Core Viewpoint - Matinas BioPharma Holdings, Inc. has appointed Keith Murphy and Edward Neugeboren as independent members of its Board of Directors, effective March 11, 2025, while Matthew Wikler and Natasha Giordano have stepped down from the Board [1][2] Group 1: Board Appointments - Keith Murphy and Edward Neugeboren bring extensive biotech industry experience to Matinas BioPharma's Board, which is expected to enhance the company's strategic direction and shareholder value [2] - Mr. Murphy will chair the Nominating and Governance Committee and join the Compensation Committee, while Mr. Neugeboren will chair the Compensation Committee and join the Audit Committee [2] Group 2: Profiles of New Board Members - Keith Murphy has a strong background in biotech, having co-founded Viscient Bio and previously led Organovo Holdings, with significant experience at Amgen, where he was involved in the development of denosumab, generating over $6 billion in annual sales [3][4] - Edward Neugeboren has over 33 years of experience in healthcare, including roles in corporate management and investment banking, and currently serves as Chief Strategy Officer at Cronus Pharma, leading various commercial operations [5][6][7] Group 3: Company Overview - Matinas BioPharma focuses on innovative therapies utilizing its lipid nanocrystal (LNC) platform technology [8] - The company's MAT2203 is a potential oral treatment for invasive fungal infections, designed to overcome limitations of existing therapies, and has shown promising results in Phase 2 studies [9]

Financial Data and Key Metrics Changes - For the full year 2024, the company recognized approximately EUR2.8 billion in revenues, a decrease from around EUR3.8 billion in 2023, primarily due to lower COVID-19 vaccine market demand [57][58] - The net loss for 2024 was EUR665 million, compared to a net profit of EUR930 million in the prior year [61] - The diluted loss per share for 2024 was EUR2.77, compared to EUR3.83 for the prior year [61] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses for 2024 reached approximately EUR2.3 billion, up from roughly EUR1.8 billion in 2023, driven by advancing priority programs [58] - Selling, general and administrative (SG&A) expenses for 2024 amounted to approximately EUR599 million, compared to EUR558 million in 2023, primarily due to the build-out of the commercial organization [59] Market Data and Key Metrics Changes - The company maintained a leading market share globally for its COVID-19 vaccine in collaboration with Pfizer [15] - The revenue guidance for 2025 is projected to be in the range of EUR1.7 billion to EUR2.2 billion, assuming stable vaccination rates and market share compared to 2024 [65] Company Strategy and Development Direction - The company aims to become a fully integrated biopharmaceutical company with multiple approved products, focusing on oncology and infectious diseases [8][10] - Significant investments are being made in clinical development for key programs, including BNT327 and mRNA cancer immunotherapies, with a strategic focus on late-stage trials [11][67] - The acquisition of Biotheus is expected to enhance the company's capabilities in immunotherapy and expand its global development efforts [19][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the company's intellectual property and its ability to navigate ongoing legal disputes [80] - The company anticipates 2025 to be a data-rich year with multiple updates across its oncology pipeline, particularly for BNT327 and mRNA cancer immunotherapies [72][74] Other Important Information - The company plans to share multiple clinical updates throughout 2025, including data for BNT327 and its mRNA cancer immunotherapies at upcoming oncology conferences [74] - The company expects to continue its commercial build-out for oncology in preparation for potential product launches [69] Q&A Session Summary Question: Overview of legal events and potential outcomes - Management indicated that predicting the timing of legal disputes is challenging and referred to the 20-F filing for detailed explanations [79] Question: Context for FixVac data in melanoma - Management confirmed that the FixVac candidate BNT111 met its primary endpoint in a Phase 2 trial and further data will be presented later this year [82] Question: Status of partnership for BNT327 - Management stated that they are currently proceeding independently with BNT327 but are evaluating potential collaborations for broader applications [92] Question: Efficacy expectations for BNT323 in endometrial cancer - Management expects response rates around 50% for HER2+ tumors and is confident in meeting registration requirements [112] Question: Expectations for upcoming data on small cell lung cancer - Management anticipates further validation of previous data with new datasets expected to support aggressive movement into pivotal trials [119]

