Shares of Cellectis S.A. (NASDAQ:CLLS) tanked on Tuesday after Allogene Therapeutics Inc. (NASDAQ:ALLO) cited a favorable arbitration outcome for partner Servier in its dispute with Cellectis related to the CAR-T therapy cemacabtagene ansegedleucel (cema-cel).The win reconfirmed Allogene’s full development and commercial control of cema-cel in the U.S., the EU and the U.K., while clearing the path to obtain full global commercialization rights from Servier.Also Read: Why Cellectis Stock Is Trading Higher To ...

Arbitration Ruling Reaffirms Allogene’s Full Control of Cemacabtagene Ansegedleucel (Cema-Cel)Decision Reconfirms Allogene’s Expanded Sub-License Covering EU and UK Rights with Options for Japan and China, Clearing the Path for Allogene to Acquire Full Global Rights 1H 2026 Interim Futility Analysis from the Pivotal Phase 2 ALPHA3 Trial with Cema-Cel in First-Line (1L) Consolidation Large B-Cell Lymphoma (LBCL) Remains on Track SOUTH SAN FRANCISCO, Calif., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Allogene Therapeu ...

Arbitration Ruling Reaffirms Allogene’s Full Control of Cemacabtagene Ansegedleucel (Cema-Cel)Decision Reconfirms Allogene’s Expanded Sub-License Covering EU and UK Rights with Options for Japan and China, Clearing the Path for Allogene to Acquire Full Global Rights 1H 2026 Interim Futility Analysis from the Pivotal Phase 2 ALPHA3 Trial with Cema-Cel in First-Line (1L) Consolidation Large B-Cell Lymphoma (LBCL) Remains on Track SOUTH SAN FRANCISCO, Calif., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Allogene Therapeu ...

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]

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.

Summary of Allogene Therapeutics Conference Call Company Overview - **Company**: Allogene Therapeutics (NasdaqGS:ALLO) - **Event**: Conference at TD Cowen's I&I Summit on November 12, 2025 Key Points on ALLO-329 and Autoimmune Research - **Product Introduction**: ALLO-329 is an allogeneic, off-the-shelf CAR T therapy currently in phase 1 clinical trials targeting autoimmune conditions [4][5] - **Differentiation**: ALLO-329 is designed to bypass lymphodepletion requirements, which is a common issue in CAR T therapies. This is expected to enhance safety and broaden its application in autoimmune disorders [5][6] - **Mechanism of Action**: ALLO-329 targets both CD19 and CD70, allowing it to address not only B cells but also T cells and antigen-presenting cells, which are crucial in the development of autoimmunity [6][7] - **Patient Population**: The phase 1 study focuses on patients with rheumatologic disorders, including lupus and lupus nephritis, inflammatory myositis, and scleroderma [10][11] - **Study Design**: The trial includes two cohorts: one with reduced lymphodepletion and another without any lymphodepletion, aiming to establish safety and early efficacy [12][20] Enrollment and Study Progress - **Enrollment Strategy**: The study is primarily enrolling patients at academic centers, with a focus on generating excitement around the unique mechanism of action and off-the-shelf availability of ALLO-329 [19][20] - **Initial Data Expectations**: Initial proof of concept data is anticipated in the first half of the following year, with a focus on biomarkers related to CAR T cell behavior and disease-related biomarkers [21][22] Dagger Technology and Lymphodepletion - **Confidence in Technology**: The ability to reduce or eliminate lymphodepletion is supported by preclinical data and clinical experience with CD70 targeting in other studies [13][14] - **Clinical Outcomes**: The goal is to reset the immune system without permanently depleting B or T cells, allowing for a more manageable immune response [16][17] ALPHA3 Trial and MRD Conversion - **Trial Overview**: The ALPHA3 trial aims to convert MRD-positive patients to MRD-negative status using cema-cel, with a focus on high-risk patients post-R-CHOP treatment [32][34] - **Expected Outcomes**: A MRD conversion rate of around 30% is considered a benchmark for continued pivotal development, with the control arm expected to show minimal spontaneous conversions [40][42] Conclusion - **Overall Sentiment**: There is significant optimism regarding the enrollment and initial data from both ALLO-329 and the ALPHA3 trial, with a strong focus on innovative treatment approaches in the autoimmune and oncology spaces [30][41]

Allogene Corporate Overview November 2025 Legal Disclaimers This presentation contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. To the extent that statements contained in this presentation are not descriptions of historical facts regarding Allogene Therapeutics, Inc. ("Allogene," "we," "us," or "our"), they are forward-looking statements reflecting management's current beliefs and expectations. Forward-looking statem ...

Group 1 - The article is authored by Terry Chrisomalis, who operates the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace, offering a two-week free trial for new subscribers [1] - Chrisomalis has extensive experience as a private investor in the Biotech sector, leveraging his Applied Science background to create long-term value in Healthcare [2] - The Biotech Analysis Central group includes over 600 Biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and various analysis and news reports to assist Healthcare investors [2]

Core Insights - Allogene Therapeutics reported a narrower loss of 19 cents per share for Q3 2025, compared to an expected loss of 23 cents and a loss of 32 cents per share in the same period last year [1][6] - The company's shares have decreased by 51% year-to-date, while the industry has seen an 11% growth [1] Financial Performance - Research and development (R&D) expenses were $31 million, a decrease of 30% from the previous year [3][6] - General and administrative (G&A) expenses fell by 16% year-over-year to approximately $14 million [3][6] - As of September 30, 2025, Allogene had $277 million in cash and cash equivalents, down from $303 million as of June 30, 2025 [3][6] 2025 Guidance - The company reiterated its guidance for 2025, expecting total operating expenses to be around $230 million, which includes nearly $45 million in non-cash stock-based compensation [4] - Cash burn for 2025 is anticipated to be around $150 million, with the current cash position expected to fund operations into the second half of 2027 [4][6] Pipeline Updates - Allogene is focused on the pivotal phase II ALPHA3 study for its lead drug cema-cel, targeting newly diagnosed large B-cell lymphoma patients [7] - The company has initiated the phase I RESOLUTION basket study for ALLO-329, exploring its potential in various autoimmune diseases, with data expected in the first half of 2026 [8] - Allogene is also developing ALLO-316, currently in the phase I TRAVERSE study for advanced renal cell carcinoma, and is seeking partnership opportunities for its development [9] Market Position - Allogene currently holds a Zacks Rank of 4 (Sell) [10]

Financial Data and Key Metrics Changes - As of September 30, 2025, the company reported $277.1 million in cash, cash equivalents, and investments, with a cash runway extending into the second half of 2027 [17] - R&D expenses for Q3 2025 were $31.2 million, including $2.8 million of non-cash stock-based compensation, while G&A expenses were $13.7 million, including $5.9 million in non-cash stock-based compensation [17] - The net loss for Q3 was $41.4 million, or $0.19 per share, with an expected cash burn of approximately $150 million for 2025 [17][18] Business Line Data and Key Metrics Changes - The AlphaTru trial of cema-cel has been streamlined into a two-arm randomized study, with over 50 active sites across the U.S. and Canada, and expansion into Australia and South Korea expected early next year [8][9] - The Dagger technology has shown durable responses in nearly one-third of patients with metastatic kidney cancer, highlighting its potential in solid tumors [11][12] Market Data and Key Metrics Changes - The company is preparing for pivotal interim data from cema-cel in the AlphaTru trial and proof of concept from Allo329 in autoimmune disease, both expected to shape the next era of cell therapy [6][7] Company Strategy and Development Direction - The company aims to democratize access to cell therapies through Allogene XL Technology, which is designed to reduce costs and expand access to transformative treatments [5][6] - The focus remains on building scalable, reproducible therapies ready for patients, with significant milestones expected in the first half of 2026 [66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the AlphaTru program and its potential to advance lymphoma treatment, with a focus on delivering meaningful clinical outcomes [11][15] - The company is optimistic about the upcoming milestones and believes they will validate the Allogene XL platform, shaping the company's trajectory [66] Other Important Information - The company is not waiting for the future of cell therapy but is actively creating it with a focus on data and a platform built for lasting impact [6][15] - The operational and scientific progress is supported by disciplined capital management, ensuring long-term value for shareholders [17][18] Q&A Session Summary Question: Can you see any data beyond MRD conversion for the futility analysis? - Management plans to focus on MRD conversion and not on primary endpoints for efficacy during the futility analysis [20][21] Question: What percentage of active sites are now able to start actively enrolling patients? - Nearly all of the over 50 active sites are open to enrollment, with only the most recently activated sites having minor setup tasks remaining [25][26] Question: What is the expected size and breadth of the data set for Allo329 next year? - Initial communication will involve a handful of patients showing biomarker and early clinical responses [29][30] Question: How many patients have consented for MRD testing in AlphaTru? - The pace of consenting has held steady, and the MRD positive rate is consistent with initial assumptions [33][34] Question: How are you controlling for variability in the MRD assay across different sites? - The MRD test is centrally conducted by Foresight Diagnostics, ensuring consistency in test performance [62][63]