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Elicio Therapeutics, Inc.

For the period ended Sep 30, 2026. Filed Nov 5, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2026 · Filed Nov 5, 2026

ELTX$1.51+7.9%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-13.

0001601485-26-000056

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-05.

0001601485-26-000066

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 115 previous paragraphs and 113 current paragraphs.

64 unchanged; 33 reworded; 16 added; 17 removed; 1 previous and 0 current paragraphs rearranged.

Tables are not compared: 3 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (16)

Current report

We are a clinical-stage biotechnology company developing next-generation immunotherapies for KRAS-driven cancers. Our pipeline targets biologically validated driver tumor mutations, using common, well-characterized neoantigens, to treat mutant KRAS (“mKRAS”)-positive pancreatic, colorectal (“CRC”), lung, and other solid tumor cancers. This strategy results in an “off-the-shelf” therapeutic option, reducing the delays and costs for patients that are typically associated with personalized immunotherapy approaches.

Current report

In October 2026, we presented the complete Phase 2 AMPLIFY-7P trial results in a late-breaking Proffered Paper oral session at the ESMO Congress 2026 and simultaneously published such results in Nature Medicine.

Current report

•Multiple pre-specified subgroup analyses favored camupepimut, including patients with and without detectable baseline ctDNA and patients without prior radiation.

Current report

•While the study did not meet its pre-specified primary DFS endpoint in the ITT population (HR 0.85), encouraging DFS outcomes were observed in both ctDNA-negative (HR 0.51) and ctDNA-positive (HR 0.57) patients.

Current report

•Baseline prognostic imbalances provide important context for the ITT results, including a 53% lower risk of recurrence or death with camupepimut (multivariable adjusted HR 0.47; p=0.0086). Since the multivariable analysis adjusts for imbalances in prognostic factors, and both ctDNA positive and ctDNA negative subgroups showed a camupepimut treatment effect, together these results suggest that stratification to balance ctDNA status is needed to balance the treatment and control arm in future adjuvant studies of camupepimut.

Current report

•The study findings were strengthened by the observation that camupepimut induced mutant KRAS-specific T-cell responses in 99% of evaluable treated patients (median 44.3-fold increase from baseline) with 85% generating both CD4 and CD8 responses; T cell responses above a threshold value of 9.17 correlated with longer DFS (HR 0.22). Based on these findings, we believe that camupepimut’s mechanism of action inducing KRAS-specific T cells explains the improved outcomes observed in the study.

Current report

•Pre-specified analysis of six-month DFS was 75.7% with camupepimut vs. 61.7% with observation. The 14.0 percentage-point difference immediately following the treatment period supports evaluating longer treatment duration in future studies.

Current report

Camupepimut was well tolerated, with no new safety signals observed. No adverse events led to withdrawal of study medication.

Current report

We intend to further refine our Phase 3 development strategy in adjuvant PDAC. Based on the Phase 2 readout, areas for consideration for the potential Phase 3 study include baseline ctDNA and other prognostic factors in stratification and patient selection, treatment duration and combination strategies intended to deepen or sustain mutant KRAS-specific immune activity. Any future Phase 3 study design remains subject to regulatory discussion, further development planning, and financing.

Current report

For the three and nine months ended September 30, 2026, income tax expense consisted of certain tax adjustments.

Current report

The Company’s effective income tax rate was approximately (0.7)% for the three months ended September 30, 2026, compared to 0.0% for the three months ended September 30, 2025. The difference in the effective income tax rate between periods was primarily attributable to certain tax adjustments recorded during the three months ended September 30, 2026. The Company continues to maintain a full valuation allowance against its deferred tax assets due to its history of cumulative net losses.

Current report

Comparison of the Nine Months Ended September 30, 2026 and 2025

Current report

The Company’s effective income tax rate was approximately (0.2)% for the nine months ended September 30, 2026, compared to 0.0% for the nine months ended September 30, 2025. The difference in the effective income tax rate between periods was primarily attributable to certain tax adjustments recorded during the nine months ended September 30, 2026. The Company continues to maintain a full valuation allowance against its deferred tax assets due to its history of cumulative net losses.

