Core Insights - FibroBiologics, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for chronic diseases using fibroblasts and fibroblast-derived materials [1][5] - The company presented research on the immunomodulatory potential of human dermal fibroblast spheroids in psoriasis therapy at the Society for Investigative Dermatology Annual Meeting [2][3] Company Overview - FibroBiologics holds over 240 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer [5] - The company aims to advance innovative, cell-based treatments for chronic inflammatory diseases, with a focus on providing durable therapeutic options with lower adverse side effects [3][5] Research Highlights - The poster presentation titled "Immunomodulatory Potential of Human Dermal Fibroblast Spheroids in Psoriasis Therapy" demonstrated the potential of HDF spheroids to reduce psoriasis severity in preclinical models [2] - The research indicates that fibroblast-based candidates may offer sustained remission and reduced relapse rates in psoriasis treatment [3]

Mink Therapeutics (INKT) Q1 2025 Earnings Call May 15, 2025 08:30 AM ET Company Participants Zack Armen - Head of IR & Corporate DevelopmentJennifer Buell - President and CEOChristine Klaskin - CFOThiago Favano - Senior Director, Portfolio Operations Conference Call Participants Emily Bodnar - Biotech Equity Research AnalystMatthew Phipps - Equity Research Analyst Operator Thank you for standing by. My name is Roselle, and I will be your conference operator today. At this time, I would like to welcome every ...

BioCardia (BCDA) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Company Participants Miranda Peto Benvenuti - Investor RelationsPeter Altman - CEO, President & DirectorDavid McClung - Chief Financial OfficerLaura Suriel - Equity Research Associate Conference Call Participants Joseph Pantginis - MD & Senior Healthcare AnalystNone - Analyst Operator Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback pur ...

BioRestorative Therapies (BRTX) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Company Participants Stephen Kilmer - Investor RelationsLance Alstodt - Chairman of the Board, President & CEORobert Kristal - CFOFrancisco Silva - Chief Scientist, VP of Research & Development, Secretary and DirectorJason Mccarthy - Senior Managing Director & Head of Biotechnology Research Conference Call Participants Jonathan Aschoff - Managing Director, Senior Research Analyst Operator Please note this conference is being reco ...

Financial Data and Key Metrics Changes - For Q1 2025, revenues were $25,000, a decrease from $35,000 in the same period last year [6] - Deferred revenues for Q1 2025 were $150,000 compared to nil in Q1 2024, indicating a timing difference in revenue recognition [6] - The loss from operations for Q1 2025 was $4,800,000, compared to $4,100,000 for Q1 2024 [7] - The net loss for Q1 2025 was $5,300,000 or $0.64 per share, compared to a net loss of $2,200,000 or $0.33 per share in Q1 2024 [7] - Cash used in operating activities in Q1 2025 was $2,800,000, with cash, cash equivalents, and marketable securities totaling $9,100,000 and no outstanding debt [8][19] Business Line Data and Key Metrics Changes - The lead clinical stage candidate, BRTX-one hundred, is being evaluated in a Phase II trial for chronic lumbar disc disease (CLDD) [10] - Preliminary data from the trial shows positive trends in safety and efficacy, with no serious adverse events reported [11][12] - The FDA granted Fast Track designation for BRTX-one hundred, facilitating its development and review process [13] Market Data and Key Metrics Changes - The company is developing ThermoStem, a cell-based therapy targeting obesity and metabolic disorders, using brown adipose-derived stem cells [14] - The company has built a comprehensive patent portfolio to protect its intellectual property in both US and international markets [15] Company Strategy and Development Direction - The company is focused on advancing its two core clinical development programs: BRTX-one hundred and ThermoStem [16] - There are ongoing discussions regarding a potential licensing agreement for the ThermoStem metabolic disease programs [15][19] - The company aims to leverage positive preliminary data to potentially shorten the regulatory process for BLA approval [45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing Phase II trial for BRTX-one hundred, expecting data to remain consistent with previous trends [17] - The company is actively managing resources while executing strategic goals, ending the quarter with a strong financial position [19] Other Important Information - The company is preparing for a presentation of data from 45 subjects at an upcoming conference in June [26] - Management emphasized the importance of maintaining a clean and valid data set for the trial [36] Q&A Session Summary Question: Clarification on efficacy endpoint - Management confirmed that the primary endpoint is safety, with a secondary efficacy endpoint of greater than or equal to 30% improvement [22] Question: Interim analysis status - Management stated that an interim analysis is still a potential option but has not been determined yet [23][24] Question: Enrollment pace and characteristics - Management indicated that enrollment is picking up due to new recruitment strategies and that they expect to counteract any summer slowdown [36] Question: FDA emphasis on pain or function - Management noted that both pain reduction and functional improvement are being collected, with ongoing discussions with the FDA [38] Question: Morphological changes observed - Management provided details on encouraging morphological changes observed in patients, including increased hydration and decreased protrusion size [42][44]

