Core Viewpoint - FibroBiologics, Inc. is advancing its clinical-stage biotechnology efforts with a focus on fibroblast-based therapies for chronic diseases, reporting significant progress in research and development, as well as financial results for the second quarter of 2025 [1][4]. Recent Highlights - The company successfully closed the third $5 million tranche of a $25 million financing round to support research and development and upcoming clinical trials [6]. - A new Chief Financial Officer, Jason D. Davis, was appointed, bringing over 25 years of experience [6]. - Pre-clinical evidence was presented at a major dermatology meeting, indicating the potential of fibroblast spheroids to reduce psoriasis severity [6]. - The company confirmed the use of the CYWC628 master cell bank for manufacturing CybroCell™, a therapy for degenerative disc disease [6]. Upcoming Milestones - The initiation of a Phase 1/2 clinical trial in Australia for CYWC628 in diabetic foot ulcer patients is planned for the first quarter of 2026 [6]. - The completion of the Phase 1/2 clinical trial in DFU patients is expected in the third quarter of 2026 [6]. - Pre-clinical IND-enabling studies for CYPS317, a treatment for psoriasis, are anticipated to be completed by the end of 2025 [6]. Financial Highlights - Research and development expenses for the six months ended June 30, 2025, were approximately $3.8 million, up from $1.9 million in the same period of 2024, primarily due to increased costs in various areas [7]. - General and administrative expenses rose to approximately $5.2 million for the same period, compared to $4.7 million in 2024, driven by increased personnel and professional fees [7]. - The net loss for the six months ended June 30, 2025, was approximately $9.6 million, compared to a net loss of $7.6 million for the same period in 2024 [11]. - Cash and cash equivalents totaled approximately $8.8 million as of June 30, 2025 [11].

Core Insights - FibroBiologics has made significant progress in its cartilage repair program, confirming that CYWC628 spheroids can differentiate into chondrocytes, which are essential for cartilage formation [1][2] - The company plans to utilize its CYWC628 master cell bank to create a working cell bank for manufacturing CybroCell™, its investigational cell therapy for degenerative disc disease (DDD), and is moving forward with amending its IND clearance with the FDA for a Phase I clinical trial [2][3] - The use of the current master cell bank is expected to streamline the manufacturing process for CybroCell, reducing development time and costs, while demonstrating the scalability of FibroBiologics' fibroblast-based platform for multiple indications [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 275 patents issued and pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer, positioning itself as a leader in cell therapy and tissue regeneration [6]

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].

Proprietary master cell bank of fibroblast-based spheroids product candidate, CYWC628, completed in accordance with Good Manufacturing Practices after successfully passing all required safety testing Preparations for Phase 1/2 clinical trial in Australia utilizing CYWC628 to treat diabetic foot ulcers are proceeding with plans to initiate in the second quarter of 2025 Cash and cash equivalents of approximately $14.0 million at December 31, 2024 HOUSTON, March 31, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc ...