Immunome Inc. 10-Q

Item 2. Management’s Discussion an d Analysis of Financial Condition and Results of Operations You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our audited financial statements and notes thereto and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2025. Unless otherwise indicated, all references in this Quarterly Report on Form 10-Q to “Immunome,” the “company,” “we,” “our,” “us” or similar terms refer to Immunome, Inc. and its subsidiary. Forward-Looking Statements In addition to historical financial information, this discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in the section titled “Risk Factors” under Part II, Item 1A below. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “should,” “will” or the negative of these terms or other similar expressions. Furthermore, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. Overview We are a biotechnology company committed to the development of first-in-class and best-in-class targeted oncology therapies. Our goal is to establish a broad portfolio of differentiated clinical assets to improve the lives of cancer patients. Key to that strategy is our deep expertise in the discovery, design, development, manufacturing, and ultimately commercialization of antibody-drug conjugates and other oncology therapeutics. We are advancing a pipeline that includes four clinical assets and two preclinical assets. Varegacestat, formerly AL102, is an investigational, oral, once-daily gamma secretase inhibitor, or GSI. In December 2025, we announced positive topline results from the global pivotal Phase 3 RINGSIDE trial of varegacestat in patients with progressing desmoid tumors. We submitted a new drug application, or NDA, for varegacestat in April 2026, and we plan to submit a marketing authorization application, or MAA, with the European Medicines Agency, or EMA, by the end of 2026. IM-1021, a receptor tyrosine kinase-like orphan receptor 1, or ROR1, antibody-drug conjugate, is currently under evaluation in a Phase 1 trial. In November 2025, we reported observed objective responses at multiple dose levels in B-cell lymphoma patients treated with IM-1021, and we plan to share initial lymphoma data in 2026. IM-3050 is a fibroblast activation protein, or FAP, targeted radioligand therapy, or RLT. In March 2026, we initiated the first site for a Phase 1 trial of IM-3050 in patients with FAP-expressing solid tumors. IM-1617, a first-in-class ADC, received initial new drug, or IND, clearance in April 2026, and we plan to initiate a Phase 1 trial in the second quarter of 2026. Our preclinical assets include two solid tumor ADCs with anticipated 2026 IND submissions: IM-1340, and IM-1335. Our pipeline also includes numerous early-stage ADCs produced by our internal discovery efforts, providing opportunities for additional IND submissions in 2027 and beyond. Our approach to discovery centers on designing ADCs against novel or underexplored targets, which we believe provides a path to significant clinical benefit and meaningful market opportunities. HC74, our differentiated, novel topoisomerase 1, or TOP1, inhibitor payload, supports this strategy, and we have efforts underway to develop additional linkers and payloads with favorable safety and efficacy profiles. We believe that combining novel targets with a broad toolbox of linkers and payloads supports our mission to design and develop a diverse pipeline of ADCs that address unmet medical need. 17 Table of Contents Our current programs Varegacestat (formerly AL102) Our lead clinical asset is varegacestat, an investigational, oral, once-daily GSI therapy under evaluation for the treatment of desmoid tumors. In December 2025, we reported positive Phase 3 RINGSIDE (Part B) topline results showing that the study met all primary and key secondary endpoints. Varegacestat achieved the primary endpoint of progression free survival, delivering an 84% reduction in the risk of disease progression or death versus placebo (HR=0.16, p<0.0001). The confirmed objective response rate, or ORR, based on RECIST v1.1 was 56% with varegacestat vs. 9% with placebo (p<0.0001), as assessed by blinded independent central review. In an exploratory analysis, varegacestat demonstrated a median best change in tumor volume of -83% vs. +11% with placebo, as assessed by blinded independent central review. In addition, the trial met all key secondary endpoints, with varegacestat achieving statistically significant improvements vs. placebo in landmark tumor volume reduction and worst pain intensity. The Phase 3 RINGSIDE topline and Phase 2 RINGSIDE data also show that varegacestat has a safety profile consistent with other GSI therapies. We acquired varegacestat from Ayala Pharmaceuticals, Inc., or Ayala, in March 2024. We submitted an NDA for varegacestat in April 2026, and we plan to submit an MAA with the EMA by the end of 2026. IM-1021 (Solid Tumor and B-Cell Lymphoma ADC) IM-1021 is a ROR1 ADC that incorporates HC74, our proprietary TOP1i payload. ROR1 is expressed in both hematologic malignancies and solid tumors with limited normal tissue expression. Previous ADCs targeting ROR1 have demonstrated clinical activity. We believe that IM-1021 may provide improved therapeutic index as compared to other ROR1-targeted ADCs in development. The Phase 1 clinical trial is ongoing, with objective responses observed in participants with B-cell lymphomas at multiple dose levels. We expect to present initial lymphoma data for IM-1021 in 2026. IM-3050 (FAP Radioligand Therapy) IM-3050 is a FAP-targeted lutetium-177, Lu-177 or 177Lu, RLT product candidate for the treatment of solid