Immuneering Corp

Previous wording

You should read the following discussion and analysis of our financial condition and results of operations together with our interim condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and with our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, including the audited consolidated financial statements and notes thereto. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Current wording

You should read the following discussion and analysis of our financial condition and results of operations together with our interim condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and with our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, including the audited consolidated financial statements and notes thereto. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Previous 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.

Current wording

Deep Cyclic Inhibition® ("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. Our Deep Cyclic Inhibitors inhibit clinically-validated core signaling pathways, such as the MAPK pathway. Our novel approach is designed to improve durability and tolerability, and differentiates us from chronically targeted precision therapies, which are generally limited by toxicity, resistance and/or application to specific mutations only.

Previous 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.

Current wording

In January 2026, we announced positive interim response and safety data from our ongoing Phase 2a clinical trial arm evaluating atebimetinib in combination with mGnP in first-line pancreatic cancer patients, which is part of our ongoing Phase 1/2a clinical trial of atebimetinib in patients with advanced solid tumors.

Previous wording

BioArkive was a San Diego based contract research organization that previously provided preclinical research services and biosample storage to us and other biotechnology companies. BioArkive was fully integrated into our operations following the acquisition and now exclusively supports our internal preclinical research activities for our oncology pipeline. In connection with the acquisition, we assumed the obligations under BioArkive’s three lease agreements.

Current wording

On December 22, 2021, we completed the acquisition of all outstanding shares of capital stock of BioArkive, Inc., a California corporation (“BioArkive”), for a market value of $8.75 million. BioArkive was a San Diego based contract research organization that previously provided preclinical research services and biosample storage to us and other biotechnology companies. BioArkive was fully integrated into our operations following the acquisition and now exclusively supports our internal preclinical research activities for our oncology pipeline. In connection with the acquisition, we assumed BioArkive’s lease agreement obligations.

Previous 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.

Current wording

We did not sell any shares of common stock under the 2022 ATM Program during the three months ended March 31, 2026. We sold 4,836,804 shares of common stock under the 2022 ATM Program, at a weighted 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 common stock under the 2025 ATM Program during the three months ended March 31, 2026 or March 31, 2025.

Previous wording

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 wording

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); following the October 2025 Cashless Exercise, no Pre-Funded Warrants remained issued and outstanding. The Purchase Warrants were issued with an exercise price of $5.50 per share; as of March 31, 2026, no Purchase Warrants had been exercised. As of March 31, 2026, 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.

Previous wording

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 wording

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 $23.4 million from the September 2025 Private Placement, after deducting placement agent discounts and commissions of $1.5 million and placement costs of $0.1 million. The September 2025 Private Placement closed on September 26, 2025.

Previous wording

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 wording

On September 26, 2025, we completed the September 2025 Offering, pursuant to which we issued and sold 18,959,914 shares of our 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, as well as offering costs of $0.4 million.

Previous 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.

Current wording

Since our inception, we have had significant annual operating losses. Our net loss was approximately $13.5 million for the three months ended March 31, 2026 and approximately $56.0 million for the year ended December 31, 2025. As of March 31, 2026, we had an accumulated deficit of approximately $293.8 million and approximately $198.6 million in cash, cash equivalents and marketable securities.

Previous wording

Based on our current business plans, we believe that our existing cash and cash equivalents as of September 30, 2025 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. We may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate some or all planned activities to reduce costs.

Current wording

Based on our current business plans, we believe that our existing cash, cash equivalents and marketable securities as of March 31, 2026 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. We may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate some or all planned activities to reduce costs.

Previous 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.

Current wording

As of May 15, 2026, the issuance date of the interim condensed consolidated financial statements for the three-months ended March 31, 2026 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, cash equivalents and marketable securities 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

•facility and equipment related expenses, consisting of indirect and allocated expenses for rent, depreciation, maintenance of facilities, insurance, and other supplies.

Current wording

•facility and equipment related expenses, consisting of indirect and allocated expenses for rent, depreciation and amortization, maintenance of facilities, insurance, and other supplies.

