Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2022 | May 05, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-38129 | |
Entity Registrant Name | Mersana Therapeutics, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 04-3562403 | |
Entity Address, Address Line One | 840 Memorial Drive | |
Entity Address, City or Town | Cambridge | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02139 | |
City Area Code | 617 | |
Local Phone Number | 498-0020 | |
Title of 12(b) Security | Common Stock, $0.0001 par value | |
Trading Symbol | MRSN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 96,991,298 | |
Entity Central Index Key | 0001442836 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 230,057 | $ 177,947 |
Prepaid expenses and other current assets | 11,413 | 10,951 |
Total current assets | 241,470 | 188,898 |
Property and equipment, net | 2,549 | 1,968 |
Operating lease right-of-use assets | 12,001 | 12,889 |
Other assets, noncurrent | 2,247 | 2,356 |
Total assets | 258,267 | 206,111 |
Current liabilities: | ||
Accounts payable | 9,775 | 12,321 |
Accrued expenses | 27,475 | 28,716 |
Deferred revenue | 16,578 | 3,944 |
Operating lease liabilities | 2,404 | 2,303 |
Other current liabilities | 231 | 239 |
Total current liabilities | 56,463 | 47,523 |
Operating lease liabilities, noncurrent | 10,567 | 11,247 |
Long-term debt, net | 24,702 | 24,626 |
Deferred revenue, noncurrent | 25,620 | 0 |
Other liabilities, noncurrent | 389 | 974 |
Total liabilities | 117,741 | 84,370 |
Commitments | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; 25,000,000 shares authorized; 0 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | 0 | 0 |
Common stock, $0.0001 par value; 175,000,000 shares authorized; 87,073,084 and 73,709,056 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | 9 | 7 |
Additional paid-in capital | 638,254 | 572,213 |
Accumulated deficit | (497,737) | (450,479) |
Total stockholders’ equity | 140,526 | 121,741 |
Total liabilities and stockholders’ equity | $ 258,267 | $ 206,111 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
Stockholders' equity: | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 25,000,000 | 25,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 175,000,000 | 175,000,000 |
Common stock, shares issued (in shares) | 87,073,084 | 73,709,056 |
Common stock, shares outstanding (in shares) | 87,073,084 | 73,709,056 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Income Statement [Abstract] | ||
Collaboration revenue | $ 2,036 | $ 11 |
Operating expenses: | ||
Research and development | 35,806 | 27,415 |
General and administrative | 12,782 | 7,208 |
Total operating expenses | 48,588 | 34,623 |
Other income (expense): | ||
Interest income | 18 | 12 |
Interest expense | (724) | (93) |
Total other income (expense), net | (706) | (81) |
Net loss | (47,258) | (34,693) |
Net loss attributable to common stockholders - basic | (47,258) | (34,693) |
Net loss attributable to common stockholders - diluted | $ (47,258) | $ (34,693) |
Net loss per share attributable to common stockholders - basic (in dollars per share) | $ (0.59) | $ (0.50) |
Net loss per share attributable to common stockholders - diluted (in dollars per share) | $ (0.59) | $ (0.50) |
Weighted-average number of shares of common stock used in net loss per share attributable to common stockholders - basic (in shares) | 79,928,591 | 68,987,857 |
Weighted-average number of shares of common stock used in net loss per share attributable to common stockholders - diluted (in shares) | 79,928,591 | 68,987,857 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | At Market Equity Offering Programs | Common Stock | Common StockAt Market Equity Offering Programs | Common Stock2020 ATM | Additional Paid-in Capital | Additional Paid-in CapitalAt Market Equity Offering Programs | Accumulated Deficit |
Balance at beginning of period (in shares) at Dec. 31, 2020 | 68,841,288 | |||||||
Balance at beginning of period at Dec. 31, 2020 | $ 228,087 | $ 7 | $ 508,499 | $ (280,419) | ||||
Increase (Decrease) in Stockholders' Equity | ||||||||
Exercise of stock options (in shares) | 148,472 | |||||||
Exercise of stock options | 764 | 764 | ||||||
Vesting of restricted stock units, net of employee tax obligations (in shares) | 61,678 | |||||||
Vesting of restricted stock units, net of employee tax obligations | (259) | (259) | ||||||
Stock-based compensation expense | 4,039 | 4,039 | ||||||
Net (loss) income | (34,693) | (34,693) | ||||||
Balance at end of period (in shares) at Mar. 31, 2021 | 69,051,438 | |||||||
Balance at end of period at Mar. 31, 2021 | 197,938 | $ 7 | 513,043 | (315,112) | ||||
Balance at beginning of period (in shares) at Dec. 31, 2021 | 73,709,056 | |||||||
Balance at beginning of period at Dec. 31, 2021 | $ 121,741 | $ 7 | 572,213 | (450,479) | ||||
Increase (Decrease) in Stockholders' Equity | ||||||||
Issuance of common stock under public offering, net of issuance costs (in shares) | 13,169,903 | 11,740,210 | ||||||
Issuance of common stock under public offering, net of issuance costs | $ 60,462 | $ 2 | $ 60,460 | |||||
Exercise of stock options (in shares) | 26,951 | 26,951 | ||||||
Exercise of stock options | $ 96 | 96 | ||||||
Vesting of restricted stock units, net of employee tax obligations (in shares) | 167,174 | |||||||
Vesting of restricted stock units, net of employee tax obligations | 0 | 0 | ||||||
Stock-based compensation expense | 5,485 | 5,485 | ||||||
Net (loss) income | (47,258) | (47,258) | ||||||
Balance at end of period (in shares) at Mar. 31, 2022 | 87,073,084 | |||||||
Balance at end of period at Mar. 31, 2022 | $ 140,526 | $ 9 | $ 638,254 | $ (497,737) | ||||
Increase (Decrease) in Stockholders' Equity | ||||||||
Stock issuance costs | $ 1,322 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2022USD ($) | |
At Market Equity Offering Programs | |
Stock issuance costs | $ 1,322 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (47,258) | $ (34,693) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 205 | 226 |
Stock-based compensation | 5,485 | 4,039 |
Other non-cash items | 194 | 38 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (462) | (37) |
Other assets | 0 | (1,366) |
Accounts payable | (2,524) | 3,415 |
Accrued expenses | (2,159) | 1,251 |
Operating lease right-of-use assets | 889 | 415 |
Operating lease liabilities | (579) | (299) |
Deferred revenue | 38,254 | (11) |
Net cash used in operating activities | (7,955) | (27,022) |
Cash flows from investing activities | ||
Purchase of property and equipment | (329) | (114) |
Net cash used in investing activities | (329) | (114) |
Cash flows from financing activities | ||
Proceeds from exercise of stock options | 96 | 764 |
Payment of employee tax obligations related to vesting of restricted stock units | 0 | (259) |
Payments under capital lease obligations | (76) | (33) |
Net cash provided by financing activities | 60,394 | 472 |
Increase (decrease) in cash, cash equivalents and restricted cash | 52,110 | (26,664) |
Cash, cash equivalents and restricted cash, beginning of period | 178,425 | 255,415 |
Cash, cash equivalents and restricted cash, end of period | 230,535 | 228,751 |
Supplemental disclosures of non-cash activities: | ||
Purchases of property and equipment in accounts payable and accrued expenses | 457 | 189 |
Cash paid for interest | 531 | 60 |
Right-of-use assets obtained in exchange for financing lease liabilities | 0 | 213 |
At Market Equity Offering Program | ||
Cash flows from financing activities | ||
Net proceeds from the at-the-market facility | $ 60,374 | $ 0 |
Nature of business and basis of
Nature of business and basis of presentation | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of business and basis of presentation | Nature of business and basis of presentation Mersana Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing antibody drug conjugates ("ADCs") that offer a clinically meaningful benefit for cancer patients with significant unmet need. The Company has leveraged over 20 years of industry learning in the ADC field to develop proprietary and differentiated technology platforms that enable it to develop ADCs that are designed to have improved efficacy, safety and tolerability relative to existing ADC therapies. The Company’s innovative platforms include Dolaflexin and Dolasynthen, each of which deliver the DolaLock payload, as well as Immunosynthen, which delivers a novel stimulator of interferon genes ("STING") agonist ImmunoLock payload. Together, these platforms provide an efficient product engine that has enabled a robust discovery pipeline for the Company and its partners. The Company’s clinical candidates include upifitamab rilsodotin ("UpRi") and XMT-1592. The Company's early-stage programs include XMT-1660, a Dolasynthen ADC targeting B7-H4, as well as XMT-2056, a STING-agonist ADC developed using the Company's Immunosynthen platform and targeting a novel epitope of human epidermal growth factor receptor 2 ("HER2"). The Company also has two earlier stage preclinical candidates, XMT-2068 and XMT-2175, both of which leverage the Company's Immunosynthen platform and target tumor-associated antigens. The Company's lead product candidate, UpRi, is a first-in-class Dolaflexin ADC targeting NaPi2b, an antigen broadly