Current report

Our material cash requirements include our obligations under the June 2025 Promissory Note, under which interest is payable in cash and principal payments commence on July 1, 2027 (of which $2.5 million is classified as current as of September 30, 2026), and our operating lease obligations under the Boston Lease, which totaled $5.0 million in undiscounted remaining payments as of September 30, 2026, as well as ongoing obligations under our license agreement with MIT. See Notes 9, 10 and 11 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Removed paragraphs (17)

Previous report

We are a clinical-stage biotechnology company developing next-generation immunotherapies for the treatment of cancer, including mutant Kirsten rat sarcoma viral oncogene homolog (“mKRAS”)-positive pancreatic cancer, colorectal cancer (“CRC”), lung cancer and other mKRAS-positive cancers. We intend to build on recent clinical successes in the personalized cancer immunotherapy space to develop effective, off-the-shelf immunotherapies. Our proprietary Amphiphile (“AMP”) technology aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional immunotherapy strategies, with the goal of promoting durable cancer immunosurveillance in patients. Recent advances have identified T cell responses as a key component of effective cancer immunotherapy, and we believe our AMP technology can generate robust T cell responses in patients that can potentially translate to meaningful clinical benefit.

Previous report

Our lead programs focus on our cancer immunotherapy product candidates, which target biologically validated driver tumor mutations using common and well-characterized neoantigens. This strategy results in an “off-the-shelf” therapeutic option allowing patients to receive treatment without delays due to manufacturing timelines and without the increased costs associated with personalized immunotherapy approaches.

Previous report

In addition, based on preliminary post-study observations suggesting that ELI-002 7P-induced immune responses may enhance sensitivity to checkpoint inhibition, we intend to initiate a Phase 1 study evaluating ELI-002 7P in combination with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor in recurrent and treatment-naïve metastatic mKRAS PDAC. We also may seek to expand ELI-002 7P to other indications, including mKRAS-positive lung cancer and other mKRAS-positive cancers, subject to financing.

Previous report

On June 15, 2026, we reported results from our randomized Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with adjuvant mKRAS-driven PDAC following completion of standard locoregional therapy. The study enrolled 144 patients across 24 U.S. sites and evaluated ELI-002 7P versus observation in patients with resected Stage I-III mKRAS-driven PDAC who had completed surgery and standard locoregional therapy and were radiographically free of disease at enrollment.

Previous report

The AMPLIFY-7P study did not meet its pre-specified primary DFS endpoint in the intent-to-treat population. However, DFS analyses showed an approximately 14% absolute DFS benefit during active treatment at both three and six months, with treatment-arm separation persisting through nine months, suggesting early clinical activity.

Previous report

Although nodal status, the prespecified stratification factor for randomization, was balanced between the treatment arms, a higher proportion of patients with other adverse prognostic factors were included in the ELI-002 7P arm relative to the comparator standard of care arm. Subgroup analyses intended to account for these imbalances showed a significant DFS improvement, helping to inform our Phase 3 strategy. There are currently no approved therapies following locoregional treatment.

Previous report

The study also demonstrated a strong association between mKRAS-specific immune responses and clinical outcomes (HR 0.22, p<0.0001, n=90), supporting the biological activity of ELI-002 7P, and ELI-002 7P demonstrated a favorable safety profile, with no treatment-related discontinuations or deaths. We continue to evaluate pre-specified subgroups, including the R0 resected population, and intend to further refine our Phase 3 development strategy, which may include stratification and/or exclusion for adverse baseline factors and additional dosing, as described below.

Previous report

Insights from AMPLIFY-7P have enabled us to refine our Phase 3 development strategy, focusing on patients with the greatest potential to benefit from treatment and extending treatment duration to enhance the durability of anti-tumor immunity. Accordingly, and subject to financing, we plan to initiate a Phase 3 study with the following key elements:

Previous report

•Additional dosing beyond the initial ELI-002 7P immunization and booster regimen;

Previous report

•Potential evaluations of combinations with checkpoint inhibition; and

Previous report

We continue to evaluate pre-specified subgroups from the AMPLIFY-7P trial, including the R0 resected population, and may further refine our Phase 3 development strategy based upon the results of such evaluation.

Previous report

Preliminary Post-Study Observations and Planned Phase 1 Study in Metastatic PDAC

Previous report

All three patients were microsatellite stable/mismatch repair proficient, a population that has historically demonstrated limited responsiveness to immune checkpoint inhibitors. Published studies evaluating chemotherapy-, checkpoint inhibitor-, or RAS inhibitor-based regimens in metastatic pancreatic cancer have reported complete response rates of approximately 0% to 8%, with durable complete responses rarely observed.

Previous report

We believe these observations provide preliminary clinical support for the hypothesis that ELI-002 7P-induced immune responses may enhance sensitivity to checkpoint inhibition and support prospective evaluation of combination strategies.
Reworded paragraphs (33)

Previous wording

You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q and in our audited financial statements and accompanying notes for the years ended December 31, 2025 and 2024 included in the Form 10-K. In addition to the historical financial information, this discussion contains forward-looking statements that involve risks, assumptions and uncertainties, such as statements of our plans, objectives, expectations, intentions, forecasts and projections. Our actual results and the timing of selected events could differ materially from those discussed in these forward-looking statements as a result of several factors, including those set forth under the sections titled “Risk Factors” in this Quarterly Report on Form 10-Q and the Form 10-K, which you should read carefully to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section titled“Forward-Looking Statements”at the beginning of this report.

