Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________________________ FORM 10-Q _________________________________________________ | | For the quarterly period ended March 31, 2024 | | --- | --- | | x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 or | o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to Commissi ...

- Reported Positive Topline Results from Phase 1 Portion of its Phase 1/2a Clinical Trial of IMM-1-104 in RAS-Mutant Solid Tumors - - First Patient Dosed in Phase 2a Portion of Phase 1/2a Clinical Trial of IMM-1-104; Initial Data from Multiple IMM-1-104 Phase 2a Arms Expected in 2024 - - Presented Preclinical Data at AACR Demonstrating that Combining IMM-1-104 with Chemotherapies Used in The Treatment of First-line Pancreatic Cancer Yielded Deeper and More Durable Tumor Growth Inhibition Than Either Treatm ...

[Q1 2024 Earnings Release Overview](index=1&type=section&id=Q1_2024_Earnings_Release_Overview) [Highlights and CEO Commentary](index=1&type=section&id=Highlights_and_CEO_Commentary) Immuneering reported positive top-line Phase 1 results for IMM-1-104 in RAS-mutant solid tumors, demonstrating tumor shrinkage potential and good tolerability, with the CEO anticipating a data-rich 2024 - IMM-1-104 Phase 1 results reported positive top-line data from the first stage of the Phase 1/2a clinical trial in RAS-mutant solid tumors[1](index=1&type=chunk) - The Deep Cyclic Inhibition mechanism aims to attack cancer cells while protecting healthy cells, enabling well-tolerated tumor shrinkage[2](index=2&type=chunk) - Preliminary data for multiple IMM-1-104 Phase 2a cohorts and initial PK, PD, and safety data for IMM-6-415 Phase 1/2a study are expected in 2024[1](index=1&type=chunk)[2](index=2&type=chunk) [Clinical Development and Corporate Updates](index=1&type=section&id=Clinical_Development_and_Corporate_Updates) [Corporate Highlights](index=1&type=section&id=Corporate_Highlights) Immuneering achieved significant milestones, including positive IMM-1-104 Phase 1 results, initiation of Phase 2a trials for IMM-1-104 and IMM-6-415, a new board appointment, and FDA Fast Track designation for IMM-1-104 in pancreatic cancer - IMM-1-104 demonstrated synergy with chemotherapy in pancreatic cancer models, supporting the ongoing Phase 2a trial[3](index=3&type=chunk) - IMM-1-104 Phase 1 top-line results showed **good tolerability** with potential for a differentiated safety profile[3](index=3&type=chunk) - **100% acquired RAS mutation inhibition** observed in evaluable patients[4](index=4&type=chunk) - Over half of patients at 320mg or 240mg QD doses showed target lesion regression, with a best individual lesion regression of **-35.7%** and best RECIST Sum of Longest Diameters (SLD) of **-18.9%** (both at 320mg dose)[3](index=3&type=chunk)[4](index=4&type=chunk) - Recommended Phase 2 Dose (RP2D) is **320mg QD**, supported by tolerability, PK/PD, ctDNA results, and preliminary anti-tumor activity[4](index=4&type=chunk) - Clinical trial progress includes the first patient dosed in the IMM-1-104 Phase 2a clinical trial, comprising three monotherapy and two combination therapy cohorts[7](index=7&type=chunk) - The first patient has been dosed in the IMM-6-415 Phase 1/2a trial for RAF or RAS-mutant advanced solid tumors; IMM-6-415 is a Deep Cyclic Inhibitor with a shorter half-life than IMM-1-104, designed for twice-daily oral dosing[7](index=7&type=chunk) - Dr. Thomas J. Schall, former Chairman, CEO, and Founder of ChemoCentryx, was appointed to the Board of Directors[7](index=7&type=chunk) - IMM-1-104 received FDA Fast Track designation for treating patients with pancreatic ductal adenocarcinoma (PDAC) who have failed first-line therapy[7](index=7&type=chunk) [Near-Term Milestone Expectations](index=2&type=section&id=Near-Term_Milestone_Expectations) Immuneering anticipates significant clinical data releases in 2024 for its lead candidates, including preliminary data from multiple IMM-1-104 Phase 2a cohorts and initial PK, PD, and safety data for IMM-6-415 - Preliminary data from multiple cohorts of the IMM-1-104 Phase 2a portion are expected in 2024[5](index=5&type=chunk) - Initial pharmacokinetic (PK), pharmacodynamic (PD), and safety data for IMM-6-415 are anticipated in 2024[6](index=6&type=chunk) [Financial Performance and Outlook](index=2&type=section&id=Financial_Performance_and_Outlook) [First