Immunome Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 12 May 2026: press release. Guidance figures: 2 new, 5 kept. The quarter’s numbers.

Key takeaways

Net loss widened to $53.8M: The company reported a net loss of $53.8 million for the quarter ended March 31, 2026, against $41.6 million a year earlier. Net loss per share was $0.48, against $0.52. Source
NDA submitted to FDA in April: In April 2026 the company submitted a New Drug Application to the U.S. FDA for varegacestat in adults with desmoid tumors. The prior release had planned the filing for the second quarter. Source
84% lower risk of progression: Restating December 2025 topline results, the company reported an 84% reduction in the risk of progression or death versus placebo in RINGSIDE, with a hazard ratio of 0.16. Source
ASCO oral presentation selected: Detailed RINGSIDE Phase 3 data were selected for an oral abstract session at the 2026 ASCO Annual Meeting. Source
IM-1617 cleared for Phase 1: IM-1617 is described as a potential first-in-class ADC for an undisclosed solid tumor target. It uses HC74, the company's proprietary TOP1 inhibitor payload. Source
R&D spend rose to $46.4M: Research and development expense was $46.4 million, against $36.9 million a year earlier, including $3.7 million of stock-based compensation. Source
Cash fell to $582.7M: Cash and cash equivalents were $582.7 million at March 31, 2026, against $653.5 million at December 31, 2025. Source

“This quarter reflects the progress we are making in building Immunome into a multi-program targeted oncology company,”
Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome

Guidance

Area	Period	Figure	Against last quarter
Varegacestat EU filing Source	by end of 2026	by the end of 2026	New
IM-1617 Phase 1 start Source	second quarter of 2026	second quarter of 2026	New
IM-1021 lymphoma data Source	2026	2026	Kept
IM-1340 IND submission Source	mid-2026	mid-2026	Kept
IM-1335 IND submission Source	late 2026	late 2026	Kept
Additional ADC INDs	2027 and beyond	2027 and beyond	Kept
Cash runway Source	into 2028	into 2028	Kept

What changed from last quarter

New: Immunome submitted a New Drug Application to the FDA for varegacestat in April 2026. The prior release had planned the submission for the second quarter of 2026. Source
New: IM-1617 received IND clearance in April 2026. The prior release had expected the IND submission in early 2026. Source
New: The first clinical trial site for a Phase 1 trial of IM-3050 was initiated in March 2026. The prior release had planned the Phase 1 start for early 2026. Source
New: RINGSIDE Phase 3 data were selected for an oral presentation at the 2026 ASCO Annual Meeting. Source
New guidance: A European Marketing Authorization Application timing was given for varegacestat, by the end of 2026. The prior release did not give this timing. Source
New guidance: A Phase 1 start timing was given for IM-1617, in the second quarter of 2026. The prior release did not give this timing. Source

First quarter financial results

Net loss widened to $53.8M: The company reported a net loss of $53.8 million for the quarter ended March 31, 2026, against $41.6 million a year earlier. Net loss per share was $0.48, against $0.52. Source
No collaboration revenue this quarter: Collaboration revenue was nil, against $2.9 million a year earlier. Interest income was $5.5 million, against $3.0 million. Source

Varegacestat regulatory progress

NDA submitted to FDA in April: In April 2026 the company submitted a New Drug Application to the U.S. FDA for varegacestat in adults with desmoid tumors. The prior release had planned the filing for the second quarter. Source
European filing planned by year-end: Management plans to submit a Marketing Authorization Application to the European Medicines Agency for varegacestat by the end of 2026. Source

“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.”
Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome

Clinical data and presentations

84% lower risk of progression: Restating December 2025 topline results, the company reported an 84% reduction in the risk of progression or death versus placebo in RINGSIDE, with a hazard ratio of 0.16. Source
Response rate 56% against 9%: The objective response rate was 56% with varegacestat against 9% with placebo, as assessed by blinded independent central review. Source
Safety described as manageable: Management described varegacestat as generally well tolerated, with a manageable safety profile consistent with the gamma secretase inhibitor class. Source
ASCO oral presentation selected: Detailed RINGSIDE Phase 3 data were selected for an oral abstract session at the 2026 ASCO Annual Meeting. Source

