AGENUS INC 10-Q

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 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. 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 are included in Part I-Item 1A “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. 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. Overview Agenus is a clinical-stage biotechnology company focused on discovering and developing immunotherapies for cancer and infectious disease Our primary business is immuno-oncology ("I-O"), where we are advancing antibody-based programs to activate innate and adaptive immunity, overcome tumor immune evasion and expand the population of patients who may benefit from immunotherapy. Our lead clinical program is BOT, a multifunctional, Fc-enhanced anti-CTLA-4 antibody, alone and in combination with BAL, a fully human monoclonal IgG4 anti-PD-1 antibody. BOT is designed to prime and activate T cells, downregulate intratumoral regulatory T cells, activate myeloid cells and induce long-term memory responses, with the goal of extending immunotherapy benefit to “cold” tumors that generally respond poorly to standard of care and to conventional PD-1 and CTLA-4 therapies. BAL is designed to block PD-1 from interacting with PD-L1 and PD-L2. BOT/BAL is investigational and has not been approved by the U.S. Food and Drug Administration (the “FDA”) or authorized for commercial sale in the European Union or any other jurisdiction. We also maintain select clinical-stage immuno-oncology assets that may be used as standalone agents or as complements to BOT/BAL. Agenus also maintains an equity investment in MiNK Therapeutics, Inc. ("MiNK"), with an approximate fair value of $25.5 million as of June 30, 2026, and a majority ownership of a vaccine adjuvant business through our subsidiary SaponiQx, Inc. ("SaponiQx"). Our common stock is listed on The Nasdaq Capital Market under the symbol "AGEN." The six months ended June 30, 2026 and the period shortly thereafter included several developments that materially advanced our strategic priorities: the closing of the strategic collaboration with Zydus Lifesciences Ltd. and the Company meeting the conditions for the first payment into escrow of $20.0 million (only for use in making payments to Zydus), reflecting the total value of the first tranche of clinical supply expected to be delivered by Zydus in 2026; the conclusion of the SEC’s investigation as to the Company; the dismissal of the related putative securities class action; continued expansion of physician engagement through regulatory-authorized access pathways and the appointment of an exclusive global access distribution partner; the announcement of ROBBIN, our planned registrational Phase 3 trial of neoadjuvant BOT/BAL in high-risk Stage II and Stage III MSS colon cancer, together with the discontinuation of our financial support for the CCTG-sponsored BATTMAN Phase 3 study in late-line metastatic MSS colorectal cancer and the closing of a private placement providing approximately $85.0 million in upfront gross proceeds, before the deduction of placement expenses, and up to an additional $255.0 million upon the full exercise of the accompanying purchase warrants. Strategic Prioritization of Neoadjuvant BOT/BAL in MSS Colon Cancer On July 13, 2026, in connection with the Private Placement, the Company announced that it will conduct, and that the net proceeds of the Private Placement are expected to support, a strategic prioritization of BOT/BAL for the neoadjuvant treatment of 24 microsatellite-stable (“MSS”) colon cancer, including the advancement of ROBBIN. High-risk Stage II and Stage III MSS colon cancer affects an estimated 38,000 patients annually in the United States and more than 200,000 patients worldwide, representing an estimated U.S. addressable annual sales opportunity of more than $7 billion, with no new curative-intent therapies approved in more than 20 years. The addressable opportunity is a Company estimate based on third-party epidemiology data and internal assumptions regarding pricing and market penetration, and actual results may differ materially. ROBBIN is a planned global randomized Phase 3 trial evaluating neoadjuvant BOT/BAL followed by standard of care versus standard of care alone in previously untreated high-risk Stage II and Stage III MSS colon cancer. The ROBBIN trial will enroll 850 patients, randomized 1:1, with event free survival (“EFS”) as its primary endpoint. Following interactions with the FDA, key elements of the proposed ROBBIN Phase 3 trial design, including patient population, experimental regimen, control arm, primary endpoint, and interim analysis plan, have been informed by FDA feedback. Anticipated ROBBIN milestones are as follows: a) First patient dosed: anticipated in the first quarter of 2027 b) Interim pathologic response data: anticipated in the second half of 2027 c) Interim analysis of EFS: anticipated in the second half of 2029 d) Final analysis of EFS: anticipated in the second half of 2030 The clinical rationale for ROBBIN is derived from NEST and UNICORN, two independent investigator-sponsored Phase 2 studies evaluating neoadjuvant BOT/BAL in MSS colorectal cancer. Across those studies, BOT/BAL produced pathologic response in approximately 60% to 70% of patients, major pathologic response in approximately 35% to 40% of patients, and pathologic complete response in approximately 30% of patients. Deep pathologic responses in the neoadjuvant setting are positively correlated with event-free survival in many tumor types, including MSS colon cancer. With median follow-up of approximately 9 to 18 months, all treated patients