tumors. FAP is a cell surface protease that serves as a tumor-specific marker due to its broad expression on cancer associated fibroblasts, the most common tumor stromal cell. FAP is expressed in 75% of solid tumors. IM-3050 is designed to deliver radioactive 177Lu directly to FAP-expressing cells, where the “bystander” effect of the radiation may damage or kill nearby tumor cells. We believe this RLT approach could overcome the limitations, such as poor internalization and low expression on tumor cells, that make FAP an unsuitable target for ADCs. In vivo data show single dose antitumor activity and tolerability. In March 2026, we initiated the first site for a Phase 1 trial of IM-3050 in patients with FAP-expressing solid tumors. IM-1617 (Solid Tumor ADC) IM-1617 is a potential first-in-class ADC that targets an undisclosed receptor that is preferentially expressed in a broad array of solid tumors, including colorectal cancer, or CRC, non-small cell lung cancer, or NSCLC, and breast and ovarian cancers. The target is a receptor tyrosine kinase that promotes tumor cell survival and mediates immune cell exclusion, providing potential for a secondary mechanism of action. We received IND clearance for this program in April 2026 and plan to initiate a Phase 1 trial in the second quarter of 2026. IM-1340 (Solid Tumor ADC) IM-1340 is a potential first-in-class ADC for the treatment of multiple solid tumors. The target of IM-1340 is underexplored and non-obvious in cancer and, to our knowledge, there are no ADCs or other therapeutic modalities in development against it. It has a unique expression profile that spans neuroendocrine tumors, or NETs, and other carcinomas, including lung and prostate tumors, with limited expression in normal tissue. IND-enabling work for IM-1340 is ongoing and we expect to submit an IND for this program to the FDA in mid-2026. IM-1335 (Solid Tumor ADC) IM-1335 is being developed for the treatment of solid tumor indications. It shares a target with a competitor’s now-discontinued investigational ADC that showed clinical activity prior to discontinuation. Our goal in designing IM-1335 was to optimize the safety and efficacy through a deep understanding of target biology and ADC optimization. We identified limitations that we expect contributed to the failure of the prior ADC against this target, and we believe that IM-1335 overcomes these limitations. IND-enabling work for IM-1335 is ongoing and we expect to submit an IND for this program to the FDA in late 2026. 18 Table of Contents Other Programs and Platforms In addition to the already described current programs, we expect to continue to invest in discovery efforts intended to expand our pipeline. Additional ADC programs are the primary focus of these efforts. We believe that our team’s ADC expertise positions us to develop the next generation of transformative ADCs. This expertise comprises executive leadership with a proven record of success, an ADC-focused discovery team with deep experience in ADC design, and a seasoned development team whose members spearheaded the development of multiple FDA-approved ADCs. We pair our portfolio of antibodies to potential first-in-class ADC targets with rigorous target selection based on a deep understanding of target biology. That target-driven approach is complemented by HC74, our differentiated, proprietary TOP1i payload and our optimized, proprietary linkers. Components of our results of operations Collaboration revenue We have not generated any revenue from product sales and do not expect to do so for the foreseeable future. To date, we have generated our revenue through a Collaboration and Option Agreement, or the Collaboration Agreement, with AbbVie Global Enterprises Ltd., or AbbVie, which terminated in accordance with its terms in July 2025. Revenue recognized under the Collaboration Agreement consisted of payments received from AbbVie and was recognized over the performance period. No further collaboration revenue will be recognized under the Collaboration Agreement. Research and development expenses Research and development expenses consist of costs incurred in performing research and development activities, which include: • personnel-related expenses, including salaries, bonuses, benefits and share-based compensation for employees engaged in research and development functions; • expenses incurred in connection with the advancement of our programs and product candidates, including under agreements with consultants, contractors, contract research organizations, or CROs, and other third-party vendors and suppliers; • expenses to conduct clinical trials including regulatory and quality assurance; • the cost of process development, validation, and the manufacturing of drug supplies for use in our preclinical studies and clinical trials; • laboratory supplies and research materials and other infrastructure-related expenses; and • facilities, depreciation and amortization and other expenses which include direct and allocated expenses. We expense research and development costs as incurred. Advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the benefits are consumed. Research and development activities are central to our business model and may vary substantially from year to year and quarter to quarter depending on the stage of product development. For example, product candidates in later stages of clinical development generally have higher costs than those in earlier stages of development, primarily due to the size and cost of later-stage clinical trials compared to early development activities. We expect that our research and development expenses will increase substantially in connection with the continuation of our activities and new agreements. 