, or the Inducement Plan, pursuant to which we reserved 3,000,000 shares of Geron common stock (subject to customary adjustments in the event of a change in capital structure) to be used exclusively for grants of inducement awards to individuals who were not previously Geron employees or directors, other than following a bona fide period of non-employment. In January 2019 and February 2020, our Compensation Committee approved amendments to increase the reserve of shares of our common stock under the 2018 Inducement Award Plan by 5,000,000 and 1,300,000 shares, respectively. The Inducement Plan provides for the grant of nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock units and other stock awards, and all awards under the Inducement Plan are intended to meet the standards under Rule 5635(c)(4) of the Nasdaq Listing Rules. The terms and conditions of the Inducement Plan and the inducement awards to be granted thereunder are substantially similar to our stockholder-approved 2018 Equity Incentive Plan.

On July ~~2019,~~10, 2018, we filed a prospectus supplement, or the ATM Prospectus Supplement, pursuant to which we may offer and sell, from time to time, shares of our common stock having an aggregate offering price of up to $62,821,700 under the 2018 Sales Agreement. In the second quarter of 2020, we sold an aggregate of ~~1,784,705~~2,966,388 shares of our common stock pursuant to the 2018 Sales Agreement, resulting in net cash proceeds to us of approximately ~~$2,471,000,~~$3,391,000 after deducting sales commissions and ~~other~~estimated offering expenses payable by us. In connection with the public offering in May 2020 described below, we have terminated the ATM Prospectus Supplement, but the 2018 Sales Agreement remains in full force and effect. We cannot make any sales of common stock under the 2018 Sales Agreement for 90 days after completion of our public offering and unless and until we file an updated prospectus supplement. For further discussion of the 2018 Sales Agreement, see Note 56 on Stockholders’ Equity.

On May 27, 2020, we completed an underwritten public offering of 107,049,375 shares of our common stock and pre-funded warrants to purchase 8,335,239 shares of our common stock, also known as the pre-funded warrants, together with accompanying warrants to purchase 57,692,307 shares of our common stock, also known as the stock purchase warrants. The combined public offering price to the public of common stock and accompanying stock purchase warrants is $1.30 per share. The combined public offering price to the public of pre-funded warrants and accompanying stock purchase warrants is $1.299 per share. The estimated net cash proceeds from this offering, assuming no exercise of the pre-funded warrants or the stock purchase warrants, is approximately $140,200,000, after deducting the underwriting discount and estimated offering expenses payable by us.

This Form 10-Q contains forward-looking statements that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “expects,” “plans,” “intends,” “will,” “should,” “projects,” “believes,” “predicts,” “anticipates,” “estimates,” “potential” or “continue,” or the negative thereof or other comparable terminology. These statements are within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements appear throughout the Form 10-Q and are statements regarding our intent, belief, or current expectations, primarily with respect to our business and related industry developments. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this Form 10-Q. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including the risks faced by us and described in Part II, Item 1A, entitled “Risk Factors,” and in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part I, Item 2 of this Form 10-Q.

The following discussion should be read in conjunction with the unaudited condensed financial statements and notes thereto included in Part I, Item 1 of this Form ~~10-Q and with~~10-Q; the sections entitled “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in our Annual Report on Form 10-K for the year ended December 31, ~~2018,~~2019, as filed with the Securities and Exchange Commission, or SEC, on March ~~7, 2019.~~12, 2020.

We are a late-stage clinical biopharmaceutical company that is focused on the development and potential commercialization of imetelstat, an innovative ~~therapeutics~~therapeutic for hematologic myeloid malignancies. We have global rights to imetelstat, a first-in-class telomerase inhibitor, which was discovered and is being developed at Geron. We believe ~~clinical data~~targeting telomerase has the potential to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in hematologic myeloid malignancies to reduce dysfunctional blood cell production and enable potential recovery of normal blood cell production, or hematopoiesis. Data from ~~two Phase 2~~our prior clinical trials suggest potential disease-modifying activity from imetelstat treatment. Currently, our imetelstat development program is focused on Low or Intermediate-1 risk myelodysplastic syndromes, also referred to as lower risk MDS, and Intermediate-2 or High-risk myelofibrosis, or MF.

Imetelstat has been granted both Orphan Drug and Fast Track designations by the United States Food and Drug Administration, or FDA, for the treatment of patients with transfusion-dependent anemia due to lower risk MDS, who do not have a deletion 5q chromosomal abnormality, also known as non-del(5q), and who are refractory or resistant to treatment with an erythropoiesis stimulating agent, or ESA, and for the treatment of patients with Intermediate-2 or High-risk MF relapsed after or refractory to janus kinase, or JAK, inhibitor treatment, or relapsed/refractory MF.

We are evaluating imetelstat ~~(IMerge, for~~in IMerge, a Phase 2/3 clinical trial in patients with lower risk ~~myelodysplastic syndromes,~~MDS, who are relapsed after or ~~MDS,~~refractory to prior treatment with an ESA, or relapsed/refractory to ESA. The Phase 2 portion of IMerge is closed to enrollment, and ~~IMbark, for~~ patients ~~with relapsed/refractory myelofibrosis, or MF, as discussed~~remaining in ~~detail below) initiated by Janssen Biotech, Inc., or Janssen, support further development of~~the treatment phase continue to receive imetelstat ~~in hematologic myeloid malignancies.~~treatment. In May ~~2019,~~2020, we ~~assumed the~~announced that an imetelstat ~~investigational new drug, or IND, sponsorship from Janssen upon which we became sponsors of the ongoing IMerge and IMbark clinical trials of imetelstat in the United States.~~

~~Based on the~~abstract with more mature data from the Phase 2 portion of IMerge was accepted for oral presentation at the 2020 European Hematology Association, or EHA, Annual Congress being held in a virtual format from June 11 to 14, 2020. Further information about the abstract is described below. The Phase 3 portion of IMerge is enrolling patients to the extent practicable under the current COVID-19 pandemic conditions as described below.

In the second quarter of 2020, we conducted a meeting with the FDA to discuss our proposed Phase 3 trial design of imetelstat in patients with Intermediate-2 or High-risk MF, who are refractory to prior treatment with a JAK inhibitor, or refractory MF. The FDA accepted our proposed trial design, including our definition of the refractory MF patient population; the primary efficacy endpoint of overall survival, or OS; secondary endpoints; and the statistical design and methods to be used to analyze data from the trial for the interim and final analyses. The FDA also accepted our proposed control arm using best available therapy, or BAT, that excludes a JAK inhibitor. Although the FDA urged us to consider adding a third dosing arm to assess a lower dose and/or a more frequent dosing schedule that might improve the planned trial’s chance of success by identifying a less toxic regimen and/or more effective spleen response, one of the trial’s secondary endpoints, the FDA did not object to our proposed imetelstat dose and schedule of 9.4 mg/kg every three weeks.

In order to evaluate whether to add such a third arm to the trial, and in consultation with two academic MF advisors who also participated in the FDA meeting, we conducted analyses of imetelstat’s dose response and exposure response for safety and efficacy using data from ourIMbark Phase 2 clinical trial, in which imetelstat had been administered at two starting dose regimens of 9.4 mg/kg and 4.7 mg/kg every three weeks. Based on these analyses, the 9.4 mg/kg dosing regimen in the Phase 2 IMbark trial, when compared with the 4.7 mg/kg dosing regimen, was associated with optimal target engagement, defined as telomerase inhibition, had an acceptable and manageable clinical safety profile, and demonstrated consistently stronger results in terms of OS, symptom response and other endpoints. On the basis of these analyses, we believe that testing a lower dose regimen would likely result in a lower median OS, the trial’s primary endpoint, in the imetelstat treatment arm without a clinically meaningful reduction in toxicity; we have therefore chosen, as originally proposed by us and as accepted by the FDA, the 9.4 mg/kg every three weeks as the dosing regimen for imetelstat for the planned Phase 3 clinical trial in refractory MF. Further information about the planned Phase 3 clinical trial in refractory MF is described below.

In May 2020, we announced our decision to move forward with late stage development of imetelstat in MF with a planned Phase 3 clinical trial in refractory MF. We plan to open this trial for screening and enrollment in the first quarter of 2021 to the extent practicable under the current COVID-19 pandemic conditions as described below. Our ability to complete the planned Phase 3 clinical trial in refractory MF will be dependent on our ability to raise substantial additional capital.

In May 2020, we also announced that three imetelstat abstracts related to MF were accepted as poster presentations at the upcoming EHA Annual Congress. These abstracts report new analyses from the IMbark Phase 2 clinical trial that correlate the median OS observed with other clinical endpoints from the trial. In addition, the new analyses provide further support for the potential improvement in OS as an indication of disease-modifying activity of imetelstat treatment in MF. Further information about these abstracts is described below.

The COVID-19 pandemic has resulted, and is expected to continue to result, in significant economic disruption, and has adversely affected and will likely continue to adversely affect our business. As of the date of this filing, significant uncertainty exists concerning the magnitude of the impact and duration of the COVID-19 pandemic. We are actively monitoring the situation and intend to take those actions that may be required by federal, state or local authorities or that we determine are in the best interests of our patients, investigators, employees and stockholders. While we are unable to determine or predict the nature, duration or scope of the overall impact that the COVID-19 pandemic will have on our business and business prospects, our financial condition and the future of imetelstat or our liquidity, we believe that it is important to share where our company stands today, how our response to COVID-19 is progressing, and how our operations and financial condition may change as the fight against COVID-19 progresses.

Like many other biopharmaceutical companies, we are experiencing delays in clinical site initiations and patient screening and enrollment in athe Phase 3 portion of IMerge due to the shift in health care resources to care for COVID-19 patients. In addition, many of our clinical ~~trial (Part 2~~sites have established self-imposed holds on site initiations and enrollment during this period out of ~~IMerge) in August 2019. We plan~~concern for patient exposure to ~~conduct an End~~COVID-19 and due to lack of ~~Phase 2 meeting~~available staff. In alignment with recent guidance from the FDA on clinical trials, “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic Guidance for Industry, Investigators, and Institutional Review Boards,” together with other national and regional guidelines outside the United States, ~~Food~~or U.S., we have taken steps designed to address unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 control measures. In addition, we issued an Urgent Safety Measure together with a Dear Investigator Letter to all our clinical sites involved with the Phase 3 portion of IMerge to apply certain measures to protect patient safety that include enhanced ongoing monitoring for signs and ~~Drug Administration,~~symptoms of or exposure to COVID-19 as well as guidance for withholding treatment to patients who have tested positive, who show signs and/or symptoms of COVID-19, or who have potential exposure to COVID-19.

We continue to monitor each clinical site through our contract research organizations, or CROs, as well as to conduct direct outreach to investigators and study staff. Due to the ~~FDA,~~evolving effects of the COVID-19 pandemic on our clinical trial activities, we now expect to complete patient enrollment in the Phase 3 portion of IMerge by the end of the first quarter of 2021, instead of the end of 2020 as we had previously planned. Due to ~~discuss~~this anticipated delay in enrollment and the ~~IMbark~~continued uncertainty around the evolving effects of the COVID-19 pandemic on our clinical trial activities, we now expect top-line results from the Phase ~~2 data and regulatory strategies for potential approval~~3 portion of ~~imetelstat~~IMerge in ~~relapsed/~~the second half of 2022, instead of mid-2022 as we originally planned. Similarly, we anticipate opening the planned Phase 3 clinical trial in refractory MF for screening and enrollment in the first quarter of 2021 to account for anticipated delays at clinical sites related to the effects of the COVID-19. Given our focus on completion of the ongoing Phase 3 portion of IMerge and the planned Phase 3 clinical trial in refractory MF, we have decided to postpone commencement of our proof-of-concept study in high risk MDS and acute myeloid leukemia, or AML, that we had previously planned to commence in 2020, and will ~~subsequently provide~~reconsider whether to proceed with and if so, the timing of, this proof-of-concept study at a ~~decision regarding late-stage development~~future date.

The effects of ~~imetelstat~~the COVID-19 pandemic continue to rapidly evolve. These effects have increased market volatility and could result in ~~relapsed/~~a significant long-term disruption of global financial markets, reducing or eliminating our ability to raise additional capital, which could negatively affect our liquidity and our ability to conduct and complete our planned Phase 3 clinical trial in refractory MF. To conserve our cash resources to support the completion of the Phase 3 portion of IMerge and the commencement of our planned Phase 3 clinical trial in refractory MF, ~~if any.~~ we have taken steps to reduce spending across our organization, including eliminating non-essential business travel, reevaluating hiring plans and limiting discretionary spending. In any event, our ability to complete the planned Phase 3 clinical trial in refractory MF will be dependent on our ability to raise substantial additional capital.

~~IMerge (Phase 2/3~~Lead Clinical ~~Trial)~~Indication in Development: Lower Risk Myelodysplastic Syndromes

MDS is a group of blood disorders in which the continuous upregulation of telomerase is associated with the proliferation of malignant progenitor cells which produces multiple malignant cell clones in the bone marrow resulting in disordered and ineffective production of the myeloid lineage, which includes red blood cells, white blood cells and platelets. In MDS, bone marrow and peripheral blood cells may have abnormal, or dysplastic, cell morphology. MDS is frequently characterized clinically by severe anemia, or low red blood cell counts, and low hemoglobin. In addition, other peripheral cytopenias, or low numbers of white blood cells and platelets, may cause life-threatening infections and bleeding. Transformation to AML occurs in up to 30% of MDS cases and results in poorer OS.

MDS is the most common of the myeloid malignancies and is primarily a disease of the elderly, with median age at diagnosis around 70 years. In addition, MDS patients are grouped using the World Health Organization (WHO) classification system, which was most recently updated in 2016. It divides MDS into types based mainly on how the cells in the bone marrow look under the microscope, as well as other factors. Common MDS subgroups include ringed sideroblast positive, or RS+, and ringed sideroblast negative, or RS-.The majority of MDS patients, approximately 70%, fall into what are considered to be the lower risk groups at diagnosis, according to the International Prognostic Scoring System that takes into account the presence of a number of disease factors, such as cytopenias and cytogenetics, to assign relative risk of progression to AML and OS. There are more than 100,000 people worldwide and 40,000 people in the U.S. living with lower risk MDS. In addition, more than 10,000 new cases of lower risk MDS are reported each year in the U.S.

Chronic anemia is the predominant clinical problem in patients who have lower risk MDS. Many of these patients become dependent on red blood cell transfusions due to low hemoglobin. Serial red blood cell transfusions can lead to elevated levels of iron in the blood and other tissues, which the body has no normal way to eliminate. Iron overload is a potentially dangerous condition. Studies in patients with MDS have shown that iron overload resulting from regular red blood cell transfusions is associated with poorer OS and a higher risk of developing AML.

As a telomerase inhibitor, we believe that imetelstat has the potential to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in MDS to reduce dysfunctional blood cell production and potentially enable recovery of normal hematopoiesis.

IMerge is a two-part Phase 2/3 clinical trial evaluating imetelstat in transfusion dependent patients with ~~Low or Intermediate-1 risk, also referred to as~~ lower risk MDS, who are ~~relapsed after or~~ relapsed/refractory to ESA. To be eligible for IMerge, patients are required to be transfusion dependent, defined as requiring at least four units of packed red blood cells, or RBCs, over an eight-week period during the 16 weeks prior ~~treatment with erythropoiesis stimulating agents, or ESAs.~~to entry into the trial. Part 1 of IMerge was designed as a Phase 2, open-label, single-arm trial to assess the efficacy and safety of a 7.5 mg/kg dose of imetelstat administered as an intravenous infusion over two hours every four weeks in approximately 30 patients. ~~The first patient was dosed in January 2016. To be eligible for the Phase~~Part 2 ~~portion~~ of IMerge is a Phase 3 double-blind, randomized, placebo-controlled clinical trial that, based on discussions with U.S. and European regulatory authorities, we believe may support, if successful, the registration of imetelstat in lower risk MDS. The trial is designed to enroll approximately 170 patients ~~were required to be~~with lower risk transfusion dependent ~~defined as requiring at least four units of packed red blood cells,~~MDS who are relapsed or ~~RBCs, over~~refractory to an ~~eight week period during the 16 weeks~~ESA, have not received prior ~~to entry into the trial.~~

treatment with either a hypomethylating agent, or HMA, or lenalidomide and who are non-del(5q).

The primary efficacy endpoint of IMerge is the rate of RBC transfusion independence, or RBC-TI, lasting at least eight weeks, defined as the proportion of patients ~~without~~not receiving any RBC transfusion during any consecutive eight weeks since entry ~~into~~to the trial, or ~~8-week~~eight-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, and the rate of hematologic improvement-erythroid, or HI-E, defined as ~~the proportion of patients with~~ a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least eight weeks or a reduction of at least four units of RBC transfusions over eight weeks compared with

the prior RBC transfusion burden. Other secondary efficacy endpoints include the time to and duration of RBC-TI; the proportion of patients

achieving ~~Complete Response,~~complete response or ~~CR, or Partial Response, or PR,~~partial response according to the 2006 International Working Group ~~or IWG,~~ criteria for MDS; the ~~amount~~proportion of patients requiring RBC transfusions and ~~relative change in RBC transfusions;~~the transfusion burden; the proportion of patients requiring the use of myeloid growth factors and the dose; assessments of the change in the patients’ quality of life using several validated instruments; as well as an assessment of ~~overall survival~~OS and time to progression to ~~acute myeloid leukemia,~~AML. The Phase 3 portion of IMerge has been designed with more than 85% power to detect a statistically significant difference in the primary endpoint of eight-week transfusion independence between the imetelstat treatment arm and the placebo arm.

The Phase 3 portion of IMerge opened for patient screening and enrollment in August 2019, and the first patient was dosed in October 2019. As of the end of April 2020, approximately 68% of the original planned clinical sites were opened for enrollment. We plan to complete patient enrollment by the end of the first quarter of 2021. To facilitate this timing, we are currently evaluating the feasibility of increasing the number of participating countries by approximately six, and the number of clinical sites by approximately 40. Following 15 months from the last patient being enrolled, a primary analysis of efficacy and safety data from the trial will begin to enable top-line results. Under current assumptions, we expect such top-line results to be available in the second half of 2022. This anticipated timing is subject to potential delays or ~~AML.~~interruptions associated with the evolving effects of the COVID-19 pandemic, regardless of our evaluation of additional countries and sites.

~~Thirty-two patients were initially enrolled in~~Recent Data from the Phase 2 ~~portion~~Portion of IMerge ~~of which a cohort of 13 patients had not received prior treatment~~

In May 2020, we announced that an imetelstat abstract with ~~either an hypomethylating agent, or HMA, or lenalidomide and did not have a deletion 5q chromosomal abnormality, also known as non-del(5q). Preliminary~~more mature data from the Phase 2 portion of IMerge ~~were presented~~was accepted for oral presentation at the ~~European Hematology Association, or~~2020 EHA Annual Congress being held in a virtual format from June ~~2018. These~~11 to 14, 2020.

Abstract Title: Treatment with Imetelstat Provides Durable Transfusion Independence (TI) in Heavily Transfused Non-del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESAs)

The abstract reports more mature data showed that the 13-patient initial cohort exhibited an increased rate and durability of transfusion independence versus the overall trial population (8-week RBC-TI rate: 54% vs. 34%). The safety profile infrom the Phase 2 portion of IMerge ~~was consistent with prior~~in lower risk MDS, including long-term efficacy and safety data, based on a February 4, 2020 clinical ~~trials~~cut-off date and a median follow-up of ~~imetelstat in hematologic malignancies,~~24 months. Long-term efficacy data included the following: eight-week transfusion independence, or TI, which is defined as the proportion of patients achieving RBC transfusion independence during any consecutive eight weeks since entry into the trial; 24-week RBC-TI; 1-year RBC-TI; longest and ~~no new safety signals were identified. The most frequently reported adverse events were cytopenias, which were predictable, manageable~~cumulative duration of TI for patients who achieved an initial eight-week RBC-TI; and reversible, in most cases, including Grade 3 and 4, or severe, neutropenia and thrombocytopenia. In addition, reported adverse events did not differ significantly between the overall trial population and the 13-patient initial cohort.duration of HI-E.

~~To increase the clinical experience and confirm the benefit-risk profile of imetelstat from the 13-patient initial cohort, Janssen expanded new patient enrollment in~~From the Phase 2 portion of IMerge ~~and enrolled 25 additional patients in an expansion cohort. In November 2017, the first patient was dosed in the expansion cohort and enrollment was completed in February 2018.~~

The combined initial cohort of 13 patients and the expansion cohort of 25 patients (n=38) represent a target patient population of transfusion dependent, non-del(5q) lower risk MDS patients who were relapsed or refractory to ESAs and naïve to HMA and lenalidomide treatment. These patients depend on serial RBC transfusions to manage anemia and fatigue. Moreover, dependency on RBC transfusions is associated with iron overload leading to secondary organ complications which results in poor survival. Therefore, the ultimate goal for most clinical trials in lower risk MDS, 42% (16/38) of patients achieved eight-week RBC-TI, and 75% (12/16) of these patients showed a hemoglobin rise of at least 3 grams per deciliter during the transfusion free interval when compared to pretreatment level. In addition, 32% (12/38) of patients achieved a 24-week RBC-TI, and 29% of patients (11/38) were transfusion free for more than one year. The median duration of RBC-TI observed in the trial was 88 weeks and the longest TI was 2.7 years. HI-E was achieved by 68% (26/38) of patients with a median duration of 93 weeks. Most frequently reported adverse events were manageable and reversible grade > 3 cytopenias.

MF, a type of myeloproliferative neoplasm, is a chronic blood cancer in which abnormal or malignant precursor cells in the bone marrow proliferate rapidly, causing scar tissue, or fibrosis, to ~~enable~~form. As a result, normal blood production in the bone marrow is impaired and may shift to other organs, such as the spleen and liver, which can cause them to enlarge. People with MF may have abnormally low or high numbers of circulating red blood cells, white blood cells or platelets, and abnormally high numbers of immature cells in the blood or bone marrow. MF patients can also suffer from debilitating constitutional symptoms, such as drenching night sweats, fatigue, severe itching, or pruritus, abdominal pain, fever and bone pain.

Approximately 70% of MF patients are classified as having Intermediate-2 or High-risk disease, as defined by the Dynamic International Prognostic Scoring System Plus described in a 2011 Journal of Clinical Oncology article. There are more than 35,000 patients worldwide and more than 13,000 patients in the U.S. living with Intermediate-2 or High-risk MF. In addition, more than 2,000 new cases are reported each year in the U.S.

The only drug therapies approved by the FDA for treating MF patients with Intermediate-2 or High-risk disease are the JAK inhibitors, ruxolitinib and fedratinib. According to medical literature, approximately 50% of patients discontinue treatment with ruxolitinib within three years and 75% within five years due to disease progression, adverse events, and unsatisfactory response to treatment. Currently, no drug therapy is approved by the FDA for those patients who fail or no longer respond to JAK inhibitor

treatment, and median survival for such refractory MF patients after discontinuation from ruxolitinib is only approximately 14 to 16 months, representing a significant unmet medical need.

As a telomerase inhibitor, we believe that imetelstat has the potential to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in MF patients to ~~become transfusion independent~~reduce dysfunctional blood cell production and potentially enable recovery of normal hematopoiesis.

Our planned Phase 3 clinical trial in refractory MF is designed to be an open label 2:1 randomized, controlled clinical trial to evaluate imetelstat (9.4 mg/kg administered by intravenous infusion over two hours every three weeks) in approximately 320 patients with Intermediate-2 or High-risk disease who are refractory to prior treatment with a JAK inhibitor. Patients eligible for the trial will be required to be refractory to a JAK inhibitor, an inclusion criterion that is planned to be defined as ~~long~~having an inadequate spleen response or symptom response after treatment with a JAK inhibitor for at least six months, including an optimal dose of a JAK inhibitor for at least two months. The control arm is planned to be BAT, excluding JAK inhibitors. The primary efficacy endpoint for the trial is planned to be OS. Planned key secondary endpoints include symptom response, spleen response, progression free survival, complete response, partial response, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes. Currently, we expect to engage over 150 sites to participate in the global Phase 3 clinical trial in refractory MF across North America, Europe and Asia. Based on our discussions with the FDA, we believe the current design of the planned Phase 3 clinical trial may support, if the trial is successful, the registration of imetelstat in refractory MF.

Currently, the planned Phase 3 clinical trial in refractory MF has been designed with greater than 85% power to detect a 40% reduction in the risk of death (hazard ratio=0.60; one-sided alpha=0.025), for example, 23 months for the imetelstat arm and 14 months for the BAT arm. The final analysis for OS is planned to be conducted after more than 50% of the patients planned to be enrolled in the trial have died (each death referred to herein as ~~possible.~~ ~~Preliminary~~an “event”). An interim analysis of OS, in which the alpha spend is expected to be approximately 0.01, is planned to be conducted after approximately 70% of the total projected number of events for the final analysis have occurred. Both the planned interim and final analyses are event driven and could occur on different timelines than we currently expect.

Under our current assumptions, we expect to complete patient enrollment in the planned Phase 3 clinical trial in refractory MF in the second half of 2022, to conduct an interim analysis in the first half of 2023 and to conduct a final analysis in the first half of 2024. At the interim analysis, if the pre-specified statistical OS criterion is met, then Geron expects such data ~~from~~may support the ~~combined initial and expansion cohorts (n=38) were reported~~registration of imetelstat in refractory MF. If the pre-specified OS criterion is not met at the 60^th ~~American Society~~interim analysis, the trial will continue to the final analysis. The timing and achievement of ~~Hematology,~~enrollment completion and either or ~~ASH, Annual Meeting~~both of the planned analyses depend on numerous factors, including obtaining regulatory clearance of the trial protocol and delays or interruptions related to the evolving effects of the COVID-19 pandemic. Our ability to complete the planned Phase 3 clinical trial in ~~December 2018.~~refractory MF will be dependent on our ability to raise substantial additional capital.

~~Recently Reported Clinical~~Recent Data from the IMbark Phase 2 ~~Portion of IMerge~~Clinical Trial in Relapsed/Refractory MF

In June 2019, an oral presentation was made at the EHA Annual Congress meeting reporting updated efficacy and safety data for an aggregate of 38 patients from the combined initial and expansion cohortsThe purpose of the IMbark Phase 2 ~~portion~~clinical trial was to evaluate two doses of ~~IMerge. In~~imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered by intravenous infusion over two hours every three weeks) in patients with relapsed/refractory MF. The co-primary efficacy endpoints for IMbark were spleen response rate, defined as the ~~EHA presentation, data were reported using~~proportion of patients who achieve at least a 35% reduction in spleen volume assessed by imaging, and symptom response rate, defined as the proportion of patients who achieve at least a 50% reduction in Total Symptom Score, at 24 weeks. Secondary endpoints include OS and safety.

The primary analysis for IMbark used a clinical cut-off date of April ~~30, 2019. The 8-week RBC-TI rate~~26, 2018. A total of 107 patients were enrolled in IMbark (48 in the 4.7 mg/kg dosing arm and 59 in the 9.4 mg/kg dosing arm). At the time of the clinical cut-off for the ~~combined cohorts was 42% (16/38) and 29% (11/38) of~~primary analysis, six patients achieved a durable response with 24-week RBC-TI. The median duration of RBC-TI was 85.9 weeks (range: 8.0-140.9). The median follow-up was 15.7 months and the median treatment duration was 8.5 months (range: 0.02-37.5). The median number of treatment cycles was 9.0 (range: 1-39) and the median dose intensity was 95.2% of the dose of 7.5 mg/kg every four weeks. The baseline characteristics of the 38 patients highlight the high transfusion burden of these patients, with a median baseline transfusion burden of 8 units per 8 weeks, and with the majority of the patients having received more than 4 units per 8 weeks prior to study entry.

~~Key efficacy data reported~~ in the ~~June 2019 EHA presentation are summarized~~9.4 mg/kg dosing arm and no patients in the ~~table below:~~

~~As summarized~~35% reduction in spleen volume assessed by imaging. In addition, 22 patients (37%) in the ~~table below,~~9.4 mg/kg arm had at least a 10% reduction in spleen volume assessed by imaging. Nineteen patients (32%) in the 9.4 mg/kg dosing arm and three patients (6%) in the 4.7 mg/kg dosing arm had a symptom response at 24 weeks. In addition, 31 patients (52%) in the 9.4 mg/kg dosing arm had a symptom response at any time.

Safety data from the primary analysis included hematologic and non-hematologic adverse events. The safety profile was consistent with prior clinical trials of imetelstat in hematologic malignancies, and no new safety signals were identified. ~~Reversible and manageable Grade~~Most grade 3/4 cytopenias resolved within four weeks, including 91% of the observed grade 3/4 neutropenias and ~~cytopenias were reported in 61% and 55% of the patients, respectively, and they were without significant clinical consequences. Furthermore, 91%~~85% of the observed ~~Grade~~grade 3/4 neutropenias and 92% of the observed Grade 3/4 thrombocytopenias were reversible within four weeks. Most frequent non-hematologic toxicities are listed in the table below. Grade 3 liver function test, or LFT, elevations reported in the trial were reversible.

^a ~~In 3/7 (43%) patients back pain was an adverse event associated with infusion-related reaction.~~

~~Based on~~At the ~~results~~time of the ~~Phase 2 portion of IMerge, we intend to continue~~primary analysis, the development of imetelstat in lower risk MDS. In doing so, we will be leveraging the prior experience of several members of our newly recruited clinical/regulatory development team with imetelstat gained during the Phase 2 portion of the trial, as well as their broader experience developing other oncology products. In August 2019, we plan to open patient screening and enrollment in the Phase 3 portion of IMerge. The planned Phase 3 portion of IMerge is designed as a double-blind, randomized, placebo-controlled trial of approximately 170 patients to evaluate imetelstat in non-del(5q) lower risk MDS patients who are transfusion dependent, are relapsed after or refractory to prior treatment with an ESA, and havemedian OS had not received treatment with either an HMA or lenalidomide. This is the same patient population as the target patient population in the Phase 2 portion of IMerge. Moreover, the dose of imetelstat, as well as the primary and secondary endpoints, will be the same as those used in the Phase 2 portion of IMerge. In addition, many of the clinical trial sites that participated in the Phase 2 portion of IMerge will be participating in the Phase 3 portion of IMerge.