Financial Data and Key Metrics Changes - As of December 31, 2024, the company reported year-end cash, cash equivalents, and marketable securities of $47.8 million, along with approximately $5.5 million in net proceeds from a financing event [40] - Total revenues for Q4 2024 were approximately $2.9 million, a net increase of $0.8 million compared to $2.1 million for the same period in 2023 [43] - The net loss attributable to the company for Q4 was $3.3 million or $0.02 per share, compared to a net loss of $4.8 million or $0.03 per share for the same period in 2023 [46] Business Line Data and Key Metrics Changes - R&D expenses for Q4 2024 were $3.4 million, a decrease of $0.5 million compared to $3.9 million for the same period in 2023, primarily driven by a decrease in OPC1 program expenses [44] - Total operating expenses for Q4 were $7.8 million, a decrease of $0.4 million compared to $8.2 million for the same period in 2023 [44] Market Data and Key Metrics Changes - The company noted an increase in OpRegen activity, with Roche and Genentech entering into an additional agreement to provide services for manufacturing and long-term follow-up of Phase 1/2a patients [11][12] - The ongoing GAlette Study has been enrolling for nearly two years, indicating a significant amount of data should be available for decision-making [10] Company Strategy and Development Direction - The company is focused on scalable GMP manufacturing, which is crucial for the success of allogeneic cell therapy products [22][30] - The company aims to establish a leading position in allogeneic process development and production, emphasizing the need for large-scale production capabilities [29][30] - The company is advancing its second clinical stage allogeneic program, OPC1, with plans for a larger clinical trial in spinal cord injury [31][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for OpRegen to drive positive clinical outcomes in dry AMD, supported by independent evidence from other RPE transplant trials [52] - The company is strategically balancing cost and investment while exploring other potential funding sources, including milestone payments and program grants [42][90] Other Important Information - The company has continued to add value to its patent portfolio, with two additional OpRegen patents issued earlier this year [38] - The company is preparing for a clinical study called the DOSED Study to test a novel delivery device for OPC1, which is expected to enhance the administration process [34][37] Q&A Session Summary Question: What is the company doing to protect its market leadership in RPE cell placements? - Management emphasized the importance of having the right attributes for success, highlighting the combination of Lineage's manufacturing, Genentech's product development, and Roche's commercialization capabilities as a competitive advantage [59][61] Question: When will the updated three-year data for OpRegen be available? - Management indicated that inquiries regarding the timeline for the three-year data should be directed to Genentech, as they control the announcement schedule [64] Question: Can you describe any changes in logistics for getting patients to the surgical suite faster? - Management noted improvements in training and the development of an immediate use formulation to streamline the process, reducing preparation time for cell administration [77][78] Question: Will the FDA require proof of device safety before fully enrolling across all planned sites for the DOSED study? - Management confirmed that there is a staging process, starting with a few patients before moving to broader enrollment [83] Question: What are the plans for the resonance program given market uncertainty? - Management stated that while the resonance program remains important, they are being prudent with investment decisions in the current market environment [88][90]

Summary of MAIA Biotechnology Inc (MAIA) 2025 Conference Call Company Overview - **Company**: MAIA Biotechnology Inc (MAIA) - **Focus**: Development of telomere targeting immunotherapies for cancer, specifically the lead molecule "thio" [2][10] Key Points and Arguments Clinical Trials and Efficacy - **Current Trials**: - THIO-101 is a pivotal phase two trial targeting non-small cell lung cancer (NSCLC) in combination with Regeneron's checkpoint inhibitor Libtayo, expected to enroll patients in 2025 [3][5] - THIO-102 will focus on colorectal cancer, hepatocellular carcinoma (HCC), and small cell lung cancer, with plans for separate trials [7][27] - THIO-103 is a planned phase two/three trial for first-line therapy, likely starting in 2026 [8][30] - **Efficacy Results**: - THIO-101 has shown over 80% disease control rates and response rates significantly higher than standard chemotherapy [4][25] - In preclinical studies, THIO combined with checkpoint inhibitors demonstrated a 60% complete response rate, compared to 2-5% with existing therapies [18][20] Market Opportunity - **Market Size**: The NSCLC market generated over $34 billion in sales last year, with significant opportunities in other hard-to-treat cancers [5][33] - **FDA Designations**: THIO has received three orphan drug designations and one rare pediatric disease designation, indicating high unmet medical need [5][6] Pipeline Development - **Second Generation Agents**: MAIA is developing a franchise of telomere targeting agents, with 84 new molecules in development, seven of which show superior efficacy [8][10] - **Intellectual Property**: The company holds a robust patent portfolio with over 30 patents, ensuring market exclusivity until at least 2041 [31] Financial Projections - **Sales Expectations**: The checkpoint inhibitor market was valued at $46 billion in early 2023, with expectations to exceed $50 billion in 2024 [33] - **Investment Potential**: The company anticipates significant revenue potential across multiple tumor types, with comparable companies valued between $1 billion and $4 billion at similar stages [35] Additional Important Information - **Safety Profile**: THIO has demonstrated a safety profile far superior to traditional chemotherapy, making it a promising alternative for patients [4][21] - **Management Experience**: The management team has extensive experience in oncology and drug development, enhancing investor confidence [32] Upcoming Milestones - **Data Releases**: - Full efficacy data from THIO-101 expected mid-2025, with median survival data anticipated in Q2 2025 [36][38] - **Regulatory Filings**: Plans for filing for US approval with potential accelerated approval in 2026 [37]