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Abeona Therapeutics® Reports Full Year 2025 Financial Results and Corporate Updates
Globenewswire· 2026-03-17 11:30
Core Insights - Abeona Therapeutics has completed its first commercial patient treatment of ZEVASKYN in December 2025, with plans to build momentum for its launch in the first quarter of 2026 [1][7] - The company reported total revenue of $5.8 million for the year ended December 31, 2025, which includes $3.4 million in license and other revenues and $2.4 million in net product revenue [3][9] - Abeona's net income for 2025 was $71.2 million, a significant turnaround from a net loss of $63.7 million in 2024 [9][14] Financial Performance - Total revenue for 2025 was $5.8 million, consisting of $2.4 million in net product revenue and $3.4 million in license and other revenues [3][14] - Cost of sales for 2025 was $1.5 million, primarily due to the first commercial treatment of ZEVASKYN and production costs from an August batch that faced technical challenges [5][14] - Research and development (R&D) spending decreased to $26.8 million in 2025 from $34.4 million in 2024, attributed to the FDA approval of ZEVASKYN [6][14] - Selling, general and administrative (SG&A) expenses rose to $65.0 million in 2025, an increase of $35.1 million over 2024, reflecting the company's commercial transition post-FDA approval [7][14] Operational Updates - The first ZEVASKYN treatment was completed in December 2025, with ongoing efforts to streamline the treatment process and expand patient access [1][4][7] - Abeona has activated The University of Texas Medical Branch (UTMB) as the fourth Qualified Treatment Center (QTC) for ZEVASKYN, enhancing patient access in Texas and the Gulf Coast region [7] - The company anticipates that positive patient experiences will drive sustained demand for ZEVASKYN within the recessive dystrophic epidermolysis bullosa (RDEB) community [7] Cash Position - As of December 31, 2025, Abeona reported cash, cash equivalents, and short-term investments totaling $191.4 million [1][9]
Cellectis to Report Fourth Quarter and Full Year 2025 Financial Results on March 19, 2026
Globenewswire· 2026-03-12 20:30
Core Insights - Cellectis will report its financial results for Q4 and full year 2025 on March 19, 2026, after the US market closes [1] - An investor conference call and webcast will take place on March 20, 2026, at 8:00 AM ET, to discuss the financial results and business updates [2] Company Overview - Cellectis is a clinical-stage biotechnology company focused on developing life-saving cell and gene therapies using a pioneering gene-editing platform [3] - The company employs an allogeneic approach for CAR T immunotherapies, aiming to provide off-the-shelf, ready-to-use gene-edited CAR T-cells for cancer treatment [3] - Cellectis has in-house manufacturing capabilities, making it one of the few end-to-end gene editing companies that control the entire cell and gene therapy value chain [3] Company Locations and Listings - Cellectis is headquartered in Paris, France, with additional locations in New York and Raleigh, NC [4] - The company is listed on the Nasdaq Global Market under the ticker CLLS and on Euronext Growth under the ticker ALCLS [4]
Senti Biosciences to Present at Leerink Partners 2026 Global Healthcare Conference
Globenewswire· 2026-03-03 14:05
Core Insights - Senti Biosciences, Inc. is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][3] - The company will present at the Leerink Partners 2026 Global Healthcare Conference on March 9, 2026, at 2:20 PM ET [1] Company Overview - Senti Bio is dedicated to creating innovative cell and gene therapies for patients with incurable diseases, utilizing a synthetic biology platform to engineer Gene Circuits [3] - The Gene Circuits are designed to selectively target and kill cancer cells while sparing healthy cells, enhancing specificity to target tissues, and allowing for control post-administration [3] - The company's pipeline includes cell therapies engineered with Gene Circuits aimed at addressing challenging liquid and solid tumor indications, with preclinical evidence supporting their efficacy in both NK and T cells [3] - Senti Bio is also exploring the application of Gene Circuits in other disease modalities beyond oncology through ongoing partnerships [3]
Abeona Therapeutics® Announces Date of Fourth Quarter / Full Year 2025 Financial Results and Participation in Upcoming 2026 Leerink Global Healthcare Conference
Globenewswire· 2026-03-03 12:30
