Company Overview - Immuneering Corporation is a clinical-stage oncology company focused on developing and commercializing more effective and better tolerated therapies for cancer patients [3] - The company's lead product candidate, IMM-1-104, is an oral, once-daily deep cyclic inhibitor of MEK aimed at improving tolerability and expanding indications to include RAS-driven tumors, such as most pancreatic cancers [3] - IMM-1-104 is currently undergoing a Phase 1/2a trial in patients with advanced solid tumors, including pancreatic cancer [3] - Another product, IMM-6-415, is an oral, twice-daily deep cyclic inhibitor of MEK, also in a Phase 1/2a trial for patients with advanced solid tumors harboring RAS or RAF mutations [3] Upcoming Events - Immuneering management will present at the 24th Annual Needham Virtual Healthcare Conference from April 7-10, 2025, discussing the company's pipeline, platform, and business strategy [1] - The presentation is scheduled for April 9 from 1:30 – 2:10 pm ET and will be webcast live, with an archive available on the company's Investor Relations website [2]

Core Insights - Immuneering Corporation has appointed Igor Matushansky, M.D., Ph.D., as Chief Medical Officer, effective March 20, 2025 [1] - Dr. Matushansky received an option to purchase 118,000 shares of Class A common stock at an exercise price of $1.80, which is the closing price on March 21, 2025 [1] - The stock option has a ten-year term and vests 25% on March 17, 2026, with the remaining 75% vesting in equal monthly installments over three years, fully vesting by March 17, 2029 [1] Company Overview - Immuneering is a clinical-stage oncology company focused on developing and commercializing therapies for cancer patients [2] - The lead product candidate, IMM-1-104, is an oral MEK inhibitor aimed at improving tolerability and expanding indications for RAS-driven tumors, currently in a Phase 1/2a trial [2] - Another product candidate, IMM-6-415, is also a MEK inhibitor in a Phase 1/2a trial for advanced solid tumors with RAS or RAF mutations [2]

Financial Performance and Concerns - The company has incurred significant net losses for the past several years and expects to continue incurring substantial losses for the foreseeable future [22]. - The company has raised substantial doubt about its ability to continue as a going concern due to recurring losses and cash usage in operations [609]. - The company will require substantial additional capital to finance its operations, and failure to raise such capital may delay or eliminate research and drug development programs [22]. Regulatory and Development Challenges - The regulatory approval processes for product candidates are lengthy and unpredictable, which could substantially harm the business if approvals are not obtained [22]. - The company has not completed any clinical trials and has no products approved for commercial sale, making it difficult to evaluate its current business and predict future success [22]. - The company is substantially dependent on the successful development of its current and future product candidates, which may face significant delays or failures [22]. - The company relies on third parties for conducting preclinical studies and clinical trials, which increases the risk of not obtaining regulatory approval [24]. Competition and Market Risks - The company faces significant competition, and if competitors develop more effective or cheaper products, it could negatively impact commercial opportunities [24]. - The company has never commercialized a product candidate and may lack the necessary expertise and resources for successful commercialization [22]. - The company’s long-term prospects depend on discovering and developing product candidates, which may fail in development or suffer delays [22].

Financial Performance - Net loss attributable to common stockholders for Q4 2024 was $18.1 million, or $0.58 per share, compared to a net loss of $15.1 million, or $0.52 per share, in Q4 2023[10] - Full-year net loss attributable to common stockholders for 2024 was $61.0 million, or $2.04 per share, compared to $53.5 million, or $1.88 per share, for 2023[10] - Cash, cash equivalents, and marketable securities as of December 31, 2024, were $36.1 million, down from $85.7 million as of December 31, 2023[10] Research and Development - Reported an overall response rate (ORR) of 43% and a disease control rate (DCR) of 86% for IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients[3] - Research and Development (R&D) expenses for Q4 2024 were $14.9 million, compared to $11.9 million in Q4 2023, with full-year R&D expenses of $48.0 million versus $41.6 million in 2023[10] - Initiation of multiple Phase 2a arms of IMM-1-104 in combination with various inhibitors planned for 2025[10] - FDA granted Fast Track designation for IMM-1-104 in advanced melanoma and Orphan Drug designation for pancreatic cancer[6][7] Management and Leadership - New Chief Medical Officer, Dr. Igor Matushansky, appointed to oversee clinical activities and development programs[4] Assets and Liabilities - Total assets decreased from $102,584,538 in December 31, 2023 to $52,714,413 in December 31, 2024, representing a decline of approximately 48.5%[20] - Current assets fell from $89,083,669 in December 31, 2023 to $39,587,569 in December 31, 2024, a decrease of about 55.6%[20] - Total liabilities reduced from $12,008,355 in December 31, 2023 to $11,328,187 in December 31, 2024, a decrease of about 5.7%[20] - Stockholders' equity decreased from $90,576,183 to $41,386,226, reflecting a decline of approximately 54.4%[20] - The accumulated deficit increased from $(163,258,578) to $(224,295,186), indicating a worsening of approximately 37.4%[20] Capital Structure - Additional paid-in capital rose from $253,806,267 to $265,650,362, an increase of about 4.7%[20] - Class A common stock shares issued increased from 29,271,629 to 31,050,448, representing a growth of about 6.1%[20] - Cash runway extended into 2026, supported by recent funding activities[9] - General and Administrative (G&A) expenses for Q4 2024 were $3.7 million, down from $4.4 million in Q4 2023, with full-year G&A expenses of $16.1 million compared to $16.8 million in 2023[10] - Total current liabilities slightly decreased from $7,845,503 to $7,503,768, a reduction of approximately 4.4%[20] - Lease liabilities, net of current portion decreased from $4,162,852 to $3,824,419, a decline of approximately 8.1%[20] - Cash and cash equivalents decreased significantly from $59,405,817 to $36,144,720, a drop of approximately 39.0%[20]

