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Immunome Inc.

For the period ended Sep 30, 2025. Filed Nov 6, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 6, 2025

IMNM$18.71+4.5%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-06.

0000950170-25-104035

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-06.

0001193125-25-269603

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 109 previous paragraphs and 109 current paragraphs.

79 unchanged; 25 reworded; 5 added; 4 removed; 1 previous and 0 current paragraphs rearranged.

Tables are not compared: 7 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (5)

Current report

Research and development expenses increased by $12.0 million, from $37.2 million for the three months ended September 30, 2024 to $49.2 million for the three months ended September 30, 2025.

Current report

Comparison of the nine months ended September 30, 2025 and 2024

Current report

Research and development expenses increased by $44.9 million, from $81.7 million for the nine months ended September 30, 2024 to $126.5 million for the nine months ended September 30, 2025.

Current report

The increase for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was due primarily to clinical trial activities, as well as manufacturing and consulting activities associated with our Phase 3 trial and in preparation for potential a future NDA submission

Current report

The decrease for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was due primarily to the timing of outsourced research, manufacturing and IND-enabling activities. We received IND clearance for this program in April 2025.
Removed paragraphs (4)

Previous report

Research and development expenses increased by $11.4 million, from $29.1 million for the three months ended June 30, 2024 to $40.5 million for the three months ended June 30, 2025.

Previous report

Research and development expenses increased by $32.9 million, from $44.5 million for the six months ended June 30, 2024 to $77.3 million for the six months ended June 30, 2025.

Previous report

The increase for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was due primarily to manufacturing and clinical trial activities related to varegacestat, which we acquired from Ayala in March 2024.
Reworded paragraphs (25)

Previous wording

We are advancing a pipeline that includes three clinical assets and three preclinical assets. Varegacestat, formerly AL102, is an investigational gamma secretase inhibitor, or GSI, currently under evaluation in a Phase 3 clinical trial for the treatment of desmoid tumors. IM-1021, a receptor tyrosine kinase-like orphan receptor 1, or ROR1, antibody-drug conjugate, is currently under evaluation in a Phase 1 trial with the first patient dosed in February 2025. IM-3050, a fibroblast activation protein, or FAP, targeted radioligand therapy, or RLT, received IND clearance in April 2025 and we expect to initiate a Phase 1 trial in the second half of 2025. Our preclinical assets include three solid tumor ADC drug candidates: IM-1617, IM-1340, and IM-1335, all of which are undergoing IND-enabling activities. In addition, we have multiple ADCs currently undergoing lead optimization in advance of future development decisions.

Current wording

We are advancing a pipeline that includes three clinical assets and three preclinical assets. Varegacestat, formerly AL102, is an investigational gamma secretase inhibitor, or GSI, currently under evaluation in a Phase 3 clinical trial for the treatment of desmoid tumors. IM-1021, a receptor tyrosine kinase-like orphan receptor 1, or ROR1, antibody-drug conjugate, is currently under evaluation in a Phase 1 trial with the first patient dosed in February 2025. 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 ADC drug candidates: IM-1617, IM-1340, and IM-1335, all of which are advancing towards 2026 IND submissions. In addition, we have multiple ADCs currently undergoing lead optimization in advance of future development decisions.

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, and previous ADCs targeting ROR1 have demonstrated clinical activity. In preclinical studies, IM-1021 showed sustained tumor regression in preclinical models, including a mouse model of triple-negative breast cancer, or TNBC, and a mouse model of mantle cell lymphoma, or MCL. We believe that IM-1021 may provide improved therapeutic index as compared to other ROR1-targeted ADCs in development. IM-1021 received IND clearance in December 2024, and the Phase 1 clinical trial is ongoing with a starting dose of 2 mg/kg of adjusted ideal body weight. We expect dose escalation to include patients both with solid tumors and with B-cell lymphomas.

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, and previous ADCs targeting ROR1 have demonstrated clinical activity. In preclinical studies, IM-1021 showed sustained tumor regression in preclinical models, including a mouse model of triple-negative breast cancer, or TNBC, and a mouse model of mantle cell lymphoma, or MCL. 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 patients with B-cell lymphomas at multiple dose levels. We expect to present initial data for IM-1021 in 2026.

