~~Table of Contents~~ONCONOVA THERAPEUTICS, INC.

~~ONCONOVA THERAPEUTICS, INC.~~

TABLE OF CONTENTS FOR QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTER ENDED ~~SEPTEMBER~~JUNE 30, ~~2017~~2020

	Page
PART I — FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited)
Condensed Consolidated Balance Sheets	3 2
Condensed Consolidated Statements of Operations	4 3
Condensed Consolidated Statements of Comprehensive Loss	5 4
Consolidated Statement of Stockholders’ Equity (Deficit)	6 5
Condensed Consolidated Statements of Cash Flows	7 6
Notes to Condensed Consolidated Financial Statements	8 7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	28 25
Item 3. Quantitative and Qualitative Disclosures About Market Risk	38 41
Item 4. Controls and Procedures	39 42

PART II — OTHER INFORMATION

Item 1. Legal Proceedings	40 43
Item 1A. Risk Factors	40 43
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	40 45
Item 3. Defaults Upon Senior Securities	40 45
Item 4. Mine Safety Disclosures	40 45
Item 5. Other Information	40 45
Item 6. Exhibits	41 46
SIGNATURES	43 48

PART I — FINANCIAL INFORMATION

Item 1. Financial Statements

Onconova Therapeutics, Inc.

Condensed Consolidated Balance Sheets

	September 30,			December 31,			June 30,			December 31,
	2017			2016			2020			2019
	(unaudited)						(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	7,600,000		$	21,400,000		$	27,228,000		$	22,726,000
Receivables	57,000			31,000				41,000			98,000
Prepaid expenses and other current assets	1,000,000			1,588,000				720,000			650,000
Restricted cash	50,000			50,000
Total current assets	8,707,000			23,069,000				27,989,000			23,474,000
Property and equipment, net	83,000			152,000				60,000			50,000
Other non-current assets	12,000			12,000				150,000			150,000
Total assets	$	8,802,000		$	23,233,000		$	28,199,000		$	23,674,000

Liabilities and stockholders’ equity
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	5,436,000		$	5,323,000		$	5,148,000		$	4,271,000
Accrued expenses and other current liabilities	3,098,000			4,382,000				3,377,000			3,795,000
Deferred revenue	455,000			455,000				226,000			226,000
Total current liabilities	8,989,000			10,160,000				8,751,000			8,292,000
Warrant liability	1,686,000			3,401,000				232,000			113,000
Deferred revenue, non-current	4,205,000			4,545,000				3,583,000			3,695,000
Total liabilities	14,880,000			18,106,000				12,566,000			12,100,000

Commitments and contingencies

Stockholders’ equity:
Preferred stock, $0.01 par value, 5,000,000 authorized at September 30, 2017 and December 31, 2016, none issued and outstanding at Septemeber 30, 2017 and December 31, 2016	—			—
Common stock, $0.01 par value, 25,000,000 authorized at September 30, 2017 and December 31, 2016, 9,851,164 and 6,759,895 shares issued and outstanding at September 30, 2017 and December 31, 2016	99,000			68,000
Stockholders' equity:
Preferred stock, $0.01 par value, 5,000,000 authorized at June 30, 2020 and December 31, 2019, none issued and outstanding at June 30, 2020 and December 31, 2019								-			-
Common stock, $0.01 par value, 250,000,000 authorized at June 30, 2020 and December 31, 2019, 174,177,448 and 111,167,352 shares issued and outstanding at June 30, 2020 and December 31, 2019								1,742,000			1,112,000
Additional paid in capital	349,103,000			342,484,000				429,794,000			413,879,000
Accumulated other comprehensive income	(1,000		)	(31,000		)
Accumulated other comprehensive loss								(17,000	)		(18,000	)
Accumulated deficit	(356,109,000		)	(338,224,000		)		(415,886,000	)		(403,399,000	)
Total Onconova Therapeutics, Inc. stockholders’ (deficit) equity	(6,908,000		)	4,297,000
Non-controlling interest	830,000			830,000
Total stockholders’ (deficit) equity	(6,078,000		)	5,127,000
Total stockholders' equity								15,633,000			11,574,000

Total liabilities and stockholders’ (deficit) equity	$	8,802,000		$	23,233,000
Total liabilities and stockholders' equity							$	28,199,000		$	23,674,000

See accompanying notes to condensed consolidated financial statements.

Onconova Therapeutics, Inc.

Condensed Consolidated Statements of Operations (unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2017			2016			2017			2016			Three Months Ended June 30,						Six Months Ended June 30,
													2020			2019			2020			2019
Revenue	$	110,000		$	1,651,000		$	644,000		$	5,373,000		$	56,000		$	2,022,000		$	108,000		$	2,090,000
Operating expenses:
General and administrative	1,728,000			1,975,000			5,623,000			7,229,000				2,594,000			1,760,000			4,401,000			4,994,000
Research and development	5,141,000			3,991,000			14,641,000			15,377,000				4,801,000			3,895,000			8,171,000			7,969,000
Total operating expenses	6,869,000			5,966,000			20,264,000			22,606,000				7,395,000			5,655,000			12,572,000			12,963,000
Loss from operations	(6,759,000		)	(4,315,000		)	(19,620,000		)	(17,233,000		)		(7,339,000	)		(3,633,000	)		(12,464,000	)		(10,873,000	)

Change in fair value of warrant liability	(210,000		)	2,706,000			1,716,000			2,985,000				(56,000	)		32,000			(119,000	)		(395,000	)
Other income, net	8,000			10,000			19,000			28,000				-			40,000			96,000			107,000
Net loss	(6,961,000		)	(1,599,000		)	(17,885,000		)	(14,220,000		)	$	(7,395,000	)	$	(3,561,000	)	$	(12,487,000	)	$	(11,161,000	)
Net loss attributable to non-controlling interest	—			—			—			—
Net loss attributable to Onconova Therapeutics, Inc	$	(6,961,000	)	$	(1,599,000	)	$	(17,885,000	)	$	(14,220,000	)

Net loss per share, basic and diluted	$	(0.71	)	$	(0.29	)	$	(2.09	)	$	(3.90	)	$	(0.04	)	$	(0.60	)	$	(0.08	)	$	(1.89	)
Basic and diluted weighted average shares outstanding	9,851,164			5,438,105			8,551,839			3,643,210				169,552,619			5,948,471			164,949,353			5,919,446

See accompanying notes to condensed consolidated financial statements.

Onconova Therapeutics, Inc.

Condensed Consolidated Statements of Comprehensive Loss (unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2017			2016			2017			2016			Three Months Ended June 30,						Six Months Ended June 30,
													2020			2019			2020			2019
Net loss	$	(6,961,000	)	$	(1,599,000	)	$	(17,885,000	)	$	(14,220,000	)	$	(7,395,000	)	$	(3,561,000	)	$	(12,487,000	)	$	(11,161,000	)
Other comprehensive income (loss), before tax:
Other comprehensive loss, before tax:
Foreign currency translation adjustments, net	9,000			2,000			30,000			5,000				7,000			4,000			1,000			(2,000	)
Other comprehensive income (loss), net of tax	9,000			2,000			30,000			5,000				7,000			4,000			1,000			(2,000	)
Comprehensive loss	(6,952,000		)	(1,597,000		)	(17,855,000		)	(14,215,000		)	$	(7,388,000	)	$	(3,557,000	)	$	(12,486,000	)	$	(11,163,000	)
Comprehensive loss attributable to non-controlling interest	—			—			—			—
Comprehensive loss attributable to Onconova Therapeutics, Inc.	$	(6,952,000	)	$	(1,597,000	)	$	(17,855,000	)	$	(14,215,000	)

See accompanying notes to condensed consolidated financial statements.

Onconova Therapeutics, Inc.

Consolidated Statement of Stockholders’ Equity (Deficit) (unaudited)

	Stockholders’ Equity (Deficit)																Three Month Periods Ended June 30, 2020 and 2019
									Accumulated																		Accumulated
				Additional					other												Additional						other
	Common Stock			Paid in		Accumulated			comprehensive			Non-controlling					Common Stock				Paid in			Accumulated			comprehensive
	Shares	Amount		Capital		deficit			income (loss)			interest		Total			Shares		Amount		Capital			deficit			income (loss)			Total
Balance at March 31, 2020																		167,416,070	$	1,674,000	$	428,189,000		$	(408,491,000	)	$	(24,000	)	$	21,348,000

Balance at December 31, 2016	6,759,895	$	68,000	$	342,484,000	$	(338,224,000	)	$	(31,000	)	$	830,000	$	5,127,000
Net loss																		-		-		-			(7,395,000	)		-			(7,395,000	)
Other comprehensive income																		-		-		-			-			7,000			7,000
Stock-based compensation																		-		-		92,000			-			-			92,000
Issuance of common stock upon exercise of warrants																		5,511,378		55,000		1,525,000			-			-			1,580,000
Issuance of common stock upon exercise of pre-funded warrants																		1,250,000		13,000		(12,000	)		-			-			1,000
Balance at June 30, 2020																		174,177,448	$	1,742,000	$	429,794,000		$	(415,886,000	)	$	(17,000	)	$	15,633,000

Balance at March 31, 2019																		5,895,004	$	59,000	$	387,919,000		$	(389,496,000	)	$	(18,000	)	$	(1,536,000	)

Net loss	—	—		—		(17,885,000		)	—			—		(17,885,000		)		-		-		-			(3,561,000	)		-			(3,561,000	)
Other comprehensive income	—	—		—		—			30,000			—		30,000				-		-		-			-			4,000			4,000
Stock-based compensation	—	—		1,333,000		—			—			—		1,333,000				-		-		155,000			-			-			155,000
Issuance of common stock, net	3,091,269	31,000		5,286,000		—			—			—		5,317,000				103,520		1,000		391,000			-			-			392,000
Balance at September 30, 2017	9,851,164	$	99,000	$	349,103,000	$	(356,109,000	)	$	(1,000	)	$	830,000	$	(6,078,000	)
Balance at June 30, 2019																		5,998,524	$	60,000	$	388,465,000		$	(393,057,000	)	$	(14,000	)	$	(4,546,000	)

	Six Month Periods Ended June 30, 2020 and 2019
											Accumulated
					Additional						other
	Common Stock				Paid in			Accumulated			comprehensive
	Shares		Amount		Capital			deficit			income (loss)			Total
Balance at December 31, 2019		111,167,352	$	1,112,000	$	413,879,000		$	(403,399,000	)	$	(18,000	)	$	11,574,000

Net loss		-		-		-			(12,487,000	)		-			(12,487,000	)
Other comprehensive income		-		-		-			-			1,000			1,000
Stock-based compensation		-		-		185,000			-			-			185,000
Issuance of common stock, net		27,662,518		276,000		8,786,000			-			-			9,062,000
Issuance of common stock upon exercise of warrants		34,097,578		341,000		6,956,000			-			-			7,297,000
Issuance of common stock upon exercise of pre-funded warrants		1,250,000		13,000		(12,000	)		-			-			1,000
Balance at June 30, 2020		174,177,448	$	1,742,000	$	429,794,000		$	(415,886,000	)	$	(17,000	)	$	15,633,000

Balance at December 31, 2018		5,674,220	$	57,000	$	387,238,000		$	(381,896,000	)	$	(12,000	)	$	5,387,000

Net loss		-		-		-			(11,161,000	)		-			(11,161,000	)
Other comprehensive loss		-		-		-			-			(2,000	)		(2,000	)
Stock-based compensation		-		-		805,000			-			-			805,000
Issuance of common stock upon
exercise of warrants		220,784		2,000		31,000			-			-			33,000
Issuance of common stock, net		103,520		1,000		391,000			-			-			392,000
Balance at June 30, 2019		5,998,524	$	60,000	$	388,465,000		$	(393,057,000	)	$	(14,000	)	$	(4,546,000	)

See accompanying notes to condensed consolidated financial statements.

Onconova Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows (unaudited)

	Nine Months ended September 30,						Six Months ended June 30,
	2017			2016			2020			2019
Operating activities:
Net loss	$	(17,885,000	)	$	(14,220,000	)	$	(12,487,000	)	$	(11,161,000	)
Adjustment to reconcile net loss to net cash used in operating activities:
Adjustment to reconcile net loss to net cash used in
operating activities:
Depreciation and amortization	69,000			72,000				5,000			8,000
Change in fair value of warrant liabilities	(1,716,000		)	(2,985,000		)		119,000			395,000
Stock compensation expense	1,333,000			3,357,000				185,000			805,000
Changes in assets and liabilities:
Receivables	(26,000		)	600,000				57,000			(1,679,000	)
Prepaid expenses and other current assets	588,000			664,000				(70,000	)		(73,000	)
Accounts payable	113,000			650,000				877,000			711,000
Accrued expenses and other current liabilities	(1,283,000		)	753,000				(418,000	)		(403,000	)
Deferred revenue	(340,000		)	(341,000		)		(112,000	)		(113,000	)
Net cash used in operating activities	(19,147,000		)	(11,450,000		)		(11,844,000	)		(11,510,000	)

Investing activities:
Net cash provided by investing activities	—			—
Payments for purchase of property and equipment								(15,000	)		-
Net cash used in investing activities								(15,000	)		-

Financing activities:
Proceeds from the sale of common stock and warrants, net of costs	5,317,000			17,421,000				9,062,000			391,000
Proceeds from the exercise of stock options	—			3,000
Proceeds from the exercise of warrants								7,298,000			33,000
Net cash provided by financing activities	5,317,000			17,424,000				16,360,000			424,000
Effect of foreign currency translation on cash	30,000			5,000				1,000			(2,000	)
Net (decrease) increase in cash and cash equivalents	(13,800,000		)	5,979,000
Net increase (decrease) in cash and cash equivalents								4,502,000			(11,088,000	)
Cash and cash equivalents at beginning of period	21,400,000			19,799,000				22,726,000			16,970,000
Cash and cash equivalents at end of period	$	7,600,000		$	25,778,000		$	27,228,000		$	5,882,000

See accompanying notes to condensed consolidated financial statements.

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1. Nature of Business

~~Reverse Stock Split~~

All Common Stock (as defined below), equity, share and per share amounts in the financial statements and notes have been retroactively adjusted to reflect a one-for-ten reverse stock split which was effective May 31, 2016.

The Company

Onconova Therapeutics, Inc. (the ~~“Company”~~"Company") was incorporated in the State of Delaware on December 22, 1998 and commenced operations on January 1, 1999. The ~~Company’s~~Company's headquarters are located in Newtown, Pennsylvania. The Company is a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule product candidates primarily to treat cancer. ~~Using its proprietary chemistry platform, the~~The Company has ~~created a library of~~proprietary targeted cancer agents designed to work against specific cellular pathways that are important to cancer cells. ~~The Company believes~~We believe that the product candidates in ~~its~~our pipeline have the potential to be efficacious in a variety of cancers. The Company has three clinical-stage product candidates and several preclinical programs. In 2011, the Company entered into a license agreement, as subsequently amended, with SymBio Pharmaceuticals Limited (“SymBio”), which grants SymBio certain rights to commercialize rigosertib in Japan and Korea. In 2012, the Company entered into a development and license agreement with Baxter Healthcare SA, the predecessor in interest to Baxalta GmbH (together with its affiliates, “Baxalta”), pursuant to which the Company granted an exclusive, royalty-bearing license for the research, development, commercialization and manufacture (in specified instances) of rigosertib in all therapeutic indications in Europe. The Baxalta agreement terminated effective August 30, 2016, at which time the rights the Company licensed to Baxalta reverted to the Company at no cost. The Company has retained development and commercialization rights to rigosertib in the rest of the world, including the United States. During 2012, Onconova Europe GmbH was established as a wholly owned subsidiary of the Company for the purpose of further developing business in Europe.

The Company has entered into several license and collaboration agreements. In ~~April 2013, GBO, LLC,~~2011, the Company entered into a ~~Delaware limited liability company, (“GBO”~~license agreement, as subsequently amended, with SymBio Pharmaceuticals Limited ("SymBio") ~~was formed pursuant~~, which grants SymBio certain rights to ancommercialize rigosertib in Japan and Korea. In December 2017, the Company entered into a license and collaboration agreement with ~~GVK Biosciences Private Limited,~~HanX for the further development, registration and commercialization of ON 123300 in greater China. ON 123300 is a ~~private limited company located~~preclinical compound which the Company believes has the potential to overcome the limitations of current generation CDK 4/6 inhibitors. Under the terms of the agreement, the Company received an upfront payment, and will receive regulatory and commercial milestone payments, as well as royalties on Chinese sales. The key feature of the collaboration is that HanX provides all funding required for Chinese IND enabling studies performed for Chinese Food and Drug Administration IND approval. The Company and HanX also intended for these studies to comply with the FDA standards. Accordingly, such studies may be used by the Company for an IND filing with the FDA. The Chinese IND was approved in ~~India, (“GVK”~~January 2020. The Company anticipates filing a US IND related to ON 123300 in Q4 of 2020. The Company maintains global rights outside of China. On March 2, 2018, the Company entered into a License, Development and Commercialization Agreement (the “Pint License Agreement”) with Pint International SA (which, together with its affiliate Pint Pharma GmbH, are collectively referred to ~~collaborate~~as "Pint"). Under the terms of the agreement, the Company granted Pint an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how, to develop ~~two programs using~~and commercialize any pharmaceutical product containing rigosertib in all uses of rigosertib in certain Latin American countries. In May 2019, the ~~Company’s technology platform. The two preclinical programs sublicensed~~Company entered into a License and Collaboration Agreement (the "HanX License Agreement") with HanX Biopharmaceuticals, Inc. ("HanX"). Under the terms of the HanX License Agreement, the Company granted HanX an exclusive, royalty-bearing license, with the right to ~~GBO have~~sublicense, under certain Company patent rights and know-how, to develop and commercialize any pharmaceutical product (the "HanX Product") containing rigosertib in all uses of rigosertib or the HanX Product in human therapeutic uses in the People's Republic of China, Hong Kong, Macau and Taiwan (the "HanX Territory"). In connection with the HanX License Agreement, the Company also entered into a Securities Purchase Agreement with each of HanX and Abundant New Investments Ltd. ("Abundant"), an affiliate of HanX (each, a "Securities Purchase Agreement" and together, the "Securities Purchase Agreements"). HanX did not ~~been developed~~fulfill its obligations under the HanX License Agreement and in January 2020, in accordance with the terms of the HanX License Agreement, the HanX License Agreement was deemed to ~~clinical stage~~be void ab initio. Upon this termination, the rights to HanX Product in the HanX Territory reverted to the Company in accordance with the terms of the HanX License Agreement. In addition, the Securities Purchase Agreements terminated automatically effective upon the termination of the HanX License Agreement in accordance with the Securities Purchase Agreements. In November 2019, the Company entered into a Distribution, License and Supply Agreement (the "Knight License Agreement") with Knight Therapeutics Inc. ("Knight"). Under the terms of the Knight License Agreement, the Company granted Knight (i) a non-exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how, to develop and manufacture any product (the "Knight Licensed Product") containing rigosertib for Canada (and Israel, should Knight exercise its option as ~~initially hoped,~~set forth in the Knight License Agreement) (the "Knight Territory") and in human uses (the "Field"), and (ii) an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how, to commercialize the Knight Licensed Product in the Knight Territory and in the Field. Knight has also agreed to obtain from the Company all of its requirements of the Knight Licensed Products for the Knight Territory, and the Company ishas agreed to supply Knight with all of its requirements of the Knight Licensed Products. In December 2019, the Company entered into a Distribution, License and Supply Agreement (the "STA License Agreement") with Specialised Therapeutics Asia Pte. Ltd. ("STA"). Under the terms of the STA License Agreement, the Company granted STA (i) a non-exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how, to develop and manufacture any product (the "STA Licensed Product") containing rigosertib for Australia and New Zealand (the "STA Territory") and in ~~discussions~~human uses (the "Field"), and (ii) an exclusive, royalty-bearing license, with ~~GVK regarding~~ the ~~future~~right to sublicense, under certain Company patent rights and know-how, to commercialize the STA Licensed Product in the STA Territory and in the Field. STA has also agreed to obtain from the Company all of ~~GBO.~~its requirements of the STA Licensed Products for the STA Territory, and the Company has agreed to supply STA with all of its requirements of the STA Licensed Products.

