[Executive Summary](index=1&type=section&id=Executive%20Summary) [Key Announcements](index=1&type=section&id=Key%20Announcements) Immuneering Corporation reported Q2 2025 financial results and provided significant business updates, including exceptional 6-month overall survival data for atebimetinib in first-line pancreatic cancer, a new U.S. composition of matter patent, and plans for a pivotal trial - Updated OS and PFS data from first-line pancreatic cancer patients (N=34) treated with atebimetinib + mGnP will be shared in Q3 2025, earlier than previously guided[1](index=1&type=chunk) - Exceptional **94% overall survival (OS)** observed at 6 months in the ongoing Phase 2a trial of atebimetinib plus modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (N=34)[1](index=1&type=chunk) - A newly issued U.S. composition of matter patent for atebimetinib is expected to provide exclusivity into **2042**, with potential for patent term extension[1](index=1&type=chunk) - A Request for End of Phase 2 meeting has been submitted to the FDA, with the pivotal trial expected to initiate in **2026**[1](index=1&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) The CEO highlighted the exceptional 6-month OS data for atebimetinib in first-line pancreatic cancer, noting strong interest from pharmaceutical companies and investors, and emphasized the importance of the new patent for maximizing therapeutic potential across multiple indications - The **6-month OS of 94%** for atebimetinib + mGnP in first-line pancreatic cancer compares favorably to the **67% OS** in the pivotal study of standard of care GnP, which dropped to **50% by 8.5 months**[2](index=2&type=chunk) - The exceptional OS data is generating strong interest from leading pharmaceutical companies and top-tier investors[2](index=2&type=chunk) - The granting of the composition of matter patent for atebimetinib is a significant milestone, expected to support efforts to maximize its therapeutic potential across multiple indications[2](index=2&type=chunk) [Corporate Highlights & Business Updates](index=1&type=section&id=Corporate%20Highlights) [Atebimetinib Clinical Trial Updates](index=1&type=section&id=Atebimetinib%20Clinical%20Trial%20Updates) Immuneering reported positive data from its Phase 2a trial in first-line pancreatic cancer, showing high OS and PFS at 6 months, and provided an update on a long-term responder in the Phase 1 trial for third-line pancreatic cancer [First-Line Pancreatic Cancer (Phase 2a)](index=1&type=section&id=First-Line%20Pancreatic%20Cancer%20(Phase%202a)) Phase 2a Trial Results (Atebimetinib + mGnP in First-Line Pancreatic Cancer at 6 months) | Metric | Value | | :----- | :---- | | OS | 94% | | PFS | 72% | - Median OS and PFS have not yet been reached[3](index=3&type=chunk) - A markedly favorable tolerability profile was observed[3](index=3&type=chunk) - The company plans to initiate a pivotal trial in **2026**, subject to regulatory feedback[3](index=3&type=chunk) [Third-Line Pancreatic Cancer (Phase 1 Monotherapy)](index=2&type=section&id=Third-Line%20Pancreatic%20Cancer%20(Phase%201%20Monotherapy)) - A third-line pancreatic cancer patient has received atebimetinib monotherapy for over **18 months** and remains on treatment[8](index=8&type=chunk) - The patient maintained a partial response, including a **34% reduction** in target lesions (RECIST sum of longest diameters) and a **96% reduction** in peak CA 19-9 levels[8](index=8&type=chunk) - Treatment continued to be well tolerated, with a **~16% weight gain** observed[8](index=8&type=chunk) [Intellectual Property & Regulatory Milestones](index=1&type=section&id=Intellectual%20Property%20%26%20Regulatory%20Milestones) Immuneering secured a key U.S. composition of matter patent for atebimetinib, extending exclusivity into 2042, and has submitted an End of Phase 2 meeting request to the FDA, signaling progress towards a pivotal trial - A U.S. composition of matter patent for atebimetinib was granted in July, providing exclusivity into **2042**, with potential for patent term extension[1](index=1&type=chunk)[8](index=8&type=chunk) - This is the first U.S. patent granted for a deep cyclic inhibitor, designed to drive longer-lasting benefit by outpacing resistance mechanisms[8](index=8&type=chunk) - Additional patent applications for atebimetinib are pending, directed to compounds, pharmaceutical compositions, and methods of use, with expiration expected into **2044**[8](index=8&type=chunk) - An End of Phase 2 meeting request has been submitted to the FDA[1](index=1&type=chunk)[2](index=2&type=chunk) [Near-Term Milestone Expectations](index=2&type=section&id=Near-Term%20Milestone%20Expectations) Immuneering anticipates several key milestones for atebimetinib, including sharing updated clinical data in Q3 2025, receiving regulatory feedback in Q4 2025, and initiating a pivotal trial and additional combination arms in 2026 - Upcoming milestones include: * Announce updated OS and PFS data from first-line pancreatic cancer patients (n=34) treated with atebimetinib + mGnP in **Q3 2025**[8](index=8&type=chunk) * Receive regulatory feedback on pivotal study plans in **Q4 2025**[8](index=8&type=chunk) * Initiate pivotal, randomized trial of atebimetinib in combination with mGnP in first-line pancreatic cancer in **2026**[8](index=8&type=chunk) * Initiate additional atebimetinib clinical trial combination arms in **2026**[8](index=8&type=chunk) [Financial Results (Second Quarter 2025)](index=2&type=section&id=Financial%20Results%20(Second%20Quarter%202025)) [Financial Highlights](index=2&type=section&id=Financial%20Highlights) Immuneering reported a decrease in cash and cash equivalents, a slight decrease in R&D expenses, consistent G&A expenses, and an increased net loss for Q2 2025 compared to the prior year [Cash Position](index=2&type=section&id=Cash%20Position) Cash and Cash Equivalents | Metric | June 30, 2025 | December 31, 2024 | Change | | :----- | :------------ | :---------------- | :----- | | Amount | $26.4 million | $36.1 million | -$9.7 million | [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Operating Expenses (Three Months Ended June 30) | Expense Type | 2025 (USD) | 2024 (USD) | Change (YoY, USD) | | :----------- | :------------ | :------------ | :---------------- | | R&D Expenses | $10.5 million | $10.7 million | -$0.2 million | | G&A Expenses | $4.3 million | $4.3 million | $0 million | - The decrease in R&D expenses was primarily attributable to decreases in spend for preclinical programs, the IMM-6-415 program, and personnel costs, offset by higher clinical costs related to the atebimetinib program[5](index=5&type=chunk) - G&A expenses for Q2 2025 were consistent with the comparable prior period[6](index=6&type=chunk) [Net Loss](index=2&type=section&id=Net%20Loss) Net Loss (Three Months Ended June 30) | Metric | 2025 (USD) | 2024 (USD) | Change (YoY, USD) | | :----- | :------------ | :------------ | :---------------- | | Net Loss | $14.4 million | $14.1 million | +$0.3 million | | EPS | $0.40 | $0.47 | -$0.07 | [2025 Financial Guidance](index=2&type=section&id=2025%20Financial%20Guidance) Based on current cash and operating plans, Immuneering expects its cash runway to be sufficient to fund operations into 2026 - Cash and cash equivalents as of June 30, 2025, are expected to fund operations into **2026**[7](index=7&type=chunk) [About Immuneering Corporation](index=3&type=section&id=About%20Immuneering%20Corporation) [Company Overview](index=3&type=section&id=Company%20Overview) Immuneering is a clinical-stage oncology company focused on developing treatments that outpace cancer. Its lead candidate, atebimetinib, is an oral MEK inhibitor in Phase 2a for advanced solid tumors, including pancreatic cancer, with early-stage programs also in its pipeline - Immuneering is a clinical-stage oncology company focused on outpacing cancer to help patients outlive their disease[9](index=9&type=chunk) - The Company's lead product candidate, atebimetinib (IMM-1-104), is an oral, once-daily deep cyclic inhibitor of MEK[9](index=9&type=chunk) - Atebimetinib is designed to improve durability and tolerability, and expand indications to include MAPK pathway-driven tumors such as most pancreatic cancers[9](index=9&type=chunk) - Atebimetinib is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer, and the Company's development pipeline also includes early-stage programs[9](index=9&type=chunk) [Forward-Looking Statements & Risks](index=3&type=section&id=Forward-Looking%20Statements%20%26%20Risks) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements regarding product development, clinical trials, regulatory approvals, intellectual property, and financial outlook, along with a disclaimer outlining inherent risks and uncertainties that could cause actual results to differ materially - Statements include plans for product candidate development, treatment potential of atebimetinib, timing of clinical trials and regulatory feedback, cash runway expectations, and patent expiration[10](index=10&type=chunk) - These statements are subject to known and unknown risks, uncertainties, and other important factors, including those inherent in oncology drug R&D, funding needs, regulatory processes, reliance on third parties, competition, and intellectual property protection[11](index=11&type=chunk) - Readers are cautioned not to rely on these statements as representing views beyond the press release date, and the company disclaims any obligation to update them, except as required by law[12](index=12&type=chunk) [Contact Information](index=4&type=section&id=Contact%20Information) [Contact Details](index=4&type=section&id=Contact%20Details) Provides contact details for media and investor inquiries - Media Contact: Gina Nugent (Gina.nugent.external@immuneering.com)[13](index=13&type=chunk) - Investor Contact: Laurence Watts (619-916-7620, laurence@newstreetir.com)[13](index=13&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) This statement presents the company's revenues, expenses, and net loss for the three and six months ended June 30, 2025, and 2024, showing an increase in net loss for both periods Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) | Metric | Three Months Ended June 30, 2025 (USD) | Three Months Ended June 30, 2024 (USD) | Six Months Ended June 30, 2025 (USD) | Six Months Ended June 30, 2024 (USD) | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $10,454,160 | $10,651,958 | $21,925,852 | $21,854,372 | | General and administrative | $4,296,417 | $4,254,473 | $8,302,059 | $8,370,493 | | Total operating expenses | $14,757,894 | $14,913,748 | $30,242,544 | $30,239,498 | | Net loss | $(14,433,881) | $(14,079,927) | $(29,480,012) | $(28,387,756) | | Net loss per share (basic and diluted)| $(0.40) | $(0.47) | $(0.82) | $(0.96) | | Weighted-average common shares outstanding | 35,985,878 | 29,653,355 | 35,759,026 | 29,511,856 | [Condensed Consolidated Balance Sheets](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) This statement provides a snapshot of the company's assets, liabilities, and stockholders' equity as of June 30, 2025, and December 31, 2024, indicating a decrease in total assets and stockholders' equity Condensed Consolidated Balance Sheets (Unaudited) | Metric | June 30, 2025 (USD) | December 31, 2024 (USD) | | :------------------------------------ | :------------ | :---------------- | | Cash and cash equivalents | $26,355,498 | $36,144,720 | | Total current assets | $27,725,426 | $39,587,569 | | Total assets | $40,056,468 | $52,714,413 | | Total current liabilities | $7,486,830 | $7,503,768 | | Total liabilities | $11,120,431 | $11,328,187 | | Total stockholders' equity | $28,936,037 | $41,386,226 |

