STOCK TITAN
  1. Home
  2. Sec-filings
  3. IMNM
  4. [8-K] Immunome Inc. Reports Material Event

Immunome (IMNM) widens Q2 loss as varegacestat wins FDA review date

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Immunome, Inc. reported second quarter 2026 results and highlighted major oncology pipeline progress. Varegacestat advanced with U.S. FDA acceptance of its New Drug Application for adults with desmoid tumors and a PDUFA target action date of April 28, 2027, following positive Phase 3 RINGSIDE data that showed an 84% reduction in risk of disease progression or death versus placebo and higher objective response rates.

The company dosed first patients in 2026 Phase 1 trials for IM-1617, a solid tumor antibody-drug conjugate, and IM-3050, a FAP-targeted radioligand therapy, while the IM-1021 Phase 1 trial continues with objective responses in B-cell lymphoma. As of June 30, 2026, Immunome held $520.0 million in cash, cash equivalents and marketable securities and expects this to fund operations into 2028. For the quarter, there was no collaboration revenue compared with $4.0 million a year earlier, operating expenses increased, and the company recorded a net loss of $73.1 million.

Positive

  • FDA accepted NDA for varegacestat in desmoid tumors with a PDUFA target action date of April 28, 2027, supported by positive Phase 3 RINGSIDE data.
  • Phase 3 RINGSIDE trial met its primary endpoint, showing an 84% reduction in risk of disease progression or death (hazard ratio 0.16, p<0.0001) and higher objective response rate.
  • Strong liquidity with cash, cash equivalents and marketable securities of $520.0 million as of June 30, 2026, expected to fund operations into 2028.
  • Clinical pipeline momentum with first patients dosed in 2026 Phase 1 trials for IM-1617 and IM-3050, and ongoing IM-1021 trial showing objective responses in B-cell lymphoma.

Negative

  • Collaboration revenue declined to $0 in Q2 2026 from $4.0 million in Q2 2025, contributing to a larger operating loss.
  • Net loss widened to $73.1 million for Q2 2026 from $43.4 million a year earlier as research and development and general and administrative expenses increased.
  • Accumulated deficit increased to $855.1 million as of June 30, 2026, and total stockholders’ equity decreased to $525.1 million from $634.3 million at year-end 2025.
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, cash equivalents and marketable securities $520.0 million As of June 30, 2026; expected to fund operations into 2028
Research and development expenses $59.9 million Quarter ended June 30, 2026; includes $4.2 million share-based compensation
General and administrative expenses $18.3 million Quarter ended June 30, 2026; includes $4.6 million share-based compensation
Net loss $73.1 million Quarter ended June 30, 2026, compared with $43.4 million in Q2 2025
Collaboration revenue $0 Quarter ended June 30, 2026, compared with $4.0 million in Q2 2025
Varegacestat hazard ratio 0.16 Phase 3 RINGSIDE primary endpoint; 84% reduction in risk vs. placebo
Varegacestat objective response rate 56% vs. 9% Confirmed objective response rate in Phase 3 RINGSIDE vs. placebo
PDUFA target action date April 28, 2027 FDA review date for varegacestat NDA in adults with desmoid tumors
PDUFA target action date regulatory
"Varegacestat PDUFA target action date set for April 28, 2027"
The PDUFA target action date is the deadline set by the U.S. Food and Drug Administration (FDA) by which it aims to decide whether to approve or reject a new drug application. This date helps investors gauge when a company’s new medication might reach the market, potentially influencing sales and revenue expectations. It acts as a key milestone signaling progress in the drug approval process.
New Drug Application regulatory
"following U.S. FDA acceptance of New Drug Application (NDA) for adults with desmoid tumors"
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.
objective response rate medical
"including a confirmed objective response rate of 56% vs. 9% with placebo"
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 incorporating HC74"
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.
radioligand therapy medical
"IM-3050, an investigational fibroblast activation protein (FAP)-targeted radioligand therapy"
A treatment that uses a small molecule or antibody designed to seek out specific cells and deliver a tiny dose of radiation directly to them, like a guided missile carrying a limited explosive to a particular target rather than carpeting an area. Investors care because successful radioligand therapies can become high-value prescription products with clear market niches, regulatory hurdles, and reimbursement decisions that strongly affect a developer’s revenue and risk profile.
Investigational New Drug applications regulatory
"expects to submit Investigational New Drug applications (INDs) for IM-1340 and IM-1335"
An investigational new drug application is the formal request a drug developer files with a regulatory agency to begin testing an experimental medicine in humans. Think of it as asking permission to move from lab work into human trials; it matters to investors because approval to start clinical testing signals a clear development milestone, unlocks further funding and partnerships, and helps determine the timeline and risk for potential future sales.
Collaboration revenue $0 Compared with $4.0 million in the quarter ended June 30, 2025
Net loss $73.1 million Compared with $43.4 million in the quarter ended June 30, 2025
Research and development expenses $59.9 million Compared with $40.5 million in the quarter ended June 30, 2025
General and administrative expenses $18.3 million Compared with $10.0 million in the quarter ended June 30, 2025

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
Understanding 8-K Material Events →

FAQ

What were Immunome (IMNM)’s key clinical milestones in the second quarter of 2026?
Immunome advanced several programs, including FDA acceptance of its varegacestat NDA with a PDUFA date of April 28, 2027. The company also dosed first patients in Phase 1 trials of IM-1617 and IM-3050, and continued its IM-1021 Phase 1 lymphoma trial.

