HOUSTON, Jan. 06, 2026 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics” or the “Company”), a clinical-stage biotechnology company with 270+ 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 Founder and Chief Executive Officer, Pete O’Heeron, will present at the 9th Annual BFC Global Healthcare Business Development and Investment Conference taking ...

Core Insights - FibroBiologics is advancing preparations for the manufacturing of its fibroblast-based spheroids product candidate, CYWC628, for a Phase 1/2 clinical trial targeting diabetic foot ulcers (DFU) patients [1] - The company is also preparing to submit Investigational New Drug (IND) applications for treatments of psoriasis with CYPS317 and multiple sclerosis with CYMS101 [1] Recent Highlights - The CEO emphasized the strategic focus on moving advanced product candidates towards clinical trials while establishing fibroblasts as a scalable platform [4] - Positive updates from the psoriasis research program indicate the potential of human dermal fibroblast spheroids as a novel therapeutic approach [6] - The Bone Marrow Organoid platform has been advanced, presenting new treatment options for hematopoietic cancers and age-related immune decline [6] Financial Highlights - Research and development expenses for the nine months ended September 30, 2025, were approximately $6.6 million, up from $3.1 million in the same period of 2024, primarily due to increased contract research costs and personnel-related expenses [5] - General and administrative expenses were approximately $7.4 million for the same period, compared to $6.9 million in 2024, driven by increased personnel and professional fees [10] - The net loss for the nine months ended September 30, 2025, was approximately $15.4 million, compared to a net loss of $8.1 million in 2024 [10] Upcoming Milestones - The company plans to complete manufacturing training runs for CYWC628 and confirm the sterility of the manufacturing process by the end of 2025 [6] - The initiation of the Phase 1/2 clinical trial in Australia for CYWC628 is expected in the first quarter of 2026, with completion anticipated in the third quarter of 2026 [6] - Pre-clinical IND-enabling studies for psoriasis and multiple sclerosis treatments are also set to be completed, with IND submissions planned [6]

Core Insights - FibroBiologics, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for chronic diseases using fibroblasts and fibroblast-derived materials, holding over 270 patents [1][4] - The company will present updates on its fibroblast-based technologies at the 2025 Cell & Gene Meeting on the Mesa Conference scheduled for October 6-8, 2025 [2] - A clinical trial for diabetic foot ulcers is planned to be initiated in the first quarter of 2026 [2] Company Overview - FibroBiologics is based in Houston and is developing a pipeline of treatments targeting chronic diseases, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer [4] - The company represents advancements in cell therapy and tissue regeneration [4] Event Details - The presentation at the 2025 Cell & Gene Meeting on the Mesa will take place on October 7, 2025, at 2:15 p.m. MST in FLW Ballroom F [2]

Core Viewpoint - FibroBiologics presents fibroblast cells as a superior alternative to stem cells for chronic disease therapies, highlighting their therapeutic advantages and potential to transform treatment outcomes [1][2][3]. Company Overview - FibroBiologics is a clinical-stage biotechnology company based in Houston, focusing on developing therapeutics and potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials [5][6]. - The company holds over 270 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, and cancer [5][6]. Research and Findings - The editorial authored by company leadership reviews extensive research indicating that fibroblast cells have faster proliferation rates, better sourcing capabilities, and enhanced immune modulation properties compared to stem cells [2][3]. - The evidence suggests that fibroblasts may not only match but potentially exceed the efficacy of mesenchymal stem cells in clinical applications [3]. Future Implications - The leadership at FibroBiologics believes that the transition from stem cell therapies to fibroblast-based solutions represents a paradigm shift in medicine, aiming for long-term improvements in patient outcomes [3]. - The company emphasizes the scalability and effectiveness of fibroblast therapies, which could fundamentally change how chronic diseases are treated [3].

Core Insights - FibroBiologics, Inc. has made significant advancements in its Bone Marrow Organoid platform, which may provide new treatment options for hematopoietic cancers and age-related immune decline [1][2] - The proprietary Bone Marrow Organoids have shown potential in various therapeutic applications, including regenerating immune cell types and restoring immune function in compromised patients [2] - The company is laying the groundwork for IND-enabling preclinical development, aiming to position its technology for clinical advancement [2] Company Overview - FibroBiologics is a clinical-stage biotechnology company based in Houston, focusing on developing therapeutics and potential cures for chronic diseases using fibroblast cells and materials [6] - The company holds over 270 patents issued and pending, covering various clinical pathways such as wound healing, multiple sclerosis, cancer, and human longevity [6] Research and Development - Pre-IND animal trials indicate that the transplantation of Bone Marrow Organoids into a xenografted melanoma mouse model significantly reduced tumor size [5] - The organoids facilitate efficient ex vivo gene editing, allowing for targeted therapeutic interventions before transplantation [5] - The ability to cryopreserve Bone Marrow Organoids offers a scalable and readily available treatment option for bone marrow transplantation [5]