Quarter 2024 Financial Highlights](index=2&type=section&id=First_Quarter_2024_Financial_Highlights) Immuneering's cash decreased to $71.3 million by March 31, 2024, with increased R&D expenses, decreased G&A expenses, and a slight rise in net loss to $14.3 million Cash Position | Metric | March 31, 2024 | December 31, 2023 | | :------------------------------------ | :--------------- | :---------------- | | Cash, Cash Equivalents, and Marketable Securities | $71.3 million | $85.7 million | Operating Expenses (Q1 2024 vs Q1 2023) | Expense Category | Q1 2024 | Q1 2023 | Year-over-Year Change | | :-------------------------------- | :---------- | :---------- | :-------------------- | | Research and Development Expenses | $11.2 million | $10.2 million | +$1.0 million | | General and Administrative Expenses | $4.1 million | $4.5 million | -$0.4 million | Net Loss | Metric | Q1 2024 | Q1 2023 | Year-over-Year Change | | :------------------------------------ | :---------- | :---------- | :-------------------- | | Net Loss Attributable to Common Stockholders | $14.3 million | $13.6 million | +$0.7 million | | Net Loss Per Share (Basic and Diluted) | $0.49 | $0.51 | -$0.02 | [2024 Financial Guidance](index=3&type=section&id=2024_Financial_Guidance) Based on current cash and operational plans, Immuneering expects its cash resources to fund operations into the second half of 2025 - Cash flow is projected to be sufficient to support operations into the **second half of 2025**[10](index=10&type=chunk) [Company Profile](index=3&type=section&id=Company_Profile) [About Immuneering Corporation](index=3&type=section&id=About_Immuneering_Corporation) Immuneering is a clinical-stage oncology company developing universal RAS/RAF drugs using Deep Cyclic Inhibition to selectively target cancer cells, with lead candidates IMM-1-104 and IMM-6-415 in Phase 1/2a trials - Company mission is to develop and commercialize universal RAS/RAF drugs to treat a broad patient population, with an initial focus on universal RAS therapies[11](index=11&type=chunk) - Mechanism of action involves Deep Cyclic Inhibition of the MAPK pathway, designed to impact cancer cells while sparing healthy cells[11](index=11&type=chunk) - Key product candidates include IMM-1-104, an oral, once-daily Deep Cyclic Inhibitor in Phase 1/2a trials for advanced solid tumors with RAS mutations[11](index=11&type=chunk) - IMM-6-415 is an oral, twice-daily Deep Cyclic Inhibitor in Phase 1/2a trials for advanced solid tumors with RAS or RAF mutations[11](index=11&type=chunk) [Legal and Investor Information](index=3&type=section&id=Legal_and_Investor_Information) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking_Statements) This section contains forward-looking statements regarding Immuneering's product development, clinical trials, and financial projections, subject to inherent risks and uncertainties - All statements not concerning historical facts are considered forward-looking, including plans for developing, manufacturing, and commercializing product candidates, potential of IMM-1-104 and IMM-6-415, clinical trial design and implementation, translation of preclinical data, potential benefits and efficacy of candidates, and timing of IMM-1-104 Phase 2a and IMM-6-415 preliminary data[12](index=12&type=chunk) - Key risks include those inherent in oncology drug development, such as target discovery, validation, lead identification, and optimization[13](index=13&type=chunk) - Significant losses incurred, no current profitability, and potential future unprofitability; anticipated cash flow; and the need for additional funding[13](index=13&type=chunk) - Unproven therapeutic interventions; ability to address regulatory issues and uncertainties related to regulatory filings, review, and approval[13](index=13&type=chunk) - Long, expensive, and uncertain clinical drug development process, including potential delays or failure to obtain regulatory approval[14](index=14&type=chunk) - Reliance on third parties and collaborators for clinical trials, manufacturing, and commercialization of product candidates if approved[14](index=14&type=chunk) - Failure to compete successfully with other pharmaceutical companies; protecting proprietary technology and trade secret confidentiality; potential third-party intellectual property infringement lawsuits or claims, or challenges to