Previous wording

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. We received IND clearance for this program in April 2025 and expect to initiate a Phase 1 clinical trial in the second half of 2025.

Current wording

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. We received IND clearance for this program in April 2025 and plan to initiate a Phase 1 trial in early 2026 after delivery of third-party diagnostic radiotracer supply.

Previous wording

Collaboration revenue increased by $1.7 million, from $2.4 million for the three months ended June 30, 2024 to $4.0 million for the three months ended June 30, 2025. The increase was primarily due to an increase in certain research and development activities allocated to AbbVie during the three months ended June 30, 2025 compared to the same period in 2024. As of June 30, 2025, we have recognized all revenue and costs associated with our performance obligation under the agreement.

Current wording

There was no collaboration revenue for the three months ended September 30, 2025. Collaboration revenue for the three months ended September 30, 2024 of $2.9 million was related to certain research and development activities under the Collaboration Agreement with AbbVie. As of June 30, 2025, we had recognized all revenue and costs associated with our performance obligation under the agreement.

Previous wording

The increase for the three months ended June 30, 2025 compared to the three months ended June 30, 2024 was due primarily to increases in manufacturing and clinical trial activities related to varegacestat, which we acquired from Ayala in March 2024.

Current wording

The increase for the three months ended September 30, 2025 compared to the three months ended September 30, 2024 was due primarily to increases in consulting and manufacturing activities to support our Phase 3 trial and a potential future NDA submission.

Previous wording

General and administrative expenses increased by $7.7 million, from $13.0 million for the six months ended June 30, 2024 to $20.7 million for the six months ended June 30, 2025. The increase was primarily a result of a $5.2 million increase in personnel-related costs from an increase in headcount, including a $2.4 million increase in share-based compensation.

Current wording

General and administrative expenses increased by $1.4 million, from $9.5 million for the three months ended September 30, 2024 to $10.9 million for the three months ended September 30, 2025. The increase was primarily a result of a $1.6 million increase in personnel-related costs from an increase in headcount, including a $0.8 million increase in share-based compensation, which was partially offset by decreases in other general operating costs.

Previous wording

Interest income decreased by $0.8 million from $3.9 million for the three months ended June 30, 2024 to $3.1 million for the three months ended June 30, 2025. The decrease was primarily a result of lower interest rates during the three months ended June 30, 2025 compared to the three months ended June 30, 2024.

Current wording

Interest income decreased by $0.7 million from $3.4 million for the three months ended September 30, 2024 to $2.7 million for the three months ended September 30, 2025. The decrease was primarily a result of lower interest rates during the three months ended September 30, 2025 compared to the three months ended September 30, 2024.

Previous wording

Collaboration revenue increased by $3.5 million, from $3.4 million for the six months ended June 30, 2024 to $6.9 million for the six months ended June 30, 2025. The increase was primarily due to an increase in certain research and development activities allocated to AbbVie during the six months ended June 30, 2025 compared to the same period in 2024. As of June 30, 2025, we have recognized all revenue and costs associated with our performance obligation under the agreement.

Current wording

Collaboration revenue increased by $0.6 million, from $6.3 million for the nine months ended September 30, 2024 to $6.9 million for the nine months ended September 30, 2025. The increase was primarily due to an increase in certain research and development activities allocated to AbbVie during the nine months ended September 30, 2025 compared to the same period in 2024. As of June 30, 2025,we had recognized all revenue and costs associated with our performance obligation under the agreement.

Previous wording

There was no IPR&D expense for the six months ended June 30, 2025. IPR&D expense for the six months ended June 30, 2024 primarily related to the write-off of IPR&D assets that were acquired from Zentalis, Ayala and others and determined to have no alternative future use.

Current wording

There was no IPR&D expense for the nine months ended September 30, 2025. IPR&D expense for the nine months ended September 30, 2024 primarily related to the write-off of IPR&D assets that were acquired from Zentalis, Ayala and others and determined to have no alternative future use.