How strong is Immunome (IMNM)’s cash position after Q2 2026?
As of June 30, 2026, Immunome reported $520.0 million in cash, cash equivalents and marketable securities. Management stated this cash position is expected to fund operations into 2028, supporting ongoing clinical trials and planned IND submissions across its oncology pipeline.

What were Immunome (IMNM)’s revenues and net loss for Q2 2026?
For the quarter ended June 30, 2026, Immunome reported no collaboration revenue, compared with $4.0 million a year earlier. The company recorded a net loss of $73.1 million, versus a net loss of $43.4 million in the second quarter of 2025, reflecting higher operating expenses.

How did Immunome (IMNM)’s operating expenses change in Q2 2026?
In Q2 2026, research and development expenses were $59.9 million and general and administrative expenses were $18.3 million. This compares with $40.5 million and $10.0 million, respectively, in Q2 2025, indicating significantly higher spending on pipeline development and corporate functions.

What were the key efficacy results for varegacestat reported by Immunome (IMNM)?
The Phase 3 RINGSIDE trial of varegacestat in desmoid tumors showed an 84% reduction in risk of disease progression or death vs. placebo (hazard ratio 0.16, p<0.0001). The trial also achieved all key secondary endpoints, including a 56% objective response rate vs. 9% with placebo.

What guidance did Immunome (IMNM) provide on future regulatory filings for varegacestat?
Immunome stated it plans to submit a Marketing Authorization Application to the European Medicines Agency for varegacestat by the end of 2026. This would follow U.S. NDA acceptance and expands the potential regulatory pathway for treating adults with desmoid tumors.
0001472012false00014720122026-08-112026-08-11

 

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 11, 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 August 11, 2026, Immunome, Inc. (the “Company”) announced its financial results for the second quarter ended June 30, 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 August 11, 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: August 11, 2026

Immunome, Inc.

 

 

 

By:

/s/ Max Rosett

 

Name:

Max Rosett

 

Title:

Chief Financial Officer

 

 

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 for the quarter ended June 30, 2026, were $18.3 million, including stock-based compensation expense of $4.6 million.
•
Immunome reported a net loss of $73.1 million for the quarter ended June 30, 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 accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. 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 design and anticipated scope of Immunome’s ongoing and planned clinical trials; 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 preclinical 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the Securities and Exchange Commission (“SEC”) on May 12, 2026, and in Immunome’s Quarterly Report on Form 10-Q for the quarter ended June 30, 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)

 

 

June 30, 2026

 

 

December 31, 2025

 

 

 

(unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

217,706

 

 

$

653,482

 

Marketable securities

 

 

302,290

 

 

 

—

 

Prepaid expenses and other current assets

 

 

18,453

 

 

 

7,295

 

Total current assets

 

 

538,449

 

 

 

660,777

 

Property and equipment, net

 

 

17,359

 

 

 

14,636

 

Operating right-of-use assets

 

 

3,942

 

 

 

2,978

 

Restricted cash

 

 

210

 

 

 

210

 

Other long-term assets

 

 

5,424

 

 

 

4,587

 

Total assets

 

$

565,384

 

 

$

683,188

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

5,996

 

 

$

3,339

 

Accrued expenses and other current liabilities

 

 

29,717

 

 

 

41,651

 

Total current liabilities

 

 

35,713

 

 

 

44,990

 

Operating lease liabilities, net of current portion

 

 

4,588

 

 

 

3,855

 

Total liabilities

 

 

40,301

 

 

 

48,845

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock

 

 

—

 

 

 

—

 

Common stock

 

 

11

 

 

 

11

 

Additional paid-in capital

 

 

1,380,535

 

 

 

1,362,496

 

Accumulated other comprehensive loss

 

 

(333)

 

 

 

—

 

Accumulated deficit

 

 

(855,130

)

 

 

(728,164

)

Total stockholders’ equity

 

 

525,083

 

 

 

634,343

 

Total liabilities and stockholders’ equity

 

$

565,384

 

 

$

683,188

 

 

 

 

IMMUNOME, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(unaudited)

 

 

Three Months Ended June 30,

 

 

2026

 

 

2025

 

Collaboration revenue

 

$

—

 

 

$

4,015

 

Operating expenses:

 

 

 

 

 

 

Research and development(1)

 

 

59,885

 

 

 

40,451

 

General and administrative(1)

 

 

18,250

 

 

 

10,042

 

Total operating expenses

 

 

78,135

 

 

 

50,493

 

Loss from operations

 

 

(78,135

)

 

 

(46,478

)

Interest income

 

 

5,008

 

 

 

3,081

 

Net loss

 

$

(73,127

)

 

$

(43,397

)

Net loss per share, basic and diluted

 

$

(0.65

)

 

$

(0.50

)

Weighted-average shares outstanding, basic and diluted

 

 

113,272,931

 

 

 

87,010,742

 

Comprehensive loss:

 

 

 

 

 

 

Net loss

 

$

(73,127

)

 

$

(43,397

)

Unrealized loss on marketable securities

 

 

(333)

 

 

 

(21)

 

Comprehensive loss

 

$

(73,460

)

 

$

(43,418

)

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

 

2026

 

 

2025

 

Research and development

 

$

4,161

 

 

$

2,233

 

General and administrative

 

 

4,638

 

 

 

3,114

 

Total share-based compensation expense

 

$

8,799

 

 

$

5,347

 

 

 

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

2 documents

Press Releases

Other Documents