Core Viewpoint - Abeona Therapeutics Inc. is set to discuss its fourth quarter and full year 2025 financial results and corporate progress in a conference call on March 17, 2026 [1] Group 1: Conference Call Details - The conference call will take place at 8:30 a.m. ET and will be accessible via phone and webcast [1][2] - Participants can join the call by dialing 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) with Entry Code: 977217 [2] - A live webcast and archived replay will be available on the Investors & Media section of Abeona's website for 30 days following the call [2] Group 2: Upcoming Events - Abeona management will participate in a fireside chat at the 2026 Leerink Global Healthcare Conference on March 10, 2026, at 8:40 a.m. ET [3] - The fireside chat will also be available via a live webcast and archived for 30 days on the company's website [3] Group 3: Company Overview - Abeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases [4] - The company's ZEVASKYN is the first autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [4] - Abeona operates a fully integrated cGMP manufacturing facility in Cleveland, Ohio, which is used for ZEVASKYN's commercial production [4] - The company is also developing adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with high unmet medical needs [4]
J&J to build $1bn US CGT manufacturing site in Pennsylvania
Yahoo Finance· 2026-02-19 12:02
Core Insights - Johnson & Johnson (J&J) has selected Pennsylvania for a new $1 billion cell therapy manufacturing facility, aligning with the Trump administration's push to onshore drug production in the US amid increasing global competition [1] - The new facility is expected to create over 500 skilled biomanufacturing jobs and 4,000 construction positions, marking J&J's eleventh site in Pennsylvania [2] - J&J's current cell therapy product, Carvykti, generated $1.9 billion in global sales in FY2025, with forecasts predicting sales of $7.8 billion by 2031 [3] Manufacturing Expansion - The Pennsylvania facility is part of J&J's broader $55 billion initiative to expand its manufacturing footprint in the US, which includes a $2 billion biologics production facility under construction in North Carolina [4] - J&J's decision to onshore manufacturing reflects a trend in the pharmaceutical industry, with companies aligning their operations with governmental goals, particularly in emerging biotech hubs like North Carolina and Virginia [6] Industry Trends - The approach to cell and gene therapies varies among pharmaceutical companies; while J&J is investing in cell therapy, others like Takeda have shifted focus away from this modality [7] - Conversely, companies such as Eli Lilly are actively pursuing cell and gene therapy opportunities, evidenced by significant deals in this area [8]
Senti Biosciences Selected for On-Stage Presentation at Healthcare Conference Taipei 2026
Globenewswire· 2026-02-03 14:00
Core Insights - Senti Biosciences, Inc. has been selected to present at the Healthcare Conference Taipei 2026, showcasing its Gene Circuit technology platform and strategic priorities [1][2][3] Company Overview - Senti Bio is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][4] - The company aims to create therapies that precisely target and kill cancer cells while sparing healthy cells, enhancing specificity to target tissues, and allowing control post-administration [4] Presentation Details - The presentation is scheduled for February 10, 2026, from 10:30 AM to 10:40 AM local time, and will last for eight minutes [2] - The focus will be on the Gene Circuit technology, pipeline progress, and opportunities for partnerships in investment, research and development, manufacturing, and clinical collaboration [2][3] Strategic Importance - The conference will gather global investors and strategic partners, providing a platform for Senti Bio to discuss potential collaborations aimed at advancing transformative therapeutic programs [3]
Cellectis Announces 2026 Strategy and Catalysts
Globenewswire· 2026-01-08 21:30
Core Insights - Cellectis is focusing on advancing its late-stage allogeneic CAR-T therapies, particularly lasme-cel and eti-cel, with significant clinical trials and partnerships expected to drive growth in 2026 [2][3][4]. Clinical Development - The pivotal Phase 2 trial for lasme-cel in relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) has commenced, with interim data anticipated in Q4 2026 [2][3]. - Lasme-cel has shown a 68% overall response rate (ORR) and a 56% complete remission rate in early trials, indicating strong efficacy [5]. - The NATHALI-01 trial for eti-cel in relapsed/refractory non-Hodgkin lymphoma (NHL) reported an 88% ORR and a 63% complete remission rate, with further data expected in Q4 2026 [6]. Strategic Partnerships - Cellectis is collaborating with AstraZeneca to develop up to 10 novel cell and gene therapy products targeting high unmet medical needs, leveraging Cellectis' gene editing and manufacturing capabilities [4]. Financial Position - The company projects that its cash reserves will sustain operations into the second half of 2027, indicating a stable financial outlook [8]. Upcoming Events - Cellectis management will participate in the J.P. Morgan Healthcare Conference from January 12-15, 2026, for investor meetings [9].
