Core Insights - Cellectis is advancing its clinical-stage biotechnology efforts with promising data from its CAR-T therapies, particularly lasme-cel, which has shown a 100% overall response rate in a pivotal Phase 2 trial for relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) [3][5][11] - The company reported financial results for the year ending December 31, 2025, highlighting a significant increase in revenues and ongoing investments in research and development [2][33][39] Clinical Developments - Lasme-cel has demonstrated a 100% overall response rate in the target Phase 2 population, converting all patients into transplant-eligible candidates [3][10] - The pivotal Phase 2 trial (BALLI-01) is currently enrolling, with interim analysis expected in Q4 2026 and a Biologics License Application (BLA) submission anticipated in 2028 [3][11] - Eti-cel, another product in development for relapsed or refractory non-Hodgkin lymphoma (r/r NHL), has shown an 88% overall response rate and 63% complete response rate in preliminary Phase 1 data [16][33] Financial Performance - Cellectis reported consolidated revenues of $79.6 million for the year ended December 31, 2025, compared to $49.2 million in 2024, marking a $30.4 million increase primarily driven by research activities and collaboration agreements [33][39] - The company had cash, cash equivalents, and fixed-term deposits totaling $211 million as of December 31, 2025, providing a financial runway into H2 2027 [4][30] - Consolidated net loss attributable to shareholders was $67.6 million for 2025, compared to a loss of $36.8 million in 2024, reflecting increased revenues offset by higher operating expenses and financial losses [39][40] Research and Development - Cellectis is focusing on the development of its pipeline, including lasme-cel and eti-cel, with ongoing clinical trials and the exploration of new product candidates [32][33] - The company is also advancing its gene editing technologies, including the use of circular single-stranded DNA (cssDNA) as a non-viral template for gene therapy, which has shown superior efficiency compared to traditional methods [13][17] Partnerships - Cellectis has established a Joint Research and Collaboration Agreement with AstraZeneca to develop up to 10 novel cell and gene therapy products targeting high unmet medical needs [21][27] - The company is also collaborating with Servier and Allogene on various CAR-T therapies, with potential milestone payments and royalties from these partnerships [27][21]

CRISPR Corporate Update 44th Annual J.P. Morgan Healthcare Conference January 12, 2026 1 Forward-Looking Statements This presentation and related materials may contain statements regarding matters that are not historical facts and are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Suc ...

Summary of Allogene Therapeutics Conference Call Company Overview - **Company**: Allogene Therapeutics (NasdaqGS:ALLO) - **Founded**: 2018 - **Focus**: Development of Allogene CAR-T therapies, particularly in hematologic malignancies and autoimmune diseases [2][3] Key Programs and Developments 1. Cema-cel (CD19-directed CAR-T) - **Indications**: Hodgkin's lymphoma and large B-cell lymphoma - **Clinical Setting**: Targeting MRD positive patients post R-CHOP treatment, aiming for frontline consolidation therapy [3][9] - **Study Design**: Randomized one-to-one trial comparing cema-cel treatment to observation, with an expected enrollment of approximately 220 patients [10] - **Market Opportunity**: Estimated market size for frontline consolidation therapy is around $5 billion in the US and Europe, compared to $2.5 billion-$3 billion for relapse refractory settings [12] 2. Allo329 (Dual CD19/CD70 CAR-T) - **Indications**: Autoimmune diseases - **Objective**: Reduce lymphodepletion while targeting both B-cells and T-cells [4][5] - **Current Status**: Enrolling patients in a dose escalation study, with initial data expected in the first half of 2026 [14] 3. Allo316 (Solid Tumor Program) - **Indications**: Renal cell cancer - **Response Rate**: Approximately 31% in heavily pre-treated patients, with durable responses observed beyond one year [15][16] - **Safety Profile**: Consistent with active CAR-T therapies, including lymphodepletion-related cytopenia and cytokine release syndrome [17] Clinical and Market Insights - **MRD Testing**: Utilized to identify high-risk patients for targeted therapy, with a projected 25%-30% improvement in MRD conversion seen as a significant breakthrough [21][22] - **Regulatory Engagement**: Event-free survival (EFS) is the primary endpoint for the AlphaTreE study, with MRD negativity used as a proxy for efficacy [29] Strategic Initiatives - **Community-Based Treatment**: Expanding access to CAR-T therapies in community cancer centers to capture more patients [11][20] - **Manufacturing Capacity**: Dedicated facility capable of producing up to 60,000 doses per year, with reduced cost of goods to biologic levels [6] Future Expectations - **Upcoming Data Releases**: Initial interim analysis for cema-cel and proof of concept data for autoimmune studies expected in the first half of 2026 [32] Conclusion Allogene Therapeutics is advancing its innovative CAR-T therapies with a focus on addressing unmet needs in hematologic malignancies and autoimmune diseases. The company is strategically positioning itself to capture significant market opportunities while enhancing patient access through community-based treatment initiatives.

