8-K
false 0001601485 0001601485 2025-09-17 2025-09-17
 
 

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.

 

2


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)

 

3


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)

 

4

Exhibit 99.1

Elicio Therapeutics Reports ELI-002 7P Achieved Robust mKRAS-Specific T Cell

Responses in 99% of Evaluable Patients in Ongoing Phase 2 AMPLIFY-7P Trial

 

   

ELI-002 induced mKRAS-specific T cell responses in 99% of evaluable patients (89 of 90) who were treated with the investigational vaccine immunotherapy

 

   

Robust mKRAS-specific T cell responses were observed with an average of 145.3x increase over baseline (median 44.3x; range 2.13-1310x), consistent with prior ELI-002 Phase 1 trial results

 

   

T cell responses included both mKRAS-specific CD4 and CD8 T cells in 85% of patients

BOSTON, September 17, 2025 — 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 announced immunogenicity testing data showing that approximately 99% of evaluable patients (89 of 90) enrolled in its ongoing Phase 2 AMPLIFY-7P trial who were administered ELI-002 7P generated strong 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.

Robert Connelly, Chief Executive Officer of Elicio, commented, “We are extremely encouraged by the T cell immunogenicity data from the ongoing Phase 2 ELI-002 7P trial. The robust T cell responses observed are highly consistent with our positive Phase 1 results and further enhance our confidence in the ongoing Phase 2 trial, as T cell immune responses in ELI-002 2P and ELI-002 7P Phase 1 trials were significantly correlated with clinical activity in minimal residual disease positive (“MRD+”) patients. These important data set the stage for the final disease-free survival analysis in the AMPLIFY-7P trial, which is anticipated to occur in the fourth quarter of 2025.”

Phase 2 AMPLIFY-7P Immunogenicity Data

 

    

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

Building on the ELI-002 2P (AMPLIFY-201) and ELI-002 7P (AMPLIFY-7P) Phase 1 trials, which enrolled only MRD+ patients, the Phase 2 AMPLIFY-7P trial also includes MRD-negative (“MRD–”) patients. If Phase 2 results are supportive, expanding to a broader population could enable more PDAC patients to benefit from the vaccine, and also enhance the commercial opportunity for Elicio.


The Company recently published updated Phase 1 ELI-002 2P (AMPLIFY-201) data in Nature Medicine. The results showed that an mKRAS-specific T cell response of approximately 9x over baseline was correlated with clinical activity, including delayed relapse or death in MRD+ patients (i.e., patients who are ctDNA positive or have increased serum tumor biomarkers, such as CA19-9, following completion of locoregional therapy). Responses, including both CD4 and CD8 T cell subsets, showed further correlation with clinical activity.

An Independent Data Monitoring Committee (“IDMC”), following its pre-specified interim review of the unblinded safety and efficacy data in the Company’s Phase 2 AMPLIFY-7P trial, recently recommended that the trial continue to the final analysis without modifications, which Elicio believes is an indication that ELI-002 7P has shown preliminary signals of efficacy.

The Company remains blinded to the Phase 2 trial clinical efficacy outcomes and to any correlation between observed T cell responses and antitumor response in patients.

About ELI-002

Elicio’s lead product candidate, ELI-002, is a structurally novel investigational Amphiphile (“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.

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 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 trials. 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 www.elicio.com.


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 Elicio’s planned clinical programs, including the timing and outcome of planned clinical trials; the timing of the expected final disease-free survival analysis of the Phase 2 AMPLIFY-7P clinical trial; the potential of Elicio’s product candidates and the anticipated benefits and goals of Elicio’s AMP platform, approaches and technology, including the significant correlation of T-cell immune responses with ELI-002 2P and ELI-002 7P in Elicio’s Phase 1 trials with clinical activity in MRD+ patients; the potential for any correlation between the immunogenicity data from the Phase 2 AMPLIFY-7P trial and clinical efficacy outcomes; Elicio’s belief that the IDMC’s recommendation that the Phase 2 AMPLIFY-7P trial continue to the final analysis without modifications indicates that ELI-002 7P has shown preliminary signals of efficacy; the potential to expand to a broader population with supportive Phase 2 results, to enable more PDAC patients to benefit from the vaccine and to expand Elicio’s commercial opportunity; the potential for future expansion of ELI-002 to other indications, including mKRAS positive lung cancer and other mKRAS positive cancers; 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 final disease-free survival analysis from the Phase 2 AMPLIFY-7P trial anticipated 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; Elicio’s estimates regarding future revenue, expenses, capital requirements and need for additional financing; 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 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 Elicio’s 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.

