Immunome Inc.

Previous wording

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.

Current wording

We are a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class cancer 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, or ADCs, and other oncology therapeutics.

Previous wording

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, which has been accepted by the U.S. Food and Drug Administration, or FDA, and assigned a Prescription Drug User Fee Act, or PDUFA, target action date of April 28, 2027. Additionally, 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. In June 2026, we dosed the first participant in a Phase 1 trial of IM-1617, a potential first-in-class ADC, in patients with advanced solid tumors. IM-3050 is a fibroblast activation protein, or FAP, targeted radioligand therapy, or RLT. In July 2026, we dosed the first participant in a Phase 1 trial of IM-3050 in patients with FAP-expressing solid tumors. Our preclinical assets include two solid tumor ADCs with anticipated 2026 IND submissions: IM-1340, and IM-1335.

Current wording

We are advancing a broad portfolio of clinical and 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, which has been accepted by the U.S. Food and Drug Administration, or FDA, and assigned a Prescription Drug User Fee Act, or PDUFA, target action date of April 28, 2027. Additionally, we submitted a marketing authorization application, or MAA, with the European Medicines Agency, or EMA, in October 2026. The EMA has validated the MAA and will initiate review under the centralized marketing authorization procedure. IM-1021, a receptor tyrosine kinase-like orphan receptor 1, or ROR1, ADC, is currently under evaluation in a Phase 1 trial. Initial data from the ongoing Phase 1 trial of IM-1021 showed objective responses across all dose levels evaluated in heavily pretreated patients with B-cell non-Hodgkin lymphoma, or B-NHL. In June 2026, we dosed the first participant in a Phase 1 trial of IM-1617, a potential first-in-class ADC, in patients with advanced solid tumors. IM-3050 is a fibroblast activation protein, or FAP, targeted radioligand therapy, or RLT. In July 2026, we dosed the first participant in a Phase 1 trial of IM-3050 in patients with FAP-expressing solid tumors. IM-1340, a potential first-in-class ADC, received investigational new drug, or IND, clearance in September 2026, and we plan to initiate a Phase 1 trial in patients with advanced solid tumors by the end of 2026. IM-1335, a solid tumor ADC, is in preclinical development with an anticipated IND submission in late 2026.

Previous wording

We acquired varegacestat from Ayala Pharmaceuticals, Inc., or Ayala, in March 2024. We submitted an NDA for varegacestat in April 2026. In July 2026, the FDA accepted the NDA and assigned a PDUFA target action date of April 28, 2027. We plan to submit an MAA with the EMA by the end of 2026.

Current wording

We acquired varegacestat from Ayala Pharmaceuticals, Inc., or Ayala, in March 2024. We submitted an NDA for varegacestat in April 2026. In July 2026, the FDA accepted the NDA and assigned a PDUFA target action date of April 28, 2027. We submitted an MAA with the EMA in October 2026. The EMA has validated the MAA and will initiate review under the centralized marketing authorization procedure.

Previous wording

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.

Current wording

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. In November 2026, we announced that initial clinical data from the ongoing Phase 1 trial of IM-1021 will be presented in a poster at the 68th American Society of Hematology, or ASH, Annual Meeting. As of the abstract data cutoff of June 26, 2026, 35 patients had received IM-1021, including 25 patients with B-NHL. Patients with B-NHL had received a median of four prior lines of therapy, and prior T-cell redirecting therapy was common. The abstract reported objective responses across all dose levels evaluated in patients with B-NHL. Among 19 response-evaluable patients with B-NHL, the objective response rate, or ORR, was 53% (10/19), including five complete responses, or CRs, and five partial responses, or PRs. Among 11 response-evaluable patients with diffuse large B-cell lymphoma, or DLBCL, the ORR was 64% (7/11), including three CRs and four PRs. Treatment-emergent adverse events, or TEAEs, were reported in 92% of patients with B-NHL. The most common TEAE was neutropenia, reported in 44% of patients with B-NHL. Dose optimization across multiple dosing regimens remains ongoing.

Previous wording

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.

Current wording

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. We received IND clearance for this program in September 2026 and plan to initiate a Phase 1 trial in patients with advanced solid tumors by the end of 2026.

