Immunome, Inc.
PART I
Item 1. Business
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 three clinical assets and three 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 anticipate submitting a new drug application, or NDA, in the second quarter 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 data in 2026. IM-3050, a fibroblast activation protein, or FAP, targeted radioligand therapy, or RLT, received IND clearance in April 2025, and we plan to initiate a Phase 1 trial in early 2026 after delivery of third-party diagnostic radiotracer supply. Our preclinical assets include three solid tumor ADCs with anticipated 2026 IND submissions: IM-1617, 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. We believe that pursuing differentiated targets provides a path to significant clinical benefit and meaningful market opportunities. HC74, our differentiated, novel topoisomerase 1, or TOP1, inhibitor payload, supports this strategy. We have efforts underway to develop additional linkers and payloads and believe that a broad toolbox of linkers and payloads supports our mission to design and develop a diverse pipeline of ADCs with differentiated safety, efficacy, and tolerability profiles that address unmet medical need.
To expand and advance our innovative portfolio of therapeutics, we draw on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including the first ADCs commercialized for Hodgkin and T-cell lymphoma, urothelial cancer and cervical cancer.
Our Strategy
Our mission is to build an oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. Key elements of our business strategy are to:
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Immunome Pipeline
Varegacestat (formerly AL102)
Varegacestat is 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 (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 (Part A) 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.
Disease background
Desmoid tumors, also known as aggressive fibromatosis or desmoid-type fibromatosis, are rare, non-metastatic, locally aggressive sarcomas of fibroblastic origin. They often strike in young adulthood, with 1,000-1,650 patients diagnosed each year in the United States. Desmoid tumors can lead to debilitating pain, deformity, and life-threatening organ damage depending on location. Quality of life is a major challenge for people living with desmoid tumors, and a majority of patients experience chronic pain that can significantly limit physical functioning. Up to ~60-80% of patients experience recurrence, which can be exacerbated by surgery. Following progression during initial active surveillance, systemic therapy is recommended for ~75% of tumors based on location.
Desmoid tumors arise in connective tissue and can occur anywhere in the body where connective tissue is found. These tumors are locally aggressive, which means that while they do not metastasize to other parts of the body, they can grow into the surrounding or adjacent tissue. While some people with desmoid tumors do not experience symptoms, others may experience pain, swelling, difficulty sleeping and reduced mobility. Symptoms largely depend on the location of the tumor and the extent of invasion or compression of surrounding tissue. The pain and physical limitations associated with desmoid tumors can lead to high clinical burdens and reduced quality of life. Additionally, a study conducted in Denmark found that patients with desmoid tumors have substantially higher healthcare resource utilization compared with matched patients at one and three years post-diagnosis, including increases in both in-patient and out-patient visits as well as days of hospitalization.
The vast majority (85-90%) of desmoid tumors are sporadic and of these, 85% result from somatic mutations in the CTNNB1 gene, which encodes β-catenin protein. Desmoid tumors may also result from germline mutation of the APC gene, which is also associated with familial adenomatous polyposis, that leads to accumulation of β-catenin in the nucleus and drives overexpression of its target genes. Risk factors for developing desmoid tumors in patients with these mutations include trauma (especially abdominal surgery), estrogen, and pregnancy.
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Desmoid tumors exhibit a variable clinical course, but evidence suggests that the initial period of tumor growth is followed by a long period during which the tumor is stable or may even regress. The recurrence rate of desmoid tumors is associated with tumor location and underlying genetic mutation. For example, tumors on the extremities have recurrence rates of up to 77% and intra-abdominal tumors recur much more frequently than extra-abdominal tumors in patients with familial adenomatous polyposis. Risk factors for the initial development of desmoid tumors can also increase the risk of recurrence.
Prior to the November 2023 FDA approval of the GSI OGSIVEO® (nirogacestat) for the treatment of adult patients with progressing desmoid tumors who require systemic treatment, the treatment landscape for desmoid tumors included active surveillance, surgery, radiation therapy, low-dose or conventional chemotherapy, or tyrosine kinase inhibitors. Treatment considerations include tumor progression, symptoms, risk of morbidity, surgical risk, and the need for a fast response. The uptake of OGSIVEO® in the United States in the treatment of desmoid tumors demonstrates the potential for GSIs to address unmet need, and we believe that GSIs may ultimately capture much of the market for desmoid tumor therapy.
Proposed mechanism of action
Varegacestat is an investigational, oral, once-daily GSI. GSIs alter signaling through the Notch pathway, which is involved in embryonic development and the renewal and maintenance of adult tissues. Notch plays a critical role in the proliferation, survival, migration, invasion, and metastasis of cancer cells, which contribute to the development and progression of cancer. Notch also contributes to resistance to cancer therapeutics. Gamma secretase-mediated cleavage of Notch releases the Notch intracellular domain which travels to the nucleus and activates the genes that mediate oncologic behavior. Inhibition of gamma secretase by varegacestat may block this cleavage and inhibits Notch pathway activation.