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

[email protected]

Slide 1

September 2025 AMPLIFY-7P Phase 2 ​ Immunogenicity Data​ Nasdaq: ELTX Exhibit 99.2


Slide 2

Disclaimers No Representation or Warranty We do not make and hereby expressly disclaim any representation or warranty, express or implied, as to the reasonableness of the assumptions made in the Presentation or the accuracy or completeness or the information contained in or incorporated by reference into the Presentation. We will not have any liability for any representations or warranties, express or implied, contained in, or omissions from, the Presentation. The data contained herein is derived from various internal and external sources. We do not assume any obligation to provide the recipient with access to any additional information or to update the information in the Presentation. Industry and Market Data The Presentation contains certain market data and other statistical information such as the size, growth and share of the industries and the market segments we operate in, which are based on information from independent industry organizations and other third-party sources, industry publications, surveys and forecasts. Such data may include projections based upon a number of assumptions. Neither we nor any third parties that provide information to us guarantee the accuracy, completeness, timeliness or availability of any information. We are not responsible for any errors or omissions (negligent or otherwise), regardless of the cause, or the results obtained from the use of such content. We do not give any express or implied warranties, including, but not limited to, any warranties of merchantability or fitness for a particular purpose or use, and we expressly disclaim any responsibility or liability for direct, indirect, incidental, exemplary, compensatory, punitive, special or consequential damages, costs, expenses, legal fees or losses (including lost income or profits and opportunity costs) in connection with the use of the information herein. The industry may not grow at the rate projected by market data, or at all. Failure of our industries to grow at the projected rate may have a material adverse effect on our business and the market price of our securities. In addition, if any one or more of the assumptions underlying the market data are later found to be incorrect, actual results may differ from the projections based upon these assumptions. You should not place undue reliance on these forward-looking statements.


Slide 3

Disclaimers Forward-Looking Statements This presentation contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. Statements in this presentation that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding our planned clinical programs, including planned clinical trials and the potential of our product candidates, including the potential clinical benefits, the potential clinical utility, the potential benefits and market acceptance of our product candidates, the potential advantages of our product candidates over those of existing therapeutics and/or those of our competitors, the expected receipt of clinical data, the timing of initiation of our planned clinical trials, our plans to develop and commercialize our product candidates, including ELI-002, the timing of the availability of data from our clinical trials, including the disease-free survival final analysis from the ELI-002 7P Phase 2 trial, the potential for any correlation between the immunogenicity data from the Phase 2 AMPLIFY-7P trial and clinical efficacy outcomes, the timing of any planned investigational new drug application or new drug application, our plans to research, develop and commercialize our current and future product candidates, our estimates regarding future revenue, expenses, capital requirements and need for additional financing, and the advancement of and funding for our developmental programs generally. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake 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. 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 in our Annual Report on Form 10-K filed with the SEC on March 31, 2025, and our Quarterly Reports on Form 10-Q for the quarter ended March 31, 2025 filed with the SEC on May 13, 2025 and for the quarter ended June 30, 2025 filed with the SEC on August 7, 2025, under the heading “Risk Factors”, and any 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 us as of the date of this release. We do 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.


