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Immuneering (IMRX) Earnings Call Presentation
2025-06-17 12:47
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]
Immuneering Reports Positive Overall Survival Data for Atebimetinib (IMM-1-104) from Ongoing Phase 2a Trial in First-Line Pancreatic Cancer Patients
Globenewswire· 2025-06-17 10:00
Core Insights - Immuneering Corporation announced positive results from its Phase 2a clinical trial of atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP) for first-line pancreatic cancer patients, showing a 94% overall survival (OS) at 6 months and a 72% progression-free survival (PFS) at the same time point [2][3][6] Group 1: Clinical Trial Results - The trial reported a 39% overall response rate (ORR) and an 81% disease control rate (DCR), with many patients experiencing deepening and durable regressions [6][9] - The median OS and PFS have not yet been reached, indicating ongoing efficacy [6] - The tolerability profile of atebimetinib in combination with mGnP was markedly favorable, with no Grade 3+ adverse events observed in most categories [6][10] Group 2: Future Plans and Milestones - A pivotal trial for atebimetinib in combination with mGnP is planned for 2026, reflecting the company's commitment to advancing this treatment option [1][11][14] - The company has increased target enrollment for the trial to approximately 50 patients based on the encouraging data [6][11] - Immuneering will host a conference call to discuss the data and provide a business update, indicating proactive communication with stakeholders [11]
Immuneering to Provide Updates from Phase 2a Clinical Trial of IMM-1-104 in First-Line Pancreatic Cancer Patients on Tuesday, June 17, 2025
Globenewswire· 2025-06-16 12:00
CAMBRIDGE, Mass., June 16, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company outpacing cancer to help patients outlive their disease, today announced that it will host a conference call and live webcast at 8:00 am ET on June 17, 2025. The company is excited to provide updates from its ongoing Phase 2a clinical trial of IMM-1-104 in first-line pancreatic cancer patients. The conference call will be webcast live and archived in the Investor Relations section of ...
Immuneering (IMRX) 2025 Conference Transcript
2025-06-05 17:50
Summary of Immuneering (IMRX) Conference Call Company Overview - **Company**: Immuneering Corporation (IMRX) - **Focus**: Development of cancer therapies aimed at making cancer a chronic disease rather than a fatal one [3][4][5] Core Industry Insights - **Industry**: Oncology, specifically targeting pancreatic cancer and the MAP kinase pathway [19][20] - **Current Challenges**: Traditional cancer therapies often focus on rapid tumor destruction, leading to resistance and poor patient quality of life [4][6][7][8] Key Points and Arguments 1. **Long-term Goals**: Immuneering aims to help cancer patients live longer by making cancer manageable, similar to chronic diseases like diabetes [3][5] 2. **Durability and Tolerability**: The company emphasizes the importance of both durability (maximizing overall survival) and tolerability (minimizing adverse events) in cancer treatment [5][6][29] 3. **Innovative Approach**: Immuneering's strategy involves "deep cyclic inhibition," which allows for a more adaptable treatment that outpaces cancer's ability to develop resistance [16][19][35] 4. **Lead Program - IMM114**: Currently in phase 2A trials, IMM114 targets the MEK in the MAP kinase pathway, showing promising results in combination with modified gemcitabine NAB paclitaxel for pancreatic cancer [19][49] 5. **Clinical Data**: Early clinical data indicates that patients treated with IMM114 have experienced significant improvements in quality of life and tumor reduction, with one patient showing a 28% tumor reduction over 13 months [24][26][50] 6. **Survival Rates**: The standard of care for first-line pancreatic cancer shows a dismal six-month survival rate of 67% to 76%, highlighting the urgent need for better therapies [49][54] 7. **Combination Therapy**: The combination of IMM114 with chemotherapy has shown a disease control rate of 86%, indicating potential for improved efficacy [52][54] 8. **Future Plans**: Immuneering is planning a global randomized pivotal trial for IMM114 in first-line pancreatic cancer, with potential applications across various cancer types due to the broad applicability of the MAP kinase pathway [57][58] Additional Important Insights - **Patient-Centric Focus**: The company aims to improve not just survival but also the quality of life for patients, with a focus on tolerability that allows patients to maintain their normal lives [40][41][29] - **Potential for Broader Applications**: While the initial focus is on pancreatic cancer, the MAP kinase pathway's involvement in many cancers suggests that IMM114 could have wide-ranging applications [57] - **Collaboration with Regeneron**: Immuneering has announced a partnership with Regeneron to explore the use of IMM114 in combination with their anti-PD-1 therapy in lung cancer [42][57] This summary encapsulates the key points discussed during the Immuneering conference call, highlighting the company's innovative approach to cancer treatment and its commitment to improving patient outcomes.