Previous wording

General and administrative expenses increased by $8.2 million, from $10.0 million for the three months ended June 30, 2025 to $18.3 million for the three months ended June 30, 2026. The increase was primarily related to increases in expenses related to commercialization readiness, as well as an increase in personnel-related costs including share-based compensation from an increase in headcount to support overall growth.

Current wording

General and administrative expenses increased by $9.9 million, from $10.9 million for the three months ended September 30, 2025 to $20.9 million for the three months ended September 30, 2026. The increase was primarily related to increases in expenses related to commercialization readiness, personnel-related costs including share-based compensation from an increase in headcount to support overall growth, and other professional services expenses.

Previous wording

Interest income increased by $1.9 million from $3.1 million for the three months ended June 30, 2025 to $5.0 million for the three months ended June 30, 2026. The increase was primarily a result of higher cash, cash equivalent, and marketable securities balances, partially offset by lower interest rates during the three months ended June 30, 2026 compared to the three months ended June 30, 2025.

Current wording

Interest income increased by $1.9 million from $2.7 million for the three months ended September 30, 2025 to $4.6 million for the three months ended September 30, 2026. The increase was primarily a result of higher cash, cash equivalent, and marketable securities balances, partially offset by lower interest rates during the three months ended September 30, 2026 compared to the three months ended September 30, 2025.

Previous wording

There was no collaboration revenue for the three months ended June 30, 2026. Collaboration revenue for the three months ended June 30, 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.

Current wording

There was no collaboration revenue for the nine months ended September 30, 2026. Collaboration revenue for the nine months ended September 30, 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.

Previous wording

The decrease for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 was due primarily to a decrease in clinical trial and manufacturing activities required to support our NDA filing in April 2026.

Current wording

The decrease for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025 was due primarily to a decrease in clinical trial and manufacturing activities required to support our NDA filing in April 2026.

Previous wording

The increase for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was due primarily to increased IND-enabling activities for our product candidates.

Current wording

The increase for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025 was due primarily to increased IND-enabling activities for our product candidates.

Previous wording

The increase for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was due primarily to an increase in personnel related costs, including share-based compensation and allocated support costs, in support of our product candidates and discovery programs.

Current wording

The increase for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025 was due primarily to an increase in personnel related costs, including share-based compensation and allocated support costs, in support of our product candidates and discovery programs.

Previous wording

General and administrative expenses increased by $10.5 million, from $20.7 million for the six months ended June 30, 2025 to $31.2 million for the six months ended June 30, 2026. The increase was primarily related to increases in expenses related to commercialization readiness, as well as an increase in personnel-related costs including share-based compensation from an increase in headcount to support overall growth.

Current wording

General and administrative expenses increased by $20.4 million, from $31.7 million for the nine months ended September 30, 2025 to $52.1 million for the nine months ended September 30, 2026. The increase was primarily related to increases in expenses related to commercialization readiness, personnel-related costs including share-based compensation from an increase in headcount to support overall growth, and other professional services expenses.

Previous wording

Interest income increased by $4.4 million from $6.1 million for the six months ended June 30, 2025 to $10.5 million for the six months ended June 30, 2026. The increase was primarily a result of higher cash, cash equivalent, and marketable securities balances, partially offset by lower interest rates during the six months ended June 30, 2026 compared to the six months ended June 30, 2025.

Current wording

Interest income increased by $6.3 million from $8.8 million for the nine months ended September 30, 2025 to $15.1 million for the nine months ended September 30, 2026. The increase was primarily a result of higher cash, cash equivalent, and marketable securities balances, partially offset by lower interest rates during the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025.

Previous wording

To date, we have not generated any revenue from the commercial sale of productsand 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 $73.1 million and $43.4 million for the three months ended June 30, 2026 and 2025, respectively, and $127.0 million and $85.0 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had cash and cash equivalents of $217.7 million, marketable securities of $302.3 million and an accumulated deficit of $855.1 million.

Current wording

To date, we have not generated any revenue from the commercial sale of productsand 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 $85.8 million and $57.5 million for the three months ended September 30, 2026 and 2025, respectively, and $212.7 million and $142.5 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had cash and cash equivalents of $212.8 million, marketable securities of $248.7 million and an accumulated deficit of $940.9 million.

Previous wording

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 June 30, 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 six months ended June 30, 2026.