Core Viewpoint - Immuneering Corporation is advancing its clinical-stage oncology product, atebimetinib, showing promising overall survival (OS) and progression-free survival (PFS) data in first-line pancreatic cancer patients, with plans for a pivotal trial in 2026 [1][2][5]. Financial Highlights - As of June 30, 2025, the company reported cash and cash equivalents of $26.4 million, down from $36.1 million at the end of 2024 [6]. - Research and development (R&D) expenses for Q2 2025 were $10.5 million, slightly lower than $10.7 million in Q2 2024 [7]. - General and administrative (G&A) expenses remained stable at $4.3 million for both Q2 2025 and Q2 2024 [8]. - The net loss for Q2 2025 was $14.4 million, or $0.40 per share, compared to a net loss of $14.1 million, or $0.47 per share, in Q2 2024 [8][16]. Clinical Development Updates - The ongoing Phase 2a trial of atebimetinib in combination with modified Gemcitabine/nab-paclitaxel (mGnP) has shown a 94% OS at 6 months in first-line pancreatic cancer patients (N = 34) [4][5]. - The company plans to share updated OS and PFS data from the trial in Q3 2025, earlier than previously indicated [4]. - A composition of matter patent for atebimetinib was granted, expected to provide exclusivity until 2042, with potential extensions [4][5]. Future Milestones - Immuneering aims to initiate a pivotal, randomized trial of atebimetinib in combination with mGnP in first-line pancreatic cancer in 2026 [12]. - The company is preparing for regulatory feedback on pivotal study plans in Q4 2025 [12]. Patient Outcomes - A pancreatic cancer patient in the third-line setting has been on atebimetinib monotherapy for over 18 months, showing a 34% reduction in target lesions and a 96% reduction in peak CA 19-9 levels [5].