19 Table of Contents General and administrative expenses General and administrative expenses consist primarily of salaries and other related costs, including share-based compensation for personnel in our executive, business development, and administrative functions. General and administrative expenses also include legal fees relating to intellectual property and corporate matters, professional fees for accounting, auditing, tax and consulting services, insurance costs, travel, direct and allocated facility related expenses and other operating costs. We anticipate that our general and administrative expenses will increase in the future to support increased and progressed research and development activities, activities to prepare for the potential commercialization of varegacestat, and increased activities and costs to operate as a public company. Interest income Interest income consists of interest earned on our marketable securities and on our cash and cash equivalent balances held with financial institutions. Results of operations Comparison of the three months ended March 31, 2026 and 2025 The following table summarizes our results of operations for the periods presented (in thousands): Three Months Ended March 31, 2026 2025 Change Collaboration revenue $ — $ 2,926 $ (2,926 ) Operating expenses: Research and development (1) 46,381 36,872 9,509 General and administrative (1) 12,950 10,690 2,260 Total operating expenses 59,331 47,562 11,769 Loss from operations (59,331 ) (44,636 ) (14,695 ) Interest income 5,492 2,996 2,496 Net loss $ (53,839 ) $ (41,640 ) $ (12,199 ) (1) Amounts include non-cash share-based compensation expense as follows (in thousands): Three Months Ended March 31, 2026 2025 Change Research and development $ 3,711 $ 2,434 $ 1,277 General and administrative 4,242 3,269 973 Total share-based compensation expense $ 7,953 $ 5,703 $ 2,250 Collaboration revenue There was no collaboration revenue for the three months ended March 31, 2026. Collaboration revenue for the three months ended March 31, 2025 related to certain research and development activities allocated to AbbVie. As of June 30, 2025, we had recognized all revenue and costs associated with our performance obligation under the agreement. 20 Table of Contents Research and development expenses Research and development expenses increased by $9.5 million, from $36.9 million for the three months ended March 31, 2025 to $46.4 million for the three months ended March 31, 2026. The table below summarizes the components of our research and development expenses for the periods presented (in thousands). For the three months ended March 31, 2026, we revised the presentation of our research and development expenses in the table below to align with how management evaluates our research programs and expenses. Prior period amounts have been reclassified to conform to the current year presentation. Three Months Ended March 31, 2026 2025 Change Direct research and development Varegacestat (1) $ 9,832 $ 14,387 $ (4,555 ) IM-1021 (2) 3,864 3,067 797 IM-3050 (3) 1,307 1,033 274 IM-1617 (4) 838 375 463 Other (5) 9,971 4,673 5,298 Indirect research and development (6) 20,569 13,337 7,232 Total $ 46,381 $ 36,872 $ 9,509 (1) The decrease for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was due primarily to a decrease in clinical trial activities following the readout of topline data for our Phase 3 trial in December 2025. (2) The increase for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was due primarily to an increase in clinical trial activities associated with our Phase 1 trial. (3) The increase for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was due primarily to an increase in activities associated with our planned Phase 1 trial. (4) The increase for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was due primarily to IND-enabling and clinical trial activities associated with our planned Phase 1 trial. (5) The increase for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was due primarily to increased IND-enabling activities for our product candidates. (6) The increase for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was due primarily to an increase in personnel related costs, including share-based compensation, in support of our product candidates and discovery programs. General and administrative expenses General and administrative expenses increased by $2.3 million, from $10.7 million for the three months ended March 31, 2025 to $13.0 million for the three months ended March 31, 2026. The increase was primarily a result of a $1.8 million increase in personnel-related costs from an increase in headcount, including a $1.0 million increase in share-based compensation. Interest income Interest income increased by $2.5 million from $3.0 million for the three months ended March 31, 2025 to $5.5 million for the three months ended March 31, 2026. The increase was primarily a result of higher cash and cash equivalent balances, partially offset by lower interest rates during the three months ended March 31, 2026 compared to the three months ended March 31, 2025. 