Immuneering Corp

Previous wording

We are a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients. We aim to achieve this goal through Deep Cyclic Inhibition® ("DCI") of clinically-validated core signaling pathways such as the mitogen-activated protein kinase ("MAPK") pathway, impacting cancer cells while sparing healthy cells. Our inclusive approach differentiates us from chronically targeted precision therapies, which are generally limited by toxicity, resistance and/or application to specific mutations only.

Current wording

We are a clinical-stage oncology company outpacing cancer to help patients outlive their disease. We aim to achieve this goal through Deep Cyclic Inhibition® ("DCI") of clinically-validated core signaling pathways such as the mitogen-activated protein kinase ("MAPK") pathway, impacting cancer cells while sparing healthy cells. Our inclusive approach differentiates us from chronically targeted precision therapies, which are generally limited by toxicity, resistance and/or application to specific mutations only.

Previous wording

We are currently evaluating our lead product candidate, IMM-1-104, in a Phase 1/2a clinical trial in patients with advanced solid tumors including those harboring RAS or RAF mutations. IMM-1-104 is being developed as a once-daily oral deep cyclic inhibitor of the MAPK signaling pathway, specifically at the level of mitogen-activated protein kinase kinase ("MEK"). IMM-1-104 is designed to improve tolerability and expand indications beyond currently registered MEK inhibitors to include RAS-driven tumors such as most pancreatic cancers.

Current wording

We are currently evaluating our lead product candidate, atebimetinib (also referred to as IMM-1-104), in a Phase 1/2a clinical trial in patients with advanced or metastatic solid tumors. Atebimetinib is being developed as a once-daily oral deep cyclic inhibitor of the MAPK signaling pathway, specifically at the level of mitogen-activated protein kinase kinase ("MEK"). Atebimetinib is designed to improve tolerability and expand indications beyond currently registered MEK inhibitors to include RAS-driven tumors such as most pancreatic cancers.

Previous wording

In September 2022, the FDA cleared our IND application for IMM-1-104 and, in November 2022, we commenced dosing in our Phase 1/2a clinical trial of IMM-1-104 for the potential treatment of patients with advanced solid tumors including those harboring RAS or RAF mutations. The Phase 2a portion includes evaluating IMM-1-104 in multiple dose expansion and combination arms. We began dosing the Phase 2a cohorts in March 2024.

Current wording

In September 2022, the FDA cleared our IND application for atebimetinib and, in November 2022, we commenced dosing in our Phase 1/2a clinical trial of atebimetinib for the potential treatment of patients with advanced or metastatic solid tumors. The Phase 2a portion includes evaluating atebimetinib in multiple dose expansion and combination arms. We began dosing the Phase 2a cohorts in March 2024.

Previous wording

In January 2025, we announced positive interim response and safety data from three Phase 2a pancreatic cancer arms of the IMM-1-104 clinical trial, as well as our plans to initiate additional Phase 2a combination arms. In February 2025, we announced entry into a clinical supply agreement with Regeneron Pharmaceuticals for its anti-PD-1 therapy, Libtayo® (cemiplimab), which intends to support the evaluation of IMM-1-104 in combination with Libtayo in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer. We expect additional data from the Phase 2a portion of the trial in the second quarter of 2025.

Current wording

In February 2025, we announced entry into a clinical supply agreement with Regeneron Pharmaceuticals for its anti-PD-1 therapy, Libtayo® (cemiplimab), which intends to support the evaluation of atebimetinib in combination with Libtayo in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer.

Previous wording

In January 2025, we announced initial interim PK, PD and safety data from the Phase 1 portion of the IMM-6-415 Phase 1/2a clinical trial. In February 2025, we paused further patient enrollment in the IMM-6-415 Phase 1/2a clinical trial in order to evaluate the data from patients being treated at the 120 mg dose level and determine next steps for the program. In April 2025, we made the strategic decision to pause further internal advancement of IMM-6-415 and focus resources on our lead product candidate IMM-1-104. We are pursuing partnership opportunities and considering other potential developmental paths for IMM-6-415.