On May 31, 2016, the Company amended its certificate of incorporation to effect a 1 for 10 reverse stock split of its common stock par value $0.01 per share (“Common Stock”) and to decrease the number of authorized shares of Common Stock from 75,000,000 to 25,000,000.

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Liquidity

The Company has incurred recurring operating losses since inception. For the ~~nine~~six months ended ~~September~~June 30, ~~2017,~~2020, the Company incurred a net loss of ~~$17,885,000~~$12,487,000 and as of ~~September~~June 30, ~~2017~~2020 the Company had generated an accumulated deficit of ~~$356,109,000.~~$415,886,000. The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research, development of its product candidates and its preclinical programs, strategic alliances and its administrative organization. At ~~September~~June 30, ~~2017,~~2020, the Company had cash and cash equivalents of ~~$7,600,000.~~$27,228,000. The Company will require substantial additional financing to fund its ongoing clinical trials and operations, and to continue to execute its strategy.

~~From its inception through July 2013,~~In February and March 2019 the Company ~~raised capital through~~implemented a workforce reduction. Six employees were terminated, which represented approximately 24% of the ~~private issuance~~Company's workforce. A severance related charge of ~~preferred stock. On July 30, 2013, the Company completed its initial public offering (the “IPO”)~~approximately $1,843,000, which included a non-cash charge of 594,167 shares of Common Stock, at a price of $150.00 per share. The Company received net proceeds of $79,811,000 from the sale, net of underwriting discounts and commissions and other estimated offering expenses. Immediately priorapproximately $415,000 related to the ~~consummation~~accelerated vesting of outstanding stock options, was recorded in the ~~IPO, all outstanding shares~~three months ended March 31, 2019. Of the total severance related charge of ~~preferred stock automatically converted into shares of Common Stock at the applicable conversion ratio then~~$1,843,000, $1,562,000 was recorded in ~~effect.~~

~~In October 2014, the Company entered into a sales agreement with Cantor Fitzgerald & Co. (“Cantor”) to create an at-the-market equity program under which the Company had the ability to offer~~general and ~~sell shares of its Common Stock having an aggregate offering price of up to $20,000,000~~administrative operating expenses and $281,000 was recorded in research and development operating expenses. The severance expense was paid in periodic amounts through Cantor (see Note 13). Net proceeds from sales of Common Stock under this program were $6,018,000 during the year ended December 31, 2015. The sales agreement with Cantor was terminated on January 5, 2016, and there were no sales of Common Stock under this program during the year ended December 31, 2016.

In October 2015 the Company entered into a purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Upon execution of this purchase agreement, Lincoln Park purchased 84,676 shares of the Company’s Common Stock for $1,500,000. Subject to the terms and conditions of the purchase agreement, including the effectiveness of a registration statement covering the resale of the shares, the Company may sell additional shares of its Common Stock, having an aggregate offering price of up to $15,000,000 to Lincoln Park from time to time until December 1, 2018.February 2020.

On January 5, 2016, the Company entered into a securities purchase agreement with an institutional investor providing for the issuance and sale by the Company of 193,684 shares of the Company’s Common Stock and warrants to purchase 96,842 shares of the Company’s Common Stock for aggregate net proceeds of $1.6 million. (See Note 13)

~~On July 29, 2016~~September 25, 2019 the Company closed on an offering of common stock to certain investors. The Company issued 2,198,938 shares of common stock and amended warrants for the purchase of 2,198,938 shares of common stock. The investors, who were also holders of the Company's preferred stock warrants issued in February 2018 and/or May 2018, received a ~~rights~~warrant amendment under which a certain number of such investors' preferred stock warrants received a reduction in exercise price and an extension of term. Net proceeds from the sale of common stock and the amendment of preferred stock warrants were approximately $3.3 million. In November 2019, the Company closed on an offering of units of ~~Common Stock~~common stock and warrants. The Company issued ~~3,599,786~~30,250,000 shares of ~~Common Stock, 3,192,022 tradable warrants and 656,400~~common stock, pre-funded warrants ~~in connection with the rights offering.~~to purchase 24,750,000 shares of common stock, and common stock warrants to purchase 55,000,000 shares of common stock. Net proceeds were approximately ~~$15.8~~$9.7 million. ~~(See Note 13)~~

On ~~April 26, 2017~~December 10, 2019, the Company closed on an ~~underwritten public~~ offering of ~~2,476,190~~units of common stock and warrants. The Company issued 14,326,648 shares of ~~Common Stock.~~common stock and common stock warrants to purchase 7,163,324 shares of common stock. Net proceeds were approximately $4.4 million. On ~~May 17, 2017,~~December 19, 2019, the Company ~~sold~~also closed on an ~~additional 363,580~~offering of units of common stock and warrants. The Company issued 13,878,864 shares ~~as a result~~ of ~~the underwriter’s exercise~~common stock and common stock warrants to purchase 6,939,432 shares of ~~its over-allotment option.~~common stock. Net proceeds ~~from these transactions~~ were approximately ~~$5.3~~$4.4 million. ~~(See Note 13)~~During 2019, pre-funded warrants were exercised for 23,720,784 shares of common stock and net proceeds were $35,000. Also during 2019, common warrants were exercised for 21,014,378 shares of common stock and net proceeds were approximately $4.9 million.

On January 3, 2020, the Company closed on an offering of common stock. The Company issued 27,662,518 shares of common stock and net proceeds were approximately $9.0 million. In addition, during the six months ended June 30, 2020; 35,347,578 warrants from the November and December 2019 offerings described above have been exercised, resulting in proceeds of $7.3 million. From July 1, 2020 to August 12, 2020, 9,400,819 warrants have been exercised resulting in proceeds of $2.5 million.

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Continued)

(Unaudited)

The Company has and may continue to delay, scale-back, or eliminate certain of its research and development activities and other aspects of its operations until such time as the Company is successful in securing additional funding. The Company is exploring various dilutive and non-dilutive sources of funding, including equity financings, strategic alliances, business development and other sources. The future success of the Company is dependent upon its ability to obtain additional funding. There can be no assurance, however, that the Company will be successful in obtaining such funding in sufficient amounts, on terms acceptable to the Company, or at all. The Company currently anticipates that current cash and cash equivalents will be sufficient to meet its anticipated cash requirements tointo the ~~end~~fourth quarter of ~~2017. These factors raise substantial doubt about the Company’s ability to continue as a going concern.~~

~~Onconova Therapeutics, Inc.~~

~~Notes to Condensed Consolidated Financial Statements (Continued)~~

~~(Unaudited)~~2021.

2. Summary of Significant Accounting Policies

Basis of Presentation

The condensed consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States (“GAAP”) for interim financial information. Certain information and footnotes normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The financial statements include the consolidated accounts of the Company and its wholly-owned subsidiary, Onconova Europe ~~GmbH, and GBO.~~GmbH. All significant intercompany transactions have been eliminated.

Unaudited Interim Financial Information

The accompanying condensed consolidated balance sheet as of ~~September~~June 30, ~~2017,~~2020, the condensed consolidated statements of operations and comprehensive loss for the three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 and ~~2016,~~2019, the consolidated ~~statement~~statements of stockholders’ equity (deficit) for the ~~nine~~three and six months ended ~~September~~June 30, ~~2017~~2020 and 2019 and the condensed consolidated statements of cash flows for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 and ~~2016~~2019 are unaudited. The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of ~~September~~June 30, ~~2017,~~2020, the results of its operations for the three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 and ~~2016,~~2019, and its cash flows for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 and ~~2016.~~2019. The financial data and other information disclosed in these notes related to the three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 and ~~2016~~2019 are unaudited. The results for the three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 are not necessarily indicative of results to be expected for the year ending December 31, ~~2017,~~2020, any other interim periods, or any future year or period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, ~~2016~~2019 included in the Company’s annual report on Form 10-K filed with the SEC on March ~~29, 2017.~~27, 2020.

Segment Information

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment, which is the identification and development of oncology therapeutics.

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Continued)

(Unaudited)

2. Summary of Significant Accounting Policies (Continued)

Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, ~~2016~~2019 included in the Company’s annual report on Form 10-K filed with the SEC on March ~~29, 2017.~~27, 2020. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies.

Fair Value Measurements

The carrying amounts reported in the accompanying consolidated financial statements for cash and cash equivalents, ~~marketable securities,~~ accounts payable, and accrued liabilities approximate their respective fair values because of the short-term nature of these accounts. The fair value of the warrant liability is discussed in Note 7, “Fair Value Measurements.”

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Continued)

(Unaudited)

2. Summary of Significant Accounting Policies (Continued)

Recent Accounting Pronouncements

In May 2014, the FASB issued guidance on revenue from contracts with customers that will supersede most current revenue recognition guidance. The underlying principle is that an entity will recognize revenue to depict the transfer of goods or services to customers at an amount that the entity expects to be entitled to in exchange for those goods or services. Currently, the only revenue the Company is recognizing is under its license and collaboration agreements with SymBio (See Note 10). The new guidance permits the use of either a retrospective or cumulative effect transition method and is effective for interim and annual periods beginning on or after December 15, 2017. Early adoption is permitted but not before December 15, 2016. The Company expects to adopt this guidance effective January 1, 2018 and is currently reviewing its contracts with SymBio, but it has not yet selected a transition method and is evaluating the impact of the amended guidance on the Company’s consolidated financial position, results of operations and related disclosures.

In August 2014, the FASB issued guidance on determining when and how to disclose going-concern uncertainties in the financial statements. The new standard requires management to perform interim and annual assessments of an entity’s ability to continue as a going concern within one year of the date the financial statements are issued. An entity must provide certain disclosures if conditions or events raise substantial doubt about the entity’s ability to continue as a going concern. The guidance applies to all entities and is effective for annual periods ending after December 15, 2016, and interim periods thereafter, with early adoption permitted. The Company adopted the new guidance as of December 31, 2016. Based on its current cash position and an evaluation of expected future net cash outflows the Company has determined there is substantial doubt about its ability to continue as a going concern (See Note 1).

In February 2016 and through subsequent amendments, the FASB issued guidance which supersedes much of the ~~current~~previous guidance for leases. The new ~~standard~~guidance requires lessees to recognize a right-of-use asset and a lease liability on their balance sheets for all the leases with terms greater than twelve months. Based on certain criteria, leases ~~will be~~are classified as either financing or operating, with classification affecting the pattern of expense recognition in the income statement. For leases with a term of twelve months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities. If a lessee makes this election, it should recognize lease expense for such leases generally on a straight-line basis over the lease term. The guidance iswas effective for fiscal years beginning after December 15, 2018, and interim periods within those years, with early adoption permitted. In transition, lessees and lessors ~~are required~~were permitted to recognize and measure leases at the ~~beginning~~date of ~~the earliest period presented~~adoption using a modified retrospective approach. The modified retrospective approach includes a number of optional practical expedients primarily focused on leases that commenced before the effective date of the new guidance, including continuing to account for leases that commence before the effective date in accordance with previous guidance, unless the lease is modified. The Company adopted the guidance in ASC 842 effective January 1, 2019 using the modified retrospective method, which does not require the restatement of prior period amounts. There was no impact to the Company’s financial position and results of operations as a result of the adoption.

In August 2018, the FASB issued guidance which changes the disclosure requirements for fair value measurement. The guidance amends the disclosure requirements in ASC Topic 820 by adding, changing, or removing certain disclosures. The guidance is effective for fiscal years beginning after December 15, 2019. The Company adopted this guidance effective January 1, 2020. There was no impact to the Company’s financial position, results of operations or financial statement disclosures as a result of the adoption.

In November 2018, the FASB issued guidance, which clarifies the interaction between ASC Topic 808, Collaborative Arrangements , and ASC Topic 606, Revenue from Contracts with Customers . The guidance, among other items, clarifies that certain transactions between collaborative participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. The guidance is effective for fiscal years beginning after December 15, 2019. The Company adopted this guidance effective January 1, 2020. There was no impact to the Company’s financial position and results of operations as a result of the adoption.

In June 2016, the FASB issued new guidance on the accounting for credit losses on financial instruments. The guidance was amended in November 2019. The new guidance introduces an expected loss model for estimating credit losses, replacing the incurred loss model. The new guidance also changes the impairment model for available-for-sale debt securities, requiring the use of an allowance to record estimated credit losses (and subsequent recoveries). The guidance is effective for fiscal years beginning after December 15, 2022, and interim periods within those years, with early adoption permitted. The Company is evaluating the impact of the adoption of the standard on its consolidated financial statements.

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Continued)

(Unaudited)

~~2. Summary of Significant Accounting Policies (Continued)~~

In March 2016, the FASB issued guidance which clarifies the implementation guidance on principal versus agent considerations in the revenue recognition standard issued in May 2014. The new standard clarifies how an entity should identify the unit of accounting (i.e. the specified good or service) for the principal versus agent evaluation and how it should apply the control principle to certain types of arrangements. The effective date and transition requirements are the same as the effective date and transition requirements in the May 2014 revenue standard (Accounting Standards Codification 606). The Company is currently assessing the adoption methodology and the impact the adoption of these ASUs will have on its consolidated financial position, results of operations and related disclosures.

In March 2016, the FASB issued guidance that addresses the income tax effects of stock-based payments and eliminates the windfall pool concept, as all of the tax effects related to stock-based payments will now be recorded at settlement (or expiration) through the income statement. The new guidance also permits entities to make an accounting policy election for the impact of forfeitures on the recognition of expense for stock-based payment awards. Forfeitures can be estimated or recognized when they occur. The standard is effective for annual periods beginning after December 15, 2016 and interim periods within that reporting period. Early adoption is permitted in any interim or annual period, with any adjustment reflected as of the beginning of the fiscal year of adoption. The Company adopted the new guidance as of January 1, 2017. The adoption did not have a material impact on the Company’s condensed consolidated financial statements and related disclosures.

In November 2016, the FASB issued guidance requiring that amounts generally described as restricted cash and restricted cash equivalents be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The guidance is effective for interim and annual periods beginning in 2018 and should be applied using a retrospective transition method to each period presented. Early adoption is permitted. The Company is currently evaluating the effect of the standard on its Consolidated Statement of Cash Flows.

3. Revenue

The ~~Company recognized~~Company’s revenue ~~under~~during the three and six months ended June 30, 2020 and 2019 was from its license and collaboration agreements with ~~Baxalta~~SymBio and ~~SymBio~~HanX.

	Three Months Ended June 30,				Six Months Ended June 30,
	2020		2019		2020			2019
Symbio
Upfront license fee recognition over time	$	56,000	$	56,000	$	112,000		$	113,000
Supplies and other		-		1,000		(4,000	)		12,000

HanX - rigosertib
Upfront license payment		-		1,965,000		-			1,965,000

	$	56,000	$	2,022,000	$	108,000		$	2,090,000

Deferred revenue is as follows:

Three Months Ended September 30,

Nine Months Ended September 30,

2017

2016

2017

2016

Baxalta

$
—

$
1,538,000

$
—

$
4,857,000

Symbio

110,000

113,000

644,000

516,000

$
110,000

$
1,651,000

$
644,000

$
5,373,000

	Symbio
	Upfront Payment
Deferred balance at December 31, 2019	$	3,921,000
Recognition to revenue		112,000

Deferred balance at June 30, 2020	$	3,809,000

~~See Note 10, “License and Collaboration Agreements,” for a further discussion of the agreements with Baxalta and SymBio.~~

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Continued)

(Unaudited)

4. Net Loss Per Share of Common Stock

The following potentially dilutive securities outstanding at ~~September~~June 30, ~~2017~~2020 and ~~2016~~2019 have been excluded from the computation of diluted weighted average shares outstanding, as they would be ~~antidilutive:~~antidilutive (reflects the number of common shares as if the dilutive securities had been converted to common stock):

	September 30,		June 30,
	2017	2016	2020		2019
Warrants	3,294,771	3,525,771		21,862,189		5,504,722
Stock options	907,373	709,227		1,044,591		355,794
	4,202,144	4,234,998		22,906,780		5,860,516

5. Warrants

Common Stock warrants are accounted for in accordance with applicable accounting guidance provided in ASC Topic 815, Derivatives and Hedging — Contracts in Entity’s Own Equity~~(ASC~~ (ASC Topic 815), as either derivative liabilities or as equity instruments depending on the specific terms of the warrant agreement. Some of the Company’s warrants are classified as liabilities because in certain circumstances they could require cash settlement.

Warrants outstanding and warrant activity (reflects the number of common shares as if the warrants were converted to common stock) for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 is as follows:

Balance

Balance

Exercise

Expiration

Decemeber 31,

Warrants

Warrants

Warrants

September 30,

Description

Classification

Price

Date

2016

Issued

Exercised

Expired

2017

Non-tradable warrants

Liability

$
11.50

July 2021

96,842

—

—

—

96,842

Tradable warrants

Liability

$
4.92

July 2021

3,192,022

—

—

—

3,192,022

Non-tradable pre-funded warrants

Equity

$
0.01

July 2023

236,907

—

(231,000
)
—

5,907

3,525,771

—

(231,000
)
—

3,294,771

					Balance							Balance
		Exercise		Expiration	December 31,		Warrants		Warrants			June 30,
Description	Classification	Price		Date	2019		Issued		Exercised			2020
Non-tradable warrants	Liability	$	172.50	July 2021		6,456		-		-			6,456
Tradable warrants	Liability	$	73.80	July 2021		212,801		-		-			212,801
Non-tradable pre-funded warrants	Equity	$	0.15	July 2023		394		-		-			394
Non-tradable warrants	Equity	$	1.60	December 2022		392,834		-		-			392,834
Non-tradable warrants	Equity	$	14.10	March 2021		5,000		-		-			5,000
Non-tradable warrants	Equity	$	21.15	March 2021		8,333		-		-			8,333
Non-tradable warrants	Equity	$	7.7895	June 2021		15,000		-		-			15,000
Non-tradable pre-funded warrants	Equity	$	0.15	none		52,834		-		-			52,834
Non-tradable warrants	Equity	$	1.600	December 2022		1,806,104		-		-			1,806,104
Non-tradable pre-funded warrants	Equity	$	0.15	none		74,617		-		-			74,617
Non-tradable warrants	Equity	$	2.00	September 2023		109,585		-		-			109,585
Non-tradable pre-funded warrants	Equity	$	0.0001	none		1,250,000		-		(1,250,000	)		-
Non-tradable warrants	Equity	$	0.20	November 2024		41,037,000		-		(29,046,200	)		11,990,800
Non-tradable warrants	Equity	$	0.250	November 2024		2,521,875		-		-			2,521,875
Non-tradable warrants	Equity	$	0.287	December 2024		3,581,662		-		(1,581,662	)		2,000,000
Non-tradable warrants	Equity	$	0.43625	December 2024		716,332		-		-			716,332
Non-tradable warrants	Equity	$	0.298	December 2024		3,469,716		-		(3,469,716	)		-
Non-tradable warrants	Equity	$	0.45030	December 2024		693,943		-					693,943
Non-tradable warrants	Equity	$	0.45190	December 2023		-		1,383,126					1,383,126

						55,954,486		1,383,126		(35,347,578	)		21,990,034

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Continued)

(Unaudited)

6. Balance Sheet Detail

Prepaid expenses and other current assets:

	September 30,		December 31,
	2017		2016		June 30,		December 31,
					2020		2019
Research and development	$	632,000	$	1,075,000	$	281,000	$	321,000
Manufacturing	43,000		90,000			70,000		25,000
Insurance	204,000		350,000			57,000		164,000
Other	121,000		73,000			312,000		140,000
	$	1,000,000	$	1,588,000	$	720,000	$	650,000

Property and equipment:

	September 30,			December 31,
	2017			2016			June 30,			December 31,
							2020			2019
Property and equipment	$	2,228,000		$	2,228,000		$	2,298,000		$	2,283,000
Accumulated depreciation	(2,145,000		)	(2,076,000		)		(2,238,000	)		(2,233,000	)
	$	83,000		$	152,000		$	60,000		$	50,000

Accrued expenses and other current liabilities:

September 30,

December 31,

2017

2016

Research and development

$
1,982,000

$
2,376,000

Employee compensation

945,000

1,573,000

Professional fees

171,000

235,000

Other

—

198,000

$
3,098,000

$
4,382,000

	June 30,		December 31,
	2020		2019
Research and development	$	2,165,000	$	2,016,000
Employee compensation		977,000		1,537,000
Professional fees		235,000		242,000
	$	3,377,000	$	3,795,000

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Continued)

(Unaudited)

7. Fair Value Measurements

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.

