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 ...

Exhibit 99.1 Immuneering Reports Second Quarter 2025 Financial Results and Provides Business Updates - Company now plans to share updated OS and PFS data from first-line pancreatic cancer patients (N = 34) treated with atebimetinib + mGnP in Q3 2025, earlier than prior guidance - - Exceptional 94% overall survival (OS) observed at 6 months in ongoing Phase 2a trial of atebimetinib plus modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (N = 34) - - Newly issued U.S. composit ...

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.

Clinical Trial Results of Atebimetinib - Atebimetinib + mGnP in first-line pancreatic cancer (1L PDAC) showed a 6-month Overall Survival (OS) of 94% in a Phase 2a trial (N=34)[18, 21] - The same combination also demonstrated a 6-month Progression-Free Survival (PFS) of 72%[24, 27] - The Overall Response Rate (ORR) for Atebimetinib + mGnP in 1L PDAC was 39% (14/36), and the Disease Control Rate (DCR) was 81% (29/36)[30] - Grade ≥ 3 Neutropenia adverse event incidence was 15%, Fatigue was 3%, Diarrhea was 0%, Sensory Neuropathy was 0%, Leukopenia was 0%, Vomiting was 3%, Febrile Neutropenia was 0%, Thrombocytopenia was 0%, Anemia was 18%, Hypokalemia was 3%, Nausea was 0%[35] Patient Characteristics - The median age of patients in the Atebimetinib + mGnP Phase 2a trial was 69 years, with 65% of patients being 65 years or older[37] Mechanism and Rationale - Atebimetinib targets the MAPK pathway with Deep Cyclic Inhibition (DCI) to improve durability and tolerability[71, 81] - Approximately 97% of pancreatic cancers are driven by the MAPK pathway[70] Future Plans - The company plans to initiate a pivotal study in 2026 for atebimetinib in 1L pancreatic cancer[81]

Summary of Immuneering (IMRX) Conference Call Company Overview - **Company**: Immuneering Corporation (IMRX) - **Focus**: Development of cancer therapies aimed at making cancer a chronic disease rather than a fatal one [3][4][5] Core Industry Insights - **Industry**: Oncology, specifically targeting pancreatic cancer and the MAP kinase pathway [19][20] - **Current Challenges**: Traditional cancer therapies often focus on rapid tumor destruction, leading to resistance and poor patient quality of life [4][6][7][8] Key Points and Arguments 1. **Long-term Goals**: Immuneering aims to help cancer patients live longer by making cancer manageable, similar to chronic diseases like diabetes [3][5] 2. **Durability and Tolerability**: The company emphasizes the importance of both durability (maximizing overall survival) and tolerability (minimizing adverse events) in cancer treatment [5][6][29] 3. **Innovative Approach**: Immuneering's strategy involves "deep cyclic inhibition," which allows for a more adaptable treatment that outpaces cancer's ability to develop resistance [16][19][35] 4. **Lead Program - IMM114**: Currently in phase 2A trials, IMM114 targets the MEK in the MAP kinase pathway, showing promising results in combination with modified gemcitabine NAB paclitaxel for pancreatic cancer [19][49] 5. **Clinical Data**: Early clinical data indicates that patients treated with IMM114 have experienced significant improvements in quality of life and tumor reduction, with one patient showing a 28% tumor reduction over 13 months [24][26][50] 6. **Survival Rates**: The standard of care for first-line pancreatic cancer shows a dismal six-month survival rate of 67% to 76%, highlighting the urgent need for better therapies [49][54] 7. **Combination Therapy**: The combination of IMM114 with chemotherapy has shown a disease control rate of 86%, indicating potential for improved efficacy [52][54] 8. **Future Plans**: Immuneering is planning a global randomized pivotal trial for IMM114 in first-line pancreatic cancer, with potential applications across various cancer types due to the broad applicability of the MAP kinase pathway [57][58] Additional Important Insights - **Patient-Centric Focus**: The company aims to improve not just survival but also the quality of life for patients, with a focus on tolerability that allows patients to maintain their normal lives [40][41][29] - **Potential for Broader Applications**: While the initial focus is on pancreatic cancer, the MAP kinase pathway's involvement in many cancers suggests that IMM114 could have wide-ranging applications [57] - **Collaboration with Regeneron**: Immuneering has announced a partnership with Regeneron to explore the use of IMM114 in combination with their anti-PD-1 therapy in lung cancer [42][57] This summary encapsulates the key points discussed during the Immuneering conference call, highlighting the company's innovative approach to cancer treatment and its commitment to improving patient outcomes.