IMbark was designed as a Phase 2 clinical trial to evaluate two doses of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered by intravenous infusion every three weeks) in approximately 200 patients with Intermediate-2 or High-risk MF who have relapsed after or are refractory to prior treatment with a janus kinase, or JAK, inhibitor, or relapsed/refractory MF. In December 2018, at the ASH Annual Meeting, withyet been reached. Subsequently, using a clinical cut-off date of October 22, 2018 and a median follow-up of 27.4 months (range: ~~0.2-33.0)~~0.2 – 33.0), ~~we reported a~~the median ~~overall survival, or~~ OS for the 9.4 mg/kg dosing arm ofwas 29.9 months. In May 2019, ~~with~~using a clinical cut-off date of April 30, 2019, ~~we reported a~~the median OS in the 9.4 mg/kg dosing arm was 28.1 months. In May 2020, using a clinical cut-off of February 19, 2020 and a median follow-up of 41.7 months, the median OS in the 9.4 mg/kg dosing arm was 28.1 months. Our data compare favorably to the median ~~overall survival~~OS of 14 to 16 months reported in medical literature for patients previously treated with JAK inhibitors.

~~Recently Reported Comparative Analyses~~ In addition, comparative analyses of our IMbark ~~Data and Real-World Data~~

~~Statistical analyses comparing IMbark clinical trial~~ data to ~~closely matched~~ real-world data ~~or RWD, were recently presented in a poster presentation at the EHA Annual Congress meeting in June 2019. The goal~~ of ~~the analyses was to further assess the potential OS benefit of imetelstat in relapsed/refractory~~closely-matched MF patients treated with ~~9.4 mg/kg~~BAT provide further evidence of the potential improvement in ~~IMbark compared~~OS with treatment with imetelstat.

In May 2020, we announced that three imetelstat abstracts related to ~~a closely matched patient population from RWD who~~MF were ~~treated with best available therapy, or BAT.~~

~~The RWD were collected~~accepted as poster presentations at the ~~Moffitt Cancer Center~~upcoming EHA Annual Congress. The three MF abstracts describe data and analyses from ~~patients who had discontinued treatment from a JAK inhibitor~~IMbark that suggest the following: (1) dose-related improvement in OS and ~~were subsequently treated~~correlation with BAT. To mimic the effect of randomization and improve comparability, a propensity score analysis approach was taken to match individual patients within each of the datasets to balance the populations with respect to baseline characteristics and prognostic factors that may impact OS. Guidelines for inclusion and exclusion criteria as definedother clinical benefits observed in the IMbark ~~clinical protocol~~trial, such as symptom response and spleen volume reduction as well as fibrosis improvement; (2) improvements in OS in a patient subpopulation with poor prognosis due to the ~~following baseline patient characteristics were used for matching purposes:~~

Ofabsence of the ~~59 patients treated~~three primary driver mutations in MF; and (3) dose-dependent inhibition of telomerase with imetelstat, 9.4 mg/kg in IMbark, two could not be matched with RWD and were excluded from the analyses. Similarly, of the 96 patients treated with BAT from RWD, 58 patients did not meet the matching criteria. Therefore, the populations used for the analyses consisted of 57 patients from IMbark and 38 patients from RWD. Using the data from these matched populations prior to statistical adjustments, the calculated median OS was 33.8 months for the imetelstat-treated patients and 12.0 months for the patients from RWD treated with BAT, resulting in ~~a hazard ratio~~on-target activity that correlates with improvement in OS and dose-dependent reduction in variant allele frequency of ~~0.35 and a p-value of 0.0003, as shown in~~driver mutations, indicating imetelstat targets the ~~table below.~~

A propensity score analysis approach was used for each of the datasets and two statistical adjustment methods were applied to calculate median OS for each of the datasets (ATO and sIPTW, as indicated in the table below). Based on either of the statistical adjustment methods used, median OS of 30.7 months was reported for the imetelstat-treated patients. This was more than double the median OS of 12.0 months for patients from RWD treated with BAT. The hazard ratios for all three statistical methods were similar (0.33-0.35). Based on hazard ratios, there was a 65% to 67% lower risk of death for patients treated with imetelstat, compared to closely matched patients from RWD treated with BAT in relapsed/refractory MF.

Two sensitivity analyses were conducted on the datasets to assess the potential impact on OS as a result of early deaths post-JAK inhibitor discontinuation observed in RWD and the use of hematopoietic stem cell transplantation as a subsequent therapy. The results of the sensitivity analyses were consistent with results from the main analysis.

~~While~~underlying malignant clone. Taken together, we believe these ~~analyses suggest favorable~~three MF abstracts substantiate the OS ~~for imetelstat-treated relapsed/refractory MF patients compared to BAT~~outcome observed in ~~closely matched patients from RWD, comparative analyses between RWD~~IMbark and ~~our~~support the planned Phase 3 clinical trial data have several limitations. For instance, the analyses create a balance between treatment groups with respect to commonly available covariates, but do not take into account the unmeasured and unknown covariates that may affect the outcomes of the analyses. Potential biases are introduced by factors which include, for example, the selection of the patients included in the analyses, misclassification in the matching process, the small sample size, and estimates that may not represent the outcomes for the true treated patient population. For these and other reasons, such comparative analyses should be considered carefully and with caution, and should not be relied upon as demonstrative or otherwise predictive or indicative of any future clinical trial results of imetelstat in relapsed/refractory MF.

WeIn February 2020, we closed IMbark and the trial is now completed, since we believe we have ~~recently refined our strategies for potentially pursuing regulatory approval of imetelstat in relapsed/refractory MF. As a result, we plan to perform analyses necessary~~obtained sufficient data from the trial to support ~~these strategies for future~~ potential discussions with regulatory authorities. We believe the results of these analyses may enhance the potential for reaching agreement with the FDA on a timely and cost-effective regulatory strategy for imetelstat in relapsed/refractory MF. We plan to conduct an End of Phase 2 meeting with the FDA by the end of the first quarter of 2020. Subsequent to the End of Phase 2 meeting, we expect to provide a decision regarding late-stage development of imetelstat in relapsed/refractory MF, if any. This decision will be influenced by, among other things, our assessment of what would be required to achieve clinical and regulatory success in relapsed/refractory MF, including the cost and duration of any potential clinical trials required for regulatory approvals in the United States and European Union.

On November 13, 2014, we entered into a collaboration and license agreement, or the Collaboration Agreement, pursuant to which we granted Janssen the exclusive rights to develop and commercialize imetelstat worldwide for all indications in oncology, including hematologic myeloid malignancies, and all other human therapeutic uses. Janssen terminated the Collaboration Agreement effective September 28, 2018. Upon the effective date of termination, we regained the global rights to the imetelstat program.MF. As ~~a result of the termination of the Collaboration Agreement,~~ ~~we will not receive any further milestone payments or royalties from Janssen for the development or commercialization of~~ ~~imetelstat, including any clinical development or sales milestones, and Janssen has~~such, no further ~~obligations to us or any third parties, such as clinical sites or vendors, to fund any~~follow-up of ~~the ongoing or any potential future imetelstat clinical trials.~~

Under the termination provisions of the Collaboration Agreement, Janssen is required to provide certain operational support for the imetelstat program through September 2019 during transition of the program to us. Each company is responsible for its own costs incurred related to transition activities unless otherwise specified in the Collaboration Agreement. ~~As of May 14, 2019, we assumed the imetelstat U.S. IND sponsorship from Janssen,~~ upon which we became sponsors of the ongoing IMerge and IMbark clinical trials of imetelstat in the United States, and we assumed sponsorship in certain countries outside of the United States in the second quarter of 2019. ~~We expect to obtain country-specific health authority and ethics committee approvals for change of sponsorship to us in~~

remaining ~~countries outside of the United States on a country-by-country basis during the third quarter of 2019. We expect the program transition to be completed by~~patients has been conducted since the end of ~~September 2019, including the transfer of the remaining non-clinical, manufacturing and ex-U.S. clinical and regulatory responsibilities from Janssen.In June 2019,~~ ~~we entered into a Clinical Supply Agreement, or Supply Agreement, with Janssen to purchase certain inventories of drug product, drug substance and raw materials for imetelstat manufacturing.~~ ~~Under the Supply Agreement, we will pay Janssen approximately $7.5 million~~ for drug product upon shipment of the product to our specified drug distribution centers, which is expected to occur in the third quarter of 2019. We have also agreed to pay up to approximately $6.7 million for drug substance and raw materials, upon testing, which we expect to occur in the third and fourth quarters of 2019, and confirmation that such materials meet certain specifications. We are not obligated to purchase materials that do not pass testing and conform to our specifications.

Until the sponsorship responsibilities for imetelstat in countries outside of the United States fully transfer from Janssen to us, Janssen will continue supporting IMbark and the Phase 2 portion of IMerge. Patients currently enrolled in IMbark and the Phase 2 portion of IMerge continue to receive treatment and follow-up under the respective trial protocols. After September 28, 2018, the effective termination date of the Collaboration Agreement, our responsibility for imetelstat development costs, including ongoing support of IMbark and the Phase 2 portion of IMerge, and costs for the prosecution of patents that were licensed to Janssen under the Collaboration Agreement increased from 50% to 100%.

For a further discussion of the former Collaboration Agreement with Janssen, see Note 3 on Former Collaboration Agreement in Notes to Condensed Financial Statements of this Form 10-Q. Information about the transition of the imetelstat program from Janssen to us should be reviewed in the context of the section entitled “Risks Related to Transition of the Imetelstat Program from Janssen to Geron” included in Part II, Item 1A, “Risk Factors” of this Form 10-Q.February 2020.

WeSince our inception, we have primarily financed our operations through the sale of equity securities, interest income on our marketable securities and payments we received under our collaborative and licensing arrangements. As of March 31, 2020, we had approximately ~~$162.3~~$133.4 million in cash, cash equivalents, restricted cash and current and noncurrent marketable ~~securities~~securities. On May 27, 2020, we completed an underwritten public offering of 107,049,375 shares of our common stock and pre-funded warrants to purchase 8,335,239 shares of our common stock, also known as the pre-funded warrants, together with accompanying warrants to purchase 57,692,307 shares of ~~June 30, 2019. We will require substantial additional capital in order~~our common stock, also known as the stock purchase warrants. The combined public offering price to ~~further advance~~ the ~~imetelstat program, including conducting~~public of common stock and accompanying stock purchase warrants is $1.30 per share. The combined public offering price to the ~~research~~public of pre-funded warrants and development and clinical and regulatory activities necessary to bring imetelstat to market, such as completing the planned Phase 3 portion of IMerge and potential clinical trials in other indications, and establishing sales and marketing capabilities to commercialize imetelstat in the United States on our own, if regulatory approvalaccompanying stock purchase warrants is ~~granted. If approved for marketing by regulatory authorities, we plan to seek potential commercialization partners for territories outside~~$1.299 per share. The estimated net cash proceeds from this offering, assuming no exercise of the ~~United States.~~pre-funded warrants or the stock purchase warrants, is approximately $140.2 million, after deducting the underwriting discount and estimated offering expenses payable by us.

Substantially all of our revenues to date have been payments under collaboration agreements, and milestones, royalties and other revenues from our licensing arrangements. We currently have no source of product revenue. While we reported a small profit for the year ended December 31, 2015 due to our recognition of revenue in connection with the upfront payment from Janssen under the Collaboration Agreement, until 2015 we had never been profitable, and have not reported any profit since. We have incurred significant net losses since our inception in 1990, resulting principally from costs incurred in connection with our research and development activities and from general and administrative costs associated with our operations. As of ~~June 30, 2019,~~March 31, 2020, we had an accumulated deficit of approximately ~~$1.0~~$1.1 billion. Since our inception, we have primarily financed our operations through the sale of equity securities, interest income on our marketable securities and payments we received under our collaborative and licensing arrangements.

Substantially all of our revenues to date have been payments under collaboration agreements, and milestones, royalties and other revenues from our licensing arrangements. We currently have no source of product revenue. The significance of future losses, future revenues and any potential future profitability will depend primarily on the clinical and commercial success of imetelstat. In any event, imetelstat will require significant additional clinical testing prior to possible regulatory approval in the United States and other countries. ~~In addition, as a result of the termination of the Collaboration Agreement, we~~We expect research and development expenses, general and administrative expenses, and losses to substantially increase in future periods as we ~~undertake sole financial responsibility for~~continue to support the imetelstat development ~~program.~~program through late-stage development, including the anticipated completion of the Phase 3 portion of IMerge and commencement and completion of the planned Phase 3 clinical trial in refractory MF. To further advance the imetelstat program, including conducting the clinical and regulatory activities necessary to obtain regulatory approval for imetelstat and establishing sales and marketing capabilities to commercialize imetelstat in the United States on our own, if regulatory approval is granted, substantial additional capital will be required. If approved for marketing by regulatory authorities, we plan to seek potential commercialization partners for territories outside of the United States. We do not expect imetelstat to be commercially available for many years, if at all.

There have been no significant changes in our critical accounting policies and estimates during the ~~six~~three months ended ~~June 30, 2019,~~March 31, 2020, as compared to the critical accounting policies and estimates disclosed in our Annual Report on Form 10-K for the year ended December 31, ~~2018, other than the adoption of the new accounting pronouncement on January 1, 2019 as described below.~~2019.

Our condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information. The preparation of these financial statements requires management to make estimates and assumptions that affect the reported assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Note 1 of Notes to Condensed Financial Statements of this Form 10-Q describes the significant accounting policies used in the preparation of the condensed financial statements.

Estimates and assumptions about future events and their effects cannot be determined with certainty. We base our estimates on historical experience and on various other assumptions believed to be applicable and reasonable under the circumstances. These estimates may change as new events occur, as additional information is obtained and as our operating environment changes. These changes historically have been minor and have been included in the condensed financial statements as soon as they became known. Based on a critical assessment of our accounting policies and the underlying judgments and uncertainties affecting the application of those policies, management believes that our condensed financial statements are fairly stated in accordance with accounting principles generally accepted in the United States, and present a meaningful presentation of our financial condition and results of operations.

We adopted Topic 842 on January 1, 2019 using the modified retrospective approach as allowed under ASU 2018-11, and we elected to utilize the available practical expedients. Financial results for the reporting periods beginning after January 1, 2019 are presented under Topic 842, while prior period amounts have not been adjusted and continue to be reported in accordance with our historical accounting under Topic 840.

In connection with the adoption of Topic 842 as of January 1, 2019, we recorded an operating lease, right-of-use asset and a corresponding operating lease liability for the net present value of remaining lease payments of our current operating lease for our office space in Menlo Park. To calculate the net present value of lease payments, we apply our incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as of the lease commencement date. We may adjust the right-of-use asset for certain adjustments, such as initial direct costs paid or incentives received. In addition, we include any options to extend or terminate the lease in the expected lease term when it is reasonably certain that we will exercise any such option. Lease expense is recognized on a straight-line basis over the expected lease term. The adoption of Topic 842 did not have a material impact on our condensed statements of operations. See Note 4 on Operating Leases in Notes to Condensed Financial Statements of this Form 10-Q for further discussion of our operating lease obligation.

Our results of operations have fluctuated from period to period and may continue to fluctuate in the ~~future, especially in light of the termination of the Collaboration Agreement with Janssen effective September 28, 2018.~~future. Results of operations for any period may be unrelated to results of operations for any other period. Thus, historical results should not be viewed as indicative of future operating results. For example, in 2015 we reported net income for the first time due to recognition of revenue in connection with the upfront payment from Janssen under the Collaboration Agreement. Effective September 28, 2018, the Collaboration Agreement with Janssen was terminated. As a result, we will not receive any ~~further~~ milestone payments or royalties from Janssen for the development or commercialization of imetelstat. In addition, we expect to incur increasing operating losses in the future as we ~~undertake sole financial responsibility for the development~~support two Phase 3 clinical trials of imetelstat, ~~to enable potential commercialization~~the ongoing Phase 3 portion of ~~imetelstat~~IMerge and the planned Phase 3 clinical trial in ~~the United States and other countries.~~refractory MF. We are subject to risks common to companies in our industry and at our stage of development, including, but not limited to, risks inherent in research and development efforts, including ~~the transition of the imetelstat program from Janssen to us,~~ the development, manufacture, regulatory approval for and commercialization of, imetelstat, uncertainty of non-clinical and clinical trial results or regulatory approvals or clearances, the future development of imetelstat by us, including any future efficacy or safety results that may cause the benefit-risk profile of imetelstat to become unacceptable, overcoming disruptions and/or delays due to the COVID-19 pandemic, our need for future capital, enforcement of our patent and proprietary rights, reliance upon our consultants, licensees, investigators and other third parties, and potential competition. In order for imetelstat to be commercialized, we must conduct non-clinical tests and clinical trials to demonstrate the safety and efficacy of imetelstat, obtain regulatory approvals or clearances and enter into manufacturing, distribution and marketing arrangements, as well as obtain market acceptance. We do not expect to receive revenue based on sales of imetelstat for many years, if at all.

We ~~have~~previously entered into ~~several~~ license or collaboration agreements with companies involved with oncology, diagnostics, research tools and biologics production, whereby we ~~have~~ granted certain rights to our non-imetelstat related technologies. ~~In connection with these agreements, we are eligible to receive license fees, option fees, milestone payments and royalties on future sales~~As of ~~products, or any combination thereof.~~

~~We recognized license fee revenues of $18,000 in each of the periods for the three and six months ended June 30, 2019, compared to $92,000 and $340,000 for the same periods in 2018 related to~~March 31, 2020, our ~~various agreements. The decrease in license fee revenues for the three and six months ended June 30, 2019 compared to the same periods in 2018 reflects a reduction in the number of active~~ license agreements ~~in 2019 for research licenses~~ related to our human telomerase reverse transcriptase, or hTERT, technology

~~as a result of~~ have been terminated or expired due to patent expirations on such technology. The remaining active license agreement is a license related to our specialized oligonucleotide backbone chemistry, as well as patent rights covering the ~~underlying technology.~~ synthesis of monomers, the building blocks of oligonucleotides. Economic terms of this agreement include non-refundable annual license maintenance payments, milestone payments upon achievement of certain research, development and regulatory milestones, and royalties on potential future product sales. Also, in connection with the divestiture of Geron’s human embryonic stem cell assets, including intellectual property and proprietary technology, to Lineage Cell Therapeutics, Inc. (formerly BioTime, Inc. which acquired Asterias Biotherapeutics, Inc.) in 2013, we are entitled to receive royalties on future product sales.

We recognized royalty revenues of ~~$83,000 and $140,000~~$52,000 for the three ~~and six~~ months ended ~~June 30, 2019, respectively,~~March 31, 2020, compared to ~~$116,000 and $186,000~~$57,000 for the same ~~periods~~period in ~~2018. The decrease~~2019. Royalty revenues in ~~royalty revenues for the three~~2020 and ~~six months ended June 30,~~ 2019 ~~compared to the same periods in 2018~~ ~~reflects expiration~~primarily reflect estimated royalties from sales of ~~licenses which eliminated the obligation to pay royalties on product sales~~.cell-based research products from our divested stem cell assets.

Future license fee and royalty revenues are dependent on additional agreements being signed, if any, our current ~~agreements~~license agreement being maintained and the underlying patent rights for the ~~licenses~~license remaining active. Current revenues may not be predictive of future revenues. We expect ~~license fee and~~ royalty revenues ~~under~~in 2020 to be lower than 2019 due to the termination and expiration of our license agreements related to our hTERT technology ~~to be lower in 2019 than in previous years, and to be eliminated by the end of 2019,~~ due to ~~upcoming~~the patent expirations on such technology. Because product sales have not commenced, and may not ever commence, under our remaining active license agreement, we do not expect significant royalty revenue, if any, in 2020. In addition, due to disruptions caused by the COVID-19 pandemic, product sales from our divested stem cell programs are expected to be lower which reduces the royalties payable to us.

During the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 2019, ~~and 2018,~~ imetelstat was the sole research and development program we supported. For the imetelstat research and development program, we incur direct external, personnel-related and other research and development costs. For the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 2019, direct external expenses included costs for our contract research organization, or CRO, consultants and other clinical-related ~~vendors and~~vendors. Also in 2019, direct external expenses included 100% of clinical development costs incurred by Janssen for operational support of the imetelstat program during the transition period. ~~For~~However, costs associated with transition activities, such as transfer of the ~~three~~sponsorship of ongoing imetelstat clinical trials, moving databases and ~~six months ended June 30, 2018, direct external expenses primarily consisted of our 50% share of clinical development costs~~related systems and transmitting regulatory files, were incurred separately by ~~Janssen under~~each company, unless otherwise specified in the Collaboration Agreement. As of the end of September 2019, the transition of the imetelstat program to us from Janssen has been completed according to the terms of the Collaboration Agreement. Personnel-related expenses primarily consist of salaries and wages, stock-based compensation, payroll taxes and benefits for Geron employees involved with ongoing research and development efforts. Other research and development expenses primarily consist of research-related overhead associated with allocated expenses for rent and maintenance of facilities and other supplies.

Research and development expenses ~~were $10.1 million and $16.0 million~~ for the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 2019 ~~respectively, compared to $3.2 million and $5.6 million for the same periods in 2018.~~ were as follows:

The increase in research and development expenses for the three ~~and six~~ months ended ~~June 30, 2019~~March 31, 2020 compared to the same ~~periods~~period in ~~2018~~2019 primarily reflects higher direct external costs for clinical development ~~activities. Such costs included: a) fees~~ activities to ~~our CRO, consultants and other clinical-related vendors for~~support the development of imetelstat ~~program transition; b) start-up expenses for~~in lower risk MDS, including the ~~planned~~ Phase 3 portion of ~~IMerge; and c) 100% reimbursement to Janssen for operational support of the imetelstat program.~~IMerge. In addition, ~~increased~~ personnel-related expenses ~~for~~have increased in the first quarter of 2020 compared to the same period in 2019 as a result of additional development headcount ~~have been incurred~~being hired in ~~2019 compared~~2019. Our spending in the first quarter of 2020 reflected normal business activities into March and then a curtailment of certain costs, due to ~~2018.~~

~~Research~~the impact of the COVID-19 pandemic. While direct external expenses are expected to decrease in the second quarter of 2020 as a result of a reduction in clinical trial activities limited by the COVID-19 pandemic, much of our personnel-related expenses will continue in line with the first quarter of 2020, with some decline as a result of travel restrictions. Due to the uncertainties of the COVID-19 pandemic, we cannot predict the level of research and development expenses ~~for~~to be incurred during the ~~three and six months ended June 30, 2019 and 2018 were as follows:~~

~~Since cost sharing between Janssen and us for imetelstat clinical development ceased on September 28, 2018, the effective date~~remainder of ~~termination of the Collaboration Agreement,~~2020. However, we expect research and development expenses to increase substantially in the future ~~periods~~ as we ~~undertake sole financial responsibility for the imetelstat development program, including all ongoing or potential future clinical trials, engage third parties and other~~ ~~service providers~~ ~~to conduct~~support two Phase 3 clinical trials of imetelstat, the ongoing Phase 3 portion of IMerge and ~~hire additional senior personnel to oversee~~ the ~~program. Under the terms of the Collaboration Agreement, Janssen is required to provide operational support for the imetelstat program, including continuing to support ongoing imetelstat~~planned Phase 3 clinical trials, during transition of the program to us. We reimburse Janssen for 100% of the costs for such operational support. However, costs associated with transition activities, such as transfer of the sponsorship of ongoing imetelstat clinical trials, moving databases and related systems and transmitting regulatory files, are being incurred by each company, unless otherwise specifiedtrial in ~~the Collaboration Agreement. We expect the program transition to be completed by the end of September 2019.~~

refractory MF. At this time, we cannot provide reliable estimates of how much time or investment will be necessary to advance imetelstat toward commercialization. For a more complete discussion of the risks and uncertainties associated with the development of imetelstat, see the sub‑sections entitled “Risks Related to the Development of Imetelstat” and “Risks Related to Regulatory Approval and Commercialization of Imetelstat” in Part II, Item 1A entitled “Risk Factors” and elsewhere in this Form 10‑Q.

General and administrative expenses were ~~$5.2 million and $10.6~~$6.1 million for the three ~~and six~~ months ended ~~June 30, 2019, respectively,~~March 31, 2020, compared to ~~$4.2 million and $9.6~~$5.5 million for the same ~~periods~~period in ~~2018.~~2019. The increase in general and administrative expenses for the three ~~and six~~ months ended June 30, 2019 compared to the same periods in 2018 primarily reflects higher corporate and patent legal costs and additional personnel to support operational activities. We expect general and administrative expenses to increase in the future since the cost sharing between Janssen and us for patent prosecution expenses related to the imetelstat program ceased upon termination of the Collaboration Agreement, and we expect to continue to hire additional personnel to support our operations.

Interest and other income was $1.1 million and $2.3 million for the three and six months ended June 30, 2019, respectively, compared to $717,000 and $1.1 million for the same periods in 2018. The increase in interest and other income for the three and six months ended June 30, 2019March 31, 2020 compared to the same period in ~~2018~~2019 primarily reflects higher ~~yields on~~personnel-related costs for the hiring of additional headcount to support growing operational activities associated with bi-coastal offices, increased company headcount and international clinical trial activities . For the remainder of 2020, the majority of general and administrative expenses will continue at the same level as the first quarter of 2020, as we continue to support our ~~marketable securities portfolio~~development organization and maintain compliance with regulatory requirements as a publicly traded company. Certain costs will decline as the underlying activities are restricted by the COVID-19 pandemic, including travel and support for clinical site initiation. Such decrease may be offset by the potential increase in support activities related to the ~~size~~planned Phase 3 clinical trial in refractory MF which is expected to be open for screening and enrollment in the first quarter of ~~our marketable securities portfolio~~2021.

Interest and other income was $754,000 for the three months ended March 31, 2020, compared to $1.2 million for the same period in 2019. The decrease in interest income for the three months ended March 31, 2020 compared to the same period in 2019 reflected lower cash and investment balances resulting from the ~~receipt~~use of ~~net~~ cash proceeds from issuances of common stock pursuant to our At Market Issuance Sales Agreement, or the 2015 Sales Agreement, with MLV & Co. LLC, or MLV, and our At Market Issuance Sales Agreement, or the 2018 Sales Agreement, with B. Riley FBR, Inc., or B. Riley FBR, in the first half of 2018.for operations. Interest earned in future periods ~~will depend~~depends on the size of our marketable securities portfolio and prevailing interest rates. In 2020, we expect interest income to decline due to

lower interest rates, which may be partially offset by the increase in our marketable securities portfolio with the net proceeds from the public offering completed on May 27, 2020.

With the adoption of ASU 2016-01 on January 1, 2018, we remeasure the fair value of our equity investment in Sienna Cancer Diagnostics Limited, or Sienna, at each reporting date and any resulting change in fair value based on observable price changes is included in our condensed statements of operations. For the three months ended ~~June 30, 2019 and 2018,~~March 31, 2020, the decrease in the fair value of our equity investment in Sienna resulting from observable price changes in Sienna’s stock was ~~$98,000 and $350,000, respectively. There was no change~~$195,000, compared to the increase in ~~the~~ fair value of ~~equity investment for the six months ended June 30, 2019, compared to a decrease of $475,000~~$98,000 for the same period in ~~2018.~~2019. The fair value of our equity investment in Sienna fluctuates based on changes in Sienna’s stock price and is therefore subject to volatility, especially in light of the unpredictable market conditions due to the COVID-19 pandemic, that could adversely affect our future operating results.

Other expense was ~~$30,000 and $48,000~~$44,000 for the three ~~and six~~ months ended ~~June 30, 2019, respectively,~~March 31, 2020, compared to ~~$59,000 and $77,000~~$18,000 for the same ~~periods~~period in ~~2018.~~2019. Other expense primarily reflects changes in the fair value of our equity investment in Sienna resulting from foreign currency translation and bank charges related to our cash operating accounts and marketable securities portfolio. Other expense for the three ~~and six~~ months ended ~~June 30, 2019~~March 31, 2020 included a loss of ~~$8,000 and $3,000, respectively,~~$25,000, related to foreign currency translation for our equity investment in Sienna, compared to a ~~loss~~gain of ~~$38,000~~$5,000 for ~~each of~~ the ~~comparable 2018 periods.~~same period in 2019. The fair value of our equity investment in Sienna fluctuates based on changes in the exchange rate between the U.S. dollar and Australian dollar and is therefore subject to volatility, especially in light of the unpredictable market conditions due to the COVID-19 pandemic, that could adversely affect our future operating results.

As of ~~June 30, 2019,~~March 31, 2020, we had cash, restricted cash, cash equivalents, and current and noncurrent marketable securities of ~~$162.3~~$133.4 million, compared to ~~$182.1~~$159.2 million at December 31, ~~2018.~~2019. The net decrease in cash, restricted cash, cash equivalents, and current and noncurrent marketable securities during the ~~six~~three months ended ~~June 30, 2019~~March 31, 2020 was the net result of cash being used for operations,~~. We estimate that our existing capital resources and future interest income will be sufficient to fund our current level~~ partially offset by the receipt of ~~operations through at least the next 12 months. However, we expect to experience negative~~net cash ~~flow for the foreseeable future as we undertake sole financial responsibility for the development of the imetelstat program.~~

We have an investment policy to invest our cash in liquid, investment grade securities, such as interest-bearing money market funds, certificates of deposit, municipal securities, U.S. government and agency securities, corporate notes and commercial paper. Our investment portfolio does not contain securities with exposure to sub-prime mortgages, collateralized debt obligations, asset-backed securities or auction rate securities and, to date, we have not recognized any other-than-temporary impairment charges on our marketable securities or any significant changes in aggregate fair value that would impact our cash resources or liquidity. To date, we have not experienced lack of access to our invested cash and cash equivalents; however, access to our invested cash and cash equivalents may be impacted by adverse conditions in the financial and credit markets.