The Company utilizes a valuation hierarchy for disclosure of the inputs to the valuations used to measure fair value. This hierarchy prioritizes the inputs into three broad levels as follows. Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 inputs are unobservable inputs based on the Company’s own assumptions used to measure assets and liabilities at fair value. A financial asset or liability’s classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement.

On January 5, 2016, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with an institutional investor providing for the issuance and sale by the Company of ~~193,684~~12,912 shares of Common Stock, at a purchase price of ~~$9.50~~$142.50 per share and warrants to purchase up to ~~96,842~~6,456 shares of Common Stock (the “Warrants”) for aggregate gross proceeds of ~~$1,840,000 (see Note 13).~~$1,840,000. The Company has classified the warrants as a liability (see Note 5). The estimated fair value ~~was estimated~~ using the Black-Scholes pricing ~~model.~~model was approximately $0 at June 30, 2020 and December 31, 2019.

On July 29, 2016 the Company closed on a Rights Offering, issuing ~~3,599,786~~239,986 shares of Common Stock, ~~3,192,022~~212,801 Tradable Warrants and ~~656,400~~43,760 Pre-Funded Warrants. The Tradable Warrants are exercisable for a period of five years for one share of Common Stock at an exercise price of ~~$4.92~~$73.80 per share. After the one-year anniversary of issuance, the Company may redeem the Tradable Warrants for $0.001 per Tradable Warrant if the volume weighted average price of its Common Stock is above ~~$12.30~~$184.50 for each of 10 consecutive trading ~~days (see Note 13).~~days. The Company has classified the Tradable Warrants as a liability (see Note 5). The Tradable Warrants have been listed on the ~~NASDAQ~~Nasdaq Capital Market since issuance and the Company regularly monitors the trading activity. ~~During the period from issuance on July 29, 2016 through March 31, 2017 the~~The Company determined that trading volume was insufficient to use the NASDAQ Capital Market value to determine the fair value of the warrant liability. The fair value was estimated using the Black-Scholes pricing model. During the quarter ended June 30, 2017, the Companyhas determined that an active and orderly market for the Tradable Warrants ~~had~~has developed and that the ~~NASDAQ~~Nasdaq Capital Market price ~~was~~is the best indicator of fair value of the warrant liability. Consequently, the Company changed its valuation technique from the Black-Scholes pricing model to the quoted market price, effective April 1, 2017. The change in valuation technique resulted in a reclassification of the liability within the valuation hierarchy form Level 3 to Level 1. The quoted market price was ~~also~~ used to determine the fair value at ~~September~~December 31, 2019 and June 30, ~~2017.~~2020.

The Company estimated the fair value of the non-tradable warrant liability at ~~September~~June 30, ~~2017,~~2020, using the Black-Scholes option pricing model with the following weighted-average assumptions:

Risk-free interest rate	~~2.04%~~	0.16	%
Expected volatility	~~76.06%~~	105.44	%
Expected term	~~3.79~~	1.08 years
Expected dividend yield	0%	0	%

Expected volatility is based on the historical volatility of the Company’s Common Stock since its IPO in July 2013.

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Continued)

(Unaudited)

7. Fair Value Measurements (Continued)

The following fair value hierarchy table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of ~~September~~June 30, ~~2017~~2020 and December 31, ~~2016:~~2019:

Fair Value Measurement as of:

September 30, 2017

December 31, 2016

Level 1

Level 2

Level 3

Balance

Level 1

Level 2

Level 3

Balance

Tradable warrants liability

$
1,659,000

$
—

$
—

$
1,659,000

$
—

$
—

$
3,338,000

$
3,338,000

Non-tradable warrants liability

—

—

27,000

27,000

—

—

63,000

63,000

Total

$
1,659,000

$
—

$
27,000

$
1,686,000

$
—

$
—

$
3,401,000

$
3,401,000

The following table presents a reconciliation of the Company’s liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the nine months ended September 30, 2017:

Warrant Liability

Balance at December 31, 2016

$
3,401,000

Change in fair value upon re-measurement

1,549,000

Balance at March 31, 2017

4,950,000

Reclassification of tradable warrants to Level 1

(4,857,000
)
Change in fair value upon re-measurement

(53,000
)
Balance at June 30, 2017

40,000

Change in fair value upon re-measurement

(13,000
)
Balance at September 30, 2017

$
27,000

	Fair Value Measurement as of:
	June 30, 2020								December 31, 2019
	Level 1		Level 2		Level 3		Balance		Level 1		Level 2		Level 3		Balance
Tradable warrants liability	$	232,000	$	-	$	-	$	232,000	$	113,000	$	-	$	-	$	113,000
Non-tradable warrants liability		-		-		-		-		-		-		-		-
Total	$	232,000	$	-	$	-	$	232,000	$	113,000	$	-	$	-	$	113,000

There were no transfers between Level 1 and Level 2 in any of the periods reported.

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Continued)

(Unaudited)

8. Stock-Based Compensation

~~In January 2008, the board of directors approved the~~The 2007 Equity Compensation Plan as amended (the “2007 Plan”), ~~which~~ amended, restated and renamed the Company’s 1999 Stock Based Compensation Plan (the “1999 Plan”), which provided for the granting of incentive and nonqualified stock options and restricted stock to its employees, directors and consultants at the discretion of the board of directors.

~~Further, in July 2013, the Company’s board of directors and stockholders approved the~~The 2013 Equity Compensation Plan (the “2013 Plan”), ~~which~~ amended, restated and renamed the 2007 Plan. Under the 2013 Plan, the Company may grant incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units, deferred share awards, performance awards and other equity-based awards to employees, directors and consultants. The Company initially reserved ~~610,783~~40,718 shares of Common Stock for issuance, subject to adjustment as set forth in the 2013 Plan. The 2013 Plan ~~includes~~included an evergreen provision, pursuant to which the maximum aggregate number of shares that may be issued under the 2013 Plan is increased on the first day of each fiscal year by the lesser of (a) a number of shares equal to four percent (4%) of the issued and outstanding Common Stock of the Company, without duplication, (b) ~~200,000~~13,333 shares and (c) such lesser number as determined by the Company’s board of directors, subject to specified limitations.

The 2018 Omnibus Incentive Compensation Plan (the “2018 Plan”) was unanimously approved by the Company’s Board of Directors on May 24, 2018 and was approved by the Company’s stockholders on June 27, 2018. The 2018 Plan replaces the 2013 Plan. Upon stockholders’ approval of the 2018 Plan, no further awards will be made under the 2013 Plan. Awards granted under the 2013 Plan will continue in effect in accordance with the terms of the applicable award agreement and the terms of the 2013 Plan in effect when the awards were granted.

Under the 2018 Plan, the Company may grant incentive stock options, non-qualified stock options, stock awards, stock units, stock appreciation rights and other stock-based awards to employees, non-employee directors and consultants, and advisors. The maximum aggregate number of shares of the Company’s common stock that may be issued under the 2018 Plan is 402,354, which is equal to the sum of (i) 400,000 shares of the Company’s common stock, plus (ii) 2,354 shares, which is the number of shares of the Company common stock reserved for issuance under the 2013 Plan that remained available as of the effective date of the 2018 Plan. In addition, the number of shares of common stock subject to outstanding awards under the 2013 Plan that terminate, expire, or are cancelled, forfeited, exchanged, or surrendered without having been exercised, vested, or paid in shares under the 2013 Plan after the effective date of the 2018 Plan will be available for issuance under the 2018 Plan.

The 2018 Plan was amended following unanimous approval of the Company’s Board of Directors on April 24, 2019 and was approved by the Company’s shareholders on June 17, 2019. The amended 2018 Plan (the “Amended Plan”) allowed for an additional 589,500 shares of the Company’s common stock that may be issued under the Amended Plan with respect to awards made on and after June 17, 2019. At ~~September~~June 30, ~~2017,~~2020, there were ~~45,255~~9,593 shares available for future issuance.

Stock-based compensation expense includes stock options granted to employees and non-employees and has been reported in the Company’s statements of operations and comprehensive loss in either research and development expenses or general and administrative expenses depending on the function performed by the optionee. No net tax benefits related to the stock-based compensation costs have been recognized since the Company’s inception. The Company recognized stock-based compensation expense as follows for the three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 and ~~2016:~~2019:

Three Months ended September 30,

Nine Months Ended September 30,

2017

2016

2017

2016

General and administrative

$
251,000

$
288,000

$
770,000

$
1,571,000

Research and development

180,000

288,000

563,000

1,786,000

$
431,000

$
576,000

$
1,333,000

$
3,357,000

	Three Months ended June 30,				Six Months ended June 30,
	2020		2019		2020		2019
General and administrative	$	46,000	$	67,000	$	91,000	$	606,000
Research and development		46,000		88,000		94,000		199,000
	$	92,000	$	155,000	$	185,000	$	805,000

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Continued)

(Unaudited)

8. Stock-Based Compensation (Continued)

A summary of stock option activity for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 is as follows:

			Options Outstanding										Options Outstanding
	Shares Available for Grant		Number of Shares		Weighted- Average Exercise Price		Weighted Average Remaining Contractual Term (in years)	Aggregate Intrinsic Value		Shares Available for Grant			Number of Shares			Weighted- Average Exercise Price		Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value
Balance, December 31, 2016	6,275		746,353		$	53.50	7.70	$	0
Balance, December 31, 2019											59,731			994,453		$	27.37		9.32	$	—
Authorized	200,000		—								—			—
Granted	(196,811	)	196,811		$	2.58					(63,250	)		63,250		$	0.307		9.77
Exercised	—		—		$	—					—			—		$	—
Forfeitures	35,791		(35,791	)	$	88.27					13,112			(13,112	)	$	168.21		7.92
Balance, September 30, 2017	45,255		907,373		$	41.09	7.56	$	0
Vested or expected to vest, September 30, 2017			893,634		$	60.82	6.75	$	0
Exercisable at September 30, 2017			575,522		$	60.82	6.75	$	0
Balance, June 30, 2020											9,593			1,044,591		$	24.08		8.89	$	—
Vested or expected to vest, June 30, 2020														1,012,646		$	89.06		7.60	$	—
Exercisable at June 30, 2020														272,982		$	89.06		7.60	$	—

Information with respect to stock options outstanding and exercisable at ~~September~~June 30, ~~2017~~2020 is as follows:

Exercise Price

Shares

Exercisable

$1.94 - $6.50

487,578

200,294

$14.80 - $15.00

37,550

23,787

$23.20 - $39.80

101,064

77,076

$43.40 - $75.30

98,123

93,349

$132.80 - $151.20

177,708

175,666

$277.10 - $291.40

5,350

5,350

907,373

575,522

~~Options granted after April 23, 2013~~

The Company accounts for all stock-based payments made after April 23, 2013 to employees and directors using an option pricing model for estimating fair value. Accordingly, stock-based compensation expense is measured based on the estimated fair value of the awards on the date of grant, net of forfeitures. Compensation expense is recognized for the portion that is ultimately expected to vest over the period during which the recipient renders the required services to the Company using the straight-line single option method. In accordance with authoritative guidance, the fair value of non-employee stock based awards is re-measured as the awards vest, and the resulting increase in fair value, if any, is recognized as expense in the period the related services are rendered.

~~Onconova Therapeutics, Inc.~~

~~Notes to Condensed Consolidated Financial Statements (Continued)~~

~~(Unaudited)~~

~~8. Stock-Based Compensation (Continued)~~

Exercise Price	Shares		Exercisable
$0.29 - $0.36		658,250		—
$3.39 – $3.72		51,998		9,916
$4.34 – $7.05		269,222		199,860
$16.35 – $97.50		47,897		45,996
$222.00 - $225.00		1,871		1,871
$348.00 – $597.00		4,801		4,800
$651.00 – $1,129.50		3,481		3,468
$1,992.00 - $2,268.00		6,736		6,736
$4,156.50 - $4,371.00		335		335
		1,044,591		272,982

The Company uses the Black-Scholes option-pricing model to estimate the fair value of stock options at the grant date. The Black-Scholes model requires the Company to make certain estimates and assumptions, including estimating the fair value of the Company’s Common Stock, assumptions related to the expected price volatility of the Common Stock, the period during which the options will be outstanding, the rate of return on risk-free investments and the expected dividend yield for the Company’s stock.

As of ~~September~~June 30, ~~2017,~~2020, there was ~~$1,414,000~~$525,000 of unrecognized compensation expense related to the unvested stock options issued from April 24, 2013 through ~~September~~June 30, ~~2017,~~2020, which is expected to be recognized over a weighted-average period of approximately ~~1.83~~2.12 years.

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Continued)

(Unaudited)

8. Stock-Based Compensation (Continued)

The weighted-average assumptions underlying the Black-Scholes calculation of grant date fair value include the following:

	Nine Months ended September 30,		Six Months ended June 30,
	2017	2016	2020			2019
Risk-free interest rate	2.03%	1.35%		0.45	%		2.27	%
Expected volatility	79.06%	75.71%		105.14	%		83.68	%
Expected term	6.00 years	5.78 years		6.00 years			6.25 years
Expected dividend yield	0%	0%		0	%		0	%
Weighted average grant date fair value	$1.77	$2.87	$	0.25		$	12.60

The weighted-average valuation assumptions were determined as follows:

· Risk-free interest rate: The Company based the risk-free interest rate on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected option term.

· Expected term of options: Due to its lack of sufficient historical data, the Company estimates the expected life of its employee stock options using the “simplified” method, as prescribed in Staff Accounting Bulletin (SAB) No. 107, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option.

· Expected stock price volatility: Expected volatility is based on the historical volatility of the Company’s Common Stock since its IPO in July 2013.

· Expected annual dividend yield: The Company has never paid, and does not expect to pay, dividends in the foreseeable future. Accordingly, the Company assumed an expected dividend yield of 0.0%.

· Estimated forfeiture rate: The Company’s estimated annual forfeiture rate on stock option grants was 4.14% in ~~2017~~2020 and ~~2016,~~2019, based on the historical forfeiture experience.

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Continued)

(Unaudited)

~~8. Stock-Based Compensation (Continued)~~

~~Options granted through April 23, 2013~~

At certain times throughout the Company’s history, the chairman of the Company’s board of directors, who is also a significant stockholder of the Company (the “Significant Holder”), has afforded option holders the opportunity for liquidity in transactions in which options were exercised and the shares of Common Stock issued in connection therewith were simultaneously purchased by the Significant Holder (each, a “Purchase Transaction”). Because the Company had established a pattern of providing cash settlement alternatives for option holders, the Company has accounted for its stock-based compensation awards as liability awards, the fair value of which is then re-measured at each balance sheet date.

On April 23, 2013, the Company distributed a notification letter to all equity award holders under the Company’s 2007 Equity Compensation Plan (the “2007 Plan”) advising them that Purchase Transactions would no longer occur, unless, at the time of a Purchase Transaction, the option holder has held the Common Stock issued upon exercise of options for a period of greater than six months prior to selling such Common Stock to the Significant Holder and that any such sale to the Significant Holder would be at the fair value of the Common Stock on the date of such sale. Based on these new criteria for Purchase Transactions, the Company remeasured options outstanding under the 2007 Plan as of April 23, 2013 to their intrinsic value and reclassified such options from liabilities to stockholders’ deficit within the Company’s consolidated balance sheets, which amounted to $14,482,000. As of September 30, 2017, there was no unrecognized compensation expense related to these awards.

9. Research Agreements

The Company has entered into various licensing and right-to-sublicense agreements with educational institutions for the exclusive use of patents and patent applications, as well as any patents that may develop from research being conducted by such educational institutions in the field of anticancer therapy, genes and proteins. Results from this research have been licensed to the Company pursuant to these agreements. Under one of these agreements with Temple University (“Temple”), the Company is required to make annual maintenance payments to Temple and royalty payments based upon a percentage of sales generated from any products covered by the licensed patents, with minimum specified royalty payments. As no sales had been generated through ~~September~~June 30, ~~2017~~2020 under the licensed patents, the Company has not incurred any royalty expenses related to this agreement. In addition, the Company is required to pay Temple a percentage of any sublicensing fees received by the Company.

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Continued)

(Unaudited)

10. License and Collaboration ~~Agreements~~Agreement

~~Baxalta~~HanX Rigosertib Agreement (terminated)

~~In September 2012,~~On May 10, 2019, the Company entered into a development and license agreement with Baxter Healthcare SA, the predecessor in interest to Baxalta, pursuant to which the Company granted an exclusive, royalty-bearing license for the research, development, commercialization and manufacture (in specified instances) of rigosertib in all therapeutic indications in Europe. In accordance with this agreement, the Company received an upfront cash payment of $50,000,000 in 2012. On March 3, 2016, the Company received a notification of Baxalta’s election to terminate the development and license agreement based on a strategic reprioritization review, effective August 30, 2016, at which time, the rights licensed to Baxalta reverted to the Company at no cost. Additionally, any rights the Company had to funding, pre-commercial milestone payments and royalties from Baxalta terminated in accordance with the agreement.

Among other things, the Baxalta agreement contemplated development of rigosertib IV in higher-risk MDS patients, through the Company’s ONTIME trial and, potentially, additional Phase 3 clinical trials. The ONTIME trial did not achieve its primary endpoint and the Company is continuing the development of rigosertib IV in higher-risk MDS patients through its INSPIRE trial. In accordance with the agreement, the Company elected to have Baxalta fund fifty percent of the costs of the INSPIRE trial, up to $15.0 million. The funding from Baxalta terminated effective August 30, 2016. The Company recorded revenue related to Baxalta’s funding of the INSPIRE trial of $1,538,000 and $4,857,000 during the three and nine months ended September 30, 2016, respectively. The Company has overall responsibility for the trial, including determination of the trial specifications, selection of third party service providers and payment for all services and materials.

~~Onconova Therapeutics, Inc.~~

~~Notes to Condensed Consolidated Financial Statements (Continued)~~

~~(Unaudited)~~

~~10.~~ License and Collaboration Agreement (the "HanX License Agreement") with HanX and two Securities Purchase Agreements ~~(Continued)~~

~~SymBio Agreement~~

~~In July 2011, the Company entered into a license agreement~~(the "HanX Securities Purchase Agreements"), one with SymBio, which has been subsequently amended, granting SymBio an exclusive, royalty-bearing license for the development and commercialization of rigosertib in Japan and Korea. Under the SymBio license agreement, SymBio is obligated to use commercially reasonable efforts to develop and obtain market approval for rigosertib inside the licensed territoryHanX and the ~~Company has similar obligations outside~~other with an affiliate of the licensed territory. The Company has also entered into an agreement with SymBio providing for it to supply SymBio with development-stage product. Under the SymBio license agreement, the Company also agreed to supply commercial product to SymBio under specified terms that will be included in a commercial supply agreement to be negotiated prior to the first commercial sale of rigosertib. The supply of development-stage product and the supply of commercial product will be at the Company’s cost plus a defined profit margin. Sales of development-stage product have been de minimis. The Company has additionally granted SymBio a right of first negotiation to license or obtain the rights to develop and commercialize compounds having a chemical structure similar to rigosertib in the licensed territory.HanX.

Under the terms of the ~~SymBio license agreement,~~HanX License Agreement, the Company ~~received~~granted HanX an exclusive, royalty-bearing license, with the right to sublicense, to study and commercialize rigosertib in greater China (the "HanX Territory," including the People's Republic of China, Hong Kong, Macau and Taiwan).

In exchange for these rights, the agreement required HanX to make upfront ~~payment~~payments to the Company totaling $4 million, including a $2.0 million upfront fee and an investment totaling $2.0 million to purchase shares of ~~$7,500,000.~~the Company at a premium to market. HanX was also required to dedicate $2.0 million in local currency, to be placed in escrow, for clinical development expenses in the HanX Territory. In addition, the agreement provided for potential payments to the Company for regulatory, development and sales-based milestone payments up to $45.5 million and tiered royalties up to double digits on net sales in in the HanX Territory. The Company ~~is eligible to receive milestone payments of up to an aggregate of $22,000,000 from SymBio upon the achievement of specified development and regulatory milestones~~would supply rigosertib for ~~specified indications. Of the regulatory milestones, $5,000,000 is due upon receipt of marketing approval~~sale in the ~~United States~~HanX Territory.