21 Table of Contents Liquidity and capital resources Sources of liquidity To date, we have financed our operations primarily through sales of our equity securities. We have devoted substantially all our resources to research and development programs and to general and administrative costs to support our operations, raising capital, building our management team, building our intellectual property portfolio and entering and executing on collaborations and strategic transactions. To date, we have not generated any revenue from the commercial sale of products and do not expect to generate revenue from commercial sales unless and until we receive marketing approval for one or more of our product candidates . Since inception, we have incurred significant operating losses and negative cash flows from operations. Our net losses were $53.8 million and $41.6 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had cash and cash equivalents of $582.7 million and an accumulated deficit of $782.0 million. In January 2025, we issued and sold 22,258,064 shares of our common stock at $7.75 per share in a public offering for net proceeds of $161.7 million, after deducting underwriting discounts and commissions and offering expenses payable by us. In December 2025, we issued and sold 21,418,750 shares of our common stock at $21.50 per share in a public offering for net proceeds of $432.4 million, after deducting underwriting discounts and commissions and offering expenses payable by us. In May 2024, we entered into an “at the market” sales agreement, or the 2024 ATM Agreement, with TD Securities (USA) LLC, or TD Cowen, as sales agent, pursuant to which we may offer and sell from time to time shares of our common stock having an aggregate offering price of up to $200.0 million, or the ATM Shares . We have agreed to pay TD Cowen a commission of up to 3.0% of the aggregate gross proceeds from any ATM Shares sold through the 2024 ATM Agreement. As of March 31, 2026, we had sold an aggregate of 6,655,587 shares of common stock under the 2024 ATM Agreement for gross proceeds of $65.9 million and net proceeds of approximately $64.5 million, with approximately $134.1 million remaining available for future offerings. No shares of common stock were sold under the 2024 ATM Agreement during the three months ended March 31, 2026 and 2025. Cash flows The following table summarizes our sources and uses of cash for the three months ended March 31, 2026 and 2025 (in thousands): Three Months Ended March 31, 2026 2025 Cash used in operating activities $ (58,638 ) $ (53,055 ) Cash (used in) provided by investing activities (12,016 ) 5,089 Cash (used in) provided by financing activities (135 ) 162,228 Net (decrease) increase in cash and cash equivalents and restricted cash $ (70,789 ) $ 114,262 Operating activities Net cash used in operating activities for the three months ended March 31, 2026 was $58.6 million, consisting primarily of our net loss of $53.8 million and a net change in operating assets and liabilities of $13.6 million, partially offset by noncash charges of $8.8 million. The noncash charges primarily consisted of $8.0 million of share-based compensation. The change in operating assets and liabilities primarily consisted of an increase in accounts payable of $1.4 million, an increase in prepaid expenses and other assets of $5.1 million, and a decrease in accrued expenses and other current liabilities of $9.7 million. Net cash used in operating activities for the three months ended March 31, 2025 was $53.1 million, consisting primarily of our net loss of $41.6 million and a net change in operating assets and liabilities of $17.0 million, partially offset by noncash charges of $5.6 million. The noncash charges primarily consisted of $5.7 million of share-based compensation. The change in operating assets and liabilities primarily consisted of a decrease in accrued expenses and other current liabilities of $8.5 million, a decrease in accounts payable of $3.8 million, a decrease in deferred revenue of $2.9 million and an increase in prepaid expenses and other assets of $1.7 million. 22 Table of Contents Investing activities Net cash used in investing activities for the three months ended March 31, 2026 was $12.0 million, consisting of $9.0 million in payments related to in-process research and development (IPR&D) assets included in accrued expenses and other current liabilities as of December 31, 2025, and $3.0 million of purchases of property and equipment. Net cash provided by investing activities for the three months ended March 31, 2025 was $5.1 million, consisting of $15.0 million from maturities of marketable securities, partially offset by $6.2 million of upfront and milestone payments related to IPR&D assets and $3.7 million of purchases of property and equipment. Financing activities Net cash used in financing activities for the three months ended March 31, 2026 was $0.1 million, consisting of $0.4 million in payments related to offering costs from the December 2025 financing accrued as of December 31, 2025, partially offset by $0.2 million from the exercise of options. Net cash provided by financing activities for the three months ended March 31, 2025 was $162.2 million, consisting of gross proceeds of $172.5 million from the January 2025 financing and $0.2 million from the exercise of options, partially offset by offering costs of $10.5 million from the January 2025 financing. Funding requirements We expect our expenses to increase substantially in connection with our ongoing and future activities, particularly as we advance and expand our clinical development of varegacestat, seek regulatory approval for varegacestat, prepare for the commercialization of varegacestat, if approved, advance the clinical development of IM-1021, IM-3050, and IM-1617, continue the development of our other current product candidates and any future product candidates, and continue to pursue our business development strategy. We expect that our primary uses of capital will be for the potential commercial launch