Immunome Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 3 March 2026: press release. Guidance figures: 1 raised, 2 new, 3 kept. The quarter’s numbers.

Key takeaways

Net loss was $212.4 million: Net loss for 2025 was $212.4 million, against $293.0 million in 2024. Net loss per share was $(2.43), compared with $(5.00). Weighted-average shares rose to 87.35 million from 58.64 million. Source
Progression-free survival met primary endpoint: The hazard ratio of 0.16 (p<0.0001) corresponds to an 84% reduction in the risk of progression or death versus placebo, per the RINGSIDE trial. Source
Response rate higher than placebo: Objective response rate was 56% against 9% with placebo, by blinded independent central review. All key secondary endpoints were met. Source
IM-1021 shows responses in lymphoma: The Phase 1 trial of IM-1021, a ROR1 ADC, is ongoing. Objective responses were observed in B-cell lymphoma patients at multiple dose levels. Source
R&D expense rose to $177.3 million: R&D expense was $177.3 million, against $129.5 million in 2024. It included $11.2 million of share-based compensation, against $5.1 million. Source
Cash rose to $653.5 million: Cash and cash equivalents were $653.5 million at year end, against $143.4 million at December 31, 2024. Marketable securities of $74.0 million were held at the prior year end. Source

“Immunome made substantial progress in 2025. The positive Phase 3 RINGSIDE results represent a significant milestone for patients living with desmoid tumors and will support our planned NDA submission for varegacestat in the second quarter of 2026.”
Clay B. Siegall, Ph.D., President and Chief Executive Officer

Guidance

Area	Period	Figure	Against last quarter
Varegacestat regulatory filing Source	2Q 2026	second quarter of 2026	New
Cash runway Source	From the current cash position	into 2028	Raised from into 2027
IM-1021 initial data Source	2026	in 2026	Kept
Preclinical ADC IND submissions Source	2026	early, mid, and late-2026, respectively (IM-1617, IM-1340, IM-1335)	Kept
Additional ADC IND submissions Source	2027 and beyond	INDs in 2027 and beyond	New
IM-3050 Phase 1 start Source	Early 2026	early 2026	Kept

What changed from last quarter

Guidance raised: Projected cash runway extended to into 2028, from into 2027 in the prior quarter's release. Source
New: Positive topline results from the Phase 3 RINGSIDE trial of varegacestat were announced in December 2025. Source
New: An underwritten public offering in December 2025 raised $460.5 million in gross proceeds. Source
New guidance: The prior release tied an NDA submission to topline data being warranted. The current release states a planned submission in the second quarter of 2026. Source

Full year results

Net loss was $212.4 million: Net loss for 2025 was $212.4 million, against $293.0 million in 2024. Net loss per share was $(2.43), compared with $(5.00). Weighted-average shares rose to 87.35 million from 58.64 million. Source
Collaboration revenue declined: Collaboration revenue was $6.9 million in 2025, against $9.0 million in 2024. Interest income was $11.7 million, against $12.8 million. Source
Operating expenses and operating loss: Total operating expenses were $231.1 million, against $314.8 million. Loss from operations was $224.1 million, against $305.8 million. Source

Varegacestat Phase 3 results

Progression-free survival met primary endpoint: The hazard ratio of 0.16 (p<0.0001) corresponds to an 84% reduction in the risk of progression or death versus placebo, per the RINGSIDE trial. Source
Response rate higher than placebo: Objective response rate was 56% against 9% with placebo, by blinded independent central review. All key secondary endpoints were met. Source
Tumor volume change in exploratory analysis: In an exploratory analysis, median best change in tumor volume was -83% for varegacestat and +11% with placebo, by blinded independent central review. Source
Safety profile described as manageable: Management said varegacestat was generally well tolerated, with a safety profile consistent with the gamma secretase inhibitor class. Source

“These programs have substantial potential to benefit cancer patients, and we intend to rapidly advance them.”
Clay B. Siegall, Ph.D., President and Chief Executive Officer

ADC pipeline and IM-1021

IM-1021 shows responses in lymphoma: The Phase 1 trial of IM-1021, a ROR1 ADC, is ongoing. Objective responses were observed in B-cell lymphoma patients at multiple dose levels. Source
Three preclinical ADCs use HC74: IM-1617, IM-1340 and IM-1335 are preclinical ADCs against undisclosed solid tumor targets. Each incorporates HC74, the proprietary TOP1 inhibitor payload. Source
IM-3050 cleared for IND in April 2025: IM-3050, a FAP-targeted radiotherapy, received IND clearance in April 2025, according to the prior quarter's release.

