AGENUS INC. Forward Looking Statements
This Quarterly Report on Form 10-Q and other written and oral statements we make from time to time contain certain "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the "Exchange Act"). You can identify these forward-looking statements by the fact they use words such as "could," "expect," "anticipate," "estimate," "target," "may," "project," "guidance," "intend," "plan," "believe," "will," "potential," "opportunity," "future" and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. You can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements relate to, among other things, our business strategy, our research and development, our product development efforts, our ability to commercialize our product candidates, the activities of our licensees, our prospects for initiating partnerships or collaborations, the timing of the introduction of products, the effect of new accounting pronouncements, uncertainty regarding our future operating results and our profitability, anticipated sources of funds as well as our plans, objectives, expectations, and intentions. We have included more detailed descriptions of these risks and uncertainties and other risks and uncertainties applicable to our business that we believe could cause actual results to differ materially from any forward-looking statements in Part II-Item 1A "Risk Factors" of this Quarterly Report on Form 10-Q. We encourage you to read those descriptions carefully. Although we believe we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved. We caution investors not to place significant reliance on forward-looking statements contained in this document; such statements need to be evaluated in light of all the information contained in this document. Furthermore, the statements speak only as of the date of this document, and we undertake no obligation to update or revise these statements. ASV™, Agenus™, AutoSynVax™, MiNK™, PSV™, PhosPhoSynVax™, Prophage™, Retrocyte Display™ and Stimulon™ are trademarks ofAgenus Inc. and its subsidiaries. All rights reserved. Overview We are a clinical-stage immuno-oncology ("I-O") company advancing an extensive pipeline of immune checkpoint antibodies, adoptive cell therapies and neoantigen vaccines, to fight cancer and infections. Our business is designed to drive success in I-O through speed, innovation and effective combination therapies. We believe that combination therapies and a deep understanding of each patient's cancer will drive substantial expansion of the patient population benefiting from current I-O therapies. In addition to a diverse pipeline, we have assembled fully integrated end-to-end capabilities including novel target discovery, antibody generation, cell line development and current good manufacturing practice manufacturing. We believe that these fully integrated capabilities enable us to produce novel candidates on timelines that are shorter than the industry standard. Leveraging our science and capabilities, we have forged important partnerships to advance our innovation.
We are developing a comprehensive I-O portfolio driven by the following platforms and programs, which we intend to utilize individually and in combination:
• our multiple antibody discovery platforms, including our proprietary
display technologies, designed to drive the discovery of future CPM
antibody candidates;
• our antibody candidate programs, including our CPM programs;
• our vaccine programs, including Prophage™, AutoSynVax™ and PhosPhoSynVax™;
• our saponin-based vaccine adjuvants, principally our QS-21 Stimulon™
adjuvant, or QS-21 Stimulon; and
• our cell therapy subsidiary, MiNK Therapeutics, Inc. ("MiNKTherapeutics"), which is designed to drive the advancement of a novel
allogeneic invariant natural killer T cell ("iNKT") therapy in immune
diseases.
