Immuneering (IMRX) - 2025 Q2 - Quarterly Results

Executive Summary Key Announcements 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] - 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] - 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] - A Request for End of Phase 2 meeting has been submitted to the FDA, with the pivotal trial expected to initiate in 2026[1] CEO Commentary 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] - The exceptional OS data is generating strong interest from leading pharmaceutical companies and top-tier investors[2] - 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] Corporate Highlights & Business Updates Atebimetinib Clinical Trial Updates 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) 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] - A markedly favorable tolerability profile was observed[3] - The company plans to initiate a pivotal trial in 2026, subject to regulatory feedback[3] Third-Line Pancreatic Cancer (Phase 1 Monotherapy) - A third-line pancreatic cancer patient has received atebimetinib monotherapy for over 18 months and remains on treatment[8] - 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] - Treatment continued to be well tolerated, with a ~16% weight gain observed[8] Intellectual Property & Regulatory Milestones 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][8] - This is the first U.S. patent granted for a deep cyclic inhibitor, designed to drive longer-lasting benefit by outpacing resistance mechanisms[8] - Additional patent applications for atebimetinib are pending, directed to compounds, pharmaceutical compositions, and methods of use, with expiration expected into 2044[8] - An End of Phase 2 meeting request has been submitted to the FDA[1][2] Near-Term Milestone Expectations 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] * Receive regulatory feedback on pivotal study plans in Q4 2025[8] * Initiate pivotal, randomized trial of atebimetinib in combination with mGnP in first-line pancreatic cancer in 2026[8] * Initiate additional atebimetinib clinical trial combination arms in 2026[8] Financial Results (Second Quarter 2025) Financial Highlights 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 Cash and Cash Equivalents | Metric | June 30, 2025 | December 31, 2024 | Change | | :----- | :------------ | :---------------- | :----- | | Amount | $26.4 million | $36.1 million | -$9.7 million | Operating Expenses 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] - G&A expenses for Q2 2025 were consistent with the comparable prior period[6] Net Loss 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 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] About Immuneering Corporation Company Overview 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] - The Company's lead product candidate, atebimetinib (IMM-1-104), is an oral, once-daily deep cyclic inhibitor of MEK[9] - Atebimetinib is designed to improve durability and tolerability, and expand indications to include MAPK pathway-driven tumors such as most pancreatic cancers[9] - 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] Forward-Looking Statements & Risks Forward-Looking Statements 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] - 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] - 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] Contact Information Contact Details Provides contact details for media and investor inquiries - Media Contact: Gina Nugent (Gina.nugent.external@immuneering.com)[13] - Investor Contact: Laurence Watts (619-916-7620, laurence@newstreetir.com)[13] Financial Statements Condensed Consolidated Statements of Operations and Comprehensive Loss 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 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 |