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Immuneering: Positive Pancreatic Cancer Data Atebimetinib Leads To Q4 2025 Catalyst
Seeking Alpha· 2025-09-25 18:19
Core Insights - The article discusses the offerings of the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and investment opportunities in the biotech sector [1][2]. Group 1: Service Offerings - Biotech Analysis Central offers a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and live chat features for investors [2]. - The service is available for $49 per month, with a discounted annual plan at $399, representing a 33.50% savings [1]. Group 2: Analyst Background - The author of the article runs the Biotech Analysis Central service and emphasizes the depth of analysis provided to help healthcare investors make informed decisions [2].
Morning Market Movers: PEPG, XXII, IMRX, RIG See Big Swings
RTTNews· 2025-09-25 11:55
Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential opportunities for traders [1] Premarket Gainers - PepGen Inc. (PEPG) is up 151% at $6.68 [3] - 22nd Century Group, Inc. (XXII) is up 27% at $1.93 [3] - Immuneering Corporation (IMRX) is up 23% at $11.36 [3] - uniQure N.V. (QURE) is up 10% at $52.58 [3] - Lithium Americas Corp. (LAC) is up 9% at $6.60 [3] - Jasper Therapeutics, Inc. (JSPR) is up 9% at $2.55 [3] - American Shared Hospital Services (AMS) is up 8% at $2.75 [3] - PSQ Holdings, Inc. (PSQH) is up 7% at $3.06 [3] - K Wave Media Ltd. (KWM) is up 7% at $2.48 [3] - ClearPoint Neuro, Inc. (CLPT) is up 5% at $20.48 [3] Premarket Losers - Transocean Ltd. (RIG) is down 14% at $3.11 [4] - Cyclerion Therapeutics, Inc. (CYCN) is down 12% at $2.83 [4] - CarMax, Inc. (KMX) is down 11% at $50.38 [4] - ARB IOT Group Limited (ARBB) is down 11% at $10.45 [4] - SHF Holdings, Inc. (SHFS) is down 10% at $6.49 [4] - Digital Brands Group, Inc. (DBGI) is down 10% at $6.21 [4] - Aqua Metals, Inc. (AQMS) is down 9% at $5.29 [4] - Akanda Corp. (AKAN) is down 8% at $3.96 [4] - Galecto, Inc. (GLTO) is down 8% at $3.88 [4] - Platinum Analytics Cayman Limited (PLTS) is down 7% at $11.12 [4]
Immuneering Announces Pricing of $175 Million Underwritten Public Offering of Class A Common Stock and Concurrent $25 Million Private Placement of Class A Common Stock to Sanofi
Globenewswire· 2025-09-25 04:08
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]
Immuneering Announces Proposed Underwritten Public Offering of Class A Common Stock and Pre-Funded Warrants and Proposed Concurrent Private Placement of Class A Common Stock and Class B Common Stock to Sanofi
Globenewswire· 2025-09-24 20:05
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].
Immuneering Announces Extraordinary 86% Overall Survival at 9 Months in First-Line Pancreatic Cancer Patients Treated with Atebimetinib + mGnP
Globenewswire· 2025-09-24 20:01
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]
Immuneering Appoints Dr. Thomas Schall as Chairman of the Board
Globenewswire· 2025-09-16 11:00
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].
Immuneering to Announce Updated Overall Survival Data from Phase 2a Clinical Trial of Atebimetinib + mGnP in First-Line Pancreatic Cancer Patients on September 25
Globenewswire· 2025-09-10 11:00
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]
Immuneering Announces Closing of $25 Million Private Placement
Globenewswire· 2025-08-26 20:05
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].
Immuneering Stock Rises 21.7% on Supply Agreement With LLY
ZACKS· 2025-08-26 16:21
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]
Immuneering Announces Clinical Supply Agreement with Lilly to Evaluate Atebimetinib in Combination with Olomorasib
Globenewswire· 2025-08-25 12:00
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]