The HanX License Agreement also contained certain provisions for rigosertib IV in higher-risk MDS patients, $3,000,000 is due upon receipt of marketing approval in Japan for rigosertib IV in higher-risk MDS patients, $5,000,000 is due upon receipt of marketing approvaltermination by either party in the ~~United States for rigosertib oral in lower-risk MDS patients, and $5,000,000 is due upon receipt~~event of ~~marketing approval in Japan for rigosertib oral in lower-risk MDS patients. Furthermore, upon receipt~~breach of ~~marketing approval in~~ the ~~United States and Japan for an additional specified indication~~HanX License Agreement by the other party, subject to a cure period, or bankruptcy of ~~rigosertib, which~~ the Company is currently not pursuing, an aggregate of $4,000,000 would be due. In addition to these pre-commercial milestones, the Company is eligible to receive tiered milestone payments based upon annual net sales of rigosertib by SymBio of up to an aggregate of $30,000,000.other party.

~~Further, under~~Under the terms of the ~~SymBio~~HanX Securities Purchase Agreement, HanX and its affiliate agreed to make upfront equity investments in the Company at a specified premium to the Company's share price. The common stock purchased by HanX and its affiliates is subject to certain lock-up restrictions and HanX and its affiliates are entitled to certain registration and participation rights.

The Company assessed the HanX License Agreement for revenue recognition in accordance with ASC 606 and determined that there are two distinct performance obligations: the license ~~agreement, SymBio will make royalty~~and the supply of rigosertib for sale in the HanX Territory. The Company concluded that control of the license had been transferred to HanX during the three months ended June 30, 2019 and recognized license revenue of $1.7 million, which is net of applicable taxes withheld by the Chinese government, related to the $2.0 million upfront fee. The Company believes a portion of the tax being withheld by the Chinese government may be recoverable at a later date and could be recognized as license revenue if and when recovered by the Company. The $1.7 million was recorded as a receivable at June 30, 2019 and the payment was received in August 2019.

Pursuant to the HanX Securities Purchase Agreements, closing of one of the upfront equity investments occurred on May 15, 2019 when an affiliate of HanX purchased 103,520 shares of common stock for $0.5 million. The total amount of the premium was $0.1 million and this amount was recognized as license revenue during the three months ended June 30, 2019. The remaining upfront equity investments represent equity-classified forward contracts for the purchase of the Company's equity at a pre-determined price. The premium of the future equity purchase from HanX as of the contract date of $0.2 million was recognized as license revenue during the three months ended June 30, 2019 and was included in other current assets, pending receipt of payment.

On July 9, 2019, the Company extended the deadline for payments under the HanX License Agreement and the HanX Securities Purchase Agreements. On August 8, 2019 the Company received the non-refundable license fee from HanX. On August 14, 2019, the Company further extended the deadline of HanX's remaining upfront payments relating to its equity investment in the Company while HanX continued to seek Chinese regulatory approval for such equity investment. In December 2019, the Company reassessed the likelihood of receiving the $0.2 million premium on the equity investment previously recorded as revenue. The Company reversed the $0.2 million revenue in December 2019.

On January 16, 2020, the Company determined HanX did not fulfill its obligations under the License Agreement and, in accordance with the terms of the License Agreement, the License Agreement was deemed to be void ab initio. Upon this termination, the rights to Product in the Territory reverted to the Company ~~at percentage rates ranging from~~in accordance with the ~~mid-teens to 20% based on net sales of rigosertib by SymBio.~~

~~Royalties will be payable under the SymBio agreement on a country-by-country basis in the licensed territory, until the later~~terms of the expiration of marketing exclusivity in those countries, a specified period of time after first commercial sale of rigosertib in such country, or the expiration of all valid claims of the licensed patents covering rigosertib or the manufacture or use of rigosertib in such country. If no valid claim exists covering the composition of matter of rigosertib or the use of or treatment with rigosertib in a particular country before the expiration of the royalty term, and specified competing products achieve a specified market share percentage in such country, SymBio’s obligation to pay the Company royalties will continue at a reduced royalty rate until the end of the royalty term.License Agreement. In addition, the ~~applicable royalties payable to~~Securities Purchase Agreements terminated automatically effective upon the Company may be reduced if SymBio is required to pay royalties to third-parties for licenses to intellectual property rights necessary to develop, use, manufacture or commercialize rigosertib in the licensed territory. The license agreement with SymBio will remain in effect until the expirationtermination of the ~~royalty term. However,~~License Agreement in accordance with the SymBio license agreement may be terminated earlier due to the uncured material breach or bankruptcy of a party, or force majeure. If SymBio terminates the license agreement in these circumstances, its licenses to rigosertib will survive, subject to SymBio’s milestone and royalty obligations, which SymBio may elect to defer and offset against any damages that may be determined to be due from the Company. In addition, the Company may terminate the license agreement in the event that SymBio brings a challenge against it in relation to the licensed patents, and SymBio may terminate the license agreement without cause by providing the Company with written notice within a specified period of time in advance of termination.Securities Purchase Agreements.

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Continued)

(Unaudited)

~~10. License and Collaboration Agreements (Continued)~~

The Company determined that the deliverables under the SymBio agreement include the exclusive, royalty-bearing, sublicensable license to rigosertib, the research and development services to be provided by the Company and its obligation to serve on a joint committee. The Company concluded that the license did not have standalone value to SymBio and was not separable from the research and development services, because of the uncertainty of SymBio’s ability to develop rigosertib in the SymBio territory on its own and the uncertainty of SymBio’s ability to sublicense rigosertib and recover a substantial portion of the original upfront payment of $7,500,000 paid by SymBio to the Company.

The supply of rigosertib for SymBio’s commercial requirements is contingent upon the receipt of regulatory approvals to commercialize rigosertib in Japan and Korea. Because the Company’s commercial supply obligation was contingent upon the receipt of future regulatory approvals, and there were no binding commitments or firm purchase orders pending for commercial supply at or near the execution of the agreement, the commercial supply obligation is deemed to be contingent and is not valued as a deliverable under the SymBio agreement. If SymBio orders the supplies from the Company, the Company expects the pricing for this supply to equal its third-party manufacturing cost plus a pre-negotiated percentage, which will not result in a significant incremental discount to market rates.

Due to the lack of standalone value for the license, research and development services, and joint committee obligation, the upfront payment is being recognized ratably using the straight line method through December 2027, the expected term of the agreement.

11. ~~Preclinical Collaboration~~

In December 2012, the Company agreed to form GBO, an entity owned by the Company and GVK. The purpose of GBO is to collaborate on and develop two programs through filing of an investigational new drug application and/or conducting proof of concept studies using the Company’s technology platform. If a program failure occurs for one or both programs, the Company may contribute additional assets to GBO to establish a replacement program or programs.

During 2013, GVK made an initial capital contribution of $500,000 in exchange for a 10% interest in GBO, and the Company made an initial capital contribution of a sublicense to all the intellectual property controlled by the Company related to the two specified programs in exchange for a 90% interest. Under the terms of the agreement, GVK may make additional capital contributions. The GVK percentage interest in GBO may change from the initial 10% to up to 50%, depending on the amount of its total capital contributions. During November 2014, GVK made an additional capital contribution of $500,000 which increased its interest in GBO to 17.5%. The Company evaluates its variable interests in GBO on a quarterly basis and has determined that it is the primary beneficiary.

For thirty days following the 15-month anniversary of the commencement of either of the two programs, the Company will have an option to (i) cancel the license and (ii) purchase all rights in and to that program. There are three of these buy-back scenarios depending on the stage of development of the underlying assets. In addition, upon the occurrence of certain events, namely termination of the Company’s participation in the programs either with or without a change in control, GVK will be entitled to purchase or obtain the Company’s interest in GBO. GVK will have operational control of GBO and the Company will have strategic and scientific control.

The two preclinical programs sublicensed to GBO have not been developed to clinical stage as initially hoped, and the Company is in discussions with GVK regarding the future of GBO. There was no activity in GBO during the nine months ended September 30, 2017 and 2016.

~~Onconova Therapeutics, Inc.~~

~~Notes to Condensed Consolidated Financial Statements (Continued)~~

~~(Unaudited)~~

~~12.~~ Related-Party Transactions

The Company has entered into a research agreement, as subsequently amended, with the Mount Sinai School of Medicine (“Mount Sinai”), with which a member of its board of directors and a ~~significant~~ stockholder is affiliated. Mount Sinai is undertaking research on behalf of the Company on the terms set forth in the agreements. Mount Sinai, in ~~connection~~collaboration with the Company, will prepare applications for patents generated from the research. Results from all projects will belong exclusively to Mount Sinai, but the Company will have an exclusive option to license any ~~inventions.~~inventions, resulting therefrom. Payments to Mount Sinai under this research agreement for the three months ended ~~September~~June 30, ~~2017~~2020 and ~~2016~~2019 were ~~$88,000~~$77,000 and ~~$187,000,~~$88,000, respectively, and for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 and ~~2016~~2019 were ~~$263,000~~$201,000 and ~~$374,000,~~$175,000, respectively. At ~~September~~June 30, ~~2017~~2020 and December 31, ~~2016,~~2019, the Company had ~~$438,000~~$77,000 and ~~$175,000,~~$150,000, respectively, payable to Mount Sinai under this agreement.

The Company has entered into a consulting agreement with a member of its board of ~~directors, who is also a significant stockholder of the Company.~~directors. The board member provides consulting services to the Company on the terms set forth in the agreement. Payments to this board member for both the three months ended ~~September~~June 30, ~~2017~~2020 and ~~2016~~2019 were $33,000 and ~~$33,000, respectively and~~ for both the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 and ~~2016~~2019 were ~~$99,000 and $99,000, respectively.~~$66,000. At ~~September~~both June 30, ~~2017~~2020 and December 31, ~~2016,~~2019, the Company had ~~$0 and~~ $33,000 ~~respectively,~~ payable under this agreement.

Onconova Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements (Continued)

(Unaudited)

~~13.~~12. Securities Registrations and Sales Agreements

January 2020 Offering

~~In October 2014,~~On December 31, 2019, the Company entered into definitive securities purchase agreements with institutional investors for the issuance and sale in a ~~sales agreement with Cantor Fitzgerald & Co. (“Cantor”) to create an at-the-market equity program under which the Company from time to time was able to offer and sell~~registered direct offering of 27,662,518 shares of ~~its Common Stock through Cantor. A registration statement (Form S-3 No. 333-199219), relating to~~ the shares, which was filed with the SEC became effective on November 20, 2014. During the year ended December 31, 2015, 2,715,165 shares were sold under the Cantor sales agreement for net proceeds of $6,018,000. The Cantor sales agreement was terminated on January 5, 2016, and there were no sales of Common Stock under this program during the year ended December 31, 2016.

On October 8, 2015, the Company entered into a Purchase Agreement, and a registration rights agreement with Lincoln Park. A registration statement (Form S-1 No. 333-207533), relating to the shares, which was filed with the SEC became effective on November 3, 2015.

Subject to the terms and conditions of the purchase agreement, including the effectiveness of a registration statement covering the resale of the shares, the Company may sell additional shares of its Common Stock, havingCompany's common stock at an ~~aggregate~~ offering price of ~~up to $15,000,000 to Lincoln Park from time to time until December 1, 2018.~~$0.3615 per share.

~~Upon execution~~Pursuant to a December 2019 engagement letter with H. C. Wainwright & Co., HCW agreed to serve as exclusive placement agent for the offering. In connection with the offering, the Company paid HCW an aggregate cash fee equal to 7.0% of the ~~Lincoln Park purchase agreement, Lincoln Park made an initial purchase of 84,676 shares~~gross proceeds in the offering, management fee equal to 1.0% of the ~~Company’s Common Stock~~gross proceeds raised in the offering, $85,000 for ~~$1,500,000. Subject~~non-accountable expenses; and $10,000 for clearing fees. The Company also issued to the terms and conditions of the purchase agreement, including the effectiveness of a registration statement covering the resale of the shares, the Company has the right to sell to and Lincoln Park is obligatedHCW or its designees placement agent warrants to purchase up to ~~an additional $15,000,000 of~~1,383,126 shares of ~~Common Stock, subject to certain limitations, from time to time until December 1, 2018. The Company may direct Lincoln Park,~~common stock at ~~its sole discretion and subject to certain conditions, to purchase up to 10,000 shares of Common Stock on any business day, increasing to up to 25,000 shares depending upon the closing sale~~an exercise price of ~~the Common Stock (such purchases, “Regular Purchases”). However, in no event shall a Regular Purchase be more than $1,000,000.~~$0.4519 per share. The ~~purchase price of shares of Common Stock related to the future funding~~placement agent warrants are immediately exercisable and will ~~be based~~expire on the prevailing market prices of such shares at the time of sales. In addition, the Company may direct Lincoln Park to purchase additional amounts as accelerated purchases if on the date of a Regular Purchase the closing sale price of the Common Stock is not below the threshold price as set forth in the Purchase Agreement. The Company’s sales of shares of Common Stock to Lincoln Park under the Purchase Agreement were limited to no more than the number of shares that would result in the beneficial ownership by Lincoln Park and its affiliates, at any single point in time, of more than 4.99% of the then-outstanding shares of the Common Stock, which limit increased to 9.99% on May 1, 2016.

Pursuant to the terms of the Lincoln Park purchase agreement and to comply with the listing rules of the NASDAQ Stock Market, the number of shares issued to Lincoln Park thereunder shall not exceed 19.99% of the Company’s shares outstanding on October 8, 2015 unless the approval of the Company’s stockholders is obtained. This limitation shall not apply if the average price paid for all shares issued and sold under the purchase agreement is equal to or greater than $15.56. The Company is not required or permitted to issue any shares of Common Stock under the Lincoln Park purchase agreement if such issuance would breach the Company’s obligations under the listing rules of the NASDAQ Stock Market.

As consideration for entering into the purchase agreement, the Company issued to Lincoln Park 20,000 shares of Common Stock. Lincoln Park represented to the Company, among other things, that it was an “accredited investor” (as such term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as amended (the “Securities Act”), and the Company sold the securities in reliance upon an exemption from registration contained in Section 4(2) under the Securities Act. The securities sold may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.December 31, 2023.

The net proceeds to the Company ~~under the Lincoln Park purchase agreement will depend on the frequency and prices at which the Company may sell shares of Common Stock to Lincoln Park. The Company expects that the proceeds received~~ from the ~~initial purchase~~offering, after deducting HCW's placement agent fees and ~~any additional proceeds from future sales to Lincoln Park will be used to fund the development of the Company’s clinical~~expenses and ~~preclinical programs, for~~ other ~~research and development activities and for general corporate purposes.~~

~~Onconova Therapeutics, Inc.~~
~~Notes to Condensed Consolidated Financial Statements (Continued)~~
~~(Unaudited)~~
~~13. Securities Registrations and Sales Agreements (continued)~~
~~On January 5, 2016, the Company entered into the Securities Purchase Agreement with an institutional investor providing for the issuance and sale~~estimated offering expenses payable by the Company of 193,684 shares of the Company’s Common Stock, at a purchase price of $9.50 per share and warrants to purchase up to 96,842 shares of the Company’s Common Stock for aggregate gross proceeds of $1,840,000. The Warrants will be exercisable from July 11, 2016 through July 11, 2021 at an exercise price of $11.50 per share of Common Stock, subject to customary adjustments. Net proceeds from the sale of the Common Stock and Warrants (not including any future proceeds from the exercise of the Warrants) were approximately ~~$1,609,000 after deducting certain fees due to the placement agent~~$9.0 million and ~~the Company’s estimated transaction expenses. The net proceeds~~were received by the Company from the transactions will be used to fund the development of the Company’s clinical and preclinical programs, for other research and development activities and for general corporate purposes.in January 2020.

The ~~shares of Common Stock sold by the Company~~offering was pursuant to ~~the Securities Purchase Agreement were sold pursuant~~a prospectus dated December 28, 2017, and a prospectus supplement dated as of December 31, 2019 to ~~an effective shelf registration statement on Form S-3, which was initially~~be filed ~~with the SEC on October 8, 2014 and subsequently declared effective on November 20, 2014 (File No. 333-199219).~~
The Warrants were issued and sold without registration under the Securities Act in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder and in reliance on similar exemptions under applicable state laws. Accordingly, the Warrants and the shares of Common Stock underlying the Warrants may not be offered or sold except pursuant to an effective registration statement under the Securities Act or pursuant to an available exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in accordance with applicable state securities laws. These warrants are classified as liabilities because under certain specific circumstances the warrants could require cash settlement.
On July 8, 2016, the Company distributed to holders of its Common Stock and to holders of certain of outstanding warrants, at no charge, non-transferable subscription rights to purchase units. Each unit consisted of one share of Common Stock and 0.75 of a tradable warrant representing the right to purchase one share of Common Stock (“Tradeable Warrants”). The offering of units pursuant to the subscription rights is referred to as the “Rights Offering.” On July 7, 2016, the Company entered into a dealer-manager agreement with Maxim Group LLC (“Maxim”), to engage Maxim as dealer-manager for the Rights Offering.
In the Rights Offering, holders received 1.5 subscription rights for each share of Common Stock, or each share of Common Stock underlying participating warrants owned on the record date, July 7, 2016. Subscribers whose subscriptions otherwise would have resulted in their beneficial ownership of more than 4.99% of the Company’s Common Stock could elect to receive, in lieu of shares of Common Stock in excess of that threshold, pre-funded warrants to purchase the same number of shares of Common Stock for $0.01 (“Pre-Funded Warrants”), and the subscription price per unit consisting of a Pre-Funded Warrant in lieu of a share of Common Stock was reduced by the $0.01 exercise price.
The Rights Offering closed on July 29, 2016. Gross proceeds from the offering were $17.4 million, which represents the sale of all 4,256,186, units at approximately $4.10 per unit. Net proceeds were approximately $15.8 million. The Company issued 3,599,786 shares of Common Stock, 3,192,022 Tradable Warrants and 656,400 Pre-Funded Warrants in the Rights Offering. The Tradable Warrants are exercisable for a period of five years for one share of Common Stock at an exercise price of $4.92 per share. After the one-year anniversary of issuance, the Company may redeem the Tradable Warrants for $0.001 per Tradable Warrant if the volume weighted average price of our Common Stock is above $12.30 for each of 10 consecutive trading days. On August 3, 2016, the Tradable Warrants were listed for trading on the NASDAQ Capital Market under the symbol “ONTXW.” The tradable warrants are classified as liabilities because under certain specific circumstances the warrants could require cash settlement.
~~Onconova Therapeutics, Inc.~~
~~Notes to Condensed Consolidated Financial Statements (Continued)~~
~~(Unaudited)~~
~~13. Securities Registrations and Sales Agreements (continued)~~
The Pre-Funded Warrants are exercisable for one share of Common Stock at an exercise price of $0.01. The exercise period for the Pre-Funded Warrants is seven years, which may be extended if an exercise would result in the holder’s beneficial ownership of our Common Stock exceeding 4.99%.
In connection with the Rights Offering, the Company paid to Maxim a cash fee equal to (a) 4.5% of the dollar amount of the units sold to any holders of subscription rights who were beneficial owners of shares of the Company’s Common Stock prior to July 30, 2013, and (b) 8.0% of the dollar amount of the units sold to any other holders of subscription rights, plus a non-accountable expense allowance of $100,000 for expenses incurred in connection with a takedown from the ~~Rights Offering.~~
A registration statement on Form S-1, as amended (File No. 333-211769), relating to the securities being offered and sold in connection with the Rights Offering was declared effective by the SEC on July 7, 2016. A prospectus and prospectus supplement relating to and describing the terms of the Rights Offering has been filed with the SEC as a part of the registration statement and is available on the SEC’s web site at http://www.sec.gov.
In December 2016, the Company entered into a sales agreement (the “Sales Agreement”) with FBR Capital Markets & Co. (“FBR”) to create an at-the-market equity program (“ATM Program”) under which the Company from time to time may offer and sell shares of its Common Stock through FBR. The Shares to be sold under the Sales Agreement were issued and sold pursuant to the Company’sCompany's shelf registration statement on Form S-3 (File ~~No 333-199219), previously filed with~~No. 333-221684). The offering closed on January 3, 2020.