Financial Performance - Net loss for the three months ended March 31, 2025, was $15.05 million, compared to a net loss of $14.31 million for the same period in 2024, representing an increase in loss of about 5.16%[21]. - The company reported a net loss of $15.046 million for the three months ended March 31, 2025, compared to a net loss of $14.307 million for the same period in 2024, representing an increase in loss of 5.2%[129]. - The company incurred net losses of approximately $15.0 million for the three months ended March 31, 2025, and $61.0 million for the year ended December 31, 2024, with an accumulated deficit of approximately $239.3 million as of March 31, 2025[167]. - The company expects to continue incurring significant losses for the foreseeable future, with fluctuations in net losses from quarter to quarter[168]. - Management expects to continue generating operating losses and will require additional funding through various means to sustain operations[36]. Cash and Liquidity - Cash and cash equivalents decreased from $36.14 million at the end of 2024 to $35.87 million by March 31, 2025, a reduction of about 0.76%[25]. - As of March 31, 2025, the Company had cash equivalents of $35,577,746, down from $35,865,754 as of December 31, 2024[55][57]. - The company expects existing cash and cash equivalents to fund operations into 2026, but there is substantial doubt about its ability to continue as a going concern for at least one year from the issuance date of the financial statements[140][142]. - The company anticipates needing substantial additional capital to finance operations and product development, with existing cash resources insufficient to fund all necessary activities[174]. - The company plans to raise additional capital through equity or debt financings and strategic partnerships to mitigate risks associated with ongoing operating losses[150]. Shareholder Equity and Stock Activity - Total stockholders' equity increased from $41.39 million on December 31, 2024, to $41.84 million on March 31, 2025, a rise of approximately 1.08%[19]. - The weighted-average common shares outstanding increased from 29.37 million in Q1 2024 to 35.53 million in Q1 2025, an increase of about 20.94%[21]. - The Company completed a follow-on equity offering, issuing 2,727,273 shares at $11.00 per share, raising net proceeds of $28,200,003[33]. - The Company sold 4,836,804 shares of Class A common stock through its ATM Program at an average price of $2.95, generating gross proceeds of $14.2 million during the three months ended March 31, 2025[64]. - The Company had 35,985,702 shares of Class A common stock issued and outstanding as of March 31, 2025, an increase from 31,050,448 shares as of December 31, 2024[60]. Research and Development - Research and development expenses for Q1 2025 were $11.47 million, compared to $11.20 million in Q1 2024, reflecting an increase of approximately 2.41%[21]. - Research and development expenses increased by approximately $0.3 million, or 2.4%, to approximately $11.5 million for the three months ended March 31, 2025, compared to approximately $11.2 million for the same period in 2024[130]. - Research and development expenses for the three months ended March 31, 2025, included $4,257,936 for IMM-1-104 and $1,623,755 for IMM-6-415[92]. - The company expects research and development expenses to substantially increase as it continues to advance product candidates through clinical development and seeks regulatory approvals[121]. - The company plans to expand research and development activities and establish a sales and marketing infrastructure for future product commercialization[170]. Clinical Trials and Product Development - The company’s lead product candidate, IMM-1-104, is currently in a Phase 1/2a clinical trial targeting patients with advanced solid tumors harboring RAS or RAF mutations[27]. - The ongoing Phase 1/2a clinical trial of IMM-1-104 for advanced solid tumors is a key focus, but the company has not yet demonstrated the ability to complete clinical trials successfully[165][166]. - The company plans to initiate additional Phase 2a combination arms for IMM-1-104 following positive interim data[100]. - The FDA cleared the IND application for IMM-6-415 in December 2023, with dosing commenced in March 2024[101]. - The company has not yet generated any revenue from product sales and has no products approved for commercial sale, which complicates future success predictions[165]. Going Concern and Financial Risks - There is substantial doubt about the company's ability to continue as a going concern for the next year due to recurring losses and the need for additional capital[111]. - The company has identified conditions raising substantial doubt about its ability to continue as a going concern for at least one year from the issuance of its financial statements, with only $35.9 million in cash and cash equivalents as of March 31, 2025[172]. - The company has concluded that there is substantial doubt about its ability to continue as a going concern, necessitating significant reductions in spending if adequate funding is not secured[150]. - The company may face significant dilution of stockholder ownership if additional capital is raised through equity offerings or other means[181]. - The lengthy regulatory approval process and unpredictability of clinical trial results may significantly harm the company's business and prospects[185]. Regulatory and Market Challenges - The regulatory approval processes for the company's product candidates are lengthy and unpredictable, with no current approvals obtained[183]. - Delays in clinical trials can arise from disagreements with regulatory authorities regarding trial design and implementation[192]. - Regulatory authorities may impose additional requirements or restrictions that could delay marketing approval or limit product indications[200]. - The outcome of preclinical studies and early clinical trials may not predict success in later trials, leading to potential failures[201]. - Adverse events or side effects associated with product candidates could inhibit regulatory approval and market acceptance, significantly harming business prospects[208].