Current wording

You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q and in our audited financial statements and accompanying notes for the years ended December 31, 2025 and 2024 included in the Form 10-K. In addition to the historical financial information, this discussion contains forward-looking statements that involve risks, assumptions and uncertainties, such as statements of our plans, objectives, expectations, intentions, forecasts and projections. Our actual results and the timing of selected events could differ materially from those discussed in these forward-looking statements as a result of several factors, including those set forth under the sections titled “Risk Factors” in this Quarterly Report on Form 10-Q, the Quarterly Reports for the quarters ended March 31, 2026 and June 30, 2026, and the Form 10-K, which you should read carefully to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section titled“Forward-Looking Statements”at the beginning of this report.

Previous wording

We believe the therapeutic utility of currently approved and development stage cancer immunotherapies is limited in many cases due to their inability to sufficiently localize to lymph nodes and adequately engage with the critical immune cells responsible for stimulating adaptive immunity. Our AMP technology is specifically intended to localize payloads to lymph nodes leading to the generation of a robust T cell response that we believe is critical to generate an anticancer immune response.

Current wording

We believe the therapeutic utility of currently approved and development stage cancer immunotherapies is limited in many cases due to their inability to sufficiently localize lymph nodes to engage key immune cells. Our proprietary amphiphile (“AMP”) technology solves this by directly targeting payloads to the lymph nodes. This precise localization enhances the education, activation, and amplification of cancer-specific T cells, with the goal of generating robust immune responses and durable immunosurveillance necessary to deliver meaningful clinical benefits.

Previous wording

Our clinical pipeline includes the lymph node-targeted cancer immunotherapy ELI-002 7P, which we evaluated in a Phase 1/2 study, AMPLIFY-7P, designed to stimulate an immune response against mKRAS pancreatic ductal adenocarcinoma (“PDAC”), the most common form of pancreatic cancer. The ELI-002 7P formulation is designed to provide broad immune responses targeting seven Kirsten rat sarcoma viral oncogene homolog mutations that are observed in approximately 88% of PDAC patients and 25% of all solid tumors, thereby increasing the potential patient population for ELI-002 7P beyond PDAC alone.

Current wording

Our clinical pipeline includes the lymph node-targeted cancer immunotherapy camupepimut (ELI-002 7P), which we evaluated in a Phase 1/2 study, AMPLIFY-7P, designed to stimulate an immune response against mKRAS pancreatic ductal adenocarcinoma (“PDAC”), the most common form of pancreatic cancer. The camupepimut formulation is designed to provide broad immune responses targeting seven Kirsten rat sarcoma viral oncogene homolog mutations that are observed in approximately 90-95% of PDAC patients and 25% of all solid tumors, thereby increasing the potential patient population for camupepimut beyond PDAC alone.

Previous wording

ELI-002 2P (2-peptide formulation) has been studied previously in the Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy. ELI-002 2P and ELI-002 7P also have been studied in patients with mKRAS-positive CRC in Phase 1 studies. The AMPLIFY-201 Phase 1 data for PDAC and CRC was presented at the ESMO Immuno-Oncology Congress 2024 and published in Nature Medicine (Wainberg et al, 2025) and included a 16.3-month median recurrence-free survival and 28.9-month median overall survival for the full study population.

Current wording

ELI-002 2P (2-peptide formulation) has been studied previously in the Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy. ELI-002 2P and camupepimut also have been studied in patients with mKRAS-positive CRC in Phase 1 studies. The AMPLIFY-201 Phase 1 data for PDAC and CRC was presented at the European Society for Medical Oncology (“ESMO”) Immuno-Oncology Congress 2024 and published in Nature Medicine (Wainberg et al, 2025) and included a 16.3-month median recurrence-free survival and 28.9-month median overall survival for the full study population.

Previous wording

In June 2026, we reported that the Phase 2 AMPLIFY-7P trial did not meet its pre-specified primary disease-free survival (“DFS”) endpoint in the intent-to-treat population; however, DFS analysis at three months and six months showed early treatment benefit and a stronger treatment effect in subsets of the patient population, and ELI-002 7P demonstrated a favorable safety profile. We are continuing to evaluate pre-specified subgroups including, the R0 resected population, and intend, based upon such results, to further refine our development strategy for the planned Phase 3 study for ELI-002 7P in adjuvant PDAC. For additional information, see “Recent Developments.”

