The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securi ...

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]