remained disease free, and circulating tumor DNA clearance was observed during treatment. NEST and UNICORN were small studies. Neither included a comparison arm, and neither was designed to determine whether BOT/BAL reduces the risk of recurrence. ROBBIN is intended to address that question. Further details from both studies are anticipated to be published in the second half of 2026. In connection with this prioritization, Agenus discontinued financial support for the BATTMAN Phase 3 study in late-line metastatic MSS colorectal cancer, after which CCTG formally terminated the study. See Note U. Regulatory Strategy in Metastatic Disease Refractory MSS metastatic colorectal cancer without active liver metastases remains our lead regulatory development focus in the metastatic setting. Based on existing data, we intend during 2026 to seek Accelerated Approval in the United States and Conditional Marketing Authorization in the European Union for BOT/BAL in that indication. There can be no assurance that either submission will be made on the anticipated timeline, that either will be accepted for review, or that either will result in approval or authorization, and the requirements applicable to each pathway, including any requirement for a confirmatory trial, are subject to the discretion of the applicable regulatory authority. Clinical Data At the European Society for Medical Oncology Gastrointestinal Cancers Congress in July 2026, follow-up from the fully enrolled 123-patient Phase 1b cohort in refractory MSS metastatic colorectal cancer without active liver metastases showed median overall survival of 21.2 months and three-year overall survival of 33%. Median duration of response was not reached, and 17% of patients were alive and off all systemic cancer therapy at last follow-up. Extended follow-up identified no new safety signals and no treatment-related deaths. Treatment-related immune-mediated diarrhea or colitis, the most common immune-mediated adverse event, resolved in 98% of affected patients. Data reported during the quarter also showed activity in checkpoint-refractory melanoma and in hepatocellular carcinoma following prior immunotherapy. Previously reported data include the following. In our randomized Phase 2 trial reported at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in January 2025, the BOT 75 mg plus BAL regimen achieved a 19% objective response rate and a 55% disease control rate in heavily pretreated patients with refractory MSS metastatic colorectal cancer without active liver metastases, with no objective responses observed in the control arm. Pan-tumor data from more than 400 heavily pretreated patients in the Phase 1b C-800-01 study, presented in October 2025, showed approximately 39% two-year overall survival and median overall survival of 17.2 months across multiple tumor types. Sarcoma data published in the Journal of Clinical Oncology in January 2025 (n=52) showed a 19.2% overall response rate, with 27.8% in angiosarcoma. Ovarian cancer data published in the Journal for ImmunoTherapy of Cancer in December 2025 showed a 23% overall response rate and 14.8 months median overall survival in heavily pretreated patients. 25 BOT, alone and in combination with BAL, has been evaluated in approximately 1,300 patients across more than 60 centers worldwide and across nine tumor types, including colorectal cancer, sarcoma, non-small cell lung cancer, hepatocellular cancer, pancreatic cancer, melanoma, ovarian cancer and triple-negative breast cancer. Patient Access Programs In France, BOT/BAL is available under the national Autorisation d'Accès Compassionnel ("AAC") framework for eligible patients in MSS metastatic colorectal cancer without active liver metastases (added September 2025), platinum-resistant or platinum-refractory ovarian cancer (added January 2026), and certain advanced soft-tissue sarcomas (added January 2026). Treatment under the AAC framework is reimbursed through the French national health system. Outside France, BOT/BAL may be available in select countries through paid named-patient programs initiated by treating physicians and governed by local regulations and national reimbursement or coverage frameworks. In April 2026, we named BAP Pharma as our global distribution partner to support BOT/BAL access programs end-to-end, including request coordination, regulatory navigation, distribution logistics and payment processing. These programs are physician-driven and are not promotional. They do not constitute marketing approval, may be modified or discontinued by applicable authorities, and do not assure future regulatory approvals. Zydus Collaboration In January 2026, we closed the strategic collaboration with Zydus Lifesciences Ltd. ("Zydus"), under which we sold our Emeryville and Berkeley biologics manufacturing facilities and received $91.0 million in cash consideration at closing, comprising $75.0 million for the facilities and a $16.0 million equity investment in Agenus common stock. The collaboration also includes an exclusive license for Zydus to develop and commercialize BOT and BAL in India and Sri Lanka, with Agenus eligible to receive royalties on net sales in those territories, and provides for up to $50.0 million in additional contingent payments tied to BOT and BAL production orders restricted to services provided to us by Zydus. In March 2026, the conditions for the first payment into escrow of $20.0 million (only for use in making payments to Zydus), reflecting the total value of the first tranche of clinical supply expected to be delivered by Zydus in 2026, were met based on contracted work orders for BOT/BAL chemistry, manufacturing