We assess development, commercialization and partnering strategies for each of our product candidates periodically based on several factors, including pre-clinical and clinical trial results, competitive positioning and funding requirements and resources. Our anti-CTLA-4 and anti-PD-1 programs (zalifrelimab and balstilimab, respectively) are in late phase clinical trials designed to support BLA filings under theU.S. Food and Drug Administration ("FDA") accelerated approval pathway. We announced interim data from these trials in February, March andSeptember 2020 . We initiated the rolling submission of our BLA for balstilimab monotherapy to treat 2nd line cervical cancer inSeptember 2020 . We completed this BLA filing inApril 2021 and the FDA accepted this application inJune 2021 , granting it priority review with a Prescription Drug User Fee Act ("PDUFA") target action date ofDecember 16, 2021 . We expect to solidify our strategy for the balstilimab/zalifrelimab combination filing, pending further discussion with the FDA. 18 -------------------------------------------------------------------------------- We have formed collaborations with companies such as Bristol Myers Squibb Company ("BMS"), Betta Pharmaceuticals Co., Ltd. ("Betta"), Gilead Sciences, Inc. ("Gilead"), Incyte Corporation ("Incyte"), Merck Sharpe & Dohme ("Merck") andRecepta Biopharma SA ("Recepta"). Through these alliances, as well as our own internal programs, we currently have more than a dozen antibody programs in pre-clinical or clinical development. Pursuant to our collaboration agreement with Incyte, we have exclusively licensed to Incyte monospecific antibodies targeting GITR, OX40, TIM-3 and LAG-3, which Incyte is currently advancing in various clinical trials, as well as an additional undisclosed target that Incyte is advancing in preclinical studies. Under the terms of our agreement, Incyte is responsible for all future development expenses, and we are eligible to receive up to an additional$500.0 million in potential milestone payments plus royalties on any future sales. Pursuant to our collaboration and license agreement with Merck, we exclusively licensed to Merck a monospecific antibody targeting ILT4, which Merck is advancing in a Phase 2 clinical trial. Under the terms of our agreement, Merck is responsible for all future development expenses, and we are eligible to receive up to an additional$85.0 million in potential milestone payments plus royalties on any future sales. InSeptember 2018 , we, through our wholly-owned subsidiary,Agenus Royalty Fund, LLC , entered into a royalty purchase agreement (the "XOMA Royalty Purchase Agreement") withXOMA (US) LLC ("XOMA"). Pursuant to the terms of the XOMA Royalty Purchase Agreement, XOMA purchased 33% of all future royalties and 10% of all future milestone payments that we are entitled to receive from Incyte and Merck, net of certain of our obligations to a third party. After taking into account our obligations under the XOMA Royalty Purchase Agreement, as ofJune 30, 2021 , we remain eligible to receive up to$450.0 million and$76.5 million in potential development, regulatory and commercial milestones from Incyte and Merck, respectively. InDecember 2018 , we entered into a series of agreements with Gilead to collaborate on the development and commercialization of up to five novel I-O therapies (the "Gilead Collaboration Agreements"). Pursuant to the Gilead Collaboration Agreements, Gilead received worldwide exclusive rights to our bispecific antibody, AGEN1423, as well as the exclusive option to exclusively license AGEN1223, a bispecific antibody, and AGEN2373, a monospecific antibody. All three assets have entered clinical development. InNovember 2020 , Gilead elected to return AGEN1423 to us and to voluntarily terminate the license agreement effective as ofFebruary 4, 2021 . The option agreements remain in place, and we are responsible for developing each program up to the option decision points, at which time Gilead may acquire exclusive rights to the programs on option exercise. For either, but not both, of the option programs, we have the right to opt-in to share Gilead's development and commercialization costs inthe United States in exchange for a profit (loss) share on a 50:50 basis and revised milestone payments. Pursuant to the terms of the Gilead option agreements, we remain eligible to receive up to$100.0 million in option exercise fees and, if exercised, up to an additional$1.0 billion in aggregate milestone payments, as well as royalties on any future sales. InJune 2020 , we entered into a license and collaboration agreement (the "Betta License Agreement") with Betta, pursuant to which we granted Betta an exclusive license to develop, manufacture and commercialize balstilimab and zalifrelimab inGreater China . Under the terms of the Betta License Agreement, we received$15.0 million upfront and are eligible to receive up to$100.0 million in milestone payments plus royalties on any future sales inGreater China . InMay 2021 , we entered into a License, Development and Commercialization Agreement ("BMS License Agreement") with BMS to collaborate on the development and commercialization of our pre-clinical proprietary anti-TIGIT bispecific antibody program AGEN1777. Under the BMS License Agreement, we granted BMS an exclusive worldwide license under certain of our intellectual property rights to develop, manufacture and commercialize