Previous 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.

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/amortization 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

We may never succeed in achieving regulatory approval for any of our product candidates. Further, a number of factors, including those outside of our control, could adversely impact the timing and duration of our product candidates’ development, which could increase our research and development expense. We may obtain unexpected results from our preclinical studies and clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. A change in the outcome of any of these factors could mean a significant change in the costs and timing associated with the development of our current and future preclinical and clinical product candidates. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development, or if we experience significant delays in execution of or enrollment in any of our preclinical studies or clinical trials, we could be required to expend significant additional financial resources and time on the completion of preclinical and clinical development.

Current wording

We may never succeed in achieving regulatory approval for any of our product candidates. Further, a number of factors, including those outside of our control, could adversely impact the timing and duration of our product candidates’ development, which could increase our research and development expenses. We may obtain unexpected results from our preclinical studies and clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. A change in the outcome of any of these factors could mean a significant change in the costs and timing associated with the development of our current and future preclinical and clinical product candidates. For example, if the FDA, EMA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development, or if we experience significant delays in execution of or enrollment in any of our preclinical studies or clinical trials, we could be required to expend significant additional financial resources and time on the advancement of preclinical and clinical development.

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

We expect that our research and development expenses will substantially increase for the foreseeable future as we continue to implement our business strategy, which includes: advancing our product candidates through clinical development (including atebimetinib in our MAPKeeper 301 Phase 3 clinical trial), 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

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.

Current wording

We expect our general and administrative expenses will 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 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.

Current wording

Research and development expenses decreased by approximately $0.8 million, or 7.2%, to approximately $10.6 million for the three months ended March 31, 2026, as compared to approximately $11.5 million for the three months ended March 31, 2025. The decrease of approximately $0.8 million was primarily due to a decrease in direct costs of $1.0 million, primarily driven by a $1.6 million decrease in expenses related to the envometinib program due to the Company's prioritization of the atebimetinib program, in addition to a $0.2 million decrease in expenses related to atebimetinib due to the timing of expenses related to the initiation of the MAPKeeper 301 trial. The decrease to research and development expenses was offset by increased preclinical spend of approximately $0.8 million, driven by development pipeline activities, and by an increase in indirect expenses of approximately $0.2 million, primarily driven by increased employee-related costs of $0.3 million, further offset by stock-based compensation costs of $0.1 million, in addition to depreciation/amortization and facilities and other expenses of $5 thousand.

Previous 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.

Current wording

General and administrative expenses increased by approximately $0.7 million, or 16.9%, to approximately $4.7 million for the three months ended March 31, 2026, as compared to approximately $4.0 million for the three months ended March 31, 2025. The increase of approximately $0.7 million was primarily driven by a $0.4 million increase in employee-related costs, a $0.2 million increase in professional fees for accounting, auditing and legal services, and a $0.1 million increase in other expenses, stock-based compensation, and facilities and other allocated expenses, in the aggregate.

Previous wording

Amortization of intangible asset was $7,317 for the three months ended September 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 $7,317 for the three months ended March 31, 2026 and 2025. This amortization is related to the technology acquired from the BioArkive acquisition completed in December 2021.

Previous 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.

Current wording

Interest income from the interest earned on our cash, cash equivalents and marketable securities balances increased by approximately $0.9 million for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025, driven primarily by an increased total cash balance resulting from various financing events in August and September 2025.

Previous 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.

Current wording

Other income for the three months ended March 31, 2026 was $0.5 million, compared to no other income for the three months ended March 31, 2025. This was primarily driven by the accretion of marketable securities during the three months ended March 31, 2026. There were no marketable securities as of March 31, 2025.

Previous 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.

Current wording

As of March 31, 2026, we had an accumulated deficit of $293.8 million and $198.6 million in cash, cash equivalents and marketable securities. Cash, cash equivalents and marketable securities 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 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.

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 did not sell any shares of common stock under the 2022 ATM Program during the three months ended March 31, 2026. We sold 4,836,804 shares of common stock under the 2022 ATM Program, at a weighted 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. In August 2025, the 2022 Shelf Registration Statement and the 2022 ATM Program expired, and the 2022 Sales Agreement was terminated.

