Company Overview - Sernova Biotherapeutics is a clinical-stage company focused on developing regenerative medicine therapeutics, specifically its Cell Pouch Bio-hybrid Organ as a functional cure for type 1 diabetes (T1D) [3] - The company collaborates with Evotec to create Bio-hybrid Organs that integrate human donor cells or stem-cell derived islet-like clusters with its Cell Pouch [3] Recent Developments - Mr. Ross Haghighat resigned as Chair of Sernova Biotherapeutics on May 24, 2025, and his resignation was accepted by the Board of Directors [2] - The Board expressed gratitude for Mr. Haghighat's service and wished him well in his future endeavors [2] Product Focus - The Bio-hybrid Organ developed by Sernova consists of non-biomaterials, such as the Cell Pouch, combined with living tissues to restore or enhance the function of compromised organs [3] - The initial focus of Sernova's innovative approach is on treating chronic diseases, particularly T1D and thyroid disorders [3]

Core Insights - Sernova Biotherapeutics has formed a Clinical Advisory Board to guide the development of its Cell Pouch Bio-hybrid Organ as a potential functional cure for type 1 diabetes (T1D) [1][7] Group 1: Clinical Advisory Board Composition - The board consists of five members, chaired by Dr. Robert Gabbay, who has extensive experience in diabetes care and research [2] - Other notable members include: - Dr. Mark Atkinson, a leading researcher in T1D with over 750 publications [3] - Dr. Melena Bellin, an expert in islet cell transplantation for T1D [4] - Dr. Andrew Posselt, a surgeon-scientist specializing in transplant immunology [5] - Dr. Holger Russ, who focuses on regenerative medicine and autoimmune type 1 diabetes [6] Group 2: Company Overview and Technology - Sernova Biotherapeutics is a clinical-stage company developing regenerative medicine therapeutics, specifically the Cell Pouch integrated with human donor cells or stem-cell derived islet-like clusters [8] - The Cell Pouch is designed to create bio-hybrid organs that restore or enhance organ function, initially targeting T1D and thyroid disorders [9]

Core Viewpoint - Longeveron Inc. is actively pursuing partnerships for its Alzheimer's disease program, which has shown promising results in clinical trials, particularly with its lead candidate, laromestrocel [2][5]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, with laromestrocel as its lead investigational product [7]. - Laromestrocel is an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors, with potential applications across various disease areas [7]. Clinical Trial Results - The Phase 2a clinical trial (CLEAR MIND) demonstrated that laromestrocel treated patients experienced an overall slowing or prevention of disease worsening compared to placebo, achieving primary safety and secondary efficacy endpoints [3][4]. - Statistically significant improvements were observed in pre-specified clinical and biomarker endpoints for specific laromestrocel groups compared to placebo [3]. Regulatory Designations - The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer's disease, facilitating greater access to FDA interactions during its development [5]. - Laromestrocel is noted as the first cellular therapeutic candidate to receive FDA RMAT designation for Alzheimer's disease [5]. Upcoming Events - Longeveron will participate in the BIO International Convention from June 16-19, 2025, to explore potential partnerships and strategic opportunities for its Alzheimer's disease program [1][2].

– SLE and LN registrational discussions with FDA anticipated in 3Q25; systemic sclerosis registrational discussions with FDA anticipated in 4Q25 – – New clinical data on rese-cel in myositis, SLE / LN and systemic sclerosis to be presented in three oral sessions at the EULAR 2025 Congress in June – – Two subtype specific cohorts with ~15 patients each added to the ongoing RESET-Myositis™ trial – As of March 31, 2025, the Company had cash and cash equivalents of $131.8 million, per our Form 10-Q being filed ...

MELVILLE, N.Y., May 14, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a regenerative medicine innovator focused on stem cell-based therapies and products, today reported financial results for the first quarter ended March 31, 2025 and provided an update on its business. “We have continued to execute well across our business, including the achievement of key clinical program milestones, since the start of 2025,” said Lance Alstodt, the Comp ...

Fate Therapeutics (FATE) reported a loss of 32 cents per share for the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of 39 cents. The company had reported a loss of 47 cents per share in the year-ago period.The company earned collaboration revenues of $1.6 million, which surpassed the Zacks Consensus Estimate of $1 million. Revenues declined 15.8% on a year-over-year basis. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)Revenues in the first quarter we ...

Anika Therapeutics (ANIK) Q1 2025 Earnings Call May 09, 2025 08:30 AM ET Speaker0 morning, ladies and gentlemen. Welcome to Anika's First Quarter Earnings Conference Call. At this time, all lines are in a listen only mode. Following the presentation, we will conduct a question and answer session. I will now turn the call over to Matt Hall, Director, Corporate Development and Investor Relations. Please proceed. Speaker1 Thank you. Good morning, and thank you for joining us for Anika's first quarter twenty tw ...

- This RMAT designation is based on data from 3 clinical studies demonstrating the potential benefit of AAV-GAD as a one-time treatment for Parkinson’s disease - RMAT designation includes the benefits of the Fast Track and Breakthrough Therapy designations, allows frequent regulatory interactions with the FDA, and potential routes to accelerated approval and Priority Review LONDON and NEW YORK, May 09, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage gen ...

Organogenesis (ORGO) came out with a quarterly loss of $0.13 per share versus the Zacks Consensus Estimate of $0.04. This compares to loss of $0.02 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -425%. A quarter ago, it was expected that this regenerative medicine company would post a loss of $0.03 per share when it actually produced earnings of $0.04, delivering a surprise of 233.33%.Over the last four quarters, the company ...

Wa'el Hashad Wa'el Hashad, CEO, Longeveron Pivotal Phase 2b clinical trial (ELPIS II) evaluating laromestrocel in HLHS, a rare pediatric disease and orphan-designated indication, has reached approximately 95% enrollment and is expected to complete enrollment in the second quarter of 2025Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II is successfulResults from the Phase 2a clinical trial (CLEAR MIND) evaluating laromest ...