expressed in ovarian cancer and other cancers with limited expression in healthy tissues. The Company is currently evaluating UpRi in platinum-resistant ovarian cancer in a single-arm registrational trial, referred to as UPLIFT. The Company is also conducting a Phase 1/2 umbrella combination trial, referred to as UPGRADE. Initially, the Company is exploring the combination of UpRi with carboplatin, a standard platinum chemotherapy broadly used in the treatment of platinum-sensitive ovarian cancer. The Company may explore other combinations in the future. The Company's second clinical candidate, XMT-1592, is a NaPi2b-targeted ADC leveraging the Dolasynthen platform. The Company is conducting a Phase 1 dose exploration trial in patients with ovarian cancer and non-small cell lung cancer ("NSCLC"). The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, the need for additional capital, risks of failure of preclinical studies and clinical trials, the need to obtain marketing approval and reimbursement for any drug product candidate that it may identify and develop, the need to successfully commercialize and gain market acceptance of its product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development of technological innovations by competitors, reliance on third party manufacturers and the ability to transition from pilot-scale production to large-scale manufacturing of products. The Company has incurred cumulative net losses since inception. For the three months ended March 31, 2022, the net loss was $47.3 million, compared to net loss of $34.7 million in the three months ended March 31, 2021. The Company expects to continue to incur operating losses for at least the next several years. As of March 31, 2022, the Company had an accumulated deficit of $497.7 million. The future success of the Company is dependent on, among other factors, its ability to identify and develop its product candidates and ultimately upon its ability to attain profitable operations. The Company has devoted substantially all of its financial resources and efforts to research and development and general and administrative expense to support such research and development. Net losses and negative operating cash flows have had, and will continue to have, an adverse effect on the Company’s stockholders' equity and working capital. The Company believes that its currently available funds will be sufficient to fund the Company’s operations through at least the next twelve months from the issuance of this Quarterly Report on Form 10-Q. Management’s belief with respect to its ability to fund operations is based on estimates that are subject to risks and uncertainties. If actual results are different from management’s estimates, the Company may need to seek additional funding. The Company’s unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP") and the rules and regulations of the Securities and Exchange Commission ("SEC"). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification ("ASC") and Accounting Standards Updates ("ASU") of the Financial Accounting Standards Board ("FASB"). Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2021 and the notes thereto, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on February 28, 2022. The unaudited condensed consolidated financial statements have been prepared on the same basis as the audited financial statements. In the opinion of the Company’s management, the accompanying unaudited condensed consolidated financial statements contain all adjustments that are necessary to present fairly the Company’s financial position as of March 31, 2022, the results of its operations for the three months ended March 31, 2022 and 2021, the statements of stockholders’ equity for the three months ended March 31, 2022 and 2021 and statements of cash flows for the three months ended March 31, 2022 and 2021. Such adjustments are of a normal and recurring nature. The results for the three months ended March 31, 2022 are not necessarily indicative of the results for the year ending December 31, 2022, or for any future period. |
Summary of significant accounti
Summary of significant accounting policies | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of significant accounting policies | Summary of significant accounting policies Principles of Consolidation The accompanying unaudited condensed consolidated financial statements include those of the Company and its wholly owned subsidiary, Mersana Securities Corp. All intercompany balances and transactions have been eliminated. Use of Estimates The preparation of the Company’s unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenue, expenses and related disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. On an ongoing basis, the Company’s management evaluates its estimates which include, but are not limited to, management’s judgments with respect to the identification of performance obligations and standalone selling prices of those performance obligations within its revenue arrangements, accrued preclinical, manufacturing and clinical expenses, valuation of stock-based awards and income taxes. Actual results could differ from those estimates. 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 assess performance. The Company views its operations and manages its business as a single operating segment, which is the business of discovering and developing ADCs. Summary of Accounting Policies The significant accounting policies used in preparation of these condensed consolidated financial statements for the three months ended March 31, 2022 are consistent with those discussed in Note 2, Summary of Significant Accounting Policies , in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. Fair Value Measurements Fair value is defined as the price that would be received upon sale of an asset or paid to transfer a liability between market participants at measurement dates. ASC 820, Fair Value Measurement, establishes a three-level valuation hierarchy for instruments measured at fair value. The hierarchy is based on the transparency of inputs to the valuation of an asset or liability as of the measurement date. The three levels are defined as follows: Level 1—Inputs to the valuation methodology are quoted prices (unadjusted) for identical assets or liabilities in active markets. Level 2—Inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the financial instrument. Level 3—Inputs to the valuation methodology are unobservable and significant to the fair value measurement. Cash and Cash Equivalents The Company considers all highly-liquid investments with an original maturity, or a remaining maturity at the time of purchase, of three months or less to be cash equivalents. The Company invests excess cash primarily in money market funds, commercial paper and government agency securities, which are highly liquid and have strong credit ratings. These investments are subject to minimal credit and market risks. Cash and cash equivalents are stated at cost, which approximates market value. Three Months Ended Three Months Ended (in thousands) Beginning End Beginning End Cash and cash equivalents $ 177,947 $ 230,057 $ 255,094 $ 228,430 Restricted cash included in other assets, noncurrent 478 478 321 321 Total cash, cash equivalents and restricted cash per statement of cash flows $ 178,425 $ 230,535 $ 255,415 $ 228,751 Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on our condensed consolidated financial statements or disclosures. |
Collaboration agreements
Collaboration agreements | 3 Months Ended |
Mar. 31, 2022 | |
Collaboration agreements | |
Collaboration agreements | Collaboration agreements Janssen Biotech Inc. In February 2022, the Company entered into a research collaboration and license agreement with Janssen Biotech Inc. ("Janssen" and such agreement, the "Janssen Agreement") focused on the research, development and commercialization of novel ADCs for three oncology targets by leveraging Mersana’s ADC expertise and Dolasynthen platform with Janssen’s proprietary antibodies. Upon execution of the Janssen Agreement, the Company received a non-refundable upfront payment of $40.0 million from Janssen. Pursuant to the Janssen Agreement, the Company granted Janssen two exclusive, non-transferrable, worldwide licenses - the Research License and the Commercialization License (together, the "Licenses"). The Research License provides Janssen, on a target-by-target basis, rights under the Company’s technology and the Company’s interest in the technology developed jointly through the collaboration solely to conduct Janssen’s activities under the research and Chemistry, Manufacturing and Controls ("CMC") plans with respect to each target. The Commercialization License is a royalty-bearing license granted on a target-by-target basis under the Company’s technology and the Company’s interest in the technology developed jointly through the collaboration to develop, manufacture, commercialize and otherwise exploit licensed ADCs and any licensed products containing licensed ADCs directed toward a target. Janssen may select up to three targets and may substitute each target once prior to a substitution deadline. Janssen is not required to pay a fee for its first substitution right, but must pay a one-time fee for access to the subsequent substitution rights following its exercise of its second substitution right. Pursuant to mutually agreed research and CMC plans, the Company will perform bioconjugation, production development, preclinical manufacturing, and certain related research and preclinical development activities, in order to progress the targets through IND submission for further development, manufacture and commercialization by Janssen. Janssen will have sole responsibility for IND-enabling studies, IND submission, clinical development, regulatory activities and commercialization of the licensed ADCs. Both the Company and Janssen will have equal representation on a Joint Research Committee and Joint Manufacturing Committee to oversee the research and CMC activities. The Company estimates that its activities under the research plans for the targets will be performed through 2024. The Company's CMC activities will be compensated by Janssen at agreed upon rates. Assuming successful development and commercialization of all the three targets by Janssen, the Company could receive up to an additional $505 million in development and regulatory milestones and $530 million in sales milestones as well as tiered mid single-digit to low double-digit royalties on aggregate net sales of the ADC products. To date, the Company has not achieved any of the specified milestones. Unless earlier terminated, the Janssen Agreement will expire upon the expiration of the last royalty term for a product under the Janssen Agreement. The Janssen Agreement contains customary provisions for termination by either party, including in the event of breach of the Janssen Agreement, subject to cure, by Janssen for convenience and by Mersana upon a challenge of the licensed patents, and customary provisions regarding the effects of termination. Janssen may request that the Company perform clinical manufacturing services under a separate clinical supply agreement. Janssen may also request that the Company perform a technology transfer of bioconjugation and manufacturing process technology, at Janssen's cost, at an agreed upon rate. Accounting Analysis The Company assessed the Janssen Agreement in accordance with ASC 606, Revenue from Contracts with Customers , and concluded that that the contract counter party, Janssen, is a customer. The Company identified the following seven material performance obligations under the Janssen Agreement: (i) exclusive Licenses and research activities for each of the three designated targets, (ii) CMC activities for each of the three designated targets and (iii) the first target substitution right. The Company concluded that the Licenses and research activities are one combined performance obligation for each target as the Licenses are not capable of being distinct from the research activities given their proprietary nature. The CMC activities are considered a distinct performance obligation for each target as the activities could be performed by a third-party provider. The first target substitution right is considered a material right as there is no option exercise fee and, as such, is a distinct performance obligation. In accordance with ASC 606, the Company determined that the initial transaction price under the Janssen Agreement equals $40.0 million, consisting of the upfront, non-refundable and non-creditable payment. None of the development and the regulatory milestones have been included in the transaction price, as all milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including stage of development and the remaining risks associated with the development required to achieve the milestones, as well as whether the achievement of the milestones is outside the control of the Company or Janssen. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as such milestones were determined to relate predominantly to the license granted to Janssen and therefore have also been excluded from the transaction price. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of each milestone and any related constraint, and if necessary, adjust its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect the reported amount of revenues in the period of adjustment. The Company determined that the consideration for CMC activities represents variable consideration. The Company has not included potential cost reimbursements within the transaction price as no CMC activities for any of the three targets have been initiated. The Company elected to apply the Right to Invoice practical expedient under ASC 606. As such, the Company will recognize revenue related to the CMC activities when the services are performed. Consistent with the allocation objective under ASC 606, the Company allocated the $40.0 million fixed upfront payment in the transaction price to the Licenses and research activities and first substitution right based on each performance obligation’s relative standalone selling price. Each of the standalone selling prices for the Licenses and research activities and for the first substitution right were estimated utilizing an income approach, along with the likelihood of exercise for the substitution right and included the following key assumptions: the development timeline, revenue forecast, discount rate and probabilities of technical and regulatory success. The Company is recognizing revenue related to the Licenses and research services performance obligation over the estimated period of the research services using a proportional performance model. The Company measures proportional performance based on the costs incurred relative to the total costs expected to be incurred. The Company will recognize revenue related to the first target substitution right over time in congruence with the Licenses and research activities, upon the exercise of the option. If the first target substitution option is not exercised, the Company will recognize the entirety of the revenue in the period when the option expires. During the three months ended March 31, 2022, the Company recorded collaboration revenue of $1.7 million related to its efforts under the Janssen Agreement. As of March 31, 2022, the Company had recorded $38.3 million in deferred revenue related to the Janssen Agreement that will be recognized over the remaining performance period and classified as current or noncurrent on the accompanying consolidated balance sheets based upon the expected timing of satisfaction of respective performance obligations. The aggregate amount of the transaction price allocated to unsatisfied performance obligations was $38.3 million as of March 31, 2022, which is expected to be recognized over the period the associated research activities are performed for each target. Summary of Contract Assets and Liabilities The Company did not record any contract assets as of March 31, 2022 related to the Janssen Agreement. The following table presents changes in the balances of the Company's contract liabilities related to the Janssen Agreement during the three months ended March 31, 2022: (in thousands) Balance at Additions Deductions Balance at Three months ended March 31, 2022 Contract liabilities: Deferred revenue $ — $ 40,000 $ 1,735 $ 38,265 During the three months ended March 31, 2022, the Company recognized the following revenues related to the Janssen Agreement as a result of changes in the contract liability balances in the respective periods: Three Months Ended (in thousands) 2022 Revenue recognized in the period from: Amounts included in the contract liability at the beginning of the period $ — Performance obligations satisfied in previous periods $ — Merck KGaA In June 2014, the Company entered into a collaboration and commercial license agreement with Merck KGaA (the "Merck KGaA Agreement"). Upon the execution of the Merck KGaA Agreement, Merck KGaA paid the Company a non-refundable technology access fee of $12.0 million for the right to develop ADCs directed to six exclusive targets over a specified period of time. No additional fees are due when a target is designated and the commercial license to the target is granted. Merck KGaA will be responsible for the product development and marketing of any products resulting from this collaboration. Under the terms of the Merck KGaA Agreement, the Company and Merck KGaA develop research plans to evaluate Merck KGaA's antibodies as ADCs incorporating the Company's technology. The Company receives reimbursement for its efforts under the research plans. The goal of the research plans is to provide Merck KGaA with sufficient information to formally nominate a development candidate and begin IND-enabling studies. All six targets were designated prior to 2018. The next potential milestone payment that the Company is eligible to receive is a development milestone of $0.5 million on Merck KGaA’s designation of a preclinical development candidate for a target. Revenue will be recognized when achievement of the milestone is considered probable. In May 2018, the Company entered into a supply agreement with Merck KGaA (the "Merck KGaA Supply Agreement"). Under the terms of the Merck KGaA Supply Agreement, the Company will provide Merck KGaA preclinical non-GMP ADC drug substance and clinical GMP drug substance for use in clinical trials associated with one of the