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Cancer NDA and wider Q1 2026 loss at Immunome (IMNM) with strong Phase 3 data

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(Moderate)
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(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Immunome, Inc. reported first quarter 2026 results and highlighted major advances in its oncology pipeline. For the quarter ended March 31, 2026, the company recorded a net loss of $53.8 million, or $0.48 per share, compared with a net loss of $41.6 million a year earlier, as research and development expenses rose to $46.4 million. Cash and cash equivalents were $582.7 million, which the company believes can fund operations into 2028.

Strategically, Immunome submitted a New Drug Application to the U.S. FDA in April 2026 for varegacestat in adults with desmoid tumors, following the Phase 3 RINGSIDE trial. That trial showed an 84% reduction in the risk of disease progression or death versus placebo, with a hazard ratio of 0.16 and objective response rate of 56% vs. 9%. The company also advanced multiple antibody-drug conjugate programs, with IM-1021 in Phase 1, IM-3050 initiating Phase 1, and IM-1617 receiving IND clearance.

Positive

  • NDA submission for varegacestat: Immunome submitted a New Drug Application to the U.S. FDA in April 2026 for varegacestat in adults with desmoid tumors, supported by Phase 3 data showing an 84% reduction in risk of progression or death (hazard ratio 0.16) and a 56% vs. 9% objective response rate.
  • Robust cash position and runway: Cash and cash equivalents of $582.7 million as of March 31, 2026 are expected by the company to fund operations into 2028, supporting simultaneous development of multiple oncology programs.

Negative

  • None.

Insights

NDA filing for varegacestat and strong Phase 3 data anchor Immunome’s Q1 update.

Immunome combined a wider quarterly loss with clearly advancing assets. Varegacestat’s Phase 3 RINGSIDE results showed an 84% reduction in risk of progression or death (hazard ratio 0.16) and a 56% objective response rate versus 9% on placebo, supporting the April NDA filing.

The company is spending more on development, with research and development expenses rising to $46.4M and general and administrative costs to $13.0M. Net loss increased to $53.8M, but cash and cash equivalents of $582.7M are described as sufficient to fund operations into 2028, which is important for sustaining multiple programs.

Beyond varegacestat, pipeline breadth matters: IM-1021 is generating objective responses in a Phase 1 lymphoma study, IM-3050 has started clinical evaluation, and IM-1617 received IND clearance with a Phase 1 start planned in Q2 2026. Future company filings may clarify regulatory feedback on the NDA and provide more mature data across these programs.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Cash and cash equivalents $582.7 million As of March 31, 2026; company expects this to fund operations into 2028
Research and development expense $46.4 million Quarter ended March 31, 2026, including $3.7 million share-based compensation
General and administrative expense $13.0 million Quarter ended March 31, 2026, including $4.2 million share-based compensation
Net loss $53.8 million Quarter ended March 31, 2026; net loss per share $0.48 basic and diluted
Collaboration revenue $0 Quarter ended March 31, 2026, versus $2.9 million in 2025
Weighted-average shares outstanding 113,136,836 shares Basic and diluted for the quarter ended March 31, 2026
Progression-free survival risk reduction 84% Phase 3 RINGSIDE trial for varegacestat vs. placebo; hazard ratio 0.16
Objective response rate 56% vs. 9% Phase 3 RINGSIDE trial, varegacestat vs. placebo, blinded independent central review
New Drug Application regulatory
"New Drug Application (NDA) submitted to the U.S. Food and Drug Administration (FDA) in April 2026"
A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.
hazard ratio medical
"an 84% reduction in the risk of disease progression or death (hazard ratio = 0.16, p<0.0001)"
A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.
objective response rate medical
"achieving an objective response rate of 56% vs. 9% with placebo (p<0.0001)"
The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.
antibody-drug conjugate medical
"IM-1617, a potential first-in-class solid tumor antibody-drug conjugate (ADC)"
An antibody-drug conjugate is a targeted medicine that combines an antibody, which can identify specific cells, with a powerful drug designed to destroy those cells. This approach allows for precise treatment, minimizing damage to healthy tissue. For investors, developments in this area can signal advances in cancer therapies and potential growth opportunities in the biotech sector.
Investigational New Drug regulatory
"Investigational New Drug (IND) clearance received in April 2026 for IM-1617"
An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.
progression-free survival medical
"The registrational trial met its primary endpoint of improving progression-free survival vs. placebo"
Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.
Net loss $53.8 million vs $41.6 million in Q1 2025
Net loss per share $0.48 vs $0.52 in Q1 2025
Collaboration revenue $0 vs $2.9 million in Q1 2025
Research and development expense $46.4 million vs $36.9 million in Q1 2025
General and administrative expense $13.0 million vs $10.7 million in Q1 2025
Cash and cash equivalents $582.7 million vs $653.5 million as of December 31, 2025
Understanding 8-K Material Events →
false000147201200014720122026-05-122026-05-12

 

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):

May 12, 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 May 12, 2026, Immunome, Inc. (the “Company”) announced its financial results for the first quarter ended March 31, 2026 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 May 12, 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: May 12, 2026

Immunome, Inc.

