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

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Elicio Therapeutics (NASDAQ:ELTX) reported Q2 2025 financial results and provided updates on its cancer immunotherapy pipeline. The Independent Data Monitoring Committee (IDMC) recommended continuing the ELI-002 7P Phase 2 study in pancreatic cancer without modifications, with final disease-free survival (DFS) analysis expected in Q4 2025.

Financial highlights include a $10 million non-dilutive financing secured in June 2025. Q2 2025 showed R&D expenses of $7.0 million (down from $8.2M in Q2 2024) and a net loss of $10.6 million. Cash position of $22.1 million is expected to fund operations into Q1 2026, beyond the anticipated Phase 2 final analysis.

The company plans to request an End-of-Phase 2 FDA meeting to finalize the regulatory strategy for ELI-002's pivotal Phase 3 trial following the final DFS analysis.

Elicio Therapeutics (NASDAQ:ELTX) ha comunicato i risultati finanziari del secondo trimestre 2025 e aggiornamenti sulla sua pipeline di immunoterapia oncologica. Il Comitato Indipendente di Monitoraggio dei Dati (IDMC) ha raccomandato di proseguire lo studio di Fase 2 ELI-002 7P nel carcinoma pancreatico senza modifiche, con l'analisi finale della sopravvivenza libera da malattia (DFS) prevista per il quarto trimestre 2025.

Tra i principali dati finanziari, è stato ottenuto un finanziamento non diluitivo di 10 milioni di dollari a giugno 2025. Nel secondo trimestre 2025 le spese per ricerca e sviluppo sono state di 7,0 milioni di dollari (in calo rispetto agli 8,2 milioni del secondo trimestre 2024) e la perdita netta è stata di 10,6 milioni di dollari. La liquidità disponibile di 22,1 milioni di dollari dovrebbe coprire le operazioni fino al primo trimestre 2026, oltre la prevista analisi finale di Fase 2.

L'azienda intende richiedere un incontro End-of-Phase 2 con la FDA per definire la strategia regolatoria del trial pivotale di Fase 3 di ELI-002, successivamente all'analisi finale della DFS.

Elicio Therapeutics (NASDAQ:ELTX) informó los resultados financieros del segundo trimestre de 2025 y proporcionó actualizaciones sobre su cartera de inmunoterapia contra el cáncer. El Comité Independiente de Monitoreo de Datos (IDMC) recomendó continuar el estudio de Fase 2 ELI-002 7P en cáncer de páncreas sin modificaciones, con el análisis final de supervivencia libre de enfermedad (DFS) previsto para el cuarto trimestre de 2025.

Entre los aspectos financieros destacados, se aseguró un financiamiento no dilutivo de 10 millones de dólares en junio de 2025. En el segundo trimestre de 2025, los gastos en I+D fueron de 7,0 millones de dólares (menos que los 8,2 millones del segundo trimestre de 2024) y la pérdida neta fue de 10,6 millones de dólares. La posición de caja de 22,1 millones de dólares se espera que financie las operaciones hasta el primer trimestre de 2026, más allá del análisis final de Fase 2 anticipado.

La compañía planea solicitar una reunión End-of-Phase 2 con la FDA para finalizar la estrategia regulatoria del ensayo pivotal de Fase 3 de ELI-002 tras el análisis final de DFS.

Elicio Therapeutics (NASDAQ:ELTX)� 2025� 2분기 재무 결과� 발표하고 � 면역치료� 파이프라인에 대� 업데이트� 제공했습니다. 독립 데이� 모니터링 위원�(IDMC)� 췌장� 대상의 ELI-002 7P 2� 연구� 수정 없이 계속 진행� 것을 권고했으�, 최종 무병생존기간(DFS) 분석은 2025� 4분기� 예정되어 있습니다.

재무 주요 내용으로� 2025� 6월에 확보� 1,000� 달러 비희석성 자금 조달� 포함됩니�. 2025� 2분기 연구개발 비용은 700� 달러(2024� 2분기 820� 달러에서 감소)였으며 순손실은 1,060� 달러옶습니�. 2,210� 달러� 현금 보유고는 2� 최종 분석 예상 시점 이후� 2026� 1분기까지 운영 자금� 지원할 것으� 예상됩니�.

회사� 최종 DFS 분석 � ELI-002� 중대� 3� 시험� 대� 규제 전략� 확정하기 위해 FDA와� End-of-Phase 2 미팅� 요청� 계획입니�.