antibodies designated under the Merck KGaA Agreement. The Company receives fees for its efforts under the Merck KGaA Supply Agreement and reimbursement equal to the supply cost. The Company may also enter into future supply agreements to provide clinical supply material should Merck KGaA pursue clinical development of any other candidates nominated under the Merck KGaA Agreement. Accounting Analysis The Company concluded that Merck KGaA is a customer and accounted for the Merck KGaA Agreement in accordance with ASC 606. The Company identified the following performance obligations under the Merck KGaA Agreement: (i) exclusive license and research services for six designated targets, (ii) rights to future technological improvements and (iii) participation of project team leaders and providing joint research committee services. The Company is recognizing revenue related to the exclusive license and research and development services performance obligations over the estimated period of the research and development services using a proportional performance model. The Company measures proportional performance based on the costs incurred relative to the total costs expected to be incurred. To the extent that the Company receives fees for the research services as they are performed, these amounts are recorded as deferred revenue. Revenue related to future technological improvements and joint research committee services will be recognized ratably over the respective performance period (which in the case of the joint research committee services approximate the time and cost incurred each period), which are 10 and 5 years, respectively. The Company is continuing to reassess the estimated remaining term at each subsequent reporting period. As of March 31, 2022, the Company had completed its research service obligations associated with four of the six designated targets. The Company did not recognize any corresponding research and development expense related to the Merck KGaA Supply Agreement during the three months ended March 31, 2022 and 2021. As of March 31, 2022 and December 31, 2021, the Company had $3.9 million in deferred revenue related to the Merck KGaA Agreement and Merck KGaA Supply Agreement. Such amounts will be recognized over the remaining performance period. Summary of Contract Assets and Liabilities The Company did not record any contract assets as of March 31, 2022 and December 31, 2021. The following table presents changes in the balances of the Company's contract liabilities related to the Merck KGaA Agreement and Merck KGaA Supply Agreement during the three months ended March 31, 2022 and 2021: (in thousands) Balance at Additions Deductions Balance at Three months ended March 31, 2022 Contract liabilities: Deferred revenue $ 3,944 $ — $ 11 $ 3,933 (in thousands) Balance at Additions Deductions Balance at Three months ended March 31, 2021 Contract liabilities: Deferred revenue $ 3,987 $ — $ 11 $ 3,976 During the three months ended March 31, 2022 and 2021, the Company recognized the following revenues related to the Merck KGaA Agreement and Merck KGaA Supply Agreement as a result of changes in the contract liability balances in the respective periods: Three Months Ended (in thousands) 2022 2021 Revenue recognized in the period from: Amounts included in the contract liability at the beginning of the period $ 11 $ 11 Performance obligations satisfied in previous periods $ — $ — Other Revenue The Company has provided limited services for a collaboration partner, Asana BioSciences, LLC ("Asana Biosciences"). For the three months ended March 31, 2022, the Company recognized revenue of $0.3 million related to these services and for the three months ended March 31, 2021, the Company did not recognize revenue related to these services. The next potential milestone the Company is eligible to receive is $2.5 million upon dosing the fifth patient in a Phase 1 clinical study by Asana BioSciences. While the first patient was dosed in April 2022, as of March 31, 2022, the Company considers this next milestone to be fully constrained as there is considerable judgment involved in determining whether it is probable that a significant revenue reversal would occur. As part of its evaluation of the constraint, the Company considered numerous factors, including the fact that achievement of the milestone is outside the control of the Company and there is a high level of uncertainty in achieving this milestone, as the collaboration partner continues to evaluate its candidate in the phase 1 trial. The Company reevaluates the probability of achievement of a milestone subject to constraint at each reporting period and as uncertain events are resolved or other changes in circumstances occur. |
Fair value measurements
Fair value measurements | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | Fair value measurements The carrying amounts reflected in the consolidated balance sheets for prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair values due to their short-term nature. As of March 31, 2022 and December 31, 2021, the carrying value of the Company’s outstanding borrowing under the New Credit Facility (as defined in Note 6) approximated fair value (a Level 2 fair value measurement), reflecting interest rates currently available to the Company. The New Credit Facility is discussed in more detail in Note 6, Debt . |
Accrued expenses
Accrued expenses | 3 Months Ended |
Mar. 31, 2022 | |
Accrued Liabilities, Current [Abstract] | |
Accrued expenses | Accrued expenses Accrued expenses consisted of the following as of March 31, 2022 and December 31, 2021: (in thousands) March 31, December 31, Accrued manufacturing expenses $ 9,381 $ 8,476 Accrued clinical expenses 7,569 7,879 Accrued preclinical expenses 4,824 3,848 Accrued payroll and related expenses 3,456 7,319 Accrued professional fees 1,751 909 Accrued other 494 285 $ 27,475 $ 28,716 |
Debt
Debt | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Debt | Debt On May 8, 2019, the Company entered into a loan and security agreement (the "Prior Credit Facility") with Silicon Valley Bank ("SVB"), which was subsequently amended on June 29, 2019, August 28, 2020, and August 27, 2021. Refer to Note 7, Debt, in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 for more information regarding the Prior Credit Facility. On October 29, 2021, the Company entered into a loan and security agreement (the "New Credit Facility") with SVB and Oxford Finance, LLC ("Oxford" and, together with SVB, the "Lenders"). Pursuant to the New Credit Facility, as amended on February 17, 2022, the Company can borrow term loans in an aggregate amount of $100.0 million, which includes (i) $60.0 million in up to three principal advances through December 31, 2022, (ii) an additional $20.0 million in one principal advance, if the Company reaches certain development milestone events through June 30, 2023, (iii) and an additional tranche of $20.0 million, subject to conditional approval from the Lenders. The New Credit Facility is secured by substantially all of the Company's personal property owned or later acquired, excluding intellectual property (but including the rights to payments and proceeds from intellectual property), and a negative pledge on intellectual property. The Company drew $25.0 million upon execution of the New Credit Facility, of which $5.5 million of the proceeds was used to repay the existing balance under the Prior Credit Facility and satisfy its obligations to SVB. Upon entering into the New Credit Facility, the Company terminated all commitments by SVB to extend further credit under the Prior Credit Facility and all guarantees and security interests granted by the Company to SVB under the Prior Credit Facility. Refer to Note 7, Debt , in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 for more information regarding the New Credit Facility. As of March 31, 2022, the Company was in compliance with all covenants under the New Credit Facility. There are no events of default as of March 31, 2022. Unamortized debt financing costs are recorded as a reduction of the carrying amount on the term loan and amortized as interest expense using the effective-interest method. Unamortized deferred financing costs of $0.4 million were recorded in other assets as of March 31, 2022 related to the Company's right to borrow additional amounts from the Lenders in the future and amortized to interest expense over the relevant draw period on a straight-line basis. The following is a summary of obligations under the term loan as of March 31, 2022: (in thousands) March 31, Total debt $ 25,000 Less: Current portion of long-term debt — Total debt, net of current portion 25,000 Debt financing costs, net of accretion (388) Accretion related to final payment 90 Long-term debt, net $ 24,702 During the three months ended March 31, 2022 and 2021, the Company recognized $0.7 million and $0.1 million, respectively, of interest expense related to the New Credit Facility and Prior Credit Facility, respectively. |
Stockholders' equity
Stockholders' equity | 3 Months Ended |