of varegacestat for the treatment of desmoid tumors, if approved, continued commercial development and manufacturing scale-up for varegacestat, continued clinical and preclinical development of other pipeline assets, as well as for working capital and other general corporate purposes including potential strategic transactions, legal and other regulatory compliance expenses, compensation and related expenses, risk management and general overhead costs. We expect that our existing cash and cash equivalents as of March 31, 2026 will be sufficient to fund our current and planned operating expenses and capital expenditures for at least 12 months from the filing date of this Quarterly Report on Form 10-Q. We will need additional financing to support our continuing operations and pursue our research and development strategy and commercialization of varegacestat, if approved. We have based these estimates on assumptions that may prove to be imprecise, and we may exhaust our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development of our programs, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the research and development of our programs and product candidates. Our future funding requirements will depend on many factors including: • the scope, progress, results and costs of discovery, preclinical development, manufacturing and clinical trials for programs and product candidates that we currently own and those that we may discover or acquire rights to in the future; • the costs, timing and outcome of regulatory review of the programs and product candidates we may develop; • the costs of future activities, including product sales, medical affairs, marketing, manufacturing, distribution, coverage and reimbursement for any programs or product candidates for which we receive regulatory approval; • the extent to which we acquire or in-license products, intellectual property and other technologies and the terms on which we acquire or in-license those assets; • the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights, and defending intellectual property-related claims and the success of our intellectual property portfolio; 23 Table of Contents • the success of our existing and any future license agreements, collaborations and other strategic transactions and the achievement of milestones or occurrence of other developments that trigger payments to or from us under any such agreements and transactions; and • the costs of operating as a public company. Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, including pursuant to the 2024 ATM Agreement, debt financings, collaborations, strategic alliances and licensing arrangements. As a result of wars, conflicts, trade wars, bank failures, inflationary pressures on the economy and monetary policy responses taken by government agencies and other macroeconomic and geopolitical factors, the global credit and financial markets have experienced extreme volatility, including diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth and uncertainty about economic stability. There can be no assurance that deterioration in credit and financial markets and confidence in economic conditions will not occur. If equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult to obtain, more costly and/or more dilutive. To the extent that we raise additional capital through the sale of equity, including pursuant to the 2024 ATM Agreement, or convertible debt securities, the ownership interest of any purchaser will be or could be diluted and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market programs and product candidates that we would otherwise prefer to develop and market ourselves. If we cannot obtain the necessary funding to support these activities on favorable terms, or at all, we will need to delay, scale back or eliminate some or all of our research and development programs, including our clinical and preclinical development of our product candidates. Contractual obligations and contingencies We have no material non-cancelable purchase commitments with service providers, as we have generally contracted on a cancelable, purchase order basis. Our expected material cash requirements do not include potential contingent payments that we may be required to pay upon the achievement of development, regulatory or commercial milestones pursuant to asset acquisitions and license agreements to which we are a party, nor do they include potential contingent payments upon the achievement of development, regulatory and commercial milestones or royalty payments that we may be required to make under license agreements we have entered into or may enter into with various entities pursuant to which we have in-licensed certain intellectual property. For further details on the potential contingent payments related to asset acquisitions and license agreements, see Note 7 to our condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q. Critical accounting policies and estimates There have been no material changes in our critical accounting policies and estimates from those disclosed in our Form 10-K for the fiscal year ended December 31, 2025. For a discussion of our critical accounting policies and estimates, refer to “ Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical accounting policies and estimates ” in Part II, Item 7 of our Form 10-K for the fiscal year ended December 31, 2025. Recent accounting pronouncements See Note 2, Summary of significant accounting policies , to our condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for more information regarding recently issued accounting pronouncements. 24 Table of Contents