Previous wording

The decrease for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was due primarily to the timing of outsourced research, manufacturing and IND-enabling activities, partially offset by an increase in clinical trial activities as we initiated our Phase 1 trial in February 2025.

Current wording

The decrease for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was due primarily to the timing of outsourced research, manufacturing and IND-enabling activities, partially offset by an increase in clinical trial activities as we initiated our Phase 1 trial in February 2025.

Previous wording

The increase for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was due primarily to increased manufacturing activities for our product candidates, partially offset by reductions in recruiting, professional and contract laboratory services due to the replacement of certain outsourced services with internal resources.

Current wording

The increase for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was due primarily to increased manufacturing activities for our product candidates, partially offset by reductions in professional and contract laboratory services due to the replacement of certain outsourced services with internal resources.

Previous wording

The increase for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was due primarily to an increase in personnel and personnel-related costs in support of our product candidates and discovery programs.

Current wording

The increase for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was due primarily to an increase in personnel and personnel-related costs in support of our product candidates and discovery programs.

Previous wording

General and administrative expenses increased by $3.1 million, from $7.0 million for the three months ended June 30, 2024 to $10.0 million for the three months ended June 30, 2025. The increase was primarily a result of a $2.0 million increase in personnel-related costs from an increase in headcount, including a $0.9 million increase in share-based compensation.

Current wording

General and administrative expenses increased by $9.2 million, from $22.5 million for the nine months ended September 30, 2024 to $31.7 million for the nine months ended September 30, 2025. The increase was primarily a result of a $6.8 million increase in personnel-related costs from an increase in headcount, including a $3.2 million increase in share-based compensation.

Previous wording

Interest income decreased by $0.6 million from $6.7 million for the six months ended June 30, 2024 to $6.1 million for the six months ended June 30, 2025. The decrease was primarily a result of lower interest rates during the six months ended June 30, 2025 compared to the six months ended June 30, 2024.

Current wording

Interest income decreased by $1.4 million from $10.1 million for the nine months ended September 30, 2024 to $8.8 million for the nine months ended September 30, 2025. The decrease was primarily a result of lower interest rates during the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024.

Previous wording

To date, we have not generated any revenue from commercial sale of products and do not expect to generate revenue from commercial sales for the foreseeable future. Since inception, we have incurred significant operating losses and negative cash flows from operations. Our net losses were $43.4 million and $36.1 million for the three months ended June 30, 2025 and 2024, respectively, and $85.0 million and $165.6 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had cash, cash equivalents and marketable securities of $268.0 million and an accumulated deficit of $600.8 million.

Current wording

To date, we have not generated any revenue from commercial sale of products and do not expect to generate revenue from commercial sales for the foreseeable future. Since inception, we have incurred significant operating losses and negative cash flows from operations. Our net losses were $57.5 million and $47.1 million for the three months ended September 30, 2025 and 2024, respectively, and $142.5 million and $212.7 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had cash and cash equivalents of $272.6 million and an accumulated deficit of $658.3 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, 2025, we had sold an aggregate of 2,030,431 shares of common stock under the 2024 ATM Agreement for gross proceeds of $20.0 million and net proceeds of approximately $19.6 million, with approximately $180.0 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, 2025.

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. During the three and nine months ended September 30, 2025, the Company sold 4,625,156 shares of common stock in two transactions under the 2024 ATM Agreement for gross proceeds of $45.9 million and net proceeds of approximately $44.9 million. As of September 30, 2025, 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.

Previous wording

The following table summarizes our sources and uses of cash for the six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our sources and uses of cash for the nine months ended September 30, 2025 and 2024 (in thousands):

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 operating activities for the six months ended June 30, 2024 was $34.6 million, consisting primarily of our net loss of $165.6 million, partially offset by noncash charges of $123.7 million and a net change in operating assets and liabilities of $7.3 million. The noncash charges primarily consisted of $118.3 million of in-process research and development assets acquired without alternative future use and $5.4 million of share-based compensation. The change in operating assets and liabilities primarily consisted of an increase in accrued expenses and other current liabilities of $7.6 million, an increase in accounts payable of $2.4 million and a decrease in prepaid expenses and other assets of $0.9 million, partially offset by a decrease in deferred revenue of $3.4 million.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2024 was $68.7 million, consisting primarily of our net loss of $212.7 million, partially offset by noncash charges of $134.4 million and a net change in operating assets and liabilities of $9.6 million. The noncash charges primarily consisted of $125.0 million of in-process research and development assets acquired without alternative future use and $10.3 million of share-based compensation. The change in operating assets and liabilities primarily consisted of an increase in accrued expenses and other current liabilities of $13.5 million and a decrease in prepaid expenses and other assets of $2.3 million, partially offset by a decrease in deferred revenue of $6.3 million.