Slide 4

Key take-home points: Phase 2: mKRAS-specific T cell Responses to ELI-002 were Consistent with Observations in Phase 1 Trials that Correlated with Clinical Activity1 Phase 1: mKRAS-specific T cell Responses above ~9x over baseline correlated with clinical activity in two previous Phase 1 trials of ELI-0021 1 The response threshold correlated with clinical activity has not been determined for Phase 2 Pant, et al. Nature Medicine. 2024; Devoe, et al. ASCO. 2024; Wainberg, O’Reilly, et al. Nature Medicine. 2025


Slide 5

Phase 1, 2 ELI-002 2P/7P ELI-002 7P Generated Robust T-Cell Responses In Ongoing Phase 2 Response Consistent with Observations in Phase 1 Trials of ELI-002 that Correlated with Clinical Activity ELI-002 7P data based on n = 90 evaluable Patients (4.9 mg AMP-Peptides) Robust expansion of mKRAS-specific T cells (median fold change from baseline): 99% mKRAS-specific T cell Response Rate (n = 89/90); 44.3x median increase over baseline; 145.3x average increase over baseline Responses above ~9x over baseline correlated with clinical activity in two previous Phase 1 trials1 Consistent CD4 + CD8 T cell Responses: 85% CD4 + CD8 Response Rate (compared to 75.0% in Phase 1) Induction of combined CD4 and CD8 responses correlated with clinical activity in previous Phase 1 trial Consistent Responses to all included mKRAS antigens: 67.4% Response Rate for all 7 mKRAS Antigens (compared to 50.0% in Phase 1) >80% Response Rate for each individual mKRAS antigen Consistent Responses to Patient-specific mKRAS Tumor antigen: 87.6% Response Rate to Patient Tumor Antigen (compared to 83.3% in Phase 1) Consistent Overall Vaccine Immunogenicity: Positive T cell Responses to 85.7% of vaccine antigens (compared to 66.7% in Phase 1) Phase 2: mKRAS-specific T cell Responses to ELI-002 7P were Consistent with Previous Phase 1 Observations 1 The response threshold correlated with clinical activity has not been determined for Phase 2 Pant, et al. Nature Medicine. 2024; Devoe, et al. ASCO. 2024; Wainberg, O’Reilly, et al. Nature Medicine. 2025


Slide 6

mKRAS: Expanded Antigen Coverage G12D / R / V / C / A / S / G13D CLINICAL STUDY OVERVIEW: NCT05726864 Includes: mKRAS G12D/R/V/C/A/S/G13D Up front resectable Stage I, II or III disease (PDAC) Complete R0/R1 resection Radiographic NED status within 6 months following completion of locoregional treatment MRD agnostic (biomarker +/- included) Phase 2: Key Inclusion Criteria Primary Endpoint: Disease Free Survival Secondary: Tumor Biomarker Response (biomarker subset) Secondary: Overall Survival, Safety, iRECIST Overall Response Rate Exploratory: Immunogenicity Direct Ex vivo T cell Analysis Fold change from baseline CD4 + CD8 T cells Response to mKRAS variants Endpoints ELI-002 7P 8wk immunization (1,2,3,4,6,8) 8wk observation, 4wk boosting Observation: SOC n~90 n~45 R 2:1 Crossover @ PD Schema N=144 pts, 24 Enrolling U.S. Sites Monotherapy (no chemo, CPI combo) Phase 2 ELI-002 7P ELI-002 7P Phase 2 trial in PDAC patients: Disease-free survival final analysis expected in Q4 2025 Key Elements of Phase 3 Design aligned in FDA meeting Randomized, blinded trial; primary endpoint will be investigator assessed DFS using modified RECIST (new lesions confirmed by biopsy/imaging) Enrollment Complete for ELI-002 7P Randomized Phase 2 PDAC Event Driven Interim DFS Analysis Completed: Preliminary Signals of Clinical Activity, IDMC Confirmed Favorable Safety Profile to Continue Trial1 Final Analysis Expected Q4 2025 for 2:1 Randomized, Open Label Study Exploratory: Immunogenicity 1 Data cutoff: 6-June-25; NED: no evidence of disease


