[8-K] Elicio Therapeutics, Inc. Reports Material Event

Rhea-AI Filing Summary

Elicio Therapeutics, Inc. (ELTX) filed a Form 8-K reporting a material event and included three exhibits: a press release dated September 17, 2025, a corporate presentation dated September 17, 2025, and the AMPLIFY-7P trial attachment listed as Exhibit 99.2. The filing references T‑cell response metrics related to mKRAS (including T cell response rate, average and median fold change, and thresholds correlating with clinical activity) and notes the inclusion of CD4+ and CD8+ responses as well as responses to seven mKRAS antigens and patient tumor antigens. The document is signed by Robert Connelly, President and Chief Executive Officer.

The filing supplies named exhibits that investors can review for trial details and corporate messaging; the 8-K itself does not disclose additional numerical trial outcomes in the provided excerpt, so readers should consult the attached press release, presentation, and Exhibit 99.2 for complete data.

Positive

• Material event disclosed via Form 8‑K with attached exhibits for investor review
• Exhibit 99.2 (AMPLIFY-7P) included, enabling access to trial documentation
• Press release and corporate presentation dated September 17, 2025 provide coordinated public disclosures

Negative

• None.

Insights

Clinical Development Analyst

TL;DR: The filing attaches trial materials and a press release that likely contain clinical-response data for the AMPLIFY-7P program.

The company submitted a Form 8-K that attaches a press release, a corporate presentation, and Exhibit 99.2 describing the AMPLIFY-7P trial and T‑cell response metrics related to mKRAS antigens. These exhibits are the primary sources for any clinical data; the filing text alone lists response categories (CD4+ and CD8+ responses, responses to seven mKRAS antigens, and tumor antigen responses) but does not present specific numeric outcomes in the excerpt provided.

Key dependencies include the full exhibits for concrete efficacy and safety figures; review the September 17, 2025 press release and Exhibit 99.2 to confirm response rates, fold‑change magnitudes, and the correlation thresholds noted here within the next reporting cycle.

Investor Communications Specialist

TL;DR: The 8‑K is a standard disclosure that centralizes public communications and trial materials for investor review.

The filing formally documents corporate messaging by attaching the press release and presentation dated September 17, 2025, which ensures investors have access to the same trial summaries and corporate talking points. The CEO signature indicates company authorization of the disclosed materials.

Material impact for investors depends on the numerical details inside the attached exhibits; monitor the posted press release and Exhibit 99.2 for specific metrics and any subsequent regulatory or clinical updates over the coming weeks.

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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): September 17, 2025

Elicio Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-39990		11-3430072
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

451 D Street, 5th Floor

Boston, Massachusetts 02210

(Address of principal executive offices, including zip code)

(857) 209-0050

Registrant’s telephone number, including area code

Not Applicable

(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:

☐ 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 240.14a12)

☐ 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))

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.01 par value per share		ELTX		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 7.01 Regulation FD Disclosure.

On September 17, 2025, Elicio Therapeutics, Inc. (the “Company”) issued a press release reporting that ELI-002 7P achieved robust mKRAS-specific T cell responses in 99% of evaluable patients in the ongoing Phase 2 AMPLIFY-7P trial. A copy of the press release is furnished as Exhibit 99.1 hereto.

The information set forth in this Item 7.01 and Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.

On September 17, 2025, the Company announced immunogenicity testing data showing that T cell responses from its ongoing Phase 2 AMPLIFY-7P trial were robust and consistent across a number of metrics of magnitude and functional quality with responses observed in its previous Phase 1 studies of ELI-002 2P and ELI-002 7P where T cell response was correlated to clinical activity. This consistency was observed with CD4 and CD8 T cell responses with an 85% CD4 and CD8 response rate, compared to 75% in the Company’s previous Phase 1 trial of ELI-002 7P, where the induction of combined CD4 and CD8 responses correlated with clinical activity. Similarly, the Company observed consistent responses to all included mKRAS antigens. 67.4% of patients exhibited responses for all seven mKRAS antigens, compared to 50% in the Company’s Phase 1 trial of ELI-002 7P, and consistent responses to patient-specific mKRAS tumor antigens, with an 87.6% response rate to the patient’s tumor mKRAS antigen compared to 83.3% in the Company’s ELI-002 7P Phase 1 trial. Overall vaccine immunogenicity was also observed to be consistent with the Company’s Phase 1 trial with positive T cell responses to 85.7% of vaccine antigens compared to 66.7% in the Company’s ELI-002 7P Phase 1 trial. Approximately 99% of evaluable patients (89 of 90) enrolled in the Company’s ongoing Phase 2 AMPLIFY-7P trial who were administered ELI-002 7P generated robust mKRAS-specific T cell responses, with an average increase of 145.3x over baseline responses, consistent with observations from prior Phase 1 trials of ELI-002. Further, the data showed a 44.3x median increase over baseline. In the Company’s Phase 1 trials, responses above ~9x over baseline correlated with clinical activity.