Core Insights - Immuneering has received a composition of matter patent for atebimetinib, a deep cyclic inhibitor of MEK, which is crucial in cancer signaling pathways [1][3][5] - The Phase 2a study shows that first-line pancreatic cancer patients treated with atebimetinib plus chemotherapy have a 94% probability of surviving 6 months, significantly higher than the 67% survival rate with standard chemotherapy [2] - The patent for atebimetinib is expected to provide exclusivity until August 2042, with potential for extension, supporting the company's strategy to maximize its therapeutic potential across various cancers [3][5][8] Company Overview - Immuneering is a clinical-stage oncology company focused on developing therapies that improve patient outcomes and quality of life [6] - The lead product candidate, atebimetinib, is designed to enhance durability and tolerability in treating MAPK pathway-driven tumors, including pancreatic cancer [6] - The company plans to explore atebimetinib in combination with other therapies for various cancer types [5][9] Intellectual Property Strategy - The granted patent validates the innovative approach of Immuneering and secures key intellectual property for atebimetinib [5] - Additional patent applications are pending, with expiration expected into 2044, further strengthening the company's intellectual property portfolio [8]

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.

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]

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]

Core Insights - Immuneering Corporation is hosting a conference call and live webcast on June 17, 2025, to provide updates on its Phase 2a clinical trial of IMM-1-104 for first-line pancreatic cancer patients [1][2] Company Overview - Immuneering Corporation is a clinical-stage oncology company focused on developing treatments that help patients outlive their disease [3] - The lead product candidate, IMM-1-104, is an oral, once-daily deep cyclic inhibitor of MEK, aimed at improving durability and tolerability while expanding indications to include MAPK pathway-driven tumors, particularly pancreatic cancers [3] - IMM-1-104 is currently undergoing a Phase 2a trial in patients with advanced solid tumors, including pancreatic cancer [3] - The company also has early-stage programs in its development pipeline [3]

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].