In August 2015, we entered into the 2015 Sales Agreement with MLV, under which we could elect to issue and sell shares of our common stock having an aggregate offering price of up to $50 million. Pursuant to the 2015 Sales Agreement, common stock was sold at market prices prevailing at the time of sale through MLV as our sales agent. We paid MLV an aggregate commission rate equal to up to 3.0% of the gross proceeds of ~~the~~approximately $686,000 from sales ~~price per share for common stock sold through MLV under the 2015 Sales Agreement. From January 2018 through April 2018, we sold an aggregate of 13,195,106 shares~~ of our common stock under the ~~2015~~2018 Sales Agreement resulting in net cash proceeds to us of approximately $47.7 million after deducting sales commissions and other offering expenses payable by us. Under the 2015 Sales Agreement, we sold a cumulative total of 13,809,336 shares of our common stock resulting in net cash proceeds to us of approximately $48.7 million after deducting sales commissions and other offering expenses payable by us. No further shares of common stock may be sold under the 2015 Sales Agreement..

In May 2018, we entered into the 2018 Sales Agreement with B. Riley FBR, pursuant to which we may elect to issue and sell shares of our common stock having an aggregate offering price of up to $100 million in such quantities and on such minimum price terms as we set from time to time through B. Riley FBR as our sales agent. Pursuant to the 2018 Sales Agreement, B. Riley FBR sells our common stock at market prices prevailing at the time of sale for which B. Riley FBR receives an aggregate commission rate equal to up to 3.0% of the gross proceeds. On July 10, 2018, we filed a prospectus supplement, or the ATM Prospectus Supplement, pursuant to which we may offer and sell, from time to time, shares of our common stock having an aggregate offering price of up to $62,821,700 under the 2018 Sales Agreement. From ~~May 2018~~January 2020 through ~~July 2018,~~April 2020, we sold an aggregate of ~~10,083,079~~3,496,616 shares of our common stock under the 2018 Sales Agreement, resulting in net cash proceeds to us of approximately $38.4 million after deducting sales commissions and other offering expenses payable by us. From May 2019 through July 2019, we sold an aggregate of 1,893,091 shares of our common stock under the 2018 Sales Agreement, resulting in net cash proceeds to us of approximately $2.6$4.1 million after deducting sales commissions and other offering expenses payable by us. As of ~~July 31, 2019,~~April 30, 2020, approximately ~~$57.8~~$26.3 million of our common stock remained available for issuance under the 2018 Sales Agreement. The 2018 Sales Agreement will expire upon the earlier of the remaining common stock being sold or May 2021.In connection with the public offering in May 2020 described below, we have terminated the ATM Prospectus Supplement, but the 2018 Sales Agreement remains in full force and effect. We cannot make any sales of common stock under the 2018 Sales Agreement for 90 days after completion of our public offering and unless and until we file an updated prospectus supplement.

On May 27, 2020, we completed an underwritten public offering of 107,049,375 shares of our common stock and pre-funded warrants to purchase 8,335,239 shares of our common stock, also known as the pre-funded warrants, together with accompanying warrants to purchase 57,692,307 shares of our common stock, also known as the stock purchase warrants. The combined public offering price to the public of common stock and accompanying stock purchase warrants is $1.30 per share. The combined public offering price to the public of pre-funded warrants and accompanying stock purchase warrants is $1.299 per share. The estimated net cash proceeds from this offering, assuming no exercise of the pre-funded warrants or the stock purchase warrants, is approximately $140.2 million, after deducting the underwriting discount and estimated offering expenses payable by us.

have not experienced lack of access to our invested cash and cash equivalents; however, access to our invested cash and cash equivalents may be impacted by adverse conditions in the financial and credit markets.

We estimate that our existing capital resources and future interest income will be sufficient to fund our current level of operations through at least the next 12 months. We will require substantial additional capital in order to further advance the imetelstat program, including ~~conducting~~to conduct and complete the planned Phase 3 clinical trial in refractory MF, and to conduct the research and development, clinical, regulatory and ~~clinical and regulatory~~potential commercialization activities necessary to bring imetelstat to ~~market, such as completion of~~market. In this regard, our ability to conduct and complete the planned Phase 3 ~~portion of IMerge~~clinical trial in refractory MF, or to commence, conduct and complete other potential future clinical trials of imetelstat, such as potential proof-of-concept studies in other ~~indications, and~~hematologic myeloid malignancies, will be dependent on our ability to raise substantial additional capital. In addition, our ability to commercialize imetelstat in the U.S., if regulatory approval is granted, depends on us being able to establish sales and marketing ~~capabilities to commercialize imetelstat in the United States on our own, if regulatory approval is granted.~~capabilities. Because the outcome of any clinical activities and/or regulatory approval process is highly uncertain, we cannot reasonably estimate whether any development activities we may undertake will succeed, and we may never recoup our investment in any imetelstat development, which would adversely affect our financial condition and our business and business prospects, and might cause us to cease operations. Our future capital requirements are difficult to forecast and will depend on many factors, including:

the sales price for imetelstat;

•

~~the sales price for imetelstat;~~

the availability of coverage and adequate third-party reimbursement for imetelstat;

expenses associated with the pending putative securities class action lawsuits and potential additional related lawsuits, as well as any other litigation;

the extent and scope of our general and administrative expenses, including expenses associated with pending and potential future litigation; ~~and~~

the costs of maintaining and operating facilities in California and New Jersey, including costs related to the extension of the lease term for our Menlo Park facility due to the “shelter in place” orders issued by the County of San Mateo and the State of California as a result of the COVID-19 pandemic, as well as higher expenses for travel when travel becomes possible in light of the COVID-19 pandemic, telecommunications and administrative ~~oversight.~~oversight; and

the costs of enabling our personnel to telecommute as required by federal, state and local “shelter in place” or comparable orders, including providing supplies, equipment and technology necessary for them to perform their responsibilities.

As a result of the termination of the Collaboration Agreement effective September 28, 2018, we are responsible for funding all clinical development, manufacturing, intellectual property maintenance and potential commercial activities for ~~imetelstat.~~the imetelstat program. In order to further advance the imetelstat program, including ~~completion of~~conducting and completing, the planned Phase 3 ~~portion of IMerge~~clinical trial in refractory MF or commencing, conducting and completing other potential future clinical trials in other indications, such as potential proof-of-concept studies in other hematologic myeloid malignancies, we will need to raise substantial additional capital or establish additional collaborative arrangements with third-party collaborative partners, which may not be possible. In addition, as a result of the termination of the Collaboration Agreement, we will not receive any ~~further~~ milestone payments or royalties from Janssen for the development or sale of imetelstat,, including any clinical development ~~milestones~~.milestones. If we are unable to raise additional capital or establish alternative collaborative arrangements with third-party collaborative partners for imetelstat, the development of imetelstat may be further delayed, altered or abandoned, which might cause us to cease operations.

Additional financing through public or private equity financings, including pursuant to ~~our~~the 2018 Sales Agreement ~~with B. Riley FBR,~~when it becomes available, capital lease transactions or other financing sources may not be available on acceptable terms, or at all. We may be unable to raise equity capital, or may be forced to do so at a stock price or on other terms that could result in substantial dilution of ownership for our stockholders. The receptivity of the public and private equity markets to proposed financings ishas been substantially affected by uncertainty in the general economic, market and political climate caused by the evolving effects of the COVID-19 pandemic, and may in the future be affected by other factors which are unpredictable and over which we have no control. In this regard, the effects of the COVID-19 pandemic have increased market volatility and ~~instability~~could result in ~~the~~a significant long-term disruption of global financial markets, ~~and political climate~~which could ~~adversely affect~~reduce or eliminate our ability to raise additional funds through financings, and could negatively impact the terms upon which we may raise those funds.

In addition, we may seek additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Due to uncertainty in the general economic, market and political climate, we may determine that it is necessary or appropriate to raise additional funds proactively to meet longer-term anticipated operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, ~~the~~your ownership ~~interests of our stockholders~~interest may be diluted, and the terms may include liquidation or other preferences that materially and adversely affect ~~the~~your rights ~~of our stockholders.~~as a stockholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through alliance, collaborative or licensing arrangements with third parties, we may have to relinquish valuable rights to imetelstat or our technologies or grant licenses on terms that are not favorable to us.

We cannot assure you that our existing capital resources, future interest income, and potential future sales of our common stock, including under ~~our~~the 2018 Sales Agreement ~~with B. Riley FBR,~~when it becomes available, will be sufficient to fund our operating plans. WeIn any event, we will continue to need substantial additional funds to meet operational needs and capital requirements to advance the imetelstat program in clinical development, including to conduct and complete the planned Phase 3 clinical trial in refractory MF and potential commercialization, and our need for additional funds may arise sooner than planned. If adequate funds are not available on a timely basis, if at all, we may be unable to pursue further development, including conducting and completing the planned Phase 3 clinical trial in refractory MF, or commencing, conducting or completing potential proof-of-concept studies in other hematologic myeloid malignancies, or pursuing potential commercialization of imetelstat, which ~~could adversely affect~~would severely harm our business and we might cease ~~operations~~.operations.

Cash Flows from Operating Activities. Net cash used in operations for the ~~six~~three months ended ~~June 30,~~March 31, 2020 and 2019 ~~and 2018~~ was ~~$21.5~~$26.2 million and ~~$11.9~~$12.7 million, respectively. The increase in net cash used in operations for the ~~six~~three months ended ~~June 30, 2019~~March 31, 2020 compared to the same period in ~~2018~~2019 primarily reflects higher payments for research and development expenses in connection with ~~the transition of the imetelstat program from Janssen to us, start-up activities for~~supporting the Phase 3 portion of IMerge and increases in development headcount.

Cash Flows from Investing Activities. Net cash provided by investing activities for the ~~six~~three months ended ~~June 30,~~March 31, 2020 and 2019 was ~~$28.4 million. Net cash used in investing activities for the six months ended June 30, 2018 was $69.2~~$32.2 million and $9.0 million. The increase in net cash provided by investing activities in ~~2019~~2020 compared to ~~2018~~2019 primarily reflects a higher rate of maturities than purchases of marketable securities in ~~2019.~~2020.

Cash Flows from Financing Activities. Net cash provided by financing activities for the ~~six~~three months ended ~~June 30,~~March 31, 2020 and 2019 was $686,000 and ~~2018 was $243,000 and $83.9 million,~~none, respectively. InFinancing activities in 2020 primarily reflect the ~~second quarter~~receipt of ~~2019, we sold an aggregate of 108,386 shares~~net cash proceeds from the sales of our common stock ~~for net cash proceeds of approximately $101,000, after deducting sales commissions and other offering expenses payable by us,~~ under the 2018 Sales Agreement with B. Riley FBR. In the first six months of 2018, we sold 22,642,132 shares of our common stock for net cash proceeds of approximately $83.9 million, after deducting sales commissions and other offering expenses payable by us, under the 2015 Sales Agreement with MLV and the 2018 Sales Agreement with B. Riley FBR. See Note 56 on

Stockholders’ Equity ~~in Notes to Condensed Financial Statements of this Form 10-Q~~ for additional information about ~~the 2015 Sales Agreement with MLV and~~ the 2018 Sales Agreement with B. Riley FBR.

Contractual Obligations

Our future minimum contractual obligations at December 31, 2019 were reported in our Annual Report on Form 10-K for the year ended December 31, ~~2018,~~2019, as filed with the SEC.

In ~~June 2019, we entered into a Clinical Supply Agreement, or Supply Agreement,~~March 2020, in connection with ~~Janssen to purchase certain inventories of drug product, drug substance and raw materials for imetelstat manufacturing. Under~~ the ~~Supply Agreement, we will pay Janssen approximately $7.5 million for drug product upon shipment~~“shelter in place” orders issued by the Health Officer of the ~~product~~County of San Mateo and the Governor of the State of California on March 16 and March 19, 2020, respectively, which directed non-essential businesses to ~~our specified drug distribution centers, which is expected to occur in~~cease operations until the third quarter of 2019. We have also agreed to pay up to approximately $6.7 million for drug substance and raw materials upon testing and confirmation such materials meet certain specifications and expect such testing to occur inorders are rescinded, we amended the ~~third and fourth quarters of 2019. We are not obligated to purchase materials that do not pass testing and conform to our specifications.~~

~~In April 2019, we entered into an operating~~ lease agreement for our office space ~~located~~ at ~~3 Sylvan Way, Parsippany, New Jersey. The initial~~149 Commonwealth Drive, Menlo Park, California, or Menlo Park Lease, to extend the lease term until the 15th day after the later of: a) April 7, 2020; b) the expiration or termination of the ~~lease is 11 years with an option to extend for an additional five years and a one-time option to terminate~~“shelter in place” orders; or c) the ~~lease without cause as~~modification of the ~~103~~^rd ~~month anniversary of~~“shelter in place” orders such that non-essential business operations and non-essential travel are expressly permitted. Assuming the commencement date of the lease. We have not yet occupied the space as it is being renovated for our use. The lease term commences upon the earlier of the date of completion of the construction work or the date upon which we occupy and use the space for its intended purpose, which we expect to occur by“shelter in place” orders expire at the end of ~~the third quarter of 2019. Upon the commencement of the lease,~~May 2020, the aggregate minimum future lease payments for the ~~initial lease term~~extension is approximately $3.7 million, net of a seven-month rent abatement period. Under the lease, we are also obligated to pay certain variable expenses separately from the base rent, including electricity and common area maintenance.$149,000.

Other than as described above, during the ~~six~~three months ended ~~June 30, 2019,~~March 31, 2020, there have been no other material changes from the contractual obligations previously disclosed in our Annual Report on Form 10-K for the year ended December 31, ~~2018.~~2019.

Off-Balance Sheet Arrangements

We have not engaged in any off-balance sheet arrangements, including the use of structured finance, special purpose entities or variable interest entities.

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

~~During~~We are a smaller reporting company as defined by Rule 12b-2 of the ~~six months ended June 30, 2019, there were no material changes~~Securities Exchange Act of 1934, as amended, or the Exchange Act, and are not required to ~~our market risk disclosures as set forth in Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk” in our Annual Report on Form 10-K for~~provide the ~~year ended December 31, 2018.~~information specified under this item.

ITEM 4.

CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, prior to the filing of this quarterly report. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that, as of the end of the period covered by this quarterly report, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting during the quarter to which this report relates that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Limitations on Effectiveness of Controls and Procedures

In designing and evaluating disclosure controls and procedures, our management recognizes that any system of controls, however well designed and operated, can provide only reasonable assurance, and not absolute assurance, that the desired control objectives of the system are met. In addition, the design of any control system is based in part upon certain assumptions about the likelihood of future events. Because of these and other inherent limitations of control systems, there can be no assurance that any design will succeed in achieving its stated goals in all future circumstances. Accordingly, our disclosure controls and procedures are

designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met and, as set forth above, our Chief Executive Officer and our Chief Financial Officer have concluded, based on their evaluation as of the end of the period covered by this quarterly report, that our disclosure controls and procedures were effective to provide reasonable assurance that the objectives of our disclosure control system were met.

PART II. OTHER INFORMATION

ITEM 1.

LEGAL PROCEEDINGS

~~None.~~On January 23 and February 14, 2020, two putative securities class action lawsuits were commenced in the United States District Court, or the Court, for the Northern District of California, or the Northern District, naming as defendants us and one of our officers. On March 5, 2020, a third putative securities class action lawsuit was commenced in the United States District Court for the District of New Jersey, naming as defendants us and two of our officers. On March 19, 2020, the New Jersey lawsuit was voluntarily dismissed without prejudice. The remaining putative securities class action lawsuits allege violations of the Securities Exchange Act of 1934 in connection with allegedly false and misleading statements made by us related to IMbark during the period from March 19, 2018 to September 26, 2018. The plaintiffs allege, among other things, that we failed to disclose facts related to the alleged failure by IMbark to meet the two primary endpoints of the trial, spleen response rate and Total Symptom Score, and that our stock price dropped when such information was disclosed. The plaintiffs seek damages and interest, and an award of reasonable costs, including attorneys’ fees. On May 14, 2020, the Court consolidated the remaining putative securities class action lawsuits, appointed a lead plaintiff, and invited applications for lead counsel. It is possible that additional suits will be filed, or allegations made by stockholders, with respect to these same or other matters and also naming us and/or our officers and directors as defendants. We believe that we have meritorious defenses and intend to vigorously defend against the pending lawsuits.

The pending lawsuits and any other related lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors. The outcome of the pending lawsuits and any other related lawsuits is necessarily uncertain. We could be forced to expend significant resources in the defense of the pending lawsuits and any additional lawsuits, and we may not prevail. In addition, we may incur substantial legal fees and costs in connection with such lawsuits. We currently are not able to estimate the possible cost to us from these matters, as the pending lawsuits are currently at an early stage, and we cannot be certain how long it may take to resolve the pending lawsuits or the possible amount of any damages that we may be required to pay. Such amounts could be material to our financial statements if we do not prevail in the defense of the pending lawsuits and any other related lawsuits, or even if we do prevail.

ITEM 1A.RISK FACTORS

~~RISK FACTORS~~

Our business is subject to various risks and uncertainties that may have a material adverse effect on our business, financial condition or results of operations. You should carefully consider the risks and uncertainties described below, together with all of the other information included in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, ~~2018,~~2019, or the Form 10-K. Our business faces significant risks and uncertainties, and those described below may not be the only risks and uncertainties we face. Additional risks and uncertainties not presently known to us or that we currently believe are immaterial may also significantly impair our business, financial condition or results of operations. If any of these risks or uncertainties occur, our business, financial condition or results of operations could suffer, the market price of our common stock could decline and you could lose all or part of your investment in our common stock. We have marked with an asterisk (*) those risks described below that reflect substantive changes from, oro r additions to, the risks described under Part I, Item 1A, “Risk Factors” included in the Form 10-K.

RISKS RELATED TO THE DEVELOPMENT OF IMETELSTAT

The evolving effects of the ongoing COVID-19 global pandemic have negatively impacted, and will likely conti nue to negatively impact, our business and health care resources around the world, including a significant number of clinical sites involved with the Phase 3 portion of IMerge. Our business and business prospects, our financial condition and the future of imetelstat could be materially and adversely affected by the evolving effects of the COVID-19 pandemic as a result of the current and potential future impacts on our regulatory and clinical development activities, clinical supply chain and other business operations, in addition to the impact of a global economic slowdown.*

Our business and business prospects, our financial condition and the future of imetelstat generally could be materially and adversely affected by the evolving effects of the ongoing global COVID-19 pandemic. The ongoing COVID-19 pandemic and

government measures taken in response to COVID-19 have had a significant impact, both direct and indirect, on businesses, as significant reductions in business-related activities have occurred, supply chains have been disrupted, and manufacturing and clinical development activities have been curtailed, delayed or suspended. In response to the spread of COVID-19 and “shelter in place” and similar orders issued by state and local governments, we have temporarily restricted access to our offices in California and New Jersey. Many of our employees are conducting their work remotely, and our employees otherwise have minimal presence in our offices for essential activities. The effects of the “shelter in place” and similar orders, as well our own policies, may negatively impact productivity, disrupt our business and continue to delay our imetelstat development program and clinical trial timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course. In addition, our increased reliance on personnel working remotely could increase our cybersecurity risk, create data accessibility concerns and make us more susceptible to communication disruptions, any of which could adversely impact our business operations. These and similar, and perhaps more severe, disruptions in our operations could continue to negatively impact our business and business prospects, our financial condition and the future of imetelstat.

Due to the evolving effects of the COVID-19 pandemic, we have had and expect to continue to have, or we may potentially have in the future, disruptions and/or delays in our imetelstat development program, including with respect to our ability to initiate trial sites, screen, enroll and assess patients, maintain patient enrollment, ensure patient clinical and lab collection visits, conduct monitoring visits, supply study drug, report trial results, or interact with regulators or other important agencies due to limitations in employee resources or otherwise. For the Phase 3 portion of IMerge, we have clinical trial sites in many countries that have had high incident rates of COVID-19. Restrictions on travel, availability of site personnel, and diversion of hospital staff and resources to COVID-19 patients, have disrupted our trial operations, as well as patient recruitment in many areas, resulting in a slowdown in patient enrollment and/or deviations from or disruptions in key clinical trial activities, such as clinical trial site initiation and monitoring. As a result, we no longer expect to complete patient enrollment in the Phase 3 portion of IMerge by the end of 2020 and now expect to complete patient enrollment in the Phase 3 portion of IMerge by the end of the first quarter of 2021. Additionally, the effects of the COVID-19 pandemic have resulted in our decision to postpone the commencement of our previously disclosed proof-of-concept study in high risk MDS and AML that we had previously planned to commence in 2020. If the COVID-19 pandemic continues and persists for an extended period of time, we could experience significant disruptions to our clinical development timelines, continued delays in enrollment and clinical trial site initiation in the Phase 3 portion of IMerge, and other disruptions that could severely impact our business and the imetelstat development program, including those resulting from:

•

new, continued or heightened difficulties in enrolling patients and recruiting clinical site investigators and clinical site staff for the Phase 3 portion of IMerge, the planned Phase 3 clinical trial in refractory MF and any other potential future clinical trials of imetelstat;

continued or heightened delays or difficulties in the Phase 3 portion of IMerge caused by missed patient clinical and lab collection visits, and uncertainty how the FDA will view these deviations from the protocol caused by COVID-19;

•

continued or heightened delays or disruptions in clinical trial activities due to the availability of personnel at our CROs and vendors;

•

substantial reduction of health care resources available for the conduct of clinical trials, including the temporary postponement of clinical trial activities at certain hospitals serving as our clinical trial sites and diversion of hospital staff away from the conduct of our clinical trials, such as those experienced by us to date in the Phase 3 portion of IMerge;

interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others or interruption of clinical trial subject visits and study procedures (particularly any procedures that may be deemed non-essential), which may impact the integrity of subject data and clinical study endpoints;

loss of recruited subjects in clinical trials due to clinical site COVID-19 activities or loss of life of subjects due to COVID-19;

interruption of, or delays in receiving, supplies of imetelstat from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in supply chain and production systems, import/export complications; and

•

limitations on employee resources that would otherwise be focused on the conduct of our clinical trials, product development, manufacturing, and general company operations, including because of sickness of employees or their families, the desire of employees to avoid contact with large groups of people, an increased reliance on working from home, or mass transit disruptions.

These and other factors arising from the evolving effects of the COVID-19 pandemic could further adversely impact our ability to conduct and complete the Phase 3 portion of IMerge or to enroll, conduct and complete the planned Phase 3 clinical trial in

refractory MF and any other potential future clinical trials of imetelstat, and could otherwise materially and adversely affect our business and business prospects, our financial condition and the future of imetelstat.

In addition, we rely on third-party CROs or other third parties to assist us with clinical trial activities, and we cannot guarantee that they will continue to perform their contractual duties in a timely and satisfactory manner as a result of the COVID-19 pandemic. Also, absenteeism by governmental employees or the focus of regulatory authorities’ efforts and attention on the approval of other therapeutics or other activities related to COVID-19 could likewise impact the timeliness of regulatory authority responses and the processing of regulatory submissions for imetelstat. Moreover, while at this time we believe that we have sufficient drug supply for the Phase 3 portion of IMerge, we could experience disruptions to our supply chain as a result of the evolving effects of the COVID-19 pandemic, and associated delays or limitations in our ability to obtain sufficient materials for the manufacture of imetelstat for our current and potential future clinical trials, which could adversely affect our ability to conduct ongoing and potential future clinical trials of imetelstat. For example, some of our suppliers of certain materials used in the production of imetelstat are located in countries that are heavily affected by the COVID-19 pandemic . In these countries, closures and other restrictions resulting from the COVID-19 outbreak in the region could disrupt our supply chain or limit our ability to obtain sufficient materials for the manufacture of imetelstat, including for the planned Phase 3 clinical trial in refractory MF. In any event, if the COVID-19 pandemic continues and persists for an extended period of time, we could experience significant disruptions to our clinical development timelines, which would materially and adversely affect our business and business prospects, our financial condition and the future of imetelstat.

The effects of the COVID-19 pandemic continue to rapidly evolve. These effects have increased market volatility and could result in a significant long-term disruption of global financial markets, reducing or eliminating our ability to raise additional capital, which could negatively affect our liquidity and our ability to conduct and complete the planned Phase 3 clinical trial in refractory MF or to commence, conduct and complete any other potential future clinical trials of imetelstat. In addition, the global economic slowdown caused by the COVID-19 pandemic could materially and adversely affect our business and the value of our common stock. The extent to which the COVID-19 pandemic impacts our business, our regulatory and clinical development activities, clinical supply chain and other business operations, as well as the value of and market for our common stock, will dep end on future developments that are highly uncertain and cannot be predicted with confidence at this time , such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat COVID-19. Accordingly, we do not yet know the full extent of potential delays or impacts on our business, our regulatory and clinical development activities, clinical supply chain and other business operations or the global economy as a whole. However, these effects could materially and adversely affect our business and business prospects, our financial condition and the future of imetelstat. In addition, to the extent the evolving effects of the COVID-19 pandemic adversely affect our business and financial condition, it may also have the effect of heightening many of the other risks and uncertainties described elsewhere under the heading “Risk Factors”.

Our future success depends solely on imetelstat, our only product candidate, and we cannot be certain that we will be able to continue to develop imetelstat or advance imetelstat to subsequent clinical trials, or that we will be able to receive regulatory approval for imetelstat on a timely basis, or at all.*

Imetelstat is our sole product candidate, upon whose success we are wholly dependent. We do not have any other products or product candidates. Our ability to develop imetelstat to and through regulatory approval and potential commercial launch is subject to significant risks and uncertainties, including, among other things, our ability to:

•

overcome enrollment challenges related to the evolving effects of the COVID-19 pandemic in the Phase 3 portion of IMerge, and successfully retain patients in, and complete the Phase 3 portion of IMerge;

•

obtain regulatory clearance from the FDA and regulatory authorities in other countries to commence our planned Phase 3 clinical trial in refractory MF;

•

commence, enroll, conduct and complete the planned Phase 3 clinical trial in refractory MF if regulatory clearance is obtained;

•

develop clinical plans for, and successfully commence, enroll and complete, other potential future clinical trials of imetelstat, such as potential proof-of-concept studies in other hematologic myeloid malignancies;

~~open patient screening~~obtain substantial additional capital in order to enable us to conduct our operations and ~~enrollment in~~to advance imetelstat to and through current clinical trials, including conducting and completing the ~~planned~~ongoing Phase 3 portion of IMerge ~~for~~and the planned Phase 3 clinical trial in refractory MF, and commencing, conducting and completing other potential future clinical trials of imetelstat, such as potential proof-of-concept studies in ~~patients with lower risk MDS in August 2019, or at all;~~other hematologic myeloid malignancies, as well as regulatory approval and potential commercial launch;

proceed with further clinical development, or identify a feasible registration pathway, if any, for imetelstat in patients with Intermediate-2 or High risk MF who have relapsed after or are refractory to prior treatment with a JAK inhibitor, or relapsed/refractory MF;

~~successfully perform the analyses necessary to support our recently refined strategies for potential regulatory approval in relapsed/refractory MF,~~ ~~and satisfactorily provide to the FDA the data or analyses they require in order to conduct an End of Phase 2 meeting by the end of the first quarter of 2020;~~

~~obtain sufficient feedback from the End of Phase 2 meeting with the FDA by the end of the first quarter of 2020~~ ~~to enable us to make a timely decision regarding late-stage development of imetelstat in relapsed/refractory MF, if any;~~

~~cause the IND for imetelstat to be maintained without such IND being placed on full or partial clinical hold by the United States Food and Drug Administration, or FDA;~~

•

maintain the INDs and foreign equivalent submissions for imetelstat without such INDs and/or foreign equivalent submissions being placed on full or partial clinical hold, suspended or subject to other requirements by the FDA or other regulatory authorities;

generate ~~additional~~sufficient safety and efficacy data from current ~~clinical trials of imetelstat, including the Phase 2 portion of IMerge and IMbark,~~ and potential future clinical trials of imetelstat ~~including the planned Phase 3 portion of IMerge, providing~~that provide a positive benefit-risk profile ~~that supports~~and support the continued and future development of imetelstat in hematologic myeloid malignancies;

ascertain that the use of imetelstat does not result in significant systemic or organ toxicities, including hepatotoxicity, or other safety issues resulting in an unacceptable benefit-risk profile;

develop clinical plans for, and successfully commence, enroll and complete, potential future clinical trials of imetelstat in hematologic myeloid malignancies, including the planned Phase 3 portion of IMerge;

•

collaborate successfully with clinical trial sites, academic institutions, clinical research organizations, or CROs, contractors, physician investigators and other third ~~parties;~~ parties, including with respect to challenges and delays that have arisen and may continue to arise from the evolving effects of the COVID-19 pandemic;

obtain and maintain required regulatory clearances and approvals for imetelstat; for example, it is uncertain:

▪

whether the FDA and regulatory authorities in other countries will require us to obtain and submit additional non-clinical, manufacturing, or clinical data to proceed with any other potential future clinical trials of imetelstat apart from IMerge and the planned Phase 3 clinical trial in refractory MF,

▪

how the FDA and other regulatory authorities will interpret safety and efficacy data from any current or future clinical ~~trial,~~trials, including from IMbark or IMerge, or the planned Phase 3 clinical trial in refractory MF,

▪

what scope and type of clinical development and other data will be required before the FDA and other regulatory authorities might grant us marketing approval, if any, and

▪

what the length of time and cost for us will be to complete any such requirements;

enter into and maintain arrangements with third parties to provide services needed to further research and develop imetelstat, including maintaining the agreement with our ~~CRO,~~CROs, or to manufacture imetelstat, in each case at commercially reasonable costs;

enter into and maintain arrangements with third parties, or establish internal capabilities, to provide sales, marketing, distribution and ~~distribution~~other commercialization functions in compliance with applicable laws;

obtain appropriate coverage and reimbursement levels for the cost of imetelstat from governmental authorities, private health insurers and other third-party payors;

obtain, maintain and enforce adequate intellectual property protection for imetelstat; and

~~maintain adequate financial resources,~~recruit and retain personnel to support the development and potential commercialization of imetelstat, including ~~obtaining funding necessary to conduct our operations, to advance imetelstat to and through potential future clinical trials, including~~completion of the ~~planned~~ Phase 3 portion of IMerge ~~regulatory approval and potential commercial launch; and~~

~~recruit and retain personnel to~~ ~~support the development of imetelstat,~~ ~~including completion of~~or the planned Phase 3 ~~portion of IMerge~~clinical trial in refractory MF, and potential clinical development of imetelstat in other ~~indications.~~indications and maintain sufficient commercial resources to launch imetelstat.

