CAMBRIDGE, Mass., April 22, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today announced that new data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago. About ErnexaTherapeutics Ernexa Therapeutics (Nasdaq: ERNA) is developing innovative cell therapies for the treatment of advanced solid tumors and autoimmune disease. Ernexa's core technolog ...

Core Insights - FibroBiologics, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for chronic diseases using fibroblast cells and materials [1][3] - The company holds over 240 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, and cancer [3] - Hamid Khoja, Ph.D., the Chief Scientific Officer, will present at The Cell & Gene Meeting On The Mediterranean, highlighting a fibroblast cell-based therapeutic approach [1][2] Company Overview - FibroBiologics is based in Houston and is engaged in the development of a pipeline of treatments aimed at chronic diseases [3] - The company represents advancements in cell therapy and tissue regeneration, with a focus on innovative medical solutions [3] Conference Details - The presentation titled "Restoring Immune system homeostasis using a fibroblast cell-based therapeutic targeting three chronic inflammation-mediated diseases" will take place on April 16, 2025, at 9:00 AM CEST [2] - The event is a significant gathering for the Advanced Therapy Medicinal Products community in Europe [1][2]

Company Overview - MaxCyte, Inc. is a leading company focused on cell engineering, providing platform technologies to advance the discovery, development, and commercialization of next-generation cell therapeutics [1][3] - The company has over 25 years of expertise in building best-in-class platforms and innovating solutions for the cell therapy market [3] Financial Results Announcement - MaxCyte will release its financial results for the first quarter of 2025 after the U.S. market closes on May 7, 2025 [1] - A conference call to discuss these financial results will be hosted by company management at 4:30 p.m. Eastern Time on the same day [1] Conference Call Registration - Investors interested in the conference call must register online, with a recommendation to do so at least a day in advance [2] - A live and archived webcast of the event will be available on the MaxCyte website [2]

Core Insights - Ernexa Therapeutics is advancing its strategic focus on innovative cell therapies for cancer and autoimmune diseases, particularly ovarian cancer [1][2][3] - The company has entered into a securities purchase agreement for a private placement of approximately 69.3 million shares at a price of $0.1046 per share, totaling around $7.25 million, pending stockholder approval [1][2] - The first closing of this transaction occurred on April 2, 2025, raising approximately $1.1 million from the issuance of about 10.4 million shares [2] Company Overview - Ernexa Therapeutics specializes in developing cell therapies targeting advanced solid tumors and autoimmune diseases, utilizing induced pluripotent stem cells (iPSCs) to create allogeneic synthetic mesenchymal stem cells (iMSCs) [4] - The company is currently focused on two preclinical cell therapy products: ERNA-101, aimed at treating ovarian cancer, and ERNA-102, designed to address inflammation in autoimmune diseases [5] Recent Developments - The recent fundraising follows a previous private investment in public equity (PIPE) round in 2024, which secured $5 million in financing [3] - Ernexa has undergone a rebranding to reflect its new strategic direction, emphasizing its commitment to advancing therapeutic innovation [2][3]

Core Insights - Ernexa Therapeutics has shifted its strategic focus from a cell therapy platform to prioritizing product development, emphasizing its commitment to patient impact with the new tagline "Breaking Through Defenses, Delivering Hope" [1][2] Company Overview - Ernexa Therapeutics, formerly Eterna Therapeutics, is a leader in cell therapies targeting advanced cancer and autoimmune diseases, with a focus on engineering induced pluripotent stem cells (iPSCs) into induced mesenchymal stem cells (iMSCs) [1][6] - The company aims to provide scalable, off-the-shelf treatment solutions through its allogeneic synthetic iMSCs, addressing challenges such as immune rejection and donor shortages [2][6] Product Development - Ernexa is developing two cell therapy products currently in preclinical trials: ERNA-101, aimed at enhancing the immune system's response to cancer, and ERNA-102, designed to treat inflammation and autoimmune diseases [3][7] - ERNA-101 is specifically being developed for ovarian cancer, a field with significant unmet medical needs due to the lack of effective targeted therapies [4][5] Market Potential - The company highlights the potential of ERNA-101 and ERNA-102 to significantly impact the treatment landscape for ovarian cancer and autoimmune diseases, respectively [5][7]

HOUSTON, March 21, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (NASDAQ:FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced that Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics, will present on FibroBiologics' unique fibroblast cell-based approach for the potential treatment of chronic di ...

