Elicio Therapeutics, Inc.

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, 2024 and 2023 included in our Annual Report on 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 Report for the quarter ended March 31, 2025, 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, 2024 and 2023 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, 2025 and June 30, 2025, 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

Our lead programs focus on our cancer immunotherapy vaccine 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 delayed manufacturing timelines and increased costs associated with personalized vaccine approaches.

Current wording

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 delayed manufacturing timelines and increased costs associated with personalized immunotherapy approaches.

Previous wording

Our clinical pipeline includes the lymph node targeted therapeutic cancer immunotherapy vaccine ELI-002 7P, currently being evaluated in a Phase 2 study (NCT05726864), designed to stimulate an immune response against mutant KRAS (“mKRAS”) pancreatic ductal adenocarcinoma (“PDAC”), the most common form of pancreatic cancer. The ELI-002 7P formulation is designed to provide immune response coverage against seven KRAS mutations in 88% of PDAC patients and 25% of all solid tumors, thereby increasing the potential patient population for ELI-002 7P. In August 2025, we announced that following the Independent Data Monitoring Committee’s (“IDMC”) pre-specified interim review of unblinded safety and efficacy data in our Phase 2 AMPLIFY-7P study in mKRAS-driven PDAC, the IDMC recommended that the trial continue to the final analysis without modifications. In addition, the IDMC confirmed the favorable safety profile of ELI-002 7P to date. We anticipate the final disease-free survival analysis to occur in the fourth quarter of 2025. 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 (NCT04853017). Our preclinical pipeline includes the lymph node targeted therapeutic immunotherapy cancer vaccines 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 reduce the risk of recurrence of tumors carrying specific oncogenic driver mutations.

Current wording

Our clinical pipeline includes the lymph node targeted therapeutic cancer immunotherapy ELI-002 7P, currently being evaluated in a Phase 2 study, designed to stimulate an immune response against mutant KRAS (“mKRAS”) pancreatic ductal adenocarcinoma (“PDAC”), the most common form of pancreatic cancer. The ELI-002 7P formulation is designed to provide immune response coverage against seven KRAS mutations in 88% of PDAC patients and 25% of all solid tumors, thereby increasing the potential patient population for ELI-002 7P. In August 2025, we announced that following the Independent Data Monitoring Committee’s (“IDMC”) pre-specified interim review of unblinded safety and efficacy data in our Phase 2 AMPLIFY-7P study in mKRAS-driven PDAC, the IDMC recommended that the trial continue to the final analysis without modifications. In addition, the IDMC confirmed the favorable safety profile of ELI-002 7P to date. We anticipate the final disease-free survival analysis to occur in the first half of 2026. 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. Our preclinical pipeline includes the lymph node targeted therapeutic 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 reduce the risk of recurrence of tumors carrying specific oncogenic driver mutations.

Previous wording

Our operations to date have been financed primarily by aggregate net proceeds of $205.2 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 annual operating losses. Our net loss was $10.6 million and $21.8 million for the three and six months ended June 30, 2025, respectively, and $7.2 million and $19.1 million for the three and six months ended June 30, 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $215.9 million and $22.1 million in cash and cash equivalents.

Current wording

Our operations to date have been financed primarily by aggregate net proceeds of $214.8 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 annual operating losses. Our net loss was $10.1 million and $31.9 million for the three and nine months ended September 30, 2025, respectively, and $18.8 million and $37.9 million for the three and nine months ended September 30, 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $226.0 million and $20.6 million in cash and cash equivalents.

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 2026 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 through the second quarter of 2026 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

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 2026 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. 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.

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 through the second quarter of 2026 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. 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.

Previous wording

For the three and six months ended June 30, 2025 and 2024, other income and expense consisted primarily of interest income, foreign exchange transaction gains and losses, gain on sale of equipment, interest expense, and gains and losses related to the re-measurement of our warrant liabilities.

Current wording

For the three and nine months ended September 30, 2025 and 2024, other income and expense consisted primarily of interest income, foreign exchange transaction gains and losses, gain on sale of equipment, interest expense, gains and losses related to the re-measurement of our warrant liabilities, and a loss on issuance of the July 2024 Pre-Funded Warrants.

Previous wording

Research and development expenses were $7.0 million for the three months ended June 30, 2025, compared to $8.2 million for the three months ended June 30, 2024. The decrease of $1.2 million was primarily due to less clinical trial manufacturing as we advanced ELI-002 7P clinical development.

Current wording

Research and development expenses were $5.0 million for the three months ended September 30, 2025, compared to $7.2 million for the three months ended September 30, 2024. The decrease of $2.2 million was primarily due to less clinical trial costs as patients progressed through the Phase 2 study of ELI-002 7P.

Previous wording

General and administrative expenses were $3.0 million for the three months ended June 30, 2025, compared to $2.7 million for the three months ended June 30, 2024. The increase of $0.3 million was primarily due to higher professional fees incurred in connection with the June 2025 Promissory Note Financing.

Current wording

General and administrative expenses were $3.0 million for the three months ended September 30, 2025, compared to $3.1 million for the three months ended September 30, 2024. The decrease of $0.1 million was primarily due to lower professional fees incurred in connection with general corporate matters.

Previous wording

Other (expense) income for the three months ended June 30, 2025 was expense of $(0.5) million compared to $3.7 million for the three months ended June 30, 2024. The decrease of $4.2 million was primarily due to the change in fair value associated with the outstanding liability-classified common warrants, the one-time grant income recognized related to the third GI Research Foundation Agreement, and the initial loss recognized resulting from the March 2024 Offering.

