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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):

August 6, 2025

 

 

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 August 6, 2025, Immunome, Inc. (the “Company”) announced its financial results for the second quarter ended June 30, 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 August 6, 2025

 

 

 

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: August 6, 2025

Immunome, Inc.

 

 

 

By:

/s/ Max Rosett

 

Name:

Max Rosett

 

Title:

Chief Financial Officer

 

 


EX-99.1 2 imnm-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

Immunome Reports Second Quarter 2025 Financial Results and Provides Business Update

8/6/2025

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 June 30, 2025 and provided a business update.

“Immunome made substantial progress in the second quarter of 2025, underscored by the continued advancement of our clinical programs towards key milestones,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. “We look forward to sharing topline data for the RINGSIDE trial of varegacestat before the end of this year, and we are well-positioned to support a new drug application submission for that program as appropriate.”

“We recently dosed the third cohort of patients in the dose escalation study of IM-1021, our ROR1 ADC. We are excited by the profile of HC74, the proprietary TOP1 inhibitor payload contained in IM-1021, and are making progress towards IND submission for three additional ADCs utilizing that technology.”

Pipeline Highlights

Varegacestat:

Immunome expects to report topline data for the Phase 3 RINGSIDE Part B study before the end of 2025.
Two additional analyses of the Phase 2 RINGSIDE Part A study were presented at 2025 ASCO Annual Meeting in June 2025, both of which can be found in the Investors portion of Immunome’s website:
o
Subgroup Analysis of the Phase 2 Part of the RINGSIDE Phase 2/3 Trial of Varegacestat for Treatment of Desmoid Tumors
o
Change in T2-Weighted Signal Intensity, Change in Tumor Volume, and Exposure-Response Analysis in the RINGSIDE Phase 2 Study of Varegacestat in Patients with Desmoid Tumors
The European Medicines Agency granted Orphan Drug Designation to varegacestat in July 2025. Varegacestat previously received Orphan Drug Designation from the U.S. Food and Drug Administration in November 2023.

IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with patients recently dosed at the third dose level. The trial is an open-label, multicenter dose-escalation and expansion study that is expected to include participants with advanced B-cell lymphomas and advanced solid tumors.

IM-3050: Immunome received IND clearance for IM-3050 in April 2025 and expects to initiate a Phase 1 clinical trial before the end of 2025.

Preclinical Pipeline: Immunome’s three preclinical ADCs against solid tumor targets, IM-1617, IM-1340 and IM-1335, each of which incorporates HC74, are currently undergoing IND-enabling work. Additional undisclosed ADCs are in discovery and lead optimization.


 

Second Quarter 2025 Financial Results

As of June 30, 2025, cash, cash equivalents and marketable securities totaled $268.0 million. Immunome expects its current cash position to fund operations into 2027.
Research and development expenses for the quarter ended June 30, 2025 were $40.5 million, including stock-based compensation costs of $2.2 million.
General and administrative expenses for the quarter ended June 30, 2025 were $10.0 million, including stock-based compensation expense of $3.1 million.
Immunome reported a net loss of $43.4 million for the quarter ended June 30, 2025.

About Immunome, Inc.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. 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 targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors. For more information, visit www.immunome.com.

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 “focused,” “on track,” “optimistic,” “will,” “potential,” “expect,” and similar expressions to identify these forward-looking statements. These forward-looking statements include progress of Immunome’s clinical programs to key milestones; Immunome’s expected timing for providing topline data for the Phase 3 RINGSIDE Part B trial and that it is well positioned to support a new drug application submission; Immunome’s progress towards submitting INDs for three additional ADCs; the expected tumor and cancer types of patients in Immunome’s Phase 3 RINGSIDE Part B trial; the expected timing for initiating a Phase 1 clinical trial for IM-3050; Immunome’s expected cash runway; the potential of Immunome’s ADC programs 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; 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 March 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on May 12, 2025 and in Immunome’s Quarterly Report on Form 10-Q for the quarter ended June 30, 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.

Condensed Consolidated Balance Sheets

(Unaudited; in thousands)

 

 

 

June 30, 2025

 

December 31, 2024

Assets

 

 

 

 

Current assets:

 

 

 

 

Cash and cash equivalents

 

 $ 143,876

 

 $ 143,351

Marketable securities

 

  124,160

 

  73,952

Prepaid expenses and other current assets

 

  9,396

 

  4,036

Total current assets

 

  277,432

 

  221,339

Property and equipment, net

 

  11,025

 

  10,113

Operating right-of-use assets

 

  3,269

 

  4,278

Restricted cash

 

  210

 

  100

Other long-term assets

 

  4,354

 

  4,411

Total assets

 

 $ 296,290

 

 $ 240,241

Liabilities and stockholders’ equity

 

 

 

 

Current liabilities:

 

 

 

 

Accounts payable

 

 $ 4,660

 

 $ 14,189

Accrued expenses and other current liabilities

 

  18,218

 

  33,177

Deferred revenue, current

 

  —

 

  6,941

Total current liabilities

 

  22,878

 

  54,307

Operating lease liabilities, net of current portion

 

  4,142

 

  4,769

Total liabilities

 

  27,020

 

  59,076

Stockholders’ equity:

 

 

 

 

Preferred stock

 

  —

 

  —

Common stock

 

  9

 

  6

Additional paid-in capital

 

  870,092

 

  696,872

Accumulated other comprehensive (loss) income

 

  (24)

 

  57

Accumulated deficit

 

  (600,807)

 

  (515,770)

Total stockholders’ equity

 

  269,270

 

  181,165

Total liabilities and stockholders’ equity

 

 $ 296,290

 

 $ 240,241

 

 


 

IMMUNOME, INC.

Condensed Consolidated Statement of Operations and Comprehensive Loss

(Unaudited; in thousands, except share and per share amounts)

 

 

 

Three Months Ended June 30,

 

2025

 

2024

Collaboration revenue

 

 $ 4,015

 

 $ 2,364

Operating expenses:

 

 

 

 

In-process research and development

 

  —

 

  6,312

Research and development(1)

 

  40,451

 

  29,083

General and administrative(1)

 

  10,042

 

  6,978

Total operating expenses

 

  50,493

 

  42,373

Loss from operations

 

  (46,478)

 

  (40,009)

Interest income

 

  3,081

 

  3,887

Net loss

 

 $ (43,397)

 

 $ (36,122)

Net loss per share, basic and diluted

 

 $ (0.50)

 

 $ (0.60)

Weighted-average shares outstanding, basic and diluted

 

  87,010,742

 

  59,936,703

Comprehensive loss:

 

 

 

 

Net loss

 

 $ (43,397)

 

 $ (36,122)

Unrealized loss on marketable securities

 

  (21)

 

  (2)

Comprehensive loss

 

 $ (43,418)

 

 $ (36,124)

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

2025

 

2024

Research and development

 

 $ 2,233

 

 $ 1,041

General and administrative

 

  3,114

 

  2,186

Total share-based compensation expense

 

 $ 5,347

 

 $ 3,227