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.

Outpacing Cancer to Help Patients Outlive their Disease June 2025 This presentation contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements including, without limitation, statements regarding: Immuneering Corporation's (the "Company") plans to develop, manufacture and commercialize its product candida ...

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.

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].

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].

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]

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]