Slide 7

Phase 1 ELI-002 2P Phase 1 ELI-002 7P Phase 2 ELI-002 7P # of patients (n) 25 14 144 Component dose optimized Adjuvant AMP-CpG Antigen AMP-Peptides 7P Uses recommended Phase 2 Dose of 10.0 mg adjuvant, 4.9 mg antigens KRAS mutations eligible G12D, G12R G12D, G12V, G12R, G12C, G12A, G12S, G13D G12D, G12V, G12R, G12C, G12A, G12S, G13D Minimal Residual Disease (MRD+) Required Required Both MRD+ and MRD- are eligible Resected oligometastatic Stage IV disease Eligible Not eligible Not eligible Tumor Stages Eligible I, II, III and IV I, II and III I, II and III Low screening lymphocyte count below normal range Eligible Eligible Not eligible Enrollment within 6 months of completing locoregional treatment Not required Required Required Upfront resectable tumors (surgeon able to operate before any chemo given) Not required Required Required Crossover Not Applicable Single Arm Not Applicable Single Arm Control arm patients may elect to cross over after DFS endpoint met Interval between ELI-002 Prime and Booster Doses 12 weeks 8 weeks 8 weeks Key Differences between ELI-002 Phase 1 and Phase 2 Trials Pant, et al. Nature Medicine. 2024; Devoe, et al. ASCO. 2024; Wainberg, O’Reilly, et al. Nature Medicine. 2025 Phase 1, 2 ELI-002 2P/7P


Slide 8

ELI-002 2P (Nature Medicine) Phase 1 (n=25) Patients MRD+ only mKRAS T Cell Response T cell Response Rate (%, n) 84% (21/25) Median Fold Change1 (range) 16.4x (2.1x to 423x) Threshold Above Which Clinical Activity was Correlated (% of Patients Above Threshold) 9.17x (68%) 12.75x (56%) CD4 + CD8 T cell Response2 70.6% Response to 7 mKRAS Antigens1 57.1% Response to Patient Tumor Antigen1 81.0% Overall Antigen Response Rate 74.0% 1 Responses shown are best overall responses vs baseline for assessable patients at any timepoint during the assessment period, measured among T cell Responders; ND = Not Determined; TBD = To be Determined; MRD = Minimal Residual Disease 2 Measured among evaluable patients with samples assessable by Ex Vivo Intracellular Cytokine Staining assay ELI-002 2P: Data cutoff 24-Sept-24; ELI-002 7P Phase 1: Data cutoff 24-Sept-24 88% reduction in Risk of Progression or Death due to any cause in above 9.17x threshold T cell Responders to ELI-002 Pant, et al. Nature Medicine. 2024; Devoe, et al. ASCO. 2024; Wainberg, O’Reilly, et al. Nature Medicine. 2025 ELI-002 T Cell Responses in Phase 1 Correlated with Clinical Activity mKRAS-specific T Cell Responses Above 9.17x Threshold Associated with Improved RFS in MRD+ Median RFS: not reached Median RFS: 3.02 months Median Relapse-Free Survival ≥ 9.17x Threshold T Cell Not Reached < 9.17x Threshold T Cell 3.02 months HR (95% CI) 0.12 (0.022 - 0.615) P-value 0.0002 Phase 1A ELI-002 2P


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Pant et al. Nature Medicine. 2024 Wainberg, et al. Nature Medicine. 2025 Data Cut-off 6 Sept 2023 24 Sept 2024 Median Follow-up 8.5 months 19.7 months Historic MRD+ PDAC Median RFS (n=25) 16.33 months 16.33 months 5.0 – 6.4 months Median OS (n=25) 16.33 months 28.94 months 17 months mKRAS T Cell Response Threshold 12.75x (median) 9.17x (ROC-defined) Patients ≥ mKRAS T Cell Response Threshold 13 / 25 17 / 25 mKRAS T Cell Response Correlation to: Tumor Biomarker Response Tumor Biomarker Response P = 0.0014 P = 0.0024 RFS RFS HR 0.14, P = 0.0167 HR 0.12, P = 0.0002 OS OS NR HR 0.23, P = 0.0099 RFS: Relapse-free survival; OS: Overall survival; ROC: Receiver-operating curve; NR: Not reported Phase 1A ELI-002 2P Final Analysis of ELI-002 2P Phase 1: mKRAS T cell Response Correlated To Clinical Activity Risk of Relapse and Death Reduced in 68% of Patients with T cell Responses Above 9.17x Threshold Botta, Jurdi, et al. Oncologist. 2024; Groot, Eshleman, et al. Clin Cancer Research. 2019; Pant, O’Reilly, et al. Nature Medicine. 2024; Wainberg, O’Reilly, et al. Nature Medicine. 2025