AGEN1777 and its derivatives in all fields; provided, we retained an option to access the licensed antibodies for use in clinical studies in combination with certain of our other pipeline assets subject to certain restrictions. Pursuant to the BMS License Agreement, we received an upfront cash payment of$200.0 million inJuly 2021 and are eligible to receive up to$1.36 billion in aggregate development, regulatory and commercial milestone payments plus tiered royalties. In exchange, BMS is responsible for all of the development, regulatory approval, manufacturing and commercialization costs with respect to products containing AGEN1777. We have the option, but not the obligation, to co-fund a minority of the global development costs of products containing AGEN1777 or its derivatives, in exchange for increased tiered royalties. Finally, we also have the option to co-promote AGEN1777 in theU.S. Our QS-21 Stimulon adjuvant is partnered with GlaxoSmithKline ("GSK") and is a key component in multiple GSK vaccine programs. These programs are in various stages, with the most advanced being GSK's shingles vaccine, Shingrix. InOctober 2017 , GSK's shingles vaccine was approved inthe United States by the FDA. InJanuary 2018 , we entered into a Royalty Purchase Agreement withHealthcare Royalty Partners III, L.P. and certain of its affiliates (together, "HCR"), pursuant to which HCR purchased 100% of our worldwide rights to receive royalties from GSK on GSK's sales of vaccines containing our QS-21 Stimulon adjuvant. We do not incur clinical development costs for products partnered with GSK. We were also entitled to receive up to$40.35 million in milestone payments from HCR based on sales of GSK's vaccines as follows: (i)$15.1 million upon reaching$2.0 billion last-twelve-months net sales any time prior to 2024 (the "First HCR Milestone") and (ii)$25.25 million upon reaching$2.75 billion last-twelve-months net sales any time prior to 2026 (the "Second HCR Milestone"). We received the First HCR Milestone after GSK's net sales of Shingrix for the twelve months endedDecember 31, 2019 exceeded$2.0 billion , and we remain eligible to receive the Second HCR Milestone. 19 -------------------------------------------------------------------------------- Our business activities include product research and development, intellectual property prosecution, manufacturing, regulatory and clinical affairs, corporate finance and development activities, and support of our collaborations. Our product candidates require clinical trials and approvals from regulatory agencies, as well as acceptance in the marketplace. Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing arrangements with academic and corporate collaborators and licensees and by entering into new collaborations. Our subsidiary MiNK Therapeutics (formerlyAgenTus Therapeutics, Inc. ) is focused on the development of unmodified iNKT cell therapies for the treatment of cancer and other life-threatening illnesses. InMay 2020 andJune 2020 , the FDA cleared Investigational New Drug applications for AGENT-797, an allogeneic iNKT therapy, for the treatment of patients with hematological malignancies, including multiple myeloma and B cell lymphoma, and COVID-19-realted pneumonia, respectively. InNovember 2020 , MiNK Therapeutics dosed its first COVID-19 patient with AGENT-797, and trials for hematological malignancies commenced inApril 2021 . InJuly 2021 MiNK Therapeutics announced that it had confidentially submitted a draft registration statement on Form S-1 with theSecurities and Exchange Commission (the "SEC") relating to the proposed initial public offering of its common stock. The number of shares to be offered and the price range for the proposed offering have not yet been determined. The initial public offering is expected to take place after theSEC completes its review process, subject to market and other conditions. MiNK Therapeutics licenses intellectual property assets fromAgenus and has its own governance.
Historical Results of Operations
Three months ended
Research and development revenue
We recognized research and development revenue of approximately$1.7 million and$18.1 million during the three months endedJune 30, 2021 and 2020, respectively. Research and development revenues in the second quarter of 2021 primarily consisted of$1.4 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements and$0.2 million of research service revenue earned under our Incyte Collaboration Agreement. Research and development revenues in the second quarter of 2020 primarily consisted of$4.0 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements and$13.9 million related to the recognition of an upfront fee under our Betta License Agreement.
Non-cash royalty revenue related to the sale of future royalties
InJanuary 2018 , we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK's vaccines containing our QS-21 Stimulon adjuvant to HCR. As described in Note F to our Condensed Consolidated Financial Statements, this transaction has been recorded as a liability that amortizes over the estimated life of our Royalty Purchase Agreement with HCR. As a result of this liability accounting, even though the royalties are remitted directly to HCR, we record these royalties from GSK as revenue. During both the three months endedJune 30, 2021 and 2020, we recognized approximately$7.8 million , in non-cash royalty revenue related to our agreement with GSK.