Mar. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Stockholders’ equity | Stockholders’ equity Preferred stock As of March 31, 2022, the Company had 25,000,000 shares of authorized preferred stock. No shares of preferred stock have been issued. At-the-market ("ATM") equity offering program In May 2020, the Company established a new ATM equity offering program (the "2020 ATM"), pursuant to which it was able to offer and sell up to $100.0 million of its common stock from time to time at prevailing market prices. During the three months ended March 31, 2022, the Company sold 11,740,210 shares of common stock and received net proceeds of $54.8 million under the 2020 ATM. As of March 31, 2022, the 2020 ATM had been fully utilized. In February 2022, the Company established a new ATM equity offering program (the "2022 ATM"), pursuant to which it is able to offer and sell up to $100.0 million of its common stock from time to time at prevailing market prices. During the three months ended March 31, 2022, the Company sold approximately 1,429,693 shares of common stock and received net proceeds of $5.8 million under the 2022 ATM. Subsequent to March 31, 2022 and through May 5, 2022, the Company sold 9,904,964 shares of common stock resulting in net proceeds of $40.0 million under the 2022 ATM. As of May 5, 2022, approximately $53.3 million remains unsold and available for sale under the 2022 ATM. Warrants In connection with a 2013 Series A-1 Preferred Stock issuance, the Company granted to certain investors warrants to purchase 129,491 shares of common stock. The warrants have a $0.05 per share exercise price and a contractual life of 10 years. The fair value of these warrants was recorded as a component of equity at the time of issuance. As of March 31, 2022, there were warrants to purchase 39,474 shares of common stock outstanding. During the three months ended March 31, 2022, there were no exercises of warrants in exchange for shares of common stock. Common stock The holders of the common stock are entitled to one vote for each share held. Common stockholders are not entitled to receive dividends, unless declared by the Board of Directors (the "Board"). As of March 31, 2022 and December 31, 2021, there were 11,524,655 and 9,199,512, respectively, shares of common stock reserved for the exercise of outstanding stock options, restricted stock units ("RSUs") and warrants. March 31, December 31, Stock options 10,028,741 8,342,429 Restricted stock units 1,456,440 817,609 Warrants 39,474 39,474 11,524,655 9,199,512 |
Stock-based compensation
Stock-based compensation | 3 Months Ended |
Mar. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Stock-based compensation | Stock-based compensation Stock incentive plans As of June 30, 2017, there were 3,141,625 stock options outstanding under the Company’s 2007 Stock Incentive Plan (the "2007 Plan"). The 2007 Plan expired in June 2017. Any cancellations or forfeitures of options granted under the 2007 Plan will increase the options available under the 2017 Stock Incentive Plan (the "2017 Plan"), as described below. In June 2017, the Company’s stockholders approved the 2017 Plan. Under the 2017 Plan initially, up to 2,255,000 shares of common stock may be granted to the Company's employees, officers, directors, consultants and advisors in the form of options, RSUs or other stock-based awards. The number of shares of common stock issuable under the 2017 Plan will be cumulatively increased annually on January 1 by the lesser of (a) 4% of the outstanding shares on the immediately preceding December 31 or (b) such other amount specified by the Board. The terms of the awards are determined by the Board, subject to the provisions of the 2017 Plan. Any cancellations or forfeitures of options granted under the 2007 Plan, which expired in June 2017, would increase the number of shares that could be granted under the 2017 Plan. On January 1, 2022, the number of shares of common stock issuable under the 2017 Plan was increased by 2,948,362 shares. As of March 31, 2022, there were 1,737,277 shares available for future issuance under the 2017 Plan. During the three months ended March 31, 2022, the Company granted 2,788,158 RSUs and options to purchase shares of common stock to employees under the 2017 Plan. Under the 2017 Plan, both with respect to incentive stock options and nonqualified stock options, the exercise price per share will not be less than the fair market value of the common stock on the date of grant and the vesting period is generally four years. Options granted under the 2017 Plan expire no later than 10 years from the date of grant. Options under the 2007 Plan were granted at an exercise price established by the Board (or a committee thereof) that was not less than the fair market value of the underlying common stock on the date of grant and subject to such vesting provisions determined by the Board (or a committee thereof). The Board may accelerate vesting or otherwise adjust the terms of granted options in the case of a merger, consolidation, dissolution, or liquidation of the Company. Inducement awards From time to time, the Company grants to its employees, upon approval by the Board or an authorized committee thereof, options to purchase shares of common stock as an inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4). Historically, these options were granted outside of an existing equity incentive plan and were issued pursuant to Section 4(a)(2) under the Securities Act of 1933, as amended, relating to transactions by an issuer not involving any public offering. These options are subject to terms substantially the same as the 2017 Plan. In February 2022, the Board adopted the Company's 2022 Inducement Stock Incentive Plan (the "Inducement Plan"), which provides for the grant of nonstatutory options, stock appreciation rights, restricted stock, RSUs and other stock-based awards, with respect to an aggregate of 2,000,000 shares of the Company's common stock (subject to adjustment as provided in the Inducement Plan). As of March 31, 2022 there were 757,500 options to purchase shares of common stock granted as inducement awards outstanding, none of which had been issued under the Inducement Plan. Stock option activity A summary of stock option activity is as follows: Number Weighted- Outstanding at January 1, 2022 8,342,429 $ 11.25 Granted 1,917,634 6.05 Exercised (26,951) 3.58 Cancelled (204,371) 12.74 Outstanding at March 31, 2022 10,028,741 $ 10.25 Vested and expected to vest at March 31, 2022 10,028,741 $ 10.25 Exercisable at March 31, 2022 4,307,274 $ 8.14 The weighted-average grant date fair value of options granted during the three months ended March 31, 2022 and 2021, was $4.39 and $14.51 per share, respectively. The total intrinsic value of options exercised during the three months ended March 31, 2022 and 2021, was $0.1 million and $2.4 million, respectively. The aggregate intrinsic value represents the difference between the exercise price and the selling price received by option holders upon the exercise of stock options during the period. Cash received from the exercise of stock options was $0.1 million and $0.8 million for the three months ended March 31, 2022 and 2021, respectively. Restricted stock units The Company periodically issues RSUs with a service condition to certain officers and other employees that typically vest between one year and four years from the grant date. As of March 31, 2022, the Company has only granted RSUs under the 2017 Plan. A summary of the RSU activity is as follows: Number of Shares Unvested at January 1, 2022 817,609 Granted 870,524 Vested (167,174) Forfeited (64,519) Unvested at March 31, 2022 1,456,440 Stock-based compensation expense The Company uses the provisions of ASC 718, Stock Compensation , to account for all stock-based awards to employees and non-employees. The measurement date for employee awards is generally the date of grant. Stock-based compensation expense is recognized over the requisite service period, which is generally the vesting period, using the straight-line method. The following table presents stock-based compensation expense by award type included within the Company’s condensed consolidated statement of operations and comprehensive loss: Three Months Ended (in thousands) 2022 2021 Stock options $ 4,118 $ 3,114 Restricted stock units 1,209 806 Employee stock purchase plan 158 119 Stock-based compensation expense included in total operating expenses $ 5,485 $ 4,039 The following table presents stock-based compensation expense as reflected in the Company’s condensed consolidated statements of operations and comprehensive loss: Three Months Ended (in thousands) 2022 2021 Research and development $ 2,933 $ 2,301 General and administrative 2,552 1,738 Stock-based compensation expense included in total operating expenses $ 5,485 $ 4,039 As of March 31, 2022, there was $41.8 million and $13.5 million of unrecognized stock-based compensation expense related to unvested stock options and unvested RSUs, respectively, that is expected to be recognized over a weighted-average period of 2.5 years and 3.0 years, respectively. The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model with the following weighted average assumptions: Three Months Ended 2022 2021 Risk-free interest rate 1.6 % 0.6 % Expected dividend yield — % — % Expected term (years) 6.04 6.06 Expected stock price volatility 87 % 83 % Expected volatility for the Company’s