Core Insights - Immuneering Corporation reported positive data from its ongoing Phase 2a trial of IMM-1-104, showing an overall response rate (ORR) of 43% and a disease control rate (DCR) of 86% in combination with modified gemcitabine/nab-paclitaxel for first-line pancreatic cancer [3][4] - The company has entered a clinical trial supply agreement with Regeneron Pharmaceuticals to evaluate IMM-1-104 in combination with Libtayo for non-small cell lung cancer [4][8] - Cash runway has been extended into 2026, providing sufficient funding for ongoing operations [9] Clinical Developments - The Phase 2a trial of IMM-1-104 demonstrated promising results, with an ORR of 50% when combined with modified FOLFIRINOX, compared to historical benchmarks of 23% and 32% for the respective chemotherapy agents [3][4] - Plans are underway for a potential global pivotal trial of IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel [3][4] - Additional combination arms for IMM-1-104 are expected to be initiated in 2025, including studies with a BRAF inhibitor, a G12C inhibitor, and a PD-1 inhibitor [4][8] Financial Performance - As of December 31, 2024, the company reported cash and cash equivalents of $36.1 million, a decrease from $85.7 million as of December 31, 2023 [7][19] - Research and development (R&D) expenses for Q4 2024 were $14.9 million, up from $11.9 million in Q4 2023, reflecting increased clinical costs related to IMM-1-104 [7][17] - The net loss for Q4 2024 was $18.1 million, or $0.58 per share, compared to a net loss of $15.1 million, or $0.52 per share, for Q4 2023 [7][17] Leadership Changes - Dr. Igor Matushansky has been appointed as Chief Medical Officer to oversee clinical activities and development programs [4][5]

Core Viewpoint - Immuneering has appointed Dr. Igor Matushansky as Chief Medical Officer to lead clinical activities and oversee the ongoing Phase 2a study of IMM-1-104 in pancreatic cancer, with plans for a pivotal Phase 3 trial in the future [1][2] Company Overview - Immuneering is a clinical-stage oncology company focused on developing and commercializing therapies that are more effective and better tolerated for cancer patients [3] - The lead product candidate, IMM-1-104, is an oral, once-daily deep cyclic inhibitor of MEK aimed at improving tolerability and expanding indications for RAS-driven tumors, including pancreatic cancer [3] Clinical Development - The ongoing Phase 2a trial of IMM-1-104 is designed to provide first-line pancreatic cancer patients with a new treatment option that is more effective and better tolerated than current standard care [2] - The company plans to present updated data from the Phase 2a trial in Q2 2025 [1] Leadership Experience - Dr. Matushansky brings extensive oncology drug development experience, having previously served as Chief Medical Officer at Sail Biomedicines and held senior roles at Ipsen Pharmaceuticals and Hookipa Pharma [2] - His background includes overseeing the completion of NAPOLI-3, which led to the approval of NALIRIFOX for first-line pancreatic cancer [2]

- Immuneering plans to evaluate IMM-1-104 in combination with Libtayo in patients with advanced non-small cell lung cancer in its ongoing Phase 2a trial – - Data presented at AACR 2023 supports dual-targeting potential of IMM-1-104 in combination with anti-PD-1 – CAMBRIDGE, Mass., Feb. 06, 2025 (GLOBE NEWSWIRE) --  Immuneering Corporation (NASDAQ:IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, today announced a ...

CAMBRIDGE, Mass., Feb. 03, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, today announced that management will present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference, which is taking place virtually from February 11-12, 2025, to discuss the company’s pipeline, platform, and business strategy. Participating will be Ben Zeskind, Chief E ...

- Two new partial responses (PRs) reported in Phase 2a arm studying IMM-1-104 in combination with modified FOLFIRINOX (mFFX) in first-line pancreatic cancer - - Overall Response Rate (ORR) of 50%; historic benchmark of 32% for FOLFIRINOX alone - - Nearly $14M in net proceeds raised in January 2025 through utilization of Company's ATM - CAMBRIDGE, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (NASDAQ:IMRX), a clinical-stage oncology company seeking to develop and commercialize more effecti ...

- Updated data for IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients show favorable overall response rate (ORR = 43%) and disease control rate (DCR = 86%); planning for pivotal trial underway - - Favorable initial data for IMM-1-104 in combination with modified FOLFIRINOX (mFFX) in first-line pancreatic cancer patients show target lesion shrinkage in all evaluable patients, including a 100% reduction (PR) - - Encouraging initial data for IMM-1- ...