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Immuneering Corp

For the period ended Sep 30, 2025. Filed Nov 12, 2025.

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, 2025 · Filed Nov 12, 2025

IMRX$3.68+9.2%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 2025-06-30; filed 2025-08-13.

0001790340-25-000104

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

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-12.

0001790340-25-000135

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 133 previous paragraphs and 142 current paragraphs.

93 unchanged; 34 reworded; 13 added; 4 removed; 2 previous and 2 current paragraphs rearranged.

Tables are not compared: 7 previous and 7 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 (13)

Current report

In August 2025, we announced entry into a clinical supply agreement with Eli Lilly and Company for its second-generation KRAS G12C inhibitor, olomorasib (LY3537982), which intends to support the evaluation of atebimetinib in combination with olomorasib in a planned clinical trial in patients with locally advanced or metastatic KRAS G12c-mutant non-small cell lung cancer (NSCLC) who have progressed on prior therapy.

Current report

As of the Cutoff Date, the median OS of the 320 mg ITT Population had not been reached and the median PFS was 9.6 months. Also as of the Cutoff Date, 94% OS and 70% PFS were observed in the 320 mg ITT Population at six months. The standard of care reported a 67% OS and 44% PFS at six months. All data reported by us were from the same patient cohort (N=34) as we previously reported in June 2025.

Current report

The estimates of standard of care set forth above with respect to the nine-month follow-up data as of the Cutoff Date were extrapolated and reconstructed by us based on the publicly available third-party MPACT pivotal trial data for gemcitabine/nab-paclitaxel (the "MPACT Trial"). The references to standard of care set forth above with respect to the six-month follow-up data as of the Cutoff Date were reported out directly from the MPACT trial. Our Phase 1/2a clinical trial of atebimetinib does not include a head-to-head comparison against any other agents, and caution should be exercised when comparing data across trials.

Current report

We sold 327,355 shares of common stock under the 2022 ATM Program, at a weighted average price per share of $4.27, for aggregate gross proceeds of $1.4 million ($1.3 million net of offering expenses) during the three months ended

Current report

On August 21, 2025, we entered into the August 2025 Purchase Agreement with the purchasers party thereto, pursuant to which we agreed to sell securities to such purchasers in the August 2025 Private Placement. The August 2025 Purchase Agreement provided for the sale and issuance by us to the purchasers of: (i) an aggregate of 5,251,349 shares of our common stock at a purchase price of $3.95 per share, (ii) for certain purchasers, in lieu of common stock, an aggregate of 1,077,764 Pre-Funded Warrants to purchase up to the same number of shares of our common stock, and (iii) an aggregate of 2,848,096 Purchase Warrants to purchase up to the same number of shares of our common stock. The Pre-Funded Warrants were issued for a purchase price equating to $3.949 per Pre-Funded Warrant (which was the per share purchase price for the common stock issued in the August 2025 Private Placement, less the $0.001 per share unfunded exercise price for each Pre-Funded Warrant); see "Notes to Unaudited Condensed Consolidated Financial Statements - Note 12 - Subsequent Events" for additional information related to the October 2025 Cashless Exercise of the Pre-Funded Warrants. The Purchase Warrants were issued with an exercise price of $5.50 per share; as of September 30, 2025, no Purchase Warrants had been exercised. As of September 30, 2025, we had received aggregate net proceeds of $23.4 million from the August 2025 Private Placement, after deducting placement expenses of $1.6 million. The August 2025 Private Placement closed on August 26, 2025.

Current report

On September 24, 2025, we entered into the September 2025 Purchase Agreement with Aventis (a wholly owned subsidiary of Sanofi), pursuant to which we agreed to sell securities to Aventis in the September 2025 Private Placement. The September 2025 Purchase Agreement provided for the sale and issuance by us to Aventis of an aggregate of 2,708,559 shares of our common stock at a purchase price of $9.23 per share. We received aggregate net proceeds of $23.3 million from the September 2025 Private Placement, after deducting placement agent discounts and commissions, but before deducting placement costs payable by us, which were estimated to be approximately $0.2 million. The September 2025 Private Placement closed on September 26, 2025.

Current report

On September 26, 2025, we completed the September 2025 Offering, pursuant to which we issued and sold 18,959,914 shares of our Class A common stock at an offering price of $9.23 per share, with Leerink Partners LLC and Oppenheimer & Co. Inc. acting as underwriters. The aggregate net proceeds received by us from the September 2025 Offering were $164.1 million, after deducting underwriting discounts and commissions, but before deducting offering costs payable by us, which were estimated to be approximately $0.4 million.