 

 

 

By:

/s/ Max Rosett

 

Name:

Max Rosett

 

Title:

Chief Financial Officer

 

 

Exhibit 99.1

Immunome Reports First Quarter 2026 Financial Results and Provides Business Update

May 12, 2026

•
New Drug Application (NDA) submitted to the U.S. Food and Drug Administration (FDA) in April 2026 seeking approval of varegacestat for the treatment of adults with desmoid tumors
•
Detailed Phase 3 RINGSIDE data selected for oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting
•
Phase 1 study ongoing for IM-1021, with initial lymphoma data expected in 2026
•
Investigational New Drug (IND) clearance received in April 2026 for IM-1617, a potential first-in-class solid tumor antibody-drug conjugate (ADC)

 

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 quarter ended March 31, 2026, and provided a business update.

“This quarter reflects the progress we are making in building Immunome into a multi-program targeted oncology company,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. “The NDA submission for varegacestat is an important milestone that reflects our commitment to improving the lives of patients with desmoid tumors, for whom new treatment options are still needed. We are also pleased that detailed Phase 3 RINGSIDE data were selected for oral presentation at ASCO. In parallel, we continue to advance our ADC pipeline, with IM-1021 progressing in Phase 1 and IM-1617 recently receiving IND clearance.”

Pipeline Highlights

Varegacestat:

•
In April 2026, Immunome submitted an NDA to the U.S. FDA for varegacestat for the treatment of adults with desmoid tumors.
•
Immunome plans to submit a Marketing Authorization Application to the European Medicines Agency for varegacestat by the end of 2026.
•
Data from RINGSIDE, the global, Phase 3, randomized, placebo-controlled trial of varegacestat in patients with progressing desmoid tumors, have been selected for presentation in an oral abstract session at the 2026 ASCO Annual Meeting.
•
In December 2025, Immunome announced positive topline results from RINGSIDE:
o
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).
o
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.
o
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.
o
Varegacestat was generally well tolerated with a manageable safety profile, consistent with the gamma secretase inhibitor class.

 

 

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

IM-3050: In March 2026, Immunome initiated the first clinical trial site for a Phase 1 trial of IM-3050 in patients with FAP-expressing solid tumors.

IM-1617: In April 2026, Immunome received IND clearance for IM-1617 and plans to initiate a Phase 1 trial in the second quarter of 2026. IM-1617 is a potential first-in-class ADC directed at an undisclosed solid tumor target and incorporates HC74, Immunome’s proprietary TOP1 inhibitor payload.

Preclinical ADC Pipeline: Immunome expects to submit INDs for IM-1340 and IM-1335 in mid- and late 2026, respectively. The programs are each directed at undisclosed solid tumor targets and incorporate HC74. Additional undisclosed ADCs are in discovery and lead optimization to support INDs in 2027 and beyond.


First Quarter 2026 Financial Results

•
As of March 31, 2026, cash and cash equivalents totaled $582.7 million. Immunome expects its current cash position to fund operations into 2028.
•
Research and development expenses for the quarter ended March 31, 2026, were $46.4 million, including stock-based compensation costs of $3.7 million.
•
General and administrative expenses for the quarter ended March 31, 2026, were $13.0 million, including stock-based compensation expense of $4.2 million.
•
Immunome reported a net loss of $53.8 million for the quarter ended March 31, 2026.

 

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, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. 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 proposed timeline for expected data with respect to Immunome’s pipeline; Immunome’s plans and timing for submission of additional INDs; the potential of Immunome’s pipeline of assets to be first-in-class and best-in-class; Immunome’s plans and timeline for initiating additional clinical trials; Immunome’s anticipated timing for submitting a Marketing Authorization Application to the European Medicines Agency for varegacestat; Immunome’s expected cash runway; 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 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; the risk that Immunome will not be able to realize the benefits of its strategic transactions; 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 Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 3, 2026, and in Immunome’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, 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.

