Core Points - Immuneering Corporation has priced its underwritten public offering of 18,959,914 shares of Class A common stock at $9.23 per share, with gross proceeds expected to be approximately $175 million before deductions [1][2] - Sanofi has agreed to purchase 2,708,559 shares of Immuneering's Class A common stock at the same price in a separate private placement transaction [1] - The public offering and private placement are expected to close concurrently on or about September 26, 2025, subject to customary closing conditions [1] Use of Proceeds - The net proceeds from the public offering and private placement will be used to advance the preclinical and clinical development of Immuneering's product candidates, as well as for working capital and other general corporate purposes [2] Offering Details - The public offering is made pursuant to a shelf registration statement on Form S-3, which was filed with the SEC on August 13, 2025, and declared effective on August 20, 2025 [3] - A prospectus supplement relating to the offering will be filed with the SEC [3] Private Placement - The shares sold in the private placement have not been registered under the Securities Act of 1933 and may not be offered or sold in the U.S. without registration or an applicable exemption [4]

Core Viewpoint - Immuneering Corporation has announced a proposed underwritten public offering of its Class A common stock and a concurrent private placement with Sanofi for $25 million, aimed at advancing its oncology product candidates and general corporate purposes [1][2]. Group 1: Offering Details - The public offering includes shares of Class A common stock and pre-funded warrants, with underwriters granted a 30-day option to purchase an additional 15% of the offered shares [1]. - Sanofi will purchase $25 million worth of Immuneering's Class A common stock or non-voting Class B common stock at the public offering price, in a private placement expected to close concurrently with the public offering [1][2]. - The offering is subject to market conditions and the private placement is contingent upon the closing of the public offering [1]. Group 2: Use of Proceeds - The net proceeds from both the public offering and private placement will be utilized to advance preclinical and clinical development of product candidates, as well as for working capital and other general corporate purposes [2]. Group 3: Regulatory Information - The offering is being conducted under a shelf registration statement filed with the SEC, which was declared effective on August 20, 2025 [3]. - A preliminary prospectus supplement will be filed with the SEC, and copies will be available through the underwriters [3][7]. Group 4: Securities Registration - The shares sold in the private placement will not be registered under the Securities Act of 1933 and cannot be offered or sold in the U.S. without registration or an applicable exemption [4].

Core Insights - Immuneering Corporation announced positive survival and safety data from its Phase 2a trial of atebimetinib in combination with modified gemcitabine/nab-paclitaxel for first-line pancreatic cancer patients, showing an overall survival (OS) of 86% at 9 months, significantly higher than the standard of care benchmark of approximately 47% [1][6][10] Survival Data - The trial reported a 94% OS at 6 months, which was sustained to 86% at 9 months, indicating a substantial improvement over standard care [2][6] - Progression-free survival (PFS) was observed at 53% at 9 months, compared to a standard of care benchmark of around 29% [5][6] Safety Profile - The combination therapy demonstrated a favorable tolerability profile, with only neutropenia and anemia observed at Grade 3 in more than 10% of patients, which are common in standard chemotherapy [10][11] - No new safety signals were identified, reinforcing the treatment's tolerability [10] Mechanism of Action - Atebimetinib is classified as a Deep Cyclic Inhibitor, targeting MEK, which is a key control point in the MAPK pathway, potentially offering a more durable treatment option for pancreatic cancer [12][13] Future Plans - The company anticipates regulatory feedback on pivotal trial plans in Q4 2025 and aims to initiate a pivotal trial by the end of 2025, with patient dosing expected to begin by mid-2026 [5][18] - Immuneering is also planning to expand clinical trials for atebimetinib in other cancer types, including non-small cell lung cancer [18]

Core Viewpoint - Immuneering Corporation has appointed Dr. Thomas J. Schall as Chairman of the Board of Directors, which is seen as a strategic move to advance the company's oncology programs, particularly the lead product candidate, atebimetinib [1][4]. Company Overview - Immuneering is a clinical-stage oncology company focused on developing a new category of cancer medicines known as Deep Cyclic Inhibitors. The lead product candidate, atebimetinib, is designed to improve durability and tolerability for patients with MAPK pathway-driven tumors, including pancreatic cancer [5]. Leadership Background - Dr. Schall has over 30 years of experience in drug discovery and development, previously serving as the founder and CEO of ChemoCentryx, where he led the development of Tavneos®, a therapy for ANCA-associated vasculitis. ChemoCentryx was acquired by Amgen in 2022 for nearly $4 billion [2][4]. Strategic Importance - The appointment of Dr. Schall is considered pivotal as Immuneering prepares for late-stage development, regulatory filings, and commercialization of its therapies. His expertise in navigating the complex path from early science to market is expected to be critical for the company's success [3][4]. Upcoming Developments - Immuneering plans to announce updated data from its ongoing phase 2a study of atebimetinib in pancreatic cancer patients on September 25, with further presentations at the Pancreatic Cancer Action Network Annual Scientific Summit on September 28 [3].

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]

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]