Elicio Therapeutics (NASDAQ:ELTX) a publié ses résultats financiers du deuxième trimestre 2025 et a fourni des mises à jour sur son pipeline d'immunothérapie contre le cancer. Le Comité Indépendant de Surveillance des Données (IDMC) a recommandé de poursuivre l'étude de phase 2 ELI-002 7P dans le cancer du pancréas sans modifications, avec une analyse finale de la survie sans maladie (DFS) prévue au quatrième trimestre 2025.

Les points financiers clés incluent un financement non dilutif de 10 millions de dollars obtenu en juin 2025. Au deuxième trimestre 2025, les dépenses en R&D se sont élevées à 7,0 millions de dollars (en baisse par rapport à 8,2 millions au T2 2024) et la perte nette à 10,6 millions de dollars. La trésorerie de 22,1 millions de dollars devrait financer les opérations jusqu'au premier trimestre 2026, au-delà de l'analyse finale de la phase 2 prévue.

L'entreprise prévoit de demander une réunion de fin de phase 2 avec la FDA afin de finaliser la stratégie réglementaire pour l'essai pivot de phase 3 d'ELI-002 après l'analyse finale de la DFS.

Elicio Therapeutics (NASDAQ:ELTX) meldete die Finanzergebnisse für das zweite Quartal 2025 und gab Updates zu seiner Krebsimmuntherapie-Pipeline bekannt. Das Unabhängige Datenüberwachungskomitee (IDMC) empfahl, die ELI-002 7P Phase-2-Studie bei Bauchspeicheldrüsenkrebs ohne Änderungen fortzusetzen, mit der finalen Analyse des krankheitsfreien Überlebens (DFS) im vierten Quartal 2025.

Zu den finanziellen Highlights zählt eine im Juni 2025 gesicherte nicht verwässernde Finanzierung in Höhe von 10 Millionen US-Dollar. Im zweiten Quartal 2025 beliefen sich die F&E-Ausgaben auf 7,0 Millionen US-Dollar (gegenüber 8,2 Mio. im zweiten Quartal 2024) und der Nettoverlust betrug 10,6 Millionen US-Dollar. Die Kassenposition von 22,1 Millionen US-Dollar soll die Geschäftstätigkeit bis ins erste Quartal 2026 finanzieren, also über die erwartete finale Phase-2-Analyse hinaus.

Das Unternehmen plant, ein End-of-Phase-2-Meeting mit der FDA anzufordern, um die Zulassungsstrategie für die entscheidende Phase-3-Studie von ELI-002 nach der finalen DFS-Analyse festzulegen.

Positive
  • IDMC's positive recommendation to continue Phase 2 study indicates preliminary efficacy signals
  • Secured $10 million non-dilutive financing in Q2 2025
  • R&D expenses decreased by $1.2 million year-over-year
  • Cash runway extended into Q1 2026, beyond Phase 2 final analysis
  • Previous Phase 1 data showed 16.3-month median recurrence-free survival
Negative
  • Net loss increased to $10.6 million from $7.2 million year-over-year
  • Total liabilities of $27.7 million as of June 30, 2025

Insights

Positive IDMC recommendation for Elicio's pancreatic cancer therapy signals efficacy; final DFS data expected Q4 2025.

The Independent Data Monitoring Committee's recommendation to continue Elicio's AMPLIFY-7P study without modifications represents a significant clinical milestone. When an IDMC allows a trial to proceed without changes after reviewing unblinded interim data, it typically suggests the therapy is showing preliminary efficacy signals while maintaining an acceptable safety profile - both critical hurdles in pancreatic cancer treatment development.

The focus on disease-free survival (DFS) as the primary endpoint is strategically sound for pancreatic ductal adenocarcinoma (PDAC), where recurrence rates remain devastatingly high. The event-driven final analysis approach means the study will conclude once a predetermined number of recurrence events occur, providing statistical power while potentially shortening the overall study timeline.

Elicio's technology targeting mutant KRAS addresses a fundamental driver in pancreatic cancer pathogenesis. KRAS mutations occur in approximately 90% of PDAC cases, making it an ideal target. Their AMP platform's mechanism of enhancing T-cell education could potentially overcome the notoriously immunosuppressive microenvironment of pancreatic tumors.