Core Viewpoint - FibroBiologics is advancing its clinical-stage biotechnology efforts with plans to initiate a Phase 1/2 clinical trial for its fibroblast-based product candidate, CYWC628, aimed at treating diabetic foot ulcers in Australia by the third quarter of 2025 [1][4]. Recent Highlights - The company completed the CYWC628 master cell bank with Charles River, establishing a foundation for the upcoming clinical trial [4]. - A new patent was filed to enhance mitochondrial activity using the fibroblast platform, indicating a strategic move to strengthen competitive advantage [4]. - FibroBiologics presented at several investor and scientific conferences, enhancing visibility and interest in its platform [6]. Upcoming Milestones - The Phase 1/2 clinical trial for CYWC628 is set to begin in the third quarter of 2025, with completion expected in the first quarter of 2026 [6]. - Pre-clinical IND-enabling studies for the treatment of psoriasis with the fibroblast spheroid product candidate, CYPS317, are anticipated to be completed by the end of 2025 [6]. Financial Highlights - For the quarter ended March 31, 2025, research and development expenses were approximately $1.8 million, up from $1.0 million in the same period in 2024, primarily due to increased drug product expenses and hiring [7]. - General and administrative expenses rose to approximately $2.8 million from $2.5 million year-over-year, mainly due to additional personnel costs [8]. - The net loss for the quarter was approximately $5.0 million, a decrease from $8.5 million in the same period in 2024, attributed to changes in the fair value of the warrant liability [12].

Mechelen, Belgium; May 14, 2025, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG), a global biotechnology company dedicated to transforming patient outcomes through life-changing science and innovation, today announced that new data from our ongoing ATALANTA-1 Phase 1/2 study of GLPG5101 in relapsed/refractory non-Hodgkin lymphoma (R/R NHL) have been accepted for oral presentations at the 2025 European Hematology Association (EHA) Congress taking place June 12-15, 2025, in Milan, Italy, and the Internation ...

Summary of Vericel (VCEL) 2025 Conference Call Company Overview - **Company**: Vericel Corporation - **Industry**: Advanced therapies for sports medicine and severe burn care markets - **Key Products**: MACI (cell therapy for cartilage repair), NexoBrid (eschar removal), Epicel (permanent skin replacement) [1][2][4] Core Points and Arguments Product Leadership - Vericel is a leader in advanced therapies with a unique portfolio of specialty biologics and advanced cell therapies [2][3] - MACI is the leading restorative cartilage repair product and the only FDA-approved product in its class [3][5] - Recent FDA approval for AC Arthro is expected to enhance market penetration [3] Financial Performance - The company has shown significant revenue growth, with a compounded annual growth rate of approximately 20% since the launch of MACI in 2017 [9][11] - Burn care franchise grew by 22% last year, indicating strong performance in both segments [8] - Strong financial position with over $160 million in cash and no debt [7] Market Opportunity - Total Addressable Market (TAM) for the core portfolio is approximately $4 billion, potentially increasing to over $5 billion with the addition of MACI ankle indications [9] - There are about 750,000 knee cartilage repair procedures annually, with a significant commercial opportunity for MACI [13] Growth Initiatives - Plans to initiate a MACI ankle study and expand manufacturing capabilities to support international launches [8][10] - The MACI Arthro launch is expected to simplify procedures and increase market penetration [16][19] Burn Care Innovations - NexoBrid is positioned to change the standard of care for burn treatment by providing a less traumatic eschar removal method [22][23] - Epicel is the only FDA-approved permanent skin replacement, showing significant survival benefits for patients [26] Adoption and Training - Over 400 surgeons trained for MACI Arthro, with a biopsy growth rate exceeding 30% among trained surgeons [20][19] - Focus on expanding the commercial footprint and increasing utilization of both NexoBrid and Epicel [26][27] Additional Important Content - The company emphasizes the lack of near-term competitors and significant barriers to entry in the market [5][6] - The innovative nature of MACI and its broad label contribute to its market leadership [15] - Continuous exploration for new products in sports medicine and burn care markets to leverage existing capabilities [28]

LONDON, May 14, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces the online publication of three abstracts submitted to the European Hematology Association (EHA) Congress, to be held June 12-15, 2025, Milan, Italy. Autolus will have two oral and one poster presentation, which includes updated follow up from the FELIX study of obecabtagene autole ...

New entity, ErnexaTX2, reflects progress toward clinical readinessCAMBRIDGE, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today announced the formation of ErnexaTX2, a wholly owned subsidiary based in Texas. The new entity has been established to support ongoing preclinical development of the company’s lead program, ERNA-101 for ovarian cancer, and to lay the operational groundwor ...