Immuneering (IMRX) - 2025 Q1 - Quarterly Report
2025-05-05 20:34
Financial Performance - Net loss for the three months ended March 31, 2025, was $15.05 million, compared to a net loss of $14.31 million for the same period in 2024, representing an increase in loss of about 5.16%[21]. - The company reported a net loss of $15.046 million for the three months ended March 31, 2025, compared to a net loss of $14.307 million for the same period in 2024, representing an increase in loss of 5.2%[129]. - The company incurred net losses of approximately $15.0 million for the three months ended March 31, 2025, and $61.0 million for the year ended December 31, 2024, with an accumulated deficit of approximately $239.3 million as of March 31, 2025[167]. - The company expects to continue incurring significant losses for the foreseeable future, with fluctuations in net losses from quarter to quarter[168]. - Management expects to continue generating operating losses and will require additional funding through various means to sustain operations[36]. Cash and Liquidity - Cash and cash equivalents decreased from $36.14 million at the end of 2024 to $35.87 million by March 31, 2025, a reduction of about 0.76%[25]. - As of March 31, 2025, the Company had cash equivalents of $35,577,746, down from $35,865,754 as of December 31, 2024[55][57]. - The company expects existing cash and cash equivalents to fund operations into 2026, but there is substantial doubt about its ability to continue as a going concern for at least one year from the issuance date of the financial statements[140][142]. - The company anticipates needing substantial additional capital to finance operations and product development, with existing cash resources insufficient to fund all necessary activities[174]. - The company plans to raise additional capital through equity or debt financings and strategic partnerships to mitigate risks associated with ongoing operating losses[150]. Shareholder Equity and Stock Activity - Total stockholders' equity increased from $41.39 million on December 31, 2024, to $41.84 million on March 31, 2025, a rise of approximately 1.08%[19]. - The weighted-average common shares outstanding increased from 29.37 million in Q1 2024 to 35.53 million in Q1 2025, an increase of about 20.94%[21]. - The Company completed a follow-on equity offering, issuing 2,727,273 shares at $11.00 per share, raising net proceeds of $28,200,003[33]. - The Company sold 4,836,804 shares of Class A common stock through its ATM Program at an average price of $2.95, generating gross proceeds of $14.2 million during the three months ended March 31, 2025[64]. - The Company had 35,985,702 shares of Class A common stock issued and outstanding as of March 31, 2025, an increase from 31,050,448 shares as of December 31, 2024[60]. Research and Development - Research and development expenses for Q1 2025 were $11.47 million, compared to $11.20 million in Q1 2024, reflecting an increase of approximately 2.41%[21]. - Research and development expenses increased by approximately $0.3 million, or 2.4%, to approximately $11.5 million for the three months ended March 31, 2025, compared to approximately $11.2 million for the same period in 2024[130]. - Research and development expenses for the three months ended March 31, 2025, included $4,257,936 for IMM-1-104 and $1,623,755 for IMM-6-415[92]. - The company expects research and development expenses to substantially increase as it continues to advance product candidates through clinical development and seeks regulatory approvals[121]. - The company plans to expand research and development activities and establish a sales and marketing infrastructure for future product commercialization[170]. Clinical Trials and Product Development - The company’s lead product candidate, IMM-1-104, is currently in a Phase 1/2a clinical trial targeting patients with advanced solid tumors harboring RAS or RAF mutations[27]. - The ongoing Phase 1/2a clinical trial of IMM-1-104 for advanced solid tumors is a key focus, but the company has not yet demonstrated the ability to complete clinical trials successfully[165][166]. - The company plans to initiate additional Phase 2a combination arms for IMM-1-104 following positive interim data[100]. - The FDA cleared the IND application for IMM-6-415 in December 2023, with dosing commenced in March 2024[101]. - The company has not yet generated any revenue from product sales and has no products approved for commercial sale, which complicates future success predictions[165]. Going Concern and Financial Risks - There is substantial doubt about the company's ability to continue as a going concern for the next year due to recurring losses and the need for additional capital[111]. - The company has identified conditions raising substantial doubt about its ability to continue as a going concern for at least one year from the issuance of its financial statements, with only $35.9 million in cash and cash equivalents as of March 31, 2025[172]. - The company has concluded that there is substantial doubt about its ability to continue as a going concern, necessitating significant reductions in spending if adequate funding is not secured[150]. - The company may face significant dilution of stockholder ownership if additional capital is raised through equity offerings or other means[181]. - The lengthy regulatory approval process and unpredictability of clinical trial results may significantly harm the company's business and prospects[185]. Regulatory and Market Challenges - The regulatory approval processes for the company's product candidates are lengthy and unpredictable, with no current approvals obtained[183]. - Delays in clinical trials can arise from disagreements with regulatory authorities regarding trial design and implementation[192]. - Regulatory authorities may impose additional requirements or restrictions that could delay marketing approval or limit product indications[200]. - The outcome of preclinical studies and early clinical trials may not predict success in later trials, leading to potential failures[201]. - Adverse events or side effects associated with product candidates could inhibit regulatory approval and market acceptance, significantly harming business prospects[208].
