Elicio Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Updates

Rhea-AI Summary

Elicio Therapeutics (Nasdaq: ELTX) reported Q3 2025 results and clinical updates on Nov 13, 2025. The company now expects the event-driven primary DFS analysis in 1H 2026 after observing fewer than projected disease progressions and deaths in the Phase 2 AMPLIFY-7P trial. Updated data show strong immunogenicity: 99% (89/90) mKRAS-specific T cell responses and 86.8% cytotoxic responses in evaluable patients. IDMC recommended continuing the trial with no modifications and confirmed a favorable safety profile. Q3 net loss narrowed to $10.1M and cash and equivalents were $20.6M as of Sept 30, 2025; ~$11.1M gross was raised via ATM in Q3, supporting operations through Q2 2026.

Positive

• mKRAS T cell responses in 99% (89/90) of evaluable patients
• Cytotoxic mKRAS responses in 86.8% (66/76) of evaluable patients
• IDMC recommended continuing Phase 2 with no modifications
• Net loss improved from $18.8M to $10.1M (~46% reduction)
• Raised ~$11.1M via ATM; cash of $20.6M supports runway to Q2 2026

Negative

• Cash runway limited to Q2 2026, requiring further financing for later-stage trials
• Weighted average shares increased from 13.58M to 16.69M (potential dilution ~23%)

Insights

Clinical Development & Finance Expert

Early trial events slower than projected and added ATM proceeds extend runway toward a 1H 2026 event‑driven DFS readout.

Fewer observed disease progressions and deaths in the randomized Phase 2 AMPLIFY-7P study imply the event-driven primary DFS analysis now targets 1H 2026. The Independent Data Monitoring Committee previously recommended continuation without changes and noted a favorable safety profile, and biological activity is robust with mKRAS-specific T cell responses in 99% (89/90) of evaluable patients and cytotoxic responses in 86.8% (66/76).

On the finance side, the company raised approximately $11.1 million via its ATM and reported $20.6 million cash as of September 30, 2025, which it expects will fund operations through Q2 2026, beyond the anticipated DFS analysis in 1H 2026. Key dependencies remain the blinded event count and the eventual unblinded DFS result; the clinical signals and IDMC position reduce near-term execution risk but do not confirm efficacy until the unblinded primary analysis.

Watch for the event-driven DFS analysis in 1H 2026, the post-readout FDA End of Phase 2 request, and any cash updates or financings before Q2 2026. These items will materially change the program’s outlook and the company’s need for additional capital.

• In the ongoing Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with pancreatic ductal adenocarcinoma (“PDAC”), fewer disease progressions and deaths than projected have been observed as of November 6, 2025. 
  
• Based on 2:1 randomization with twice as many patients in the ELI-002 7P treatment arm compared to the observation arm, Elicio believes the lower-than-projected number of disease progressions and deaths may reflect a favorable impact on disease-free survival (“DFS”); event-driven primary DFS analysis now anticipated in 1H 2026.
  
• Since the beginning of Q3 2025, the Company has raised gross proceeds of approximately $11.1 million through its established at-the-market program, extending Elicio’s cash runway through Q2 2026.
• Current cash position is expected to support operations beyond the anticipated Phase 2 AMPLIFY-7P event-driven primary DFS endpoint analysis anticipated in 1H 2026.
  
• The Company remains blinded to the Phase 2 AMPLIFY-7P trial clinical efficacy outcomes.
  

BOSTON, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today reported financial results for the third quarter ended September 30, 2025, and provided recent corporate and clinical updates.

“We are encouraged to see fewer disease progressions and deaths in the Phase 2 AMPLIFY-7P study than originally projected in our statistical modeling. This may reflect a favorable impact on DFS. Because the DFS analysis is event-driven and triggered by a predefined number of events, we are updating our guidance for the timing of the event-driven primary DFS endpoint analysis to the first half of 2026. Importantly, we believe our current cash position will allow us to reach this critical catalyst and beyond as we continue advancing ELI-002 7P toward its potential to meaningfully improve outcomes for patients with KRAS-mutant pancreatic cancer,” said Robert Connelly, Chief Executive Officer of Elicio.

