Core Insights - Immuneering Corporation plans to announce updated overall survival data for first-line pancreatic cancer patients treated with atebimetinib + mGnP on September 25, 2025, following a 9-month median follow-up [1][3][6] - The company has reported a 94% overall survival (OS) rate at 6 months for patients treated with atebimetinib + mGnP, compared to 67% OS for standard care, which drops to approximately 47% by 9 months [3][6] - Immuneering is developing a new category of cancer medicines called Deep Cyclic Inhibitors, with atebimetinib being the lead candidate currently in a Phase 2a trial [4][6] Company Plans and Presentations - An investor call is scheduled for 8 a.m. ET on September 25, 2025, to discuss the updated data [1][6] - Immuneering will present a poster on "Atebimetinib + mGnP: Overall Survival and Safety in First Line Pancreatic Cancer Patients" at the PanCAN Scientific Summit on September 28, 2025 [6] - The company will also present preclinical data on Deep Cyclic Inhibitors at the 7th RAS-Targeted Drug Development Summit on September 17, 2025 [5][6]

Core Viewpoint - Immuneering Corporation has successfully closed a private placement, raising approximately $25 million from institutional and accredited investors, aimed at advancing its oncology drug development efforts [1][2]. Group 1: Private Placement Details - The private placement involved the sale of 6,329,113 unregistered shares of Class A common stock at a price of $3.95 per share, along with purchase warrants for an additional 2,848,096 shares at an exercise price of $5.50 per share [2]. - The pre-funded warrants were issued at a price of $3.949 per share, reflecting the common stock price minus a nominal exercise price [2]. - Investors received registration rights as part of the transaction, and the purchase warrants are exercisable for five years post-registration [2]. Group 2: Company Overview - Immuneering is a clinical-stage oncology company focused on developing Deep Cyclic Inhibitors, with its lead product candidate, atebimetinib (IMM-1-104), currently in a Phase 2a trial for advanced solid tumors, including pancreatic cancer [5]. - The company aims to improve the durability and tolerability of cancer treatments and expand indications for MAPK pathway-driven tumors [5].

Core Insights - Immuneering Corporation (IMRX) has entered into a clinical supply agreement with Eli Lilly (LLY) for the KRAS G12C inhibitor, olomorasib (LY3537982) [1] - The agreement supports a planned phase II study evaluating Immuneering's atebimetinib (IMM-1-104) in combination with olomorasib for treating advanced KRAS G12C-mutant non-small cell lung cancer (NSCLC) [2] - Immuneering's shares rose by 21.7% following the announcement, and the stock has increased by 170.5% year-to-date compared to the industry's 4.1% rise [2][3] Agreement Details - The combination of atebimetinib and olomorasib is expected to provide a vertical blockade of the RAS-MAPK pathway, with preclinical data showing enhanced tumor regression and prolonged survival compared to monotherapy [5] - This is Immuneering's second collaboration announcement in 2025, following a similar agreement with Regeneron Pharmaceuticals to evaluate atebimetinib with Libtayo for advanced NSCLC [6][7] - In both agreements, Immuneering retains full worldwide development and commercialization rights to atebimetinib [8] Ongoing Studies - Immuneering is advancing atebimetinib in other cancer studies, including a phase IIa study in combination with modified gemcitabine/nab-paclitaxel for first-line pancreatic cancer [9] - Preliminary data from this study indicated a 94% overall survival and 72% progression-free survival at six months, with updated data expected later in Q3 2025 [10] - The company plans to initiate a pivotal study for atebimetinib in combination with modified gemcitabine/nab-paclitaxel in 2026, pending regulatory feedback [11]

Core Viewpoint - Immuneering Corporation has announced a clinical supply agreement with Eli Lilly for the evaluation of atebimetinib in combination with olomorasib in a Phase 2 trial targeting advanced non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations [1][2] Group 1: Clinical Development - The agreement supports the evaluation of Immuneering's lead product candidate, atebimetinib, a novel dual MEK inhibitor, in combination with olomorasib [1] - Immuneering is also evaluating atebimetinib in combination with Regeneron's anti-PD-1 therapy Libtayo in advanced NSCLC patients [1] - The combination aims to provide a vertical blockade of the RAS-MAPK pathway, potentially improving treatment outcomes in patients with limited options [3] Group 2: Product and Pipeline - Immuneering maintains global development and commercialization rights to atebimetinib [4] - The company is developing Deep Cyclic Inhibitors, with atebimetinib designed to improve durability and tolerability for MAPK pathway-driven tumors [5] - Atebimetinib is currently in a Phase 2a trial for advanced solid tumors, including pancreatic cancer [5]