Financial Data and Key Metrics Changes - The company reported Q4 product revenue of $1.2 million from TECELRA, with expectations to invoice 3 to 4 times as many patients in Q1 2025 compared to the previous quarter [9][10][17] - The consensus analyst forecast for 2025 sales is approximately $25 million, which the company believes is achievable [17][30] Business Line Data and Key Metrics Changes - The launch of TECELRA has seen significant momentum, with 20 authorized treatment centers (ATCs) established, ahead of the planned 30 by the end of 2026 [6][8] - The company has a pipeline of around 20 biomarker-positive patients expected to be treated in Q2 and Q3 2025, with over 80 patients having completed MAGE-A4 testing [11][12] Market Data and Key Metrics Changes - Over 70% of commercial and Medicare lives have established reimbursement policies for TECELRA, with no denials reported to date [12] - The company anticipates that Lete-cel will expand the sarcoma franchise, potentially doubling the number of treatable patients in the US each year [25] Company Strategy and Development Direction - The company aims to build a successful business with two FDA-approved products in sarcoma and achieve cash flow breakeven by 2027 [26][30] - The company is exploring strategic options, including partnerships and collaborations, to optimize shareholder value and ensure financial stability [28][56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the acceleration of TECELRA sales and the successful launch of Lete-cel, which is expected to be on the market by 2027 [17][18] - The company is focused on managing costs effectively while pushing towards profitability in 2027, with a significant reduction in cash flow demands due to paused preclinical programs [27][68] Other Important Information - The company has engaged TD Cowen to explore strategic options and financial opportunities [28] - The manufacturing process for TECELRA has exceeded expectations, with 100% of released products manufactured to specification and no capacity bottlenecks reported [14][16] Q&A Session Summary Question: Can you comment on the pace of apheresis during Q1? - The pace of apheresis has been increasing, with more patients being treated as additional ATCs come online [35] Question: What proportion of double positive patients have undergone apheresis? - The majority of double positive patients have started the treatment journey, with some expected to drop out for various reasons [40] Question: What are the assumptions for achieving profitability in 2027? - The company plans to reduce spending significantly and anticipates sales from TECELRA and Lete-cel to contribute to profitability [47][50] Question: Are there any updates on ex-US strategies? - The company is focused on establishing a viable business in the US first, while exploring opportunities for international expansion [66] Question: What is the status of PRAME and CD70 programs? - Both programs are of interest to various pharma companies, and the company is exploring monetization opportunities [82]

Core Viewpoint - Adaptimmune Therapeutics plc is set to report its financial results and business updates for Q4 and the full year of 2024 on March 20, 2025, before US markets open, followed by a live webcast [1]. Company Overview - Adaptimmune is a clinical-stage biopharmaceutical company focused on developing cell therapies aimed at treating solid tumor cancers [3]. - The company utilizes a unique engineered T-cell receptor (TCR) platform to create T-cells that target and destroy various solid tumor types [3]. Upcoming Events - The financial results announcement will be accompanied by a live webcast at 8:00 a.m. EDT on the same day [1]. - Investors can access the press release in the investor section of Adaptimmune's corporate website and participate in the live webcast [2].

Gilead Sciences (GILD) Conference Summary Company Overview - Gilead Sciences is focusing on building a sustainable pipeline, particularly in HIV, virology, oncology, and inflammation [3][4] Key Products and Pipeline Trodelvy - Trodelvy has received approvals for triple-negative breast cancer and bladder cancer, with recent approval for HR positive HER2 negative breast cancer [5][6] - The strategy includes expanding indications and moving into earlier treatment lines, with ongoing studies in triple-negative and HR positive HER2 negative breast cancer, as well as non-small cell lung cancer [7][8] - Revenue trajectory for Trodelvy is positive, with expectations for continued growth [9] Non-Small Cell Lung Cancer - Comparison with AstraZeneca's TROP-two highlights differences in linker technology and payload, which may affect efficacy and safety profiles [10][11] - Gilead's hydrolyzable linker and moderately toxic payload are expected to provide a differentiated profile in lung cancer treatment [12][13] - Ongoing trials are similar in size and patient population to AstraZeneca's, but with key differences in patient selection criteria [15][16] TIGIT Development - Data presented at ASCO indicates that TIGIT adds value to PD-1 inhibitors in non-small cell lung cancer, with a promising PFS improvement [18][19] - Ongoing trials are designed to assess the efficacy of TIGIT in combination therapies [20][21] Cell Therapy - Kite, a Gilead subsidiary, is positioned as a leader in cell therapy, with a focus on optimizing CAR T technology and reducing delivery times [22][23] - Partnerships, including with Galapagos, are being leveraged to enhance cell therapy offerings [24][25] Magrolimab - Magrolimab is being developed for both solid tumors and hematological malignancies, with ongoing Phase III trials for MDS and AML [27][28] - The company is focused on safety and efficacy, with a patented dosing approach to minimize adverse effects [30][31] Oral COVID Treatment - Gilead is conducting trials for its oral COVID treatment, with sample sizes of approximately 2,300 for high-risk and 1,900 for standard-risk patients [37][38] - The company acknowledges challenges in recruiting patients and adapting to the evolving pandemic landscape [34][36] Lenacapavir and Inflammation Programs - Gilead is advancing multiple candidates in the inflammation space, including oral beta-seven, IRAK4, and TYPO2 programs, with Phase II studies expected in the next year or two [48][49] - The focus is on developing best-in-class differentiated molecules for various inflammatory indications [50] Additional Insights - Gilead is committed to adapting its strategies based on evolving market conditions and patient needs, particularly in the context of the COVID-19 pandemic and competitive landscape [34][36][41] - The company is actively monitoring and adjusting its clinical trial designs to ensure robust data collection and analysis [38][41] This summary encapsulates the key points discussed during the conference, highlighting Gilead's strategic focus, product pipeline, and ongoing developments in various therapeutic areas.