Recent Highlights

• In November 2025, Elicio presented updated Phase 2 AMPLIFY-7P data at the Society for Immunotherapy of Cancer’s Annual Meeting, showing that ELI-002 7P induced mutant KRAS (“mKRAS”)-specific T cell responses in 99% (89/90) of evaluable patients with an 86% antigen response rate. In addition, Elicio reported 86.8% (66/76) of evaluable patients induced cytotoxic mKRAS-specific T cell responses; 75% (57/76) induced CD8+ T cells and 75% (57/76) induced CD4+ T cells. Responses were observed across all seven mKRAS epitopes and occurred across a diverse HLA background, highlighting ELI-002 7P’s potential to benefit a broad and genetically diverse patient population.
• In October 2025, Elicio announced robust T cell responses across diverse HLA backgrounds in the ongoing Phase 2 AMPLIFY-7P trial.
• In September 2025, Elicio announced the planned investigator-initiated Phase 1 neoadjuvant trial of ELI-002 7P in resectable and borderline resectable PDAC led by Memorial Sloan Kettering Cancer Center and funded by the Lustgarten Foundation, assessing ELI-002 7P combined with mFOLFIRINOX with or without the anti-PD-1 antibody. The trial is designed to enroll 20 patients across two arms and is anticipated to begin in 1H 2026.
• In August 2025, Elicio announced the positive recommendation by the Independent Data Monitoring Committee (“IDMC”) to continue the ELI-002 7P randomized Phase 2 study in PDAC without modifications to the final analysis. In addition, the IDMC confirmed the favorable safety profile of ELI-002 7P as of such date; the Company viewed the IDMC’s positive recommendation as an indication that ELI-002 7P has shown preliminary signals of efficacy.

Upcoming Anticipated Milestones for the Phase 2 AMPLIFY-7P Trial

• Upon reaching the event-driven primary DFS endpoint analysis, Elicio will request an End of Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) to finalize the Phase 3 trial design for ELI-002 7P. Alignment on key elements of the Phase 3 study design was reached with the FDA at the End of Phase 1 meeting announced in Q1 2025.
  

Third Quarter 2025 Financial Results

R&D expense for the third quarter of 2025 was $5.0 million, compared to $7.2 million for the third quarter of 2024. The decrease of $2.2 million was primarily due to less clinical trial costs as patients progressed through the Phase 2 AMPLIFY-7P trial.

G&A expense for the third quarter of 2025 was $3.0 million, compared to $3.1 million for the third quarter of 2024. The decrease of $0.1 million was primarily due to lower fees incurred in connection with general corporate matters.

Net loss for the third quarter of 2025 was $10.1 million, compared to $18.8 million for the third quarter of 2024. Net loss for the third quarter of 2025 includes $2.0 million in other expense. Net loss per share for the third quarter of 2025 was $0.60 compared to $1.39 for the third quarter of 2024.

Cash and cash equivalents as of September 30, 2025 were $20.6 million.

The Company expects that its current cash and cash equivalents will support operations through Q2 2026, beyond the anticipated Phase 2 AMPLIFY-7P event-driven primary DFS endpoint analysis anticipated in 1H 2026.

Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)
		Three Months Ended September 30,
			2025				2024
Operating expenses:
Research and development		$	5,039			$	7,208
General and administrative			3,006				3,136
Total operating expenses			8,045				10,344
Loss from operations			(8,045	)			(10,344	)
Total other (expense) income, net			(2,038	)			(8,494	)
Net loss			(10,083	)			(18,838	)
Other comprehensive gain (loss):
Foreign currency translation adjustment			39				36
Comprehensive loss		$	(10,044	)		$	(18,802	)
Net loss per common share, basic and diluted		$	(0.60	)		$	(1.39	)
Weighted average common shares and pre-funded warrants outstanding, basic and diluted			16,692,476				13,582,345

Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
		September 30, 2025			December 31, 2024
Assets
Cash and cash equivalents		$	20,611		$	17,618
Other current assets			854			3,075
Total current assets			21,465			20,693
Other assets			6,819			7,485
Total assets		$	28,284		$	28,178
Liabilities and stockholders' (deficit) equity
Current liabilities		$	6,515		$	11,523
Long-term liabilities			17,953			27,967
Total liabilities			24,468			39,490
Total stockholders' (deficit) equity			3,816			(11,312	)
Total liabilities and stockholders' (deficit) equity		$	28,284		$	28,178

Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing novel immunotherapies for the treatment of high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers. Elicio intends to build on recent clinical successes in the personalized cancer immunotherapy space to develop effective, off-the-shelf immunotherapies. Elicio’s Amphiphile (“AMP”) technology aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional immunization strategies, with the goal of promoting durable cancer immunosurveillance in patients. Elicio’s ELI-002 lead program is an off-the-shelf immunotherapy candidate targeting the most common KRAS mutations, which drive approximately 25% of all solid tumors. Off-the-shelf immunotherapy approaches have the potential benefits of low cost, rapid commercial scale manufacturing, and rapid availability of drug to patients especially in neo-adjuvant settings and for prophylaxis in high-risk patients, contrary to personalized immunotherapy approaches. ELI-002 is being studied in an ongoing, randomized clinical trial in patients with mKRAS-positive pancreatic cancer who completed standard therapy but remain at high risk of relapse. ELI-002 also has been studied in patients with mKRAS-positive colorectal cancer (“CRC”) in Phase 1 studies. The updated AMPLIFY-201 Phase 1 data for PDAC and CRC was presented at the ESMO Immuno-Oncology Congress 2024 and included a 16.3-month median recurrence-free survival and 28.9-month median overall survival for the full study population. In the future, Elicio plans to expand ELI-002 to other indications including mKRAS positive lung cancer and other mKRAS positive cancers. Elicio’s pipeline includes additional off-the-shelf therapeutic cancer immunotherapy candidates, including ELI-007 and ELI-008, that target BRAF-driven cancers and p53 hotspot mutations, respectively. For more information, please visit www.elicio.com.