Current wording

In June 2026, we reported that the Phase 2 AMPLIFY-7P trial did not meet its pre-specified primary disease-free survival (“DFS”) endpoint in the intent-to-treat (“ITT”) population; however, pre-specified analysis at six months showed an overall DFS advantage compared to observation during the treatment period with a consistent treatment effect observed in certain large subsets of the patient population. Camupepimut also demonstrated a favorable safety profile. In October 2026, we presented the complete Phase 2 AMPLIFY-7P trial results in a late-breaking Proffered Paper oral session at the ESMO Congress 2026 and simultaneously published such results in Nature Medicine (George et al, 2026). For additional information, see “Recent Developments.”

Previous wording

On June 17, 2026, we reported preliminary clinical observations from three patients who received ELI-002 7P during the Phase 2 AMPLIFY-7P study, experienced disease progression after treatment, and subsequently achieved confirmed complete radiographic and complete metabolic responses after receiving nivolumab-based therapy with concurrent normalization of serum tumor biomarker (CA19-9) levels. Two of the three patients maintained complete responses for at least nine months, with one ongoing complete response at greater than nine months. In addition, all three patients demonstrated persistent mKRAS-specific T cell responses.

Current wording

Additionally, in June 2026, we reported preliminary clinical observations from three patients who received camupepimut during the Phase 2 AMPLIFY-7P study, experienced disease progression after treatment, and subsequently achieved confirmed complete radiographic and complete metabolic responses after receiving nivolumab-based therapy with concurrent normalization of serum tumor biomarker (CA19-9) levels. In previous PDAC clinical trials, nivolumab did not show antitumor benefit beyond the control chemotherapy or radiation, suggesting that camupepimut-induced T cells are needed to enable the efficacy of the nivolumab checkpoint inhibition (Wainberg, Clinical Cancer Research. 2020; Padron, Nature Medicine. 2022; Chen, J Clinical Oncology. 2022). Of the three patients we reported on, two of the patients maintained complete responses for at least nine months, with one ongoing complete response at greater than nine months, as of June 2026. In addition, all three patients demonstrated persistent mKRAS-specific T cell responses. These preliminary post-study observations suggest that camupepimut-induced immune responses may enhance sensitivity to checkpoint inhibition. In the fourth quarter of 2026, we intend to initiate a Phase 1 study evaluating camupepimut in combination with a RAS small molecule inhibitor (daraxonrasib) with or without an anti-PD-1 inhibitor (nivolumab) in metastatic mKRAS pancreatic cancer, with potential preliminary study readouts anticipated three to six months after study start. The planned study is designed to prospectively evaluate whether camupepimut may enhance anti-tumor immunity and improve responsiveness to daraxonrasib with or without nivolumab. We also plan to use the Phase 1 combination study findings to help inform future development strategies in metastatic PDAC and our planned adjuvant PDAC Phase 3 trial.

Previous wording

We intend to continue monitoring additional patients who participated in the AMPLIFY-7P study and the Expanded Access Program for ELI-002 7P and are currently following a similar course of treatment.

Current wording

We may also seek to expand camupepimut to other indications, including mKRAS-positive non-small cell lung cancer and other mKRAS-positive cancers, subject to financing. We intend to continue monitoring additional patients who participated in the AMPLIFY-7P study and the Expanded Access Program for camupepimut and are currently following a similar course of treatment.

Previous wording

Our preclinical pipeline includes the lymph node-targeted immunotherapies, ELI-007, currently being evaluated in preclinical studies for the treatment of mutant b-raf murine sarcoma viral oncogene homolog B1-driven cancers, and ELI-008, currently being evaluated in preclinical studies for use in the treatment of mutated tumor protein p53-expressing cancers. We believe that each of our immunotherapy product candidates, if approved, has the potential to decrease tumor burden or reduce the risk of recurrence of tumors carrying specific oncogenic driver mutations.

Current wording

Our preclinical pipeline includes the lymph node-targeted immunotherapies, ELI-007, currently being evaluated in preclinical studies for the treatment of mutant b-raf murine sarcoma viral oncogene homolog B1-driven cancers, and ELI-008, currently being evaluated in preclinical studies for use in the treatment of mutated tumor protein p53-expressing cancers. We believe that each of our immunotherapy product candidates has the potential to decrease tumor burden or reduce the risk of recurrence of tumors carrying specific oncogenic driver mutations.

