Planning for phase 1/2 clinical trial initiation in Australia utilizing CYWC628 to treat diabetic foot ulcers in the first half of 2026Improved balance sheet through multiple direct offerings; completed payments of outstanding debtHOUSTON, Feb. 24, 2026 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), 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 ...

Core Insights - FibroBiologics is focused on developing fibroblast-based therapies for chronic diseases, emphasizing innovation and patient impact in 2025 [2][3] Company Progress - The company expanded its laboratory in Houston to over 10,000 square feet, enhancing its R&D capabilities and in-house manufacturing [3] - FibroBiologics raised significant capital through multiple registered direct offerings, totaling $7.2 million in late 2025, and eliminated all outstanding debt [3] - Jason D. Davis was appointed as CFO, bringing extensive experience in corporate finance and capital markets [3] - The company actively presented its research at various conferences, enhancing its visibility in the biotech community [3] Clinical Trials and Milestones - FibroBiologics completed the CYWC628 master and working cell banks, which are crucial for its wound healing program [4] - The company received HREC approval for a Phase 1/2 trial in Australia for CYWC628, targeting diabetic foot ulcers with a study of 120 patients [4] - Positive IND-enabling data for CYPS317 indicated efficacy comparable to biologics, leading to a new IND filing on December 30, 2025 [4] - Progress was made on CYMS101 for multiple sclerosis, with plans for an IND submission [4] Scientific Advancements - The company confirmed remyelination in brain tissue repair models, supporting its approach for treating demyelinating diseases [5] - Advances in the bone marrow organoid platform showed potential in reducing tumor sizes and addressing age-related immune decline [5] Intellectual Property - FibroBiologics holds over 270 patents issued and pending, covering various therapeutic areas including wound healing and human longevity [6] - Recent patent filings include methods for generating multipotent cells from fibroblasts and a fibroblast-based chondrocyte spheroid platform for musculoskeletal conditions [6] Financial Overview - The company reported disciplined execution in its quarterly reports, with R&D expenses focused on lab expansion and cell bank development [7] - Financing efforts included closing two tranches of a $25 million financing round [7] Future Outlook - The company aims to execute clinical trials, submit INDs, and strengthen its financial position in 2026 [8] - Challenges such as regulatory hurdles and funding are acknowledged, but the company expresses confidence in overcoming these obstacles [8]

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].