HC74 payload preclinical data

Resistance linked to efflux transporters: Overexpression of ABCC1 and ABCB1 drives resistance to approved ADC payloads and standard chemotherapies, but not to HC74. The data were presented at an AACR-NCI-EORTC meeting in October 2025. Source
HC74 permeability and bystander activity: HC74 has high membrane permeability, which management linked to enhanced cytotoxicity and robust bystander activity in preclinical work. Source
Preclinical tumor models show efficacy: HC74-based ADCs were tested in colorectal cancer refractory to trastuzumab-DXd and irinotecan, in acquired trastuzumab-DXd resistance, and in non-small cell lung cancer. Source

“We continue to advance our antibody-drug conjugate pipeline, with the Phase 1 study of IM-1021 ongoing.”
Clay B. Siegall, Ph.D., President and Chief Executive Officer

Operating costs and stock compensation

R&D expense rose to $177.3 million: R&D expense was $177.3 million, against $129.5 million in 2024. It included $11.2 million of share-based compensation, against $5.1 million. Source
G&A expense rose to $43.8 million: General and administrative expense was $43.8 million, against $33.0 million. It included $14.5 million of share-based compensation, against $10.6 million. Source
In-process R&D tied to RINGSIDE milestone: In-process R&D was $10.0 million, against $152.3 million in 2024. The 2025 amount reflects a development milestone associated with reporting RINGSIDE topline results. Source
Share-based compensation rose: Total share-based compensation expense was $25.7 million, against $15.7 million in 2024. Source

Cash, financing and runway

Cash rose to $653.5 million: Cash and cash equivalents were $653.5 million at year end, against $143.4 million at December 31, 2024. Marketable securities of $74.0 million were held at the prior year end. Source
Cash before the December financing: At September 30, 2025, cash totaled $272.6 million, including $44.9 million of net proceeds from two at-the-market transactions.

Balance sheet and equity

Total assets reached $683.2 million: Total assets were $683.2 million, against $240.2 million. Total liabilities were $48.8 million, against $59.1 million at December 31, 2024. Source
Paid-in capital and accumulated deficit: Additional paid-in capital was $1,362.5 million, against $696.9 million. The accumulated deficit was $728.2 million, against $515.8 million. Source
Weighted-average shares increased: Weighted-average basic and diluted shares were 87.35 million in 2025, against 58.64 million in 2024. Source

Strategy and company focus

Targeted oncology focus stated: The company describes itself as a clinical-stage targeted oncology company developing first-in-class and best-in-class targeted cancer therapies. Source
Readiness work for varegacestat: Management said its focus is on regulatory, manufacturing and commercial readiness to position varegacestat for approval and launch. Source
Early-stage ADC portfolio expanding: The company is advancing a broad portfolio of early-stage ADCs that pursue undisclosed solid tumor targets. Source

Coming up, as management said on 3 March 2026

More RINGSIDE data to be shared: Management plans to share additional RINGSIDE trial data at an upcoming major medical conference. No date or venue is given. Source
ADC candidates in discovery: Additional undisclosed ADCs are in discovery and lead optimization, beyond the three preclinical programs. Source

Figures management reported

Figure	Reported
Phase 3 progression-free survival hazard ratio, varegacestat Source	0.16 (84% reduction in risk; p<0.0001)
Objective response rate, varegacestat vs placebo Source	56% vs 9%
Median best change in tumor volume (exploratory) Source	-83% vs +11%
Research and development expense, full year 2025 Source	$177.3 million
In-process R&D expense, full year 2025 Source	$10.0 million
IM-3050 IND clearance	April 2025

Risks management discussed

Operational: The IM-3050 Phase 1 start depends on delivery of third-party diagnostic radiotracer supply. Source

Earlier plans management reported on

Not stated: The prior release expected topline data before the end of 2025. The current release reports those results as announced in December 2025.
Not stated: The prior release tied an NDA submission to the topline data and said it would follow if warranted. The current release plans the submission for the second quarter of 2026.
Not stated: The prior release said the IM-3050 Phase 1 study would start in early 2026 after radiotracer delivery. The current release repeats that timing.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

Immunome Reports Full Year 2025 Financial Results and Provides Business Update

New Drug Application submission for varegacestat in patients with desmoid tumors planned for 2Q 2026

IM-1021 Phase 1 ongoing with initial data expected in 2026

Three IND submissions for solid tumor-targeted ADC programs planned in 2026

Underwritten public offering in December 2025 raised $460.5 million in gross proceeds, extending projected cash runway into 2028

BOTHELL, Wash. - Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced financial results for the full year ended December 31, 2025, and provided a business update.