Core Insights - Immuneering Corporation has entered into a definitive securities purchase agreement for a private placement expected to yield approximately $25 million in gross proceeds before fees and expenses [1] - The company is focused on developing a new category of cancer medicines called Deep Cyclic Inhibitors, with its lead product candidate, atebimetinib, currently in a Phase 2a trial for pancreatic cancer [2][5] - The recent data from the Phase 2a trial shows a 94% overall survival rate at 6 months for patients treated with atebimetinib in combination with mGnP, significantly higher than the 67% observed in the standard of care [2] Financing Details - The private placement involves the sale of 6,329,113 unregistered shares of Class A common stock at a price of $3.95 per share, representing a 15% premium over the last reported closing price [2] - Investors will also receive purchase warrants for an aggregate of 2,848,096 shares at an exercise price of $5.50 per share, with a five-year exercisability period following registration for resale [2] Company Overview - Immuneering is a clinical-stage oncology company dedicated to improving the survival of cancer patients through innovative treatments [5] - The company is developing atebimetinib as an oral, once-daily treatment aimed at enhancing durability and tolerability for MAPK pathway-driven tumors, including pancreatic cancers [5]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________________________ FORM 10-Q _________________________________________________ | | For the quarterly period ended June 30, 2025 | | --- | --- | | 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 ...

[Executive Summary](index=1&type=section&id=Executive%20Summary) [Key Announcements](index=1&type=section&id=Key%20Announcements) Immuneering Corporation reported Q2 2025 financial results and provided significant business updates, including exceptional 6-month overall survival data for atebimetinib in first-line pancreatic cancer, a new U.S. composition of matter patent, and plans for a pivotal trial - Updated OS and PFS data from first-line pancreatic cancer patients (N=34) treated with atebimetinib + mGnP will be shared in Q3 2025, earlier than previously guided[1](index=1&type=chunk) - Exceptional **94% overall survival (OS)** observed at 6 months in the ongoing Phase 2a trial of atebimetinib plus modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (N=34)[1](index=1&type=chunk) - A newly issued U.S. composition of matter patent for atebimetinib is expected to provide exclusivity into **2042**, with potential for patent term extension[1](index=1&type=chunk) - A Request for End of Phase 2 meeting has been submitted to the FDA, with the pivotal trial expected to initiate in **2026**[1](index=1&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) The CEO highlighted the exceptional 6-month OS data for atebimetinib in first-line pancreatic cancer, noting strong interest from pharmaceutical companies and investors, and emphasized the importance of the new patent for maximizing therapeutic potential across multiple indications - The **6-month OS of 94%** for atebimetinib + mGnP in first-line pancreatic cancer compares favorably to the **67% OS** in the pivotal study of standard of care GnP, which dropped to **50% by 8.5 months**[2](index=2&type=chunk) - The exceptional OS data is generating strong interest from leading pharmaceutical companies and top-tier investors[2](index=2&type=chunk) - The granting of the composition of matter patent for atebimetinib is a significant milestone, expected to support efforts to maximize its therapeutic potential across multiple indications[2](index=2&type=chunk) [Corporate Highlights & Business Updates](index=1&type=section&id=Corporate%20Highlights) [Atebimetinib Clinical Trial Updates](index=1&type=section&id=Atebimetinib%20Clinical%20Trial%20Updates) Immuneering reported positive data from its Phase 2a trial in first-line pancreatic cancer, showing high OS and PFS at 6 months, and provided an update on a long-term responder in the Phase 1 trial for third-line pancreatic cancer [First-Line Pancreatic Cancer (Phase 2a)](index=1&type=section&id=First-Line%20Pancreatic%20Cancer%20(Phase%202a)) Phase 2a Trial Results (Atebimetinib + mGnP in First-Line Pancreatic Cancer at 6 months) | Metric | Value | | :----- | :---- | | OS | 94% | | PFS | 72% | - Median OS and PFS have not yet been reached[3](index=3&type=chunk) - A markedly favorable tolerability profile was observed[3](index=3&type=chunk) - The company plans to initiate a pivotal trial in **2026**, subject to regulatory feedback[3](index=3&type=chunk) [Third-Line Pancreatic Cancer (Phase 1 Monotherapy)](index=2&type=section&id=Third-Line%20Pancreatic%20Cancer%20(Phase%201%20Monotherapy)) - A third-line pancreatic cancer patient has received atebimetinib monotherapy for over **18 months** and remains on treatment[8](index=8&type=chunk) - The patient maintained a partial response, including a **34% reduction** in target lesions (RECIST sum of longest diameters) and