Current wording

Other (expense) income for the three months ended September 30, 2025 was $(2.0) million compared to $(8.5) million for the three months ended September 30, 2024. The decrease of $6.5 million was primarily due to the change in fair value associated with the outstanding liability-classified common warrants, and the initial loss recognized from the Public Offering, including losses from the July 2024 Pre-Funded Warrants and July 2024 Common Warrants.

Previous wording

General and administrative expenses were $6.0 million for the six months ended June 30, 2025, compared to $5.4 million for the six months ended June 30, 2024. The increase of $0.6 million was primarily due to the external costs associated with the January 2025 Offering and June 2025 Promissory Note Financing.

Current wording

General and administrative expenses were $9.0 million for the nine months ended September 30, 2025, compared to $8.6 million for the nine months ended September 30, 2024. The increase of $0.5 million was primarily due to the external costs associated with the January 2025 Offering and June 2025 Promissory Note Financing.

Previous wording

Other (expense) income for the six months ended June 30, 2025 was expense of $(0.9) million compared to income of $2.1 million for the six months ended June 30, 2024. The decrease of $3.1 million was primarily due to the change in fair value associated with the outstanding liability-classified common warrants, the one-time grant income recognized related to the third GI Research Foundation Agreement, and the loss recognized resulting from the March 2024 Offering.

Current wording

Other (expense) income for the nine months ended September 30, 2025 was $(3.0) million compared to $(6.4) million for the nine months ended September 30, 2024. The decrease of $3.4 million was primarily due to the change in fair value associated with the outstanding liability-classified common warrants, and the losses recognized from the March 2024 Offering and the Public Offering.

Previous wording

Our operations through June 30, 2025 have been financed primarily by aggregate net proceeds of $205.2 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 $21.8 million and $19.1 million for the six months ended June 30, 2025 and six months ended June 30, 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $215.9 million and $22.1 million in cash and cash equivalents. 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, 2025 have been financed primarily by aggregate net proceeds of $214.8 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 $31.9 million and $37.9 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $226.0 million and $20.6 million in cash and cash equivalents. 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, 2025 and 2024 (in thousands):

Current wording

The following table sets forth a summary of our net cash flow activity for the nine months ended September 30, 2025 and 2024 (in thousands):

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, changes in our assets and liabilities of $0.7 million, and non-cash charges of $3.4 million. The non-cash charges were related to $1.4 million of change in the fair value of warrant liability, $1.2 million of stock-based compensation, $0.5 million amortization of the ROU asset, $0.1 million depreciation and $0.2 million of non-cash interest expense.

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, changes in our assets and liabilities of $4.9 million, and non-cash charges of $6.6 million. The non-cash charges were 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, $0.2 million depreciation and $0.6 million of non-cash interest expense.

Previous wording

For the six months ended June 30, 2024, net cash used in operating activities was $21.1 million, which consisted of a net loss of $19.1 million and changes in our assets and liabilities of $1.5 million, partially offset by non-cash charges of $0.5 million. The non-cash charges were primarily related to $2.3 million of change in the fair value of warrant liability, offset by $0.6 million loss on the issuance of the March 2024 Pre-Funded Warrants in the March 2024 Offering, $0.7 million of stock-based compensation, $0.4 million amortization of the ROU asset, and $0.2 million of depreciation.

Current wording

For the nine months ended September 30, 2024, net cash (used in) operating activities was $(28.3) million, which consisted of a net loss of $37.9 million and changes in our assets and liabilities of $0.3 million and non-cash charges of $9.3 million. The non-cash charges were primarily related to $3.3 million of change in the fair value of warrant liabilities, $3.5 million loss on the issuance of the March 2024 Pre-Funded Warrants in the March 2024 Offering, $1.0 million of stock-based compensation, $0.6 million amortization of the ROU asset, $0.5 million related to issuance costs for the July 2024 Pre-Funded Warrants and July 2024 Common Warrants, $0.1 million of non-cash interest expense, and $0.2 million of depreciation.

Previous wording

For the six months ended June 30, 2025 and 2024, net cash provided by or used in investing activities was immaterial.

Current wording

For the nine months ended September 30, 2025 and 2024, net cash provided by or used in investing activities was immaterial.

Previous wording

For the six months ended June 30, 2025, net cash provided by financing activities was $22.3 million as a result of the issuance of $2.9 million of our common stock under our at-the-market offering program with JonesTrading Institutional Services LLC, as sales agent, $9.1 million from the January 2025 Offering, $9.9 million from the June 2025 Promissory Note Financing, 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 as a result of the issuance of $11.4 million of our common stock under our at-the-market offering program with JonesTrading Institutional Services LLC, as sales agent, $9.1 million from the January 2025 Offering, $9.9 million from the June 2025 Promissory Note Financing, $1.3 million from the exercise of common warrants and $0.1 million from the exercise of stock options.

Previous wording

For the six months ended June 30, 2024, net cash provided by financing activities was $11.3 million, primarily as a result of the issuance of $5.4 million of our common stock under our at-the-market offering program with Stifel, Nicolaus & Company, Incorporated and Virtu Americas LLC, as sales agents, and $6.0 million of the March 2024 Pre-Funded Warrants in the March 2024 Offering.

Current wording

For the nine months ended September 30, 2024, net cash provided by financing activities was $42.1 million, primarily as a result of the issuance of the convertible note for $19.7 million, $10.9 million from the Public Offering, $6.0 million from the issuance of the March 2024 Pre-Funded Warrants in the March 2024 Offering, and the issuance of $5.4 million of our common stock under our at-the-market offering program with Stifel, Nicolaus & Company, Incorporated and Virtu Americas LLC, as sales agents.

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 2026. 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 through the second quarter of 2026. 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, 2025 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, 2025 compared to those disclosed in the Form 10-K.