Onconova Therapeutics, Inc.
Notes to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
12. Subsequent Events
Grants of PSUs and SARs
On July 9, 2020, the ~~SEC on October 8, 2014~~compensation committee of the board of directors and ~~declared effective by~~ the ~~SEC on November 20, 2014. A prospectus supplement related~~board approved a cash bonus program of cash-settled stock appreciation right (“SAR”) awards and cash-settled performance stock unit (“PSU”) awards to the Company’s ~~ATM Program was filed with the SEC on December 5, 2016. Sales under the Sales Agreement were 20,499 shares for net proceeds~~employees. An aggregate of ~~approximately $64,000. The Sales Agreement was terminated effective April 19, 2017.~~
~~On April 20, 2017, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Laidlaw & Company (UK) Ltd. (“Laidlaw”),~~SAR awards with respect to 3,850,700 shares of common stock and PSU awards with respect to 1,863,300 shares of common stock were granted to the ~~issuance~~Company’s employees. The SAR awards will be settled in cash, vest 33% on the first anniversary of the date of grant, and ~~sale~~the remaining 67% monthly over the next 24 months, have a per-share base amount of $0.56, which was the closing sales price of a share of the Company’s common stock on the grant date, and are in all cases subject to the terms and conditions of the Company’s form of SAR award agreement. The PSU awards vest 50% upon the submission of a new drug application (“NDA”) to the U.S. FDA for rigosertib in higher-risk myelodysplastic syndromes (“HR-MDS”) and 50% upon U.S. FDA approval of rigosertib for HR-MDS. The PSU awards have a maximum value of $1.44 per share. The maximum price per share is the per-share value based on the Company’s market capitalization at $250 million and the Company’s outstanding shares of common stock, which was 174,177,448 shares on July 9, 2020. In all cases, the PSU awards are subject to the terms and conditions of the Company’s form of PSU award agreement.
In addition, on July 9, 2020, based on the recommendation of the compensation committee, the board approved a change in the non-employee director compensation policy that would provide for an ~~underwritten public offering (the “Offering”) by~~annual SAR award with respect to 125,000 shares of common stock for each of the Company’s non-employee directors. No other changes to the non-employee director compensation policy were approved and, on July 9, 2020, the Board approved the initial 125,000 SAR award to each of the non-employee directors. The SAR awards vest on the first anniversary of grant subject to the director’s continued service and will be settled in cash, have a per-share base amount of $0.56, and are in all cases subject to the terms and conditions of the Company’s form of SAR award agreement.
Each SAR subject to an SAR award represents the right to a cash payment equal to the excess, if any, of (i) the fair market value of each underlying share of the Company’s common stock, determined on the date of exercise of the SAR minus (ii) the base amount. Pursuant to the terms of the SAR awards, in no event may the cash payment for each SAR exceed $0.88, which is the maximum price per share of $1.44, minus the base amount of $0.56, subject to adjustment in accordance with the terms of the Stock Appreciation Right Award Agreement. The maximum price per share is the per-share value based on the Company’s market capitalization at $250 million and the Company’s outstanding shares of common stock, which was 174,177,448 shares on July 9, 2020.
As of August 12, 2020, none of these SAR or PSU awards have vested. As such, no estimate of a liability for these cash-settled awards is possible. The Company ~~of 2,476,190 shares~~will evaluate these awards at each quarterly reporting period to determine what disclosure or accrual is required.
Exercise of Common Stock ~~(the “Shares”), at a price~~Warrants
From July 1, 2020 to ~~the public~~August 12, 2020, 9,400,819 warrants have been exercised resulting in proceeds of $2.10 per Share. Pursuant to the Underwriting Agreement, the Company granted Laidlaw a 45-day option to purchase up to an additional 363,580 Shares. The Underwriting Agreement contained customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and Laidlaw, including for liabilities under the Securities Act of 1933, as amended (the “Securities Act”), other obligations of the parties and termination provisions. The Offering closed on April 26, 2017 and the proceeds to the Company, net of expenses, were approximately $4.6 million. On May 12, 2017, Laidlaw exercised their option to purchase 363,580 additional shares. Closing on the additional shares was May 17, 2017 and the proceeds to the Company, net of expenses, were approximately $0.7$2.5 million.

~~14. Subsequent Events~~
Subsequent to September 30, 2017 there was an increase in the fair value of the warrant liability calculated using the NASDAQ Capital Market quoted price. The fair value at September 30, 2017 was $1,686,000. The estimated fair value at November 8, 2017 is approximately $2,260,000. The estimated increase in the warrant liability would increase the Company’s net loss by approximately $574,000.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with interim unaudited condensed consolidated financial statements contained in Part I, Item 1 of thisquarterly report, and the audited consolidated financial statements and notes thereto for the year ended December 31, ~~2016~~2019 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our annual report on Form 10-K filed with the SEC on March ~~29, 2017.~~27, 2020. As used in this report, unless the context suggests otherwise, “we,” “us,” “our,” “the Company” or “Onconova” refer to Onconova Therapeutics, Inc. and its consolidated subsidiaries.

Cautionary Note Regarding Forward-Looking Statements

This quarterly report on Form 10-Q includes forward-looking statements. We may, in some cases, use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements appear in a number of places throughout this report and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, protection of our intellectual property portfolio, the degree of clinical utility of our products, particularly in specific patient populations, our ability to develop commercial and manufacturing functions, expectations regarding clinical trial data, our results of operations, cash needs, financial condition, liquidity, collaborations, partnerships, prospects, growth and strategies, the industry in which we operate and the trends that may affect the industry or us.

By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in this report, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this report. In addition, even if our results of operations, financial condition and liquidity, and events in the industry in which we operate are consistent with the forward-looking statements contained in this report, they may not be predictive of results or developments in future periods.

Actual results could differ materially from our forward-looking statements due to a number of factors, including risks related to:

·                  our need for additional financing for our INSPIRE trial and other operations, and our ability to obtain sufficient funds on acceptable terms when needed, and our plans and future needs to scale back operations if adequate financing is not obtained;
·                  ~~our ability to continue as a going concern;~~
·                  ~~our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;~~
·                  ~~the success and timing of our preclinical studies and clinical trials, including site initiation and patient enrollment, and regulatory approval of protocols for future clinical trials;~~
·                  our ability to enter into, maintain and perform collaboration agreements with other pharmaceutical companies, for funding and commercialization of our clinical product candidates or preclinical compounds, and our ability to achieve certain milestones under those agreements;
·                  ~~the difficulties in obtaining and maintaining regulatory approval of our product candidates, and the labeling under any approval we may obtain;~~
·                  ~~our plans and ability to develop, manufacture and commercialize our product candidates;~~
·                  ~~our failure to recruit or retain key scientific or management personnel or to retain our executive officers;~~
·                  ~~the size and growth of the potential markets for our product candidates and our ability to serve those markets;~~
·                  ~~regulatory developments in the United States and foreign countries;~~
·                  ~~the rate and degree of market acceptance of any of our product candidates;~~
·                  ~~obtaining and maintaining intellectual property protection for our product candidates and our proprietary technology;~~
·                  ~~the successful development of our commercialization capabilities, including sales and marketing capabilities;~~
·                  ~~recently enacted and future legislation and regulation regarding the healthcare system;~~
·                  ~~the success of competing therapies and products that are or become available;~~
·                  ~~our ability to maintain the listing of our Common Stock on a national securities exchange;~~
·                  ~~the potential for third party disputes and litigation;~~
·                  ~~the performance of third parties, including contract research organizations (“CROs”) and third-party manufacturers; and~~
·                  ~~our expectations regarding CRO transition.~~
· our need for additional financing for our INSPIRE trial and other operations, and our ability to obtain sufficient funds on acceptable terms when needed, and our plans and future needs to scale back operations if adequate financing is not obtained;

· our ability to continue as a going concern;
· our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;
· the success and timing of our preclinical studies and clinical trials, including site initiation and patient enrollment, and regulatory approval of protocols for future clinical trials;
· our ability to enter into, maintain and perform collaboration agreements with other pharmaceutical companies, for funding and commercialization of our clinical product candidates or preclinical compounds, and our ability to achieve certain milestones under those agreements;
· the difficulties in obtaining and maintaining regulatory approval of our product candidates, and the labeling under any approval we may obtain;
· our plans and ability to develop, manufacture and commercialize our product candidates;
· our failure to recruit or retain key scientific or management personnel or to retain our executive officers;
· the size and growth of the potential markets for our product candidates and our ability to serve those markets;

· regulatory developments in the United States and foreign countries;
· the rate and degree of market acceptance of any of our product candidates;
· obtaining and maintaining intellectual property protection for our product candidates and our proprietary technology;
· the successful development of our commercialization capabilities, including sales and marketing capabilities;
· recently enacted and future legislation and regulation regarding the healthcare system;
· the success of competing therapies and products that are or become available;
· our ability to maintain the listing of our securities on a national securities exchange;
· the potential for third party disputes and litigation;
· the performance of third parties, including contract research organizations (“CROs”) and third-party manufacturers; and
· the impact of the novel coronavirus disease, COVID-19, to the global economy and capital markets, and to our business and our financial results.

Any forward-looking statements that we make in this report speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this report or to reflect the occurrence of unanticipated events. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless expressed as such, and should only be viewed as historical data.

You should also read carefully the factors described in the “Risk Factors” in our most recent annual report on Form 10-K, ~~and quarterly reports~~our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 and in this report, to better understand significant risks and uncertainties inherent in our business and underlying any forward-looking statements. As a result of these factors, actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements in this report and you should not place undue reliance on any forward-looking statements.

~~All Common Stock, equity, share and per share amounts have been retroactively adjusted to reflect a one-for-ten reverse stock split which was effective May 31, 2016.~~
Overview

We are a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule product candidates primarily to treat cancer. ~~Using our~~We have proprietary ~~chemistry platform, we have created a library of~~ targeted agents designed to work against cellular pathways important to cancer cells. We believe that the product candidates in our pipeline have the potential to be efficacious in a variety of cancers. We have one Phase 3 clinical-stage product candidate and two other clinical-stage product candidates (one of which ~~is being developed~~has been studied for treatment of acute radiation syndromes) and ~~several~~ preclinical programs. ~~Substantially all of our~~Our current ~~effort is~~efforts are focused on our lead product candidate, rigosertib. Rigosertib ~~is being~~has been tested in an intravenous formulation as a single agent ~~and an oral formulation in combination with azacitidine, in clinical trials~~ for patients with higher-risk myelodysplastic syndromes ~~(“MDS”~~("MDS")~~. The Company has~~, and ~~may continue to delay, scale-back,~~an oral formulation as a single agent in lower risk MDS or ~~eliminate certain of its research and development activities and other aspects of its operations until such time as the Company is successful~~ in ~~securing additional funding.~~combination with azacitidine for patients with higher-risk MDS.

In December 2015, we enrolled the first patient ininto our INSPIRE trial, a randomized controlled Phase 3 clinical trial of intravenous rigosertib ~~“rigosertib IV”~~("rigosertib IV") in a population of patients with higher-risk MDS after failure of hypomethylating agent ~~(“HMA”~~("HMA") therapy. ~~The trial, which we refer to as INSPIRE, is expected to enroll approximately 225 patients at more than 170 sites globally.~~ The primary endpoint of INSPIRE is improvement in overall survival. We completed enrollment of the required 360 randomized patients in March 2020. As of July 2020, the required number of survival events has been reached, and we anticipate reporting topline survival data in the third quarter of 2020.

Our net losses were ~~$17.9~~$12.5 million and ~~$14.2~~$11.2 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 and ~~2016,~~2019, respectively. As of ~~September~~June 30, ~~2017,~~2020, we had an accumulated deficit of ~~$356.1~~$415.9 million. We expect to incur significant expenses and operating losses for the foreseeable future as we continue the development and clinical trials of, and seek regulatory approval for, our product candidates, even if milestones under our license and collaboration agreements may be met.
During 2016, we took significant actions to conserve cash, including reduction in personnel and expenditures. While we will continue to take cash conservation actions where appropriate, our net expenditures may increase in 2017 as more INSPIRE sites open and more patients enroll in the INSPIRE trial. Additionally, cost sharing payments from Baxalta have terminated in August 2016. As of ~~September~~June 30, ~~2017,~~2020, we had ~~$7.6~~$27.2 million in cash and cash equivalents.

In ~~January 2016,~~September 2019 we ~~completed~~closed on an offering of common stock to certain investors. We issued 2,198,938 shares of common stock and amended warrants for the purchase of 2,198,938 shares of common stock. The investors, who were also holders of our preferred stock warrants issued in February 2018 and/or May 2018, received a warrant amendment under which a certain number of such investors' preferred stock warrants received a reduction in exercise price and an extension of term. Net proceeds from the sale of ~~Common Stock~~common stock and the amendment of preferred stock warrants ~~for net proceeds of~~were approximately ~~$1.6~~$3.3 million. In ~~July 2016,~~November 2019, we ~~completed a rights~~closed on an offering of units of ~~Common Stock~~common stock and warrants. We issued 30,250,000 shares of common stock, pre-funded warrants to purchase 24,750,000 shares of common stock, and common stock warrants to purchase 55,000,000 shares of common stock. Net proceeds were approximately $9.7 million. On December 10, 2019, we closed on an offering of units of common stock and warrants. We issued 14,326,648 shares of common stock and common stock warrants to purchase 7,163,324 shares of common stock. Net proceeds were approximately $4.4 million. On December 19, 2019, we closed on an offering of units of common stock and warrants. We issued 13,878,864 shares of common stock and common stock warrants to purchase 6,939,432 shares of common stock. Net proceeds were approximately $4.4 million. During 2019, pre-funded warrants were exercised for 23,720,784 shares of common stock and net proceeds were $35,000. Also during 2019, common warrants were exercised for 21,014,378 shares of ~~$15.8~~common stock and net proceeds were approximately $4.9 million.
In January 2020, we closed on an offering of common stock. We issued 27,662,518 shares of common stock and net proceeds were approximately $9.0 million. From December 31, 2019 to June 30, 2020; 35,347,578 warrants from our November and December 2019 offerings described above have been exercised, resulting in proceeds of $7.3 million. From July 1, 2020 to August 12, 2020, 9,400,819 warrants have been exercised resulting in proceeds of $2.5 million.

In May 2019, we and HanX entered into the HanX License Agreement. Under the terms of the HanX License Agreement, we granted HanX an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how, to develop and commercialize any pharmaceutical product containing rigosertib in all uses of rigosertib or the Product in humans therapeutics uses in the People's Republic of China, Hong Kong, Macau and Taiwan (the "Territory"). In connection with the HanX License Agreement, we also entered into the HanX Securities Purchase Agreement with each of HanX and its affiliate Abundant. HanX did not fulfill its obligations under the HanX License Agreement and effective January 16, 2020, in accordance with the terms of the HanX License Agreement, the HanX License Agreement was deemed to be void ab initio. Upon this termination, the rights to HanX Licensed Product in the HanX Territory reverted to us in accordance with the terms of the HanX License Agreement. In addition, the HanX Securities Purchase Agreements terminated automatically effective January 16, 2020 upon the termination of the License Agreement in accordance with the HanX Securities Purchase Agreements.
In November 2019, we and Knight entered into the Knight License Agreement. Under the terms of the Knight License Agreement, we granted Knight (i) a non-exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how, to develop and manufacture any product containing rigosertib for Canada (and Israel, should Knight exercise its option pursuant to the Knight License Agreement) and in human uses , and (ii) an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how, to commercialize the Knight Licensed Product in the Knight Territory and in the Knight Licensed Field. Knight made an upfront payment of $100,000 and we are eligible to receive clinical, regulatory and sale-based milestone payments up to CAD 33.95 million. We are also eligible to receive tiered double-digit royalties based on net sales in the Territory. The Knight License Agreement also contains customary provisions for termination by either party in the event of breach of the Knight License Agreement by the other party, subject to a cure period, or bankruptcy of the other party.
In December ~~2016,~~2019, we and STA entered into a sales agreement with FBR Capital Markets & Co. (“FBR”) to create an at-the-market equity program under which we from time to time may offer and sell shares of Common Stock through FBR. Sales under the agreement were 12,764 shares for net proceeds of approximately $40,000. The agreement with FBR was terminated effective April 19, 2017. In April 2017, we completed an underwritten public offering of 2,476,190 sharesSTA License Agreement. Under the terms of the ~~Company’s Common Stock, at~~STA License Agreement, we granted STA (i) a ~~price~~non-exclusive, royalty-bearing license, with the right to ~~the public of $2.10 per share~~sublicense, under certain Company patent rights and know-how, to develop and manufacture any product containing rigosertib for ~~net proceeds of approximately $4.6 million~~Australia and New Zealand and in ~~May 2017,~~human uses, and (ii) an exclusive, royalty-bearing license, with the ~~underwriter exercised their option~~right to ~~purchase~~sublicense, under certain Company patent rights and know-how, to commercialize the STA Licensed Product in the STA Territory and in the STA Licensed Field. STA made an ~~additional 363,580 shares,~~upfront payment of $50,000 and we may be entitled to receive clinical, regulatory and sale-based milestone payments up to $30.55 million. We may also be entitled to receive tiered double-digit royalties based on net sales in the STA Licensed Territory. The STA License Agreement also contains customary provisions for ~~additional net proceeds~~termination by either party in the event of ~~$0.7 million.~~breach of the STA License Agreement by the other party, subject to a cure period, or bankruptcy of the other party.
We believe that our cash and cash equivalents of $27.2 million, at June 30, 2020, will be sufficient to fund our operations and ongoing trials ~~through~~into the ~~end~~fourth quarter of ~~December 2017,~~2021. We do not have a recurring source of revenue to fund our operations and ~~there is substantial doubt about our ability~~will need to raise additional funds to continue ~~as a going concern.~~to develop and apply for regulatory approval for our drug candidates.

We are exploring various sources of funding for development and applying for regulatory approval of rigosertib as well as for our ongoing operations. If we raise additional funds through strategic collaborations and alliances or licensing arrangements with third parties, which may include existing collaboration partners, we may have to relinquish valuable rights to our technologies or product candidates, including rigosertib, or grant licenses on terms that are not favorable to us. There can be no assurance, however, that we will be successful in obtaining such financing in sufficient amounts, on terms acceptable to us, or at all. In addition, there can be no assurance that we will obtain approvals necessary to market our ~~products~~product candidates or achieve profitability or sustainable, positive cash flow. If we are unable to successfully raise sufficient additional capital, through future financings or through strategic and collaborative arrangements, we will not have sufficient cash to fund our ongoing trials and operations. Due to our ongoing losses and our accumulated deficit in combination with these factors, the opinion of our independent registered public accounting firm on our audited consolidated financial statements for our fiscal year ended December 31, 2016 contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.

Rigosertib

Rigosertib is a small molecule which we believe, as reported in the journal Cell (Athuluri-Divakar et al., 2016, Cell 165, 643—655), blocks cellular signaling by targeting RAS effector pathways. Additional information on the mechanism of action of rigosertib was reported in Molecular Cell (Baker et al., 2020, Molecular Cell 79, 180-190). This is believed to be mediated by the interaction of rigosertib to the RAS-binding domain ~~(“RBD”~~("RBD"), found in many RAS effector proteins, including the Raf and PI3K kinases. ~~We believe this~~This mechanism of action potentially provides a new approach to ~~block~~inhibit the ~~interactions between RAS and its targets containing RBD sites.~~RAS-RAF- MEK- ERK pathway. Rigosertib is currently being tested in clinical trials as a single agent, and continues to be evaluated in combination with azacitidine, in patients with MDS. We have enrolled more than 1,300 patients in rigosertib clinical trials for MDS and other conditions. We were a party to a license and development agreement with Baxalta (as defined below), which granted Baxalta certain rights to commercialize rigosertib in Europe. The Baxalta agreement was terminated on August 30, 2016, at which time the European rights reverted to us at no cost. We are party to a collaboration agreement with SymBio, which grants SymBio certain rights to commercialize rigosertib in Japan and Korea. We are also party to several license agreements which grant certain rights to commercialize rigosertib in other countries: Pint Pharma International SA ("Pint") for certain countries in Latin America, Knight Therapeutics, Inc. ("Knight") for Canada and Specialised Therapeutics Asia Pte. Ltd. ("STA") for Australia and New Zealand. We have retained development and commercialization rights to rigosertib in the rest of the world, including in the United States and Europe, although we could consider licensing commercialization rights to other territories as we continue to seek additional funding.