Current report

Comparison of the Nine Months Ended September 30, 2025 and 2024

Current report

On August 13, 2025, we entered into the 2025 Sales Agreement with the Sales Agent, to sell shares of our common stock with aggregate gross proceeds of up to $100 million, from time to time, through the 2025 ATM Program. In connection with the September 2025 Offering (as defined below), we: (i) reduced the maximum aggregate offering price for sales of shares of common stock pursuant to at-the-market transactions under the 2025 ATM Program by the Reduced Amount, resulting in a new maximum aggregate offering price of up to $98,749,993 under the 2025 ATM Program, and (ii) suspended the 2025 ATM Program and terminated the continuous offering under the 2025 ATM Program, in each case, as to the Reduced Amount. We did not sell any shares of common stock under the 2025 ATM Program during the three and nine months ended September 30, 2025 or September 30, 2024, respectively.

Current report

On August 21, 2025, we entered into the August 2025 Purchase Agreement with the purchasers party thereto, pursuant to which we agreed to sell securities to such purchasers in the August 2025 Private Placement. The August 2025 Purchase Agreement provided for the sale and issuance by us to the purchasers of: (i) an aggregate of 5,251,349 shares of our common stock at a purchase price of $3.95 per share, (ii) for certain purchasers, in lieu of common stock, an aggregate of 1,077,764 Pre-Funded Warrants to purchase up to the same number of shares of our common stock, and (iii) an aggregate of 2,848,096 Purchase Warrants to purchase up to the same number of shares of our common stock. The Pre-Funded Warrants were issued for a purchase price equating to $3.949 per Pre-Funded Warrant (which was the per share purchase price for the common stock issued in the August 2025 Private Placement, less the $0.001 per share unfunded exercise price for each Pre-Funded Warrant); see "Notes to Unaudited Condensed Consolidated Financial Statements - Note 12 - Subsequent Events" for additional information related to the cashless exercise of the Pre-Funded Warrants. The Purchase Warrants were issued with an exercise price of $5.50 per share; as of September 30, 2025, no Purchase Warrants had been exercised. As of September 30, 2025, we had received aggregate net proceeds of $23.4 million from the August 2025 Private Placement, after deducting placement expenses of $1.6 million. The August 2025 Private Placement closed on August 26, 2025.

Current report

On September 24, 2025, we entered into the September 2025 Purchase Agreement with Aventis, pursuant to which we agreed to sell securities to Aventis in the September 2025 Private Placement. The September 2025 Purchase Agreement provided for the sale and issuance by us to Aventis of an aggregate of 2,708,559 shares of our common stock at a purchase price of $9.23 per share. We received aggregate net proceeds of $23.3 million from the September 2025 Private Placement, after deducting placement agent discounts and commissions, but before deducting placement costs payable by us, which were estimated to be approximately $0.2 million. The September 2025 Private Placement closed on September 26, 2025.

Current report

On September 26, 2025, we completed the September 2025 Offering, pursuant to which we issued and sold 18,959,914 shares of our Class A common stock at an offering price of $9.23 per share, with Leerink Partners LLC and Oppenheimer & Co. Inc. acting as underwriters. The aggregate net proceeds received by us from the September 2025 Offering were $164.1 million, after deducting underwriting discounts and commissions, but before deducting offering costs payable by us, which were estimated to be approximately $0.4 million.

Current report

During the nine months ended September 30, 2025, net cash provided by financing activities was approximately $226.9 million, primarily driven by proceeds of approximately: $15.0 million from the sale of common stock under our 2022 ATM program, net of commissions; $0.4 million from the sale of common stock pursuant to our employee stock purchase plan; $0.1 million from the exercise of stock options; $25.0 million from the sale of common stock, Pre-Funded Warrants and Purchase Warrants in the August 2025 Private Placement; $25.0 million from the sale of common stock in the September 2025 Private Placement; and $164.5 million from the sale of common stock in the September 2025 Offering, net of underwriting commissions. The above were partially offset by aggregate payments of offering and placement expenses, as applicable, of $3.1 million.
Removed paragraphs (4)