If we are not able to successfully achieve the above-stated goals and overcome other challenges that we may encounter in the research, development, manufacturing and potential commercialization of imetelstat, we may be forced to abandon our development of imetelstat, which would severely harm our business and prospects, and might cause us to cease operations.

~~Commencement~~Completion of current clinical trials of imetelstat, including the Phase 3 portion of IMerge, and commencement and completion of potential future clinical trials of imetelstat, ~~including~~such as the planned Phase 3 ~~portion of IMerge, and completion of the extension phase of IMbark and the Phase 2 portion of IMerge,~~clinical trial in refractory MF, could be interrupted, further delayed or abandoned for a variety of reasons.*

Currently, ~~there are two~~the ongoing clinical trials of imetelstat ~~the extension phase of IMbark and~~are the Phase 2 and Phase 3 portions of IMerge. Due to the effects of the COVID-19 pandemic on our clinical trial activities, we no longer expect to complete patient enrollment in the Phase 3 portion of ~~IMerge.~~IMerge by the end of 2020. Due to the same challenges posed by the COVID-19 pandemic, beginning new studies of even a modest size will also be difficult to achieve in 2020, such as the planned Phase 3 clinical trial in refractory MF and the proof of concept study in high risk MDS and AML that we had previously planned to start this year and that we subsequently postponed. As a result, we do not expect to open the planned Phase 3 clinical trial in refractory MF for screening and enrollment until the first quarter of 2021 at the earliest, to the extent practicable under the current COVID-19 pandemic conditions . Completion of ~~these clinical trials,~~the Phase 3 portion of IMerge, and the commencement, conduct and completion of the planned Phase 3 clinical trial in refractory MF, and any other potential future clinical trials of imetelstat, ~~including the planned Phase 3 portion of IMerge,~~such as potential proof-of-concept studies in other hematologic myeloid malignancies, could be interrupted, delayed or abandoned for a variety of reasons, including as a result of failures or delays in:

the comprehensive transition of the imetelstat program from Janssen to us, as discussed in more detail under the heading, “Risks Related to Transition of the Imetelstat Program from Janssen to Geron”;

demonstrating sufficient safety and efficacy of imetelstat in current clinical trials, including the Phase 2 portion of IMerge and the extension phase of IMbark, and any potential future clinical trials, including the planned Phase 3 portion of IMerge, without safety issues, side effects or dose-limiting toxicities, including any additional or more severe safety issues in addition to those that have been observed to date in previous or ongoing clinical trials related to imetelstat, whether or not in the same indications or therapeutic areas;

•

demonstrating sufficient safety and efficacy of imetelstat in current and potential future clinical trials, without safety issues, side effects or dose-limiting toxicities, including any additional or more severe safety issues in addition to those that have been observed to date in previous or ongoing clinical trials related to imetelstat, whether or not in the same indications or therapeutic areas;

obtaining or maintaining regulatory clearances in the United States or other countries to conduct clinical trials, such as obtaining or maintaining regulatory clearances to commence, conduct or modify current or potential future clinical trials of imetelstat, in a timely manner, or at all, which could, for example, cause the anticipated commencement of screening and enrollment of the planned Phase 3 portion of IMerge to be delayed beyond August 2019 or prevent us from commencing, conducting or completing the planned Phase 3 portion of IMerge;

•

obtaining and/or maintaining regulatory clearances in the U.S. or other countries to conduct clinical trials, such as obtaining or maintaining regulatory clearances to commence, conduct or modify current or potential future clinical trials of imetelstat, in a timely manner, or at all, which could, for example, prevent us from, or result in substantial delays in, conducting or completing the Phase 3 portion of IMerge or commencing, conducting or completing the planned Phase 3 clinical trial in refractory MF, and even if such regulatory clearances are obtained, we may be unable to commence, conduct or complete current or potential future clinical trials of imetelstat, including the planned Phase 3 clinical trial in refractory MF, or may discontinue such trials, whether due to our inability to raise substantial additional capital or otherwise;

maintaining the ~~IND~~INDs and foreign equivalent submissions for imetelstat without such ~~IND~~INDs and/or foreign equivalent submissions being placed on full or partial clinical hold, suspended or subject to other requirements by the FDA or other regulatory authorities;

•

properly (i) ~~completing the extension phase of IMbark, including collecting data about serious adverse events and overall survival from the extension phase of IMbark; (ii)~~ completing the Phase 2 portion of IMerge, including assessing the durability of RBC-TI responses; (ii) recruiting, enrolling, conducting and completing the Phase 3 portion of IMerge, and (iii) ~~designing, commencing,~~recruiting, enrolling, conducting and completing the planned Phase 3 ~~portion of IMerge,~~clinical trial in refractory MF, and promptly or adequately reporting data from such ~~trials;~~trials, including in light of challenges and delays that have arisen and may continue to arise from the evolving effects of the COVID-19 pandemic;

•

obtaining substantial additional capital in order to advance the development of imetelstat, including conducting and completing the planned Phase 3 clinical trial in refractory MF, or commencing, enrolling, conducting and completing other potential future clinical trials of imetelstat in other indications;

determining a feasible registration path, if any, for imetelstat in relapsed/refractory MF, after performing analyses necessary to support recently refined strategies for potential regulatory approval and conducting an End of Phase 2 meeting with the FDA by the end of the first quarter of 2020;

•

obtaining and maintaining regulatory clearance from the FDA and regulatory authorities in other countries to commence the planned Phase 3 clinical trial in refractory MF;

Failures or delays with respect to any of these events could adversely affect our ability to conduct or complete any current clinical trials of imetelstat, including the Phase 3 portion of IMerge and to conduct or complete the planned Phase 3 clinical trial in refractory MF, or to commence, conduct and complete potential future clinical trials of imetelstat, ~~including the planned Phase 3 portion of IMerge,~~such as potential proof-of-concept studies in other hematologic myeloid malignancies, which could increase development costs, or interrupt, further delay or halt our development or potential commercialization of imetelstat, any of which could severely and adversely affect our financial results, business and business prospects, and the future of imetelstat, and might cause us to cease operations.

If we encounter further difficulties enrolling or retaining patients in clinical trials of imetelstat, including in the Phase 3 portion of IMerge or in our planned Phase 3 clinical trial in refractory MF, whether as a result of the evolving effects of the COVID-19 pandemic or for any other reasons, our clinical development and commercialization activities could be further delayed or otherwise adversely affected, which would cause our business and business prospects to be severely harmed, and we might cease operations.*

The timely completion of a clinical trial in accordance with its protocol depends, among other things, on the ability to enroll a sufficient number of patients who remain in the trial until its conclusion. If we encounter further challenges in screening, enrolling and retaining patients in the Phase 3 portion of IMerge, whether as a result of the evolving effects of the COVID-19 pandemic or for any other reasons, our completion of the Phase 3 portion of IMerge may be delayed or discontinu ed. If we experience difficulties in retaining patients in the treatment or follow-up phase of the Phase 2 portion of IMerge, whether as a result of the evolving effects of the COVID-19 pandemic or for any other reasons, our ability to continue to assess longer-term durability of RBC-TI responses would be adversely affected. The enrollment and retention of patients in clinical trials of imetelstat, including the ongoing Phase 3 portion of IMerge and the planned Phase 3 clinical trial in refractory MF, depends on many factors, such as:

In addition, current and potential future clinical trials of imetelstat, such as the ongoing Phase 3 portion of IMerge and the planned Phase 3 clinical trial in refractory MF, will compete with other clinical trials for product candidates that are in the same therapeutic areas with imetelstat and such trials may also be conducted at the same clinical sites. This competition will reduce the number and type of patients available to enroll or remain in current and potential future imetelstat clinical trials. Moreover, because imetelstat represents a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to use conventional therapies, rather than enroll patients into imetelstat clinical trials, or may decide not to enroll, or may not recommend enrollment, in clinical trials of imetelstat, including the Phase 3 portion of IMerge or the planned Phase 3 clinical trial in refractory MF, based on efficacy and safety results reported to date and that may be reported in the future.

Delays caused by the evolving effects of the COVID-19 pandemic or other factors in patient enrollment, or the inability to retain or treat patients, could result in increased costs due to extended timelines and other factors, and may lead to incomplete data sets, or adversely affect the timing or outcome of current and potential future clinical trials of imetelstat, such as the Phase 3 portion of IMerge or the planned Phase 3 clinical trial in refractory MF, which could prevent the commencement, conduct or completion of these trials and adversely affect the clinical development and potential commercialization of imetelstat. Such occurrences would severely and adversely affect our financial results, business and business prospects, and the future of imetelstat, and might cause us to cease operations.

Imetelstat may cause, or have attributed to it, undesirable or unintended side effects or other adverse events that could further delay or prevent the commencement and/or completion of clinical trials for imetelstat, further delay or prevent its regulatory approval, or limit its commercial potential.*

Imetelstat may cause, or have attributed to it, undesirable or unintended side effects or other adverse events affecting its safety or efficacy that could interrupt, further delay or halt current or potential future clinical trials of imetelstat, ~~including~~such as the Phase 3 portion of IMerge or the planned Phase 3 ~~portion of IMerge.~~clinical trial in refractory MF. For example, adverse events and dose-limiting toxicities observed in previous and ongoing clinical trials of imetelstat include:

~~Such adverse events and other safety issues, including deaths, were also observed in IMbark and the Phase 2 portion of IMerge.~~ If patients in any ~~potential future~~ clinical trials of imetelstat, including the Phase 2 and Phase 3 portions of IMerge, the planned Phase 3 ~~portion~~clinical trial in refractory MF, or any other potential future clinical trial of ~~IMerge,~~imetelstat, such as potential proof-of-concept studies in other hematologic myeloid malignancies, experience similar or more severe adverse events, or new or unusual adverse events, or if the FDA or other regulatory authorities determine that efficacy and safety data in current or potential future clinical trials of imetelstat do not support an adequate benefit-risk profile to justify continued treatment of patients, then the FDA or other regulatory authorities may again place one or more of the ~~IND~~INDs for imetelstat on clinical hold, as occurred in March 2014.

Further, clinical trials by their nature examine the effect of a potential therapy in a sample of the potential future patient population. As such, clinical trials conducted with imetelstat, to date and in the future, may not uncover all possible adverse events that patients treated with imetelstat may experience. Because remaining patients in the treatment phase ~~continue to receive imetelstat in~~of the Phase 2 portion of IMerge and patients in the Phase 3 portion of IMerge continue to receive imetelstat treatment, additional or more severe toxicities or safety issues, including additional serious adverse events and dose-limiting toxicities, may be observed as patient treatment continues and more data become available. In addition, ~~since~~because additional data are being generated from the Phase 2 ~~portion~~and Phase 3 portions of IMerge, the benefit-risk profile of imetelstat will continue to be assessed, including the risk of hepatotoxicity, severe cytopenias, fatal bleeding with or without any associated thrombocytopenia, patient injury or death, and any other severe adverse effects that may be associated with life-threatening clinical outcomes. If such toxicities or other safety issues in any clinical trial of imetelstat are determined by us, the FDA or any other regulatory authority to result in an unacceptable benefit-risk profile, then:

The occurrence of any of these events could interrupt, further delay, or halt, any development and potential commercialization of imetelstat by us, which would have a severe adverse effect on our results of operations, financial condition, business prospects and the future of imetelstat, any of which might cause us to cease operations.

Results ~~obtained in~~and data we disclosed from prior non-clinical studies and clinical trials domay not predict success in later clinical ~~trials. Likewise, preliminary data~~trials, and we cannot assure you that any ongoing or ~~statistical analyses from~~future clinical trials ~~should be considered carefully~~of imetelstat will lead to similar results and ~~with caution since final~~ data may be materially different from preliminary data or statistical analyses, particularly as more patient data become available.*that could potentially enable us to obtain any regulatory approvals.

Success in non-clinical testing and early clinical trials does not ensure that later clinical trials will be ~~successful.~~successful, nor does it predict final clinical trial results. We cannot be certain that any of the prior, current or potential future clinical trials of imetelstat will generate sufficient, consistent or adequate efficacy and safety data demonstrating a positive benefit-risk profile, which would be necessary to obtain regulatory approval to market imetelstat in any indication. ~~Product candidates~~Imetelstat in later stages of clinical trials may fail to show the desired benefit-risk profile despite having progressed through non-clinical studies and initial clinical trials. ~~Other~~Many companies in the biopharmaceutical industry have frequently suffered significant setbacks in later clinical trials, even after achieving promising results in earlier non-clinical studies or clinical trials.

~~Safety and efficacy data from previous or current~~A trial design that is considered appropriate for regulatory approval includes a sufficiently large sample size with appropriate statistical power, as well as proper control of bias, to allow a meaningful interpretation of the results. The preliminary results of imetelstat clinical trials with smaller sample sizes can be disproportionately influenced by the impact the treatment had on a few individuals, which limits the ability to generalize the results across a broader community, making the trial results less reliable than trials with a larger number of patients. As a result, there may be less certainty that imetelstat would achieve a statistically significant effect in ~~hematologic myeloid malignancies should not be relied upon as predictive or indicative of~~any future clinical trials. Moreover, with respect to the trial ~~results.~~design for the planned Phase 3 clinical trial in refractory MF, the FDA urged us to consider adding a third dosing arm to the trial to assess a lower dose and/or a more frequent dosing schedule that might improve the trial’s chance of success by identifying a less toxic regimen and/or more effective spleen response, one of the trial’s secondary endpoints. While we believe that testing a lower dose regimen would likely result in a lower median OS, the trial’s primary endpoint, in the imetelstat treatment arm without a clinically meaningful reduction in toxicity and we therefore determined not to add a third dosing arm to the trial design, our belief may ultimately be incorrect and our failure to add a third dosing arm, as urged to be considered by the FDA, could result in delays or failures to obtain regulatory clearance from the FDA and regulatory authorities in other countries to commence the trial or could result in the trial’s failure, or could otherwise delay, limit or prevent marketing approval of imetelstat.

In addition, in the Phase 2 portion of IMerge, the initial data review for the 25-patient expansion cohort that was conducted by Janssen in the second quarter of 2018, which Janssen called a “data snapshot,” exhibited an eight-week RBC-TI rate of 28%, while the 13-patient initial cohort exhibited an eight-week RBC-TI rate of 54%, resulting in an overall eight-week RBC-TI rate of 37% for the combined cohorts. Patients in both the initial and expansion cohorts were naïve to both HMA and lenalidomide and were non-del(5q). We believe the observed difference in eight-week RBC-TI rate between the 13-patient initial cohort and the 25-patient expansion cohort may be attributable to factors such as the maturity of the data at the time of the data snapshot, since the median follow-up time of the expansion cohort at the time of the data snapshot was less than half the length of time the 13-patient initial cohort had been followed when their data were first reported, or the higher overall baseline transfusion burden of the expansion cohort. Although the latest reported eight-week RBC-TI rate in May 2020 is higher than that reported in the data snapshot from the second quarter of 2018, we cannot assure you that the eight-week RBC-TI rate reported for the combined cohorts i n the Phase 2 portion of IMerge will improve further with longer follow-up, or at all, or that the eight-week RBC-TI rate of patients enrolled in the Phase 3 portion of IMerge will be comparable to what has been reported in the 13-patient initial cohort, the 25-patient expansion cohort, or the combined cohorts in the Phase 2 portion of IMerge. In general, Phase 3 clinical trials with larger numbers of patients or longer durations of therapy may fail to replicate efficacy results observed in earlier clinical trials, or may reveal safety concerns that were not identified in smaller or shorter trials, any of which could adversely affect future development prospects of imetelstat.

In addition, non-clinical and clinical data are often susceptible to varying interpretations and analyses. In some instances, there can be significant variability between different clinical trials of imetelstat due to numerous factors, including changes in trial procedures set forth in trial protocols, differences in the size and type of patient populations, and changes in and adherence to the dosing regimens. For example, complete and partial remissions were observed in the pilot study of imetelstat conducted at Mayo Clinic, or ~~the Pilot Study, suggested potential disease-modifying activity of imetelstat in the MF patient population enrolled in~~ the Pilot Study. However, similar activity was not observed in the MF patients enrolled in IMbark, as shown by the one partial remission observed in the IMbark primary analysis. We believe that differences in the IMbark study design when compared to the Pilot Study design, such as more restrictive patient enrollment criteria requiring either documented objective lack of response to a

JAK inhibitor or evidence of progressive disease while on treatment with a JAK inhibitor, may have contributed to the data observed in IMbark differing significantly from data reported from the Pilot Study, but we cannot assure you that any future clinical trials of imetelstat in MF will yield results comparable to IMbark or the Pilot Study. In addition, the potential improvement in survival observed in the 9.4 mg/kg dosing arm in ~~IMbark~~IMbark will need to be further assessed in a the planned Phase 3 clinical trial ~~comparing imetelstat to a control therapy,~~in refractory MF, and similar results, including potential improvement in survival, if any, with respect to any patient population or patient population subgroup, may not be ~~observed.~~observed in the planned Phase 3 clinical trial in refractory MF. Likewise, although the statistical analyses comparing IMbark data to closely matched real-world data, or RWD, ~~recently~~ reported at the EHA Annual Congress ~~meeting~~meetings in June 2019 suggest favorable ~~overall survival~~OS for imetelstat-treated relapsed/refractory MF patients compared to best available therapy using closely matched patients’ RWD, such comparative analyses between RWD and our clinical trial data have several limitations. For instance, the analyses create a balance between treatment groups with respect to commonly available covariates, but do not take into account the unmeasured and unknown covariates that may affect the outcomes of the analyses. Potential biases are introduced by factors which include, for example, the selection of the patients included in the analyses, misclassification in the matching process, the small sample size, and estimates that may not represent the outcomes for the true treated patient population. For these and other reasons, such comparative analyses and any conclusions from such analyses should be considered carefully and with caution, and should not be relied upon as demonstrative or otherwise predictive or indicative of any future clinical trial results of imetelstat in relapsed/refractory ~~MF.~~

Similarly, in the Phase 2 portion of IMerge, the initial data review for the expansion cohort that was conducted by Janssen in the second quarter of 2018, which Janssen called a “data snapshot,” exhibited 8-week RBC-TI rate of 28%, while the 13-patient initial cohort exhibited 8-week RBC-TI rate of 54% resulting in an overall 8-week RBC-TI rate of 37% for the combined cohorts. We believe the observed difference in 8-week RBC-TI rate between the 13-patient initial cohort and the 25-patient expansion cohort may be attributable to factors such as the maturity of the data at the time of the data snapshot since the median follow-up time of the expansion cohort at the time of the data snapshot was less than half the length of time the 13-patient initial cohort had been followed when their data were first reported, or the higher overall baseline transfusion burden of the expansion cohort. Although the latest reported 8-week RBC-TI rate in June 2019 is higher since the “data snapshot”, we cannot assure you that the 8-week RBC-TI rate reported for the combined cohorts in the Phase 2 portion of IMerge will improve further with longer follow-up, or at all, or that the 8-week RBC-TI rate of patients to be enrolled in theMF, including our planned Phase 3 ~~portion~~clinical trial in refractory MF.

Failure to achieve positive results in current or potential future imetelstat clinical trials would interrupt, further delay, or halt, any development and potential commercialization of ~~IMerge, if~~imetelstat by us, which would have a severe adverse effect on our results of operations, financial condition, business prospects and the future of imetelstat, any ~~will~~of which might cause us to cease operations.

Interim, “snapshot,” “top-line,” and preliminary data or statistical analyses from clinical trials that we announce or publish from time-to-time may change as more patient data become available, may not be ~~comparable~~similar to ~~what has been reported~~the final data, and are subject to audit and verification procedures that could result in material changes in the 13-patient initial cohort, the 25-patient expansion cohort, or the combined cohorts. In this regard, because patients remaining in the treatment phase in the Phase 2 portion of IMerge continue to receive imetelstat, data continue to be generated from the trial and will continue to evolve until all patients have ceased treatment. More mature data that may be reported from the Phase 2 portion of IMerge in the future may materially differ from data previously reported.final data. Thus, ~~the reported~~such preliminary data should be considered carefully and with ~~caution.~~

~~Additional or updated safety~~caution and ~~efficacy data from current or potential~~not relied upon as indicative of future ~~imetelstat~~ clinical trials may result in a benefit-risk profile that does not justify continued development of imetelstat in a particular patient population, or at all. For example, because patients remaining in the treatment phase continue to receive imetelstat in the Phase 2 portion of IMerge, efficacy and safety data continue to be generated. Such additional data could result in a lower benefit-risk profile than initially expected, which could hinder the commencement, completion and potential success of the planned Phase 3 portion of IMerge, or could cause us to abandon further development of imetelstat entirely. Data from the planned Phase 3 portion of IMerge could materially differ from the overall conclusions reported for the Phase 2 portion of IMerge. In general, Phase 3 clinical trials with larger numbers of patients or longer durations of therapy may fail to replicate efficacy results observed in earlier clinical trials, or may reveal safety concerns that were not identified in smaller or shorter trials, any of which could adversely affect future development prospects of imetelstat.results.

From time-to-time, preliminary or interim safety and efficacy data from previous and current imetelstat clinical trials have been reported or announced by us, clinical investigators or ~~Janssen.~~our prior collaboration partner(s). For example, preliminary data from the Phase 2 portion of IMerge ~~was~~were reported at the ASH Annual Meetings in December 2017 and December 2018, ~~and~~ at the EHA Annual Congress meetings in June 2018 and June ~~2019.~~2019, and in the imetelstat EHA abstracts announced in May 2020. We expect similar reports or announcements of safety and efficacy data from us or clinical investigators as data matures in current imetelstat clinical trials and from potential future clinical ~~trials.~~trials , including our planned Phase 3 clinical trial in refractory MF. Preliminary or interim results may not be reproduced in any potential future clinical trials of imetelstat, and thus should be considered carefully and with caution, and not relied upon as indicative of future clinical results. Material adverse differences in final data, compared to preliminary or interim data, could severely and adversely affect our financial results, business and business prospects, and the future of imetelstat, and might cause us to cease operations.

Additional or updated safety and efficacy data from current or potential future imetelstat clinical trials may result in a benefit-risk profile that does not justify the continued development of imetelstat in a particular patient population, or at all. For example, because patients remaining in the treatment phase continue to receive imetelstat in the Phase 2 portion of IMerge, efficacy and safety data continue to be generated from the trial and will continue to evolve until all patients have ceased treatment. More mature data that may be reported from the Phase 2 portion of IMerge and any data from the Phase 3 portion of IMerge or the planned Phase 3 clinical trial in refractory MF in the future may materially differ from data previously reported in IMerge, including with respect to the data previously reported from the initial and expansion cohorts in the Phase 2 portion of IMerge, and IMbark. Thus, the reported data should be considered carefully and with caution, and not relied upon as indicative of future clinical results. Such additional data could result in a lower benefit-risk profile than initially expected, which could hinder the enrollment, completion and potential success of the Phase 3 portion of IMerge or the planned Phase 3 clinical trial in refractory MF, or cause us to abandon further development of imetelstat entirely.

The research and development of imetelstat is subject to numerous risks and uncertainties.

The science and technology of telomere biology, telomerase and our proprietary oligonucleotide chemistry are relatively new. There is no precedent for the successful commercialization of a therapeutic product candidate based on these technologies. Significant research and development activities will be necessary to further develop imetelstat, which is our sole product candidate, which may take years to accomplish, if at all.

Because of the significant scientific, regulatory and commercial challenges that must be overcome to successfully research, develop and commercialize imetelstat, the development of imetelstat in hematologic myeloid malignancies, including MF and MDS,

or any other indications, may be further delayed or abandoned, even after significant resources have been expended on it. Examples of such situations include:

Further delay, suspension or abandonment of the development of imetelstat in hematologic myeloid malignancies, including ~~further delays~~ resulting from ~~the termination of the Collaboration Agreement, transition of the imetelstat program from Janssen to us, and~~ our ~~ability~~inability to successfully enroll, conduct and complete the ongoing Phase 3 portion of IMerge and the planned Phase 3 clinical trial in refractory MF, and to plan for, commence, conduct and ~~conduct~~complete potential future clinical trials of imetelstat, ~~including the planned Phase 3 portion of IMerge,~~such as potential proof-of-concept studies in other hematologic myeloid malignancies, could have a material adverse effect on the future of imetelstat and our business prospects, and we might cease operations.

If we encounter difficulties enrolling or retaining patients in current or potential future clinical trials of imetelstat, including in the planned Phase 3 portion of IMerge, clinical development and commercialization activities could be further delayed or otherwise adversely affected, which would cause our business and business prospects to be severely harmed, and we might cease operations.

The timely completion of a clinical trial in accordance with its protocol depends, among other things, on the ability to enroll a sufficient number of patients who remain in the trial until its conclusion. For example, if we experience difficulties in retaining patients in follow-up in the extension phase of IMbark, our ability to continue to assess overall survival, or OS, would be adversely affected. If we experience difficulties in retaining patients in the treatment or follow-up phase of the Phase 2 portion of IMerge, our ability to continue to assess the durability of RBC-TI responses would be adversely affected. In addition, we may encounter challenges in enrolling and retaining patients in potential future clinical trials of imetelstat, including the planned Phase 3 portion of IMerge, for a variety of reasons. The enrollment and retention of patients depends on many factors, including:

In addition, potential future clinical trials of imetelstat, including the planned Phase 3 portion of IMerge, will compete, with other clinical trials for product candidates that are in the same therapeutic areas with imetelstat and such trials may also be conducted at the same clinical sites, and this competition will reduce the number and type of patients available to enroll or remain in the imetelstat clinical trials. Moreover, because imetelstat represents a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to use conventional therapies, rather than enroll patients into imetelstat clinical trials, or may decide not to enroll, or may not recommend enrollment, in future clinical trials of imetelstat, based on efficacy and safety results reported to date and that may be reported in the future.

Delays in patient enrollment or the inability to retain or treat patients could result in increased costs, lead to incomplete data sets, or adversely affect the timing or outcome of current or potential future clinical trials of imetelstat, including the planned Phase 3 portion of IMerge, which could prevent completion of these trials and adversely affect the clinical development and potential commercialization of imetelstat. Such occurrences would severely and adversely affect our financial results, business and business prospects, and the future of imetelstat, and might cause us to cease operations.

We ~~do not~~ have limited experience as a company in conducting large-scale, late-stage clinical trials, such as the ~~planned~~ Phase 3 portion of IMerge, the planned Phase 3 clinical trial in refractory MF, or potential future similar trials, orand no prior experience as a company in those functional areas that would be required for the successful commercialization of our sole product candidate, imetelstat.*

Although we recently have hired individuals who have experience conducting Phase 3 clinical trials, as a company we have nolimited experience in conducting large-scale, late-stage clinical trials, such as the ~~planned~~ Phase 3 portion of IMerge ~~nor do we have experience with activities that would be required for~~or the ~~commercialization of imetelstat, should we receive future regulatory approval to do so.~~planned Phase 3 clinical trial in refractory MF. We cannot be certain that we will be able to ~~commence,~~ enroll, conduct or complete the ~~planned~~ Phase 3 portion of IMerge, the planned Phase 3 clinical trial in refractory MF, or any other future large-scale, late-stage clinical trial of imetelstat, in a timely fashion, or at all. Large-scale, late-stage clinical trials will require additional financial resources and certain internal development experience that we are ~~seeking to develop,~~developing, as well as increased reliance on third-party clinical investigators, CROs, service providers, vendors, suppliers and consultants. Relying on these third parties and establishing effective and collaborative relationships with them to conduct large-scale, late-stage clinical trials may cause further delays that are outside of our control. Any such further delays could have a material adverse effect on our business.

We ~~also~~ do not have experience as a company with activities that would be required for the commercialization ~~capabilities.~~of imetelstat, should we receive future regulatory approval to do so. Developing an internal sales, marketing and distribution capability ~~would be~~is an expensive and time-consuming process, and will require additional management expertise. We may not be able to negotiate and enter into third-party marketing and distribution agreements on terms that are economically attractive, or at all. Even if we do enter into such agreements, third-party marketers and distributors may not successfully market or distribute our sole product candidate, imetelstat.

Our inability to successfully plan, commence, enroll, conduct and complete large-scale, late-stage clinical trials, such as the ~~planned~~ Phase 3 portion of IMerge, the planned Phase 3 clinical trial in refractory MF, or future similar trials, or to successfully establish commercialization capabilities for imetelstat if we receive future regulatory approval to do so, would severely and adversely affect our financial results, business and business prospects, and the future of imetelstat, and might cause us to cease operations.

