Summary of Allogene Therapeutics FY Conference Call Company Overview - **Company**: Allogene Therapeutics (NasdaqGS:ALLO) - **Focus**: Allogeneic cell therapy, specifically targeting large B-cell lymphoma and autoimmune diseases Key Points on Allogeneic Cell Therapy - **Lead Program**: CD19-directed CAR-T therapy called cema-cel, focusing on relapsed refractory large B-cell lymphoma [4][5] - **Objective**: Democratize cell therapy by simplifying logistics and reducing manufacturing costs, allowing treatment in community-based cancer centers [4] - **Current Study**: Alpha-3 study, targeting MRD positive patients post-R-CHOP treatment to assess the efficacy of cema-cel [6][9] Study Design and Expectations - **Study Design**: Patients completing R-CHOP will be tested for MRD; MRD positive patients will be randomized to receive either cema-cel or standard care [5][6] - **Interim Analysis**: Expected in the first half of 2026, focusing on MRD conversion rates and safety [6][9] - **Primary Endpoint**: Event-free survival (EFS), with a target differential of 30% between treatment arms to predict clinical outcomes [9][10] Market Dynamics and Adoption Challenges - **Market Adoption**: Expected to be data-driven; successful outcomes could lead to high adoption rates in community settings [17][18] - **MRD Testing**: Increasing trend in hematology; adoption of MRD testing is crucial for the success of the therapy [17][18] - **Patient Population**: Approximately one-third of patients treated with R-CHOP are expected to be MRD positive [14] Autoimmune Program: ALLO-329 - **Program Overview**: ALLO-329 is a dual CAR targeting CD19 and CD70, designed to address autoimmune disorders by depleting autoreactive B-cells and activated T-cells [31][32] - **Current Study**: Conducting a basket study for conditions like lupus and inflammatory myositis, with a focus on lymphodepletion strategies [31][32] - **Expected Data**: Initial data on CAR-T cell expansion and disease-specific biomarkers anticipated in the first half of 2026 [32][33] Competitive Landscape - **In Vivo CAR-T vs. Allogeneic CAR-T**: Allogeneic CAR-T is seen as more advanced due to established manufacturing processes and clinical data, while in vivo CAR-T is still in development [43][44] - **Cost of Goods**: Allogeneic CAR-T is projected to have a cost advantage due to efficient manufacturing capabilities [46] Conclusion - Allogene Therapeutics is positioned to make significant advancements in both oncology and autoimmune therapies through its innovative allogeneic CAR-T approaches, with key data releases expected in 2026 that could shape market adoption and clinical outcomes [47][48]

Core Insights - Indaptus Therapeutics, a clinical stage biotechnology company, is focused on innovative treatments for cancer and viral infections, and will present at the 3rd Donor Selection & Cell Source Summit in San Diego [1][4] Company Overview - Indaptus Therapeutics is leveraging over a century of immunotherapy advancements, utilizing a patented Decoy platform that activates both innate and adaptive immune responses through a multi-targeted approach [5] - The Decoy platform consists of non-pathogenic, Gram-negative bacteria designed to activate immune pathways safely via intravenous administration, showing promise in treating various cancers and viral infections [5] Research and Development - Dr. Michael Newman will present research on the Decoy bacterial platform, which aims to address donor cell variability in allogeneic immune cell cancer therapy [2][4] - The lead candidate, Decoy20, utilizes killed bacteria to induce a broad immune response, potentially enhancing the quality and consistency of allogeneic immune cell products [3][4] - Preclinical data indicates that Decoy bacteria can activate key immune cell types, suggesting their potential to improve the potency and reproducibility of donor-derived cell therapies [4] Industry Context - The Donor Selection & Cell Source Summit aims to tackle challenges in donor screening and cell sourcing within the expanding allogeneic cell therapy market, bringing together industry and academic leaders [4]

Group 1 - The article expresses a cautiously optimistic view on the prospects of Allogene Therapeutics and its allogeneic cell therapy platform, highlighting concerns about the long lead time to potential drug development [1] - The author has a PhD in biochemistry and extensive experience analyzing clinical trials and biotech companies, emphasizing the importance of understanding the science behind investments in this sector [1] Group 2 - There are no disclosed stock or derivative positions in any of the companies mentioned, nor plans to initiate such positions in the near future [2] - The article reflects the author's personal opinions and is not influenced by any business relationships with the companies discussed [2]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company's cash position was $47.9 million, expected to support operations into Q1 2027 [23] - Total revenues for Q1 2025 were $1.5 million, a net increase of $0.1 million compared to $1.4 million for the same period in 2024, primarily driven by collaboration revenue from Roche [24] - Operating expenses for Q1 2025 were $8 million, a decrease of $0.1 million compared to $8.1 million in Q1 2024 [24] - The net loss for Q1 2025 was $4.1 million or $0.02 per share, compared to a net loss of $6.5 million or $0.04 per share for the same period in 2024 [25] Business Line Data and Key Metrics Changes - OpRegen is currently in a Phase 2a study called the GALET study, which is exploring various parameters of surgical delivery [7] - The OPC1 program has been tested in 30 individuals with severe spinal cord injuries, with promising long-term safety and efficacy data [18] Market Data and Key Metrics Changes - The company is encouraged by recent positive data from competing RPE companies, which supports the potential of RPE transplants to drive clinical outcomes beyond currently approved therapies [13] Company Strategy and Development Direction - The company aims to capitalize on investments in cell manufacturing and expand capabilities through partnerships beyond OpRegen and OPC1 [27] - The manufacturing platform is seen as a competitive advantage, allowing for low-cost production of allogeneic therapies [15] Management's Comments on Operating Environment and Future Outlook - Management remains confident in OpRegen's potential to drive positive clinical outcomes in dry AMD and is encouraged by partners' commitment to the program [27] - The company is preparing for success by seeking additional partnerships and funding opportunities [27] Other Important Information - The company has completed GMP production runs capable of producing millions of doses from a single cell line, marking a significant achievement in manufacturing capabilities [16] Q&A Session Summary Question: Comparison of manufacturing capabilities with peers - Management expressed frustration over the lack of detailed comparisons from peers but emphasized their differentiated capabilities in manufacturing [31][33] Question: Potential tariff impacts due to manufacturing site in Israel - Management does not expect tariff impacts and has measures in place to mitigate production issues [36][37] Question: Thoughts on potential partnerships around new manufacturing capabilities - Management indicated that partnerships would vary by opportunity, focusing on success payments and ownership in assets rather than becoming a contract manufacturer [44] Question: Expected data from the OPC1 program - Initial data from the dose study is expected to be available within 30 days, with functional assessments potentially lagging by several months [54] Question: Design of the spinal cord injury trial - The trial will enroll between six and ten patients, with a staggered approach for thoracic and cervical patients [90]