Previous report

Based on our current operating plan, we believe that we do not have sufficient cash and cash equivalents on hand to support current operations for at least one year from the date of issuance of the financial statements appearing within this Quarterly Report on Form 10-Q. To finance our operations beyond that point, we will need to raise additional capital. There can be no assurance that we will be able to obtain additional funding on acceptable terms, if at all. We have concluded that this circumstance raises substantial doubt about our ability to continue as a going concern for at least one year from the date of the issuance of our unaudited interim condensed consolidated financial statements for the period ended June 30, 2025. We intend to obtain additional funding through available financing sources which may include additional public offerings of common stock, private financing of debt or equity, and/or the pursuit of strategic partnerships, licensing arrangements or collaborations to fund our future operations and remain as a going concern. To the extent that we raise additional capital through future equity offerings, the ownership interest of common stockholders will be diluted, which may be significant. See "Note 1 - Organization and Nature of Business" to our unaudited interim condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional information on our assessment. Until such time as we can generate revenue from product sales, if ever, we expect to finance our cash needs through a combination of equity offerings, debt financings, and potential collaborations, license and development agreements.
Reworded paragraphs (34)

Previous 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.

Current wording

We are a clinical-stage oncology company focused on keeping cancer patients alive and helping them thrive. We aim to achieve this goal through Deep Cyclic Inhibitors ("DCIs") of clinically-validated core signaling pathways such as the mitogen-activated protein kinase ("MAPK") pathway, impacting cancer cells while sparing healthy cells. Deep Cyclic Inhibitors are differentiated from targeted therapies that are designed to chronically inhibit a signaling pathway 24/7, and which are generally limited by toxicity, resistance and/or application to specific mutations only.

Previous 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.

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 durability and tolerability and expand indications beyond currently registered MEK inhibitors to include RAS-driven tumors such as most pancreatic cancers.

Previous wording

DCI is a novel mechanism that aims to deprive tumor cells of the sustained proliferative signaling required for rapid growth, while sparing healthy cells through a cadenced, normalized level of signaling. This mechanism was engineered using our proprietary informatics-based discovery platform. The development of our pipeline is translationally guided by our proprietary, human-aligned 3D tumor modeling platform that we combine with bioinformatics-driven patient profiling, which we believe has the potential to increase the probability of success in clinical development versus traditional drug development approaches. Our pipeline also includes a discovery program targeting RAS, an undisclosed target, and other small molecule drug discovery programs.

Current wording

DCIs aim to achieve durability by outpacing cancer, pulsing faster than cancer can adapt so tumors shrink slowly but durably, while depriving tumor cells of the sustained proliferative signaling required for rapid growth, and sparing healthy cells through a cadenced, normalized level of signaling. This mechanism was engineered using our proprietary informatics-based discovery platform. The development of our pipeline is translationally guided by our proprietary, human-aligned 3D tumor modeling platform that we combine with bioinformatics-driven patient profiling, which we believe has the potential to increase the probability of success in clinical development versus traditional drug development approaches. Our pipeline also includes a discovery program targeting RAS, an undisclosed target, and other small molecule drug discovery programs.

Previous 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.

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 a planned clinical trial in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer. We expect to dose the first patient in this planned clinical trial in the second half of 2026.

Previous wording

In June 2025, we announced positive interim data from our ongoing Phase 2a clinical trial arm evaluating atebimetinib in combination with modified Gemcitabine/nab-Paclitaxel ("mGnP") in first-line pancreatic cancer patients (the "mGnP Arm"). As of a data cutoff date of May 26, 2025 (the "Cutoff Date"), 94% overall survival ("OS") and 72% progression free survival ("PFS") were observed at six months in the intent-to-treat population of 34 patients dosed at the 320 mg once-daily dose level of atebimetinib in combination with mGnP (the "320 mg ITT Population"). As of the Cutoff Date, neither the median OS nor the median PFS of the 320 mg ITT Population had been reached and the median follow-up time was six months. Of the 36 response evaluable patients in the mGnP Arm dosed at the 240 mg or 320 mg once-daily dose level of atebimetinib in combination with mGnP, we observed an interim 81% (29/36) disease control rate ("DCR") and an interim 39% (14/36) overall response rate ("ORR"), in each case as measured by the Response Evaluation Criteria in Solid Tumors ("RECIST") method.

