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: ...

Immuneering Corporation (NASDAQ:IMRX) Q4 2022 Earnings Conference Call March 6, 2023 4:30 PM ET Company Participants Laurence Watts - Investor Relations, Gilmartin Group Benjamin Zeskind - President and Chief Executive Officer Brett Hall - Chief Scientific Officer Scott Barrett - Chief Medical Officer Mallory Morales - Vice President of Finance, Treasurer Conference Call Participants Swapnil Malekar - Piper Sandler Jeffrey Hung - Morgan Stanley Mark Breidenbach - Oppenheimer & Co. Inc. Michael Schmidt - Gug ...

Financial Performance - The company has incurred significant net losses for the past several years and expects to continue incurring substantial losses for the foreseeable future[19]. - The company requires substantial additional capital to finance its operations, and failure to raise such capital may lead to delays or reductions in research and drug development programs[19]. Regulatory and Development Challenges - The regulatory approval processes for product candidates are lengthy and unpredictable, which could substantially harm the business if approvals are not obtained[19]. - The company has a limited operating history in developing pharmaceutical products and has not completed any clinical trials, making it difficult to evaluate its current business and predict future success[19]. - The company may encounter substantial delays in completing the development and commercialization of its product candidates[19]. Dependency and Competition - The company is substantially dependent on the successful development of its current and future product candidates, as well as its proprietary technologies such as DCT and Fluency[19]. - The company faces significant competition, and if competitors develop more effective or less expensive products, it could negatively impact commercial opportunities[21]. External Risks - The COVID-19 pandemic and potential future pandemics could adversely impact the company's business, including clinical trials and supply chain[21]. - The company relies on third parties for conducting preclinical studies and clinical trials, and any failure by these parties could harm the business[21]. Commercialization Challenges - The company has never commercialized a product candidate before and may lack the necessary expertise and resources for successful commercialization[19].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 or ☐ 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: 001-40675 Immuneering Corporation (Exact name of registrant as specified in its charter) Delaware 26-1976972 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 or ☐ 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: 001-40675 Immuneering Corporation (Exact name of registrant as specified in its charter) 245 Main St. Second Floor ...

| --- | --- | --- | |--------------|-------|-------| | | | | | | | | | | | | | | | | | Investor | | | | Presentation | | | | | | | | Nasdaq: IMRX | | | | July 2022 | | | | | | | FORWARD-LOOKING STATEMENTS AND OTHER DISCLAIMERS This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including w ...