Cellectis Announces Arbitral Decision in Dispute with Servier
Globenewswire· 2025-12-15 21:51
Core Insights - Cellectis announced a decision from the Arbitral Tribunal regarding its arbitration with Servier related to the License Agreement established on March 6, 2019 [1][2] - The Tribunal partially terminated the License Agreement concerning product UCART19 V1 and mandated Cellectis to engage in discussions for a direct license at Allogene's request [2] Company Overview - Cellectis is a clinical-stage biotechnology company focused on developing cell and gene therapies using its gene-editing platform [3] - The company specializes in allogeneic CAR T immunotherapies, aiming to provide off-the-shelf gene-edited CAR T-cells for cancer treatment [3] - Cellectis maintains in-house manufacturing capabilities, positioning itself as a comprehensive player in the gene editing value chain [3] Company Locations and Listings - Cellectis is headquartered in Paris, France, with additional locations in New York and Raleigh, NC [4] - The company is publicly traded on the Nasdaq Global Market under the ticker CLLS and on Euronext Growth under the ticker ALCLS [4]
Abeona Therapeutics® Announces Appointment of Mohamad Tabrizi as Chief Business Officer
Globenewswire· 2025-12-15 12:30
Core Viewpoint - Abeona Therapeutics Inc. has appointed Mohamad Tabrizi as Senior Vice President and Chief Business Officer to enhance corporate strategy and business development efforts [1][2]. Group 1: Appointment and Role - Mohamad Tabrizi will lead the company's corporate strategy and business development functions, focusing on driving operational efficiency [1]. - Tabrizi has extensive experience in strategic planning and business development, which the company aims to leverage for optimizing operations and forming value-creating partnerships [2]. Group 2: Professional Background - Tabrizi previously worked in the venture capital sector as a General Partner and Managing Director at Pandect Bioventures and the Berkeley Catalyst Fund, where he led investment activities and operational roles [2]. - He has a strong track record in corporate development and capital markets, having executed 20 transactions at Nektar Therapeutics and led over 40 transactions as a healthcare investment banker, raising more than $5 billion [3]. Group 3: Company Overview - Abeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases, including its product ZEVASKYN, the first autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa [4]. - The company operates a fully integrated cGMP manufacturing facility in Cleveland, Ohio, which is responsible for the commercial production of ZEVASKYN [4].
Abeona Therapeutics® Reports Third Quarter 2025 Financial Results and Corporate Updates
Globenewswire· 2025-11-12 12:30
Core Insights - Abeona Therapeutics Inc. reported financial results and operational progress for Q3 2025, highlighting the anticipated launch of ZEVASKYN and its growing patient demand [1][2][3] Financial Performance - As of September 30, 2025, the company had $207.5 million in cash, cash equivalents, restricted cash, and short-term investments, which is expected to fund operations for over two years [3][6] - R&D spending for Q3 2025 was $4.2 million, a decrease from $8.9 million in Q3 2024, primarily due to costs capitalized into inventory [7] - SG&A expenses increased to $19.3 million in Q3 2025 from $6.4 million in Q3 2024, reflecting increased headcount and costs associated with the ZEVASKYN launch [7] - The net loss for Q3 2025 was $(5.2) million, or $(0.10) per share, compared to a net loss of $(30.3) million, or $(0.63) per share, in Q3 2024 [8][14] Product Development and Launch - The launch of ZEVASKYN has been scaled to meet patient needs, with the first anticipated patient treatment shifted to Q4 2025 due to an optimized release assay [2][4] - Patient demand for ZEVASKYN has more than doubled, with approximately 30 eligible patients identified at the first two Qualified Treatment Centers (QTCs) [4] - The company has activated three QTCs, including Children's Hospital Colorado, and is onboarding additional centers across the U.S. [4] - Coverage decisions from major commercial health plans have been made, covering approximately 60% of all RDEB patients, indicating early market acceptance [4] Strategic Initiatives - The pipeline program ABO-503 has been selected for the FDA Rare Disease Endpoint Advancement Pilot Program, enhancing communication and collaboration with the FDA [2][5] - The management team has been strengthened with the appointment of James A. Gow, MD, as Senior Vice President, Head of Clinical Development & Medical Affairs [5] Balance Sheet Highlights - Total assets as of September 30, 2025, were $231.1 million, up from $108.9 million as of December 31, 2024 [16][17] - Current liabilities totaled $22.2 million, with total liabilities at $59.9 million [16][17]