The previously reported 16.3-month median recurrence-free survival from their Phase 1 data is promising when compared to historical controls. Importantly, Elicio has already aligned with the FDA on pivotal Phase 3 design elements, suggesting confidence in their approach and potentially accelerating their regulatory pathway if Q4 2025 data proves positive.

Elicio strengthens financial position with $10M financing, extending runway beyond critical Q4 2025 data readout.

Elicio's financial strategy demonstrates prudent cash management aligned with their clinical milestones. The $22.1 million cash position, bolstered by the recent $10 million non-dilutive financing, provides operational runway into Q1 2026 - critically extending beyond their Q4 2025 Phase 2 data readout. This timing buffer reduces the risk of having to raise capital from a position of weakness should data disappoint.

The R&D expense decreased by $1.2 million to $7.0 million compared to Q2 2024, reflecting lower manufacturing costs as they advance through clinical stages rather than preparing new batches. This natural progression in expense structure is expected and indicates proper trial execution.

The company's balance sheet transformation is noteworthy, with stockholders' equity improving from a $(11.3) million deficit in December 2024 to a positive $1.8 million position by June 2025. This significant reversal suggests successful liability management and strengthened financial footing.

Long-term liabilities decreased substantially from $28.0 million to $17.8 million, a 36% reduction that improves their financial flexibility. The higher net loss ($10.6 million vs $7.2 million year-over-year) includes non-cash items related to warrant valuation, making the operational burn rate less concerning than the headline figure suggests.

With FDA alignment already secured on Phase 3 design elements, Elicio has positioned themselves to potentially move quickly into pivotal studies if Phase 2 data proves positive, maximizing the efficiency of their capital deployment.

Recent positive recommendation by the Independent Data Monitoring Committee (“IDMC�) to continue ELI-002 7P randomized Phase 2 study in pancreatic cancer without modifications to final analysis

Event-driven final analysis focused on disease-free survival (“DFS�) expected in Q4 2025

Secured $10 million financing in Q2 2025; Current cash position expected to support operations beyond anticipated AMPLIFY-7P Phase 2 final analysis

BOSTON, Aug. 07, 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 second quarter endedJune 30, 2025,and provided recent corporate and clinical updates.

“Most recently, we were pleased to receive the IDMC’s positive recommendation to continue the AMPLIFY-7P study to final analysis without modification, which we believe indicates preliminary signals of efficacy from ELI-002 7P in the treatment of pancreatic ductal adenocarcinoma (“PDAC�),� said Robert Connelly, Chief Executive Officer of Elicio Therapeutics. “With final DFS data expected in the fourth quarter of this year, we are focused on advancing clinical preparations for a potential pivotal Phase 3 trial. We previously reached alignment with the U.S. Food and Drug Administration (“FDA�) on the key elements of the planned pivotal Phase 3 study design, and, upon final event-driven DFS analysis, plan to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 Phase 3 study. Importantly, during the second quarter, we secured $10 million in additional financing to extend our cash runway into the first quarter of 2026, beyond the anticipated final DFS analysis.�

Recent Highlights

  • In August 2025, Elicio announced a positive recommendation by the IDMC to continue the ELI-002 7P randomized Phase 2 study in PDAC without modifications to final analysis, based on a pre-specified unblinded interim analysis of efficacy and safety data. In addition, the IDMC confirmed the favorable safety profile of ELI-002 7P to date.
  • In June 2025, Elicio strengthened its cash position with a $10 million non-dilutive financing.
  • In June, Elicio hosted a virtual KOL event highlighting the Company’s AMP platform and lead program, ELI-002, and the unmet need in mutant KRAS (“mKRAS�)-driven PDAC.

Upcoming Anticipated Milestones

  • DFS event-driven final analysis of Phase 2 AMPLIFY-7P clinical trial anticipated in Q4 2025.
  • Upon final DFS analysis, request and conduct End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the pivotal Phase 3 trial for ELI-002.

Second Quarter 2025 Financial Results

R&D expense for the second quarter of 2025 was $7.0 million, compared to $8.2 million for the second quarter of 2024.The decrease of $1.2 million was primarily due to less clinical trial manufacturing as we advanced ELI-002 7P clinical development.

G&A expense for the second quarter of 2025 was $3.1 million, compared to $2.7 million for the second quarter of 2024. The increase of $0.4 million was primarily due to higher professional fees in connection with the June 2025 Promissory Note Financing.