		ELI-002 7P (1.4mg & 4.9mg)		ELI-002 7P (4.9 mg)
		Phase 1 (n=12)		Phase 2 (n=90)
Patients		MRD+ only		MRD+ & MRD-
mKRAS T Cell Response
T cell Response Rate (%, n)		100% (12/12)		99% (89/90)
Average Fold Changea		71.1x		145.3x
Median Fold Changea (range)		18.5x (4.2x to 351x)		44.3x (2.13x to 1310x)
Threshold Above Which Clinical Activity was Correlated (% of Patients Above Threshold)		9.5xc (75% above 9.5x)		TBD (80% above 9.5xc)
Including CD4 + CD8 T cellsb		75.0%		85.0%
Including Response to 7 mKRAS Antigensa		50.0%		67.4%
Including Response to Patient Tumor Antigena		83.3%		87.6%
Overall Antigen Response Rated		66.7% (56/84)		85.7% (540/630)

^a  Responses shown are best overall responses vs baseline for assessable patients at any timepoint during the assessment period, measured among T cell Responders; TBD = To be Determined; MRD = Minimal Residual Disease

^b  Measured among evaluable patients with samples assessable by Ex Vivo Intracellular Cytokine Staining assay

^c McNeil L.K., et al. 1473 AMPLIFY-7P phase 1a: lymph node-targeted amphiphile therapeutic cancer vaccine in patients with high relapse risk KRAS mutated pancreatic ductal adenocarcinoma and colorectal cancer. Journal for ImmunoTherapy of Cancer. 2024;12. https://doi.org/10.1136/jitc-2024-SITC2024.1473

^d Overall Antigen Response Rate calculated as the percentage of positive mKRAS-specific T cell responses among all evaluated patients against all vaccine antigens

ELI-002 2P: Data cutoff 24-Sept-24; ELI-002 7P Phase 1: Data cutoff 24-Sept-24; ELI-002 7P Phase 2: 22-Aug-25

On September 17, 2025, the Company published a corporate presentation regarding the immunogenicity testing data from its ongoing Phase 2 AMPLIFY-7P trial, which is attached hereto as Exhibit 99.2 and incorporated herein by reference.

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Item 9.01. Financial Statements and Exhibits.

(d) Exhibits. The following exhibits are being furnished herewith:

Exhibit Number		Exhibit Title or Description
99.1		Press Release, dated September 17, 2025
99.2		Corporate Presentation, dated September 17, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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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: September 17, 2025				Elicio Therapeutics, Inc.
				By:		/s/ Robert Connelly
						Robert Connelly
						President and Chief Executive Officer
						(Principal Executive Officer)

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FAQ

What did Elicio Therapeutics (ELTX) file in the Form 8-K?

The company filed a Form 8‑K reporting a material event and attached a press release, a corporate presentation, and Exhibit 99.2 (AMPLIFY‑7P trial materials).

When were the attached press release and presentation dated?

Both the press release and corporate presentation are dated September 17, 2025.

Does the 8-K excerpt include trial results for AMPLIFY‑7P?

The excerpt lists T‑cell response categories (response rates, fold changes, thresholds) but does not include specific numeric trial results; those should be in the attached exhibits.

Which antigens and T‑cell subsets are mentioned?

The filing references responses to seven mKRAS antigens, patient tumor antigens, and includes CD4+ and CD8+ T‑cell responses.

Who signed the Form 8‑K for Elicio?

The filing is signed by Robert Connelly, President and Chief Executive Officer.