a **96% reduction** in peak CA 19-9 levels[8](index=8&type=chunk) - Treatment continued to be well tolerated, with a **~16% weight gain** observed[8](index=8&type=chunk) [Intellectual Property & Regulatory Milestones](index=1&type=section&id=Intellectual%20Property%20%26%20Regulatory%20Milestones) Immuneering secured a key U.S. composition of matter patent for atebimetinib, extending exclusivity into 2042, and has submitted an End of Phase 2 meeting request to the FDA, signaling progress towards a pivotal trial - A U.S. composition of matter patent for atebimetinib was granted in July, providing exclusivity into **2042**, with potential for patent term extension[1](index=1&type=chunk)[8](index=8&type=chunk) - This is the first U.S. patent granted for a deep cyclic inhibitor, designed to drive longer-lasting benefit by outpacing resistance mechanisms[8](index=8&type=chunk) - Additional patent applications for atebimetinib are pending, directed to compounds, pharmaceutical compositions, and methods of use, with expiration expected into **2044**[8](index=8&type=chunk) - An End of Phase 2 meeting request has been submitted to the FDA[1](index=1&type=chunk)[2](index=2&type=chunk) [Near-Term Milestone Expectations](index=2&type=section&id=Near-Term%20Milestone%20Expectations) Immuneering anticipates several key milestones for atebimetinib, including sharing updated clinical data in Q3 2025, receiving regulatory feedback in Q4 2025, and initiating a pivotal trial and additional combination arms in 2026 - Upcoming milestones include: * Announce updated OS and PFS data from first-line pancreatic cancer patients (n=34) treated with atebimetinib + mGnP in **Q3 2025**[8](index=8&type=chunk) * Receive regulatory feedback on pivotal study plans in **Q4 2025**[8](index=8&type=chunk) * Initiate pivotal, randomized trial of atebimetinib in combination with mGnP in first-line pancreatic cancer in **2026**[8](index=8&type=chunk) * Initiate additional atebimetinib clinical trial combination arms in **2026**[8](index=8&type=chunk) [Financial Results (Second Quarter 2025)](index=2&type=section&id=Financial%20Results%20(Second%20Quarter%202025)) [Financial Highlights](index=2&type=section&id=Financial%20Highlights) Immuneering reported a decrease in cash and cash equivalents, a slight decrease in R&D expenses, consistent G&A expenses, and an increased net loss for Q2 2025 compared to the prior year [Cash Position](index=2&type=section&id=Cash%20Position) Cash and Cash Equivalents | Metric | June 30, 2025 | December 31, 2024 | Change | | :----- | :------------ | :---------------- | :----- | | Amount | $26.4 million | $36.1 million | -$9.7 million | [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Operating Expenses (Three Months Ended June 30) | Expense Type | 2025 (USD) | 2024 (USD) | Change (YoY, USD) | | :----------- | :------------ | :------------ | :---------------- | | R&D Expenses | $10.5 million | $10.7 million | -$0.2 million | | G&A Expenses | $4.3 million | $4.3 million | $0 million | - The decrease in R&D expenses was primarily attributable to decreases in spend for preclinical programs, the IMM-6-415 program, and personnel costs, offset by higher clinical costs related to the atebimetinib program[5](index=5&type=chunk) - G&A expenses for Q2 2025 were consistent with the comparable prior period[6](index=6&type=chunk) [Net Loss](index=2&type=section&id=Net%20Loss) Net Loss (Three Months Ended June 30) | Metric | 2025 (USD) | 2024 (USD) | Change (YoY, USD) | | :----- | :------------ | :------------ | :---------------- | | Net Loss | $14.4 million | $14.1 million | +$0.3 million | | EPS | $0.40 | $0.47 | -$0.07 | [2025 Financial Guidance](index=2&type=section&id=2025%20Financial%20Guidance) Based on current cash and operating plans, Immuneering expects its cash runway to be sufficient to fund operations into 2026 - Cash and cash equivalents as of June 30, 2025, are expected to fund operations into **2026**[7](index=7&type=chunk) [About Immuneering Corporation](index=3&type=section&id=About%20Immuneering%20Corporation) [Company Overview](index=3&type=section&id=Company%20Overview) Immuneering is a clinical-stage oncology company focused on developing treatments that outpace cancer. Its lead candidate, atebimetinib, is an oral MEK inhibitor in Phase 2a for advanced solid tumors, including pancreatic cancer, with early-stage programs also in its pipeline - Immuneering is a clinical-stage oncology company focused on outpacing cancer to help patients outlive their disease[9](index=9&type=chunk) - The Company's lead product candidate, atebimetinib (IMM-1-104), is an oral, once-daily deep cyclic inhibitor of MEK[9](index=9&type=chunk) - Atebimetinib is designed to improve durability and tolerability, and expand indications to include MAPK pathway-driven tumors such as most pancreatic cancers[9](index=9&type=chunk) - Atebimetinib is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer, and the Company's development pipeline also includes early-stage programs[9](index=9&type=chunk) [Forward-Looking