Research and development expense
Research and development expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of consultants, and administrative costs. Research and development expense increased 18% to$45.5 million for the three months endedJune 30, 2021 from$38.6 million for the three months endedJune 30, 2020 . Increased expenses in the three months endedJune 30, 2021 primarily relate to a$5.7 million increase in third-party services and other related expenses related to the advancement of our antibody programs, a$0.3 million increase in personnel related expenses, a$0.6 million increase in expenses attributable to the activities of our subsidiaries and a$0.3 million increase in other research and development expenses.
General and administrative expense
General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses increased 17% to$16.7 million for the three months endedJune 30, 2021 from$14.2 million for the three months endedJune 30, 2020 . Increased expenses in the three months endedJune 30, 2021 primarily relate to a$2.0 million increase in personnel related expenses, primarily due to increased share-based compensation expense, a$0.4 million increase in professional fees, primarily due to increased expenses related to commercial readiness activities and a$0.2 million increase in expenses attributable to the activities of our subsidiaries.
Contingent purchase price consideration fair value adjustment
Contingent purchase price consideration fair value adjustment represents the
change in the fair value of our purchase price considerations, which mainly
resulted from changes in our market capitalization and share price and changes
in the credit spread since each reporting period end. The fair value of our
contingent purchase price considerations is mainly based on estimates from a
Monte Carlo simulation of our market capitalization and share price.
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Non-operating income (expense)
Non-operating income (expense) includes our foreign currency translation adjustment and other income or expense. Non-operating expense increased$0.6 million for the three months endedJune 30, 2021 , from expense of$0.3 million for the three months endedJune 30, 2020 to expense of$0.9 million for the three months endedJune 30, 2021 , primarily due to increased foreign currency exchange losses in the second quarter of 2021 compared to the second quarter of 2020. Interest expense, net Interest expense, net increased to approximately$16.7 million for the three months endedJune 30, 2021 from$14.6 million for the three months endedJune 30, 2020 , due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR.
Six months ended
Research and development revenue
We recognized research and development revenue of approximately$3.3 million and$20.0 million during the six months endedJune 30, 2021 and 2020, respectively. Research and development revenues in the first half of 2021 primarily consisted of$2.4 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements and$0.7 million of research service revenue earned under our Incyte Collaboration Agreement. Research and development revenues in the first half of 2020 primarily consisted of$5.8 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements and$13.9 million related to the recognition of an upfront fee under our Betta License Agreement.
Non-cash royalty revenue related to the sale of future royalties
InJanuary 2018 , we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK's vaccines containing our QS-21 Stimulon adjuvant to HCR. As described in Note F to our Condensed Consolidated Financial Statements, this transaction has been recorded as a liability that amortizes over the estimated life of our Royalty Purchase Agreement with HCR. As a result of this liability accounting, even though the royalties are remitted directly to HCR, we will record these royalties from GSK as revenue. During the six months endedJune 30, 2021 and 2020, we recognized approximately$16.3 million and$21.0 million , respectively, in non-cash royalty revenue related to our agreement with GSK.
Research and development expense
Research and development expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of consultants, and administrative costs. Research and development expense increased 10% to$82.2 million for the six months endedJune 30, 2021 from$74.9 million for the six months endedJune 30, 2020 . Increased expenses in the six months endedJune 30, 2021 primarily relate to a$5.6 million increase in third-party services and other related expenses related to the advancement of our antibody programs, a$1.3 million increase in expenses attributable to the activities of our subsidiaries and a$0.4 million increase in other research and development expenses.
General and administrative expense
General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses increased 33% to$33.0 million for the six months endedJune 30, 2021 from$24.8 million for the six months endedJune 30, 2020 . Increased expenses in the six months endedJune 30, 2021 primarily relate to a$1.4 million increase in professional fees, primarily due to increased expenses related to commercial readiness activities, a$4.7 million increase in personnel related expenses, primarily due to both increased share-based compensation expense and increased headcount, a$1.4 million increase in expenses attributable to the activities of our subsidiaries and a$0.7 million increase in other general and administrative expenses.
Contingent purchase price consideration fair value adjustment
Contingent purchase price consideration fair value adjustment represents the change in the fair value of our purchase price considerations, which mainly resulted from changes in our market capitalization and share price and changes in the credit spread since each reporting period end. The fair value of our contingent purchase price considerations is mainly based on estimates from a Monte Carlo simulation of our market capitalization and share price.