Previous wording

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 wording

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, 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 months ended March 31, 2026 or March 31, 2025, respectively.

Previous wording

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 wording

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); following the October 2025 Cashless Exercise, no Pre-Funded Warrants remained issued and outstanding. The Purchase Warrants were issued with an exercise price of $5.50 per share; as of March 31, 2026, no Purchase Warrants had been exercised. As of March 31, 2026, 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.

Previous wording

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 wording

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 $23.4 million from the September 2025 Private Placement, after deducting placement agent discounts and commissions of $1.5 million and placement costs of $0.1 million. The September 2025 Private Placement closed on September 26, 2025.

Previous wording

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 wording

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, as well as offering costs of $0.4 million.

Previous 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.

Current wording

As of March 31, 2026, we had contractual obligations related to various leases of $0.6 million for 2026, $0.8 million for 2027, $0.8 million for 2028, $0.8 million for 2029, $0.9 million for 2030 and $1.2 million for the periods thereafter.

Previous wording

Based on our current business plans, we believe that our existing cash and cash equivalents as of September 30, 2025 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. We may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate some or all planned activities to reduce costs.

Current wording

Based on our current business plans, we believe that our existing cash, cash equivalents and marketable securities as of March 31, 2026 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. We may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate some or all planned activities to reduce costs.

Previous 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.

Current wording

During the three months ended March 31, 2026, operating activities used approximately $18.4 million of cash, primarily resulting from our net loss of approximately $13.5 million and changes in assets and liabilities of $6.4 million, partially offset by stock-based compensation expense of approximately $1.6 million, depreciation of approximately $0.1 million and the reduction in carrying amount of right-of-use assets of approximately $0.1 million.

Previous 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.

Current 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.

Previous wording

Net Cash (Used in) Provided by Investing Activities

Current wording

Net Cash Used in Investing Activities

Previous 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.

Current wording

During the three months ended March 31, 2026, investing activities used approximately $63.1 million of cash, primarily resulting from purchases of marketable securities of $72.0 million and purchases of property and equipment of approximately $80 thousand, offset by maturities of marketable securities of $9.0 million.

Previous 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.

Current wording

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

Previous 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.

Current 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 sale of common stock under our 2022 ATM program, net of offering expenses, in addition to $0.1 million from the sale of common stock pursuant to our employee stock purchase plan.

Previous wording

•our ability to enter into contract manufacturing arrangements for supply of active pharmaceutical ingredient, or API, and manufacture of our product candidates and the terms of such arrangements;

Current wording

•our ability to enter into contract manufacturing arrangements for supply of active pharmaceutical ingredient ("API"), and manufacture of our product candidates and the terms of such arrangements;

Previous 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.

Current wording

Based on our currently forecasted operating plan, we believe that our existing cash, cash equivalents and marketable securities as of March 31, 2026 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 May 15, 2026, the issuance date of the interim condensed consolidated financial statements for the three-months ended March 31, 2026 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, cash equivalents and marketable securities 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.

Previous wording

As an emerging growth company, or EGC, under the Jumpstart Our Business Startups Act of 2012, or JOBS Act, we may delay the adoption of certain accounting standards until such time as those standards apply to private companies. Other exemptions and reduced reporting requirements under the JOBS Act for EGCs include presentation of only two years of audited consolidated financial statements, an exemption from the requirement to provide an auditor’s report on internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act, an exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board, and less extensive disclosure about our executive compensation arrangements.

Current wording

As an emerging growth company ("EGC"), under the Jumpstart Our Business Startups Act of 2012 ("JOBS Act"), we may delay the adoption of certain accounting standards until such time as those standards apply to private companies. Other exemptions and reduced reporting requirements under the JOBS Act for EGCs include presentation of only two years of audited consolidated financial statements, an exemption from the requirement to provide an auditor’s report on internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act, an exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board, and less extensive disclosure about our executive compensation arrangements.