Current wording

In January 2025, we announced initial interim PK, PD and safety data from the Phase 1 portion of the IMM-6-415 Phase 1/2a clinical trial. In February 2025, we paused further patient enrollment in the IMM-6-415 Phase 1/2a clinical trial in order to evaluate the data from patients being treated at the 120 mg dose level and determine next steps for the program. In April 2025, we made the strategic decision to pause further internal advancement of IMM-6-415 and focus resources on our lead product candidate atebimetinib. We are pursuing partnership opportunities and considering other potential developmental paths for IMM-6-415.

Previous wording

During the three months ended March 31, 2025, we sold 4,836,804 shares of our Class A common stock under our "at the market" equity offering program (the "ATM Program"), at an average price per share of $2.95, for aggregate gross proceeds of $14.2 million ($13.7 million net of offering expenses).

Current wording

We did not sell any shares of Class A common stock under our "at the market" equity offering program (the "ATM Program") during the three months ended June 30, 2025 or June 30, 2024. We sold 4,836,804 shares of common stock under the ATM Program, at an average price per share of $2.95, for aggregate gross proceeds of $14.2 million ($13.7 million net of offering expenses) during the six months ended June 30, 2025, and did not sell any shares of Class A common stock under the ATM Program during the six months ended June 30, 2024.

Previous wording

Since inception, we have had significant annual operating losses. Our net loss was approximately $15.0 million for the three months ended March 31, 2025 and approximately $61.0 million for the year ended December 31, 2024. As of March 31, 2025, we had an accumulated deficit of approximately $239.3 million and approximately $35.9 million in cash and cash equivalents.

Current wording

Since inception, we have had significant annual operating losses. Our net loss was approximately $29.5 million for the six months ended June 30, 2025 and approximately $61.0 million for the year ended December 31, 2024. As of June 30, 2025, we had an accumulated deficit of approximately $253.8 million and approximately $26.4 million in cash and cash equivalents.

Previous wording

As of May 5, 2025, the issuance date of the interim condensed consolidated financial statements for the three-months ended March 31, 2025 included elsewhere in this Quarterly Report on Form 10-Q, based on our recurring losses from operations incurred since inception, expectation of continuing operating losses for the foreseeable future and the need to raise additional capital to finance future operations, our management has concluded that there is substantial doubt about our ability to continue as a going concern for a period of one year from the date that such interim condensed consolidated financial statements are issued. See "Note 1 - Organization and Nature of Business" to our interim condensed consolidated financial statements in this Quarterly Report on Form 10-Q above, and “Liquidity and Capital Resources” below, for additional information on our assessment.

Current wording

As of August 13, 2025, the issuance date of the interim condensed consolidated financial statements for the three and six-months ended June 30, 2025 included elsewhere in this Quarterly Report on Form 10-Q, based on our recurring losses from operations incurred since inception, expectation of continuing operating losses for the foreseeable future and the need to raise additional capital to finance future operations, our management has concluded that there is substantial doubt about our ability to continue as a going concern for a period of one year from the date that such interim condensed consolidated financial statements are issued. See "Note 1 - Organization and Nature of Business" to our interim condensed consolidated financial statements in this Quarterly Report on Form 10-Q above, and “Liquidity and Capital Resources” below, for additional information on our assessment.

Previous wording

We expect that our research and development expenses may substantially increase for the foreseeable future as we continue to implement our business strategy, which includes advancing our product candidates through clinical development, expanding our research and development efforts, including hiring additional personnel to support our research and development efforts, and seeking regulatory approvals for our product candidates that successfully complete clinical trials. In addition, product candidates in later stages of clinical development generally incur higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect our research and development expenses to increase as our product candidates advance into later stages of clinical development. As of the date of this Quarterly Report on Form 10-Q, we cannot reasonably determine or accurately project total program-specific expenses through commercialization, if such was to occur. There are numerous factors associated with the successful commercialization of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development.