Statements & Risks](index=3&type=section&id=Forward-Looking%20Statements%20%26%20Risks) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements regarding product development, clinical trials, regulatory approvals, intellectual property, and financial outlook, along with a disclaimer outlining inherent risks and uncertainties that could cause actual results to differ materially - Statements include plans for product candidate development, treatment potential of atebimetinib, timing of clinical trials and regulatory feedback, cash runway expectations, and patent expiration[10](index=10&type=chunk) - These statements are subject to known and unknown risks, uncertainties, and other important factors, including those inherent in oncology drug R&D, funding needs, regulatory processes, reliance on third parties, competition, and intellectual property protection[11](index=11&type=chunk) - Readers are cautioned not to rely on these statements as representing views beyond the press release date, and the company disclaims any obligation to update them, except as required by law[12](index=12&type=chunk) [Contact Information](index=4&type=section&id=Contact%20Information) [Contact Details](index=4&type=section&id=Contact%20Details) Provides contact details for media and investor inquiries - Media Contact: Gina Nugent (Gina.nugent.external@immuneering.com)[13](index=13&type=chunk) - Investor Contact: Laurence Watts (619-916-7620, laurence@newstreetir.com)[13](index=13&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) This statement presents the company's revenues, expenses, and net loss for the three and six months ended June 30, 2025, and 2024, showing an increase in net loss for both periods Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) | Metric | Three Months Ended June 30, 2025 (USD) | Three Months Ended June 30, 2024 (USD) | Six Months Ended June 30, 2025 (USD) | Six Months Ended June 30, 2024 (USD) | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $10,454,160 | $10,651,958 | $21,925,852 | $21,854,372 | | General and administrative | $4,296,417 | $4,254,473 | $8,302,059 | $8,370,493 | | Total operating expenses | $14,757,894 | $14,913,748 | $30,242,544 | $30,239,498 | | Net loss | $(14,433,881) | $(14,079,927) | $(29,480,012) | $(28,387,756) | | Net loss per share (basic and diluted)| $(0.40) | $(0.47) | $(0.82) | $(0.96) | | Weighted-average common shares outstanding | 35,985,878 | 29,653,355 | 35,759,026 | 29,511,856 | [Condensed Consolidated Balance Sheets](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) This statement provides a snapshot of the company's assets, liabilities, and stockholders' equity as of June 30, 2025, and December 31, 2024, indicating a decrease in total assets and stockholders' equity Condensed Consolidated Balance Sheets (Unaudited) | Metric | June 30, 2025 (USD) | December 31, 2024 (USD) | | :------------------------------------ | :------------ | :---------------- | | Cash and cash equivalents | $26,355,498 | $36,144,720 | | Total current assets | $27,725,426 | $39,587,569 | | Total assets | $40,056,468 | $52,714,413 | | Total current liabilities | $7,486,830 | $7,503,768 | | Total liabilities | $11,120,431 | $11,328,187 | | Total stockholders' equity | $28,936,037 | $41,386,226 |

Core Viewpoint - Immuneering Corporation is advancing its clinical-stage oncology product, atebimetinib, showing promising overall survival (OS) and progression-free survival (PFS) data in first-line pancreatic cancer patients, with plans for a pivotal trial in 2026 [1][2][5]. Financial Highlights - As of June 30, 2025, the company reported cash and cash equivalents of $26.4 million, down from $36.1 million at the end of 2024 [6]. - Research and development (R&D) expenses for Q2 2025 were $10.5 million, slightly lower than $10.7 million in Q2 2024 [7]. - General and administrative (G&A) expenses remained stable at $4.3 million for both Q2 2025 and Q2 2024 [8]. - The net loss for Q2 2025 was $14.4 million, or $0.40 per share, compared to a net loss of $14.1 million, or $0.47 per share, in Q2 2024 [8][16]. Clinical Development Updates - The ongoing Phase 2a trial of atebimetinib in combination with modified Gemcitabine/nab-paclitaxel (mGnP) has shown a 94% OS at 6 months in first-line pancreatic cancer patients (N = 34) [4][5]. - The company plans to share updated OS and PFS data from the trial in Q3 2025, earlier than previously indicated [4]. - A composition of matter patent for atebimetinib was granted, expected to provide exclusivity until 2042, with potential extensions [4][5]. Future Milestones - Immuneering aims to initiate a pivotal, randomized trial of atebimetinib in combination with mGnP in first-line pancreatic cancer in 2026 [12]. - The company is preparing for regulatory feedback on pivotal study plans in Q4 2025 [12]. Patient Outcomes - A pancreatic cancer patient in the third-line setting has been on atebimetinib monotherapy for over 18 months, showing a 34% reduction in target lesions and a 96% reduction in peak CA 19-9 levels [5].