Current wording

In September 2025, we announced updated interim data from our ongoing Phase 2a clinical trial arm evaluating atebimetinib in combination with modified Gemcitabine/nab-Paclitaxel ("mGnP") in first-line pancreatic cancer patients, which is part our ongoing Phase 1/2a clinical trial of atebimetinib in patients with advanced RAS- and/or RAF-mutant solid tumors.

Previous wording

Further, we announced that as of the Cutoff Date, atebimetinib in combination with mGnP was observed to be generally well tolerated. As of the Cutoff Date, Grade ≥ 3 treatment-emergent adverse events ("TEAEs") observed in 10% or greater of patients in the 320 mg ITT Population were limited to Anemia (six patients or 18%) and Neutropenia (five patients or 15%), and no Grade 5 TEAEs were observed in this subset of the patient population.

Current wording

We also announced that, as of the Cutoff Date, atebimetinib in combination with mGnP continued to be generally well tolerated. As of the Cutoff Date, Grade ≥ 3 treatment-emergent adverse events ("TEAEs") observed in 10% or greater of patients in the 320 mg ITT Population consisted of Anemia (eight patients or 24%) and Neutropenia (six patients or 18%). Grade ≥ 3 TEAEs observed in less than 10% of patients in the 320 mg ITT Population included Fatigue (6%), Vomiting (3%), Febrile Neutropenia (3%), Hypokalemia (3%) and Nausea (3%). No Grade 5 TEAEs were observed in this patient population and no new safety signals were identified.

Previous wording

We expect regulatory feedback on our registrational trial plans for atebimetinib in combination with mGnP in first-line pancreatic cancer patients in the fourth quarter of 2025, as well as to provide updated OS and PFS data from the Phase 2a portion of the Phase 1/2a atebimetinib trial in the third quarter of 2025. Pending regulatory feedback, we plan to initiate a registrational, randomized controlled trial of atebimetinib in combination with mGnP in first-line pancreatic cancer in 2026. We also plan to initiate additional atebimetinib clinical trial combination arms in 2026.

Current wording

We expect regulatory feedback on our pivotal Phase 3 clinical trial plans for atebimetinib in combination with mGnP in first-line pancreatic cancer patients in the fourth quarter of 2025. We also expect to provide further updated survival data in the first half of 2026 from first-line pancreatic cancer patients treated with atebimetinib in combination with mGnP in our ongoing Phase 2a trial, as well as to provide updated circulating tumor DNA data on acquired alterations in the second quarter of 2026, in each case including potentially at a scientific/medical conference. Subject to the regulatory feedback described above, we expect to dose the first patient in the pivotal Phase 3 clinical trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients by mid-2026.

Previous wording

Our second product candidate IMM-6-415 aims to achieve broad activity with an accelerated twice-daily oral dosing cadence, also through deep cyclic inhibition of MEK. In December 2023, the FDA cleared our IND application for IMM-6-415 and, in March 2024, we commenced dosing in a Phase 1/2a clinical trial of IMM-6-415 for the potential treatment of patients with advanced solid tumors harboring RAF or RAS mutations. The Phase 1/2a clinical trial was designed to assess the safety, tolerability, PK, PD, and preliminary anti-tumor activity of IMM-6-415. The Phase 1 portion of the clinical trial included dose escalation and dose exploration for IMM-6-415, using a mTPI-2 statistical design to establish an optimized RP2D in solid tumor patients with evidence of any RAF or RAS mutation.

Current wording

Our second product candidate IMM-6-415 aims to achieve broad activity with an accelerated twice-daily oral dosing cadence, and is also a deep cyclic inhibitor of MEK. In December 2023, the FDA cleared our IND application for IMM-6-415 and, in March 2024, we commenced dosing in a Phase 1/2a clinical trial of IMM-6-415 for the potential treatment of patients with advanced solid tumors harboring RAF or RAS mutations. The Phase 1/2a clinical trial was designed to assess the safety, tolerability, PK, PD, and preliminary anti-tumor activity of IMM-6-415. The Phase 1 portion of the clinical trial included dose escalation and dose exploration for IMM-6-415, using a mTPI-2 statistical design to establish an optimized RP2D in solid tumor patients with evidence of any RAF or RAS mutation.

Previous wording

For the period from inception through 2017, we devoted substantially all of our efforts to business planning, service revenue generation, developing tools to aid in drug discovery, and recruiting management and technical staff. Since 2018, we have focused significant effort on our own internal research and development programs, and since December 2022 have exclusively focused our efforts on such programs. We have financed our operations through service revenues (which have since ceased), the issuance of convertible debt and the sale of convertible preferred stock and common stock.