intellectual property ownership; patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst coverage or reports[14](index=14&type=chunk) - Any forward-looking statements represent management's estimates as of the press release date, with no obligation to update them unless legally required, even if subsequent events change company views[15](index=15&type=chunk) [Contacts](index=4&type=section&id=Contacts) Contact information is provided for media and investor inquiries - Media Contact: Gina Nugent, gina@nugentcommunications.com[16](index=16&type=chunk) - Investor Contact: Laurence Watts, 619-916-7620, laurence@newstreetir.com[16](index=16&type=chunk) [Condensed Consolidated Financial Statements](index=5&type=section&id=Condensed_Consolidated_Financial_Statements) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed_Consolidated_Statements_of_Operations_and_Comprehensive_Loss) This section presents the unaudited condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023, detailing operating expenses, loss, other income, net loss, and loss per share Condensed Consolidated Statements of Operations and Comprehensive Loss | | Three Months Ended March 31 | | | :---------------------------------------------------- | :----------- | :----------- | | | **2024** | **2023** | | Operating expenses: | | | | Research and development expenses | $11,202,414 | $10,210,926 | | General and administrative expenses | $4,116,019 | $4,461,331 | | Amortization of intangible assets | $7,317 | $7,317 | | **Total operating expenses** | **$15,325,750** | **$14,679,574** | | **Operating loss** | **$(15,325,750)** | **$(14,679,574)** | | Other income (expense): | | | | Interest income | $804,884 | $831,274 | | Other income, net | $213,037 | $244,129 | | **Net loss** | **$(14,307,829)** | **$(13,604,171)** | | Net loss attributable to common stockholders per share, basic and diluted | $(0.49) | $(0.51) | | Weighted-average common shares outstanding, basic and diluted | 29,370,357 | 26,442,216 | | Other comprehensive loss: | | | | Unrealized gain (loss) on marketable securities | $(306) | $30,626 | | **Comprehensive loss** | **$(14,308,135)** | **$(13,573,545)** | [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed_Consolidated_Balance_Sheets) This section provides the unaudited condensed consolidated balance sheets as of March 31, 2024, and December 31, 2023, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets | | March 31, 2024 | | December 31, 2023 | | 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Immuneering has released its Q1 2024 financial results, highlighting clinical advancements and financial standing. The company's lead candidate, IMM-1-104, showed positive Phase 1 results in RAS-mutant solid tumors, demonstrating tumor shrinkage and good tolerability. This progress, alongside the initiation of Phase 2a trials for IMM-1-104 and IMM-6-415, and FDA Fast Track designation for IMM-1-104 in pancreatic cancer, underscores Immuneering's commitment to advancing its Deep Cyclic Inhibition platform. Financially, the company reported a decrease in cash and equivalents, with a net loss of $14.3 million for the quarter, but projects sufficient cash to fund operations into the second half of 2025. [Q1 2024 Earnings Release Overview](index=1&type=section&id=Q1_2024_Earnings_Release_Overview) [Highlights and CEO Commentary](index=1&type=section&id=Highlights_and_CEO_Commentary) Immuneering reported positive top-line Phase 1 results for IMM-1-104 in RAS-mutant solid tumors, demonstrating tumor shrinkage potential and good tolerability, with the CEO anticipating a data-rich 2024 - IMM-1-104 Phase 1 results reported positive top-line data from the first stage of the Phase 1/2a clinical trial in RAS-mutant solid tumors[1](index=1&type=chunk) - The Deep Cyclic Inhibition mechanism aims to attack cancer cells while protecting healthy cells, enabling well-tolerated tumor shrinkage[2](index=2&type=chunk) - Preliminary data for multiple IMM-1-104 Phase 2a cohorts and initial PK, PD, and safety data for IMM-6-415 Phase 1/2a study are expected in 2024[1](index=1&type=chunk)[2](index=2&type=chunk) [Clinical Development and Corporate Updates](index=1&type=section&id=Clinical_Development_and_Corporate_Updates) [Corporate Highlights](index=1&type=section&id=Corporate_Highlights) Immuneering achieved significant milestones, including positive