The table below summarizes rigosertib programs.
Disease Formulation Indication Stage Expected Timelines* Potential Market Opportunity (US)/Benefit
Onconova Initiated Studies
MDS Intravenous
HR - following
HMA failure
Phase 3
-Enrollment completed
- Required number of survival events reached
Reporting of survival top-line data Q3 2020
~ 5,000
patients
No directly competing FDA approved product in the market
Oral - in combination with AZA
HR - prior to HMAs
Phase 2/3 -Outcome of September 2019 FDA meeting is that the Company expects to proceed with a Phase 2/3 plecebo controlled randomized trial, following topline reporting of INSPIRE trial. ~ 18,000 No oral NCE approved since 2005
Oral Lower Risk Phase 2 Continue to evaluate target patient population in 2020. > 10,000 Longer potential duration of treatment
Investigator Initiated Studies - RAS Mutated Cancers
Squamous cell carcinoma Intravenous and oral Recessive Dystrophic Epidermolysis bullosa (RDEB) with Advanced Squamous Cell Carcinoma (SCC) Phase 2 2H 2020 - 2H 2021
Non-small cell lung cancer Oral - in combination with nivolumab Stage IV Lung Adenocarcinoma Patients with KRAS Mutation Phase 1 Q2 2020 - Q4 2021
Other
RASopathies Intravenous and oral JMML/other RAS Cancer Pathway diseases Preclinical
-Preclinical NIH studies completed
Rare disease Pediatric clinical trial
* We are attempting to mitigate the effects on our study timelines of the COVID 19 pandemic. All of our studies have been impacted to differing extents.

Rigosertib IV for higher-risk MDS

We are developing the IV formulation of rigosertib for the treatment of higher-risk MDS following the failure of HMA therapy. In early 2014, we announced topline survival results from our ~~“ONTIME”~~"ONTIME" trial, a multi-center Phase 3 clinical trial of rigosertib IV as a single agent versus best supportive care including low dose Ara-C. The ONTIME trial did not meet its primary endpoint of an improvement in overall survival in the intent-to-treat population, although improvements in median overall survival were observed in various pre-specified and exploratory subgroups of higher-risk MDS patients. As a result ~~additional clinical work~~of these analyses, the pivotal INSPIRE trial is ~~on-going.~~an on-going study in what we believe is a more homogenous population in higher-risk MDS.

During 2014 and 2015, we held meetings with the U.S. Food and Drug Administration ~~(“FDA”~~("FDA"), European Medicines Agency ~~(“EMA”~~("EMA"), and several European national regulatory authorities to discuss and seek guidance on a path for approval of rigosertib IV in higher-risk MDS patients whose disease had failed HMA therapy. After discussions with the FDA and EMA, we refined our patient eligibility criteria by defining what we believe ~~to be~~is a more homogenous higher-risk patient population. After regulatory feedback, input from key opinion leaders in the U.S. and Europe and based on learnings from the ONTIME study, we designed a new randomized controlled Phase 3 trial, referred to as INSPIRE. The INSPIRE trial is enrolling higher-risk MDS patients under 82 years of age who have progressed on, relapsed, or failed to respond to, previous treatment with HMAs within nine months or nine cycles over the course of one year after initiation of HMA therapy, and had their last dose of HMA within six months prior to enrollment in the trial. Patients are randomized to either rigosertib with best supportive care, or the physician's choice of therapy with best supportive care. The primary endpoint of this study is the sequential analysis of overall survival of all randomized patients in the intent-to-treat ~~(“ITT”~~("ITT") population and the International Prognostic Scoring System- Revised (IPSS-R) Very High Risk ("VHR") subgroup. ~~This randomized trial of approximately 225 patients is expected to be conducted at more than 170 sites globally.~~ The first patient in the INSPIRE trial was enrolled atin the ~~MD Anderson Cancer Center~~United States in December 2015, the first patient in Europe was enrolled in March 2016, and the first patient in Japan was enrolled in July 2016.

Enrollment for the INSPIRE Phase 3 trial for second-line higher-risk MDS patients iswas highly selective ~~and required us to search extensively to identify appropriate candidates meeting the~~with stringent entry ~~criteria. Accordingly, this trial has been opened at~~criteria as outlined above. The INSPIRE study included more than ~~175~~140 trial sites ~~on four continents. Our partner, SymBio Pharmaceuticals, has opened more than 30~~which enrolled patients, including sites in Japan ~~for the INSPIRE protocol. As of October 31, 2017, the trial is active at approximately 170 sites in 22 countries.~~coordinated by our partner, SymBio Pharmaceuticals. The selection of countries and trial sites iswas carefully undertaken to ensure availability of appropriate patients meeting eligibility criteria. Since these criteria are purposely designed to be narrow and selective, extensive site screening and ~~trial site~~ education is integral to our plan.
The INSPIRE trial ~~outcome is measured by overall survival and~~
~~includes~~included a pre-planned interim analysis ~~which is~~ triggered by 88 events (deaths)., which occurred in December 2017. The ~~timing of interim analysis is difficult to precisely define. Based on our~~ statistical analysis plan ("SAP") for the ~~enrollment rate, and the expected survival in a comparable patient subgroup from the ONTIME~~INSPIRE trial ~~we expect~~featured an adaptive trial design, permitting several options following the interim analysis, ~~to occur late in the fourth quarter~~which included continuation of 2017. The interim analysis involves an initial analysis of efficacy by an independent statistical consultant. These results will be submitted to the independent data monitoring committee (DMC). The interim analysis may result in the trial ~~stopping due to~~as planned, discontinuation of the trial for futility or safety, trial expansion using pre-planned sample size re-estimation, or trial continuation for only the pre-defined treatment subgroup of patients classified as ~~planned without any changes, or continuation with changes according to~~VHR based on the preset criteria for trial expansion or continued randomization only for the Very High Risk subgroup. The adaptive design element has been reviewed by regulatory agencies in the US and Europe. The actual timingIPSS-R.

After review of the interim ~~analysis and its outcome will permit better estimates for complete enrollment and top-line analysis. Since~~data, in January 2018 the ~~date~~Independent Data Monitoring Committee ("DMC") recommended continuation of the ~~interim analysis is tied~~trial with a one-time expansion in enrollment, using a pre-planned sample size re-estimation, as determined by the SAP. As recommended by the DMC, the expanded INSPIRE study continued to enroll eligible patients based on the trial criteria of the overall ITT population and increased enrollment by adding 135 patients to the ~~unpredictability~~original target to reach a total expected enrollment of ~~reaching a pre-identified~~360 patients. The targeted number of death events required for analyzing the ~~precise time~~results of ~~completing~~the trial was increased from 176 to 288 events. Due to the adaptive trial design and the DMC's assessment of the interim data, the INSPIRE trial will continue to sequentially analyze the ITT and the VHR population for the primary endpoint of overall survival. The design of the trial with the expanded study enrollment is identical to the initial study design and includes the sequential analysis of the overall survival endpoint in the ITT population and if required the pre-specified VHR subgroup. The Company remains blinded to the interim analysis ~~which will be roughly a couple of weeks after reaching the number of events, cannot be forecast precisely, and could occur early next year.~~
In an attempt to optimize enrollment, we have taken proactive measures to increase enrollment including the addition of trial sites in three new countries, replacement of the principal CRO and addition of another CRO to our trial management group. Due to these changes full enrollment may take longer than initially expected. Sinceresults. Following the interim analysis, ~~could potentially change~~we expanded the INSPIRE Phase 3 trial to new sites in previously participating countries and into new geographical regions. We completed enrollment of the required 360 randomized patients in March 2020. As of July 2020, the required number of patients to be randomized for the trial, a better estimate of these timelines can be provided after this analysis is completed. Should enrollment not return to desired levels, full enrollment may be delayed even if the adaptive design is not required as per the statistical analysis plan.
~~As called for~~survival events have been reached, and we anticipate reporting topline survival data in the ~~INSPIRE Charter,~~third quarter of 2020, and presenting the ~~DMC has previously conducted two periodic safety reviews, and after each review, the trial continued per plan.~~full results at a major medical meeting later in 2020.

Safety and Tolerability of rigosertib in MDS and other hematologic malignancies

A comprehensive analysis of rigosertib IV and rigosertib oral ~~rigosertib~~ safety in patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) was presented in December 2016 at the American Society of Hematology (ASH) Annual Meeting. The most commonly reported treatment-emergent adverse events (TEAEs) _ in > 10% of patients with MDS/AML (n= 335) receiving rigosertib intravenous (IV) monotherapy were fatigue (33%), nausea (33%), diarrhea (27%), constipation (25%), anaemia (24%) and pyrexia (24%). The most common > Grade 3 AEs were anaemia (21%), febrile neutropenia (13%), pneumonia (12%) and thrombocytopenia (11%). The most common serious AEs were febrile neutropenia (10%), pneumonia (9%), and sepsis (7%). The most common AEs leading to discontinuation of IV rigosertib were sepsis and pneumonia (3% each).

Rigosertib oral in combination with azacitidine for higher-risk MDS

We are developing rigosertib oral for use in combination with IV azacitidine prior to treatment with HMA therapy for higher risk MDS. The results of the Phase 1 combination study oral rigosertib with injectable azacitidine were published in Leukemia Research (Navada et al., 2020, Leukemia Research 94, 106369). We presented updated information regarding our Phase 2 trial with an abstract and oral presentation at the ASH Annual Meeting in December 2019. The focus of this presentation was on patients diagnosed with HMA-naïve, HR MDS. In December ~~2016,~~2018, at the American Society of Hematology (ASH) Annual Meeting and in June 2019, at the Congress of the European Hematology Association Meeting (EHA), we presented results from a Phase 1/2, multi-institutional trial of data from the initial portion of an ongoing rigosertib oral ~~rigosertib~~ and azacitidine combination trial in higher-risk MDS. 3355 of ~~40 MDS~~74 HR-MDS patients enrolled and treated with > 840 mg/day oral rigosertib were evaluable for response at the time of the analysis. An Overall Response Rate (ORR) of 90% and Complete Remission (CR) rate (primary endpoint) of 34% was reported in this multi-institutional Phase 1/2 study in HMA naïve patients. HMA naïve patients are patients that had not previously received either azacitidine or decitabine. Such patients were not necessarily treatment naïve patents in that they may have received other therapies used for MDS. An ORR of 54% and CR/Partial Response (PR) of 8% in HMA failed patients was also reported.

The median age of patients was ~~66,~~69, with ~~73%~~59% being ~~male.~~male and 41% being female. The IPSS-R distribution was: 7.5% Low, 12.5% Intermediate, 37.5% High, 32.5% Very High and 10% unknown. 76% of patients responded per 2006 International Working Group (IWG) criteria. Responses were as follows:

~~Response per IWG 2006~~
Overall No prior Prior HMA
Evaluable HMA (failures)

Overall
Evaluable
(N=33)

No prior
HMA
(N-20)

Prior
HMA
(N=13)

(N=55) (N=29) (N=26)
Complete remission (CR)

8(24
)%
7(35
)%
1(8
)%
11(20 )% 10(34 )% 1(4 )%
Marrow CR + hematologic improvement

10(30
)%
6(30
)%
4(31
)%
10(18 )% 5(17 )% 5(19 )%
Marrow CR alone

6(18
)%
3(15
)%
3(23
)%
13(24 )% 8(28 )% 5(19 )%
Hematologic improvement alone

1(3
)%
1(5
)%
0

5(9 )% 3(10 )% 2(8 )%
Stable disease

8(24
)%
3(15
)%
5(38
)%
10(18 )% 3(10 )% 7(27 )%
Overall IWG response

25(76
)%
17(85
)%
8(62
)%
40(73 )% 26(90 )% 14(54 )%
Clinical benefit response

19(58
)%
14(70
)%
5(38
)%

The median duration of response for patients with HMA naïve MDS was 812.2 months
The median time to initial/best response for ~~CR, 12.3~~HMA naïve patients, was 1 cycle and 4 cycles, respectively
The median duration of response for the HMA failed patients was 10.8 months
The median time to initial/best response for ~~marrow CR.~~patients with HMA failure MDS, was 2 cycles and 5 cycles of treatment, respectively

Safety/Tolerability of the Combination:

~~Oral~~Based upon safety results from a comprehensive analysis of patients (HMA-failure and HMA-naïve) receiving oral rigosertib ~~(560 mg qAM, 280 mg qPM)~~in combination with azacitidine that was ~~administered on Day 1-21 of a 28-day cycle. Azacitidine 75 mg/m 2 /day SC or IV was administered for 7 days starting on Day 8. The~~presented during ASH in 2018, the combination of rigosertib oral ~~rigosertib~~(> 840 mg/day) and azacitidine was well
tolerated. The most common TEAEs in > ~~10%~~30% of patients with MDS/AML (n=74) receiving rigosertib oral and azacitidine were ~~nausea (41%~~hematuria (45%), constipation (43%), diarrhea (42%), fatigue (42%), dysuria (38%) , pyrexia (36%), nausea (35%), neutropenia (31%) thrombocytopenia (30%) .fatigue (39%), diarrhea (37%), constipation (37%) and dysuria (28%). The most common serious AEs were pneumonia (11%) and febrile neutropenia (7%). The most common AEs leading to discontinuation were AML (4%) and pneumonia (4%).
Results of the specific safety subset of patients with HMA-treatment naïve (n=39) that received oral rigosertib in combination with azacitidine were presented at the 2019 ASH conference. Overall, the safety results were similar for this subset of patients compared to those described above. The most common all grade TEAEs in > 30% of patients with HMA-naïve, HR MDS receiving oral rigosertib and azacitidine were hematuria (51%), fatigue (49%), pyrexia (44%), diarrhea (41%), nausea (38%), constipation (36%), dysuria (36%), neutropenia (36%) and thrombocytopenia (36%).

Next steps for rigosertib oral in combination with azacitidine for higher-risk MDS

~~Following an end of Phase 2~~In September 2019 we had a Type A meeting with the ~~Food~~FDA to discuss the SPA and ~~Drug Administration (FDA) in September 2016, we began~~protocol development ~~of a~~for the Company's pivotal Phase 3 ~~protocol. The Phase 3 trial will be designed as a global 1:1 randomized, placebo-controlled trial~~Trial for the combination of oral rigosertib ~~plus~~and azacitidine ~~compared to azacitidine plus placebo. Based on the results of the Phase 1/2 Study,~~in HMA naïve higher risk MDS. The FDA recommended that, if we plan to ~~use~~further study the ~~full dose~~combination of oral rigosertib in combination with azacitidine, ~~as defined~~we next conduct a dose-ranging study with an azacitidine control arm in the product insert. The patient population studied in this trial will be first-line (HMA naïve) higher-risk MDS patients. The primary endpoint for assessment of efficacy will be the composite Response Rate of complete remission (CR) + partial remission (PR,) as per the IWG 2006 Response Criteria. Formal FDA review will be sought via the Special Protocol Assessment (SPA) mechanism. We will not commence the Phase 3 trial without additional financing.
While the Phase 3 trial is being designed, we have expanded the Phase 1/2 trial cohort by up to 40 subjects. Under a protocol expansion, we plan to use the expanded cohorts to explore dose optimization by increasing the dose of rigosertib and varying the dose administration scheme of rigosertib oralorder to identify an ~~optimal~~appropriate dose and ~~schedule. After amendments were filed with~~to determine the ~~regulatory agencies, we started the expansion phase~~contribution of ~~this trial~~rigosertib in the ~~U.S. sites that participated in~~combination. We continue to evaluate the ~~initial trial. The first patient was enrolled in April~~FDA's comments and, ~~since then, more than half~~expect to submit to the FDA a protocol for a dose-finding Phase 2/3 Study of the ~~planned patients have been enrolled in the expansion trial. We~~combination with a control arm of azacitidine. The Company does not plan to ~~add more sites in~~commence the ~~U.S. to complete enrollment~~new Phase 2/3 study until after completion of the ~~expanded trial.~~INSPIRE trial and additional funding is received.

In June 2017, at the Congress of the European Hematology Association Meeting, we updated the data from the Phase 1/2 trial and highlighted results in AML patients included in this study. Response data was presented on eight evaluable patients with AML who were tested with the rigosertib and azacitidine combination. For the eight evaluable patients with AML, the combination was well tolerated, and the safety profile was similar to single-agent azacitidine, based on safety information in the azacitidine FDA approved label. Based on the presented results of the combination studies, the authors concluded that continued study in AML was warranted. We ~~will~~do not currently plan to commence further development of rigosertib oral in combination with azacitidine for AML without additional financing.

Rigosertib oral for lower-risk MDS

We have studied rigosertib oral as a single agent treatment for lower risk MDS. Higher-risk MDS patients suffer from a shortfall in normal circulating blood cells, or cytopenias, as well as elevated levels of cancer cells, or blasts in their bone marrow and sometimes in their peripheral ~~blood.~~blood with a significant rate of transformation to acute leukemia. Lower-risk MDS patients suffer mainly from cytopenias, that is low levels of red blood cells, white blood cells or platelets. Thus, lower-risk MDS patients depend on transfusions and growth factors or other therapies to improve their low blood ~~counts.~~counts; but have a lower rate of acute leukemic transformation.

We have explored single agent rigosertib oral as a treatment for lower-risk MDS in two Phase 2 clinical trials, 09-05 and 09-07. In December ~~2013,~~2017, we presented data at the Annual ASH Meeting from the 09-05 Phase 2 trial. ~~To date, Phase 2~~We believe this data demonstrated a 44% rate of achieving transfusion independence in the cohort of Lower-risk MDS patients treated with rigosertib oral at a dose of 560 mg BID (1120 mg over 24 hrs) two out of three weeks. We believe clinical data has indicated that further study of single agent rigosertib oral ~~rigosertib~~ in transfusion-dependent, lower-risk MDS patients is warranted. Rigosertib has been generally well ~~tolerated, except for urinary~~tolerated. Previously reported genitourinary side effects ~~at higher dose levels.~~have been mitigated by optimizing the dosing scheme and oral hydration (ASH 2018). Future clinical trials will be needed to evaluate dosing and schedule modifications and their impact on efficacy and safety results of rigosertib oral ~~rigosertib~~ in lower-risk MDS patients.

Data presented from the 09-05 trial also suggested the potential of a genomic methylation assessment of bone marrow cells to prospectively identify lower-risk MDS patients likely to respond to ~~oral rigosertib.~~rigosertib oral. We therefore expanded the 09-05 trial by adding an additional cohort of 20 patients to advance the development of this genomic methylation test. To date, a biomarker which would predict response has not been identified. Further testing and development of rigosertib oral ~~rigosertib~~ for lower-risk MDS will be required. We ~~will~~do not currently plan to commence further development of rigosertib oral for lower-risk MDS without additional financing.

Safety and Tolerability of rigosertib oral in MDS and other hematologic malignancies

~~Oral rigosertib~~Rigosertib oral as a monotherapy was evaluated in four Onconova Phase 1 and 2 studies in MDS and other hematologic malignancies. ~~One study is completed~~In studies of oral rigosertib as monotherapy for the treatment of MDS and ~~a clinical study report is available. The most common~~other hematologic malignancies:
•             Drug-related TEAEs in > ~~10% of patients~~that were ~~pollakiuria (increased urinary frequency) (35%), fatigue (32%), diarrhea (26%), dysuria (29%) and haematuria (24%). The most common~~ > Grade 3 ~~AEs were anaemia (17%), thrombocytopenia (5%), haematuria (4%) and urinary tract infection (4%).~~in severity occurred in 21% of patients. The most ~~common serious AE was pneumonia (6%~~frequently reported (> 2% of patients) drug-related TEAEs that were > Grade 3 were neutropenia (7%); thrombocytopenia and cystitis (3% each); and leukopenia, dysuria, and hematuria (2% each).
•             Among the 8% of patients with SAEs that were considered drug related, the events were mostly urinary related. The most ~~common AEs leading to discontinuation of patients receiving oral rigosertib as monotherapy were dysuria (8%), urinary tract pain (7%), haematuria (5%) and urinary frequency~~
~~(5%~~frequent drug-related SAE was cystitis (3%).

In addition to the above described clinical trials, we are continuing the preclinical and chemistry, manufacturing, and control work for IV and oral rigosertib.