Condensed Consolidated Balance Sheets

(In thousands)

 

 

March 31, 2026

 

 

December 31, 2025

 

 

 

(unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

582,693

 

 

$

653,482

 

Prepaid expenses and other current assets

 

 

11,616

 

 

 

7,295

 

Total current assets

 

 

594,309

 

 

 

660,777

 

Property and equipment, net

 

 

17,081

 

 

 

14,636

 

Operating right-of-use assets

 

 

2,828

 

 

 

2,978

 

Restricted cash

 

 

210

 

 

 

210

 

Other long-term assets

 

 

5,364

 

 

 

4,587

 

Total assets

 

$

619,792

 

 

$

683,188

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

5,534

 

 

$

3,339

 

Accrued expenses and other current liabilities

 

 

21,878

 

 

 

41,651

 

Total current liabilities

 

 

27,412

 

 

 

44,990

 

Operating lease liabilities, net of current portion

 

 

3,694

 

 

 

3,855

 

Total liabilities

 

 

31,106

 

 

 

48,845

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock

 

 

—

 

 

 

—

 

Common stock

 

 

11

 

 

 

11

 

Additional paid-in capital

 

 

1,370,678

 

 

 

1,362,496

 

Accumulated deficit

 

 

(782,003

)

 

 

(728,164

)

Total stockholders’ equity

 

 

588,686

 

 

 

634,343

 

Total liabilities and stockholders’ equity

 

$

619,792

 

 

$

683,188

 

 

 

 

IMMUNOME, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(unaudited)

 

 

Three Months Ended March 31,

 

 

2026

 

 

2025

 

Collaboration revenue

 

$

—

 

 

$

2,926

 

Operating expenses:

 

 

 

 

 

 

Research and development(1)

 

 

46,381

 

 

 

36,872

 

General and administrative(1)

 

 

12,950

 

 

 

10,690

 

Total operating expenses

 

 

59,331

 

 

 

47,562

 

Loss from operations

 

 

(59,331

)

 

 

(44,636

)

Interest income

 

 

5,492

 

 

 

2,996

 

Net loss

 

$

(53,839

)

 

$

(41,640

)

Net loss per share, basic and diluted

 

$

(0.48

)

 

$

(0.52

)

Weighted-average shares outstanding, basic and diluted

 

 

113,136,836

 

 

 

79,410,354

 

Comprehensive loss:

 

 

 

 

 

 

Net loss

 

$

(53,839

)

 

$

(41,640

)

Unrealized loss on marketable securities

 

 

—

 

 

 

(60

)

Comprehensive loss

 

$

(53,839

)

 

$

(41,700

)

 

 

 

 

 

 

 

(1) Amounts include non-cash share-based compensation as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended March 31,

 

 

 

2026

 

 

2025

 

Research and development

 

$

3,711

 

 

$

2,434

 

General and administrative

 

 

4,242

 

 

 

3,269

 

Total share-based compensation expense

 

$

7,953

 

 

$

5,703

 

 

 

Source: View Original Filing on SEC EDGAR

FAQ

What were Immunome (IMNM) first quarter 2026 financial results?

Immunome reported a net loss of $53.8 million, or $0.48 per share, for the quarter ended March 31, 2026. Research and development expenses were $46.4 million, and general and administrative expenses totaled $13.0 million, reflecting increased investment in its oncology pipeline.

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

The RINGSIDE trial met its primary endpoint with an 84% reduction in risk of progression or death versus placebo, hazard ratio 0.16. It also achieved a 56% objective response rate compared with 9% on placebo and showed large tumor volume reductions in an exploratory analysis.

What regulatory milestones did Immunome (IMNM) achieve in early 2026?

Immunome submitted a New Drug Application in April 2026 to the U.S. FDA for varegacestat in adults with desmoid tumors and received IND clearance for IM-1617. The company also plans a Marketing Authorization Application to the European Medicines Agency by the end of 2026.

What is Immunome’s cash position and runway after Q1 2026?

As of March 31, 2026, Immunome held $582.7 million in cash and cash equivalents. The company states this cash position is expected to fund operations into 2028, supporting ongoing trials for varegacestat, IM-1021, IM-3050, IM-1617, and earlier-stage ADCs.

Which pipeline programs did Immunome (IMNM) highlight in its Q1 2026 update?

Immunome highlighted varegacestat with an NDA submitted, IM-1021 in a Phase 1 lymphoma trial with objective responses observed, IM-3050 initiating Phase 1 in FAP-expressing tumors, IM-1617 with IND clearance, and preclinical ADCs IM-1340 and IM-1335 with planned IND submissions in 2026.

Did Immunome generate any revenue in the first quarter of 2026?

Immunome reported no collaboration revenue for the first quarter of 2026, compared with $2.9 million in collaboration revenue in the prior-year quarter. Results this period were driven primarily by research and development and general and administrative expenses, leading to the reported net loss.

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