Financial Performance - Cash and cash equivalents as of March 31, 2025, were $35.9 million, a slight decrease from $36.1 million as of December 31, 2024[6]. - Net loss attributable to common stockholders for Q1 2025 was $15.0 million, or $0.42 per share, compared to a net loss of $14.3 million, or $0.49 per share, in Q1 2024[8]. - General and Administrative (G&A) expenses for Q1 2025 were $4.0 million, down from $4.1 million in Q1 2024, reflecting a decrease in employee-related costs[7]. - Research and Development (R&D) expenses for Q1 2025 were $11.5 million, up from $11.2 million in Q1 2024, primarily due to higher clinical costs[6]. - The weighted-average common shares outstanding increased to 35,529,652 in Q1 2025 from 29,370,357 in Q1 2024[8]. Clinical Trials and Developments - The company announced positive data from the ongoing Phase 2a trial of IMM-1-104, including a patient with over 13 months of progression-free survival[3]. - A clinical trial supply agreement was established with Regeneron Pharmaceuticals to evaluate IMM-1-104 in combination with Libtayo® in non-small cell lung cancer[1]. - The company plans to initiate a Phase 3 trial of IMM-1-104 in first-line pancreatic cancer in 2026[10]. - The company reported a 91% reduction in peak CA 19-9 levels for a pancreatic cancer patient on IMM-1-104 monotherapy[5]. Cash Flow and Funding - The cash runway has been extended into 2026, ensuring sufficient funding for operations[9].

Core Insights - Immuneering Corporation reported positive data from its ongoing Phase 2a trial of IMM-1-104, showing encouraging responses in pancreatic cancer treatment [1][3] - The company has extended its cash runway into 2026, ensuring sufficient funding for ongoing operations [1][8] - Dr. Igor Matushansky has been appointed as Chief Medical Officer to lead clinical efforts, particularly for the upcoming Phase 3 trial in first-line pancreatic cancer [1][5] Clinical Developments - The Phase 2a trial of IMM-1-104 has shown exceptional efficacy, with a third-line monotherapy patient achieving over 13 months of progression-free survival and a first-line combination therapy patient achieving a complete response [3][5] - A clinical trial supply agreement has been established with Regeneron Pharmaceuticals to evaluate IMM-1-104 in combination with Libtayo® for non-small cell lung cancer [1][4] Financial Performance - As of March 31, 2025, the company reported cash and cash equivalents of $35.9 million, a slight decrease from $36.1 million at the end of 2024 [11] - Research and Development (R&D) expenses for Q1 2025 were $11.5 million, up from $11.2 million in Q1 2024, primarily due to increased clinical costs [11] - The net loss for Q1 2025 was $15.0 million, or $0.42 per share, compared to a net loss of $14.3 million, or $0.49 per share, in Q1 2024 [11][16]