IMM-1-104 Phase 1 results, initiation of Phase 2a trials for IMM-1-104 and IMM-6-415, a new board appointment, and FDA Fast Track designation for IMM-1-104 in pancreatic cancer - IMM-1-104 demonstrated synergy with chemotherapy in pancreatic cancer models, supporting the ongoing Phase 2a trial[3](index=3&type=chunk) - IMM-1-104 Phase 1 top-line results showed **good tolerability** with potential for a differentiated safety profile[3](index=3&type=chunk) - **100% acquired RAS mutation inhibition** observed in evaluable patients[4](index=4&type=chunk) - Over half of patients at 320mg or 240mg QD doses showed target lesion regression, with a best individual lesion regression of **-35.7%** and best RECIST Sum of Longest Diameters (SLD) of **-18.9%** (both at 320mg dose)[3](index=3&type=chunk)[4](index=4&type=chunk) - Recommended Phase 2 Dose (RP2D) is **320mg QD**, supported by tolerability, PK/PD, ctDNA results, and preliminary anti-tumor activity[4](index=4&type=chunk) - Clinical trial progress includes the first patient dosed in the IMM-1-104 Phase 2a clinical trial, comprising three monotherapy and two combination therapy cohorts[7](index=7&type=chunk) - The first patient has been dosed in the IMM-6-415 Phase 1/2a trial for RAF or RAS-mutant advanced solid tumors; IMM-6-415 is a Deep Cyclic Inhibitor with a shorter half-life than IMM-1-104, designed for twice-daily oral dosing[7](index=7&type=chunk) - Dr. Thomas J. Schall, former Chairman, CEO, and Founder of ChemoCentryx, was appointed to the Board of Directors[7](index=7&type=chunk) - IMM-1-104 received FDA Fast Track designation for treating patients with pancreatic ductal adenocarcinoma (PDAC) who have failed first-line therapy[7](index=7&type=chunk) [Near-Term Milestone Expectations](index=2&type=section&id=Near-Term_Milestone_Expectations) Immuneering anticipates significant clinical data releases in 2024 for its lead candidates, including preliminary data from multiple IMM-1-104 Phase 2a cohorts and initial PK, PD, and safety data for IMM-6-415 - Preliminary data from multiple cohorts of the IMM-1-104 Phase 2a portion are expected in 2024[5](index=5&type=chunk) - Initial pharmacokinetic (PK), pharmacodynamic (PD), and safety data for IMM-6-415 are anticipated in 2024[6](index=6&type=chunk) [Financial Performance and Outlook](index=2&type=section&id=Financial_Performance_and_Outlook) [First Quarter 2024 Financial Highlights](index=2&type=section&id=First_Quarter_2024_Financial_Highlights) Immuneering's cash decreased to $71.3 million by March 31, 2024, with increased R&D expenses, decreased G&A expenses, and a slight rise in net loss to $14.3 million Cash Position | Metric | March 31, 2024 | December 31, 2023 | | :------------------------------------ | :--------------- | :---------------- | | Cash, Cash Equivalents, and Marketable Securities | $71.3 million | $85.7 million | Operating Expenses (Q1 2024 vs Q1 2023) | Expense Category | Q1 2024 | Q1 2023 | Year-over-Year Change | | :-------------------------------- | :---------- | :---------- | :-------------------- | | Research and Development Expenses | $11.2 million | $10.2 million | +$1.0 million | | General and Administrative Expenses | $4.1 million | $4.5 million | -$0.4 million | Net Loss | Metric | Q1 2024 | Q1 2023 | Year-over-Year Change | | :------------------------------------ | :---------- | :---------- | :-------------------- | | Net Loss Attributable to Common Stockholders | $14.3 million | $13.6 million | +$0.7 million | | Net Loss Per Share (Basic and Diluted) | $0.49 | $0.51 | -$0.02 | [2024 Financial Guidance](index=3&type=section&id=2024_Financial_Guidance) Based on current cash and operational plans, Immuneering expects its cash resources to fund operations into the second half of 2025 - Cash flow is projected to be sufficient to support operations into the **second half of 2025**[10](index=10&type=chunk) [Company Profile](index=3&type=section&id=Company_Profile) [About Immuneering Corporation](index=3&type=section&id=About_Immuneering_Corporation) Immuneering is a clinical-stage oncology company developing universal RAS/RAF drugs using Deep Cyclic Inhibition to selectively target cancer cells, with lead candidates IMM-1-104 and IMM-6-415 in Phase 1/2a trials - Company mission is to develop and commercialize universal RAS/RAF drugs to treat a broad patient population, with an