“Immunome made substantial progress in 2025. The positive Phase 3 RINGSIDE results represent a significant milestone for patients living with desmoid tumors and will support our planned NDA submission for varegacestat in the second quarter of 2026,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. “We are focused on the regulatory, manufacturing, and commercial readiness activities necessary to position the program for approval and launch.”

“We continue to advance our antibody-drug conjugate pipeline, with the Phase 1 study of IM-1021 ongoing. Over the course of 2026, we expect to submit INDs for three differentiated solid tumor ADCs. These programs have substantial potential to benefit cancer patients, and we intend to rapidly advance them.”

Pipeline Highlights

Varegacestat:

In December 2025, Immunome announced positive topline results from the global pivotal Phase 3 RINGSIDE trial of varegacestat in patients with progressing desmoid tumors.

The registrational trial met its primary endpoint of improving progression-free survival vs. placebo, with a statistically significant and clinically meaningful 84% reduction in the risk of disease progression or death (hazard ratio = 0.16, p<0.0001).

The trial also met all key secondary endpoints, including achieving an objective response rate of 56% 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.

Varegacestat was generally well tolerated with a manageable safety profile, consistent with the gamma secretase inhibitor class.

Immunome plans to share additional data from the RINGSIDE trial at an upcoming major medical conference.

Immunome plans to submit a New Drug Application to the U.S. Food and Drug Administration for varegacestat in the second quarter of 2026.

IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with objective responses observed in B-cell lymphoma patients at multiple dose levels. Immunome expects to present initial data for IM-1021 in 2026.

IM-3050: Immunome previously received IND clearance for IM-3050 and plans to initiate a Phase 1 study in early 2026 after delivery of third-party diagnostic radiotracer supply.

Preclinical ADC Pipeline: Immunome expects to submit INDs for IM-1617, IM-1340 and IM-1335 in early, mid, and late-2026, respectively. The programs each pursue undisclosed solid tumor targets and incorporate HC74, Immunome’s proprietary TOP1 inhibitor payload. Additional undisclosed antibody drug conjugates (ADCs) are in discovery and lead optimization to support INDs in 2027 and beyond.

HC74: In October 2025, Immunome presented a poster entitled “HC74, a novel topoisomerase I inhibitor payload for antibody-drug conjugates that overcomes multi-drug resistance” at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston. HC74 is the payload included in IM-1021 and additional Immunome ADC programs. Highlights of the poster include:

Overexpression of drug efflux transporters such as ABCC1 and ABCB1 drives primary and acquired resistance to approved ADC payloads and standard chemotherapies but not to HC74.

HC74 exhibits high membrane permeability, leading to enhanced cytotoxicity and robust bystander activity.

ADCs incorporating HC74 show meaningful efficacy in multiple preclinical tumor models, including:

Colorectal cancer refractory to trastuzumab-DXd and irinotecan.

Models with acquired resistance to trastuzumab-DXd.

Non-small cell lung cancer with heterogeneous target expression.

Full-year 2025 Financial Results

As of December 31, 2025, cash and cash equivalents totaled $653.5 million, including net proceeds of $432.4 million from the December 2025 financing. Immunome expects its current cash position to fund operations into 2028.

Research and development expenses for the year ended December 31, 2025, were $177.3 million, including stock-based compensation costs of $11.2 million.

In-process research and development expenses for the year ended December 31, 2025, were $10.0 million, reflecting a development milestone associated with reporting positive topline results for the Phase 3 RINGSIDE trial of varegacestat.

General and administrative expenses for the year ended December 31, 2025, were $43.8 million, including stock-based compensation expense of $14.5 million.

Immunome reported a net loss of $212.4 million for the year ended December 31, 2025.