common stock is determined based on the historical volatility of comparable publicly traded companies. The risk-free interest rate is based on the yield of U.S. Treasury securities consistent with the expected term of the option. No dividend yield was assumed as the Company has not historically and does not expect to pay dividends on its common stock. The expected term of the options granted is based on the use of the simplified method, in which the expected term is presumed to be the mid-point between the vesting date and the end of the contractual term. The fair value of RSUs is determined based on the closing price of the Company’s common stock on the date of grant. Employee stock purchase plan During the year ended December 31, 2017, the Board adopted, and the Company’s stockholders approved the 2017 employee stock purchase plan (the "2017 ESPP"). The Company did not issue any shares under the 2017 ESPP for the three months ended March 31, 2022 and 2021. As of March 31, 2022, there were 566,565 shares available for issuance under the 2017 ESPP. |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | Net loss per share Basic net loss per share of common stock is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, without further consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock and potentially dilutive securities outstanding for the period determined using the treasury stock method. For purposes of the diluted net loss per share calculation, stock options, unvested RSUs and warrants to purchase common stock are considered to be potentially dilutive securities, but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to include them would be anti-dilutive (in common stock equivalent shares): Three Months Ended Three Months Ended Stock options 10,028,741 7,478,289 Unvested restricted stock units 1,456,440 1,082,460 Warrants 39,474 39,474 11,524,655 8,600,223 |
Commitments
Commitments | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | CommitmentsLicense agreementsDuring the three months ended March 31, 2022, the Company recorded research and development expense related to non-refundable license payments of $1.5 million. The Company did not record research and development expense related to development milestones during the three months ended March 31, 2022. The Company did not record any research and development expense related to non-refundable upfront license payments or milestone payments during the three months ended March 31, 2021 |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying unaudited condensed consolidated financial statements include those of the Company and its wholly owned subsidiary, Mersana Securities Corp. All intercompany balances and transactions have been eliminated. |
Use of Estimates | Use of Estimates The preparation of the Company’s unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenue, expenses and related disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. On an ongoing basis, the Company’s management evaluates its estimates which include, but are not limited to, management’s judgments with respect to the identification of performance obligations and standalone selling prices of those performance obligations within its revenue arrangements, accrued preclinical, manufacturing and clinical expenses, valuation of stock-based awards and income taxes. Actual results could differ from those estimates. |
Segment Information | 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 assess performance. The Company views its operations and manages its business as a single operating segment, which is the business of discovering and developing ADCs. |
Fair Value Measurements | Fair Value Measurements Fair value is defined as the price that would be received upon sale of an asset or paid to transfer a liability between market participants at measurement dates. ASC 820, Fair Value Measurement, establishes a three-level valuation hierarchy for instruments measured at fair value. The hierarchy is based on the transparency of inputs to the valuation of an asset or liability as of the measurement date. The three levels are defined as follows: Level 1—Inputs to the valuation methodology are quoted prices (unadjusted) for identical assets or liabilities in active markets. Level 2—Inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the financial instrument. Level 3—Inputs to the valuation methodology are unobservable and significant to the fair value measurement. |
Cash and Cash Equivalents | Cash and Cash EquivalentsThe Company considers all highly-liquid investments with an original maturity, or a remaining maturity at the time of purchase, of three months or less to be cash equivalents. The Company invests excess cash primarily in money market funds, commercial paper and government agency securities, which are highly liquid and have strong credit ratings. These investments are subject to minimal credit and market risks. Cash and cash equivalents are stated at cost, which approximates market value. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on our condensed consolidated financial statements or disclosures. |
Net Loss per Share | Net loss per shareBasic net loss per share of common stock is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, without further consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock and potentially dilutive securities outstanding for the period determined using the treasury stock method.For purposes of the diluted net loss per share calculation, stock options, unvested RSUs and warrants to purchase common stock are considered to be potentially dilutive securities, but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. |
Summary of significant accoun_3
Summary of significant accounting policies (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Cash and Cash Equivalents | Three Months Ended Three Months Ended (in thousands) Beginning End Beginning End Cash and cash equivalents $ 177,947 $ 230,057 $ 255,094 $ 228,430 Restricted cash included in other assets, noncurrent 478 478 321 321 Total cash, cash equivalents and restricted cash per statement of cash flows $ 178,425 $ 230,535 $ 255,415 $ 228,751 |
Schedule of Restricted Cash | Three Months Ended Three Months Ended (in thousands) Beginning End Beginning End Cash and cash equivalents $ 177,947 $ 230,057 $ 255,094 $ 228,430 Restricted cash included in other assets, noncurrent 478 478 321 321 Total cash, cash equivalents and restricted cash per statement of cash flows $ 178,425 $ 230,535 $ 255,415 $ 228,751 |
Collaboration Agreements (Table
Collaboration Agreements (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Collaboration agreements | |
Schedule of Changes in the Balance of Our Contract Assets and Liabilities and Recognized Revenue | The following table presents changes in the balances of the Company's contract liabilities related to the Janssen Agreement during the three months ended March 31, 2022: (in thousands) Balance at Additions Deductions Balance at Three months ended March 31, 2022 Contract liabilities: Deferred revenue $ — $ 40,000 $ 1,735 $ 38,265 During the three months ended March 31, 2022, the Company recognized the following revenues related to the Janssen Agreement as a result of changes in the contract liability balances in the respective periods: Three Months Ended (in thousands) 2022 Revenue recognized in the period from: Amounts included in the contract liability at the beginning of the period $ — Performance obligations satisfied in previous periods $ — (in thousands) Balance at Additions Deductions Balance at Three months ended March 31, 2022 Contract liabilities: Deferred revenue $ 3,944 $ — $ 11 $ 3,933 (in thousands) Balance at Additions Deductions Balance at Three months ended March 31, 2021 Contract liabilities: Deferred revenue $ 3,987 $ — $ 11 $ 3,976 During the three months ended March 31, 2022 and 2021, the Company recognized the following revenues related to the Merck KGaA Agreement and Merck KGaA Supply Agreement as a result of changes in the contract liability balances in the respective periods: Three Months Ended (in thousands) 2022 2021 Revenue recognized in the period from: Amounts included in the contract liability at the beginning of the period $ 11 $ 11 Performance obligations satisfied in previous periods $ — $ — |
Accrued expenses (Tables)
Accrued expenses (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Accrued Liabilities, Current [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following as of March 31, 2022 and December 31, 2021: (in thousands) March 31, December 31, Accrued manufacturing expenses $ 9,381 $ 8,476 Accrued clinical expenses 7,569 7,879 Accrued preclinical expenses 4,824 3,848 Accrued payroll and related expenses 3,456 7,319 Accrued professional fees 1,751 909 Accrued other 494 285 $ 27,475 $ 28,716 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | The following is a summary of obligations under the term loan as of March 31, 2022: (in thousands) March 31, Total debt $ 25,000 Less: Current portion of long-term debt — Total debt, net of current portion 25,000 Debt financing costs, net of accretion (388) Accretion related to final payment 90 Long-term debt, net $ 24,702 |
Stockholders' equity (Tables)