Current wording

AMPLIFY-7P Phase 2 Results Presented at ESMO Congress 2026 and Published in Nature Medicine

Previous wording

Our operations through June 30, 2026 have been financed primarily by aggregate net proceeds of $244.2 million from the issuance of common stock, pre-funded warrants, convertible preferred stock, convertible notes, promissory notes, the exercise of stock options and common warrants, the private placement of our securities, at-the-market offerings, and proceeds from the Merger with Angion. Since inception, we have had significant operating losses. Our net loss was $20.0 million and $21.8 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $253.7 million and cash and cash equivalents of $23.5 million. In July 2026, the Company entered into a securities purchase agreement with certain institutional investors (each a “July 2026 Investor” and collectively, the “July 2026 Investors”), pursuant to which the Company agreed to issue and sell, in a registered direct offering by the Company directly to the July 2026 Investors (the “July 2026 Offering”), an aggregate of 4,380,313 shares of common stock (the “July 2026 Shares”). Each July 2026 Share was sold at an offering price of $3.43. The July 2026 Offering resulted in aggregate net proceeds of approximately $13.6 million after deducting the placement agents’ fees and related offering expenses.

Current wording

Our operations through September 30, 2026 have been financed primarily by aggregate net proceeds of $262.0 million from the issuance of common stock, pre-funded warrants, convertible preferred stock, convertible notes, promissory notes, the exercise of stock options and common warrants, the private placement of our securities, at-the-market offerings, and proceeds from the Merger with Angion. Since inception, we have had significant operating losses. Our net loss was $28.0 million and $31.9 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $261.7 million and cash and cash equivalents of $30.9 million.

Previous wording

We are currently facing substantial doubt about our ability to continue as a going concern, given our cash position and cash runway. As of the filing date of this Quarterly Report on Form 10-Q, we believe that our cash on hand will enable us to fund our operations into the first quarter of 2027 based on our current financial operating plan. This period could be shortened or lengthened if there are any significant increases or decreases in planned or actual spending on development programs or more rapid progress of development programs than anticipated. There is no assurance that financing will be available when needed to allow us to continue as a going concern. Our losses from operations, negative operating cash flows and accumulated deficit, as well as the additional capital needed to fund operations for at least twelve months following the issuance of the condensed consolidated financial statements, raise substantial doubt about our ability to continue as a going concern. We expect to incur substantial expenditures in the foreseeable future for the development of our product candidates and will require additional financing to continue this development. We plan to address this condition through the sale of common stock or other securities in public offerings and/or private placements, debt financings, or through other capital sources, including licensing arrangements, partnerships and collaborations with other companies or other strategic transactions, but there is no assurance these plans will be completed successfully or at all. If we are unable to obtain additional capital when and as needed to continue as a going concern, we might have to further reduce or scale back our operations and/or liquidate our assets, and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements.

Current wording

We are currently facing substantial doubt about our ability to continue as a going concern, given our cash position and cash runway. As of the filing date of this Quarterly Report on Form 10-Q, we believe that our cash on hand will enable us to fund our operations into the second quarter of 2027 based on our current financial operating plan. This period could be shortened or lengthened if there are any significant increases or decreases in planned or actual spending on development programs or more rapid progress of development programs than anticipated. There is no assurance that financing will be available when needed to allow us to continue as a going concern. Our losses from operations, negative operating cash flows and accumulated deficit, as well as the additional capital needed to fund operations for at least twelve months following the issuance of the condensed consolidated financial statements, raise substantial doubt about our ability to continue as a going concern. We expect to incur substantial expenditures in the foreseeable future for the development of our product candidates and will require additional financing to continue this development. We plan to address this condition through the sale of common stock or other securities in public offerings and/or private placements, debt financings, or through other capital sources, including licensing arrangements, partnerships and collaborations with other companies or other strategic transactions, but there is no assurance these plans will be completed successfully or at all. If we are unable to obtain additional capital when and as needed to continue as a going concern, we might have to further reduce or scale back our operations and/or liquidate our assets, and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements.

Previous wording

•advance our lead product candidate, ELI-002 7P, to early-stage clinical trials in metastatic PDAC and to late-stage clinical trials in adjuvant PDAC;

Current wording

•advance our lead product candidate, camupepimut, to early-stage clinical trials in metastatic PDAC and to late-stage clinical trials in adjuvant PDAC;

Previous wording

As of the filing date of this Quarterly Report on Form 10-Q, we believe that our cash on hand will enable us to fund our operations into the first quarter of 2027 based on our current plan. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured.

Current wording

As of the filing date of this Quarterly Report on Form 10-Q, we believe that our cash on hand will enable us to fund our operations into the second quarter of 2027 based on our current plan. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured.