Rare Disease Program in "RASopathies"
Based on the mechanism of action data published in the journal Cell in 2016, we have initiated a collaborative development program focusing on a group of rare diseases with a well-defined molecular basis in expression or defects involving the Ras Effector Pathways. Since "RASopathies" are rare diseases affecting young children, we embarked on a multifaceted collaborative program involving patient advocacy, government and academic organizations. The RASopathies are a group of rare diseases which share a well-defined molecular basis in expression or defects involving Ras Effector Pathways. They are usually caused by germline mutations in genes that alter the RAS subfamily and mitogen-activated protein kinases that control signal transduction, and are among the most common genetic syndromes. Together, this group of diseases can impact more than 1 in 1000 individuals, according to RASopathiesNet.
In January 2018, we entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). Under the terms of the CRADA, the NCI initiated and conducted preclinical laboratory studies on rigosertib in pediatric cancer associated RASopathies. As part of the CRADA, we provided rigosertib supplies and initial funding towards the non-clinical studies. The NCI has conducted PK/PD and dose escalation studies in preclinical models of rhabdomyosarcoma.
In addition, pre-clinical studies were conducted at the University of California San Francisco and funded through the Leukemia Lymphoma Society. The focus was on Juvenile Myelomonocytic Leukemia (JMML), a well-described RASopathy affecting children which is incurable without an allogenic hematopoietic stem cell transplant.
~~Other~~Investigator Initiated Programs

~~The vast majority of~~We are currently supporting investigator-initiated studies that are exploring the ~~Company’s efforts are now devoted to the advanced stage development~~use of rigosertib for ~~unmet medical needs~~other cancers driven by mutated Ras genes, including a Phase 1 study of ~~MDS~~rigosertib in combination with a PD-1 inhibitor for patients with progressive K-Ras mutated non-small cell lung cancer. The investigator opened an Investigational New Drug application with the FDA and the trial also has received local IRB approval. The study has enrolled its first two patients. ~~Other programs~~Results are ~~either paused, inactive or require only minimal internal resources~~expected in 2021.
We also anticipate investigator-initiated studies related to rigosertib in combination with a PD-1 inhibitor for K-Ras mutated metastatic melanoma and ~~efforts.~~single agent rigosertib in squamous cell carcinoma.

COVID-19 Disease
In July 2020, we submitted an application with the National Institute of Allergy and Infectious Disease (NIAID), with the goal of obtaining funding from the National Institutes of Health (NIH) to conduct human studies with rigosertib in COVID-19 disease patients. Based on the reported mechanism of action which modulates the RAS/RAF/MEK/ERK pathway involved in proliferative signaling, rigosertib may play an important role in inhibiting COVID-19 replication in human cells, specifically lung tissue, a primary source of serious disease.

Other Programs
CDK 4/6 + ARK5 Inhibitor (ON123300)
In December 2017, we entered into a license and collaboration agreement with HanX, a company focused on development of novel oncology products, for the further development, registration and commercialization in China of ON 123300. We believe this compound has the potential to overcome the limitations of current generation CDK 4/6 inhibitors. Under the terms of the agreement, we received an upfront payment, and will receive regulatory and commercial milestone payments, as well as royalties on Chinese sales. The key feature of the collaboration is that HanX provides all funding required for Chinese IND enabling studies performed for the Chinese Food and Drug Administration (Chinese FDA) IND approval. In the fourth quarter of 2019, HanX filed an IND with the Chinese FDA. The Chinese IND was approved in January 2020. We and HanX also intended for these studies to comply with the FDA standards. Accordingly, such studies may be used by us for an IND filing with the FDA. We anticipate filing a US IND related to ON 123300 in Q4 of 2020. We maintain global rights outside of China.
Positive preclinical data was announced at the American Association for Cancer Research (AACR) annual meeting, which took place April 1-5, 2017 in Washington, DC, for ON 123300, a first-in-class dual inhibitor of CDK4/6 + ARK5. We believe our CDK inhibitor is differentiated from other agents in the market (palbociclib, ribociclib and abemaciclib) or in development by its dual inhibition of CDK4/6 + ARK5.
In a preclinical Rb+ve xenograft model for breast cancer, ON 123300 activity was shown to be similar to palbociclib (Pfizer's Ibrance ®). Moreover, based on the same preclinical model, ON 123300 may have the potential advantage of reduced neutropenia when compared to palbociclib. Whereas both compounds resulted in decreased RBC and platelet counts in this preclinical model system, palbociclib was found to have a more prominent and statistically significant (P< 0.05) inhibitory effect on neutrophil counts when compared to ON 123300.
Briciclib

Briciclib, another of our product candidates, is a small molecule targeting an important intracellular regulatory protein, Cyclin D1, which is often found at elevated levels in cancer cells. Cyclin D1 expression is regulated through a process termed cap-dependent translation, which requires the function of eukaryotic initiation factor 4E protein. In vitro evidence indicates briciclib binds to eukaryotic initiation factor 4E protein, blocking cap-dependent translation of Cyclin D1 and other cancer proteins, such as c-MYC, leading to tumor cell death. We have been conducting a Phase 1 multi-site dose-escalation trial of briciclib in patients with advanced solid tumors refractory to current therapies. Safety and efficacy assessments are complete in six of the seven dose-escalation cohorts of patients in this trial. As of December 2015, the Investigational New Drug ~~(“IND”~~("IND") for briciclib is on full clinical hold following a drug product lot testing failure. We will be required to undertake appropriate remedial actions prior to re-initiating the clinical trial and completing the final dose-escalation cohort.

Recilisib

Recilisib is a product candidate being developed in collaboration with the U.S. Department of Defense for acute radiation syndromes. We have completed four Phase 1 trials to evaluate the safety and pharmacokinetics of recilisib in healthy human adult subjects using both subcutaneous and oral formulations. We have also conducted animal studies and clinical trials of recilisib under the ~~FDA’s~~FDA's Animal Rule, which permits marketing approval for new medical countermeasures for which conventional human efficacy studies are not feasible or ethical, by relying on evidence from adequate and well-controlled studies in appropriate animal models to support efficacy in humans when the results of those studies establish that the drug is reasonably likely to produce a human clinical benefit. Human safety data, however, is still required. Ongoing studies of recilisib, focusing on animal models and biomarker development to assess the efficacy of recilisib ~~are being~~were conducted by third parties with government funding. We anticipate that any future development of recilisib beyond these ~~ongoing~~ studies would be conducted solely with government funding or by collaboration. Use of government funds to finance the research and development in whole or in part means any future effort to commercialize recilisib will be subject to federal laws and regulations on U.S. government rights in intellectual property. Additionally, we are subject to laws and regulations governing any research contracts, grants, or cooperative agreements under which government funding was provided.

~~Preclinical Product Candidates~~Some of our studies on our compounds are ongoing and results may change as data becomes available.

In addition to our three clinical-stage product candidates, we have several product candidates that target kinases, cellular metabolism or cell division in preclinical development. We may explore additional collaborations to further the development of these product candidates as we focus internally on our more advanced programs.
Positive preclinical data was announced at the American Association for Cancer Research (AACR) annual meeting, which took place April 1-5 in Washington, DC, for ON 123300, a first-in-class dual inhibitor of CDK4/6 + ARK5, and for ON 150030, a novel Type 1 inhibitor of FLT3 and Src pathways. We believe our CDK inhibitor is differentiated from other agents in the market (Palbociclib, Ribociclib and Abemaciclig) or in development (such as the compounds being developed by G1 Therapeutics) by its dual inhibition of CDK4/6 + ARK5. We continue to carry out research to enhance the pre-clinical data package for this compound in an attempt to seek partners for co-development of this novel compound.
In a preclinical Rb+ve xenograft model for breast cancer, ON 123300 activity was shown to be similar to Palbociclib (Pfizer’s Ibrance®). Moreover, based on the same preclinical model, the new molecule may have the potential advantage of reduced neutropenia when compared to Palbociclib. Whereas both compounds resulted in decreased RBC and platelet counts in this preclinical model system, Palbociclib was found to have a more prominent and statistically significant (P< 0.05) inhibitory effect on neutrophil counts when compared to ON 123300.
Critical Accounting Policies and Significant Judgments and Estimates

This management’s discussion and analysis of our financial condition and results of operations is based on our interim unaudited consolidated financial statements, which have been prepared in accordance with ~~generally accepted accounting principles.~~GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, revenue recognition, deferred revenue and stock-based compensation. We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe there have been no significant changes in our critical accounting policies as discussed in our annual report on Form 10-K filed with the SEC on March ~~29, 2017.~~27, 2020.

Results of Operations

Comparison of the Three Months Ended ~~September~~June 30, ~~2017~~2020 and ~~2016~~2019

Three Months ended September 30,

2017

2016

Change

Revenue

$
110,000

$
1,651,000

$
(1,541,000
)
Operating expenses:

General and administrative

1,728,000

1,975,000

247,000

Research and development

5,141,000

3,991,000

(1,150,000
)
Total operating expenses

6,869,000

5,966,000

(903,000
)
Loss from operations

(6,759,000
)
(4,315,000
)
(2,444,000
)
Change in fair value of warrant liability

(210,000
)
2,706,000

(2,916,000
)
Other income (expense), net

8,000

10,000

(2,000
)
Net loss

$
(6,961,000
)
$
(1,599,000
)
$
(5,362,000
)
Three Months ended June 30,
2020 2019 Change
Revenue $ 56,000 $ 2,022,000 $ (1,966,000 )
Operating expenses:
General and administrative 2,594,000 1,760,000 (834,000 )
Research and development 4,801,000 3,895,000 (906,000 )
Total operating expenses 7,395,000 5,655,000 (1,740,000 )
Loss from operations (7,339,000 ) (3,633,000 ) (3,706,000 )
Change in fair value of warrant liability (56,000 ) 32,000 88,000
Other income (expense), net — 40,000 (40,000 )
Net loss $ (7,395,000 ) $ (3,561,000 ) $ (3,658,000 )

~~Revenues~~Revenue

Revenues decreased by ~~$1.5~~$2.0 million, or 97%, for the three months ended ~~September~~June 30, ~~2017~~2020 when compared to the same period in ~~2016 primarily as a result~~2019 because of ~~contractual cost-sharing~~ revenue recognized from ~~Baxalta for a portion of~~ the ~~costs of the INSPIRE trial~~HanX rigosertib transaction in the ~~2016~~2019 period.

General and administrative expenses

General and administrative expenses ~~decreased~~increased by ~~$0.2~~$0.8 million, or ~~13%~~47%, to ~~$1.7~~$2.6 million for the three months ended ~~September~~June 30, ~~2017~~2020 from ~~$2.0~~$1.8 million for the three months ended ~~September~~June 30, ~~2016.~~2019. The ~~decrease~~increase was attributable primarily to ~~a decrease~~$0.3 million of ~~$0.1~~commercialization preparation expenses, $0.4 million inof proxy solicitation and other expenses related to our annual general meeting of stockholders and our reconvened annual general meeting of stockholders, and $0.2 million of higher legal and consulting fees. These increases were partially offset by $0.2 million less personnel related, facilities, and stock compensation ~~and personnel~~ expenses ~~and a decrease of $0.1 million~~ in ~~other general and administrative costs as~~ the ~~company continued its focus to reduce non-R&D costs.~~2020 period.

Research and development expenses

Research and development expenses increased by ~~$1.1~~$0.9 million, or ~~29%~~23%, to ~~$5.1~~$4.8 million for the three months ended ~~September~~June 30, ~~2017~~2020 from ~~$4.0~~$3.9 million for the three months ended ~~September~~June 30, ~~2016.~~2019. This increase was caused primarily by an increase of $1.6 million in clinical development spending, which was comprised of increases in INSPIRE spending of $0.9 million as more clinical sites were open and active during the 2017 period and an increase of $0.7 million ~~in spending~~higher manufacturing costs related to ~~the 09-08 expansion study, which~~our clinical supply for INSPIRE, for our oral rigosertib combination program, and for our ON123300 pre-IND product candidate. The increase was ~~commenced during the second quarter of the 2017 period.~~also caused by $0.5 million higher consulting expenses for regulatory consultants working on our new drug application (“NDA”) preparations. These increases were partially offset by ~~a decrease~~$0.2 million lower clinical expenses on the combination program and INSPIRE, and $0.1 million lower personnel costs in ~~personnel related costs of $0.3 million due to~~the 2020 period following the reduction in force ~~during~~completed in the ~~third~~
first quarter of 2016, a decrease in manufacturing costs of $0.1 million related to the timing of drug product and drug substance manufacturing in the 2016 period, as well as lower stock compensation expense due to fewer options outstanding in the 2017 period.2019.

Change in fair value of warrant liability

The fair value of the warrant liability increased ~~$0.2 million~~$56,000 for the three months ended ~~September~~June 30, ~~2017,~~2020, compared to aan decrease of ~~$2.7 million~~$32,000 for the three months ended ~~September~~June 30, ~~2016.~~2019. This change was caused by ~~the decrease~~an increase in the ~~estimate~~2020 period of the fair market value of the warrants ~~at September 30, 2016 [utilizing a Black-Scholes valuation methodology.]~~issued in our rights offering in 2016.

Other income (expense), net

Other income (expense), net, ~~decreased by $2,000~~was $0 for the three months ended ~~September~~June 30, ~~2017 compared to~~2020 and $40,000 for the three months ended ~~September~~June 30, ~~2017,~~2019. The change of $40,000 was due ~~primarily~~ to ~~higher foreign exchange loss in the 2017 period partially offset by~~ higher interest income in the ~~2017~~2019 period, as well as more foreign exchange expense in the 2020 period.

Comparison of the ~~Nine~~Six Months Ended ~~September~~June 30, ~~2017~~2020 and ~~2016~~2019

Nine Months ended September 30,

Six Months ended June 30,

2017

2016

Change

2020 2019 Change
Revenue

$
644,000

$
5,373,000

$
(4,729,000
)
$ 108,000 $ 2,090,000 $ (1,982,000 )
Operating expenses:

General and administrative

5,623,000

7,229,000

1,606,000

4,401,000 4,994,000 593,000
Research and development

14,641,000

15,377,000

736,000

8,171,000 7,969,000 (202,000 )
Total operating expenses

20,264,000

22,606,000

2,342,000

12,572,000 12,963,000 391,000
Loss from operations

(19,620,000
)
(17,233,000
)
(2,387,000
)
(12,464,000 ) (10,873,000 ) (1,591,000 )
Change in fair value option liability

1,716,000

2,985,000

(1,269,000
)
Change in fair value of warrant liability (119,000 ) (395,000 ) 276,000
Other income (expense), net

19,000

28,000

(9,000
)
96,000 107,000 (11,000 )
Net loss

$
(17,885,000
)
$
(14,220,000
)
$
(3,665,000
)
$ (12,487,000 ) $ (11,161,000 ) $ (1,326,000 )

~~Revenues~~Revenue

Revenues decreased by ~~$4.7~~$2.0 million, or 95%, for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 when compared to the same period in ~~2016 primarily as a result~~2019 because of ~~contractual cost-sharing~~ revenue recognized from ~~Baxalta for a portion of~~ the ~~costs of the INSPIRE trial~~HanX rigosertib license agreement in the ~~2016 period.~~2019 period

General and administrative expenses

General and administrative expenses decreased by ~~$1.6~~$0.6 million, or ~~22%~~12%, to ~~$5.6~~$4.4 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 from ~~$7.2~~$5.0 million for the ~~nine~~six months ended ~~September~~June 30, ~~2016.~~2019. The decrease was ~~primarily caused by a decrease~~attributable to severance and stock option vesting acceleration expenses of ~~$0.5 million of severance costs and accelerated stock compensation expense of $0.8~~$1.7 million related to ~~the reduction in force~~personnel reductions during the ~~2016~~2019 period and lower information technology facilities costs of $0.1 million in the 2020 period. ~~Lower facilities~~These decreases were partially offset by $0.8 million higher legal, consulting, and investor relations fees related ~~insurance,~~to our annual general meeting of stockholders and ~~other~~our reconvened annual general meeting of stockholders and ~~administrative costs also contributed $0.3~~$0.4 million ~~to the decrease.~~of commercialization preparation expenses.

Research and development expenses

Research and development expenses ~~decreased~~increased by ~~$0.7~~$0.2 million, or 5%3%, to ~~$14.6~~$8.2 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 from ~~$15.4~~$8.0 million for the ~~nine~~six months ended ~~September~~June 30, ~~2016.~~2019. This ~~decrease~~increase was caused primarily by ~~decreases of $1.9~~$0.7 million inhigher consulting expenses for regulatory consultants working on our new drug application (“NDA”) preparations, and by $0.6 million higher manufacturing costs related to our clinical supply for INSPIRE, for our oral rigosertib combination program, and for our ON123300 pre-IND product candidate. These increases were partially offset by $0.4 million lower clinical expenses on the combination program and INSPIRE, and $0.7 million lower personnel costs and ~~$1.2 million of~~ stock compensation expense ~~related to our~~in the 2020 period following the reduction in ~~workforce~~force completed in the first quarter of 2016. These decreases were partially offset by higher clinical development expense of $1.6 million as a result of our increased spending on INSPIRE and our 09-08 combination expansion study, which commenced during the second quarter of 2017.2019.

Change in fair value of warrant liability

The ~~change in~~ fair value of the warrant liability ~~was $1.7~~decreased $0.1 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~
2020, compared to ~~$3.0~~a decrease of $0.4 million for the ~~nine~~six months ended ~~September~~June 30, ~~2016. The~~2019. This change ~~in the fair value of the warrant liability in 2017~~ was caused by the ~~change~~decrease, during the 2020 period, in the fair market value of the warrants ~~which was estimated using a Black-Scholes methodology during the 2016 period, and based on the quoted market price of the warrants for the 2017 period.~~issued in our rights offering in 2016.

Other income (expense), net

Other income (expense), net, ~~decreased by $9,000~~was $96,000 for the ~~nine~~three months ended ~~September~~June 30, ~~2017 compared to~~2020, and $107,000 for the ~~nine~~six months ended ~~September~~June 30, ~~2016~~2019, due to higher interest income ~~partially offset by higher~~and lower foreign exchange loss in the ~~2017~~2019 period.

~~Financial Condition~~
Total assets decreased $14.4 million, or approximately 62%, from $23.2 million at December 31, 2016 to $8.8 million at September 30, 2017. The decrease in total assets was due primarily to decreases in cash, cash equivalents and prepaid expenses. Total liabilities decreased from $18.1 million at December 31, 2016 to $14.9 million at September 30, 2017, a decrease of $3.2 million, primarily as a result of the decrease in the warrant liability since December 31, 2016, lower accrued expenses, and our recognition of deferred revenue under our SymBio agreement. Total stockholders’ equity decreased from $5.1 million at December 31, 2016 to stockholders’ deficit of $6.1 million at September 30, 2017, a decrease of $11.2
million, or approximately 218%, primarily due to a net loss of $17.9 million for the nine months ended September 30, 2017, partially offset by increases in additional paid in capital related to stock compensation expense and our sale of securities during the second quarter of 2017.
Liquidity and Capital Resources

Since our inception, we have incurred net losses and experienced negative cash flows from our operations. We incurred net losses of ~~$17.9~~$12.5 million and ~~$14.2~~$11.2 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 and ~~2016,~~2019, respectively. Our operating activities used ~~$19.1~~$11.8 million and $11.5 million of net cash during the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 and ~~2016,~~2019, respectively. At ~~September~~June 30, ~~2017,~~2020, we had an accumulated deficit of ~~$356.1~~$415.9 million, ~~negative~~ working capital of ~~$0.3~~$19.2 million, and cash and cash equivalents of ~~$7.6~~$27.2 million. We believe that our cash and cash equivalents as of June 30, 2020, will be sufficient to fund our operations and ongoing trials ~~and operations through~~into the ~~end~~fourth quarter of ~~2017.~~2021.

Cash Flows

The following table summarizes our cash flows for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 and ~~2016:~~2019:

Nine Months ended September 30,

Six Months ended June 30,

2017

2016

2020 2019
Net cash (used in) provided by:

Operating activities

$
(19,147,000
)
$
(11,450,000
)
$ (11,844,000 ) $ (11,510,000 )
Investing activities

—

—

(15,000 ) -
Financing activities

5,317,000

17,424,000

16,360,000 424,000
Effect of foreign currency translation

30,000

5,000

1,000 (2,000 )
Net decrease in cash and cash equivalents

$
(13,800,000
)
$
5,979,000

Net increase (decrease) in cash and cash equivalents $ 4,502,000 $ (11,088,000 )

Net cash used in operating activities

Net cash used in operating activities was ~~$19.1~~$11.8 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2020 and consisted primarily of a net loss of ~~$17.9~~$12.5 million, including ~~a favorable change~~an increase in the fair value of warrant liability of ~~$1.7~~$0.1, and $0.2 million ~~partially offset by $1.4 million~~ of both noncash stock-based compensation and depreciation expense. Changes in operating assets and liabilities resulted in a net increase in cash of ~~$0.9~~$0.3 million. Significant changes in operating assets and liabilities included ~~a decrease~~an increase in ~~prepaid expenses and other current assets of $0.6 million as a result of the recognition of expense for clinical and manufacturing activities and insurance expense. Accounts~~accounts payable and accrued liabilities ~~decreased by $1.2~~of $0.4 million ~~as a result of the~~due to timing of ~~receipt~~invoices and ~~payment of vendor invoices, primarily related~~payments to our ~~INSPIRE trial. Deferred~~vendors, and a decrease in deferred revenue ~~decreased $0.3~~of $0.1 million due to recognition of the unamortized portion of the upfront payment under our collaboration agreement with SymBio.