Current wording

In addition, product candidates in later stages of clinical development generally incur higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect our research and development expenses to increase as our product candidates advance into later stages of clinical development. As of the date of this Quarterly Report on Form 10-Q, we cannot reasonably determine or accurately project total program-specific expenses through commercialization, if such was to occur. There are numerous factors associated with the successful commercialization of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development.

Previous wording

We also expect to continue to incur increased expenses associated with operating as a public company, including costs related to accounting, audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and rules and regulations of the Securities and Exchange Commission (“SEC”), Sarbanes-Oxley Act, director and officer insurance costs, and investor and public relations costs.

Current wording

We expect our general and administrative expenses may increase for the foreseeable future if and as we continue to increase our general and administrative headcount to support our continued research and development activities and, if any product candidates receive marketing approval, commercialization activities, as well as to support our operations generally. We also expect to continue to incur increased expenses associated with operating as a public company, including costs related to accounting, audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and rules and regulations of the Securities and Exchange Commission (“SEC”), Sarbanes-Oxley Act, director and officer insurance costs, and investor and public relations costs.

Previous wording

Research and development expenses increased by approximately $0.3 million, or 2.4%, to approximately $11.5 million for the three months ended March 31, 2025 as compared to approximately $11.2 million for the three months ended March 31, 2024. The increase of approximately $0.3 million was primarily due to an increase of approximately $0.4 million related to direct research and development expenses, including a $0.6 million increase in expenses related to IMM-1-104 and a $0.6 million increase in expenses related to IMM-6-415, offset by decreased preclinical spend of approximately $0.8 million due to the Company's prioritization of IMM-1-104. The remaining variance was driven by a decrease in unallocated research and development expenses of approximately $0.1 million, which was primarily driven by decreased employee-related costs (including due to a lower employee headcount) of $0.3 million, offset by increased stock-based compensation costs of $0.2 million, in addition to facilities and other expenses of $22 thousand.

Current wording

Research and development expenses decreased by approximately $0.2 million, or 1.9%, to approximately $10.5 million for the three months ended June 30, 2025 as compared to approximately $10.7 million for the three months ended June 30, 2024. The decrease of approximately $0.2 million was primarily due to a decrease in indirect research and development expenses of approximately $0.4 million, which was primarily driven by decreased employee-related costs (including due to a lower employee headcount) of $0.3 million, stock-based compensation costs of $0.1 million, in addition to facilities and other expenses of $15 thousand. The remaining variance was driven by an increase of approximately $0.2 million related to direct research and development expenses, including a $1.4 million increase in expenses related to atebimetinib (IMM-1-104) offset by a $0.9 million decrease in expenses related to IMM-6-415, and decreased preclinical spend of approximately $0.3 million due to the Company's prioritization of atebimetinib.

Previous wording

General and administrative expenses decreased by approximately $0.1 million, or 2.7%, to approximately $4.0 million for the three months ended March 31, 2025 compared to approximately $4.1 million for the three months ended March 31, 2024. The decrease of approximately $0.1 million was primarily due to a decrease in employee-related costs of $0.1 million, in addition to a $0.1 million decrease in professional fees for accounting, auditing and legal services and facilities and other allocated expenses, in the aggregate, offset by increased stock-based compensation expense of approximately $0.1 million.

Current wording

General and administrative expenses increased by approximately $42 thousand, or 1.0%, to approximately $4.3 million for the three months ended June 30, 2025 compared to approximately $4.3 million for the three months ended June 30, 2024. The increase of approximately $42 thousand was primarily due to $0.2 million increase in professional fees for accounting, auditing and legal services and $0.1 million increase in employee-related costs, offset by decreased stock-based compensation expense of approximately $0.1 million and $0.2 million of other costs.

Previous wording

Interest income decreased by approximately $0.4 million for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, driven primarily by a lower total cash balance.

Current wording

Interest income decreased by approximately $0.5 million for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024, driven primarily by lower interest rates and a lower total cash balance.

Previous wording

There was no other income for the three months ended March 31, 2025, compared to $0.2 million for the three months ended March 31, 2024. This was primarily a result of there being no marketable securities as of March 31, 2025 and December 31, 2024, respectively.