We rely on third parties to conduct our current and potential future clinical trials of imetelstat. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to continue the development of, obtain regulatory approval for, or commercialize imetelstat.*

We do not have the ability to independently conduct clinical trials. Therefore, we rely on medical institutions, clinical investigators, contract laboratories and other third parties, such as CROs, service providers, vendors, suppliers and consultants, to

conduct clinical trials of imetelstat. The third parties with whom we contract for execution of our current and potential future clinical trials of imetelstat play a critical role in the conduct of these trials and the subsequent collection and analysis of data. However, these third parties are not our employees, and except for contractual duties and obligations, we have limited ability to control their performance, or the amount or timing of resources that they devote to imetelstat. For example, we have retained ~~a CRO~~CROs to support our imetelstat clinical development activities, ~~including the planned Phase 3 portion of IMerge,~~ and any failure by our ~~CRO~~CROs to perform ~~its~~their contractual obligations whether due to the evolving effects of the COVID-19 pandemic or otherwise, or disputes with our ~~CRO~~CROs about the quality of ~~its~~their performance or other ~~matters,~~

matters, could ~~cause~~prevent us from enrolling, conducting or completing the ~~expected commencement~~Phase 3 portion of ~~screening and enrollment of~~IMerge or the planned Phase 3 ~~portion of IMerge to be delayed beyond August 2019 or prevent us from commencing, conducting or completing the planned Phase 3 portion of IMerge,~~clinical trial in refractory MF, or could otherwise further delay or halt our imetelstat clinical development ~~activities.~~activities including the planned Phase 3 clinical trial in refractory MF or future similar trials. These third parties may also have relationships with other commercial entities, some of which may compete with us. Under certain circumstances, these third parties may terminate their agreements with us without cause and upon immediate written notice.

Although we ~~will~~ rely on third parties to conduct any imetelstat clinical trials, including the ~~planned~~ongoing Phase 3 portion of IMerge and the planned Phase 3 clinical trial in refractory MF, we remain responsible for ensuring that each clinical trial is conducted in accordance with its investigational plan and protocol. Moreover, the FDA and foreign regulatory authorities require us to comply with regulations and standards, including regulations commonly referred to as good clinical practices, or GCPs, for conducting, monitoring, recording and reporting the results of clinical trials to ensure that the data and results are scientifically credible and accurate, and that patients are adequately informed of the potential risks of participating in clinical trials. Our ability to comply with these regulations and standards is contingent upon activities conducted by third parties, and if they fail to perform in accordance with contractual obligations and legal requirements, our development of imetelstat may be interrupted, further delayed or halted, which would have a severe adverse effect on our results of operations, financial condition, business prospects and the future of imetelstat, any of which might cause us to cease operations.

In addition, the execution of clinical trials and the subsequent compilation and analysis of the data produced, requires coordination among various parties. In order for these functions to be carried out effectively and efficiently, it is imperative that these parties communicate and coordinate with one another. If the quality or accuracy of the clinical data obtained, compiled or analyzed by third parties is compromised due to their failure to adhere to our clinical trial protocols or GCPs, or for any other reason, we may need to enter into new arrangements with alternative third parties, which would cause delay, and could be difficult, costly or impossible. If third parties conducting our clinical trials do not perform their contractual duties or obligations, experience work stoppages, do not meet expected deadlines, terminate their agreements with us or need to be replaced, our clinical trials may be extended, delayed or terminated, or may be unsuccessful or need to be repeated, which could have a material adverse effect on our business and might cause us to cease operations.

~~Encountering delays or difficulties in transitioning the imetelstat program from Janssen~~Risks Related to ~~us would prevent us from timely developing imetelstat, or preclude us from developing imetelstat at all, which could severely~~Regulatory Compliance Matters and adversely affect our financial results, business and business prospects, and might cause us to cease operations.*

~~Although in May 2019, Janssen transferred the imetelstat investigational new drug, or IND, sponsorship to us, and we assumed sponsorship in certain countries outside~~Commercialization of the United States in the second quarter of 2019, there are many remaining responsibilities that must also be transitioned to us under the terms of the Collaboration Agreement. Although we expect that the transition will proceed until the end of September 2019, and will include the transfer of all ongoing clinical, regulatory, medical affairs and non-clinical activities to us, these responsibilities may not be transitioned to us on a timely basis, or at all. For example, we expect to obtain country-specific health authority and ethics committee approvals for a change of sponsorship to us in remaining countries outside of the United States on a country-by-country basis during the third quarter of 2019; however, these approvals may not occur on a timely basis, or at all. Moreover, although we have entered into a supply agreement, or Supply Agreement, with Janssen to purchase ~~certain inventories of drug product, drug substance and raw materials for imetelstat manufacturing, the material may not meet our specifications, or Janssen may fail to ship the material to us on a timely basis, or at all.~~Imetelstat

Our ~~future clinical development plans for imetelstat substantially depend on the timely~~inability to maintain regulatory clearances and ~~comprehensive transition of the imetelstat program from Janssen~~approvals to us. Delays in completing the transition activities, failure to obtain the necessary regulatory approvals for the transition in all jurisdictions, failure by us or our contractors to successfully assume all clinical trial responsibilities, and/or unwillingness and/or inability by Janssen to fully perform all of the transition activities and its obligations to us under the Supply Agreement will further delay or precludecontinue the clinical development of, and to potentially commercialize, imetelstat, increase our operating costs and thereby negatively impact our financial results, as well as harm imetelstat’s future prospects, any of which could severely and adversely affect our business and business prospects, and might cause us to cease operations.

~~During the remainder of the transition period, we will remain dependent on Janssen for several key operational development areas. Poor or incomplete performance by Janssen in these areas could~~would severely and adversely affect imetelstat’s future value and our business and business prospects, and might cause us to cease operations.*

~~During the remainder of the transition period, we will remain dependent on Janssen to perform certain activities related to imetelstat, which subjects us to a number of risks, including:~~

~~The occurrence of any of these events could severely and adversely affect imetelstat’s future value and our business and business prospects, and might cause us to cease operations~~.

Maintaining regulatory clearances and approvals to continue the clinical development of imetelstat, and obtaining future regulatory clearances to potentially market imetelstat, in the United States and other countries, is a costly and lengthy process, and we cannot predict when or if regulatory authorities will permit additional imetelstat development or when or if regulatory authorities will approve imetelstat for commercial sale.*

Federal, state and local governments in the ~~United States~~U.S. and governments in other countries have significant regulations in place that govern drug research and development and may prevent us from successfully conducting development efforts or potentially commercializing imetelstat. Delays in obtaining or failure to maintain regulatory clearances and approvals or limitations in the scope of such clearances or approvals could:

Before we can seek to obtain regulatory approval for the commercial sale of imetelstat, multiple clinical trials, including larger-scale Phase 3 clinical trials, will need to be conducted to demonstrate if imetelstat is safe and effective for use in a diverse population. ~~Significant~~ We expect significant additional research, ~~non-clinical testing~~manufacturing activities and clinical testing isto be required before we can file any application with the FDA or other regulatory authorities for regulatory approval of imetelstat. As such, we do not expect imetelstat to be commercially available for many years, if at all. Our clinical development program for imetelstat may not lead to regulatory approval from the FDA and similar foreign regulatory authorities if we fail to demonstrate that imetelstat is safe and effective. If imetelstat cannot be successfully developed in ~~potential future~~ clinical trials, including in the ~~planned~~ Phase 3 portion of IMerge or the planned Phase 3 clinical trial in refractory MF, our business and business prospects would be severely and adversely affected, and we might cease operations. Even if we do successfully complete one or more ~~future~~ clinical trials of imetelstat in hematologic myeloid malignancies, including the ~~planned~~ Phase 3 portion of IMerge ~~those~~or the planned Phase 3 clinical trial in refractory MF, the results ~~are~~will not necessarily be predictive of results of future pivotal trials that may be needed before we may submit a New Drug Application, or NDA, to the FDA for the initial or other future indications. We may therefore fail to further develop or commercialize ~~imetelstat.~~imetelstat, which would severely and adversely affect our business and business prospects, and might cause us to cease operations.

Obtaining potential future regulatory clearances to market imetelstat in the U.S. and other countries is a costly and lengthy process, and we cannot predict when or if regulatory authorities will approve imetelstat for commercial sale.*

~~If our interpretation~~The process of obtaining marketing approvals, both in the U.S. and abroad, is lengthy, expensive and uncertain. It may take many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Securing marketing approval requires the submission of extensive non-clinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product candidate’s safety and ~~efficacy data obtained from non-clinical studies~~efficacy. Securing marketing approval also requires the submission of information about the product manufacturing process to, and ~~clinical trials varies from interpretations~~inspection of manufacturing facilities by, the regulatory authorities. The FDA or other regulatory authorities inmay determine that imetelstat is not safe and effective, only moderately effective or has undesirable or unintended side effects, toxicities or other ~~countries, this would likely further delay, limit~~characteristics that preclude us from obtaining marketing approval or prevent ~~further~~or limit imetelstat’s commercial use. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render imetelstat not commercially viable. We do not expect imetelstat to be approved for commercial sale for many years, if at all.

In addition, changes in marketing approval policies during the development ~~and approval~~period, changes in or the enactment or promulgation of ~~imetelstat. For example, we are planning to conduct an End of Phase 2 meeting with the FDA by the end of the first quarter of 2020 to discuss~~additional statutes, regulations or guidance, or changes in regulatory ~~strategies~~review for ~~potential approval of imetelstat in relapsed/refractory MF. In preparation for that meeting, we plan to perform analyses to support our proposed strategies. The FDA~~a submitted product application, may ~~require more or different data or analyses than what has been generated or that we plan to generate~~cause delays in the ~~future, which would further delay our decision regarding,~~approval or rejection of an application. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may ~~preclude altogether, any late-stage development of imetelstat in relapsed/refractory MF. In addition, delays~~decide that our data are insufficient for approval and require additional non-clinical, clinical or rejections of regulatory approvals, or limitations in marketing authorizations, may be encountered as a result of changes in the regulatory environment or regulatory policy during the period of product development and/or the period of review of any application for regulatory approval for imetelstat.

other studies. The ~~benefit-risk profile of imetelstat will also affect the assessment by the~~ FDA and regulatory authorities in other countries will assess the overall benefit-risk profile of ~~the drug’s cost-effectiveness and/or marketability, which assessment could prevent or limit its approval for marketing~~imetelstat, and ~~successful commercial use. If regulatory submissions requesting approval to market imetelstat are submitted, the FDA and regulatory authorities in other countries~~ may conclude that the overall benefit-risk profile of imetelstat ~~treatment~~ does not merit approval of imetelstat for marketing or further development for any indication. ~~Any of these events could cause~~In addition, with respect to the trial design for the planned Phase 3 clinical trial in refractory MF, the FDA urged us to ~~halt future development~~consider adding a third dosing arm to the trial to assess a lower dose and/or a more frequent dosing schedule that might improve the trial’s chance of success by identifying a less toxic regimen and/or more effective spleen response, one of the trial’s secondary endpoints. While we believe that testing a lower dose regimen would likely result in a lower median OS, the trial’s primary endpoint, in the imetelstat treatment arm without a clinically meaningful reduction in toxicity and ~~commercialization~~we therefore determined not to add a third dosing arm to the trial design, our belief may ultimately be incorrect and our failure to add a third dosing arm, as urged to be considered by the FDA, could result in delays or failures to obtain regulatory clearance from the FDA to commence the trial or could result in the trial’s failure, or could otherwise delay, limit or prevent marketing approval of imetelstat ~~if any,~~by the FDA. Varying interpretations of the data obtained from non-clinical and clinical testing could delay, limit or prevent marketing approval of imetelstat which would ~~severely~~ harm imetelstat’s future value and our business and business ~~prospects, and might cause us to cease operations.~~prospects.

Imetelstat must receive all relevant regulatory approvals before it may be marketed in the ~~United States~~U.S. or other countries. Obtaining regulatory approval is a lengthy, expensive and uncertain process. For example, following the result of a referendum in ~~June~~ 2016, ~~the electorate in~~ the United Kingdom ~~voted in favor of exiting~~left the European Union ~~and in March 2017,~~on January 31, 2020, commonly referred to as Brexit. Pursuant to the ~~Government of~~formal withdrawal arrangements agreed between the United Kingdom ~~initiated the formal procedure of withdrawal from~~and the European ~~Union.~~Union, the United Kingdom will be subject to a transition period until December 31, 2020, during which EU rules will continue to apply. Negotiations between the United Kingdom and the European Union are expected to continue in relation to the customs and trading relationship between the United Kingdom and the European Union after December 31, 2020. Although the impact of the withdrawal of the United Kingdom from the European Union will not be known for some time, this could lead to a period of considerable uncertainty in relation to the regulatory process in Europe, which could result in a delay in the review of regulatory submissions made in Europe by biotechnology and pharmaceutical companies, including potentially by us in the future, and could also lead to less efficient, more expensive, and potentially lengthier regulatory review processes for companies like us, who may seek to obtain regulatory approval for drug products in the European Union or the United Kingdom. Such regulatory changes in the United Kingdom or elsewhere could adversely affect and/or delay our ability to obtain approval of, and market and sell, imetelstat in the ~~United States~~U.S. or other countries. ~~In addition, because imetelstat involves~~

Regulatory agencies may also not approve the ~~application~~labeling claims that are necessary or desirable for the successful commercialization of ~~new technologies and~~ a ~~new therapeutic approach, it may be subject to substantial additional review by various government~~drug, such as imetelstat. For example, future regulatory ~~authorities, and, as a result, the process of obtaining regulatory approvals~~clearances, if any, that we might obtain for imetelstat may ~~proceed more slowly~~be limited to fewer or narrower indications than ~~for product candidates based upon more conventional technologies, and any approval that~~we might request, or may be ~~received could limit the use of imetelstat. We do not expect imetelstat~~granted subject to ~~be approved for commercial sale for many years, if at all.~~

Even if the necessary time and resources are committed by us, the required regulatory clearances and approvals may not be obtained for imetelstat. Further, if regulatory clearances and approvals are obtained to commence commercial sales of imetelstat, they may impose significant limitations on the indicated uses or other aspects of the product label for which imetelstat can be marketed. An approval might also be contingent on the performance of ~~costly additional~~ post-marketing ~~clinical trials.~~ studies. Future regulatory clearances, if any, may be limited to a smaller patient population, or may require a different drug formulation or a different manufacturing process, than we might in the future decide to seek.

Any ~~failure to advance imetelstat to subsequent clinical trials,~~delay in obtaining or failure to obtain ~~regulatory approval~~required approvals of imetelstat, or limitations on any regulatory approval that we might receive in the future, if any, could reduce the potential commercial use of imetelstat, and potential market demand for imetelstat and therefore result in decreased revenue for us from any commercialization of imetelstat, any of which would severely and adversely affect our financial results, the price of our common stock, our business and business prospects, and the future of imetelstat, and might cause us to cease operations.

Although orphan drug designation has been granted to imetelstat for the treatment of MF and MDS in the U.S., and for MF in the EU, these designations may not be maintained, which would eliminate the benefits associated with orphan drug designation, including the potential for market exclusivity, which would likely result in decreased sales revenue from commercialization of imetelstat, if any, and would likely harm our business and business prospects.

The FDA granted orphan drug designation to imetelstat in June 2015 for the treatment of MF and for the treatment of MDS in December 2015, and the European Medicines Agency, or EMA, granted itorphan drug designation in December 2015 to imetelstat for the treatment of MF. The designation of imetelstat as an orphan drug does not guarantee that any regulatory authority will accelerate regulatory review of, or ultimately approve, imetelstat, nor does it limit the ability of any regulatory authority to grant orphan drug designation to product candidates of other companies that treat the same indications as imetelstat prior to imetelstat receiving any exclusive marketing approval.

We may lose orphan drug exclusivity if the FDA or EMA determines that the request for orphan drug designation was materially defective or if we cannot ensure sufficient quantities of imetelstat to meet the needs of patients with MF or MDS.

Even if we maintain orphan drug exclusivity for imetelstat, the exclusivity may not effectively protect imetelstat from competition because different drugs with different active moieties can be approved for the same condition. Even after an orphan drug product is approved, the FDA or EMA can subsequently approve a different drug with the same active moiety for the same condition, if the FDA or EMA concludes that the later drug is safer, more effective, or makes a major contribution to patient care. The occurrence of any of these events could result in decreased sales of imetelstat, should it ever receive marketing approval, and may harm our business and business prospects. In addition, orphan drug designation will neither shorten the development time nor regulatory review time for imetelstat, and it does not give imetelstat any advantage in the regulatory review or approval process.

A Fast Track designation by the FDA, such as the Fast Track ~~designation~~designations received for imetelstat for MDS and relapsed/refractory MF, does not guarantee marketing approval and may not lead to a faster development, regulatory review or approval process.

In October 2017, the FDA granted ~~fast track~~Fast Track designation ~~for the~~to imetelstat ~~clinical development program~~ for the treatment of adult patients with transfusion-dependent anemia due to Low or Intermediate-1 risk MDS who are non-del(5q) and who are refractory or resistant to treatment with an ~~erythropoiesis stimulating agent.~~ESA. In September 2019, the FDA granted Fast ~~track~~Track designation to imetelstat for the treatment of adult patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to JAK inhibitor treatment.

Fast Track designation provides opportunities for frequent interactions with FDA review staff, as well as eligibility for priority review, if relevant criteria are met, and rolling ~~review.~~review of the sponsor’s NDA. Fast ~~track~~Track designation is intended to facilitate and expedite development and review of an NDA to address unmet medical needs in the treatment of serious or life-threatening conditions. However, ~~fast track~~Fast Track designation does not accelerate conduct of clinical trials or mean that the regulatory requirements are less stringent, nor does it ensure that any imetelstat NDA will ~~receive marketing approval~~be approved or that any approval will be granted within any particular timeframe. In addition, the FDA may withdraw ~~fast track~~Fast Track designation for any indication if it believes that the designation is no longer supported by data emerging from the imetelstat clinical development program.

Failure to achieve continued compliance with government regulations could delay or halt potential commercialization of imetelstat.

Approved products and their manufacturers are subject to continual review, and discovery of previously unknown problems with a product or its manufacturer may result in restrictions on the product or manufacturer, including import restrictions, seizure and withdrawal of the product from the market. If approved for commercial sale, future sales of imetelstat will be subject to government regulation related to numerous matters, including the processes of:

If, and to the extent that, we are unable to comply with these regulations, our ability to earn potential revenue from the commercialization of imetelstat, if any, would be materially and adversely impacted.

Failure to comply with regulatory requirements can result in severe civil and criminal penalties, including but not limited to:

The imposition of any of these penalties or other commercial limitations would severely and adversely affect our financial results, business and business prospects, and the future of imetelstat, and might cause us to cease operations.

~~RISKS RELATED TO MANUFACTURING IMETELSTAT~~Risks Related to Our Financial Position and Need For Additional Financing

Our failure to obtain substantial additional capital would force us to further delay, reduce or eliminate development of imetelstat, including the planned Phase 3 clinical trial in refractory MF and any potential proof-of-concept studies in other hematologic myeloid malignancies, and our potential future imetelstat commercialization efforts, any of which would severely and adversely affect our financial results, business and business prospects, and might cause us to cease operations.*

Successful drug development and commercialization requires significant amounts of capital. We will require substantial additional capital in order to further advance the imetelstat program, including to conduct and complete the planned Phase 3 clinical trial in refra ctory MF, and to conduct the research and development, clinical, regulatory and potential commercialization activities necessary to bring imetelstat to market. In this regard, our ability to conduct and complete the planned Phase 3 clinical trial in refractory MF, or to commence, conduct and complete other potential future clinical trials of imetelstat, such as potential proof-of-concept studies in other hematologic myeloid malignancies, will be dependent on our ability to raise substantial additional capital. In addition, our ability to commercialize imetelstat in the U.S., if regulatory approval is granted, depends on us being able to establish sales and marketing capabilities. Because the outcome of any clinical activities and/or regulatory approval process is highly uncertain, we cannot reasonably estimate whether any development activities we may undertake will succeed, and we may never recoup our investment in any imetelstat development, which would adversely affect our financial condition and our business and business prospects, and might cause us to cease operations. Our future capital requirements are difficult to forecast and will depend on many factors, including:

As a result of the termination of the Collaboration Agreement effective September 28, 2018, we are responsible for funding all clinical development, manufacturing, intellectual property maintenance and potential commercial activities for the imetelstat program. In order to further advance the imetelstat program, including conducting and completing the planned Phase 3 clinical trial in refractory MF or commencing, conducting and completing other potential future clinical trials in other indications, such as potential proof-of-concept studies in other hematologic myeloid malignancies, we will need to raise substantial additional capital or establish additional collaborative arrangements with third-party collaborative partners, which may not be possible. In addition, as a result of the termination of the Collaboration Agreement, we will not receive any milestone payments or royalties from Janssen for the development or sale of imetelstat, including any clinical development milestones. If we are unable to raise additional capital or establish alternative collaborative arrangements with third-party collaborative partners for imetelstat, the development of imetelstat may be further delayed, altered or abandoned, which might cause us to cease operations.

Additional financing through public or private equity financings, including pursuant to the 2018 Sales Agreement when it becomes available, capital lease transactions or other financing sources may not be available on acceptable terms, or at all. We may be unable to raise equity capital, or may be forced to do so at a stock price or on other terms that could result in substantial dilution of ownership for our stockholders. The receptivity of the public and private equity markets to proposed financings has been substan tially affected by uncertainty in the general economic, market and political climate caused by the evolving effects of the COVID-19 pandemic, and may in the future be affected by other factors which are unpredictable and over which we have no control. In t his regard, the effects of the COVID-19 pandemic have increased market volatility and could result in a significant long-term disruption of global financial markets, which could reduce or eliminate our ability to raise additional funds through financings, and could negatively impact the terms upon which we may raise those funds.

In addition, we may seek additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Due to uncertainty in the general economic, market and political climate, we may determine that it is necessary or appropriate to raise additional funds proactively to meet longer-term anticipated operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest may be diluted, and the terms may include liquidation or other preferences that materially and adversely affect your rights as a stockholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through alliance, collaborative or licensing arrangements with third parties, we may have to relinquish valuable rights to imetelstat or our technologies or grant licenses on terms that are not favorable to us.

We cannot assure you that our existing capital resources, future interest income, and potential future sales of our common stock, including under the 2018 Sales Agreement when it becomes available, will be sufficient to fund our operating plans. In any event, we will continue to need substantial additional funds to meet operational needs and capital requirements to advance the imetelstat program in clinical development, including to conduct and complete the planned Phase 3 clinical trial in refractory MF and potential commercialization, and our need for additional funds may a rise sooner than planned. If adequate funds are not available on a timely basis, if at all, we may be unable to pursue further development, including conducting and completing the planned Phase 3 clinical trial in refractory MF, or commencing, conducting or completing potential proof-of-concept studies in other hematologic myeloid malignancies, or pursuing potential commercialization of imetelstat, which would severely harm our business and we might cease operations.

We currently have no source of product revenue and may never become consistently profitable.

operations began in 1990. We will not receive any future milestone-based or royalty payments from Janssen relating to imetelstat, nor will Janssen share the cost of ongoing or future clinical trials of imetelstat or the costs for patents that were licensed to them under the terminated Collaboration Agreement, after September 28, 2018. We expect to continue to incur significant additional operating losses and our operating losses are likely to substantially i ncrease given our sole financial responsibility for imetelstat clinical development activities. As of March 31, 2020, our accumulated deficit was approximately $1.1 billion. Losses have resulted principally from costs incurred in connection with our research and development activities and from general and administrative costs associated with our operations.

Substantially all of our revenues to date have been payments under collaboration agreements and milestones, royalties and other revenues from our licensing arrangements. With the termination of the Collaboration Agreement effective September 28, 2018, we have no ongoing collaboration agreements related to imetelstat. The patents underlying our license agreements related to our human telomerase reverse transcriptase, or hTERT, technology have expired. Any final revenues generated from our remaining licensing agreements related to our hTERT technology are expected to be minimal, and will be insufficient to sustain our operations. We have no current plans to enter into any new corporate collaboration, partnership or license agreements that result in revenues.

We also expect to experience increased negative cash flow for the foreseeable future as we fund our operations and imetelstat clinical development activities advance. This will result in decreases in our working capital, total assets and stockholders’ equity. Further, we may be unable to replenish our working capital by future financings. We will need to generate significant revenues to achieve consistent future profitability. We may never achieve consistent future profitability. Even if we do become profitable in the future, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to achieve consistent future profitability could negatively impact the market price of our common stock and our ability to sustain operations.

The 2017 comprehensive tax reform bill, as modified by recent tax law changes enacted in March 2020, and possible future changes in tax laws or regulations could adversely affect our business and financial condition.*

On December 22, 2017, President Trump signed into law the Tax Cuts and Jobs Act of 2017, which we refer to as the Tax Act, which significantly revised the Internal Revenue Code of 1986, as amended, or the Code. Future guidance from the U.S. Internal Revenue Service and other tax authorities with respect to the Tax Act may affect us, and certain aspects of the Tax Act could be repealed or modified in future legislation. In addition, in response to the COVID-19 pandemic, the Coronavirus Aid, Relief and Economic Security Act, or the CARES Act, was signed into law in March 2020. The CARES Act lifts certain deduction limitations originally imposed by the Tax Act.

Changes in corporate tax rates, the realization of net deferred tax assets relating to our U.S. operations, the taxation of foreign earnings, and the deductibility of expenses under the Tax Act and the CARES Act or future tax reform legislation could have a material impact on the value of our deferred tax assets, could result in significant one-time charges in the current or future taxable years, and could increase our future U.S. tax expense. The foregoing items, as well as any other future changes in tax laws, could have a material adverse effect on our business, cash flow, financial condition, or results of operations. In addition, it is uncertain if and to what extent various states will conform to the Tax Act, the CARES Act or any newly enacted federal tax legislation.

Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.*

Our net operating loss carryforwards attributable to tax years ending before 2018 could expire unused and be unavailable to offset future income tax liabilities. Under the Tax Act, federal net operating losses incurred in taxable years beginning in 2018 and in future years may be carried forward indefinitely, but the deductibility of such federal net operating losses arising in taxable years beginning after 2020 is limited. Under the CARES Act, corporate taxpayers may carryback net operating losses originating in taxable years beginning after 2017 and before 2021 for up to five years, which was not previously allowed under the Tax Act. The CARES Act also eli minates in part the 80% of taxable income limitations of the Tax Act by allowing corporate entities to fully utilize net operating loss carryforwards to offset taxable income in taxable years beginning in 2018, 2019 or 2020. It is uncertain if and to what extent various states will conform to the federal tax law changes. In addition, under Section 382 of the Code, and corresponding provisions of state law, if a corporation undergoes an “ownership change,” generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period, the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes (such as research tax credits) to offset its post-change taxable income or taxes may be limited. Changes in our stock ownership, some of which are outside of our control, may have resulted in, or other future changes could result in, an ownership change. If a limitation were to apply, utilization of a portion of our domestic net operating loss and tax credit carryforwards could be limited in future periods. In addition, a portion of the carryforwards may expire before being available to reduce future income tax liabilities which could adversely impact our financial position.

Failure by ~~Janssen~~us to ~~ship materials as agreed under the Supply Agreement,~~ establish and/or ~~our failure to~~ ~~establish~~maintain a manufacturing supply chain to appropriately and adequately supply imetelstat for future clinical and commercial uses, would result in a further delay in or cessation of clinical trials and a further delay in or our inability to obtain regulatory approvals of imetelstat, and our business and business prospects could be severely harmed, and we could cease operations.*

Although we have ~~agreed under the Supply Agreement to purchase existing~~received inventories of drug product, ~~from Janssen and plan to purchase inventories of~~ drug substance and raw materials from Janssen under the Supply Agreement that meet our specifications, some of this material will require further processing in order to ~~supply the Phase 2 portion of IMerge and potential future~~be used in clinical trials, ~~of imetelstat, including the planned Phase 3 portion of IMerge, we~~and/or may ~~not receive these inventories on a timely basis, or at all, the materials may not meet the necessary quality standards, or the quantity of materials that meets our quality standards is insufficient~~also require regulatory review and acceptance prior to ~~supply potential future clinical trials of imetelstat, including the planned Phase 3 portion of IMerge. Accordingly,~~use. Therefore, we continue to work to ~~re-establish~~re-establish our own manufacturing supply chain in order to further process the Janssen purchased materials as well as to be able to manufacture and supply additional quantities of imetelstat that meet applicable regulatory standards for current and potential future clinical trials and potential commercial ~~uses meeting applicable regulatory standards.~~uses. The process of manufacturing imetelstat is complex and subject to several risks, including:

As a result of these and other risks, we may be unable to establish and/or maintain a manufacturing supply chain capable of providing imetelstat for the Phase 3 portion of IMerge, the planned Phase 3 clinical trial in refractory MF, and/or other potential future clinical trials of imetelstat, and potential future commercial ~~uses. In addition, Janssen may not perform as agreed or may default in its obligations to ship drug product, drug substance and raw materials for imetelstat manufacturing. Any of these occurrences~~uses, which would ~~further~~ delay or result in a cessation of the Phase 3 portion of IMerge, the planned Phase 3 clinical trial in refractory MF, or other potential future clinical trials ~~and~~of imetelstat. Occurrence of any such events would further delay or preclude any applications for regulatory approval and therefore further delay or preclude our ability to earn revenue from the commercialization, if any, of imetelstat, which would severely and adversely affect our financial results, business and business prospects, and might cause us to cease operations.