ADC pipeline and early programs

IM-1021 lymphoma responses reported: The IM-1021 Phase 1 study is ongoing, with objective responses at multiple dose levels in B-cell lymphoma. Initial lymphoma data are expected in 2026. Source
IM-1617 cleared for Phase 1: IM-1617 is described as a potential first-in-class ADC for an undisclosed solid tumor target. It uses HC74, the company's proprietary TOP1 inhibitor payload. Source
IM-3050 first trial site opened: The first clinical trial site for a Phase 1 trial of IM-3050 in FAP-expressing solid tumors was initiated in March 2026. Source
Early ADCs share HC74 payload: Preclinical ADC programs each pursue undisclosed solid tumor targets and use the HC74 payload. Source

“In parallel, we continue to advance our ADC pipeline, with IM-1021 progressing in Phase 1 and IM-1617 recently receiving IND clearance.”
Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome

Operating expenses

R&D spend rose to $46.4M: Research and development expense was $46.4 million, against $36.9 million a year earlier, including $3.7 million of stock-based compensation. Source
G&A expense rose to $13.0M: General and administrative expense was $13.0 million, including $4.2 million of stock-based compensation, against $10.7 million a year earlier. Source
Stock compensation rose to $8.0M: Total share-based compensation expense was $8.0 million for the quarter, against $5.7 million in the first quarter of 2025. Source

Capital, cash and share count

Cash fell to $582.7M: Cash and cash equivalents were $582.7 million at March 31, 2026, against $653.5 million at December 31, 2025. Source
Accumulated deficit reached $782.0M: The accumulated deficit was $782.0 million, against $728.2 million at December 31, 2025. Total stockholders’ equity was $588.7 million. Source
Accrued liabilities declined: Accrued expenses and other current liabilities were $21.9 million, against $41.7 million at December 31, 2025. Accounts payable rose to $5.5 million from $3.3 million. Source
Weighted share count rose: Weighted-average shares outstanding were 113.1 million for the quarter, against 79.4 million a year earlier. Source

Company positioning and pipeline breadth

Self-described targeted oncology company: The company describes itself as a clinical-stage targeted oncology company focused on first-in-class and best-in-class therapies. Source
Broad early-stage ADC portfolio: Beyond the named programs, the company is advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. Source

Coming up, as management said on 12 May 2026

IM-1021 lymphoma data in 2026: Management expects to present initial lymphoma data for IM-1021 in 2026. Source
IM-1617 Phase 1 start: Management plans to initiate a Phase 1 trial of IM-1617 in the second quarter of 2026. Source
EU application by end of 2026: Management plans to submit a Marketing Authorization Application to the European Medicines Agency for varegacestat by the end of 2026. Source
IM-1340 and IM-1335 IND filings: INDs for IM-1340 and IM-1335 are expected in mid- and late 2026, respectively. Source

Figures management reported

Figure	Reported
Collaboration revenue Source	nil, against $2.9 million in Q1 2025
R&D spend Source	$46.4 million for the quarter
Pipeline milestones Source	NDA submitted April 2026; IM-1617 IND cleared April 2026; IM-3050 first site March 2026
Trial readout data Source	Objective response rate 56% vs 9% with placebo; hazard ratio 0.16

Earlier plans management reported on

Not stated: The prior release planned the NDA submission for the second quarter of 2026. The current release reports the submission in April 2026.
Not stated: The prior release planned a Phase 1 study start in early 2026, after radiotracer supply delivery. The current release reports the first site initiated in March 2026.
Not stated: The prior release expected IND submissions for three ADCs in early, mid and late 2026. The current release reports IM-1617 IND clearance in April 2026.
Not stated: The prior release expected to present initial IM-1021 data in 2026. The current release repeats that expectation for lymphoma data.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

Immunome Reports First Quarter 2026 Financial Results and Provides Business Update

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:

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).

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.

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.

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

Forward-looking statements notice

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.

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	46,381	36,872
General and administrative	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

Contacts
Max Rosett
Chief Financial Officer investors@immunome.com
IMMUNOME, INC.