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ELI-002 2P (Nature Medicine) ELI-002 7P (4.9 mg) ELI-002 7P All (1.4 mg & 4.9 mg) ELI-002 7P (4.9 mg) Phase 1 (n=25) Phase 1 (n=7) Phase 1 (n=12) Phase 2 (n=90) Patients MRD+ only MRD+ only MRD+ only MRD+ & MRD- mKRAS T Cell Response T cell Response Rate (%, n) 84% (21/25) 100% (7/7) 100% (12/12) 99% (89/90) Average Fold Change1 58.6x 113.8 71.1x 145.3x Median Fold Change1 (range) 16.4x (2.1x to 423x) 113.3x (9.5x to 351x) 18.5x (4.2x to 351x) 44.3x (2.13x to 1310x) Threshold Above Which Clinical Activity was Correlated (% of Patients Above Threshold) 9.17x (68% above 9.17x) 12.75x (52% above 12.75x) ND 9.5x (75% above 9.5x) TBD (80% above 9.5x) CD4 + CD8 T cell Response2 70.6% 85.7% 75.0% 85.0% Response to 7 mKRAS Antigens1 57.1% 71.4% 50.0% 67.4% Response to Patient Tumor Antigen1 81.0% 100% 83.3% 87.6% Overall Antigen Response Rate (%, n)3 74.0% (37/50) 79.6% (39/49) 66.7% (56/84) 85.7% (540/630) 1 Responses shown are best overall responses vs baseline for assessable patients at any timepoint during the assessment period, measured among T cell Responders; ND = Not Determined; TBD = To be Determined; MRD = Minimal Residual Disease 2 Measured among evaluable patients with samples assessable by Ex Vivo Intracellular Cytokine Staining assay; 3 Overall Antigen Response Rate calculated as the percentage of positive mKRAS-specific T cell responses among all evaluated patients against all vaccine antigens The Company remains blinded to the trial efficacy outcomes and the correlation of T cell responses to antitumor response; 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 ELI-002 7P demonstrated robust T-cell activation in patients in Phase 2 AMPLIFY Trial Pant, et al. Nature Medicine. 2024; Devoe, et al. ASCO. 2024; Wainberg, O’Reilly, et al. Nature Medicine. 2025; McNeil, et al. JITC. 2024 Phase 1, 2 ELI-002 2P/7P ELI-002 7P Generated Robust T-Cell Responses In Phase 2 Immune Response Consistent with Observations in Phase 1 Trials of ELI-002 that Correlated with Clinical Activity


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Executive Summary: Key Takeaways from Phase 2 Immunogenicity Data T cell Responses from Phase 2 were consistent across numerous metrics of magnitude and functional quality with responses observed in previous Phase 1 studies of ELI-002 2P and ELI-002 7P where T cell Response was correlated to clinical activity Robust expansion of mKRAS-specific T cells Consistent CD4 + CD8 T cell responses Consistent responses to all included mKRAS antigens Consistent responses to patient-specific mKRAS tumor antigen Consistent overall vaccine immunogenicity Phase 2 ELI-002 7P-Induced mKRAS T cell Responses were Consistent with Prior Phase 1 Observations


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September 2025 AMPLIFY-7P Phase 2 ​ Immunogenicity Data​ Nasdaq: ELTX