If third parties that manufacture imetelstat fail to perform as needed, then the clinical and commercial supply of imetelstat will be limited, and we may be unable to conduct or complete current or potential future clinical trials of imetelstat ~~including the planned Phase 3 portion of IMerge,~~ or to commercialize imetelstat in the future.*

Our planned imetelstat manufacturing supply chain is expected to rely solely upon third-party contractors to perform certain process development or other technical and scientific work with respect to imetelstat, as well as to supply starting materials and manufacture drug substance and drug product. While we ~~are currently in the process of establishing~~have established arrangements with third parties for the manufacture of imetelstat, our ~~failure~~manufacturing supply chain is highly specialized, and as such we are reliant upon a small group of third-party contractors to ~~establish~~supply starting materials, drug substance and drug product. Failure by such ~~arrangements~~third-party contractors to perform in a timely manner, or at all, could further delay, perhaps substantially, or preclude our ability to pursue imetelstat development on our own, increase our costs and otherwise negatively affect our financial results, business and business prospects. We may not be able to obtain imetelstat from third-party ~~manufacturers for imetelstat~~contractors on acceptable terms, or at all. We expect to rely on third-party contractors to produce and deliver sufficient quantities of imetelstat and other materials to support clinical trials on a timely basis and to comply with applicable regulatory requirements. We will not have direct control over these third-party personnel or operations. Reliance on these third-party manufacturers is subject to numerous risks, including:

Each of these risks could lead to delays or shortages in drug supply, or the inability to manufacture drug supply necessary for non-clinical and clinical activities, and commercialization. For example, manufacturing delays could adversely impact the ~~commencement~~conduct or completion of the Phase 3 portion of IMerge or the commencement, conduct or completion of the planned Phase 3 clinical trial in refractory MF or other potential future clinical trials, or preclude or delay potential future commercial sales, which could severely and adversely affect our financial results, business and business prospects, and the future of imetelstat, and might cause us to cease operations.

In addition, third-party contractors and/or any other contractors may need to make substantial investments to enable sufficient capacity increases and cost reductions, and to implement those regulatory and compliance standards necessary for successful Phase 3 clinical trials and commercial production of imetelstat. These third-party contractors may not be willing or able to achieve such capacity increases, cost reductions, or regulatory and compliance standards, and even if they do, such achievements may not be at commercially reasonable costs. Changing manufacturers may be prolonged and difficult due to inherent technical complexities and because the number of potential manufacturers is limited. It may be difficult or impossible for us to find a replacement manufacturer on acceptable terms, or at all.

It may not be possible to manufacture imetelstat at costs or scales necessary to conduct clinical trials or potential future commercialization activities.

Oligonucleotides are relatively large molecules produced using complex chemistry, and the cost of manufacturing an oligonucleotide like imetelstat is greater than the cost of making typical small molecule drugs. Therefore, imetelstat for clinical use is more expensive to manufacture than most other treatments currently available today or that may be available in the future. Similarly, the cost of manufacturing imetelstat for commercial use will need to be significantly lower than current costs in order for imetelstat to become a commercially successful product. We may not be able to achieve sufficient scale increases or cost reductions necessary for successful commercial production of imetelstat. Failure to achieve necessary cost reductions could result in decreased sales, if any, for us, which would materially and adversely affect our financial results, business and business prospects, and the future of imetelstat, and might cause us to cease operations.

~~RISKS RELATED TO MANAGING OUR GROWTH AND OTHER BUSINESS OPERATIONS~~Risks Related to Transition of the Imetelstat Program to Geron

Poor performance by Janssen of the imetelstat program prior to its transition to us, or lack of cooperation following its transition to us, could severely and adversely affect imetelstat’s future value and our business and business prospects, and might cause us to cease operations.

Although transition of the imetelstat program to us was completed by the end of September 2019, risks to our ability to develop imetelstat related to our past collaboration remain, including:

The occurrence of any of these events could severely and adversely affect imetelstat’s future value and our business and business prospects, and might cause us to cease operations.

We may be unable to successfully retain or recruit key personnel to support the development and potential future commercialization of imetelstat or to otherwise successfully manage our growth.*

Our ability to successfully develop imetelstat in the future and to potentially commercialize imetelstat depends to a significant extent on the skills, experience and efforts of our executive officers and key members of our staff. In addition, we will need to maintain and continue to hire experienced personnel in clinical science, biostatistics, clinical operations, pharmacovigilance, quality, manufacturing, ~~and~~ regulatory affairs, medical affairs and sales and marketing, to enable us to further develop and potentially commercialize imetelstat.

We face intense competition for qualified individuals from numerous pharmaceutical, biopharmaceutical and biotechnology companies, as well as academic and other research institutions, and competition in our geographic regions is particularly intense. ~~Termination~~The substantial risks and uncertainties related to our development and potential commercialization of ~~the Collaboration Agreement by Janssen,~~imetelstat, as well as the previous restructurings we implemented and the risks and uncertainties regarding our future business viability, could have an adverse impact on our ability to retain and recruit qualified personnel or we may incur unanticipated inefficiencies caused by our reduced personnel resources. We may also face higher than expected personnel costs in order to attract new management or development personnel, or to maintain our current executive officers and staff. If we are unable

to successfully retain, motivate and incentivize our existing personnel, or to attract, assimilate and retain other highly qualified management and senior development personnel in the future on acceptable terms, our ability to further develop imetelstat will be impaired, and our business and the price of our common stock would be adversely impacted. Further, if members of our management and other key personnel in critical functions across our organization are unable to perform their duties or have limited availability due to the evolving effects of the COVID-19 pandemic, we may not be able to execute on our business strategy and/or our operations may be negatively impacted.

As our operations continue to expand, we expect that we will need to manage new and additional relationships with various service providers, vendors, suppliers and other third parties, as well as additional and expanded office locations, for example, our recently leased office in northern New ~~Jersey.~~Jersey and the relocation of our corporate headquarters in California. Our ability to timely occupy and relocate to our new corporate headquarters in California has been delayed by the “shelter in place” order currently in effect in San Mateo County, and further depends on the performance by our lessor, as well as contractors and other third parties, of their contractual obligations. Such continued growth and expansion will require members of our management to assume significant added responsibilities. Our performance in managing any such future growth, if ineffective, could negatively impact our business prospects. We may not successfully manage our ~~anticipated~~ imetelstat development efforts effectively, including our current and potential future imetelstat clinical ~~trials, including the planned Phase 3 portion of IMerge, effectively.~~trials. If we fail to achieve key development goals, our abilities to grow as a company, and to further develop and potentially commercialize imetelstat, could be prevented or hindered, and ourour business and business prospects would be severely harmed, which might cause us to cease operations.

We expect imetelstat to remain our sole product candidate for the foreseeable future. If we are unable to successfully develop or commercialize imetelstat, our business and business prospects would be severely harmed, which might cause us to cease operations.

We plan to focus our efforts on the further development of imetelstat in hematologic myeloid malignancies. Accordingly, we do not currently have any plans to engage in any efforts to discover new product candidates. In addition, the outcome of our future efforts, if any, to seek to acquire and/or in-license other oncology products, product candidates, programs or companies in order to diversify our product candidate portfolio are highly uncertain and may be unsuccessful. As a result, we will be wholly reliant upon the

development of imetelstat, our sole product candidate, for the foreseeable future. If we are unable to successfully develop and commercialize imetelstat, our business and business prospects would be severely harmed, which might cause us to cease operations.

If we are unable to establish potential future collaborative arrangements for imetelstat, we may have to delay, alter or abandon our imetelstat development and commercialization plans.*

We intend to develop imetelstat broadly for hematologic myeloid malignancies, and to potentially commercialize, market and sell imetelstat ~~by ourselves~~ in the ~~United States.~~U.S. We plan to seek another collaborative partner or partners, at an appropriate time, to assist us in the potential development and commercialization of imetelstat outside the ~~United States,~~U.S., and to provide funding for such activities. We face significant competition in seeking appropriate collaborative partners, and these potential collaborative arrangements are complex and time consuming to negotiate, document and implement. Our ability to seek and establish potential collaborative arrangements may be delayed by the evolving effects of the COVID-19 pandemic. We may not be able to negotiate collaborative arrangements on acceptable terms, or at all. In this regard, collaborative arrangements with third parties may require us to relinquish material rights, including revenue from potential commercialization, on terms that are less attractive than under the Collaboration Agreement we had with Janssen, or to assume material ongoing development obligations that we would have to fund or otherwise support.

In any event, we are unable to predict when, if ever, we will enter into any collaborative arrangements because of the numerous risks and uncertainties associated with establishing collaborative arrangements. Moreover, as a result of the termination of the Collaboration Agreement and the significant ~~uncertainty~~risks and uncertainties regarding the future imetelstat development program, potential collaborative partners may be ~~less willing~~reluctant to enter into new collaborative arrangements with us, or may only be willing to do so on terms that are not favorable to us. As a result, we may not be successful in finding a new collaborative partner or partners on favorable terms, if at all. If we are unable to negotiate collaborative arrangements, we may have to:

In order to advance the imetelstat program, including ~~completing~~to conduct and complete the planned Phase 3 ~~portion of IMerge~~clinical trial in refractory MF, or to commence, conduct and complete other potential future clinical trials ~~in other indications,~~of imetelstat, as well as undertaking potential commercialization activities for imetelstat in the ~~United States,~~U.S., we will need to raise substantial additional capital. In addition, if we elect to increase our expenditures to fund imetelstat development or commercialization activities outside the ~~United States on our own,~~ U.S., we will be required to substantially increase our personnel resources and we will need to obtain substantial further capital, which may not be available to us on acceptable terms, or at all. If we ~~do not have sufficient funds,~~are unable to raise substantial additional capital, we will

not be able to advance the imetelstat program, including conducting and completing the planned Phase 3 ~~portion of IMerge~~clinical trial in refractory MF or other potential future clinical trials of imetelstat, such as potential proof-of-concept studies in other ~~indications, or~~hematologic myeloid malignancies, nor will we be able to bring imetelstat to market and generate product revenues. Establishing the infrastructure necessary to further develop, commercialize, market and sell imetelstat worldwide will require substantial resources and may divert the attention of our management and key personnel and negatively impact our imetelstat development or commercialization efforts in the ~~United States.~~U.S.

We currently have no products approved for commercial sale and we have not yet demonstrated an ability to obtain marketing approvals for any product candidates, which makes it difficult to assess our future viability.

We have never derived any revenue from the sales of any products. Our operations to date have been limited to organizing and staffing our company, acquiring, developing and securing our technology, undertaking non-clinical studies and ~~early stage~~ clinical trials of imetelstat and past product candidates that we have subsequently discontinued, and engaging in research and development under collaboration agreements. We have not yet demonstrated an ability to obtain regulatory approvals for commercialization activities, formulate and manufacture commercial-scale products, or conduct sales and marketing activities necessary for successful product commercialization. Consequently, for these and other reasons discussed elsewhere in these risk factors, it is difficult to predict our future success and the viability of our business and the imetelstat program.

We may not be able to obtain or maintain sufficient insurance on commercially reasonable terms or with adequate coverage against potential liabilities in order to protect ourselves against product liability claims or claims related to clinical trial conduct.

Our business exposes us to potential product liability and other risks that are inherent in the testing, manufacturing and marketing of human therapeutic and diagnostic products. We may become subject to product liability claims or claims related to clinical trial conduct if the use of imetelstat is alleged to have injured patients, including any injuries alleged to arise from any hepatotoxicity or hemorrhagic event associated with the use of imetelstat. We currently have limited clinical trial liability insurance, and we may not be able to maintain this type of insurance for any clinical trials, including the ~~planned~~ Phase 3 portion of IMerge or the planned Phase 3 clinical trial in refractory MF, or this type of insurance may become too expensive for us to afford because of the highly risky and uncertain nature of clinical trials generally and the high cost of insurance for our business activities. In addition, business liability and product liability insurance are becoming increasingly expensive, particularly for biotechnology and pharmaceutical companies, and the pool of insurers offering insurance coverage to biotechnology and pharmaceutical companies generally is becoming smaller, making it more difficult to obtain insurance for our business activities at a reasonable price, or at all. Being unable to obtain or maintain product liability, clinical trial liability, or other insurance for our business activities in the future on acceptable terms or with adequate coverage against potential liabilities ~~could~~would have a material adverse effect on our ~~business.~~business, and could cause us to cease our development of imetelstat.

We and certain of our officers have been named as defendants in two putative securities class action lawsuits and ~~may~~a shareholder derivative lawsuit. These lawsuits, and potential similar or related lawsuits, could result in ~~the future be, involved in securities-related legal actions that are expensive~~substantial damages, divert management’s time and ~~time consuming. Any securities-related legal actions, if resolved adversely, could harm~~attention from our business, ~~financial condition, or~~and have a material adverse effect on our results of operations. These lawsuits, and any other lawsuits to which we are subject, will be costly to defend or pursue and are uncertain in their outcome.*

Securities-related class action lawsuits and/or derivative lawsuits have often been brought against companies, including biotechnology and biopharmaceutical companies, that experience volatility in the market price of their securities. This risk is especially relevant for us because we often experience significant stock price volatility in connection with our product development activities. ~~In fact, we~~

Between January 23 and March 5 , 2020, three putative securities class action lawsuits were filed against us and certain of our ~~officers have previously been named~~officers. One of the lawsuits was voluntarily dismissed on March 19, 2020. The other two lawsuits are pending in the U.S. District Court for the Northern Dis trict of California, or the Northern District. The remaining putative securities class action lawsuits, which were consolidated on May 14, 2020, allege violations of the Securities Exchange Act of 1934, as amended, or the Exchange Act, in connection with allegedly false and misleading statements made by us related to IMbark during the period from March 19, 2018 to September 26, 2018. The complaints allege, among other things, that we violated Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 by failing to disclose facts related to the alleged failure of IMbark to meet the two primary endpoints of the trial, spleen response rate and Total Symptom Score, and that our stock price dropped when such information was disclosed. The plaintiffs seek damages and interest, and an award of reasonable costs, including attorneys’ fees.

On April 23, 2020, a shareholder derivative action, or the Derivative Lawsuit, was filed in the Northern District, naming as defendants certain of our current and former board members. The plaintiff in ~~purported~~the Derivative Lawsuit alleges breach of fiduciary duty and violations of Section 14 of the Exchange Act, based on the same underlying facts as the putative securities class action lawsuits described above. The plaintiff seeks damages, corporate governance reforms, equitable relief, restitution, and an award of reasonable costs, including attorneys’ fees. On May 19, 2020, the court deferred the Derivative Lawsuit until 30 days after an order on a motion to dismiss in the putative securities ~~lawsuits and/or derivative lawsuit.~~class action lawsuits.

~~The termination of the Collaboration Agreement could also result in litigation arising out of any claims that our stockholders suffered financial losses. T~~he market price of our common stock declined significantly after the announcement on September 27, 2018 of the termination of the Collaboration Agreement, and certain stockholders experienced significant financial losses. ~~Therefore, it~~It is possible that additional lawsuits will be filed, or allegations received from stockholders, with respect to these same or other matters and also naming us and/or our officers and directors as ~~defendants with respect~~defendants. Such lawsuits and any other related lawsuits are subject to inherent uncertainties, and the ~~termination~~actual defense and disposition costs will depend upon many unknown factors. The outcome of such lawsuits is necessarily uncertain. We could be forced to expend significant resources in the defense of the ~~Collaboration Agreement by Janssen~~pending lawsuits and any additional lawsuits, and we may not prevail. In addition, we may incur substantial legal fees and costs in connection with such lawsuits. We currently are not able to estimate the possible cost to us from these matters, as the pending lawsuits are currently at an early stage, and we cannot be certain how long it may take to resolve the pending lawsuits or ~~other matters related~~the possible amount of any damages that we may be required to ~~the Collaboration Agreement, future clinical trials of imetelstat, if any, including the planned Phase 3 portion of IMerge, or other business activities.~~pay. Monitoring, initiating and defending against legal actions is time-consuming for our management, is likely to be expensive and may detract from our ability to fully focus our internal resources on our business activities. We could be forced to expend significant resources in the settlement or defense of the pending lawsuits and any potential future lawsuits, and we may not prevail in such lawsuits. Additionally, we may not be successful in having any such ~~lawsuit~~lawsuits dismissed or settled within the limits of our insurance coverage.

We have not established any reserve for any potential liability relating to the pending lawsuits or any potential future lawsuits. It is possible that we could, in the future, incur judgments or enter into settlements of claims for monetary damages. A decision adverse

to our interests in ~~any such lawsuit,~~the pending lawsuits, or in similar or related litigation, could result in the payment of substantial damages, or possibly fines, and could have a material adverse effect on our business, our stock price, cash flow, results of operations and financial condition.

We may be subject to third-party litigation, and such litigation would be costly to defend or pursue and uncertain in its outcome.

Our business may bring us into conflict with our licensees, licensors, or others with whom we have contractual or other business relationships, or with our competitors or others whose interests differ from ours. We may experience employment-related disputes as we seek to expand our personnel resources. ~~If we are unable to resolve those conflicts on terms that are satisfactory to all parties, we may become involved in litigation brought by or against us.~~

We may face litigation with Janssen arising from or related to the Collaboration Agreement ~~and Janssen’s termination of it. Possible disagreements with Janssen could include disagreements regarding the transition of the imetelstat program from Janssen back to us,~~ and/or ~~the ownership or use of proprietary rights arising from the work performed by Janssen under the Collaboration Agreement.~~its termination. We may become involved in performance or other disputes with the ~~CRO~~CROs we have retained to support our imetelstat clinical development activities, or with other third parties such as service providers, vendors, manufacturers, suppliers or consultants, which could result in a further delay or cessation of current and potential future clinical trials and otherwise significantly further delay our ability to develop imetelstat. If we are unable to resolve those conflicts on terms that are satisfactory to all parties, we may become involved in litigation brought by or against us.

Lawsuits are subject to inherent uncertainties, and defense and disposition costs depend upon many unknown factors. Despite the availability of insurance, we may incur substantial legal fees and costs in connection with litigation. Lawsuits could result in judgments against us that require us to pay damages, enjoin us from certain activities, or otherwise negatively affect our legal or contractual rights, which could have a significant adverse effect on our business. In addition, the inherent uncertainty of such litigation could lead to increased volatility in our stock price and a decrease in the value of our stockholders’ investment in our ~~common stock.~~securities.

~~RISKS RELATED TO PROTECTING OUR INTELLECTUAL PROPERTY~~Risks Related to Protecting Our Intellectual Property

Our success and the success of our planned future development and commercialization of imetelstat will depend on our ability to protect our technologies and imetelstat through patents and other intellectual property rights.*

Protection of our proprietary technology is critically important to our business. Our success will depend in part on our ability to obtain, maintain, enforce and extend our patents and maintain trade secrets, both in the ~~United States~~U.S. and in other countries.~~Under the Hatch-Waxman Act,~~

The issuance of a patent ~~may be eligible for future patent term restoration of up~~is not conclusive as to ~~five years under certain circumstances. Depending upon the timing, duration~~its inventorship, scope, validity or enforceability, and ~~specifics of any potential marketing approval of imetelstat, one or more of~~ our owned or licensed U.S. patents may be eligible for patent term extension under the Hatch-Waxman Act. Similar extensions are also available in certain foreign countries and territories, such as in Japan and in Europe. However, should we seek such a patent term extension, we may not be granted any such patent term extension and/or the applicable time period of patent protection afforded could be less than five years.

~~Our~~ patents may be challenged in the courts or patent offices in the U.S. and abroad. Such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated or ~~circumvented,~~held unenforceable, which could limit our ability to stop others from using or commercializing imetelstat or our technology and/or limit the duration of the patent protection for imetelstat and our ~~patent rights may not provide proprietary protection or competitive advantages to us.~~technology. In the event that we are unsuccessful in obtaining, maintaining, enforcing and extending our patents and other intellectual property rights or having our licensors maintain the intellectual property rights we have licensed, the value of imetelstat and/or our technologies ~~and imetelstat~~ will be adversely affected, and we may not be able to further develop or potentially commercialize imetelstat. Loss or impairment of our intellectual property related to imetelstat might further delay or halt ongoing or potential future clinical trials of imetelstat and any applications for regulatory approval, and therefore further delay or preclude any future development or commercialization of imetelstat by us. Further, if imetelstat is approved for commercial sale, such loss of intellectual property rights could impair our ability to exclude others from commercializing products similar or identical to imetelstat and therefore result in decreased sales for us. Occurrence of any of these events would materially and adversely affect our financial results, business and business prospects, and the future of imetelstat, and might cause us to cease operations.

Obtaining and maintaining our patent rights depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.*

The U.S. Patent and Trademark Office, or the Patent Office, and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. In addition, periodic maintenance fees, renewal fees, annuity fees and various other government fees on patents and/or patent applications will have to be paid to the Patent Office and various government patent agencies outside the U.S. over the lifetime of our owned and licensed patents and/or patent applications and any patent rights we may own or license in the future. Maintaining such compliance may be impacted by the COVID-19 pandemic. Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, nonpayment of fees and failure to properly legalize and submit formal documents. In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. There are situations, however, in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, potential competitors might be able to enter the market with imetelstat or similar products, and this circumstance could harm our business and business prospects and the future of imetelstat. In addition, if we are

responsible for patent prosecution and maintenance of patent rights in-licensed to us, any of the foregoing could expose us to liability to the applicable patent owner.

Patent terms may be inadequate to protect our competitive position on imetelstat for an adequate amount of time.

Patents have a limited lifespan. In the U.S., the natural expiration of a patent is generally 20 years after its first effective nonprovisional filing date. Given the amount of time required for the development, testing and regulatory review of imetelstat, patents protecting imetelstat might expire before imetelstat is commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to imetelstat.

Under the Hatch-Waxman Act, a patent may be eligible for future patent term restoration of up to five years under certain circumstances. Depending upon the timing, duration and specifics of any potential marketing approval of imetelstat, one or more of our owned or licensed U.S. patents may be eligible for patent term extension under the Hatch-Waxman Act. Similar extensions are also available in certain foreign countries and territories, such as in Japan and in Europe. If we fail to apply for applicable patent term extensions or adjustments, we will have a more limited time during which we can enforce our granted patent rights. In addition, should we seek such a patent term extension, we may not be granted any such patent term extension and/or the applicable time period of such patent term extension could be less than five years. Moreover, in some countries, including the U.S., the scope of protection for claims under such patent term extensions, if any, does not extend to the full scope of the claims but is limited to the product composition as approved. If we do not have sufficient patent life to protect imetelstat, our financial results, business and business prospects, and the future of imetelstat would be materially and adversely affected, which might cause us to cease operations.

Changes in U.S. or foreign patent law or interpretations of such patent laws could diminish the value of our patents in general, thereby impairing our ability to protect our technologies and imetelstat.

The patent positions of pharmaceutical and biopharmaceutical companies, including ours, are highly uncertain and involve complex legal and technical questions. In particular, legal principles for biotechnology and pharmaceutical patents in the ~~United States~~U.S. and in other countries are evolving, and the extent to which we will be able to obtain patent coverage to protect our technologies and imetelstat, or enforce or defend issued patents, is uncertain.

A number of significant changes to U.S. patent law occurred when the Leahy-Smith America Invents Act, or the AIA, was signed into law on September 16, 2011. These include provisions that affect the way patent applications are examined and may affect patent litigation. Many of the substantive changes to patent law associated with the AIA, and in particular, the first to file provisions, became effective on March 16, 2013. For example, the AIA limits where a patentee may file a patent infringement suit, and provides for post-grant review procedures, which expands the grounds for any third party to assert invalidity of issued claims before the U.S. Patent and Trademark Office. The AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.

Since the publication of discoveries in scientific or patent literature tends to lag behind actual discoveries by at least several months and sometimes several years, the persons or entities that we name as inventors in our patents and patent applications may not have been the first to invent the inventions disclosed in the patent applications or patents, or the first to file patent applications for these inventions. As a result, we may not be able to obtain patents for discoveries that we otherwise would consider patentable and that we consider to be extremely significant to the future success of imetelstat. Thus, our ability to protect our patentable intellectual

property depends, in part, on our ability to be the first to file patent applications with respect to our inventions or inventions that were developed by Janssen under the Collaboration Agreement and to which we have an exclusive license for the future development, commercialization and manufacture of imetelstat. Delay in the filing of a patent application for any purpose, including further development or refinement of an invention, may result in the risk of loss of patent rights.

A number of significant changes to U.S. patent law occurred when the Leahy-Smith America Invents Act, or the AIA, was signed into law on September 16, 2011. These include provisions that affect the way patent applications are examined and may affect patent litigation. Many of the substantive changes to patent law associated with the AIA, and in particular, the first to file provisions, became effective on March 16, 2013. For example, the AIA limits where a patentee may file a patent infringement suit. The AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.

U.S. court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. ~~For example, on June 13, 2013, the U.S. Supreme Court, or the Court, issued a decision in~~ ~~Association for Molecular Pathology v. Myriad Genetics, Inc.~~ ~~holding that claims to isolated genomic DNA were not patentable subject matter, but claims to complementary DNA, or cDNA, molecules were patentable subject matter.~~ On March 20, 2012, in Mayo Collaborative Services, DBA Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., the Court held that several claims drawn to measuring drug metabolite levels from patient samples and correlating them to drug doses were not patentable subject matter. In addition, court rulings in cases such as BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig. and Promega Corp. v. Life Technologies Corp.have also narrowed the scope of patent protection available in certain circumstances. In addition to increasing uncertainty with regard to our ability to obtain ~~patents~~certain patent claims in the future, this combination of events may have created uncertainty with respect to the value of certain patents we have previously obtained or in-licensed.

~~In addition,~~Following the result of a referendum in ~~June~~ 2016, ~~the electorate of~~ the United Kingdom ~~voted to exit~~left the European Union ~~and in March 2017~~on January 31, 2020, commonly referred to as Brexit. Pursuant to the ~~Government of~~formal withdrawal arrangements agreed between the United Kingdom ~~initiated the formal procedure of withdrawal from~~and the European ~~Union. While~~ Union,

the ~~exit~~United Kingdom will be subject to a transition period until December 31, 2020, during which EU rules will continue to apply. Negotiations between the United Kingdom and the European Union are expected to continue in relation to the customs and trading relationship between the United Kingdom and the European Union after December 31, 2020. The impact of the withdrawal of the United Kingdom from the European Union ~~is planned, the exact timing of the withdrawal and the resulting effect of withdrawal~~ will not be known for some time, which could lead to a period of considerable uncertainty relating to our ability to obtain and maintain Supplementary Protection Certificates of imetelstat based on our United Kingdom patents and our ability to establish and maintain European trademarks in the United Kingdom.

In 2012, the European Union Patent Package, or EU Patent Package, regulations were passed with the goal of providing for a single pan-European Unity Patent, or UP, and a new European Unified Patent Court, or UPC, for litigation of European patents. Once established, the UPC would have jurisdiction over traditional European patents and new UPs in the United Kingdom and all Contracting Member States of the European Union. However, ~~political activity in~~ the United Kingdom ~~and a legal challenge in Germany~~ has ~~delayed ratification of the EU Patent Package in these countries. There have been many delays~~indicated that it will not take part in the UPC after Brexit and Germany’s constitutional court has recently ruled against ratification. It is uncertain that implementation of the EU Patent Package ~~and further delays may occur. When~~will occur in 2020. If the EU Patent Package is ratified and in effect, all European patents, including those issued prior to ratification, would by default automatically fall under the jurisdiction of the UPC and allow for the possibility of obtaining pan-European injunctions. Under the EU Patent Package as currently proposed, once the UPC is established, patent holders are permitted to “opt out” of the UPC on a patent-by-patent basis, although the time permitted for this opt-out is not yet known. Owners of traditional European ~~Patent~~patent applications who receive notice of grant after the EU Patent Package is ratified could validate the patent nationally, and file an opt-out demand. The EU Patent Package may increase the uncertainties and costs surrounding the enforcement or defense of our issued European patents. The full impact on future European patent filing strategy and the enforcement or defense of our issued European patents in member states and/or the UPC is not known.

Depending on decisions by the U.S. federal courts, ~~the U.S. Patent and Trademark Office, or~~ the Patent Office and similar authorities in foreign jurisdictions, the interpretation of laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents. Occurrence of these events and/or significant impairment of our imetelstat patent rights would severely and adversely affect our financial results, business and business prospects, and the future of imetelstat, which might cause us to cease operations.

Challenges to our owned or licensed patent rights would result in costly and time-consuming legal proceedings that could prevent or limit development of imetelstat.

Our patents or those patent rights we have licensed, including patent rights that we may seek with respect to inventions made by ~~Janssen under the Collaboration Agreement,~~past or future collaborators, may be challenged through administrative or judicial proceedings, which could result in the loss of important patent rights. For example, where more than one party seeks U.S. patent protection for the same technology in patent applications that are subject to the law before the implementation of the AIA, the Patent Office may declare an interference proceeding in order to ascertain the party to which the patent should be issued. Patent interferences are typically complex, highly

contested legal proceedings, subject to appeal. They are usually expensive and prolonged, and can cause significant delay in the issuance of patents. Our pending patent applications or our issued patents, or those we have licensed and may license from others, ~~including Janssen,~~ may be drawn into interference proceedings or be challenged through post-grant review procedures or litigation, any of which could delay or prevent the issuance of patents, or result in the loss of issued patent rights. We may not be able to obtain from our past or future collaborators the information needed to support our patent rights which could result in the loss of important patent rights.

Under the AIA, interference proceedings between patent applications filed on or after March 16, 2013 have been replaced with other types of proceedings, including derivation proceedings. The AIA also includes post-grant review procedures subjecting U.S. patents to post-grant review procedures similar to European oppositions, such as inter partesreview, or IPR, covered business method post-grant reviews and other post-grant reviews. This applies to all of our U.S. patents and those we have licensed and may license from others, ~~including Janssen,~~ even those issued before March 16, 2013. Because of a lower evidentiary standard necessary to invalidate a patent claim in Patent Office proceedings compared to the evidentiary standard in U.S. federal court, a ~~third party~~third-party could potentially provide evidence in a Patent Office proceeding sufficient for the Patent Office to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a ~~third party~~third-party could attempt to use the Patent Office procedures to invalidate patent claims that would not have been invalidated if first challenged by the ~~third party~~third-party as a defendant in a district court action. U.S. patents owned or licensed by us may therefore be subject to post-grant review procedures, as well as other forms of review and re-examination. In addition, the IPR process under the AIA permits any person, whether they are accused of infringing the patent at issue or not, to challenge the validity of certain patents. As a result, entities associated with hedge funds have challenged valuable pharmaceutical patents through the IPR process. Significant impairment of our imetelstat patent rights would severely and adversely affect our financial results, business and business prospects, and the future of imetelstat, which might cause us to cease operations.

