Immunome (IMNM) posts 2025 loss but scores major Phase 3 cancer win

Rhea-AI Filing Summary

Immunome, Inc. reported full-year 2025 results and highlighted major progress across its oncology pipeline. The company posted a net loss of $212.4 million, improving from $293.0 million in 2024, on collaboration revenue of $6.9 million. Research and development expenses were $177.3 million and general and administrative expenses were $43.8 million, both reflecting higher investment and share-based compensation.

Immunome ended 2025 with cash and cash equivalents of $653.5 million, boosted by a December underwritten public offering that raised $460.5 million in gross proceeds. Management expects this cash position to fund operations into 2028.

Clinically, the Phase 3 RINGSIDE trial of varegacestat in desmoid tumors met its primary endpoint with an 84% reduction in risk of progression or death (hazard ratio 0.16, p<0.0001) and a 56% objective response rate versus 9% on placebo. Immunome plans a New Drug Application submission in the second quarter of 2026, while also advancing IM-1021, IM-3050 and multiple early-stage ADC programs toward key 2026 milestones.

Positive

• Phase 3 success for varegacestat: The RINGSIDE trial in desmoid tumors reduced risk of progression or death by 84% (hazard ratio 0.16, p<0.0001) and achieved a 56% objective response rate versus 9% on placebo, supporting a planned NDA filing in Q2 2026.
• Strengthened balance sheet and runway: Year-end 2025 cash and cash equivalents reached $653.5 million, aided by a December 2025 underwritten offering raising $460.5 million in gross proceeds, extending projected cash runway into 2028.

Negative

• None.

Insights

Biotech equity analyst

Strong Phase 3 data and funding extend Immunome’s runway toward a potential first approval.

Immunome delivered highly compelling Phase 3 results for varegacestat in desmoid tumors, with an 84% reduction in progression or death and markedly higher response rates than placebo. This kind of effect size and very low p‑value supports management’s plan for a Q2 2026 NDA filing.

Financially, year-end cash of $653.5 million, helped by a $460.5 million offering, underpins the stated cash runway into 2028 despite a $212.4 million annual net loss. That runway gives room to execute multiple parallel programs without an immediate need for additional financing based on this snapshot.

The 2025 spend profile—R&D of $177.3 million plus milestone-related in-process R&D—shows a clear pivot toward late-stage and platform build-out. Upcoming milestones, including the varegacestat NDA and initial IM‑1021 data in 2026, will be key inflection points disclosed in future updates.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

March 3, 2026

Immunome, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-39580		77-0694340
(state or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

18702 N. Creek Parkway, Suite 100 Bothell, WA		98011
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (425) 939-7410

N/A

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		IMNM		The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On March 3, 2026, Immunome, Inc. (the “Company”) announced its financial results for the year ended December 31, 2025 and provided a business update in the press release attached hereto as Exhibit 99.1 and incorporated herein by reference.

The information in this Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, whether made before or after today’s date, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific references in such filing.

Item 9.01 Financial Statements and Exhibits.

(d)

Exhibit Number	Description
99.1		Press Release dated March 3, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: March 3, 2026	Immunome, Inc.
	By:	/s/ Max Rosett
	Name:	Max Rosett
	Title:	Chief Financial Officer

Exhibit 99.1

Immunome Reports Full Year 2025 Financial Results and Provides Business Update

Mar. 3, 2026

•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.

oThe 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).

oThe 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.

oIn 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:

oColorectal cancer refractory to trastuzumab-DXd and irinotecan.

oModels with acquired resistance to trastuzumab-DXd.

oNon-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

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.

Investor Contact:

Max Rosett

Chief Financial Officer

investors@immunome.com

IMMUNOME, INC.

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(1)		177,286		129,542
General and administrative(1)		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

FAQ

What were Immunome (IMNM) key financial results for full-year 2025?

Immunome reported a net loss of $212.4 million for 2025, compared with $293.0 million in 2024. Collaboration revenue was $6.9 million, while research and development expenses reached $177.3 million and general and administrative expenses were $43.8 million for the year.

How much cash does Immunome (IMNM) have and what is its runway?

As of December 31, 2025, Immunome held $653.5 million in cash and cash equivalents, including $432.4 million in net proceeds from a December 2025 financing. The company states this cash position is expected to fund operations into 2028, supporting ongoing development programs.

What were the Phase 3 RINGSIDE results for Immunome’s varegacestat?

The Phase 3 RINGSIDE trial of varegacestat in desmoid tumors met its primary endpoint, delivering an 84% reduction in risk of progression or death (hazard ratio 0.16, p<0.0001). It also achieved a 56% objective response rate versus 9% with placebo, with generally manageable safety.

When does Immunome (IMNM) plan to submit the NDA for varegacestat?

Immunome plans to submit a New Drug Application to the U.S. Food and Drug Administration for varegacestat in desmoid tumors in the second quarter of 2026. The submission will be supported by positive Phase 3 RINGSIDE data disclosed in the business update.

What is the status of Immunome’s IM-1021 and IM-3050 programs?

The Phase 1 trial of IM-1021 is ongoing, with objective responses observed in B-cell lymphoma and initial data expected in 2026. IM-3050 has received IND clearance, and Immunome plans to initiate a Phase 1 study in early 2026 once radiotracer supply is delivered.

Which additional ADC programs is Immunome (IMNM) advancing toward INDs?

Immunome expects to submit INDs for three ADCs—IM-1617, IM-1340 and IM-1335—in early, mid and late 2026, respectively. These solid tumor-targeted ADCs use HC74, the company’s proprietary topoisomerase I inhibitor payload designed to overcome multi-drug resistance.

Filing Exhibits & Attachments

2 documents

Press Releases

• EX-99.1 EX-99.1 140.4 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA WITH EMBEDDED LINKBASES DOCUMENT 60.1 KB