Current wording

For the period from inception through 2017, we devoted substantially all of our efforts to business planning, service revenue generation, developing tools to aid in drug discovery, and recruiting management and technical staff. Since 2018, we have focused significant effort on our own internal research and development programs, and since December 2022 have exclusively focused our efforts on such programs. We have financed our operations through service revenues (which have since ceased), the issuance of convertible debt and the sale of convertible preferred stock, common stock and warrants exercisable for common stock.

Previous 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.

Current wording

September 30, 2025. We sold 5,164,159 shares of common stock under the 2022 ATM program, at a weighted average price per share of $3.03, for aggregate gross proceeds of $15.6 million ($15.0 million net of offering expenses) during the nine months ended September 30, 2025. We sold 1,318,752 shares of common stock under the 2022 ATM Program, at a weighted average price per share of $3.38, for aggregate gross proceeds of $4.5 million ($4.2 million net of offering expenses) during the three and nine months ended September 30, 2024. We did not sell any shares of Class A common stock under the 2025 ATM Program during the three and nine months ended September 30, 2025 or September 30, 2024, respectively.

Previous 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.

Current wording

Since inception, we have had significant annual operating losses. Our net loss was approximately $44.4 million for the nine months ended September 30, 2025 and approximately $61.0 million for the year ended December 31, 2024. As of September 30, 2025, we had an accumulated deficit of approximately $268.7 million and approximately $227.6 million in cash and cash equivalents.

Previous 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.

Current wording

As of November 12, 2025, the issuance date of the interim condensed consolidated financial statements for the three and nine-months ended September 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, we believe that our existing cash and cash equivalents will enable us to fund our development activities and other operations into 2029. 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

•expenses incurred under agreements with third-party CROs and other vendors that conduct our preclinical and clinical activities on our behalf, including clinical trial sites that conduct research and development activities on our behalf;

Current wording

•program-specific expenses incurred under agreements with third-party CROs and other vendors that conduct our preclinical and clinical activities on our behalf, including clinical trial sites that conduct research and development activities on our behalf;

Previous wording

Our direct research and development expenses are tracked on a program-by-program basis once they are in Phase 1 clinical trials and consist of external costs and fees paid to consultants, contractors, CMOs and CROs in connection with our preclinical and clinical development and manufacturing activities. Such program costs also include the external costs of laboratory and consumable materials and costs of raw materials that are directly attributable to and incurred for any single program. We do not allocate employee costs, contractor/consultant fees, costs associated with our platform development and discovery efforts, payments made under third-party licensing agreements, costs of laboratory supplies and consumable materials that are not directly attributable to any single program, and facilities expenses, including rent, depreciation and other indirect costs, to specific product development programs because these costs are deployed across multiple programs and our platform technology and, as such, are not separately classified.

Current wording

Our direct research and development expenses consist of external costs and fees paid to consultants, contractors, CMOs and CROs in connection with our preclinical and clinical development and manufacturing activities. Such program costs also include the external costs of laboratory and consumable materials and costs of raw materials that are directly attributable to and incurred for any single program. We do not allocate employee costs, contractor/consultant fees, costs associated with our platform development and discovery efforts, payments made under third-party licensing agreements, costs of laboratory supplies and consumable materials that are not directly attributable to any single program, and facilities expenses, including rent, depreciation and other indirect costs, to specific product development programs because these costs are deployed across multiple programs and our platform technology and, as such, are not separately classified.

Previous 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.

Current 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.

Previous 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.

Current wording

Research and development expenses decreased by approximately $0.4 million, or 3.4%, to approximately $10.9 million for the three months ended September 30, 2025, as compared to approximately $11.3 million for the three months ended September 30, 2024. The decrease of approximately $0.4 million was primarily due to a decrease in indirect research and development expenses of approximately $0.5 million, offset by an increase of approximately $0.1 million related to direct research and development expenses. The decrease in indirect costs were 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 depreciation/amortization and facilities and other expenses of $43 thousand. The increase in direct costs was driven by a $0.5 million increase in expenses related to atebimetinib (IMM-1-104) and increased preclinical spend of approximately $0.5 million, offset by a $0.9 million decrease in expenses related to IMM-6-415 due to the Company's prioritization of atebimetinib.

Previous 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.

