IMNM

EX-99.1

2 imnm-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Immunome Reports Second Quarter 2026 Financial Results and Provides Business Update

August 11, 2026

• Varegacestat PDUFA target action date set for April 28, 2027, following U.S. FDA acceptance of New Drug Application (NDA) for adults with desmoid tumors

• Detailed Phase 3 RINGSIDE data presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrating statistically significant improvements across the primary and all key secondary endpoints

• First patient dosed in June 2026 in Phase 1 trial of IM-1617, a potential first-in-class solid tumor antibody-drug conjugate incorporating HC74, Immunome’s proprietary TOP1 inhibitor payload

• First patient dosed in July 2026 in Phase 1 trial of IM-3050, an investigational fibroblast activation protein (FAP)-targeted radioligand therapy designed to deliver radioactive lutetium-177 directly to FAP-expressing cells

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, 2026, and provided a business update.

“We continue to execute against our strategy of building a diversified targeted oncology company with multiple opportunities to bring needed therapies to patients,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. “For varegacestat, the presentation of detailed Phase 3 RINGSIDE data at ASCO and subsequent FDA acceptance of our NDA with a PDUFA target action date of April 28, 2027 represent important steps toward a potential approval and launch. We are also continuing to advance our broader pipeline, with three additional clinical-stage programs now enrolling patients. We believe this momentum positions us well for a milestone-rich second half of 2026.”

Pipeline Highlights

Varegacestat:

• In July 2026, the U.S. FDA accepted Immunome’s NDA for varegacestat for the treatment of adults with desmoid tumors and assigned a PDUFA target action date of April 28, 2027.

• Immunome plans to submit a Marketing Authorization Application to the European Medicines Agency for varegacestat by the end of 2026.

• Detailed efficacy and safety results from the Phase 3 RINGSIDE trial of varegacestat in patients with progressing desmoid tumors were presented in an oral abstract session at the 2026 ASCO Annual Meeting.

o RINGSIDE met its primary endpoint, with varegacestat demonstrating a statistically significant and clinically meaningful 84% reduction in the risk of disease progression or death vs. placebo (hazard ratio = 0.16, p<0.0001)

o Progression-free survival benefit was consistent across prespecified patient subgroups, including tumor location, baseline tumor size, patient age and prior systemic desmoid tumor therapy

o The trial met all key secondary endpoints, including a confirmed objective response rate of 56% vs. 9% with placebo (p<0.0001), as assessed by blinded independent central review

o Varegacestat demonstrated statistically significant improvement in worst pain intensity at week 12, with a clinically significant difference observed as early as the first evaluation at week 4

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-1617: In June 2026, the first patient was dosed in the Phase 1, first-in-human trial evaluating IM-1617 in patients with advanced solid tumors. The study is designed to evaluate safety, tolerability, pharmacokinetics and preliminary anti-tumor activity and is expected to include participants with advanced solid tumors, including colorectal cancer, non-small cell lung cancer and breast cancer.

IM-3050: In July 2026, the first patient was dosed in the Phase 1, first-in-human trial evaluating IM-3050 in patients with FAP-expressing advanced solid tumors. The trial is designed to evaluate safety, tolerability, dosimetry, pharmacokinetics and preliminary anti-tumor activity of the investigational FAP-targeted radioligand therapy.

Preclinical ADC Pipeline: Immunome expects to submit Investigational New Drug applications (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.

Second Quarter 2026 Financial Results

• As of June 30, 2026, cash, cash equivalents and marketable securities totaled $520.0 million. Immunome expects its current cash position to fund operations into 2028.

• Research and development expenses for the quarter ended June 30, 2026, were $59.9 million, including stock-based compensation expense of $4.2 million.

• General and administrative expenses f

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8-K

0001472012false00014720122026-03-032026-03-03

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