Previous wording

Our research and development expenses are not currently tracked on a program-by-program basis. We use our personnel and infrastructure resources across multiple research and development programs directed toward identifying and developing product candidates. Substantially all our research and development costs are incurred on the development of ELI-002 7P and our preclinical candidates.

Current wording

Our research and development expenses are not currently tracked on a program-by-program basis. We use our personnel and infrastructure resources across multiple research and development programs directed toward identifying and developing product candidates. Substantially all our research and development costs are incurred on the development of camupepimut and our preclinical candidates.

Previous wording

We expect our research and development expenses to increase substantially for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates, including investments in conducting clinical trials, manufacturing and otherwise advancing our programs. The process of conducting the clinical research necessary to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing and costs of the efforts that will be needed to complete the development of, or the period, if any, in which material net cash inflows may commence from ELI-002 7P or any of our preclinical candidates. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:

Current wording

We expect our research and development expenses to increase substantially for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates, including investments in conducting clinical trials, manufacturing and otherwise advancing our programs. The process of conducting the clinical research necessary to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing and costs of the efforts that will be needed to complete the development of, or the period, if any, in which material net cash inflows may commence from camupepimut or any of our preclinical candidates. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:

Previous wording

•the ability to market, commercialize and achieve market acceptance for ELI-002 7P, or any of our preclinical candidates that we or our future collaboration partners may develop in the future.

Current wording

•the ability to market, commercialize and achieve market acceptance for camupepimut, or any of our preclinical candidates that we or our future collaboration partners may develop in the future.

Previous wording

Any of these variables with respect to the development of ELI-002 7P, or any other of our preclinical candidates that we may develop could result in a significant change in the costs and timing associated with the development of such candidates. For example, if the FDA or other regulatory authority were to require us to conduct preclinical and clinical studies beyond those which we currently anticipate will be required for the completion of clinical development or if we experience significant delays in enrollment in any clinical trials, we could be required to expend significant additional financial resources and time on the completion of our clinical development programs.

Current wording

Any of these variables with respect to the development of camupepimut, or any other of our preclinical candidates that we may develop could result in a significant change in the costs and timing associated with the development of such candidates. For example, if the FDA or other regulatory authority were to require us to conduct preclinical and clinical studies beyond those which we currently anticipate will be required for the completion of clinical development or if we experience significant delays in enrollment in any clinical trials, we could be required to expend significant additional financial resources and time on the completion of our clinical development programs.

Previous wording

For the three and six months ended June 30, 2026 and 2025, other income and expense consisted primarily of interest income, foreign exchange transaction gains, interest expense, and the change in fair value of our warrant liabilities.

Current wording

For the three and nine months ended September 30, 2026 and 2025, other income and expense consisted primarily of interest income, foreign exchange transaction gains, interest expense, and the change in fair value of our warrant liabilities.

Previous wording

Research and development expenses were $6.8 million for the three months ended June 30, 2026, compared to $7.0 million for the three months ended June 30, 2025. The decrease of $0.2 million was primarily due to lower clinical trial costs as the Phase 2 study of ELI-002 7P continues and the patients moved out of the active dosing phase and into the follow-up phase of the trial.

Current wording

Research and development expenses were $4.9 million for the three months ended September 30, 2026, compared to $5.0 million for the three months ended September 30, 2025. The decrease of $0.1 million was primarily due to lower clinical trial costs as the Phase 2 study of camupepimut continues and the patients moved out of the active dosing phase and into the follow-up phase of the trial, partially offset by increased personnel costs.

Previous wording

General and administrative expenses were $3.6 million for the three months ended June 30, 2026, compared to $3.1 million for the three months ended June 30, 2025. The increase of $0.5 million was primarily due to increased Company headcount resulting in increased personnel costs and a slight increase in professional fees.

Current wording

General and administrative expenses were $3.6 million for the three months ended September 30, 2026, compared to $3.0 million for the three months ended September 30, 2025. The increase of $0.6 million was primarily due to increased personnel costs and an increase in professional fees.

Previous wording

Other income for the three months ended June 30, 2026 was $2.2 million compared to an other expense of $0.5 million for the three months ended June 30, 2025. The increase of $2.7 million was primarily due to the change in fair value associated with the outstanding liability-classified common warrants, partially offset by the interest expense related to the June 2025 Promissory Note.

Current wording

Other income for the three months ended September 30, 2026 was $0.5 million compared to an other expense of $2.0 million for the three months ended September 30, 2025. The increase of $2.6 million was primarily due to the change in fair value associated with the outstanding liability-classified common warrants.