Net loss for the second quarter of 2025 was $10.6 million, compared to $7.2 million for the second quarter of 2024.Net loss for the second quarter of 2025 included the change in fair value associated with outstanding common warrants and recognition of grant income. Net loss per share for the second quarter of 2025 was $0.66 compared to $0.64 for the second quarter of 2024.

Cash and cash equivalents, as of June 30, 2025, were $22.1 million.

The Company expects that its current cash and cash equivalents will support operations into Q1 2026, beyond the anticipated AMPLIFY-7P Phase 2 final analysis.

ELICIO THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)
Three Months Ended June 30,
20252024
Operating expenses:
Research and development$7,006$8,180
General and administrative3,0852,744
Total operating expenses10,09110,924
Loss from operations (10,091) (10,924)
Total other (expense) income, net(470)3,695
Net loss(10,561)(7,229)
Other comprehensive gain (loss):
Foreign currency translation adjustment7432
Comprehensive loss$ (10,487)$ (7,197)
Net loss per common share, basic and diluted$(0.66)$(0.64)
Weighted average common shares and pre-funded warrants outstanding, basic and diluted16,059,42311,284,853


ELICIO THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
June 30, 2025December 31, 2024
Assets
Cash and cash equivalents$22,088$17,618
Other current assets5103,075
Total current assets22,59820,693
Other assets6,9307,485
Total assets$ 29,528 $ 28,178
Liabilities and stockholders' (deficit) equity
Current liabilities$9,923$11,523
Long-term liabilities17,77127,967
Total liabilities27,69439,490
Total stockholders' (deficit) equity1,834(11,312)
Total liabilities and stockholders' (deficit) equity$ 29,528 $ 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 vaccine space to develop effective, off-the-shelf vaccines. Elicio’s Amphiphile (“AMP�) technology aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional vaccination strategies, with the goal of promoting durable cancer immunosurveillance in patients. Elicio’s ELI-002 lead program is an off-the-shelf vaccine candidate targeting the most common KRAS mutations, which drive approximately 25% of all solid tumors. Off-the-shelf vaccine 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 vaccines 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 vaccines candidates, including ELI-007 and ELI-008, that target BRAF-driven cancers and p53 hotspot mutations, respectively. For more information, please visit .

About ELI-002

Elicio’s lead product candidate, ELI-002, is a structurally novel investigational AMP cancer vaccine 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 into the first quarter of 2026, beyond the anticipated AMPLIFY-7P Phase 2 event-driven final DFS analysis expected in the fourth quarter of 2025; Elicio’s planned clinical programs, including the timing and outcome of planned clinical trials; the timing of the expected event-driven final DFS analysis of the Phase 2 AMPLIFY-7P clinical trial anticipated in the fourth quarter of 2025; the potential efficacy of Elicio’s product candidates, including ELI-002 7P; the potential of Elicio’s product candidates, including ELI-002; Elicio’s plan to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 Phase 3 study and the potential outcome of such meeting, if granted; the potential for future expansion of ELI-002 to other indications, including in combination regimens for PDAC and colorectal cancer; the potential benefits and effectiveness of off-the-shelf vaccine 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. We use 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 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; 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 final DFS analysis from the Phase 2 AMPLIFY-7P trial expected in the fourth quarter of 2025; 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 us to predict all such factors, nor can we 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, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 13, 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
[email protected]


FAQ

What was the outcome of ELTX's IDMC review for the ELI-002 7P Phase 2 study?

The IDMC recommended continuing the ELI-002 7P Phase 2 study in pancreatic cancer without modifications, confirming favorable safety profile and indicating preliminary efficacy signals.

What are Elicio Therapeutics' (ELTX) current cash reserves and runway?

As of June 30, 2025, ELTX had $22.1 million in cash and cash equivalents, expected to support operations into Q1 2026.

When will Elicio Therapeutics (ELTX) report final Phase 2 DFS data for ELI-002?

The final disease-free survival (DFS) analysis for the AMPLIFY-7P Phase 2 trial is expected in Q4 2025.

What was Elicio Therapeutics' (ELTX) Q2 2025 financial performance?

ELTX reported a net loss of $10.6 million, R&D expenses of $7.0 million, and secured a $10 million non-dilutive financing.

What is ELI-002's target market and potential?

ELI-002 targets the most common KRAS mutations, which drive approximately 25% of all solid tumors, including pancreatic and colorectal cancers, with potential expansion to lung cancer and other KRAS-positive cancers.
Elicio Therapeutics, Inc.

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