initial focus on universal RAS therapies[11](index=11&type=chunk) - Mechanism of action involves Deep Cyclic Inhibition of the MAPK pathway, designed to impact cancer cells while sparing healthy cells[11](index=11&type=chunk) - Key product candidates include IMM-1-104, an oral, once-daily Deep Cyclic Inhibitor in Phase 1/2a trials for advanced solid tumors with RAS mutations[11](index=11&type=chunk) - IMM-6-415 is an oral, twice-daily Deep Cyclic Inhibitor in Phase 1/2a trials for advanced solid tumors with RAS or RAF mutations[11](index=11&type=chunk) [Legal and Investor Information](index=3&type=section&id=Legal_and_Investor_Information) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking_Statements) This section contains forward-looking statements regarding Immuneering's product development, clinical trials, and financial projections, subject to inherent risks and uncertainties - All statements not concerning historical facts are considered forward-looking, including plans for developing, manufacturing, and commercializing product candidates, potential of IMM-1-104 and IMM-6-415, clinical trial design and implementation, translation of preclinical data, potential benefits and efficacy of candidates, and timing of IMM-1-104 Phase 2a and IMM-6-415 preliminary data[12](index=12&type=chunk) - Key risks include those inherent in oncology drug development, such as target discovery, validation, lead identification, and optimization[13](index=13&type=chunk) - Significant losses incurred, no current profitability, and potential future unprofitability; anticipated cash flow; and the need for additional funding[13](index=13&type=chunk) - Unproven therapeutic interventions; ability to address regulatory issues and uncertainties related to regulatory filings, review, and approval[13](index=13&type=chunk) - Long, expensive, and uncertain clinical drug development process, including potential delays or failure to obtain regulatory approval[14](index=14&type=chunk) - Reliance on third parties and collaborators for clinical trials, manufacturing, and commercialization of product candidates if approved[14](index=14&type=chunk) - Failure to compete successfully with other pharmaceutical companies; protecting proprietary technology and trade secret confidentiality; potential third-party intellectual property infringement lawsuits or claims, or challenges to intellectual property ownership; patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst coverage or reports[14](index=14&type=chunk) - Any forward-looking statements represent management's estimates as of the press release date, with no obligation to update them unless legally required, even if subsequent events change company views[15](index=15&type=chunk) [Contacts](index=4&type=section&id=Contacts) Contact information is provided for media and investor inquiries - Media Contact: Gina Nugent, gina@nugentcommunications.com[16](index=16&type=chunk) - Investor Contact: Laurence Watts, 619-916-7620, laurence@newstreetir.com[16](index=16&type=chunk) [Condensed Consolidated Financial Statements](index=5&type=section&id=Condensed_Consolidated_Financial_Statements) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed_Consolidated_Statements_of_Operations_and_Comprehensive_Loss) This section presents the unaudited condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023, detailing operating expenses, loss, other income, net loss, and loss per share Condensed Consolidated Statements of Operations and Comprehensive Loss | | Three Months Ended March 31 | | | :---------------------------------------------------- | :----------- | :----------- | | | **2024** | **2023** | | Operating expenses: | | | | Research and development expenses | $11,202,414 | $10,210,926 | | General and administrative expenses | $4,116,019 | $4,461,331 | | Amortization of intangible assets | $7,317 | $7,317 | | **Total operating expenses** | **$15,325,750** | **$14,679,574** | | **Operating loss** | **$(15,325,750)** | **$(14,679,574)** | | Other income (expense): | | | | Interest income | $804,884 | $831,274 | | Other income, net | $213,037 | $244,129 | | **Net loss** | **$(14,307,829)** | **$(13,604,171)** | | Net loss attributable to common stockholders per share, basic and diluted | $(0.49) | $(0.51) | | Weighted-average common shares outstanding, basic and diluted | 29,370,357 | 26,442,216 | | Other comprehensive loss: | | | | Unrealized gain (loss) on marketable securities | $(306) | $30,626 | | **Comprehensive loss** | **$(14,308,135)** | **$(13,573,545)** | [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed_Consolidated_Balance_Sheets) This section provides the unaudited condensed consolidated balance sheets as of March 31, 2024, and December 31, 2023, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets | | March 31, 2024 | | December 31, 2023 | | 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- Two clinical stage product candidates in development for the treatment of melanoma - - RAS mutant melanoma represents one of five arms in the company's ongoing Phase 2a clinical study of IMM-1-104 - - Melanoma also being evaluated in ongoing Phase 1/2a clinical study of IMM-6-415 in patients with advanced solid tumors harboring RAF or RAS mutations - - Immuneering expects initial data from multiple IMM-1-104 Phase 2a arms in 2024 - CAMBRIDGE, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation ...

- Preclinical data presented at AACR demonstrate that combining IMM-1-104 with chemotherapies used in the treatment of first-line pancreatic cancer yielded deeper and more durable tumor growth inhibition than either treatment alone - - Patients are now on treatment in multiple arms of the ongoing Phase 2a trial, including multiple patients with pancreatic cancer who are being treated with IMM-1-104 in combination with chemotherapy in the first-line setting - - Immuneering expects initial data from multiple ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________________________________________ FORM 10-K _________________________________________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission F ...

Immuneering Fourth Quarter and Full Year 2023 Financial Results and Business Updates [Corporate Highlights and Business Updates](index=1&type=section&id=Corporate%20Highlights%20and%20Business%20Updates) Immuneering reported significant progress in its clinical programs during 2023 and early 2024, including upcoming topline data for IMM-1-104 and initiation of IMM-6-415 dosing [IMM-1-104 Program Updates](index=1&type=section&id=IMM-1-104%20Program%20Updates) The IMM-1-104 program is rapidly advancing with expected Phase 1 topline data, expanded Phase 2a trials, and FDA Fast Track designation - Topline data from the Phase 1 portion of the Phase 1/2a trial is anticipated in **March 2024**, which will include data on tolerability, recommended Phase 2 dose (RP2D), pharmacokinetics (PK), pharmacodynamics (PD), and initial clinical activity[1](index=1&type=chunk)[4](index=4&type=chunk) - The Phase 2a portion of the trial was expanded to include **5 arms**, evaluating IMM-1-104 as a monotherapy in approximately **90 patients** across pancreatic cancer (PDAC), melanoma, and non-small cell lung cancer (NSCLC), and in combination therapy for approximately **60 PDAC patients**[4](index=4&type=chunk)[5](index=5&type=chunk) - In **February 2024**, the U.S. FDA granted Fast Track Designation for IMM-1-104 for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) who have failed one line of treatment[1](index=1&type=chunk)[5](index=5&type=chunk) - In **June 2023**, the company completed dose escalation for the Phase 1 portion, observing that doses up to **320 mg** once daily were tolerated with no dose-limiting toxicities[5](index=5&type=chunk) [IMM-6-415 Program Updates](index=2&type=section&id=IMM-6-415%20Program%20Updates) Immuneering is initiating the IMM-6-415 Phase 1/2a trial in March 2024, supported by promising preclinical data in MAPK-driven tumors - The first patient in the Phase 1/2a clinical trial of IMM-6-415 is expected to be dosed in **March 2024**[1](index=1&type=chunk)[5](index=5&type=chunk) - The Phase 1 portion will evaluate safety, tolerability, PK, and PD to identify a candidate for the recommended Phase 2 dose (RP2D), potentially enrolling up to **60 patients**. The Phase 2a dose expansion is planned for approximately **180 patients**[5](index=5&type=chunk) - Preclinical data presented in **October 2023** demonstrated high sensitivity in various MAPK-driven tumors and showed that IMM-6-415 in combination with encorafenib drove deeper regressions than the combination of binimetinib plus encorafenib in animal models[5](index=5&type=chunk) [Near-Term Milestone