Non-operating income (expense)
Non-operating income (expense) includes our foreign currency translation adjustment and other income or expense. Non-operating income increased$3.3 million for the six months endedJune 30, 2021 , from expense of$1.4 million for the six months endedJune 30, 2020 to income of$1.9 million for the six months endedJune 30, 2021 , primarily due to our increased foreign currency exchange gains in the first half of 2021 compared to the first half of 2020.
Interest expense, net:
21
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Interest expense, net increased to approximately $32.6 million for the six
months ended June 30, 2021 from $28.7 million for the six months ended June 30,
2020 , due to increased non-cash interest recorded in connection with our Royalty
Purchase Agreement with HCR.
Research and Development Programs
For the six months endedJune 30, 2021 , our research and development programs consisted largely of our antibody programs as indicated in the following table (in thousands). Six Months Ended June 30, Year Ended December 31, Research and Prior to Development Program Product 2021 2020 2019 2018 2018 Total Antibody programs* Various$ 68,191 $ 118,200
and ASV 495 1,076 13,235 13,235 335,890 363,931
Vaccine adjuvant QS-21
Stimulon 1,331 304 872 211 14,098 16,816
Cell therapies and other
research and development
programs Various 12,167 23,037 27,832 14,143 78,342 155,521
Total research and development
expenses $ 82,184 $ 142,617 $ 168,339 $ 124,600 $ 684,618 $ 1,202,358 * Prior to 2014, costs were incurred by 4-AB, which we acquired in February
2014.
Research and development program costs include compensation and other direct
costs plus an allocation of indirect costs, based on certain assumptions and our
review of the status of each program. Our product candidates are in various
stages of development and significant additional expenditures will be required
if we start new clinical trials, encounter delays in our programs, apply for
regulatory approvals, continue development of our technologies, expand our
operations, and/or bring our product candidates to market. The total cost of any
particular clinical trial is dependent on a number of factors such as trial
design, length of the trial, number of clinical sites, number of patients, and
trial sponsorship. The process of obtaining and maintaining regulatory approvals
for new therapeutic products is lengthy, expensive, and uncertain. Because of
the current stage of our product candidates, among other factors, we are unable
to reliably estimate the cost of completing our research and development
programs or the timing for bringing such programs to various markets or
substantial partnering or out-licensing arrangements, and, therefore, when, if
ever, material cash inflows are likely to commence. Active programs involving
QS-21 Stimulon depend on our licensee successfully completing clinical trials,
successfully manufacturing QS-21 Stimulon to meet demand, obtaining regulatory
approvals and successfully commercializing product candidates containing QS-21
Stimulon.
Liquidity and Capital Resources
We have incurred annual operating losses since inception, and we had an accumulated deficit of$1.6 billion as ofJune 30, 2021 . We expect to incur significant losses over the next several years as we continue development of our technologies and product candidates, manage our regulatory processes, initiate and continue clinical trials, and prepare for potential commercialization of products. To date, we have financed our operations primarily through corporate partnerships, advance royalty sales and the issuance of equity. From our inception throughJune 30, 2021 , we have raised aggregate net proceeds of approximately$1.5 billion through the sale of common and preferred stock, the exercise of stock options and warrants, proceeds from our Employee Stock Purchase Plan, royalty monetization transactions, and the issuance of convertible and other notes. We maintain an effective registration statement (the "Registration Statement"), covering an unlimited amount of common stock, preferred stock, warrants, debt securities and units. The Registration Statement includes prospectuses covering the offer, issuance and sale of up to 100 million shares of our common stock from time to time in "at-the-market offerings" pursuant to an At Market Issuance Sales Agreement (the "Sales Agreement") withB. Riley FBR, Inc. as our sales agent. We sold approximately 22.3 million shares of our common stock pursuant to the Sales Agreement during the six months endedJune 30, 2021 , and received aggregate net proceeds totaling$70.0 million . As ofJune 30, 2021 , we had approximately 60.0 million shares that remained available for sale under the Sales Agreement. As ofJune 30, 2021 , we had debt outstanding of$20.0 million in principal. InFebruary 2015 , we issued senior subordinated promissory notes in the aggregate principal amount of$14.0 million with annual interest at 8% (the "2015 Subordinated Notes"). InFebruary 2020 , we amended$13.5 million of the 2015 Subordinated Notes, extending the due date by three years toFebruary 2023 . 22 -------------------------------------------------------------------------------- The remaining$0.5 million of the 2015 Subordinated Notes were repaid inFebruary 2020 . InApril 2020 , we repaid an additional$0.5 million of the 2015 Subordinated Notes, leaving$13.0 million outstanding. InMay 2020 , we received$6.2 million under the Paycheck Protection Program of the Coronavirus Aid, Relief and Economic Security Act of 2020 (the "CARES Act") which is classified as debt in our condensed consolidated balance sheet as we cannot yet determine if the amount will be partially or fully forgiven.