Core Insights - Immuneering has received a composition of matter patent for atebimetinib, a deep cyclic inhibitor of MEK, which is crucial in cancer signaling pathways [1][3][5] - The Phase 2a study shows that first-line pancreatic cancer patients treated with atebimetinib plus chemotherapy have a 94% probability of surviving 6 months, significantly higher than the 67% survival rate with standard chemotherapy [2] - The patent for atebimetinib is expected to provide exclusivity until August 2042, with potential for extension, supporting the company's strategy to maximize its therapeutic potential across various cancers [3][5][8] Company Overview - Immuneering is a clinical-stage oncology company focused on developing therapies that improve patient outcomes and quality of life [6] - The lead product candidate, atebimetinib, is designed to enhance durability and tolerability in treating MAPK pathway-driven tumors, including pancreatic cancer [6] - The company plans to explore atebimetinib in combination with other therapies for various cancer types [5][9] Intellectual Property Strategy - The granted patent validates the innovative approach of Immuneering and secures key intellectual property for atebimetinib [5] - Additional patent applications are pending, with expiration expected into 2044, further strengthening the company's intellectual property portfolio [8]

Immuneering Conference Call Summary Company and Industry - **Company**: Immuneering - **Industry**: Oncology, specifically focused on pancreatic cancer treatment Core Points and Arguments 1. **Goal of Treatment**: Immuneering aims to help cancer patients live longer, with a focus on controlling cancer as a chronic condition rather than solely curing it [4][5][6] 2. **Focus on Durability and Tolerability**: The company prioritizes durability (long-term survival) and tolerability (minimizing side effects) in its treatment approach [7][9][10] 3. **Atebimetinib**: The drug, an oral MEK inhibitor, is being tested in a Phase IIa trial for first-line pancreatic cancer, showing promising results in terms of durability and tolerability [12][13] 4. **Patient Population**: The trial focuses on first-line pancreatic cancer patients, where the need for effective treatments is critical due to high mortality rates [14] 5. **Survival Rates**: The median overall survival has not yet been reached, with a reported 94% overall survival at six months for patients treated with atebimetinib plus modified gemcitabine and nab-paclitaxel [15][17] 6. **Comparison to Standard Care**: The standard care for pancreatic cancer (gemcitabine and nab-paclitaxel) has a six-month survival rate of only 67%, highlighting the effectiveness of atebimetinib [16][17] 7. **Progression-Free Survival**: The study reports a 72% progression-free survival at six months, significantly higher than the 43% benchmark for standard care [27][28] 8. **Response Rates**: The overall response rate for the treatment is 39%, compared to 23% for standard care, with a disease control rate of 81% [29][30] 9. **Adverse Events**: The treatment has shown a favorable safety profile, with zero grade three or higher adverse events in six out of eleven categories compared to standard therapies [36][37] 10. **Patient Quality of Life**: The tolerability of the treatment is linked to improved quality of life, with patients experiencing fewer side effects and even weight gain [84][90] Additional Important Content 1. **Mechanism of Action**: Immuneering's approach involves deep cyclic inhibition of the MAP kinase pathway, allowing for better control of tumor growth and reduced resistance development [60][66] 2. **Future Plans**: The company plans to initiate a pivotal study in 2026 to further evaluate the efficacy of atebimetinib in combination with standard care [58][79] 3. **Broader Applicability**: While the current focus is on pancreatic cancer, the MAP kinase pathway's relevance extends to other cancers, indicating potential for future treatments in various oncology settings [72][77] 4. **Competitive Landscape**: Immuneering positions itself as a leader in first-line pancreatic cancer treatment, emphasizing its unique combination approach and superior tolerability compared to competitors [102][106] This summary encapsulates the key points discussed during the Immuneering conference call, highlighting the company's innovative approach to treating pancreatic cancer and its promising clinical results.