Core Insights - FibroBiologics, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for chronic diseases using fibroblasts and fibroblast-derived materials [1][6] - The company holds over 275 patents issued and pending, indicating a strong intellectual property portfolio [1][6] - A webinar is scheduled for July 10, 2025, where the CEO will discuss the company's fibroblast-based cell therapy platform and its potential applications [2][4] Company Overview - FibroBiologics aims to treat chronic, inflammatory, and degenerative conditions through an allogeneic fibroblast approach, which is scalable and cost-efficient [2] - The company's lead candidate, CYWC628, targets diabetic foot ulcers, with additional candidates aimed at multi-billion-dollar markets such as degenerative disc disease and multiple sclerosis [2] - The company is positioned as a next-generation leader in cell therapy and tissue regeneration [6] Upcoming Events - A live Q&A session will follow the webinar presentation, and a recording will be available on the company's investor section post-event [3] - Registration for the webinar is free, and questions can be submitted in advance [4]

Core Insights - FibroBiologics has appointed Jason D. Davis as Chief Financial Officer, bringing over 20 years of experience in public company finance and capital markets to support the company's growth [1][2][3] Company Overview - FibroBiologics is a clinical-stage biotechnology company focused on developing therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, holding over 275 patents issued and pending [1][7] - The company is advancing towards its Phase 1/2 clinical trial for diabetic foot ulcers scheduled for the second half of 2025 [2] Leadership and Experience - Jason D. Davis has a proven track record in leading companies through critical growth phases, including IPOs and capital raising initiatives, which is crucial for FibroBiologics as it moves its lead program into clinical trials [2][3] - Prior to joining FibroBiologics, Mr. Davis served as CFO of Virax Biolabs, where he successfully navigated the company through its IPO and managed multiple capital raises [4] Strategic Vision - Mr. Davis emphasized that FibroBiologics' fibroblast-based platform and strong intellectual property portfolio position the company as a high-growth, high-impact enterprise [4] - The company aims to deliver meaningful value not only for shareholders but also for patients globally [4]

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].

Core Viewpoint - FibroBiologics, Inc. is advancing its clinical programs, particularly focusing on the upcoming Phase 1/2 clinical trial for its fibroblast-based spheroids product candidate, CYWC628, aimed at treating diabetic foot ulcers, with plans to initiate in Q2 2025 [1][5]. Financial Highlights - As of December 31, 2024, the company reported cash and cash equivalents of approximately $14.0 million [1][10]. - For the year ended December 31, 2024, research and development expenses were approximately $4.5 million, an increase from approximately $2.4 million in 2023, primarily due to increased drug product expenses and hiring additional personnel [10]. - General and administrative expenses rose to approximately $9.2 million for the year ended December 31, 2024, compared to approximately $6.5 million in 2023, mainly due to costs associated with operating as a public company [10]. - The net loss for the year ended December 31, 2024, was approximately $11.2 million, a decrease from a net loss of approximately $16.5 million in 2023, attributed to changes in the fair value of the warrant liability [10]. Corporate Developments - The company established a master services agreement with Charles River Laboratories for the development and manufacture of its therapeutic master cell bank and CYWC628 [4]. - FibroBiologics engaged Southern Star Research for clinical research organization services in Australia for the planned Phase 1/2 clinical trial [4]. - The company expanded its patent portfolio, including a patent from the European Patent Office for cancer treatment methods using modified fibroblasts [4]. Upcoming Milestones - The initiation of the Phase 1/2 clinical trial in Australia for CYWC628 is planned for the second quarter of 2025, with completion expected by the end of 2025 [9]. - The company aims to complete pre-clinical IND-enabling studies for the treatment of psoriasis with CYPS317 by the end of 2025 [9]. Research and Development Focus - FibroBiologics is also pursuing early-stage research in human longevity, focusing on the recovery of thymic functionality using transplanted artificial thymic organoids [4]. - The discovery phase project CYPS317 has been moved to the product candidate pipeline for psoriasis treatment [4]. Strategic Financing - The company entered into a Standby Equity Purchase Agreement (SEPA) with YA II PN LTD., allowing it to sell up to $25.0 million in common stock over two years, with an initial advance of $10.0 million received in December 2024 [4].