Previous wording

Research and development expenses were $13.6 million for the six months ended June 30, 2026, compared to $14.8 million for the six months ended June 30, 2025. The decrease of $1.2 million was primarily due to lower clinical trial costs as the Phase 2 study of ELI-002 7P continues and the patients moved out of the active dosing phase and into the follow-up phase of the trial.

Current wording

Research and development expenses were $18.5 million for the nine months ended September 30, 2026, compared to $19.8 million for the nine months ended September 30, 2025. The decrease of $1.4 million was primarily due to lower clinical trial costs as the Phase 2 study of camupepimut continues and the patients moved out of the active dosing phase and into the follow-up phase of the trial, partially offset by increased personnel and chemistry, manufacturing and controls costs.

Previous wording

General and administrative expenses were $7.5 million for the six months ended June 30, 2026, compared to $6.0 million for the six months ended June 30, 2025. The increase of $1.4 million was primarily due to increased Company headcount resulting in increased personnel costs and a slight increase in professional fees.

Current wording

General and administrative expenses were $11.0 million for the nine months ended September 30, 2026, compared to $9.0 million for the nine months ended September 30, 2025. The increase of $2.0 million was primarily due to increased Company headcount resulting in increased personnel costs as well as an increase in professional fees.

Previous wording

Other income was $1.0 million for the six months ended June 30, 2026, compared to other expense of $0.9 million for the six months ended June 30, 2025. The increase of $1.9 million was primarily due to the change in fair value associated with the outstanding liability-classified common warrants, partially offset by the interest expense related to the June 2025 Promissory Note.

Current wording

Other income was $1.5 million for the nine months ended September 30, 2026, compared to other expense of $3.0 million for the nine months ended September 30, 2025. The increase of $4.5 million was primarily due to the change in fair value associated with the outstanding liability-classified common warrants, partially offset by the interest expense related to the June 2025 Promissory Note.

Previous wording

Our operations through June 30, 2026 have been financed primarily by aggregate net proceeds of $244.2 million from the issuance of common stock, pre-funded warrants, convertible preferred stock, convertible notes, promissory notes, the exercise of stock options and common warrants, the private placement of our securities, at-the-market offerings, and proceeds from the Merger with Angion. Since inception, we have had significant operating losses. Our net loss was $20.0 million and $21.8 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $253.7 million and cash and cash equivalents of $23.5 million. In July 2026, the Company entered into the July 2026 Offering, pursuant to which the Company agreed to issue and sell directly to the July 2026 Investors the July 2026 Shares. The July 2026 Offering resulted in aggregate net proceeds of approximately $13.6 million after deducting the placement agent’s fees and related offering expenses. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

Current wording

Our operations through September 30, 2026 have been financed primarily by aggregate net proceeds of $262.0 million from the issuance of common stock, pre-funded warrants, convertible preferred stock, convertible notes, promissory notes, the exercise of stock options and common warrants, the private placement of our securities, at-the-market offerings, and proceeds from the Merger with Angion. Since inception, we have had significant operating losses. Our net loss was $28.0 million and $31.9 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $261.7 million and cash and cash equivalents of $30.9 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

Previous wording

The following table sets forth a summary of our net cash flow activity for the six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table sets forth a summary of our net cash flow activity for the nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

For the six months ended June 30, 2026, net cash used in operating activities was $19.8 million, which consisted of a net loss of $20.0 million and a decrease in our assets and liabilities of $0.8 million, partially offset by non-cash charges of $1.0 million. The non-cash charges primarily consisted of $1.8 million of stock-based compensation, $0.5 million amortization of the ROU asset, and $0.1 million of depreciation, and $0.1 million of debt discount amortization, partially offset by a $1.5 million gain from the change in the fair value of warrant liabilities.

Current wording

For the nine months ended September 30, 2026, net cash used in operating activities was $30.2 million, which consisted of a net loss of $28.0 million and a decrease in our assets and liabilities of $3.9 million, partially offset by non-cash charges of $1.7 million. The non-cash charges primarily consisted of $2.9 million of stock-based compensation, $0.7 million amortization of the ROU asset, $0.1 million of depreciation, and $0.2 million of debt discount amortization, partially offset by a $2.2 million gain from the change in the fair value of warrant liabilities.

Previous wording

For the six months ended June 30, 2025, net cash used in operating activities was $19.1 million, which consisted of a net loss of $21.8 million and a decrease in our assets and liabilities of $0.7 million, partially offset by non-cash charges of $3.4 million. The non-cash charges were primarily related to $1.4 million of change in the fair value of warrant liabilities, $1.2 million of stock-based compensation, $0.5 million amortization of the ROU asset, $0.2 million of non-cash interest expense, and $0.1 million of depreciation.