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 used in investing activities for the six months ended June 30, 2024 was $118.9 million, consisting primarily of $112.7 million of purchases of marketable securities, $41.7 million of purchases of IPR&D assets and $4.5 million of purchases of property and equipment, partially offset by $40.0 million from maturities of marketable securities.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2024 was $94.8 million, consisting primarily of $112.7 million of purchases of marketable securities, $46.1 million of purchases of IPR&D assets and $6.0 million of purchases of property and equipment, partially offset by $70.0 million from maturities of marketable securities.

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 2025 Financing and $0.4 million from the exercise of options, partially offset by offering costs of $10.8 million from the 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 2025 Financing, $45.9 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 2025 Financing and 2024 ATM Agreement.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2024 was $220.1 million, consisting of gross proceeds of $230.0 million from a follow-on public offering we completed in February 2024, or the 2024 Financing, and $4.8 million from the exercise of options and common stock warrants, partially offset by offering costs of $14.6 million from our 2024 Financing and 2024 ATM Agreement.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2024 was $220.4 million, consisting of gross proceeds of $230.0 million from a follow-on public offering we completed in February 2024, or the 2024 Financing, and $5.3 million from the exercise of options and common stock warrants, partially offset by offering costs of $14.8 million from our 2024 Financing and 2024 ATM Agreement.

Previous wording

We expect that our existing cash, cash equivalents and marketable securities as of June 30, 2025 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. 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 and cash equivalents as of September 30, 2025 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. 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

As of June 30, 2025, the market value of our common stock held by non-affiliates exceeded $700.0 million. As a result, effective December 31, 2025, we will be a large accelerated filer and thus will cease to be an emerging growth company. Additionally, we will no longer qualify as a smaller reporting company beginning with our first Quarterly Report on Form 10-Q for the quarterly period ending March 31, 2026. As a result of this transition, we will be subject to certain disclosure and compliance requirements that apply to other public companies that did not previously apply to us due to our status as an emerging growth company and smaller reporting company. These requirements include, but are not limited to: the requirement that our independent registered public accounting firm attest to the effectiveness of our internal control over financial reporting under Section 404 of the Sarbanes-Oxley Act of 2002; the requirement that we provide more detailed disclosures regarding executive compensation; and the requirement that we hold a non-binding advisory vote on executive compensation and obtain shareholder approval of any golden parachute payments not previously approved.

Current wording

As of June 30, 2025, the market value of our common stock held by non-affiliates exceeded $700.0 million. As a result, we will no longer be an emerging growth company effective as of December 31, 2025 or a smaller reporting company beginning with our Quarterly Report on Form 10-Q for the quarterly period ending March 31, 2026. Based on recent SEC guidance, we will, however, continue to be a non-accelerated filer through at least our fiscal year ending December 31, 2026. As a result of this transition, we will be subject to certain disclosure and compliance requirements that apply to other public companies that did not previously apply to us due to our status as an emerging growth company and smaller reporting company. These requirements include, but are not limited to: the requirement that we provide more detailed disclosures regarding executive compensation; and the requirement that we hold a non-binding advisory vote on executive compensation and obtain shareholder approval of any golden parachute payments not previously approved. We will not, however, be subject to the requirement that our independent registered public accounting firm attest to the effectiveness of our internal control over financial reporting under Section 404 while we are a non-accelerated filer.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

The decrease for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was due primarily to the timing of outsourced research, manufacturing and IND-enabling activities, partially offset by an increase in clinical trial start up activities as we work to initiate our Phase 1 trial. We received IND clearance for this program in April 2025.