Current wording

General and administrative expenses increased by approximately $0.5 million, or 12.2%, to approximately $4.5 million for the three months ended September 30, 2025, as compared to approximately $4.0 million for the three months ended September 30, 2024. The increase of approximately $0.5 million was primarily driven by public filing costs associated with the various financing efforts during the quarter, a $0.1 million increase in professional fees for accounting, auditing and legal services, and a $16 thousand increase in employee-related costs. This was offset by decreased stock-based compensation expense of approximately $0.1 million and a decrease of $11 thousand in facilities and other allocated expenses.

Previous 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.

Current wording

Interest income decreased by approximately $0.1 million for the three months ended September 30, 2025 as compared to the three months ended September 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 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.

Current wording

There was no other income for the three months ended September 30, 2025, compared to $0.1 million for the three months ended September 30, 2024. This was primarily a result of there being no marketable securities as of September 30, 2025 and December 31, 2024, respectively.

Previous wording

Research and development expenses increased by approximately $0.1 million, or 0.3%, to approximately $21.9 million for the six months ended June 30, 2025 as compared to approximately $21.9 million for the six months ended June 30, 2024. The increase of approximately $0.1 million was primarily due to an increase of approximately $0.6 million related to direct research and development expenses, of which there was an approximately $2.0 million increase in expenses related to atebimetinib (IMM-1-104), offset by a $0.3 million decrease in expenses related to IMM-6-415 driven by decreased manufacturing and preclinical spend, and by a $1.1 million decrease in spend for earlier stage programs. The remaining variance was attributable to decreased indirect research and development costs of approximately $528 thousand, driven by a $0.6 million decrease associated with employee-related costs, offset by minor increases in stock-based compensation expense, facilities and other expenses, in the aggregate.

Current wording

Research and development expenses decreased by approximately $0.3 million, or 0.9%, to approximately $32.8 million for the nine months ended September 30, 2025, as compared to approximately $33.1 million for the nine months ended September 30, 2024. The decrease of approximately $0.3 million was primarily due to a decrease of approximately $1.0 million related to indirect research and development expenses, offset by a $0.7 million increase in direct research and development expenses. Indirect expenses were driven by a $1.0 million decrease associated with employee-related costs, offset by minor increases in stock-based compensation expense, facilities and other expenses, in the aggregate. The offsetting increase in direct research and development expenses were primarily attributable to an approximately $2.5 million increase in expenses related to atebimetinib (IMM-1-104), offset by a $1.2 million decrease in expenses related to

Previous wording

General and administrative expenses decreased by approximately $69 thousand, or 0.8%, to approximately $8.3 million for the six months ended June 30, 2025 compared to approximately $8.4 million for the six months ended June 30, 2024. The decrease of approximately $69 thousand was primarily due to decreased stock-based compensation expense of approximately $17 thousand, a decrease of $30 thousand for facilities and other allocated expenses, and decreased other expenses of $0.3 million, offset by an increase in professional fees incurred for accounting, auditing, legal and tax services of approximately $0.2 million, and an increase in employee-related costs of $28 thousand.

Current wording

General and administrative expenses increased by approximately $0.4 million, or 3.4%, to approximately $12.8 million for the nine months ended September 30, 2025, as compared to approximately $12.4 million for the nine months ended September 30, 2024. The increase of approximately $0.4 million was due to an increase in professional fees incurred for accounting, auditing, legal and tax services of approximately $0.3 million, and increased other expenses of $0.2 million, primarily consisting of offering costs associated with various financing efforts during the current quarter, offset by decreased stock-based compensation expense of approximately $0.1 million and a decrease of $40 thousand in facilities and other allocated expenses.

Previous wording

Amortization of intangible asset was $14,633 for the six months ended June 30, 2025, and 2024. This amortization is related to the technology acquired for the BioArkive acquisition completed in December 2021.

Current wording

Amortization of intangible asset was $21,950 for the nine months ended September 30, 2025, and 2024. This amortization is related to the technology acquired for the BioArkive acquisition completed in December 2021.

Previous wording

Interest income decreased by approximately $0.9 million for the six months ended June 30, 2025, compared to the six months ended June 30, 2024, driven primarily by lower interest rates and a lower total cash balance.

Current wording

Interest income decreased by approximately $1.0 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024, driven primarily by lower interest rates and a lower total cash balance.

Previous wording

There was no other income for the six months ended June 30, 2025, compared to $0.2 million for the six 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.