and controls and production activities. The Zydus collaboration secures dedicated, long-term U.S. biologics manufacturing capacity to support clinical development, authorized access programs and potential future commercial supply. See Note R to our Condensed Consolidated Financial Statements for additional information. Legal Proceedings On May 4, 2026, the U.S. Securities and Exchange Commission informed the Company that it has concluded its investigation as to the Company and does not intend to recommend an enforcement action against the Company. On March 24, 2026, the U.S. District Court for the District of Massachusetts granted the Company's motion to dismiss the related putative securities class action in its entirety. The lead plaintiff has appealed to the U.S. Court of Appeals for the First Circuit, and briefing in the appeal commenced in June 2026. See Note S to our Condensed Consolidated Financial Statements and Part II, Item 1 (Legal Proceedings) for additional information. Our strategy is to focus capital on execution of programs that we believe have the clearest path to meaningful clinical and commercial value, led by BOT/BAL in colorectal and colon cancer and selected other tumor types. We maintain manufacturing flexibility through strategic collaborations, with an emphasis on our Zydus collaboration. Our internal discovery and translational platforms support target identification, antibody generation, biomarker analysis and candidate selection, and have supported development of agents directed to CTLA-4, PD-1, CD137, CD73/TGF-beta, ILT2, LAG-3, TIM-3 and TIGIT, all of which remain proprietary assets of Agenus. Historical Results of Operations Three months ended June 30, 2026 compared to the three months ended June 30, 2025 Pre-commercial product revenue We recognized pre-commercial product revenue of approximately $6.4 million during the three months ended June 30, 2026, representing sales of BOT/BAL provided to patients through regulatory-authorized early access pathways under both France’s Authorisation d’Accès Compassionnel ("AAC") framework and paid named patient programs ("NPPs"), where permitted. Non-cash royalty revenue related to the sale of future royalties 26 In January 2018, we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant to HCR. As described in Note H 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. Non-cash royalty revenue related to our agreement with GSK increased $3.3 million, to approximately $28.1 million for the three months ended June 30, 2026, from $24.8 million for the three months ended June 30, 2025, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant. 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 decreased 45% to $14.8 million for the three months ended June 30, 2026 from $26.7 million for the three months ended June 30, 2025. The decreased expenses in the three months ended June 30, 2026 primarily relate to a $4.5 million decrease in personnel related expenses, substantially due to a decrease in headcount due to the sale of our manufacturing operations to Zydus in January 2026, a $3.1 million decrease in other research and development expenses, primarily attributable to a decrease in facility and depreciation expense due to the sale of our manufacturing operations to Zydus in January 2026, and a $4.3 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK. General and administrative expense General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 45% to $8.5 million for the three months ended June 30, 2026 from $15.5 million for the three months ended June 30, 2025. The decreased expenses in the three months ended June 30, 2026 primarily relate to a $1.1 million decrease in personnel related expenses, substantially due to a decrease in headcount due to the sale of our manufacturing operations to Zydus in January 2026 partially offset by an increase in share-based compensation expense, a $1.4 million decrease in professional fees, mainly due to a decrease in external legal expenses, a $1.9 million decrease other general and administrative expenses, primarily attributable to a decrease in facility and depreciation expense due to the sale of our manufacturing operations to Zydus in January 2026, and a $2.8 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK. MiNK Therapeutics, Inc. equity method investment fair value adjustment The MiNK Therapeutics, Inc. equity method investment fair value adjustment of $2.5 million for the three months ended June 30, 2026, represents the fair value adjustment for our remaining investment in MiNK, for which we have elected the fair value option. The fair value of our equity investment is based on readily determinable pricing available on a securities exchange. Interest expense, net Interest expense, net increased to approximately $15.2 million for the three months ended June 30, 2026 from $13.3 million for the three months ended June 30, 2025, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR, primarily attributable to increased sales forecasts of GSK’s vaccines containing our STIMULON QS-21 adjuvant and an increase of the non-cash interest expense recorded in connection with our Ligand Purchase Agreement. Six months ended June 30, 2026 compared to the six months ended June 30, 2025 Pre-commercial product revenue We recognized pre-commercial product revenue of approximately $11.0 million during the six months ended June 30, 2026, representing sales of BOT/BAL provided to patients through regulatory-authorized early access pathways under both France’s Authorisation d’Accès Compassionnel ("AAC") framework and paid named patient programs ("NPPs"), where permitted. Non-cash royalty revenue related to the sale of future royalties In January 2018, we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant to HCR. As described in Note H 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 27 revenue. Non-cash royalty revenue related to our agreement with GSK increased $8.9 million, to approximately $57.3 million for the six months ended June 30, 2026, from $48.4 million for the six months ended June 30, 2025, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant. 