Our cash and cash equivalents at
During the past five years, we have successfully financed our operations through income and revenues generated from corporate partnerships, advance royalty sales and issuance of equity. Based on our current plans and projections, we believe our quarter end cash resources of$73.5 million as ofJune 30, 2021 , plus the$200.0 million fee received subsequently in connection with our transaction with BMS, will be sufficient to satisfy our liquidity requirements for more than one year from when these financial statements were issued. We are presently in partnership, and out licensing discussions and contemplating additional financial transactions which, if consummated, could extend our cash resources substantially beyond 2022. Management continues to address the Company's liquidity position and has the flexibility to adjust spending as needed in order to preserve liquidity. InMarch 2020 , in response to the COVID-19 pandemic, we streamlined our organization, which included a headcount reduction, and our CEO, Dr.Garo Armen , elected to receive his base salary in stock rather than cash for the remainder of 2020 and through the first half of 2021. We continuously evaluate the likelihood of success of our programs. As such, our decisions to continue to fund or eliminate funding of each of our programs are predicated on these determinations, on an ongoing basis. We are prepared to discontinue funding of any activities that do not impact our core priorities if they do not prove to be feasible, and to restrict capital expenditures and/or reduce the scale of our operations. We expect our potential sources of funding to include: (1) collaborations, out-licensing and/or partnering opportunities for our portfolio programs and product candidates with multiple parties (2) milestone payments from our existing partnerships (3) consummating additional third-party agreements, (4) selling assets, (5) securing project financing and/or (6) selling equity securities. Our future cash requirements include, but are not limited to, supporting clinical trial and regulatory efforts and continuing our other research and development programs. Since inception, we have entered into various agreements with contract manufacturers, institutions, and clinical research organizations (collectively "third party providers") to perform pre-clinical activities and to conduct and monitor our clinical studies and trials. Under these agreements, subject to the enrollment of patients and performance by the applicable third-party provider, we have estimated our total payments to be$476.8 million over the term of the related activities. ThroughJune 30, 2021 , we have expensed$351.8 million as research and development expenses and$342.9 million has been paid under these agreements. The timing of expense recognition and future payments related to these agreements is subject to the enrollment of patients and performance by the applicable third-party provider. We plan to enter into additional agreements with third party providers and we anticipate significant additional expenditures will be required to initiate and advance our various programs. Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing collaboration arrangements with academic and collaboration partners and licensees and by entering into new collaborations. As a result of our collaboration agreements, we will not completely control the efforts to attempt to bring those product candidates to market. For example, our collaboration with Incyte for the development, manufacture and commercialization of CPM antibodies against certain targets is managed by a joint steering committee, which is controlled by Incyte. Net cash used in operating activities for the six months endedJune 30, 2021 and 2020 was$98.3 million and$71.9 million , respectively. Our future ability to generate cash from operations will depend on achieving regulatory approval and market acceptance of our product candidates, achieving benchmarks as defined in existing collaboration agreements, and our ability to enter into new collaborations. See "Management's Discussion and Analysis of Financial Condition and Results of Operations-Forward Looking Statements" in Part I, Item 2, and the risks highlighted under Part II, Item 1A. "Risk Factors", of this Quarterly Report on Form 10-Q.
Off-Balance Sheet Arrangements
We did not have any off-balance sheet arrangements as of
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