Current wording

For the nine months ended September 30, 2025, net cash used in operating activities was $30.2 million, which consisted of a net loss of $31.9 million and a decrease in our assets and liabilities of $4.9 million, partially offset by non-cash charges of $6.6 million. The non-cash charges were primarily related to $3.2 million of change in the fair value of warrant liabilities, $1.9 million of stock-based compensation, $0.7 million amortization of the ROU asset, $0.6 million of non-cash interest expense, and $0.2 million of depreciation.

Previous wording

For the six months ended June 30, 2026, net cash provided by financing activities was $24.5 million as a result of the issuance of $24.4 million of our common stock under our ATM Programs net of issuance and offering costs, and $0.1 million from the exercise of stock options.

Current wording

For the nine months ended September 30, 2026, net cash provided by financing activities was $42.3 million as a result of net proceeds of $28.6 million from the issuance of our common stock under our ATM Programs, net proceeds of $13.6 million from the July 2026 Offering, and $0.1 million from the exercise of stock options.

Previous wording

For the six months ended June 30, 2025, net cash provided by financing activities was $22.3 million, primarily as a result of net proceeds of $9.9 million from the June 2025 Promissory Note Financing, net proceeds of $9.1 million from the January 2025 Offering, the issuance of $2.9 million of our common stock under our 2024 ATM Program net of issuance costs, and $0.4 million from the exercise of common warrants and stock options.

Current wording

For the nine months ended September 30, 2025, net cash provided by financing activities was $31.8 million, primarily as a result of net proceeds of $9.9 million from the June 2025 Promissory Note Financing, net proceeds of $9.1 million from the January 2025 Offering, the issuance of $11.4 million of our common stock under our 2024 ATM Program net of issuance costs, and $1.4 million from the exercise of common warrants and stock options.

Previous wording

Based on our current operating plan, as of the filing date of this Quarterly Report on Form 10-Q, we believe our cash and cash equivalents will be sufficient to fund our planned operations into the first quarter of 2027. However, we have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all our available capital resources sooner than we expect. We are unable to estimate the exact amount of our operating capital requirements. The amount and timing of our future funding requirements will depend on many factors, including, but not limited to:

Current wording

Based on our current operating plan, as of the filing date of this Quarterly Report on Form 10-Q, we believe our cash and cash equivalents will be sufficient to fund our planned operations into the second quarter of 2027. However, we have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all our available capital resources sooner than we expect. We are unable to estimate the exact amount of our operating capital requirements. The amount and timing of our future funding requirements will depend on many factors, including, but not limited to:

Previous wording

Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” in the Form 10-K. There have been no material changes in our critical accounting policies and estimates in the preparation of our condensed consolidated financial statements during the six months ended June 30, 2026 compared to those disclosed in the Form 10-K.

Current wording

Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” in the Form 10-K. There have been no material changes in our critical accounting policies and estimates in the preparation of our condensed consolidated financial statements during the nine months ended September 30, 2026 compared to those disclosed in the Form 10-K.

Previous wording

We are a smaller reporting company and an emerging growth company, as defined under the Jumpstart Our Business Startup (“JOBS”) Act. Under the JOBS Act, emerging growth companies can delay the adoption of new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. Other exemptions and reduced reporting requirements under the JOBS Act for emerging growth companies include presentation of only two years of audited financial statements in a registration statement for an initial public offering, an exemption from the requirement to provide an auditor's report on internal controls over financial reporting pursuant to Sarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley”), an exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation, and less extensive disclosure about our executive compensation arrangements.

Current wording

We are a smaller reporting company and an emerging growth company, as defined under the Jumpstart Our Business Startups (“JOBS”) Act. Under the JOBS Act, emerging growth companies can delay the adoption of new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. Other exemptions and reduced reporting requirements under the JOBS Act for emerging growth companies include presentation of only two years of audited financial statements in a registration statement for an initial public offering, an exemption from the requirement to provide an auditor's report on internal controls over financial reporting pursuant to Sarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley”), an exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation, and less extensive disclosure about our executive compensation arrangements.
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Previous report — wording carried elsewhere

We intend to initiate a Phase 1 study evaluating ELI-002 7P in combination with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor in metastatic mKRAS pancreatic cancer. The planned study is designed to prospectively evaluate whether ELI-002 7P may enhance anti-tumor immunity and improve responsiveness to a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor. We also plan to use the study findings to help inform future development strategies in metastatic PDAC and our planned adjuvant PDAC Phase 3 trial. We anticipate the Phase 1 study to initiate in the fourth quarter of 2026, with potential study readouts anticipated three to six months after study start.