Stockholders' equity (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Schedule for Number of Common Stock Reserved for Exercise of Outstanding Stock Options and Warrants | As of March 31, 2022 and December 31, 2021, there were 11,524,655 and 9,199,512, respectively, shares of common stock reserved for the exercise of outstanding stock options, restricted stock units ("RSUs") and warrants. March 31, December 31, Stock options 10,028,741 8,342,429 Restricted stock units 1,456,440 817,609 Warrants 39,474 39,474 11,524,655 9,199,512 |
Stock-based compensation (Table
Stock-based compensation (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Stock Option Activity Under Plan | A summary of stock option activity is as follows: Number Weighted- Outstanding at January 1, 2022 8,342,429 $ 11.25 Granted 1,917,634 6.05 Exercised (26,951) 3.58 Cancelled (204,371) 12.74 Outstanding at March 31, 2022 10,028,741 $ 10.25 Vested and expected to vest at March 31, 2022 10,028,741 $ 10.25 Exercisable at March 31, 2022 4,307,274 $ 8.14 |
Schedule of Restricted Stock Activity | A summary of the RSU activity is as follows: Number of Shares Unvested at January 1, 2022 817,609 Granted 870,524 Vested (167,174) Forfeited (64,519) Unvested at March 31, 2022 1,456,440 |
Schedule of Stock-Based Compensation Expense by Award Type | The following table presents stock-based compensation expense by award type included within the Company’s condensed consolidated statement of operations and comprehensive loss: Three Months Ended (in thousands) 2022 2021 Stock options $ 4,118 $ 3,114 Restricted stock units 1,209 806 Employee stock purchase plan 158 119 Stock-based compensation expense included in total operating expenses $ 5,485 $ 4,039 |
Schedule of Stock-Based Compensation Expense as Reflected in the Company's Condensed Consolidated Statements of Operations and Comprehensive Loss | The following table presents stock-based compensation expense as reflected in the Company’s condensed consolidated statements of operations and comprehensive loss: Three Months Ended (in thousands) 2022 2021 Research and development $ 2,933 $ 2,301 General and administrative 2,552 1,738 Stock-based compensation expense included in total operating expenses $ 5,485 $ 4,039 |
Schedule of Weighted Average Assumptions for Estimating Fair Value of Option Awards | The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model with the following weighted average assumptions: Three Months Ended 2022 2021 Risk-free interest rate 1.6 % 0.6 % Expected dividend yield — % — % Expected term (years) 6.04 6.06 Expected stock price volatility 87 % 83 % |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Outstanding Potentially Dilutive Securities | The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to include them would be anti-dilutive (in common stock equivalent shares): Three Months Ended Three Months Ended Stock options 10,028,741 7,478,289 Unvested restricted stock units 1,456,440 1,082,460 Warrants 39,474 39,474 11,524,655 8,600,223 |
Nature of business and basis _2
Nature of business and basis of presentation - (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Net loss | $ 47,258 | $ 34,693 | |
Accumulated deficit | $ (497,737) | $ (450,479) |
Summary of significant accoun_4
Summary of significant accounting policies - Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2021 | Dec. 31, 2020 |
Cash, cash equivalents and restricted cash | ||||
Cash and cash equivalents | $ 230,057 | $ 177,947 | $ 228,430 | $ 255,094 |
Restricted cash included in other assets, noncurrent | 478 | 478 | 321 | 321 |
Total cash, cash equivalents and restricted cash per statement of cash flows | $ 230,535 | $ 178,425 | $ 228,751 | $ 255,415 |
Collaboration agreements - Jans
Collaboration agreements - Janssen Biotech (Details) | 1 Months Ended | 3 Months Ended | |
Feb. 28, 2022USD ($)target | Mar. 31, 2022USD ($) | Mar. 31, 2021USD ($) | |
Collaboration agreements | |||
Collaboration revenue | $ 2,036,000 | $ 11,000 | |
Janssen Agreement | |||
Collaboration agreements | |||
Proceeds from Collaborators | $ 40,000,000 | ||
Deferred revenue | 38,300,000 | ||
Remaining performance obligation | 38,300,000 | ||
Contract assets | 0 | ||
Number of targets designated | target | 3 | ||
Janssen Agreement | Limited services | |||
Collaboration agreements | |||
Collaboration revenue | $ 1,700,000 | ||
Development and Regulatory | Janssen Agreement | |||
Collaboration agreements | |||
Collaboration Arrangements, Maximum Aggregate Milestones | $ 505,000,000 | ||
Commercial | Janssen Agreement | |||
Collaboration agreements | |||
Collaboration Arrangements, Maximum Aggregate Milestones | $ 530,000,000 |
Collaboration agreements - Merc
Collaboration agreements - Merck KGaA (Details) - Merck KGaA | 1 Months Ended | |||
Jun. 30, 2014USD ($)target | Mar. 31, 2022USD ($)target | Dec. 31, 2018target | Dec. 31, 2014USD ($) | |
Collaboration agreements | ||||
Proceeds from Collaborators | $ 12,000,000 | |||
Amount of additional fees receivable when target is designated and commercial license to target is granted | $ 0 | |||
Number of targets designated | target | 6 | 6 | 6 | |
Next potential development milestone payment eligible to receive | $ 500,000 |
Collaboration agreements - Me_2
Collaboration agreements - Merck KGaA - Accounting Analysis (Details) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2022USD ($)target | Mar. 31, 2021USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | |
Collaboration agreements | ||||
Collaboration revenue | $ 2,036 | $ 11 | ||
Research and development | 35,806 | 27,415 | ||
Merck KGaA Agreement and Merck KGaA Supply Agreement | ||||
Collaboration agreements | ||||
Deferred revenue | $ 3,900 | $ 3,900 | ||
Merck KGaA | ||||
Collaboration agreements | ||||
Number of targets with satisfied performance obligations | target | 4 | |||
Deferred revenue | $ 3,933 | 3,976 | $ 3,944 | $ 3,987 |
Merck KGaA Supply Agreement | ||||
Collaboration agreements | ||||
Research and development | $ 0 | $ 0 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2022-04-01 | Merck KGaA | Rights to future technological improvements | ||||
Collaboration agreements | ||||
Expected recognition period | 10 years | |||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2022-04-01 | Merck KGaA | Joint research committee services | ||||
Collaboration agreements | ||||
Expected recognition period | 5 years |
Collaboration Agreements - Cont
Collaboration Agreements - Contract Assets and Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Janssen Agreement | ||
Contract liabilities | ||
Deferred revenue beginning balance | $ 0 | |
Deferred revenue, Additions | 40,000 | |
Deferred revenue, Deductions | 1,735 | |
Deferred revenue ending balance | 38,265 | |
Amounts included in the contract liability at the beginning of the period | 0 | |
Performance obligations satisfied in previous periods | 0 | |
Merck KGaA | ||
Contract liabilities | ||
Deferred revenue beginning balance | 3,944 | $ 3,987 |
Deferred revenue, Additions | 0 | 0 |
Deferred revenue, Deductions | 11 | 11 |
Deferred revenue ending balance | 3,933 | 3,976 |
Amounts included in the contract liability at the beginning of the period | 11 | 11 |
Performance obligations satisfied in previous periods | $ 0 | $ 0 |
Collaboration Agreements - Othe
Collaboration Agreements - Other Revenue (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Collaboration agreements | ||
Collaboration revenue | $ 2,036,000 | $ 11,000 |
Asana BioSciences | ||
Collaboration agreements | ||
Next potential milestone payment eligible to receive | 2,500,000 | |
Asana BioSciences | Limited services | ||
Collaboration agreements | ||
Collaboration revenue | $ 300,000 | $ 0 |
Accrued expenses (Details)
Accrued expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Accrued Liabilities, Current [Abstract] | ||
Accrued clinical expenses | $ 7,569 | $ 7,879 |
Accrued manufacturing expenses | 9,381 | 8,476 |
Accrued preclinical expenses | 4,824 | 3,848 |
Accrued payroll and related expenses | 3,456 | 7,319 |
Accrued professional fees | 1,751 | 909 |
Accrued other | 494 | 285 |
Total | $ 27,475 | $ 28,716 |
Debt - Agreement Narrative (Det
Debt - Agreement Narrative (Details) - USD ($) | Oct. 29, 2021 | Mar. 31, 2022 | Mar. 31, 2021 |
Debt | |||
Unamortized issuance costs | $ 388,000 | ||
Interest expense | $ 700,000 | $ 100,000 | |
Amendment To Credit Facility | Line of Credit | |||
Debt | |||
Repayments of lines of credit | $ 5,500,000 | ||
New Credit Facility | Line of Credit | |||
Debt | |||
Maximum borrowing capacity | 100,000,000 | ||
Proceeds from line of credit | 25,000,000 | ||
New Credit Facility, Tranche One | Line of Credit | |||
Debt | |||
Maximum borrowing capacity | 60,000,000 | ||
New Credit Facility, Tranche Two | Line of Credit | |||
Debt | |||
Maximum borrowing capacity | 60,000,000 | ||
New Credit Facility, Tranche Three | Line of Credit | |||
Debt | |||
Maximum borrowing capacity | 60,000,000 | ||
New Credit Facility, Tranche Four | Line of Credit | |||
Debt | |||
Maximum borrowing capacity | 20,000,000 | ||
New Credit Facility, Tranche Five | Line of Credit | |||
Debt | |||
Maximum borrowing capacity | $ 20,000,000 |
Debt - Components (Details)
Debt - Components (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
Outstanding debt | $ 25,000 | |