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 decreased 45% to $26.6 million for the six months ended June 30, 2026 from $48.2 million for the six months ended June 30, 2025. The decreased expenses in the six months ended June 30, 2026 primarily relate to a 1.9 million decrease in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs and clinical trials, a $7.9 million decrease in personnel related expenses, substantially due to a decrease in headcount due to the sale of our manufacturing operations to Zydus in January 2026, a $5.6 million decrease in other research and development expenses, primarily attributable to a decrease in facility and depreciation expense due to the sale of our manufacturing operations to Zydus in January 2026, and a $6.3 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK. General and administrative expense General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 51% to $15.3 million for the six months ended June 30, 2026 from $31.2million for the six months ended June 30, 2025. The decreased expenses in the six months ended June 30, 2026 primarily relate to a $4.3 million decrease in personnel related expenses, substantially due to a decrease in headcount due to the sale of our manufacturing operations to Zydus in January 2026 and a decrease in share-based compensation expense, a $3.4 million decrease in professional fees, mainly due to a decrease in external legal expenses, a $3.5 million decrease other general and administrative expenses, primarily attributable to a decrease in facility and depreciation expense due to the sale of our manufacturing operations to Zydus in January 2026, and a $4.9 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK. MiNK Therapeutics, Inc. equity method investment fair value adjustment The MiNK Therapeutics, Inc. equity method investment fair value adjustment of $1.2 million for the six months ended June 30, 2026, represents the fair value adjustment for our remaining investment in MiNK, for which we have elected the fair value option. The fair value of our equity investment is based on readily determinable pricing available on a securities exchange. Gain on Zydus asset sale The $40.4 million gain recognized at the closing of the Zydus transactions in January 2026 represents the total gain recognized from the Zydus Asset Purchase Agreement and Securities Purchase Agreement. This gain is not expected to recur. Refer to Note R to our Condensed Consolidated Financial Statements for additional detail. Interest expense, net Interest expense, net increased to approximately $29.9 million for the six months ended June 30, 2026 from $26.1 million for the six months ended June 30, 2025, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR, primarily attributable to increased sales forecasts of GSK’s vaccines containing our STIMULON QS-21 adjuvant and an increase of the non-cash interest expense recorded in connection with our Ligand Purchase Agreement. 28 Research and Development Programs For the six months ended June 30, 2026, 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 Development Program Product 2026 2025 2024 2023 Antibody programs Various $ 18,491 $ 55,493 $ 113,135 $ 178,445 Vaccine adjuvant STIMULON cpcQS-21 158 1,638 1,844 10,296 Cell therapies Various — 3,282 7,558 16,283 Other research and development programs Various 7,932 18,925 32,991 29,545 Total research and development expenses $ 26,581 $ 79,338 $ 155,528 $ 234,569 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. Liquidity and Capital Resources We have incurred annual operating losses since inception, and we had an accumulated deficit of $2.1 billion as of June 30, 2026. 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 through June 30, 2026, we have raised aggregate net proceeds of approximately $2.08 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. Cash Position and Outstanding Debt We had cash and cash equivalents of $18.7 million as of June 30, 2026, compared with $3.0 million as of December 31, 2025. That balance excludes the $7.6 million held in escrow under the Zydus agreements, including $0.1 million of accrued interest, and excludes outstanding receivables under our early access programs, which we expect to collect during the third quarter of 2026. As of June 30, 2026, we had debt outstanding of $30.4 million in principal, of which $24.75 million is due November 2026 and $5.1 million is due January 2027. See Note G. Sources of Capital During the six months ended June 30, 2026, MiNK repaid a $5.2 million related-party note receivable, and we closed agreements with Zydus under which we received $91.0 million of consideration, subject to adjustments for reimbursable expenses, other required closing payments, including approximately $5.8 million of transaction expenses, and $7.5 million placed into a twelve-month escrow. See Note R. We maintain an effective registration statement (the “Registration Statement”) covering up to $300.0 million of common stock, preferred stock, warrants, debt securities and units. The Registration Statement includes prospectuses covering the offer, issuance and sale of up to 20.6 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”) with B. Riley Securities, Inc. as our sales agent. We sold approximately 3.9 million shares of our common stock pursuant to the Sales Agreement during the six months ended June 30, 2026 and received aggregate net proceeds totaling $15.1 million. 