Core Insights - Galapagos NV is recognized as one of the best performing biotech stocks in 2025, focusing on next-generation oncology through its CAR-T programs and decentralized manufacturing model [1] Group 1: Product Development and Clinical Trials - The momentum for Galapagos NV centers on GLPG5101, a CAR-T therapy for B-cell lymphomas, which recently received RMAT designation from the FDA for relapsed/refractory mantle cell lymphoma, showcasing promise in the ongoing Phase 1/2 ATALANTA-1 trial [2] - The company reported a 97% complete response rate and 100% MRD negativity in patients with indolent non-Hodgkin lymphoma at the 2025 ICML conference, with a vein-to-vein time of just seven days, distinguishing it from traditional CAR-T products [2][4] - Galapagos NV is expanding the ATALANTA-1 trial to new cohorts, including Richter transformation and chronic lymphocytic leukemia, while its second CAR-T candidate, GLPG5301, targeting multiple myeloma, is progressing through early development [3] Group 2: Manufacturing and Collaboration - A key differentiator for Galapagos NV is its decentralized manufacturing platform, enabling the production of "fresh" CAR-T therapies closer to patients, which enhances scalability and access [4] - Recent collaborations with the Moffitt Cancer Center in the U.S. and CELLforCURE in Paris are strengthening this decentralized manufacturing model [4]

CARVYKTI® Performance and Market Position - CARVYKTI® demonstrates superior Overall Survival (OS) compared to Standard of Care (SoC) in Multiple Myeloma[15, 25] - CARVYKTI® has a strong launch with a 79% Net Trade Sales Compound Annual Growth Rate (CAGR) since launch, leading the industry[15] - CARVYKTI® Net Trade Sales grew by 135% in Q1 2025 compared to Q1 2024[34] - Outpatient treatment represents up to approximately 48% of CARVYKTI® volume in the U S [44] Manufacturing and Supply - The company aims to achieve 10,000 annualized doses of CARVYKTI® exiting 2025 and 20,000 annualized doses exiting 2027[58] - Commercial production at the Tech Lane facility in Belgium is targeted to initiate in the second half of 2025[58] Pipeline and R&D - The company has 11 pipeline programs in Hematologic Malignancies, Solid Tumors, and Autoimmune Diseases[11] - Legend Biotech and Novartis have an exclusive agreement to advance DLL3-targeted CAR-T therapies, including LB2102 for small cell lung cancer[74] - LB2102 targets DLL-3, which is approximately 80% positive in Small Cell Lung Cancer (SCLC)[80] Multiple Myeloma Market - Multiple Myeloma accounts for 10% of all hematologic cancers[17] - There were 187,952 new cases of Multiple Myeloma worldwide in 2022[18]

Table of Contents As filed with the Securities and Exchange Commission on May 31, 2023 Registration No. 333-269782 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Pre-effective Amendment No. 2 to FORM S-1/A REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 COEPTIS THERAPEUTICS HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation) (Primary Standard Industrial Classification Code Number) Delaware 2834 98-1465952 (I.R. ...