About ELI-002

Elicio’s lead product candidate, ELI-002, is a structurally novel investigational AMP cancer immunotherapy that targets cancers that are driven by mutations in the KRAS-gene—a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio’s AMP technology consisting of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant that is available as an off-the-shelf subcutaneous administration.

ELI-002 2P (2-peptide formulation) has been studied in the Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy (NCT04853017). ELI-002 7P (7-peptide formulation) is currently being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002.

About the Amphiphile Platform

Elicio’s proprietary AMP platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. Elicio believes this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, Elicio observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. Elicio believes its AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based on preclinical studies.

Elicio’s AMP platform, originally developed at the Massachusetts Institute of Technology, has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The AMP platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue.

Cautionary Note on Forward-Looking Statements

Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements regarding the sufficiency of Elicio’s existing cash and cash equivalents to support operations; Elicio’s planned clinical programs, including the timing and outcome of planned clinical trials; the timing of the anticipated event-driven primary DFS endpoint analysis of the Phase 2 AMPLIFY-7P trial; the potential efficacy of Elicio’s product candidates, including ELI-002 7P; the potential of Elicio’s product candidates, including ELI-002 7P, to meaningfully improve outcomes for mKRAS PDAC patients; Elicio’s plan to request an End of Phase 2 meeting with the FDA to finalize the Phase 3 trial design for ELI-002 7P and the potential outcome of such meeting, if granted; the potential for future expansion of ELI-002 to other indications, including mKRAS positive lung cancer, other mKRAS positive cancers and in combination regimens for PDAC; the potential benefits and effectiveness of off-the-shelf immunotherapy approaches; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Elicio undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. Elicio uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, Elicio’s financial condition, including its anticipated cash runway, and ability to obtain the funding necessary to advance the development of ELI-002 7P and any other future product candidates, and Elicio’s ability to continue as a going concern; Elicio’s plans to develop and commercialize its product candidates, including ELI-002 7P; the timing of initiation of Elicio’s planned clinical trials; the timing of the availability of data from Elicio’s clinical trials, including the event-driven primary DFS endpoint analysis from the Phase 2 AMPLIFY-7P trial; the timing of any planned investigational new drug application or new drug application; Elicio’s plans to research, develop and commercialize its current and future product candidates; and Elicio’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time to time, and it is not possible for Elicio to predict all such factors, nor can Elicio assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These risks are more fully discussed under the heading “Risk Factors” in Elicio’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 31, 2025, Elicio’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 13, 2025, and Elicio’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 7, 2025, as updated by subsequent reports and other documents filed from time to time with the SEC. Forward-looking statements included in this release are based on information available to Elicio as of the date of this release. Elicio does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this release, except to the extent required by law.

Investor Relations Contact
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com 

FAQ

When does Elicio (ELTX) expect the Phase 2 AMPLIFY-7P primary DFS analysis?

Elicio now anticipates the event-driven primary DFS analysis in 1H 2026 due to fewer than projected events as of Nov 6, 2025.

What immunogenicity results did Elicio report for ELI-002 7P in Q3 2025?

Updated AMPLIFY-7P data showed 99% mKRAS-specific T cell responses (89/90) and 86.8% cytotoxic responses (66/76) in evaluable patients.

How long will Elicio's cash support operations after the Q3 2025 report?

The company reported $20.6M cash as of Sept 30, 2025 and raised ~$11.1M via ATM, which it expects will support operations through Q2 2026.

Did the independent data monitoring committee take action on the AMPLIFY-7P trial?

Yes; the IDMC recommended continuing the randomized Phase 2 study without modifications and confirmed a favorable safety profile as of Aug 2025.

What shareholder impact resulted from Elicio's Q3 2025 financing?

The ATM raise increased weighted average shares to 16.69M from 13.58M, indicating potential dilution versus prior period.

What are the next clinical development steps for ELI-002 7P after the DFS analysis?

Upon reaching the event-driven primary DFS endpoint, Elicio plans to request an End of Phase 2 meeting with the FDA to finalize Phase 3 design.

When will the investigator-initiated neoadjuvant Phase 1 trial of ELI-002 7P start?

The Memorial Sloan Kettering-led neoadjuvant Phase 1 investigator-initiated trial is anticipated to begin in 1H 2026.