Certain jurisdictions, such as Europe, New Zealand and Australia, permit oppositions to be filed against granted patents or patents proposed to be granted. Because we seek to enable potential global commercialization of imetelstat, securing both proprietary protection and freedom to operate outside of the ~~United States~~U.S. is important to our business. Opposition proceedings require significant time and costs, and if we are unsuccessful or are unable to commit these types of resources to protect our imetelstat patent rights, we could lose our patent rights and we could be prevented or limited in the development and commercialization of imetelstat.

As more groups become engaged in scientific research and product development in the areas of telomerase biology and hematologic malignancies, the risk of our patents, or patents that we have in-licensed, being challenged through patent interferences, derivation proceedings, IPRs, post-grant proceedings, oppositions, re-examinations, litigation or other means will likely increase. For example, litigation may arise as a result of our decision to enforce our patent rights against third parties. Challenges to our patents through these procedures would be extremely expensive and time-consuming, even if the outcome was favorable to us. An adverse outcome in a patent dispute could severely harm our ability to further develop or commercialize imetelstat, or could otherwise have a material adverse effect on our business, and might cause us to cease operations, by:

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting, maintaining, defending and enforcing patents on imetelstat and our technologies in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the U.S. are less extensive than those in the U.S. The requirements for patentability may differ in certain countries, particularly in developing countries; thus, even in countries where we do pursue patent protection, there can be no assurance that any patents will issue with claims that cover imetelstat and our technologies. There can be no assurance that we will obtain or maintain patent rights in or outside the U.S. under any future license agreements. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the U.S. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S., even in jurisdictions where we pursue patent protection, or from selling or importing products made using our inventions in and into the U.S. or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not pursued and obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the U.S. These products may compete with imetelstat and our technologies and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biotechnology and pharmaceutical products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. For example, many foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties. Proceedings to enforce our patent rights, even if obtained, in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. While we intend to protect our intellectual property rights in major markets for imetelstat, we cannot ensure that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market imetelstat. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop.

We may be subject to infringement claims that are costly to defend, and such claims may limit our ability to use disputed technologies and prevent us from pursuing research, development, manufacturing or commercialization of imetelstat.

The commercial success of imetelstat will depend upon our ability to research, develop, manufacture, market and sell imetelstat without infringing or otherwise violating the intellectual property and other proprietary rights of third parties. There is considerable intellectual property litigation in the biotechnology and pharmaceutical industries, and many pharmaceutical companies, including

potential competitors, have substantial patent portfolios. In the event our technologies infringe the rights of others or require the use of discoveries and technologies controlled by third parties, we may be prevented from pursuing research, development, manufacturing or commercialization of imetelstat, or may be required to obtain licenses to those patents or other proprietary rights or develop or obtain alternative technologies. For example, we are aware that certain third parties have or may be prosecuting patents and patent estates that may relate to imetelstat, and while we believe these patents will expire before imetelstat is able to be commercialized and/or that these patents are invalid and/or would not be infringed by the manufacture, use or sale of imetelstat, it is possible that the owner(s) of these patents will assert claims against us in the future. If that were to occur, we ~~would~~might need to obtain unblocking licenses from such third parties, develop alternative non-infringing technologies, which we may not be able to do at an acceptable cost or on acceptable terms, or at all, or cease the development of imetelstat. In addition, while ~~Janssen has~~our past collaboration agreements have terminated, ~~the Collaboration Agreement,~~ we are

still subject to indemnification obligations to ~~Janssen under the Collaboration Agreement,~~our collaborators, including with respect to claims of ~~third party~~third-party patent infringement.

Since we cannot be aware of all intellectual property rights potentially relating to imetelstat and its uses, we do not know with certainty that imetelstat, or the intended commercialization thereof, does not and will not infringe or otherwise violate any ~~third party’s~~third-party’s intellectual property. Any infringement claims against us would likely be expensive to resolve, and the cost of any unblocking license that we could be required to obtain is unpredictable and could be significant. If we are unable to resolve an infringement claim successfully, we could be subject to an injunction that would prevent us from potentially commercializing imetelstat and could also require us to pay substantial damages. In addition to infringement claims, in the future we may also be subject to other claims relating to intellectual property, such as claims that we have misappropriated the trade secrets of third parties. Provided that we are successful in continuing the development of imetelstat, we expect to see more efforts by others to obtain patents that are positioned to cover imetelstat. Our success therefore depends significantly on our ability to operate without infringing patents and the proprietary rights of others.

We may become aware of discoveries and technologies controlled by third parties that are advantageous or necessary to further develop or manufacture imetelstat. For example, as we transition the imetelstat program from Janssen to us, we may learn of changes to the imetelstat manufacturing process made by Janssen which would require us to obtain licenses to third party intellectual property rights. Under such circumstances, we may initiate negotiations for licenses to other technologies as the need or opportunity arises. We may not be able to obtain a license to a technology required to pursue the research, development, manufacture or commercialization of imetelstat on commercially favorable terms, or at all, or such licenses may be terminated on certain grounds, including as a result of our failure to comply with the obligations under such licenses. If we do not obtain a necessary license or if such a license is terminated, we may need to redesign such technologies or obtain rights to alternative technologies, which may not be possible, and even if possible, could cause further delays in the development efforts for imetelstat and could increase the development and/or production costs of imetelstat. In cases where we are unable to license necessary technologies, we could be subject to litigation and prevented from pursuing research, development, manufacturing or commercialization of imetelstat, which would materially and adversely impact our business. Failure by us to obtain rights to alternative technologies or a license to any technology that may be required to pursue research, development, manufacturing or commercialization of imetelstat would further delay current and potential future clinical trials of imetelstat and any applications for regulatory approval, impair our ability to sell imetelstat, if approved, and therefore result in decreased sales of imetelstat for us. Occurrence of any of these events would materially and adversely affect our business, and might cause us to cease operations.

We may become involved in disputes with past or future collaborator(s)~~, including Janssen,~~ over intellectual property inventorship, ownership or use, and publications by us, or by investigators, scientific consultants, research collaborators or others. Such disputes could impair our ability to obtain patent protection or protect our proprietary information, which, in either case, could have a significant impact on our business.

Inventions discovered under research, material transfer or other collaboration agreements ~~including our Collaboration Agreement with Janssen which was terminated effective September 28, 2018,~~ may become jointly owned by us and the other party to such agreements in some cases, and may be the exclusive property of either party in other cases. Under some circumstances, it may be difficult to determine who invents and owns a particular invention, or whether it is jointly owned, and disputes can arise regarding inventorship, ownership and use of those inventions. These disputes could be costly and time-consuming, and an unfavorable outcome could have a significant adverse effect on our business if we were not able to protect our license rights to these inventions. In addition, clinical trial investigators, scientific consultants and research collaborators generally have contractual rights to publish data and other proprietary information, subject to review by the trial sponsor. Publications by us, or by investigators, scientific consultants, previous employees, research collaborators or others, either with permission or in contravention of the terms of their agreements with us or ~~with Janssen~~without past or ~~otherwise,~~future collaborators, may impair our ability to obtain patent protection or protect proprietary information which would have a material adverse effect on our business, and might cause us to cease operations.

Much of the information and know-how that is critical to our business is not patentable, and we may not be able to prevent others from obtaining this information and establishing competitive enterprises.

We sometimes rely on trade secrets to protect our proprietary technology, especially in circumstances in which we believe patent protection is not appropriate or available. We attempt to protect our proprietary technology in part by confidentiality

agreements with our employees, consultants, collaborators and contractors. We cannot provide assurance that these agreements will not be breached, that we would have adequate remedies for any breach, or that our trade secrets will not otherwise become known or be independently discovered by competitors, any of which would harm our business significantly.

In May 2016, the Defend Trade Secrets Act of 2016, or the DTSA, was enacted, providing a federal cause of action for misappropriation of trade secrets. Under the DTSA, an employer may not collect enhanced damages or attorney fees from an employee or contractor in a trade secret dispute brought under the DTSA, unless certain advanced provisions are observed. We cannot provide assurance that our existing agreements with employees and contractors contain notice provisions that would enable us to seek enhanced damages or attorneys’ fees in the event of any dispute for misappropriation of trade secrets brought under the DTSA.

Significant disruptions of information technology systems, including cloud-based systems, or breaches of data security could adversely affect our business.*

Our business is increasingly dependent on critical, complex and interdependent information technology systems, including cloud-based systems, to support business processes as well as internal and external communications. ~~Our computer~~In particular, the COVID-19 pandemic has caused us to modify our business and information technology practices, including the requirement that our employees work remotely and not in our offices. Our computer and information technology systems, including in our remote work environment as a result of the COVID-19 pandemic, and those of our collaborators, service providers and contractors, are potentially vulnerable to breakdown, malicious intrusion, malware, computer viruses, natural disasters, terrorism, war, and telecommunication and electrical failures that may result in damage to or the impairment of key business processes, or the loss or corruption of confidential information, including intellectual property, proprietary business information and personal information. Such disruptions and breaches of security could have a material adverse effect on our business, financial condition and results of operations. The costs to us to mitigate network security problems, bugs, viruses, worms, malicious software programs and security vulnerabilities could be significant, and while we have implemented security measures to protect our data security and information technology systems, our efforts to address these problems may not be successful, and these problems could result in unexpected interruptions, delays, cessation of service and other harm to our business and our competitive position. In addition, we rely on our collaborators, service providers, including our ~~CRO,~~CROs, and contractors to establish and maintain appropriate information technology systems and data security protections. However, except for contractual duties and obligations, we have limited ability to control their actions related to such matters. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our imetelstat development program. For example, the loss of clinical ~~study~~trials data from completed, ongoing or planned clinical trials could result in delays in potential regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

In addition, our computer and information technology systems, as well as those of our collaborators, service providers and contractors, are potentially vulnerable to data security breaches, whether by employees, contractors, consultants, malware, phishing attacks, or other cyber-attacks, that may expose confidential information, intellectual property, proprietary business information or personal information to unauthorized persons. If a data security breach affects our systems or those of third parties upon which we rely, corrupts our data or results in the unauthorized disclosure or release of personally identifiable information by our collaborators, service providers, contractors or us, our reputation could be materially damaged, and we could be subject to significant fines, increased costs or loss of revenue. In addition, such a breach may require notification to governmental agencies, supervisory bodies, credit reporting agencies, the media or individuals pursuant to various federal, state and foreign data protection, privacy and security laws, regulations and guidelines, if applicable. These may include state breach notification laws, and the EU General Data Protection Regulation (EU) 2016/679, or GDPR. Accordingly, a data security breach or privacy violation that leads to unauthorized access to, disclosure or modification of personal information (including protected health information), that prevents access to personal information or materially compromises the privacy, security, or confidentiality of the personal information, could result in fines, increased costs or loss of revenue as a result of:

If we are unable to prevent such data security breaches or privacy violations or implement satisfactory remedial measures, our operations could be disrupted, and we may suffer loss of reputation, financial loss and other regulatory penalties because of lost or misappropriated information, including sensitive patient data. In addition, these breaches and other inappropriate access can be

difficult to detect, and any delay in identifying them may lead to increased harm of the type described above. Moreover, the prevalent use of mobile devices that access confidential information increases the risk of data security breaches, which could lead to the loss of ~~confidential~~confidential information, trade secrets or other intellectual property. While we have implemented security measures to protect our computer and information technology systems, because the techniques used to obtain unauthorized access, disable or degrade service, or sabotage systems, change frequently, become more sophisticated, and often are not recognized until launched against a target, we or our collaborators, service providers or contractors may be unable to anticipate these techniques or to implement adequate preventative

measures. In addition, failure to maintain effective internal accounting controls related to data security breaches and cybersecurity in general could impact our ability to produce timely and accurate financial statements and could subject us to regulatory scrutiny.

Changes in and failures to comply with U.S. and foreign privacy and data protection laws, regulations and standards may adversely affect our business, operations and financial performance.*

We are subject to or affected by numerous federal, state and foreign laws and regulations, as well as regulatory guidance, governing the collection, use, disclosure, retention, and security of personal data, such as information that we collect about patients and healthcare providers in connection with clinical trials in the ~~United States~~U.S. and abroad. Although we became Privacy Shield certified by the U.S. Department of Commerce’s International Trade Administration in April 2019, there is a risk that our Privacy Shield certification could be revoked or held by a court of competent jurisdiction to be an invalid basis for the transfer of personal data outside of the European Economic Area. The global data protection landscape is rapidly evolving, and implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future. This evolution may create uncertainty in our business, affect our or our collaborators’, service providers’ and contractors’ ability to operate in certain jurisdictions or to collect, store, transfer use and share personal information, necessitate the acceptance of more onerous obligations in our contracts, result in liability or impose additional costs on us. The cost of compliance with these laws, regulations and standards is high and is likely to increase in the future. Any failure or perceived failure by us or our collaborators, service providers and contractors to comply with federal, state or foreign laws or regulation, our internal policies and procedures or our contracts governing processing of personal information could result in negative publicity, diversion of management time and effort and proceedings against us by governmental entities or others. In many jurisdictions, enforcement actions and consequences for noncompliance are rising.

In the ~~United States,~~U.S., California ~~enacted~~adopted the California Consumer Privacy Act, ~~(CCPA) on June 28, 2018,~~or CCPA, which ~~takes effect on~~became effective in January 1, 2020. The CCPA ~~gives California residents expanded rights to access and delete their~~establishes a privacy framework for covered businesses, including an expansive definition of personal information ~~opt out~~and data privacy rights for California residents. The CCPA includes a framework with potentially severe statutory damages and private rights of action. The CCPA requires covered companies to provide new disclosures to California consumers (as that word is broadly defined in the CCPA), provide such consumers new ways to opt-out of certain sales of personal information, ~~sharing,~~ and ~~receive detailed information about how their personal information is used. The CCPA provides~~allow for ~~civil penalties for violations, as well as~~ a ~~private right~~new cause of action for data ~~breaches that is expected~~breaches. It remains unclear how the CCPA will be interpreted, but as currently written, it may impact our business activities and exemplifies the vulnerability of our business to ~~increase data breach litigation. The~~not only cyber threats but also the evolving regulatory environment related to personal data. As we expand our operations, the CCPA may increase our compliance costs and potential liability. Some observers have noted that the CCPA could mark the beginning of a trend toward more stringent privacy legislation in the ~~United States, which~~U.S. Other states are beginning to pass similar laws.

Compliance with these and any other applicable privacy and data security laws and regulations is a rigorous and time-intensive process, and we may be required to put in place additional mechanisms to ensure compliance with the new data protection rules. If we fail to comply with any such laws or regulations, we may face significant fines and penalties that could ~~increase our potential liability and~~ adversely affect our ~~business.~~business, financial condition and results of operations. Furthermore, the laws are not consistent, and compliance in the event of a widespread data breach is costly.

Our operations abroad may also be subject to increased scrutiny or attention from data protection authorities. Many countries in these regions have established or are in the process of establishing privacy and data security legal frameworks with which we, our collaborators, service providers, including our ~~CRO,~~CROs, and contractors must comply. For example, the EU has adopted the GDPR, which went into effect in May 2018 and introduces strict requirements for processing the personal information of EU subjects, including clinical trial data. The GDPR has and will continue to increase compliance burdens on us, including by mandating potentially burdensome documentation requirements and granting certain rights to individuals to control how we collect, use, disclose, retain and process information about them. The processing of sensitive personal data, such as physical health condition, may impose heightened compliance burdens under the GDPR and is a topic of active interest among foreign regulators. In addition, the GDPR provides for more robust regulatory enforcement and fines of up to €20 million or 4% of the annual global revenue of the noncompliant company, whichever is greater. As we expand into other foreign countries and jurisdictions, we may be subject to additional laws and regulations that may affect how we conduct business.

~~Our failure to obtain~~ ~~additional~~ capital when needed could force us to further delay, reduce or eliminate development of imetelstat, including the planned Phase 3 portion of IMerge, or our potential future imetelstat commercialization efforts, which ~~would severely and adversely affect our financial results, business and business prospects, and might cause us to cease operations~~.*

~~Successful drug development and commercialization requires significant amounts of capital. We will require substantial additional capital in order to~~ ~~further advance the imetelstat program, including~~ conducting the research and development and clinical and regulatory activities necessary to bring imetelstat to market, such as completion of the planned Phase 3 portion of IMerge and potential clinical trials in other indications, and to establish sales and marketing capabilities to commercialize imetelstat in the United States on our own, if regulatory approval is granted. Because the outcome of any clinical activities and/or regulatory approval process is highly uncertain, we cannot reasonably estimate whether any development activities we may undertake will succeed, and we may never recoup our investment in any imetelstat development, which would adversely affect our financial condition and our business and business prospects, and might cause us to cease operations. Our future capital requirements are difficult to forecast and will depend on many factors, including:

~~As a result of the termination of the Collaboration Agreement effective September 28, 2018, we~~ are responsible for funding all clinical development, manufacturing, intellectual property maintenance and potential commercial activities for imetelstat. In order to further advance the imetelstat program, including completion of the planned Phase 3 portion of IMerge and potential clinical trials in other indications, we will need to raise substantial additional capital or establish additional collaborative arrangements with third-party collaborative partners, which may not be possible. In addition, as a result of the termination of the Collaboration Agreement, ~~we will not receive any further milestone payments or royalties from Janssen for the development or sale of~~ ~~imetelstat, including any clinical development milestones~~. If we are unable to raise additional capital or establish alternative collaborative arrangements with third-party collaborative partners for imetelstat, the development of imetelstat may be further delayed, altered or abandoned, which might cause us to cease operations. Additional financing through public or private equity financings, including pursuant to our 2018 Sales Agreement with B. Riley FBR, capital lease transactions or other financing sources may not be available on acceptable terms, or at all. We may raise equity capital at a stock price or on other terms that could result in substantial dilution of ownership for our stockholders. The receptivity of the public and private equity markets to proposed financings is substantially affected by the general economic, market and political climate and by other factors which are unpredictable and over which we have no control. In this regard, volatility and instability in the global financial markets and political climate could adversely affect our ability to raise additional funds through financings and the terms upon which we may raise those funds.

In addition, we may seek additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our stockholders may be diluted, and the terms may include liquidation or other preferences that materially and adversely affect the rights of our stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through alliance, collaborative or licensing arrangements with third parties, we may have to relinquish valuable rights to imetelstat or our technologies or grant licenses on terms that are not favorable to us.

~~We cannot assure you that our existing capital resources, future interest income,~~Risks Related to Our Common Stock and ~~potential future sales of our common stock, including under our 2018 Sales Agreement with B. Riley FBR, will be sufficient to fund our operating plans.~~ Financial ReportingWe will need additional funds to meet operational needs and capital requirements to advance the imetelstat program in clinical development and potential commercialization, and our need for additional funds may arise sooner than planned. If adequate funds are not available on a timely basis, if at all, we may ~~be unable to pursue further development or potential commercialization of imetelstat, which could adversely affect our business and we might cease operations~~.

~~We currently have no source of product revenue and may never become consistently profitable.~~*

Although we were profitable in 2015 due to the recognition of revenue in connection with the upfront payment from Janssen under the Collaboration Agreement, we have otherwise never been profitable and have incurred operating losses every year since our operations began in 1990. We will not receive any future milestone-based or royalty payments from Janssen relating to imetelstat, nor will Janssen share the cost of ongoing or future clinical trials of imetelstat or the costs for patents that were licensed to them under the terminated Collaboration Agreement, after September 28, 2018. We expect to continue to incur significant additional operating losses and our operating losses are likely to substantially increase given our sole financial responsibility for imetelstat clinical development activities. As of June 30, 2019, our accumulated deficit was approximately $1.0 billion. Losses have resulted principally from costs incurred in connection with our research and development activities and from general and administrative costs associated with our operations.

Substantially all of our revenues to date have been payments under collaboration agreements and milestones, royalties and other revenues from our licensing arrangements. With the termination of the Collaboration Agreement effective September 28, 2018, we have no ongoing collaboration agreements related to imetelstat. Any revenues generated from our remaining licensing agreements related to our human telomerase reverse transcriptase, or hTERT, technology are expected to be minimal, and will be insufficient to sustain our operations. The patents underlying our license agreements related to our hTERT technology are expiring, and accordingly we expect revenues under such license agreements to be eliminated by the end of 2019. We have no current plans to enter into any new corporate collaboration, partnership or license agreements that result in revenues.

~~The comprehensive U.S. tax reform bill passed in 2017 could adversely affect our business and financial condition.~~

On December 22, 2017, President Trump signed into law legislation, known as the Tax Cuts and Jobs Act of 2017, that significantly revised the Internal Revenue Code of 1986, as amended, or the Code. The legislation, among other things, contained significant changes to corporate taxation, including reduction of the corporate tax rate from a top marginal rate of 35% to a flat rate of 21%; reduction in the percentage of allowable expenses eligible for orphan drug credit purposes; limitation of the deduction for net operating losses to 80% of current year taxable income and elimination of net operating loss carrybacks; immediate deductions for certain new investments instead of deductions for depreciation expense over time; and modifying or repealing many business deductions and credits. Notwithstanding the reduction in the corporate income tax rate, the overall long-term impact of the federal tax law changes are uncertain and our business and financial condition could be adversely affected. In addition, it is uncertain if and to what extent various states will conform to the federal tax law changes. The impact of this tax reform on holders of our common stock is also uncertain and could be adverse. We urge our stockholders to consult with their legal and tax advisors with respect to this legislation and the potential tax consequences of investing in or holding our common stock.

~~Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.~~

Our net operating loss carryforwards could expire unused and be unavailable to offset future income tax liabilities. Under the 2017 federal income tax law changes, federal net operating losses incurred in 2018 and in future years may be carried forward indefinitely, but the deductibility of such federal net operating losses is limited. It is uncertain if and to what extent various states will conform to the federal tax law changes. In addition, under Section 382 of the Code, and corresponding provisions of state law, if a corporation undergoes an “ownership change,” generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period, the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes (such as research tax credits) to offset its post-change taxable income or taxes may be limited. Changes in our stock ownership, some of which are outside of our control, may have resulted or could in the future result in an ownership change. If a limitation were to

apply, utilization of a portion of our domestic net operating loss and tax credit carryforwards could be limited in future periods. In addition, a portion of the carryforwards may expire before being available to reduce future income tax liabilities which could adversely impact our financial position.

Historically, our stock price has been extremely volatile. Between ~~July~~April 1, ~~2009~~2010 and ~~June 30, 2019,~~March 31, 2020, our stock has traded as high as ~~$9.24~~$7.79 per share and as low as ~~$0.91~~$0.75 per share. Between ~~July~~April 1, ~~2016~~2019 and ~~June 30, 2019,~~March 31, 2020, the price has ranged between a high of ~~$6.99~~$2.14 per share and a low of ~~$0.95~~$0.75 per share. The significant market price fluctuations of our common stock have been due to and may in the future be influenced by a variety of factors, including:

Stock prices and trading volumes for many biopharmaceutical companies fluctuate widely for a number of reasons, including factors which may be unrelated to their businesses or results of operations, such as media coverage, statements made on message boards and social media forums, legislative and regulatory measures and the activities of various interest groups or organizations. In

addition to the risk factors described in this section, overall market volatility, as well as general domestic or international economic, market and political conditions, including those resulting from the evolving effects of the COVID-19 pandemic, could materially and adversely affect the market price of our common stock and the return on ~~your investment.~~our stockholders’ investment in our securities.

In addition, as further discussed in the Risk Factor above ~~titled~~ “entitled “We and certain of our officers have been named as defendants in two putative securities class action lawsuitsand ~~may~~a shareholder derivative lawsuit. These lawsuits, and potential similar or related lawsuits, could result in substantial damages, divert management’s time and attention from our business, and have a material adverse effect on our results of operations. These lawsuits, and any other lawsuits to which we are subject, will be costly to defend or pursue and are uncertain in their outcome”, we and two of our officers have been named as defendants in two putative class action lawsuits. In addition, certain of our current and former board members have been named as defendants in the ~~future be, involved~~Derivative Lawsuit filed in securities-related legal actions that are expensive and time consuming. Any securities-related legal actions, if resolved adversely, could harm our business, financial condition, or results of operations”, ~~class action litigation has~~the Northern District. Such lawsuits have often been instituted against companies, including us, whose securities have experienced periods of volatility in market price. ~~Any such litigation~~The pending lawsuits and any lawsuits brought against us in the future could result in substantial costs, which would hurt our financial condition and results of operations and divert management’s attention and resources, which could result in ~~further~~ delays of the ongoing Phase 3 portion of IMerge and the planned Phase 3 clinical trial in refractory MF and/or could preclude or delay potential future clinical trials, such as potential proof-of-concept studies in other hematologic myeloid malignancies, or could preclude or delay commercialization efforts.

We may fail to continue to meet the listing standards of Nasdaq, and as a result our common stock may be delisted, which could have a material adverse effect on the liquidity of our common stock.*

Our common stock is currently traded on ~~the~~The Nasdaq Global Select Market. The Nasdaq Stock Market LLC has requirements that a company must meet in order to remain listed on Nasdaq. In particular, Nasdaq rules require us to maintain a minimum closing bid price of $1.00 per share of our common stock. On ~~December 21, 2018,~~March 12, 2020, the closing price of our common stock was ~~$0.98~~$0.99 per share, and while the closing price of our common stock rose to ~~$1.02~~$1.03 per share on ~~December 26, 2018,~~March 19, 2020, and has subsequently remained at or above the minimum closing bid price of $1.00 per share from ~~December 26, 2018~~March 19, 2020 through the date of ~~filing of~~ this ~~Quarterly Report on Form 10-Q,~~filing, it may in the future fall below the closing minimum bid price of $1.00 per share. IfAlthough Nasdaq has temporarily suspended enforcement of its continued listing rules related to the minimum bid price requirement in light of the effects of the COVID-19 pandemic, if the closing bid price of our common stock were to ~~fall~~remain below $1.00 per share for 30 consecutive trading days, or we do not meet other listing requirements, we would fail to be in compliance with Nasdaq’s listing standards. There can be no assurance that we will continue to meet the minimum bid price requirement, or any other requirement in the future. If we fail to meet the minimum bid price requirement once the temporary suspension is lifted, The Nasdaq Stock Market LLC may initiate the delisting process with a notification letter. If we were to receive such a notification, we would be afforded a grace period of 180 calendar days to regain compliance with the minimum bid price requirement. In order to regain compliance, shares of our common stock would need to maintain a minimum closing bid price of at least $1.00 per share for a minimum of 10 consecutive trading days. In addition, we may be unable to meet other applicable Nasdaq listing requirements, including maintaining minimum levels of stockholders’ equity or market values of our common stock, in which case our common stock could be delisted. If our common stock were to be delisted, the liquidity of our common stock would be adversely affected, and the market price of our common stock could decrease.

The sale of a substantial number of shares may adversely affect the market price of our common stock.

As of ~~June 30, 2019,~~March 31, 2020, we had 450,000,000 shares of common stock authorized for issuance and ~~186,638,401~~ 200,350,848 shares of common stock outstanding. In addition, we had reserved ~~45,465,319~~46,689,581 shares of our common stock for future issuance pursuant to our option and equity incentive plans and outstanding warrant as of ~~June 30, 2019. In addition,~~March 31, 2020, as well as 66,027,546 shares of our common stock reserved for future issuance under the ~~universal shelf registration statement filed by us~~warrants that we issued as part of our public offering in May 2018 and declared effective by the SEC in July 2018, we may sell any combination of common stock, preferred stock, debt securities and warrants in one or more offerings, up to a cumulative value of $250 million.2020.

Future sales of our common stock or the perception that such sales could occur, or the issuance of common stock to fund our operations and imetelstat development, including pursuant to ~~our~~the 2018 Sales Agreement ~~with B. Riley FBR,~~when it becomes available, could cause immediate dilution and adversely affect the market price of our common stock. The sale or issuance of our securities, as well as the existence of outstanding options and shares of common stock reserved for issuance under our option and equity incentive plans and outstanding warrant, also may adversely affect the terms upon which we are able to obtain additional capital through the sale of equity securities, which could negatively affect the market price of our common stock and the return on your investment.

Our undesignated preferred stock may inhibit potential acquisition bids; this may adversely affect the market price of our common stock and the voting rights of holders of our common stock.

Our certificate of incorporation provides our board of directors with the authority to issue up to 3,000,000 shares of undesignated preferred stock and to determine or alter the rights, preferences, privileges and restrictions granted to or imported upon these shares without further vote or action by our stockholders. The issuance of shares of preferred stock may delay or prevent a change in control transaction without further action by our stockholders. As a result, the market price of our common stock may be adversely affected.

In addition, if in the future, we issue preferred stock that has preference over our common stock with respect to the payment of dividends or upon our liquidation, dissolution or winding up, or if we issue preferred stock with voting rights that dilute the voting

power of our common stock, the rights of holders of our common stock or the market price of our common stock could be adversely affected.

Provisions in our charter, bylaws and Delaware law may inhibit potential acquisition bids for us, which may prevent holders of our common stock from benefiting from what they believe may be the positive aspects of acquisitions and takeovers.

Provisions of our charter documents and bylaws may make it substantially more difficult for a ~~third party~~third-party to acquire control of us and may prevent changes in our management, including provisions that:

Provisions of Delaware law may also inhibit potential acquisition bids for us or prevent us from engaging in business combinations. In addition, we have individual severance agreements with our executive officers and a company-wide severance plan, either of which could require a potential acquirer to pay a higher price. Either collectively or individually, these provisions may prevent holders of our common stock from benefiting from what they may believe are the positive aspects of acquisitions and takeovers, including the potential realization of a higher rate of return on their investment from these types of transactions.

Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.*

Our amended and restated bylaws provide that, unless we consent to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for:

~~The~~While the exclusive forum provisions in our bylaws do not apply to lawsuits brought to enforce a duty or liability created by the Exchange Act or the Securities Act of 1933, as amended, or any claim for which the federal courts have exclusive jurisdiction, these provisions may nonetheless limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our current or former directors, officers, or other employees, which may discourage such lawsuits against us and our current or former directors, officers, and other employees. Alternatively, if a court were to find the exclusive forum provisions contained in our bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could have a material and adverse impact on our business and our financial condition.