Expectations](index=3&type=section&id=Near-Term%20Milestone%20Expectations) The company anticipates key milestones in 2024, including topline data for IMM-1-104 and first patient dosing for IMM-6-415 - **IMM-1-104:** - Topline data from Phase 1 portion expected in March 2024 - First patient in Phase 2a portion expected to be dosed in March 2024 - Initial data from multiple Phase 2a arms expected in 2024[7](index=7&type=chunk) - **IMM-6-415:** - First patient in the Phase 1 portion of the Phase 1/2a trial expected to be dosed in March 2024[7](index=7&type=chunk) [Fourth Quarter and Full Year 2023 Financial Highlights](index=3&type=section&id=Fourth%20Quarter%20and%20Full%20Year%202023%20Financial%20Highlights) Immuneering's 2023 financial results show decreased cash, increased expenses, and a higher net loss, despite a $30 million offering - In **April 2023**, the company raised **$30 million** (**$28.2 million** net proceeds) through an underwritten offering of its Class A common stock[9](index=9&type=chunk) Cash, Cash Equivalents, and Marketable Securities | Metric | Dec 31, 2023 (in millions) | Dec 31, 2022 (in millions) | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $85.7 | $105.5 | Operating Expenses | Expense Category | Q4 2023 (in millions) | Q4 2022 (in millions) | Full Year 2023 (in millions) | Full Year 2022 (in millions) | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $11.9 | $9.9 | $41.6 | $36.3 | | G&A Expenses | $4.4 | $4.1 | $16.8 | $15.6 | Net Loss and Per Share Data | Metric | Q4 2023 (in millions) | Q4 2022 (in millions) | Full Year 2023 (in millions) | Full Year 2022 (in millions) | | :--- | :--- | :--- | :--- | :--- | | Net Loss | $15.1 | $13.2 | $53.5 | $50.5 | | Net Loss Per Share ($) | $0.52 | $0.50 | $1.88 | $1.91 | [2024 Financial Guidance](index=4&type=section&id=2024%20Financial%20Guidance) Immuneering projects its current financial resources will fund operations into the second half of 2025 - The company expects its cash runway to be sufficient to fund operations into the second half of **2025**[11](index=11&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) The consolidated financial statements detail Immuneering's financial position, showing a net loss and changes in assets and equity [Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Immuneering's 2023 operations show no revenue, increased expenses, and a net loss of $53.5 million, or $1.88 per share Consolidated Statements of Operations and Comprehensive Loss | (in thousands, except per share data) | Twelve Months Ended Dec 31, 2023 | Twelve Months Ended Dec 31, 2022 | | :--- | :--- | :--- | | Revenue | $0 | $317 | | Total operating expenses | $58,413 | $51,904 | | Loss from operations | ($58,413) | ($51,745) | | Net loss | ($53,472) | ($50,514) | | Net loss per share | ($1.88) | ($1.91) | [Consolidated Balance Sheets](index=7&type=section&id=Consolidated%20Balance%20Sheets) Immuneering's balance sheet as of December 31, 2023, shows decreased total assets and stockholders' equity, primarily due to reduced cash Consolidated Balance Sheets | (in thousands) | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $59,406 | $72,637 | | Marketable securities, current | $26,260 | $32,888 | | Total current assets | $89,084 | $108,747 | | **Total assets** | **$102,585** | **$122,367** | | **Liabilities & Equity** | | | | Total current liabilities | $7,846 | $8,054 | | **Total liabilities** | **$12,008** | **$12,517** | | **Total stockholders' equity** | **$90,576** | **$109,850** |

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________________________ FORM 10-Q _________________________________________________ | | For the quarterly period ended September 30, 2023 | | --- | --- | | x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 or | o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to Comm ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________________________ FORM 10-Q _________________________________________________ | | For the quarterly period ended June 30, 2023 | | --- | --- | | x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 or | o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to Commissio ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________________________ FORM 10-Q _________________________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to Commission File Number: ...