About Immunome, Inc.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage gamma secretase inhibitor; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

Cautionary Statement Regarding Forward-Looking Statements

Forward-looking statements notice

Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We use words such as “planned,” “expected,” “focused,” “advance,” “projected,” “will,” “potential,” “expect,” “intend,” “plan,” “pursue,” “support,” “expects,” “advancing,” and similar expressions to identify these forward-looking statements. These forward-looking statements include statements regarding progress of Immunome’s pipeline and achievement of key milestones; the timing for submission of a new drug application for varegacestat; the possibility that topline data for the Phase 3 RINGSIDE Part B varegacestat trial may support the new drug application submission; the potential of obtaining regulatory approval and our ability to launch of varegacestat; the significance of early clinical trial data for IM-1021; the potential of Immunome’s proprietary payload; Immunome’s progress towards submitting INDs for three additional ADCs; the expected timing for initiating a Phase 1 clinical trial for IM-3050; Immunome’s expected cash runway; the potential of Immunome’s targeted therapies to provide first-in-class or best-in-class status; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. These forward-looking statements are based on Immunome’s current expectations and involve assumptions that may never materialize or may prove to be incorrect; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including the risk that Immunome will not be able to realize the benefits of its strategic transactions; the risk that regulatory approvals for Immunome’s programs and product candidates are not obtained, are delayed or are subject to unanticipated conditions; the risk that pre-clinical data may not be predictive of clinical data or that early clinical data may not be predictive of later clinical data, regulatory approval or commercial viability; the risk of reliance on third-party vendors; the risk that Immunome’s programs and product candidates fail to achieve their intended endpoints; uncertainties related to Immunome’s capital requirements and Immunome’s expected cash runway; Immunome’s ability to grow and advance its pipeline and successfully execute on its business plan; and other risks and uncertainties included under the caption “Risk Factors” in Immunome’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the Securities and Exchange Commission (“SEC”) on November 6, 2025, and in Immunome’s Annual Report on Form 10-K for the year ended December 31, 2025, to be filed with the SEC later today. These documents can also be accessed on Immunome’s website at www.immunome.com by clicking on the link “Financials” under the “Investors” tab. The forward-looking statements included in this press release are made only as of the date hereof. Except as required by law, Immunome assumes no obligation and does not intend to update any forward-looking statements included in this press release.

Consolidated Balance Sheets

(In thousands)

	December 31, 2025	December 31, 2024
Assets
Current assets:
Cash and cash equivalents	$ 653,482	$ 143,351
Marketable securities	-	73,952
Prepaid expenses and other current assets	7,295	4,036
Total current assets	660,777	221,339
Property and equipment, net	14,636	10,113
Operating right-of-use assets	2,978	4,278
Restricted cash	210	100
Other long-term assets	4,587	4,411
Total assets	$ 683,188	$ 240,241
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$ 3,339	$ 14,189
Accrued expenses and other current liabilities	41,651	33,177
Deferred revenue, current	-	6,941
Total current liabilities	44,990	54,307
Operating lease liabilities, net of current portion	3,855	4,769
Total liabilities	48,845	59,076
Stockholders’ equity:
Preferred stock	-	-
Common stock	11	6
Additional paid-in capital	1,362,496	696,872
Accumulated other comprehensive income	-	57
Accumulated deficit	(728,164)	(515,770)
Total stockholders’ equity	634,343	181,165
Total liabilities and stockholders’ equity	$ 683,188	$ 240,241

IMMUNOME, INC.

Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

	Year Ended December 31,
	2025	2024
Collaboration revenue	$ 6,941	$ 9,041
Operating expenses:
In-process research and development	10,000	152,344
Research and development	177,286	129,542
General and administrative	43,768	32,955
Total operating expenses	231,054	314,841
Loss from operations	(224,113)	(305,800)
Interest income	11,719	12,837
Net loss	$ (212,394)	$ (292,963)
Net loss per share, basic and diluted	$ (2.43)	$ (5.00)
Weighted-average shares outstanding, basic and diluted	87,350,956	58,639,441
Comprehensive loss:
Net loss	$ (212,394)	$ (292,963)
Unrealized (loss) gain on marketable securities	(57)	35
Comprehensive loss	$ (212,451)	$ (292,928)
(1) Amounts include non-cash share-based compensation as follows (in thousands):
	Year Ended December 31,
	2025	2024
Research and development	$ 11,193	$ 5,146
General and administrative	14,497	10,602
Total share-based compensation expense	$ 25,690	$ 15,748

Contacts
Max Rosett
Chief Financial Officer investors@immunome.com
IMMUNOME, INC.