29 We have incurred significant losses since our inception in 1994. As of June 30, 2026, we had an accumulated deficit of $2.1 billion. The Private Placement closed on July 15, 2026 and provided approximately $85.0 million in upfront gross proceeds, before deducting Private Placement expenses. The accompanying Series A Warrants and Series B Warrants, if exercised in full, would provide up to an additional $255.0 million in gross proceeds. The Series A Warrants expire upon the earlier of the fifth anniversary of the closing date and 30 days following the Company’s public disclosure that at least 60 patients have been dosed in ROBBIN. The Series B Warrants expire upon the earliest of the fifth anniversary of the closing date, 30 days following the Company’s public disclosure of pathologic response data for at least 50 patients dosed in ROBBIN, and, unless the holder has by that time exercised its Series A Warrant in full, immediately following the expiration date of the Series A Warrants. Exercise of the warrants is at the discretion of the holders, and no assurance can be given that the Company will receive any additional warrant proceeds. See Note U. Funding Outlook and Going Concern Based on our current operating plan and projections, including scheduled debt payments in the look-forward period (the majority of which is secured by certain real estate properties), we believe our existing cash and cash equivalents, together with the net proceeds from the Private Placement, are expected to fund operations and capital expenditure requirements into the third quarter of 2027, assuming no exercise of the Series A or Series B Warrants. That plan reflects anticipated revenues from our early access programs and scheduled debt payments in the look-forward period. If all such warrants are exercised for cash, the Company expects these resources to fund operations through year-end 2031. Advancing our planned registration and commercialization strategy for BOT/BAL, and funding the Company through achievement of profitability, will require additional capital. We are actively pursuing additional financing and strategic alternatives, including corporate transactions, out-licensing arrangements, asset sales, project financing, additional debt or equity financings, and other strategic transactions, and we are in active discussions with potential strategic and financial partners regarding several of these alternatives. We have also implemented cost management measures to preserve liquidity. Because the timing and completion of these transactions are not entirely within our control, in accordance with applicable accounting standards, substantial doubt exists about our ability to continue as a going concern for at least one year after the filing date of this Quarterly Report on Form 10-Q. The consolidated financial statements have been prepared assuming we will continue as a going concern and contemplate the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business. We have also implemented cost management measures to preserve liquidity. Contractual Commitments Our operating expenses for the six months ended June 30, 2026, include cash and non-cash expenses. Non-cash expenses for the period include share-based compensation expense, depreciation and amortization expense and certain other non-cash items. Operating expenses in the first quarter also included expenses associated with our manufacturing facilities in the period before the facilities were sold to Zydus and costs incurred for services provided by Zydus that will be settled through the first contingent payment under the Zydus Purchase Agreement. 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 $690.7 million over the term of the related activities. Through June 30, 2026, we have expensed $630.5 million as research and development expenses and $593.4 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, including ROBBIN. 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. Cash Flows 30 Net cash used in operating activities for the six months ended June 30, 2026 and 2025 was $67.2 million and $45.8 million, respectively. Net cash used in operating activities increased principally because of working-capital changes, including a $24.0 million reduction in accounts payable and a $12.9 million increase in accounts receivable, including receivables associated with our early access programs. These outflows more than offset the benefit of the reduced operating-expense base during the period. Net cash provided by investing activities for the six months ended June 30, 2026 was $69.2 million, driven principally by $63.9 million of net proceeds from the Zydus asset sale and $5.0 million from the repayment of the MiNK related party note. Net cash provided by financing activities for the six months ended June 30, 2026 was $13.7 million, consisting principally of $15.1 million of net proceeds from at-the-market sales of common stock and $6.4 million of net proceeds from the sale of common stock under the Zynext SPA, partially offset by $8.4 million of debt repayment. 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 of this Quarterly Report on Form 10-Q and the risks highlighted in Part I, Item 1A "Risk Factors" of our 2025 Form 10-K. Item 3. Quantitative and Qualitative Disclosures About Market Risk Not required for smaller reporting companies.