Clinical development
Prior to the initiation of the Phase 3 RINGSIDE clinical trial of varegacestat in desmoid tumors, varegacestat clinical activity was observed in two clinical trials that enrolled adult participants with desmoid tumors. A Phase 1 dose-escalation clinical trial was conducted by Bristol-Myers Squibb, or BMS, in patients with solid tumors. In this trial, one patient with desmoid fibromatosis was enrolled. This patient demonstrated tumor shrinkage of 16.5% while on study. Based on these data and responses demonstrated with other GSIs, Ayala designed a seamless Phase 2/3 study called RINGSIDE to specifically evaluate the activity of varegacestat in participants with progressing desmoid tumors who required therapy. The Phase 2 portion of RINGSIDE enrolled 42 participants at three different dosing regimens of varegacestat: 2 mg once a day for two days every week, 4 mg once a day for two days every week and 1.2 mg once a day daily. Overall, the ORR in evaluable participants as measured by RECIST v1.1 by an independent radiologist was 64% for all doses tested. The 1.2 mg daily dosing cohort had an ORR of 75% in the evaluable population. Among participants in the intention-to-treat population, the overall response rate was 55% across all doses tested and the response rate was 64% for participants in the 1.2 mg daily dosing cohort. In this study, more rapid and deeper responses were achieved with 1.2 mg once-daily dosing compared with the other dosing schedules, as evaluated based on RECIST by blinded independent central review, or BICR, tumor volume, and T2W signal intensity. These data were reported in a poster presentation at ESMO in 2024.
Phase 3 RINGSIDE trial in desmoid tumors
The Phase 3 portion of RINGSIDE is a registrational, global, double-blind, randomized, placebo-controlled clinical trial, conducted at clinical sites in North America, Europe, Asia and Australia. It is designed to evaluate the efficacy, safety and tolerability of varegacestat compared to placebo in participants with progressing desmoid tumors. One hundred fifty-six participants with histologically confirmed desmoid tumors with progressive disease (defined as tumor growth of at least 20% within the past 12 months as measured by RECIST v1.1) were enrolled. Enrollment was completed in February 2024.
Enrolled participants were either treatment-naïve with desmoid tumors not amenable to surgery or had refractory or recurrent disease after at least one line of therapy. Participants in the study were randomized 1:1 and received either 1.2 mg varegacestat or placebo given once daily. Tumor progression was evaluated by RECIST v1.1 determined blinded independent central review (BICR). Participants who progress while on study are eligible to enter an open-label extension whereby they may receive varegacestat at a dose of 1.2 mg once daily until disease progression or unacceptable toxicity. The primary endpoint of Phase 3 RINGSIDE is progression-free survival with secondary endpoints of ORR, duration of response and specific patient-reported outcomes.
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In December 2025, we reported positive Phase 3 RINGSIDE topline results showing that the study met all primary and key secondary endpoints. Varegacestat achieved the primary endpoint of the Phase 3 RINGSIDE trial, delivering an 84% reduction in the risk of disease progression compared with placebo (HR=0.16, p<0.0001). To our knowledge, this is the lowest hazard ratio reported for a pivotal study in this population.
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Financial statements
data from SEC XBRL filings. Values are as-reported; restatements supersede originals. Values reported in .
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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.
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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.
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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:
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.
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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 |
) |
|
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.
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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 |
|
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.
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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.
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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:
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Recent insider activity
| Date | Insider | Role | Action | Shares | Price | Value |
|---|---|---|---|---|---|---|
| 2026-05-15 | BIENAIME JEAN JACQUES | Director | Buy | +5,000 | $20.70 | $103,500 |
| 2026-04-02 | Rosett Max | Chief Financial Officer | Sell | -65,000 ×2 | $21.92 | -$1,424,916 |
| 2026-04-02 | Higgins Jack | Chief Scientific Officer | Sell | -9,438 | $21.64 | -$204,238 |
| 2026-03-27 | SIEGALL CLAY B | President and CEO | Buy | +25,450 | $19.67 | $500,602 |
| 2026-03-23 | WAGENHEIM PHILIP | Director | Sell | -28,200 | $20.65 | -$582,330 |
| 2026-03-20 | WAGENHEIM PHILIP | Director | Sell | -36,800 | $20.47 | -$753,296 |
| 2026-03-11 | BIENAIME JEAN JACQUES | Director | Buy | +1,000 | $21.55 | $21,550 |
| 2026-03-10 | BIENAIME JEAN JACQUES | Director | Buy | +1,000 | $22.12 | $22,120 |
Source: SEC Form 4 filings.
Next expected filings
- ~2026-08-06 10-Q expected by 2026-08-10 (in 73 days)
- ~2026-11-06 10-Q expected by 2026-11-10 (in 165 days)
- ~2027-02-22 10-K expected by 2027-03-03 (in 273 days)
- ~2027-05-12 10-Q expected by 2027-05-16 (in 352 days)
Predicted from historical filing cadence; not an SEC commitment.
Recent SEC filings
- 2026-05-12 8-K Earnings Release; Financial Statements and Exhibits
- 2026-05-12 10-Q Quarterly Report
- 2026-04-24 DEF 14A Proxy Statement
- 2026-03-03 10-K Annual Report
- 2026-03-03 8-K Earnings Release; Financial Statements and Exhibits
- 2025-12-17 8-K Other Events; Financial Statements and Exhibits
- 2025-12-15 8-K Regulation FD Disclosure; Other Events; Financial Statements and Exhibits
- 2025-11-06 10-Q Quarterly Report
- 2025-11-06 8-K Earnings Release; Financial Statements and Exhibits
- 2025-08-06 10-Q Quarterly Report
- 2025-08-06 8-K Earnings Release; Financial Statements and Exhibits
- 2025-05-12 10-Q Quarterly Report
- 2025-05-12 8-K Earnings Release; Other Events; Financial Statements and Exhibits
- 2025-03-19 10-K Annual Report
- 2025-03-19 8-K Earnings Release; Financial Statements and Exhibits