Current wording

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 September 30, 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 nine months ended September 30, 2026.

Previous wording

The following table summarizes our sources and uses of cash for the six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our sources and uses of cash for the nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

Net cash used in operating activities for the six months ended June 30, 2026 was $120.3 million, consisting primarily of our net loss of $127.0 million and a net change in operating assets and liabilities of $11.7 million, partially offset by noncash charges of $18.3 million. The noncash charges primarily consisted of $16.8 million of share-based compensation. The change in operating assets and liabilities primarily consisted of an increase in prepaid expenses and other assets of $12.0 million, partially offset by an increase in accounts payable of $2.6 million.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2026 was $181.1 million, consisting primarily of our net loss of $212.7 million and a net change in operating assets and liabilities of $0.1 million, partially offset by noncash charges of $31.5 million. The noncash charges primarily consisted of $29.5 million of share-based compensation. The change in operating assets and liabilities primarily consisted of an increase in operating lease liabilities of $6.2 million, an increase in accrued expenses and other current liabilities of $4.0 million, and an increase in accounts payable of $1.1 million, partially offset by an increase in prepaid expenses and other assets of $11.3 million.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2025 was $102.5 million, consisting primarily of our net loss of $85.0 million and a net change in operating assets and liabilities of $28.8 million, partially offset by noncash charges of $11.4 million. The noncash charges primarily consisted of $11.1 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 $7.9 million, a decrease in accounts payable of $8.8 million, a decrease in deferred revenue of $6.9 million and an increase in prepaid expenses and other assets of $5.3 million.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2025 was $143.0 million, consisting primarily of our net loss of $142.5 million and a net change in operating assets and liabilities of $18.5 million, partially offset by noncash charges of $18.0 million. The noncash charges primarily consisted of $17.8 million of share-based compensation. The change in operating assets and liabilities primarily consisted of a decrease in accounts payable of $6.9 million, a decrease in deferred revenue of $6.9 million, an increase in prepaid expenses and other assets of $3.4 million and a decrease in accrued expenses and other current liabilities of $1.2 million.

Previous wording

Net cash used in investing activities for the six months ended June 30, 2026 was $316.4 million, consisting of $302.2 million of purchases of marketable securities, $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 $5.2 million of purchases of property and equipment.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2026 was $262.9 million, consisting of $302.2 million of purchases of marketable securities, $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 $5.7 million of purchases of property and equipment, partially offset by $54.0 million of maturities of marketable securities.

Previous wording

Net cash used in investing activities for the six months ended June 30, 2025 was $59.1 million, consisting of $123.3 million of purchases of marketable securities, $6.2 million of purchases of IPR&D assets and $4.6 million of purchases of property and equipment, partially offset by $75.0 million from maturities of marketable securities.

Current wording

Net cash provided by investing activities for the nine months ended September 30, 2025 was $64.8 million, consisting of $200.0 million from maturities of marketable securities, partially offset by $123.3 million of purchases of marketable securities, $6.2 million of purchases of IPR&D assets and $5.7 million of purchases of property and equipment.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2026 was $0.9 million, consisting of $1.3 million from the exercise of options, partially offset by $0.4 million in payments related to offering costs from the December 2025 financing accrued as of December 31, 2025.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2026 was $3.3 million, consisting of $3.7 million from the exercise of options, partially offset by $0.4 million in payments related to offering costs from the December 2025 financing accrued as of December 31, 2025.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2025 was $162.2 million, consisting of gross proceeds of $172.5 million from the January 2025 financing and $0.4 million from the exercise of options, partially offset by offering costs of $10.8 million from the January 2025 financing.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2025 was $207.6 million, consisting of gross proceeds of $172.5 million from the January 2025 financing, $45.9 million from the 2024 ATM Agreement, and $0.8 million from the exercise of options, partially offset by offering costs of $11.7 million from the January 2025 financing and the 2024 ATM Agreement.

Previous wording

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-1617, and IM-3050, 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.

Current wording

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 development of our broad pipeline of clinical assets, 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.

Previous wording

We expect that our existing cash, cash equivalents and marketable securities as of June 30, 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.

Current wording

We expect that our existing cash, cash equivalents and marketable securities 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.

Previous wording

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.

Current wording

Other than the foregoing, 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.