Current wording

There was no other income for the nine months ended September 30, 2025, compared to $0.4 million for the nine months ended September 30, 2024. This was primarily a result of there being no marketable securities as of September 30, 2025 and December 31, 2024, respectively.

Previous wording

We finance our operations through the issuance of convertible notes payable, convertible preferred stock, common stock, and the exercise of stock options.

Current wording

We finance our operations through the issuance of convertible notes payable, convertible preferred stock, common stock, warrants exercisable for common stock, and the exercise of stock options.

Previous 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.

Current wording

As of September 30, 2025, we had an accumulated deficit of $268.7 million and $227.6 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 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.

Current wording

On August 10, 2022, we entered into the 2022 Sales Agreement with 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 2022 ATM Program. We sold 327,355 shares of common stock under the 2022 ATM Program, at a weighted average price per share of $4.27, for aggregate gross proceeds of $1.4 million ($1.3 million net of offering expenses) during the three months ended September 30, 2025. We sold 5,164,159 shares of common stock under the 2022 ATM program, at a weighted average price per share of $3.03, for aggregate gross proceeds of $15.6 million ($15.0 million net of offering expenses) during the nine months ended September 30, 2025. We sold 1,318,752 shares of common stock under the 2022 ATM Program, at a weighted average price per share of $3.38, for aggregate gross proceeds of $4.5 million ($4.2 million net of offering expenses) during the three and nine months ended September 30, 2024. In August 2025, the 2022 Shelf Registration Statement and the 2022 ATM Program expired, and the 2022 Sales Agreement was terminated.

Previous 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.

Current wording

As of September 30, 2025, we had contractual obligations related to various leases of $0.2 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 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.

Current wording

During the nine months ended September 30, 2025, operating activities used approximately $35.5 million of cash, primarily resulting from our net loss of approximately $44.4 million, partially offset by changes in assets and liabilities of $3.7 million, stock-based compensation expense of approximately $4.7 million, depreciation of approximately $0.2 million and the reduction in carrying amount of right-of-use assets of approximately $0.3 million.

Previous 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.

Current wording

During the nine months ended September 30, 2024, operating activities used approximately $40.5 million of cash, primarily resulting from our net loss of approximately $43.0 million and changes in assets and liabilities of $2.6 million, partially offset by stock-based compensation expense of approximately $4.8 million and the reduction in carrying amount of right-of-use assets of approximately $0.2 million.

Previous 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.

Current wording

During the nine months ended September 30, 2025, investing activities used approximately $18 thousand of cash, primarily resulting from purchases of property and equipment of approximately $18 thousand.

Previous 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.

Current wording

During the nine months ended September 30, 2024, investing activities provided approximately $20.9 million, primarily resulting from the maturities of marketable securities of approximately $26.4 million, partially offset by purchases of marketable securities of $5.4 million and property and equipment of approximately $76 thousand.

Previous 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.

Current wording

During the nine months ended September 30, 2024, net cash provided by financing activities was approximately $5.3 million, primarily driven by proceeds of approximately $4.2 million from the sale of common stock under our 2022 ATM program, net of commissions; $0.4 million from the sale of common stock pursuant to our employee stock purchase plan; and $0.7 million from the exercise of stock options.

Previous 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.

Current wording

Based on our currently forecasted operating plan, we believe that our existing cash and cash equivalents as of September 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements into 2029. 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 November 12, 2025, the issuance date of the interim condensed consolidated financial statements for the three- and nine-months ended September 30, 2025 included elsewhere in this Quarterly Report on Form 10-Q, management considered whether or not there are conditions or events, in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern, and concluded that there are none as it estimates that its cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of these unaudited condensed consolidated financial statements.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

We announced that, as of a cutoff date of August 26, 2025 (the "Cutoff Date"), 86% overall survival ("OS") and 53% progression free survival ("PFS") were observed in the initial intent-to-treat population of 34 patients dosed at the 320 mg once-daily dose level of atebimetinib in combination with mGnP (the "320 mg ITT Population"), with a median follow up time of nine months. Estimates of standard of care (described below) suggest a ~47% OS and ~29% PFS at nine months.

Current report — wording carried from elsewhere

IMM-6-415 driven by decreased manufacturing and preclinical spend, and by a $0.6 million decrease in spend for earlier stage programs.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

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.

Previous report — wording carried elsewhere

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.