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]

Financial Performance - Net loss for the six months ended June 30, 2025, was $29.48 million, compared to a net loss of $28.39 million for the same period in 2024, indicating an increase in loss of about 3.8%[21] - The Company incurred a net loss of $29.5 million for the six months ended June 30, 2025, with an accumulated deficit of $253.8 million as of the same date[36] - The company reported a net loss of approximately $29.5 million for the six months ended June 30, 2025, and approximately $61.0 million for the year ended December 31, 2024[109] - The company recognized a net loss of $14,433,881 for the three months ended June 30, 2025, compared to a net loss of $14,079,927 for the same period in 2024[92] - The basic and diluted net loss per share for the three months ended June 30, 2025, was $(0.40), compared to $(0.47) for the same period in 2024, reflecting a 14.9% improvement[67] - The company expects to continue incurring significant net losses for the foreseeable future, with no revenue generated from product sales to date[176] Cash and Liquidity - Cash and cash equivalents decreased from $36.14 million at the beginning of the period to $26.36 million at the end of the period, a reduction of approximately 27%[26] - As of June 30, 2025, the Company had approximately $26.1 million in cash equivalents, down from $35.9 million as of December 31, 2024[56][59] - As of June 30, 2025, the company had approximately $26.4 million in cash and cash equivalents[109] - Existing cash and cash equivalents as of June 30, 2025, are expected to fund development activities into 2026, but additional capital will be needed thereafter[148] - The company anticipates that its existing cash and cash equivalents will fund operations into 2026, but significant reductions in spending may be necessary if additional funding is not secured[158] - As of June 30, 2025, the company had $26.4 million in cash and cash equivalents, which may not be sufficient to support operations for at least one year from the issuance of the financial statements[181] Share Issuance and Capital Raising - The company issued 4,836,804 shares of common stock under an at-the-market offering, raising approximately $13.67 million net of issuance costs[23] - The Company completed an underwritten follow-on equity offering on April 20, 2023, raising net proceeds of $28.2 million from the sale of 2,727,273 shares at an offering price of $11.00 per share[34] - The company sold 4,836,804 shares under its ATM Program at an average price of $2.95, generating gross proceeds of $14.2 million during the six months ended June 30, 2025[33] - The company sold 4,836,804 shares of common stock under the ATM Program for aggregate gross proceeds of $14.2 million during the six months ended June 30, 2025[145] - The company may need to raise additional capital through public or private equity offerings, which could dilute existing stockholders[187] Research and Development - The company is developing its lead product candidate, atebimetinib, which is currently in a Phase 1/2a clinical trial targeting advanced solid tumors with RAS or RAF mutations[28] - Research and development expenses for the three months ended June 30, 2025, were $10.45 million, slightly down from $10.65 million in the same period of 2024, a decrease of about 1.8%[21] - Research and development expenses for the six months ended June 30, 2025, increased by approximately $0.1 million, or 0.3%, to approximately $21.9 million compared to the same period in 2024[137] - Direct research and development expenses for atebimetinib (IMM-1-104) increased by $1.4 million, or 35.8%, to $5.2 million for the three months ended June 30, 2025[131] - The company plans to initiate a registrational trial for atebimetinib in combination with mGnP in first-line pancreatic cancer in 2026, pending regulatory feedback[102] Regulatory and Clinical Trials - The FDA cleared the IND application for the product candidate IMM-6-415 in December 2023, with dosing commencing in a Phase 1/2a clinical trial in March 2024[103] - The company paused further patient enrollment in the IMM-6-415 trial in February 2025 to evaluate data from the 120 mg dose level[104] - The company is conducting an ongoing Phase 1/2a clinical trial for its product candidate atebimetinib for the treatment of advanced solid tumors[176] - The company expects to provide updated overall survival and progression-free survival data from the Phase 2a trial in the third quarter of 2025[102] - The company entered into a clinical supply agreement with Regeneron Pharmaceuticals for atebimetinib in combination with Libtayo in February 2025[99] Going Concern and Financial Risks - The Company has incurred recurring losses since inception and has substantial doubt about its ability to continue as a going concern for a period of one year from the issuance date of the financial statements[37] - The company has identified conditions that raise substantial doubt about its ability to continue as a going concern, necessitating additional funding to support operations[182] - The company raised substantial doubt about its ability to continue as a going concern for at least one year from the issuance date of the financial statements[150][176] - The company expects to continue generating operating losses and will require additional funding through various means to remain operational[37] - The company may face challenges in obtaining additional funding due to macroeconomic conditions, which could adversely affect its financial condition[187] Operating Expenses - Total operating expenses for the six months ended June 30, 2025, were $30.24 million, nearly unchanged from $30.24 million in the same period of 2024[21] - Total operating expenses for the three months ended June 30, 2025, were $14.757 million, a decrease of 1.0% compared to $14.913 million for the same period in 2024[130] - General and administrative expenses increased by approximately $42 thousand, or 1.0%, to approximately $4.3 million for the three months ended June 30, 2025, compared to approximately $4.3 million for the same period in 2024[132] Interest Income - The company reported interest income of $324,013 for the three months ended June 30, 2025, down from $826,104 in the same period of 2024, a decrease of approximately 60%[21] - Interest income for the three months ended June 30, 2025, was $324,000, a decrease of 60.8% from $826,000 in 2024[130] - Interest income decreased by approximately $0.5 million for the three months ended June 30, 2025, primarily due to lower interest rates and a lower total cash balance[134] Asset Management - Total assets decreased from $52.71 million on December 31, 2024, to $40.06 million on June 30, 2025, representing a decline of approximately 24%[19] - As of June 30, 2025, the net property and equipment amounted to $964,138, a decrease of 14.1% from $1,122,865 as of December 31, 2024[60] - Total accrued expenses as of June 30, 2025, were $4,514,960, a decrease of 9.2% from $4,973,129 as of December 31, 2024[61] Stock-Based Compensation - Stock-based compensation expense for the six months ended June 30, 2025, was $3.22 million, compared to $3.14 million in the same period of 2024, an increase of about 2.6%[26] - The company recognized stock-based compensation expense of $1,524,943 during the three months ended June 30, 2025, a decrease of 8.2% from $1,661,749 in the same period of 2024[79] - The total incremental non-cash stock-based compensation expense due to option repricing was $0.6 million, with $0.2 million recognized during the three months ended June 30, 2025[76] Future Outlook - The company expects to continue incurring significant losses, with future net losses depending on the growth rate of expenses and revenue generation capabilities[177] - The company plans to mitigate funding risks by raising additional capital through equity or debt financings and potential collaborations[158] - The company anticipates significant commercialization expenses if any product candidates receive marketing approval[183] - The company may face significant delays in obtaining marketing approvals, which could harm the commercial prospects of its product candidates[210]

[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.

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]