Immuneering (IMRX) - 2025 Q1 - Quarterly Results
2025-05-05 20:17
Financial Performance - Cash and cash equivalents as of March 31, 2025, were $35.9 million, a slight decrease from $36.1 million as of December 31, 2024[6]. - Net loss attributable to common stockholders for Q1 2025 was $15.0 million, or $0.42 per share, compared to a net loss of $14.3 million, or $0.49 per share, in Q1 2024[8]. - General and Administrative (G&A) expenses for Q1 2025 were $4.0 million, down from $4.1 million in Q1 2024, reflecting a decrease in employee-related costs[7]. - Research and Development (R&D) expenses for Q1 2025 were $11.5 million, up from $11.2 million in Q1 2024, primarily due to higher clinical costs[6]. - The weighted-average common shares outstanding increased to 35,529,652 in Q1 2025 from 29,370,357 in Q1 2024[8]. Clinical Trials and Developments - The company announced positive data from the ongoing Phase 2a trial of IMM-1-104, including a patient with over 13 months of progression-free survival[3]. - A clinical trial supply agreement was established with Regeneron Pharmaceuticals to evaluate IMM-1-104 in combination with Libtayo® in non-small cell lung cancer[1]. - The company plans to initiate a Phase 3 trial of IMM-1-104 in first-line pancreatic cancer in 2026[10]. - The company reported a 91% reduction in peak CA 19-9 levels for a pancreatic cancer patient on IMM-1-104 monotherapy[5]. Cash Flow and Funding - The cash runway has been extended into 2026, ensuring sufficient funding for operations[9].
Immuneering Reports First Quarter 2025 Financial Results and Provides Business Updates
Globenewswire· 2025-05-05 20:05
Core Insights - Immuneering Corporation reported positive data from its ongoing Phase 2a trial of IMM-1-104, showing encouraging responses in pancreatic cancer treatment [1][3] - The company has extended its cash runway into 2026, ensuring sufficient funding for ongoing operations [1][8] - Dr. Igor Matushansky has been appointed as Chief Medical Officer to lead clinical efforts, particularly for the upcoming Phase 3 trial in first-line pancreatic cancer [1][5] Clinical Developments - The Phase 2a trial of IMM-1-104 has shown exceptional efficacy, with a third-line monotherapy patient achieving over 13 months of progression-free survival and a first-line combination therapy patient achieving a complete response [3][5] - A clinical trial supply agreement has been established with Regeneron Pharmaceuticals to evaluate IMM-1-104 in combination with Libtayo® for non-small cell lung cancer [1][4] Financial Performance - As of March 31, 2025, the company reported cash and cash equivalents of $35.9 million, a slight decrease from $36.1 million at the end of 2024 [11] - Research and Development (R&D) expenses for Q1 2025 were $11.5 million, up from $11.2 million in Q1 2024, primarily due to increased clinical costs [11] - The net loss for Q1 2025 was $15.0 million, or $0.42 per share, compared to a net loss of $14.3 million, or $0.49 per share, in Q1 2024 [11][16]
Immuneering to Present at the 24th Annual Needham Virtual Healthcare Conference
Globenewswire· 2025-04-02 12:00
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]
Immuneering Corporation Announces Grant of Inducement Award
Newsfilter· 2025-03-21 20:30
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]
Immuneering (IMRX) - 2024 Q4 - Annual Report
2025-03-20 20:47
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].