Less: Current portion of long-term debt | 0 | |
Long-term debt, net | 25,000 | |
Debt financing costs, net of accretion | (388) | |
Accretion related to final payment | 90 | |
Long-term debt, net | $ 24,702 | $ 24,626 |
Stockholders' Equity - Preferre
Stockholders' Equity - Preferred stock (Details) - shares | Mar. 31, 2022 | Dec. 31, 2021 |
Stockholders' Equity Note [Abstract] | ||
Preferred stock, shares authorized (in shares) | 25,000,000 | 25,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Stockholders' Equity - At-the-m
Stockholders' Equity - At-the-market equity and follow on offering programs (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |||
May 06, 2022 | Mar. 31, 2022 | May 05, 2022 | Feb. 28, 2022 | May 31, 2020 | |
2020 ATM | |||||
Offering program | |||||
Amount of shares authorized to be offered and sold | $ 100,000,000 | ||||
2020 ATM | Common Stock | |||||
Offering program | |||||
Number of shares sold (in shares) | 11,740,210 | ||||
Net proceeds from the at-the-market facility | $ 54,800,000 | ||||
2022 ATM | |||||
Offering program | |||||
Amount of shares authorized to be offered and sold | $ 100,000,000 | ||||
2022 ATM | Common Stock | |||||
Offering program | |||||
Number of shares sold (in shares) | 1,429,693 | ||||
Net proceeds from the at-the-market facility | $ 5,800,000 | ||||
2022 ATM | Common Stock | Subsequent Event | |||||
Offering program | |||||
Number of shares sold (in shares) | 9,904,964 | ||||
Net proceeds from the at-the-market facility | $ 40,000,000 | ||||
Remaining unsold and available amount | $ 53,300,000 | ||||
At Market Equity Offering Programs | Common Stock | |||||
Offering program | |||||
Number of shares sold (in shares) | 13,169,903 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants (Details) - $ / shares | 6 Months Ended | ||
Jun. 30, 2014 | Mar. 31, 2022 | Dec. 31, 2014 | |
Warrants | |||
Number of shares into which warrant issued during period may be converted (in shares) | 129,491 | ||
Warrant exercise price per share (in dollars per share) | $ 0.05 | ||
Contractual life of warrants | 10 years | ||
Number of shares of common stock into which warrants may be converted (in shares) | 39,474 |
Stockholders' Equity - Exchange
Stockholders' Equity - Exchange Warrants (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2022 | Dec. 31, 2014 | |
Class of Stock [Line Items] | ||
Warrant exercise price per share (in dollars per share) | $ 0.05 | |
Number of shares of common stock into which warrants may be converted (in shares) | 39,474 | |
Common Stock | ||
Class of Stock [Line Items] | ||
Exercise of common stock warrant in exchange for common stock (in shares) | 0 |
Stockholders' Equity - Common s
Stockholders' Equity - Common stock (Details) - shares | 3 Months Ended | |
Mar. 31, 2022 | Dec. 31, 2021 | |
Common stock | ||
Common stock voting rights | The holders of the common stock are entitled to one vote for each share held. | |
Number of shares reserved for future issuance (in shares) | 11,524,655 | 9,199,512 |
Share-based payments | Stock options | ||
Common stock | ||
Number of shares reserved for future issuance (in shares) | 10,028,741 | 8,342,429 |
Share-based payments | Restricted stock units | ||
Common stock | ||
Number of shares reserved for future issuance (in shares) | 1,456,440 | 817,609 |
Warrants | ||
Common stock | ||
Number of shares reserved for future issuance (in shares) | 39,474 | 39,474 |
Stock-based compensation - Plan
Stock-based compensation - Plans narrative (Details) - shares | Jan. 01, 2022 | Jun. 30, 2017 | Mar. 31, 2022 | Feb. 28, 2022 | Dec. 31, 2021 |
Stock options | |||||
Number of shares outstanding (in shares) | 10,028,741 | 8,342,429 | |||
Stock options | |||||
Stock options | |||||
Vesting period | 4 years | ||||
2007 Plan | |||||
Stock options | |||||
Number of shares outstanding (in shares) | 3,141,625 | ||||
2017 Plan | |||||
Stock options | |||||
Number of shares authorized (in shares) | 2,255,000 | ||||
Cumulative annual increase in number of shares issuable | 4.00% | ||||
Additional shares authorized (in shares) | 2,948,362 | ||||
Number of shares available for future issuance (in shares) | 1,737,277 | ||||
Number of options granted in period (in shares) | 2,788,158 | ||||
2017 Plan | Maximum | |||||
Stock options | |||||
Expiration period | 10 years | ||||
Inducement Award Program | |||||
Stock options | |||||
Number of shares outstanding (in shares) | 757,500 | ||||
Number of shares authorized (in shares) | 2,000,000 |
Stock-based compensation - Indu
Stock-based compensation - Inducement awards narrative (Details) - shares | Mar. 31, 2022 | Feb. 28, 2022 | Dec. 31, 2021 |
Stock options | |||
Number of shares outstanding (in shares) | 10,028,741 | 8,342,429 | |
Inducement Award Program | |||
Stock options | |||
Number of shares outstanding (in shares) | 757,500 | ||
Number of shares authorized (in shares) | 2,000,000 |
Stock-based compensation - Acti
Stock-based compensation - Activity under stock option plan (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Number of Shares | ||
Outstanding at beginning of period (in shares) | 8,342,429 | |
Granted (in shares) | 1,917,634 | |
Exercised (in shares) | (26,951) | |
Cancelled (in shares) | (204,371) | |
Outstanding at end of period (in shares) | 10,028,741 | |
Vested and expected to vest (in shares) | 10,028,741 | |
Options exercisable, at end of period (in shares) | 4,307,274 | |
Weighted- Average Exercise Price | ||
Outstanding at beginning of period (in dollars per share) | $ 11.25 | |
Granted (in dollars per share) | 6.05 | |
Exercised (in dollars per share) | 3.58 | |
Cancelled (in dollars per share) | 12.74 | |
Outstanding at end of period (in dollars per share) | 10.25 | |
Vested and expected to vest (in dollars per share) | 10.25 | |
Options exercisable, at end of period (in dollars per share) | 8.14 | |
Additional Disclosures | ||
Weighted-average grant date fair value of options granted (in dollars per share) | $ 4.39 | $ 14.51 |
Cash received from the exercise of stock options | $ 96 | $ 764 |
Stock-based compensation - Rest
Stock-based compensation - Restricted stock units (Details) - Restricted stock units | 3 Months Ended |
Mar. 31, 2022shares | |
Restricted stock units | |
Unvested at beginning of period (in shares) | 817,609 |
Granted (in shares) | 870,524 |
Vested (in shares) | (167,174) |
Forfeited (in shares) | (64,519) |
Unvested at end of period (in shares) | 1,456,440 |
Minimum | |
Stock options | |
Vesting period | 1 year |
Maximum | |
Stock options | |
Vesting period | 4 years |
Stock-based compensation - Stoc
Stock-based compensation - Stock based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Stock options | ||
Stock-based compensation expense included in total operating expenses | $ 5,485 | $ 4,039 |
Research and development | ||
Stock options | ||
Stock-based compensation expense included in total operating expenses | 2,933 | 2,301 |
General and administrative | ||
Stock options | ||
Stock-based compensation expense included in total operating expenses | 2,552 | 1,738 |
Stock options | ||
Stock options | ||
Stock-based compensation expense included in total operating expenses | 4,118 | 3,114 |
Unrecognized stock compensation cost | $ 41,800 | |
Weighted-average amortization period of unrecognized stock compensation cost | 2 years 6 months | |
Restricted stock units | ||
Stock options | ||
Stock-based compensation expense included in total operating expenses | $ 1,209 | 806 |
Unrecognized stock compensation cost | $ 13,500 | |
Weighted-average amortization period of unrecognized stock compensation cost | 3 years | |
Employee stock purchase plan | ||
Stock options | ||
Stock-based compensation expense included in total operating expenses | $ 158 | $ 119 |
Stock-based compensation - Fair
Stock-based compensation - Fair value assumptions (Details) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||
Risk-free interest rate | 1.60% | 0.60% |
Expected dividend yield | 0.00% | 0.00% |
Expected term (years) | 6 years 14 days | 6 years 21 days |
Expected stock price volatility | 87.00% | 83.00% |
Stock-based compensation - Empl
Stock-based compensation - Employee stock purchase plan narrative (Details) - Employee stock purchase plan - 2017 ESPP - shares | Mar. 31, 2022 | Mar. 31, 2021 |
Employee Stock Purchase Plan | ||
Number of shares available for future issuance (in shares) | 566,565 | |
Shares sold to date (in shares) | 0 | 0 |
Net Loss per Share (Details)
Net Loss per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Anti-dilutive securities | ||
Anti-dilutive securities (in shares) | 11,524,655 | 8,600,223 |
Stock options | ||
Anti-dilutive securities | ||
Anti-dilutive securities (in shares) | 10,028,741 | 7,478,289 |
Unvested restricted stock units | ||
Anti-dilutive securities | ||
Anti-dilutive securities (in shares) | 1,456,440 | 1,082,460 |
Warrants | ||
Anti-dilutive securities | ||
Anti-dilutive securities (in shares) | 39,474 | 39,474 |
Commitments - (Details)
Commitments - (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
License Agreement, Milestone Payments | ||
Commitments | ||
Research and development expense | $ 0 | $ 0 |
License Agreement, Upfront Payments | ||
Commitments | ||
Research and development expense | $ 1,500,000 | $ 0 |