Current wording

There was no other income for the three months ended June 30, 2025, compared to $8 thousand for the three months ended June 30, 2024. This was primarily a result of there being no marketable securities as of June 30, 2025 and December 31, 2024, respectively.

Previous wording

As of March 31, 2025, we had an accumulated deficit of $239.3 million and $35.9 million in cash and cash equivalents. Cash and cash equivalents are comprised of deposits at major financial banking institutions and highly liquid investments with an original maturity of three months or less at the date of purchase. 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, reflected in the change in our outstanding accounts payable and accrued expenses.

Current wording

As of June 30, 2025, we had an accumulated deficit of $253.8 million and $26.4 million in cash and cash equivalents. Cash and cash equivalents are comprised of deposits at major financial banking institutions and highly liquid investments with an original maturity of three months or less at the date of purchase. 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, reflected in the change in our outstanding accounts payable and accrued expenses.

Previous wording

On August 10, 2022, we entered into an Equity Distribution Agreement (the "Sales Agreement") with Piper Sandler & Co (the "Sales Agent") to sell shares of our common stock with aggregate gross proceeds of up to $50 million, from time to time, through the ATM Program. We sold 4,836,804 shares of Class A common stock under the ATM Program, at an average price per share of $2.95, for aggregate gross proceeds of $14.2 million ($13.7 million net of offering expenses) during the three months ended March 31, 2025. We did not sell any shares of Class A common stock under the ATM Program during the three months ended March 31, 2024.

Current wording

On August 10, 2022, we entered into an Equity Distribution Agreement (the "Sales Agreement") with Piper Sandler & Co (the "Sales Agent") to sell shares of our common stock with aggregate gross proceeds of up to $50 million, from time to time, through the ATM Program. We did not sell any shares of Class A common stock under our ATM Program during the three months ended June 30, 2025 or June 30, 2024. We sold 4,836,804 shares of common stock under the ATM Program, at an average price per share of $2.95, for aggregate gross proceeds of $14.2 million ($13.7 million net of offering expenses) during the six months ended June 30, 2025, and did not sell any shares of Class A common stock under the ATM Program during the six months ended June 30, 2024.

Previous wording

As of March 31, 2025, we had contractual obligations related to various leases of $0.6 million for 2025, $0.8 million for 2026, $0.8 million for 2027, $0.8 million for 2028, $0.8 million for 2029 and $2.0 million for periods thereafter.

Current wording

As of June 30, 2025, we had contractual obligations related to various leases of $0.4 million for 2025, $0.8 million for 2026, $0.8 million for 2027, $0.8 million for 2028, $0.8 million for 2029 and $2.0 million for periods thereafter.

Previous wording

During the three months ended March 31, 2024, operating activities used approximately $15.5 million of cash, primarily resulting from our net loss of approximately $14.3 million and changes in assets and liabilities of $2.7 million, partially offset by stock-based compensation expense of approximately $1.5 million and the reduction in carrying amount of right-of-use assets of approximately $0.1 million.

Current wording

During the six months ended June 30, 2025, operating activities used approximately $23.5 million of cash, primarily resulting from our net loss of approximately $29.5 million and changes in assets and liabilities of $2.4 million, partially offset by stock-based compensation expense of approximately $3.2 million, depreciation of approximately $0.2 million and the reduction in carrying amount of right-of-use assets of approximately $0.2 million.

Previous wording

During the three months ended March 31, 2025, operating activities used approximately $14.1 million of cash, primarily resulting from our net loss of approximately $15.0 million and changes in assets and liabilities of $1.0 million, partially offset by stock-based compensation expense of approximately $1.7 million and the reduction in carrying amount of right-of-use assets of approximately $0.1 million.

Current wording

During the six months ended June 30, 2024, operating activities used approximately $27.0 million of cash, primarily resulting from our net loss of approximately $28.4 million and changes in assets and liabilities of $1.9 million, partially offset by stock-based compensation expense of approximately $3.1 million and the reduction in carrying amount of right-of-use assets of approximately $0.2 million.