Net cash ~~provided by investing~~used in operating activities was $11.5 million for the six months ended June 30, 2019 and consisted primarily of a net loss of $11.2 million, including an increase in fair value of warrant liability of $0.4 million, and $0.8 million of noncash stock-based compensation and depreciation expense. Changes in operating assets and liabilities resulted in a net decrease in cash of $1.6 million. Significant changes in operating assets and liabilities included an increase in receivables of $1.7 million, an increase in prepaid expenses and other current assets of $0.1 million, and an increase in accounts payable and accrued liabilities of $0.3 million due to timing of invoices and payments to our vendors, and a decrease in deferred revenue of $0.1 million due to recognition of the unamortized portion of the upfront payment under our collaboration agreement with SymBio. The $1.7 million increase in receivables was the result of a payment due under the HanX license agreement and was received in August 2019.

~~There was no net~~Net cash ~~provided by or~~ used in investing activities ~~for~~
Net cash used in investing activities was $15,000 related to computer equipment during the ~~nine~~six months ended ~~September~~June 30, ~~2017 or 2016.~~2020. There was no cash used in investing activities during the six months ended June 30, 2019

Net cash provided by financing activities

Net cash provided by financing activities was $16.4 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017 was $5.3 million, which resulted~~2020 resulting from ~~the~~ proceeds received from the ~~sale~~sales of common ~~stock. Net~~stock and warrants and the exercise of warrants. There was $0.4 million of net cash provided by financing activities for the ~~nine~~six months ended ~~September~~June 30, ~~2016 was $17.4 million resulting from~~2019, related to the issuance of ~~common~~ stock in ~~January, 2016~~connection with the HanX rigosertib license transaction and the ~~rights offering in July, 2016.~~exercise of warrants.

Operating and Capital Expenditure Requirements

We believe that our cash and cash equivalents of $27.2 million, at June 30, 2020, will be sufficient to fund our operations and ongoing trials ~~and operations through~~into the ~~end~~fourth quarter of ~~2017.~~2021. On April 24, 2020, we filed a registration statement on Form S-3 to register $150.0 million of securities. We are exploring various dilutive and non-dilutive sources of funding, including equity and debt financings, strategic alliances, business development and other sources. If we are unable to obtain additional funding, we may not be able to continue as a going concern and may be forced to curtail all of our activities and, ultimately, potentially cease operations. If we are unable to raise sufficient additional funding, we will not have sufficient cash flows and liquidity to fund our planned business operations, and may be forced to limit many, if not all, of our programs and consider other means of creating value for our stockholders, such as licensing to others the development and commercialization of products that we consider valuable and would otherwise likely develop ourselves. Even if we are able to raise additional capital, such financings may only be available on unattractive terms, or could result in significant dilution of stockholders’ interests. The consolidated financial statements do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue in existence.

We have not achieved profitability since our inception and we expect to continue to incur net losses for the foreseeable future. We expect our net cash expenditures in ~~2017~~2020 to ~~increase from 2016 due~~be comparable to the discontinuation of payments from our former partner Baxalta for a portion of the INSPIRE costs and the advanced progress of the INSPIRE trial in 2017. In February and August 2016, we eliminated a number of employee positions as part of our ongoing commitment to reduce costs and conserve cash. Affected employees were offered severance pay in accordance with our policy or, if applicable, their employment agreements. As a result of these workforce reductions, we recorded severance-related charge totaling $3.0 million, which included non-cash charges of $1.4 million related to the accelerated vesting of the outstanding stock options for certain of the affected employees. 2017 will have no costs associated with those 2016 workforce reductions. We may however, incur other charges or cash expenditures not currently contemplated due to events that may occur as a result of, or associated with, workforce reductions.2019. We will incur substantial costs beyond the present and planned clinical trials ~~in order~~ to file a New Drug Application (NDA) for ~~rigosertib.~~rigosertib and to prepare for commercialization if the INSPIRE study is successful. The nature, design, size, and cost of further studies will depend in large part on the outcome of preceding studies and discussions with regulators.

For additional risks, ~~associated with our substantial capital requirements,~~ please see “Risk Factors” in Part II of this report and in previously disclosed in our most recent annual report on Form 10-K ~~filed with~~and our Quarterly Report on Form 10-Q for the ~~SEC on~~quarter ended March ~~29, 2017.~~31, 2020.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

As a smaller reporting company, the Company is not required to provide the information otherwise required by this Item.

Item 4. Controls and Procedures

Managements’ Evaluation of our Disclosure Controls and Procedures

Our management, with the participation of our principal executive and principal financial officers, evaluated the effectiveness of our disclosure controls and procedures as of ~~September~~June 30, ~~2017.~~2020. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Based on the evaluation of our disclosure controls and procedures as of ~~September~~June 30, ~~2017,~~2020, our principal executive and principal financial officers concluded that, as of such date, our disclosure controls and procedures were effective.

Changes in Internal Control Over Financial Reporting

Our management, with the participation of our principal executive and principal financial officers, evaluated any changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during our most recently completed fiscal quarter. Based on that evaluation, our principal executive and principal financial officers concluded that no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the fiscal quarter ended ~~September~~June 30, ~~2017~~2020 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II — OTHER INFORMATION

Item 1. Legal Proceedings

We are not party to any pending material legal proceedings and are not aware of any such proceedings contemplated by governmental authorities.

Item 1A. Risk Factors

The following risk ~~factor~~factors should be read in conjunction with the “Risk Factors” previously disclosed in our annual report on Form 10-K filed with the SEC on March ~~29, 2017.~~27, 2020 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020.

We may not comply with the Nasdaq continued listing requirements. If we are unable to comply with the continued listing requirements of the ~~NASDAQ~~Nasdaq Capital Market, our ~~common stock~~Common Stock could be delisted, which could affect our ~~common stock’s~~Common Stock's market price and liquidity and reduce our ability to raise capital.

We are required to meet certain qualitative and financial tests to maintain the listing of our ~~common stock~~securities on ~~the NASDAQ~~The Nasdaq Capital Market. As of June 30, ~~2017 and September 30, 2017, our total stockholders’ equity was $0.4 million and $(6.1) million, respectively. As a result,~~2020, we ~~did~~were not ~~comply~~in compliance with the ~~NASDAQ’s $2.5 million~~Nasdaq continued listing requirements related to minimum ~~stockholders’ equity~~bid price. On August 3, 2020, we received a letter from The Nasdaq Stock Market LLC (“Nasdaq”) stating that we had regained compliance with the minimum bid price requirement ~~under NASDAQ~~of the Nasdaq Listing Rule ~~5550(b)(1)~~5550(a)(2) because the Company’s common stock had a minimum closing price of at least $1.00 per share for ~~the listing of our common stock. Further, as~~a minimum ten consecutive business days. As of June 30, ~~2017 and September 30, 2017,~~2020 we ~~did not meet the alterative~~were in compliance standards for the listing of our common stock relating to the market value of listed securities or net income from continuing operations. On August 16, 2017, we receive a letter from NASDAQ notifying us of our noncompliance with the Nasdaq continued listing requirements related to minimum ~~stockholders’ equity requirement,~~stockholders' equity; however, at certain times during 2019 and 2018 we were not in ~~response, on October 2, 2017, we submitted our plan to regain~~ compliance ~~to NASDAQ for approval. On October 31, 2017 we submitted additional information requested by NASDAQ. We expect to receive NASDAQ’s decision regarding our compliance plan by November 15, 2017.~~ with this requirement.
There can be no assurance that ~~our plan will be accepted by NASDAQ or that if it is,~~ we will be able to ~~regain compliance. If NASDAQ does not approve our~~maintain compliance ~~plan, we intend to request a hearing before an independent Hearings Panel which has~~with the ~~authority to grant us an additional extension of time of up to 180 calendar days to regain compliance.~~minimum bid price requirement or the minimum stockholders' equity requirement or will otherwise be in compliance with other Nasdaq listing criteria.

If we ~~do not regain~~are unable to maintain compliance with the continued listing requirements ~~for~~of the ~~NASDAQ~~Nasdaq Capital Market, ~~within specified periods and subject to permitted extensions (if any),~~ our ~~common stock may~~Common Stock could be ~~recommended for delisting (subject to any appeal we would file). If our common stock is~~ delisted, making it could be more difficult to buy or sell our ~~common stock~~securities and to obtain accurate quotations, and the price of our ~~common stock~~securities could suffer a material decline. Delisting ~~would~~could also impair our ability to raise capital.
The outbreak of the novel coronavirus disease, COVID-19, could adversely impact our business, including our clinical trials, drug manufacturing and nonclinical activities.
In December 2019, a novel strain of coronavirus, COVID-19, was identified in Wuhan, China. This virus continues to spread globally and, as of June 2020, has spread to nearly every country and region in the world, including those in which we have active clinical trial sites. The outbreak and government measures taken in response have also had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods and services, such as travel, has fallen. In response to the spread of COVID-19, although we are an essential business and have maintained a limited number of staff in our offices, the majority of our corporate employees and our administrative employees are working remotely. As the COVID-19 pandemic continues to spread around the globe, we may experience disruptions that could severely impact our business, clinical trials, drug manufacturing and nonclinical activities, including:

· delays or difficulties in enrolling patients in our clinical trials, such as the previous temporary hold of enrollment in the investigator-initiated Phase 1 study of rigosertib in combination with a PD-1 inhibitor for patients with progressive K-Ras mutated non-small cell lung cancer;
· delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;
· diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;
· interruption of key clinical trial activities, such as clinical trial site 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, which may impact the integrity of subject data and clinical study endpoints;
· interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines;
· interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems;
· delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials and interruption in global shipping that may affect the transport of clinical trial materials;
· interruptions in nonclinical studies due to restricted or limited operations at our laboratory facility or those of our outsourced service providers;
· limitations on employee resources that would otherwise be focused on the conduct of our nonclinical studies or clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;
· delays in receiving approval from local regulatory authorities to initiate our planned clinical trials;
· changes in local regulations as part of a response to COVID-19 which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;
· delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees;
· refusal of the FDA to accept data from clinical trials in affected geographies outside the United States; and
· interruption or delays to our discovery and development pipeline.
In addition, the spread of COVID-19 has had and may continue to severely impact the trading price of shares of our common stock and could further severely impact our ability to raise additional capital on a timely basis or at all.
The COVID-19 pandemic continues to rapidly evolve. The extent to which the COVID-19 may impact our business, including our drug manufacturing, nonclinical activities, clinical trials and financial condition will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the pandemic, travel restrictions and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.
To the extent the COVID-19 pandemic adversely affects our business and financial results, it may also have the effect of heightening many of the other risks described in this section and in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

~~None.~~Not applicable.

Item 3. Defaults Upon Senior Securities

Not applicable.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

Not applicable.

Item 6. Exhibits
~~Exhibit~~
~~Number~~
~~Description~~
~~31.1~~
~~Rule 13a-14(a)/15d-14(a) Certifications of Principal Executive Officer~~
~~31.2~~
~~Rule 13a-14(a)/15d-14(a) Certifications of Principal Financial Officer~~
~~32.1~~
~~Section 1350 Certifications of Principal Executive Officer~~
~~32.2~~
~~Section 1350 Certifications of Principal Financial Officer~~
~~101.INS~~
~~XBRL Instance~~
~~101.SCH~~
~~XBRL Taxonomy Extension Schema Document~~
~~101.CAL~~
~~XBRL Taxonomy Extension Calculation Linkbase Document~~
~~101.DEF~~
~~XBRL Taxonomy Extension Calculation Linkbase Document~~
~~101.LAB~~
~~XBRL Taxonomy Extension Labels Linkbase Document~~
~~101.PRE~~
~~XBRL Taxonomy Extension Presentation Linkbase Document~~
~~EXHIBIT INDEX~~

Exhibit
Number
Description
31.1
~~31.1~~
Rule 13a-14(a)/15d-14(a) Certifications of Principal Executive Officer
31.2
Rule 13a-14(a)/15d-14(a) Certifications of Principal Financial Officer
32.1
Section 1350 Certifications of Principal Executive Officer
32.2
Section 1350 Certifications of Principal Financial Officer
101.INS
XBRL Instance
101.SCH
XBRL Taxonomy Extension Schema Document
101.CAL
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB
XBRL Taxonomy Extension Labels Linkbase Document
101.PRE
XBRL Taxonomy Extension Presentation Linkbase Document

EXHIBIT INDEX
Exhibit
Number
Description
31.1 Rule 13a-14(a)/15d-14(a) Certifications of Principal Executive Officer
31.2 Rule 13a-14(a)/15d-14(a) Certifications of Principal Financial Officer
32.1 Section 1350 Certifications of Principal Executive Officer
32.2 Section 1350 Certifications of Principal Financial Officer
101.INS XBRL Instance
101.SCH XBRL Taxonomy Extension Schema Document
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB XBRL Taxonomy Extension Labels Linkbase Document
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document

SIGNATURES

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.

ONCONOVA THERAPEUTICS, INC.
Dated: ~~November 9, 2017~~
August 12, 2020
/s/ ~~RAMESH KUMAR, Ph.D.~~
STEVEN M. FRUCHTMAN, M. D.
~~Ramesh Kumar, Ph.D.~~
Steven M. Fruchtman, M.D.
President and Chief Executive Officer
(Principal Executive and Principal Operating Officer)
Dated: ~~November 9, 2017~~
August 12, 2020
/s/ MARK GUERIN
Mark Guerin
Chief Financial Officer
(Principal Financial Officer)

43

Delaware		22-3627252
(State or other jurisdiction of		(I.R.S. Employer
incorporation or organization)		Identification No.)

375 Pheasant Run, Newtown, PA		18940
(Address of principal executive offices)		(Zip Code)

Large accelerated filer o¨		Accelerated filer o¨

Non-accelerated filer ox		Smaller reporting company x
~~(Do not check if a smaller reporting company)~~
		Emerging growth company x¨

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $.01 per share	ONTX	The Nasdaq Stock Market LLC
Common Stock Warrants	ONTXW	The Nasdaq Stock Market LLC

					Balance					Balance
		Exercise		Expiration	Decemeber 31,	Warrants	Warrants		Warrants	September 30,
Description	Classification	Price		Date	2016	Issued	Exercised		Expired	2017

Non-tradable warrants	Liability	$	11.50	July 2021	96,842	—	—		—	96,842
Tradable warrants	Liability	$	4.92	July 2021	3,192,022	—	—		—	3,192,022
Non-tradable pre-funded warrants	Equity	$	0.01	July 2023	236,907	—	(231,000	)	—	5,907

					3,525,771	—	(231,000	)	—	3,294,771

	Fair Value Measurement as of:
	September 30, 2017								December 31, 2016
	Level 1		Level 2		Level 3		Balance		Level 1		Level 2		Level 3		Balance

Tradable warrants liability	$	1,659,000	$	—	$	—	$	1,659,000	$	—	$	—	$	3,338,000	$	3,338,000
Non-tradable warrants liability	—		—		27,000		27,000		—		—		63,000		63,000
Total	$	1,659,000	$	—	$	27,000	$	1,686,000	$	—	$	—	$	3,401,000	$	3,401,000

	Warrant Liability
Balance at December 31, 2016	$	3,401,000
Change in fair value upon re-measurement	1,549,000
Balance at March 31, 2017	4,950,000
Reclassification of tradable warrants to Level 1	(4,857,000		)
Change in fair value upon re-measurement	(53,000		)
Balance at June 30, 2017	40,000
Change in fair value upon re-measurement	(13,000		)
Balance at September 30, 2017	$	27,000

Exercise Price	Shares	Exercisable
$1.94 - $6.50	487,578	200,294
$14.80 - $15.00	37,550	23,787
$23.20 - $39.80	101,064	77,076
$43.40 - $75.30	98,123	93,349
$132.80 - $151.20	177,708	175,666
$277.10 - $291.40	5,350	5,350
	907,373	575,522

							Overall			No prior			Prior HMA
							Evaluable			HMA			(failures)
	Overall Evaluable (N=33)		No prior HMA (N-20)		Prior HMA (N=13)		(N=55)			(N=29)			(N=26)
Complete remission (CR)	8(24	)%	7(35	)%	1(8	)%		11(20	)%		10(34	)%		1(4	)%
Marrow CR + hematologic improvement	10(30	)%	6(30	)%	4(31	)%		10(18	)%		5(17	)%		5(19	)%
Marrow CR alone	6(18	)%	3(15	)%	3(23	)%		13(24	)%		8(28	)%		5(19	)%
Hematologic improvement alone	1(3	)%	1(5	)%	0			5(9	)%		3(10	)%		2(8	)%
Stable disease	8(24	)%	3(15	)%	5(38	)%		10(18	)%		3(10	)%		7(27	)%
Overall IWG response	25(76	)%	17(85	)%	8(62	)%		40(73	)%		26(90	)%		14(54	)%
Clinical benefit response	19(58	)%	14(70	)%	5(38	)%

~~Exhibit~~ ~~Number~~		~~Description~~

~~31.1~~		~~Rule 13a-14(a)/15d-14(a) Certifications of Principal Executive Officer~~
~~31.2~~		~~Rule 13a-14(a)/15d-14(a) Certifications of Principal Financial Officer~~
~~32.1~~		~~Section 1350 Certifications of Principal Executive Officer~~
~~32.2~~		~~Section 1350 Certifications of Principal Financial Officer~~

~~101.INS~~		~~XBRL Instance~~
~~101.SCH~~		~~XBRL Taxonomy Extension Schema Document~~
~~101.CAL~~		~~XBRL Taxonomy Extension Calculation Linkbase Document~~
~~101.DEF~~		~~XBRL Taxonomy Extension Calculation Linkbase Document~~
~~101.LAB~~		~~XBRL Taxonomy Extension Labels Linkbase Document~~
~~101.PRE~~		~~XBRL Taxonomy Extension Presentation Linkbase Document~~

Exhibit Number		Description
31.1
~~31.1~~		Rule 13a-14(a)/15d-14(a) Certifications of Principal Executive Officer
31.2		Rule 13a-14(a)/15d-14(a) Certifications of Principal Financial Officer
32.1		Section 1350 Certifications of Principal Executive Officer
32.2		Section 1350 Certifications of Principal Financial Officer

101.INS		XBRL Instance
101.SCH		XBRL Taxonomy Extension Schema Document
101.CAL		XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF		XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB		XBRL Taxonomy Extension Labels Linkbase Document
101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document

Exhibit Number		Description
31.1		Rule 13a-14(a)/15d-14(a) Certifications of Principal Executive Officer
31.2		Rule 13a-14(a)/15d-14(a) Certifications of Principal Financial Officer
32.1		Section 1350 Certifications of Principal Executive Officer
32.2		Section 1350 Certifications of Principal Financial Officer

101.INS		XBRL Instance
101.SCH		XBRL Taxonomy Extension Schema Document
101.CAL		XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF		XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB		XBRL Taxonomy Extension Labels Linkbase Document
101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document

	ONCONOVA THERAPEUTICS, INC.

Dated: ~~November 9, 2017~~ August 12, 2020

	/s/ ~~RAMESH KUMAR, Ph.D.~~ STEVEN M. FRUCHTMAN, M. D.
	~~Ramesh Kumar, Ph.D.~~ Steven M. Fruchtman, M.D.
	President and Chief Executive Officer
	(Principal Executive and Principal Operating Officer)

Dated: ~~November 9, 2017~~ August 12, 2020

	/s/ MARK GUERIN
	Mark Guerin
	Chief Financial Officer
	(Principal Financial Officer)