We do not intend to pay cash dividends on our common stock in the foreseeable future.

We do not anticipate paying cash dividends on our common stock in the foreseeable future. Any payment of cash dividends will depend upon our financial condition, results of operations, capital requirements and other factors and will be at the discretion of our board of directors.

Failure to achieve and maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 could have a material adverse effect on our business and stock price.

Section 404 of the Sarbanes-Oxley Act of 2002, or Section 404, requires that we establish and maintain an adequate internal control structure and procedures for financial reporting. Our annual reports on Form 10-K must contain an annual assessment by management of the effectiveness of our internal control over financial reporting and must include disclosure of any material weaknesses in internal control over financial reporting that we have identified. In addition, our independent registered public accounting firm must provide an opinion annually on the effectiveness of our internal control over financial reporting.

The requirements of Section 404 are ongoing and also apply to future years. We expect that our internal control over financial reporting will continue to evolve as our business develops. Although we are committed to continue to improve our internal control processes and we will continue to diligently and vigorously review our internal control over financial reporting in order to ensure compliance with Section 404 requirements, any control system, regardless of how well designed, operated and evaluated, can provide only reasonable, not absolute, assurance that its objectives will be met. Therefore, we cannot be certain that material weaknesses or significant deficiencies will not exist or otherwise be ~~discovered~~discovered in the ~~future.~~future, particularly in light of our increased reliance on personnel working remotely as a result of the COVID-19 pandemic. If material weaknesses or other significant deficiencies occur, such weaknesses or deficiencies could result in misstatements of our results of operations, restatements of our financial statements, a decline in our stock price, or other material adverse effects on our business, reputation, results of operations, financial condition or liquidity.

Competitors may develop products, product candidates or technologies that are superior to or more cost-effective than ours, which may significantly impact the development and commercial viability of imetelstat, which would severely and adversely affect our financial results, business and business prospects, and the future of imetelstat, and might cause us to cease operations.*

The pharmaceutical and biotechnology industries are ~~intensely competitive. Other pharmaceutical~~characterized by intense and ~~biotechnology companies~~dynamic competition with rapidly advancing technologies and ~~research organizations currently engage in or have in the past engaged in efforts related to~~a strong emphasis on proprietary products. While we believe our proprietary oligonucleotide chemistry; experience with the biological mechanisms related to imetelstat, ~~the study of~~ telomeres ~~telomerase, or our proprietary oligonucleotide chemistry,~~ and telomerase; clinical data to date indicating potential disease-modifying activity with imetelstat treatment; and knowledge and expertise around the ~~research and~~ development of ~~therapies~~potential treatments for ~~the treatment of~~ hematologic myeloid ~~malignancies. In addition,~~malignancies provide us with competitive advantages, we face competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions and governmental agencies and public and private research institutions. Imetelstat will compete, if approved, with other products and therapies that ~~could directly compete with imetelstat~~ currently exist, or are being developed ~~by pharmaceutical and biopharmaceutical companies and by academic institutions, government agencies and other public and private research organizations.~~or will in the future be developed, some of which we may not currently be aware.

If approved for commercial sale for the treatment of lower risk MDS, imetelstat would compete against a number of ~~treatment options,~~currently existing therapies, including ~~erythropoiesis stimulating agents~~ESAs and other hematopoietic growth ~~factors;~~factors that are indicated for anemia; immunomodulators, such as ~~lenalidomide~~Revlimid (lenalidomide) by Celgene Corporation, a Bristol-Myers Squibb Corporation, or Celgene; hypomethylating agents, such as ~~azacitidine~~Vidaza (azacitidine) by Celgene or other manufacturers of generic azacitidine, Dacogen (decitabine) by Otsuka America Pharmaceutical, Inc. and ~~decitabine by Janssen;~~other manufacturers in ~~addition to investigational treatments that may be further along~~the U.S. and Janssen in ~~development than imetelstat, such as oral versions of azacitidine; histone deacetylase inhibitors;~~the EU; and Reblozyl (luspatercept), a TGF-beta ~~superfamily inhibitors, such as luspatercept~~inhibitor, by Acceleron Pharma, Inc., or Acceleron, in collaboration with Celgene; PI3 Kinase inhibitors; proteasome inhibitors; aminopeptidase inhibitors, such as tosedostat by CTI Biopharma Corporation, or CTI Biopharma; TLR2-specific antibodies; TPO agonists, such as romiplostim by Amgen Inc.; anti-CD33 antibodies; anti-CD38 antibodies, such as daratumumab by Genmab A/SCelgene.

Other therapies currently in ~~collaboration with Janssen; anti-CD123 antibodies, such as talacotuzumab by Janssen; antagonists~~Phase 3 development in lower risk MDS, some of ~~Toll-like receptor signaling; retinoic acid receptor alpha agonists, such as SY-1425 by Syros Pharmaceuticals;~~which may obtain regulatory approval earlier than imetelstat include roxadustat, a hypoxia-inducible factor prolyl hydroxylase ~~inhibitors, such as roxadustat~~inhibitor, by FibroGen, Inc.; ~~Fas ligand inhibitors; immune checkpoint regulators;~~ and ~~JAK-STAT pathway inhibitors.~~APR-246, an activator of p53 protein, by Aprea Therapeutics, Inc.

In addition, there are multiple Phase 1 and Phase 2 clinical trials of other agents for lower risk MDS, including but not limited to: LB‐100, a PP2A inhibitor being developed by Lixte Biotechnology Holdings, Inc.; ASTX727, a DNA methyltransferase (DNMT) inhibitor, being developed by Astex Pharmaceuticals; bemcentinib, an AXL inhibitor being developed by BerGenBio ASA; H3B‐8800, a spliceosome inhibitor being developed by H3 Biomedicine, Inc.; and KER-050, a TGF-beta inhibitor being developed by Keros Therapeutics.

If approved for commercial sale for the treatment of MF, imetelstat would compete against currently approved JAK inhibitors, Jakafi (ruxolitinib) by Incyte ~~Corporation’s ruxolitinib, or Jakafi®, which is orally administered. In clinical trials, Jakafi® reduced spleen size, abdominal discomfort, early satiety, bone pain, night sweats~~Corporation and ~~itching in MF patients. Recently, there have also been reports of overall survival benefit as well as improvement in bone marrow fibrosis from Jakafi® treatment.~~Inrebic (fedratinib) by Celgene. Other treatment modalities for MF include hydroxyurea for the management of splenomegaly, leukocytosis, thrombocytosis and constitutional symptoms; splenectomy and splenic irradiation for the management of splenomegaly and co-existing cytopenias, or low blood cell counts; chemotherapy and pegylated interferon. Drugs for the treatment of MF-associated anemia include ~~erythropoiesis stimulating agents,~~ESAs, androgens, danazol, corticosteroids, thalidomide and lenalidomide. ~~There are other investigational treatments for MF further along~~

Other therapies currently in Phase 3 development in Intermediate-2 or High-Risk myelofibrosis, some of which may obtain regulatory approval earlier than imetelstat ~~such as~~include pacritinib, a JAK inhibitor, by CTI Biopharma, and momelotinib, a JAK inhibitor, by Sierra ~~Oncology, and fedratinib by Celgene, which have reported results from Phase 3 clinical trials. Other investigational treatments~~Oncology. Non-JAK inhibitor approaches for MF currently under investigation that could compete with imetelstat in the future include ~~inhibitors of the JAK-STAT pathway, such as NS-018~~CPI-0610, a BET inhibitor, by ~~NS Pharma,~~Constellation Pharmaceuticals, Inc.; histone deacetylase inhibitors; interleukin-3 receptor targeted agents; inhibitors of heat shock protein 90; hypomethylating agents; PI3 Kinase and mTOR inhibitors; anti-fibrosis antibodies, such as PRM-151 from Promedior, Inc.; hedgehog and SMO inhibitors; PIM kinase inhibitors; IAP inhibitors; anti-LOX2 inhibitors; recombinant pentraxin 2 protein; KIP-1 activators; TGF-beta superfamily inhibitors, such as sotatercept and luspatercept, a TGF-beta inhibitor, by Acceleron, in collaboration with ~~Celgene; FLT inhibitors; BET inhibitors, such as CPI-0610~~Celgene. In addition, there are multiple Phase 1 and Phase 2 clinical trials of other agents including but not limited to PRM-151, an anti-fibrosis antibody, by ~~Constellation Pharmaceuticals,~~Promedior, Inc.; ~~SMAC mimetics, such as LCL161~~navitoclax, a BCLXL, BCL-2 and BCLW inhibitor, by ~~Novartis Pharmaceuticals Corporation~~AbbVie; LCL 161, an inhibitor of apoptosis protein (IAP), by Novartis; and ~~other tyrosine kinase inhibitors.~~KRT-232, an inhibitor of MDM2, by Kartos Therapeutics, Inc.

Smaller companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. We anticipate increased competition in the future as new companies explore treatments for hematologic

myeloid malignancies, which may significantly impact the commercial viability of imetelstat. Academic institutions, government agencies and other public and private research organizations may also conduct research, seek patent protection and establish collaborative arrangements for research, clinical development and marketing of products similar to imetelstat. These companies and

institutions compete with us in recruiting and retaining qualified development and management personnel as well as in acquiring technologies complementary to the imetelstat program.

~~In addition~~Many of our competitors, either alone or with their strategic partners, could have substantially greater financial, technical and human resources than we do and significantly greater experience in obtaining FDA and other regulatory approvals of treatments and commercializing those treatments. We believe that the commercial success of imetelstat is subject to ~~the above~~a number of factors, ~~imetelstat will face competition based on:~~including,

As a result of the foregoing, competitors may develop more commercially desirable or affordable products than imetelstat, or achieve earlier patent protection or product commercialization than we may be able to achieve with imetelstat. Competitors have developed, or are in the process of developing, technologies that are, or in the future may be, competitive to imetelstat. Some of these products may have an entirely different approach or means of accomplishing therapeutic effects similar or superior to those that may be demonstrated by imetelstat. Competitors may develop products that are safer, more effective, or less costly than imetelstat, or more convenient to administer to patients and, therefore, present a serious competitive threat to imetelstat. In addition, competitors may price their products below what we may determine to be an acceptable price for imetelstat, may receive better third-party payor coverage and/or reimbursement, or may be more cost-effective than imetelstat. Such competitive products or activities by competitors may render imetelstat obsolete, which may cause us to cease any further development or future commercialization of imetelstat, which would severely and adversely affect our financial results, business and business prospects, and the future of imetelstat, and might cause us to cease operations.

To be commercially successful, imetelstat must be accepted by the health care community, which can be very slow to adopt or unreceptive to new technologies and products.

If approved for marketing, imetelstat may not achieve market acceptance, or the potential worldwide or U.S. revenue we believe may be possible, since hospitals, physicians, patients or the medical community in general may decide not to accept and utilize imetelstat. If approved for commercial sale, imetelstat will compete with a number of conventional and widely accepted drugs and therapies manufactured and marketed by major pharmaceutical companies. The degree of market acceptance of imetelstat will depend on a number of factors, including:

The established use of conventional products competitive with imetelstat may limit or preclude the potential for imetelstat to receive market acceptance upon any commercialization. We may be unable to demonstrate any pharmacoeconomic advantage for imetelstat compared to established or standard-of-care therapies, or newly developed therapies, for hematologic myeloid malignancies.

Third-party payors may decide that any potential improvement that imetelstat may provide to clinical outcomes in hematologic myeloid malignancies is not adequate to justify the costs of treatment with imetelstat. If the health care community does not accept imetelstat for any of the foregoing reasons, or for any other reason, our ability to further develop or potentially commercialize imetelstat may be negatively impacted or precluded altogether, which would seriously and adversely affect our business and business prospects, and might cause us to cease operations.

If acceptable prices or adequate reimbursement for imetelstat is not obtained, the use of imetelstat could be severely limited.

The ability to successfully commercialize imetelstat, if approved, will depend significantly on obtaining acceptable prices and the availability of coverage and adequate reimbursement to the patient from third-party payors. Government payors, such as the Medicare and Medicaid programs, and other third-party payors, such as private health insurers and health maintenance organizations, determine which medications they will cover and the reimbursement levels. Assuming we obtain coverage for imetelstat by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. If imetelstat is approved for commercial sale, patients are unlikely to use it unless coverage is provided, and reimbursement is adequate to cover all or a significant portion of its cost. Therefore, coverage and adequate reimbursement will be critical to new product acceptance.

Government authorities and other third-party payors are developing increasingly sophisticated methods of controlling healthcare costs, such as by limiting coverage and the amount of reimbursement for particular medications. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices as a condition of coverage, are using restrictive formularies and preferred drug lists to leverage greater discounts in competitive classes, and are challenging the prices charged for medical products. Further, no uniform policy requirement for coverage and reimbursement for drug products exists among third-party payors in the ~~United States.~~U.S. Therefore, coverage and reimbursement for drug products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of imetelstat to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

We cannot be sure that coverage and reimbursement will be available for imetelstat, if approved for commercial sale, and, if reimbursement is available, what the level of reimbursement will be. There may also be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than the purposes for which the drug is approved by the FDA or comparable foreign regulatory authorities. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which marketing approval is obtained. If coverage and reimbursement are not available or reimbursement is available only to limited levels, we may not successfully commercialize imetelstat, even if marketing approval is obtained, which would negatively impact our business and business prospects.

The adoption of health policy changes and health care reform in the ~~United States~~ U.S. may adversely affect our business and financial results.*

In ~~March 2010,~~ the ~~Patient Protection~~U.S. and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively known as the Affordable Care Act, or ACA, became law and substantially changed the way healthcare is funded by both governmental and private insurers, and significantly impacted the pharmaceutical industry. The ACA containssome foreign jurisdictions, there have been a number of ~~provisions~~legislative and regulatory changes and proposed changes regarding the healthcare system that ~~may have a significant~~could impact on our business.

While the Supreme Court upheld the constitutionality of most elements of the ACA in June 2012 and upheld the ACA against challenges to nationwide tax subsidies in July 2015, other judicial and Congressional challenges against the ACA have been brought, and are likely to be brought in the future. Since January 2017, President Trump has signed two executive orders and other directives designed to delay, circumvent, or loosen certain requirements mandated by the ACA. Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed comprehensive repeal legislation, two bills affecting the implementation of certain taxes under the ACA have been signed into law. The Tax Cuts and Jobs Act of 2017, or Tax Act, includes a provision which repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate”. On January 22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain ACA-mandated fees. The Bipartisan Budget Act of 2018, among other things, amended the ACA, effective January 1, 2019, to close the coverage gap in most Medicare Part D drug plans, commonly referred to as the “donut hole”. In July 2018, CMS published a final rule permitting further collections and payments to and from certain ACA qualified health plans and health insurance issuers under the ACA risk adjustment program For example, in response to the ~~outcome of federal district court litigation regarding~~COVID-19 pandemic, the ~~method CMS uses to determine this risk adjustment. On December 14, 2018, a Texas U.S. District Court Judge ruled that the ACA is unconstitutional in its entirety because the “individual mandate”~~CARES Act was ~~repealed by Congress~~

as part of the Tax Act. While the Texas U.S. District Court Judge, as well as the Trump administration and CMS, have stated that the ruling will have no immediate effect pending appeal of the decision, it is unclear how this decision, subsequent appeals, and other efforts to repeal and replace the ACA will impact the ACA and our business.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. For example, in August 2011, the Budget Control Act of 2011 was enacted, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals in spending reductions. The Joint Select Committee on Deficit Reduction did not achieve a targeted deficit reduction of at least $1.2 trillion for fiscal years 2012 through 2021, triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect beginning on April 1, 2013 and, due to subsequent legislative amendments to the statute, including the Bipartisan Budget Act of 2018, will stay in effect through 2027 unless additional Congressional action is taken. Further, the American Taxpayer Relief Act of 2012, signed into law in ~~January 2013, among other things, also reduced Medicare payments to certain providers, including hospitals, imaging centers~~March 2020. The CARES Act is aimed at providing emergency assistance and ~~cancer treatment centers,~~health care for individuals, families and ~~increased~~businesses affected by the ~~statute of limitations period for the government to recover overpayments to providers from three to five years.~~

~~In the future, we anticipate additional proposals relating to the reform of~~COVID-19 pandemic and generally supporting the U.S. ~~healthcare system, some of which could further limit the prices, or the amounts of reimbursement available for imetelstat. There~~economy. Generally, there has been increasing legislative and enforcement interest in the ~~United States~~U.S. with respect to drug pricing, including specialty drug pricing practices, in light of the rising cost of prescription drugs and biologics. Specifically, there have been ~~several recent~~ U.S. Congressional inquiries and federal and state legislative activity designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the price of drugs under Medicare, and reform government program reimbursement methodologies for drugs some of which are included in the Trump administration’s budget proposal for fiscal year 2019. Additionally, the Trump administration released a “Blueprint” that contains additional proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products and ~~reduce the out of pocket costs of drug products paid by consumers.~~biologics. While a number of ~~these and other proposed~~reform measures may require ~~authorization through~~ additional ~~legislation~~authorization to become effective, Congress and the Trump Administration have each indicated that they will continue to seek new legislative and/or administrative measures to control drug costs. We expect that additional state and federal healthcare reform measures may be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could affect pricing for imetelstat if it is approved. The evolving effects of the COVID-19 pandemic may introduce temporary or permanent healthcare reform measures, which could have negative financial implications on our business.

If future legislation were to impose direct governmental price controls and access restrictions, it could have a significant adverse impact on our business and financial results. Managed care organizations, as well as Medicaid and other government agencies, continue

to seek price discounts. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biologic product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, to encourage importation from other countries and bulk purchasing. Due to the volatility in the current economic and market dynamics, we are unable to predict the impact of any unforeseen or unknown legislative, regulatory, payor or policy actions, which may include cost containment and healthcare reform measures. Such policy actions could have a material adverse impact on future worldwide sales of imetelstat, if approved. For a discussion of health reform activity, see Item 1 “Business—Government Regulation—Reimbursement and Healthcare Reform” in our Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 12, 2020.

Cost control initiatives also could decrease the price that we may receive for imetelstat in the future. If imetelstat is not considered cost-effective or adequate third-party reimbursement for the users of imetelstat cannot be obtained, then we may be unable to maintain price levels sufficient to realize an appropriate return on our investment in imetelstat. Any of these events would severely and adversely affect our financial results, business and business prospects, and might cause us to cease operations.

If we fail to comply with federal, state and foreign healthcare laws, including fraud and abuse, transparency, and health information privacy and security laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected.

Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors and customers, may expose us to broadly applicable fraud and abuse and other healthcare laws and ~~regulations.~~regulations, including federal and state fraud and abuse laws, including anti-kickback and false claims laws; data privacy and security laws; and transparency laws related to payments and/or other transfers of value made to physicians, other healthcare professionals and teaching hospitals. These laws may constrain the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute any product of ours for which marketing approval is obtained. ~~Such laws include:~~

~~Efforts~~SEC on March 12, 2020. Additionally, efforts to ensure that our current and future business arrangements will comply with applicable healthcare, privacy and data security laws and regulations will involve substantial costs. For example, the GDPR, which became effective on May 25, 2018, imposes several requirements relating to the consent of the individuals to whom the personal data relates, the information provided to the individuals, the security and confidentiality of the personal data, data breach notification and the use of third-party processors in connection with the processing of personal data. The GDPR also imposes strict rules on the transfer of personal data out of the EU, provides an enforcement authority and authorizes the imposition of large penalties for noncompliance, including the potential for fines of up to €20 million or 4% of the annual global revenues of the noncompliant company, whichever is greater. The GDPR has increased our responsibility and potential liability in relation to personal data that we process or control compared to prior EU law, including in clinical trials, and we may be required to put in place additional mechanisms to ensure compliance with the GDPR, which could divert management’s attention and increase our cost of doing business. Likewise, we expect that there will continue to be new proposed laws, regulations and industry standards relating to privacy and data protection in the ~~United States,~~U.S., the EU and other jurisdictions, such as the California Consumer Privacy Act of 2018, which has been characterized as the first “GDPR-like” privacy statute ~~to be~~ enacted in the ~~United States~~U.S. because it mirrors a number of the key provisions in the GDPR, ~~that will go into effect~~

~~beginning~~ became effective on January 1, 2020, and we cannot determine the impact such laws, regulations and standards will have on our business. In any event, it is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable healthcare or privacy laws, including the GDPR, in light of the lack of applicable precedent and regulations.

Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. If our operations are found to be in violation of any of these or any other healthcare and privacy-related regulatory laws that may apply to us, we may be subject to significant penalties, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement, imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, reputational harm, diminished profits and future earnings, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations. Defending against any such actions can be costly, time-consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.

~~DELAWARE~~Delaware		75-2287752
(State or other jurisdiction of		(I.R.S. Employer
incorporation or organization)		Identification No.)

~~149 COMMONWEALTH DRIVE,~~919 EAST HILLSDALE BOULEVARD, SUITE ~~2070, MENLO PARK,~~250, FOSTER CITY, CA		~~94025~~94404
(Address of principal executive offices)		(Zip Code)


Securities registered pursuant to Section 12(b) of the Act:
Title of each class:	Trading symbol(s):	Name of each exchange on which registered:
Common Stock, $0.001 par value	GERN	The Nasdaq Stock Market LLC

Class:		Outstanding at ~~July 26, 2019:~~May 22, 2020:
Common Stock, $0.001 par value		~~188,423,106~~203,317,236 shares

		Page
PART I. FINANCIAL INFORMATION

Item 1:	~~Condensed~~ Financial Statements (Unaudited)	1
	Condensed Balance Sheets as of ~~June 30, 2019~~March 31, 2020 and December 31, ~~2018~~2019	1
	Condensed Statements of Operations for the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 2019 ~~and 2018~~	2
	Condensed Statements of Comprehensive Loss for the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 2019 ~~and 2018~~	3
	Condensed Statements of Stockholders’ Equity for the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 2019 ~~and 2018~~	4
	Condensed Statements of Cash Flows for the ~~six~~three months ended ~~June 30,~~March 31, 2020 and 2019 ~~and 2018~~	5
	Notes to Condensed Financial Statements	6
Item 2:	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18
Item 3:	Quantitative and Qualitative Disclosures About Market Risk	29
Item 4:	Controls and Procedures	29

PART II. OTHER INFORMATION

Item 1:	Legal Proceedings	30
Item 1A:	Risk Factors	30
Item 2:	Unregistered Sales of Equity Securities and Use of Proceeds	6165
Item 3:	Defaults Upon Senior Securities	6165
Item 4:	Mine Safety Disclosures	6165
Item 5:	Other Information	6165
Item 6:	Exhibits	6265
	~~SIGNATURE~~SIGNATURES	6366

	Six Months Ended June 30,		Three Months Ended March 31,
	2019	2018	2020		2019
Dividend yield	0%	0%	0%		0%
Expected volatility range	0.802 to 0.980	0.821 to 0.832		0.781	0.925 to 0.980
Risk-free interest rate range	1.79% to 2.56%	2.55% to 2.94%	1.42% to 1.62%		2.24% to 2.56%
Expected term range	5.25 yrs to 6.44 yrs	5.25 yrs	5.25 yrs		5.25 yrs to 6.44 yrs

Large accelerated filer	☐	Accelerated filer	☒

Non-accelerated filer	☐	Smaller reporting company	☒

Emerging growth company	☐

	Three Months Ended June 30,				Six Months Ended June 30,				Three Months Ended March 31,
(In thousands)	2019		2018		2019		2018		2020		2019
Research and development	$	413	$	266	$	653	$	421	$	501	$	240
General and administrative		1,021		1,279		2,207		2,738		1,067		1,186
Stock-based compensation expense included in operating expenses	$	1,434	$	1,545	$	2,860	$	3,159	$	1,568	$	1,426

Level 1	—	Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis.
Level 2	—	Inputs (other than quoted market prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.
Level 3	—	Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.

2019	$	350
2020		58
Total lease payments		408
Less: imputed interest		(6	)
Total	$	402

Remainder of 2020	$	637
2021		913
2022		937
2023		962
2024		987
Thereafter		3,821
Total lease payments		8,257
Less: imputed interest		(2,270	)
Total	$	5,987

~~Patient Baseline Characteristics~~	~~n=38~~
~~Median age (range), years~~	~~71.5 (46-83)~~
~~Male, n (%~~(10%)	~~25 (66%)~~
~~Eastern Cooperative Oncology Group (ECOG) Performance Standard 0-1, n (%)~~	~~34 (89%)~~
~~International Prognostic Scoring System risk, n (%)~~ ~~Low~~ ~~Intermediate-1~~	~~24 (63%)~~ ~~14 (37%)~~
~~Baseline median RBC transfusion burden (range), units/8 weeks~~ ~~Patients with >4 units/8 weeks at baseline, n (%)~~	~~8 (4-14)~~ ~~35 (92%)~~
~~World Health Organization 2001 category, n (%)~~ ~~Refractory Anemia with Ringed Sideroblasts (RARS)~~ or ~~Refractory Cytopenia with Multilineage Dysplasia and Ringed Sideroblasts~~ ~~(RCMD-RS)~~ ~~All~~ ~~others~~	~~27 (71%)~~ ~~11 (29%)~~
~~Prior ESA use, n (%)~~	~~34 (89%)~~
~~Serum~~ ~~erythropoietin (sEPO)~~ ~~> 500 mU/mL, n (%)~~	12^a ~~(32%)~~

~~Key Efficacy Outcomes~~	~~n=38~~
~~Rate of 8-week RBC-TI, n (%)~~	~~16 (42%)~~
~~Rate of 24-week RBC-TI, n (%)~~	~~11 (29%)~~
~~Median time to onset of RBC-TI (range), weeks~~	~~8.3 (0.1-40.7)~~
~~Median duration~~^a ~~of RBC-TI (range), weeks~~	~~85.9 (8.0-140.9)~~
~~Hematologic improvement-erythroid, or HI-E, n (%)~~ ~~≥1.5 g/dL increase in hemoglobin lasting ≥ 8 weeks~~ ~~Transfusion reduction by ≥ 4 units/8 weeks~~	~~26 (68%)~~ ~~12 (32%)~~ ~~26 (68%)~~
~~Mean relative reduction of RBC transfusion burden from baseline, %~~	~~-68%~~

~~Treatment Emergent Adverse Events (TEAE)~~	~~All Grades~~ ~~n=38 (n, %)~~	~~Grade 3/4~~ ~~n=38 (n, %)~~
~~Hematologic Adverse Events~~
~~Thrombocytopenia~~	~~25 (66%)~~	~~23 (61%)~~
~~Neutropenia~~	~~22 (58%)~~	~~21 (55%)~~
~~Anemia~~	~~10 (26%)~~	~~8 (21%)~~
~~Non-Hematologic Adverse Events~~
~~Back Pain~~^a	~~7 (18%)~~	0
~~Alanine Aminotransferase increased~~	~~7 (18%)~~	~~2 (5%)~~
~~Aspartate Aminotransferase increased~~	~~6 (16%)~~	~~3 (8%)~~
~~Bronchitis~~	~~6 (16%)~~	~~3 (8%)~~
~~Other Adverse Events~~^b	~~6 (16%)~~	0
~~Headache~~	~~6 (16%)~~	~~1 (3%)~~

			Statistical Adjustment Methods
	Unadjusted Statistical Method		Average Treatment Effect for Overlap Population (ATO)		Stabilized Inverse Probability Treatment Weighting (sIPTW)
Main Analysis	Imetelstat (IMbark)	RWD BAT (Moffitt)	Imetelstat (IMbark)	RWD BAT (Moffitt)	Imetelstat (IMbark)	RWD BAT (Moffitt)
Median overall survival	33.77 months	12.04 months	30.69 months	12.04 months	30.69 months	12.04 months
Hazard ratio	0.35		0.35		0.33
P-value	0.0003		0.0019		0.0003

		Incorporation by Reference
Exhibit		Exhibit		Filing
Number	Description	Number	Filing	Date	File No.
3.1	Restated Certificate of Incorporation	3.3	8-K	May 18, 2012	000-20859
3.2	Certificate of Amendment of the Restated Certificate of Incorporation	3.1	8-K	June 7, 2019	000-20859
10.1#	Change Order No. 1 under Work Order No. 1 under Master Services Agreement by and between the Registrant and Parexel International (IRL) Limited, dated June 19, 2019
10.2	Office Lease Agreement by and between Registrant and 3 Sylvan Realty LLC, effective as April 30, 2019	10.18	10-Q	May 2, 2019	000-20859
31.1	Certification of Chief Executive Officer pursuant to Form of Rule 13a-14(a), as Adopted Pursuant to Section 302(a) of the Sarbanes-Oxley Act of 2002, dated August 1, 2019
31.2	Certification of Chief Financial Officer pursuant to Form of Rule 13a-14(a), as Adopted Pursuant to Section 302(a) of the Sarbanes-Oxley Act of 2002, dated August 1, 2019
32.1	Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, dated August 1, 2019 **
32.2	Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, dated August 1, 2019 **
101	The following materials from the Registrant’s June 30, 2019 Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 formatted in Extensible Business Reporting Language (XBRL) include: (i) Condensed Balance Sheets as of June 30, 2019 and December 31, 2018, (ii) Condensed Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2019 and 2018, (iii) Condensed Statements of Stockholders’ Equity for the three and six months ended June 30, 2019 and 2018, (iv) Condensed Statements of Cash Flows for the six months ended June 30, 2019 and 2018 and (v) Notes to Condensed Financial Statements

	GERON CORPORATION

Date: ~~August 1, 2019~~May 28, 2020	By:	/s/ OLIVIA K. BLOOM
		OLIVIA K. BLOOM
		Executive Vice President, Finance, Chief Financial Officer and Treasurer (Duly Authorized Officer and Principal Financial and Accounting Officer)