Previous wording

During the three months ended March 31, 2025, investing activities used approximately $9 thousand of cash, primarily resulting from purchases of property and equipment of approximately $9 thousand.

Current wording

During the six months ended June 30, 2025, investing activities used approximately $11 thousand of cash, primarily resulting from purchases of property and equipment of approximately $11 thousand.

Previous wording

During the three months ended March 31, 2024, investing activities provided approximately $21.4 million, primarily resulting from the maturities of marketable securities of approximately $21.4 million, partially offset by purchases of property and equipment of approximately $37 thousand.

Current wording

During the six months ended June 30, 2024, investing activities provided approximately $26.4 million, primarily resulting from the maturities of marketable securities of approximately $26.4 million, partially offset by purchases of property and equipment of approximately $70 thousand.

Previous wording

During the three months ended March 31, 2025, net cash provided by financing activities was approximately $13.8 million, primarily driven by proceeds of approximately $13.7 million from the issuance of common stock under the Company's ATM program, net of offering expenses, in addition to $0.1 million from the Company's employee stock purchase plan.

Current wording

During the six months ended June 30, 2025, net cash provided by financing activities was approximately $13.7 million, primarily driven by proceeds of approximately $13.7 million from the issuance of common stock under the Company's ATM program, net of offering expenses, in addition to $0.2 million from the Company's employee stock purchase plan and exercise of stock options.

Previous wording

During the three months ended March 31, 2024, net cash provided by financing activities was approximately $1.0 million, primarily driven by proceeds of approximately $0.7 million from the exercise of stock options and approximately $0.2 million from the Company's employee stock purchase plan.

Current wording

During the six months ended June 30, 2024, net cash provided by financing activities was approximately $1.0 million, primarily driven by proceeds of approximately $0.7 million from the exercise of stock options and approximately $0.2 million from the Company's employee stock purchase plan.

Previous wording

•the costs and results of our ongoing clinical trial for IMM-1-104 and potential future clinical trials for our other product candidates;

Current wording

•the costs and results of our ongoing clinical trial for atebimetinib, our planned registrational trial of atebimetinib in combination with mGnP in first-line pancreatic cancer, and potential future clinical trials for atebimetinib and our other product candidates;

Previous wording

Based on our currently forecasted operating plan, we believe that our existing cash and cash equivalents as of March 31, 2025 will enable us to fund our operating expenses and capital expenditure requirements into 2026. Based on our recurring losses from operations incurred since inception, our expectation of continuing operating losses for the foreseeable future and the need to raise additional capital to finance future operations, as of May 5, 2025, the issuance date of the interim condensed consolidated financial statements for the three-months ended March 31, 2025 included elsewhere in this Quarterly Report on Form 10-Q, management has concluded that there is substantial doubt about our ability to continue as a going concern for a period of one year from the issuance date of such interim condensed consolidated financial statements. We are developing plans to mitigate this risk, which primarily consist of raising additional capital through some combination of equity or debt financings, and/or potentially new collaborations, business transactions, and reducing cash expenditures. If we are not able to secure adequate additional funding, we plan to make significant reductions in spending. In that event, we may have to delay, scale back, or eliminate some or all of our operations, sell assets or seek other strategic solutions.

Current wording

Based on our currently forecasted operating plan, we believe that our existing cash and cash equivalents as of June 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements into 2026. Based on our recurring losses from operations incurred since inception, our expectation of continuing operating losses for the foreseeable future and the need to raise additional capital to finance future operations, as of August 13, 2025, the issuance date of the interim condensed consolidated financial statements for the three- and six-months ended June 30, 2025 included elsewhere in this Quarterly Report on Form 10-Q, management has concluded that there is substantial doubt about our ability to continue as a going concern for a period of one year from the issuance date of such interim condensed consolidated financial statements. We are developing plans to mitigate this risk, which primarily consist of raising additional capital through some combination of equity or debt financings, and/or potentially new collaborations, business transactions, and reducing cash expenditures. If we are not able to secure adequate additional funding, we plan to make significant reductions in spending. In that event, we may have to delay, scale back, or eliminate some or all of our operations, sell assets or seek other strategic solutions.