FBLG

On track for first patient dosed in phase 1/2 clinical trial evaluating CYWC628 in diabetic foot ulcers in Q2 of 2026 HOUSTON, April 30, 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 and fibroblast-derived materials, today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update. Recent Highlights Completed manufacturing of the first two batches of the CYWC628 drug product in accordance with Food & Drug Administration (FDA) Good Manufacturing Practices (cGMP) for the phase 1/2 clinical trial for the treatment of diabetic foot ulcers (DFUs). Completed site onboarding for the phase 1/2 clinical trial for CYWC628. Reported positive preclinical results for the burn program, using proprietary fibroblast spheroid technology, indicating increases in a cytokine known to support tissue repair and wound healing in skin and a significant reduction in a cytokine that is a key driver of inflammation in burn wounds. Announced positive preclinical results for a fibroblast spheroid-derived chondrocyte spheroid therapy for degenerative disc disease, demonstrating significant improvement in recovering intervertebral disc integrity versus single cell fibroblasts and fibroblast spheroids in animal models of degenerative disc disease. Raised $3M through a direct offering. Successfully regained compliance with all Nasdaq listing requirements. Expanded the patent portfolio with the issuance of a patent from the United States Patent and Trademark Office covering fibroblast cell therapy for the treatment of osteoporosis and with the Canadian Intellectual Property Office covering a novel fibroblast-based treatment for cachexia. Presented recent updates on fibroblast-based therapies for chronic disease treatments at the 9th Annual BFC Global Healthcare Business Development and Investment Conference, DealFlow Discovery Conference, and BIO Investment & Growth Summit. Upcoming Milestones Wound Healing: Phase 1/2 clinical trial evaluating fibroblast-based spheroids product candidate, CYWC628, in DFU patients: GMP batch 1 clinical drug product release and shipping to Australia Dose first patient in the second quarter of 2026. Repo...

Planning for phase 1/2 clinical trial initiation in Australia utilizing CYWC628 to treat diabetic foot ulcers in the first half of 2026 Improved balance sheet through multiple direct offerings; completed payments of outstanding debt HOUSTON, 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 and fibroblast-derived materials, today announced full year 2025 financial results and provided a corporate update. Recent Highlights Secured both public and private Human Research Ethics Committee (HREC) approvals in Australia for a Phase 1/2 clinical trial evaluating CYWC628 for the treatment of refractory diabetic foot ulcers (DFU), enabling the enrollment of 120 patients at up to 10 sites across Australia. Filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) to advance the clinical development of CYPS317 in patients with psoriasis. Raised a total of $7.2M through multiple direct offerings. Repaid all outstanding debt. Expanded the patent portfolio with the filing of a patent application with the U.S. Patent and Trademark Office (USPTO) covering a proprietary fibroblast-derived therapy platform for use in orthopedic and musculoskeletal conditions, including degenerative disc repair, cartilage repair, and joint restoration. Presented recent updates on fibroblast-based therapies for chronic disease treatments at the 2025 ThinkEquity and Bio-Europe conferences. Received a favorable determination from a Nasdaq Hearings Panel granting an extension to regain compliance for the continued listing of the Company’s common stock on The Nasdaq Capital Market. Upcoming Milestones Wound Healing: Phase 1/2 clinical trial in Australia evaluating fibroblast-based spheroids product candidate, CYWC628, in DFU patients Complete manufacturing of CYWC628 drug product in accordance with FDA Good Manufacturing Practices (cGMP) in Q1 2026. Complete enrollment of up to 10 clinical sites in Q1 2026. Dose first patient in the first half of 2026. Report interim results in the first half of 2026. Complete and report final results by the end of 2026. Psoriasis Receive IND clearance for the treatment of psoriasis with CYPS317, the Com...

FSdC demonstrated statistically significant and superior improvement in disc preservation and structural integrity compared to other treatments HOUSTON, Jan. 05, 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 and fibroblast-derived materials, today announced positive preclinical results for FSdC, an investigational FSdC spheroid-based therapy, demonstrating superior improvement in recovering intervertebral disc integrity and preventing degeneration in animal models of degenerative disc disease. These preclinical findings represent a major advancement for FibroBiologics’ regenerative medicine pipeline and highlight the potential of FSdC spheroids to address unmet needs in spinal health. Key results from the degenerative disc disease animal model study include: Significantly Improved Disc Height Recovery: FSdC spheroids exhibited the highest level of intervertebral disc height recovery at 12 weeks after treatment as compared to 2D fibroblasts and fibroblast spheroids, demonstrating superior long-term structural integrity. Highly Significant Statistical Superiority: Study data revealed FSdC spheroids exceptional performance in disc height recovery 12 weeks after treatment, achieving the most compelling statistical difference from vehicle control with an unadjusted p-value of 0.00015 as compared to 0.036 for 2D fibroblasts, and 0.068 for fibroblast spheroids—positioning it as the leading innovative approach. Breakthrough Potential for Spinal Health: By sustaining the highest average disc size index (%DHI) across all time points during the six disc height measuring periods of the 12 week study, FSdC spheroids significantly outperformed single cell fibroblasts and fibroblast spheroids, heralding a potential new era in regenerative therapies for the treatment of degenerative disc disease and joint-cartilage damage. “These compelling preclinical results for FSdC mark a significant step forward in our regenerative pipeline and advance our goal of bringing innovative fibroblast-based therapies to patients,” said Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics. “Degenerative disc disease impacts millions who face ongoing pain and limit...

Advancing preparations to begin manufacturing of fibroblast-based spheroids product candidate, CYWC628, for the Phase 1/2 clinical trial evaluating CYWC628 in diabetic foot ulcers (DFU) patients Preparing to submit Investigational New Drug applications for the treatment of psoriasis with CYPS317 and the treatment of multiple sclerosis with CYMS101 HOUSTON, Oct. 31, 2025 (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 and fibroblast-derived materials, today announced third quarter 2025 financial results and provided a corporate update. Recent Highlights Announced positive IND-enabling updates from the psoriasis research program demonstrating the potential of human dermal fibroblast spheroids as a novel therapeutic approach for chronic-relapse psoriasis. Advanced the Bone Marrow Organoid platform, offering promising new treatment options for hematopoietic cancers and age-related immune decline. Filed patent application with the United States Patent and Trademark Office covering methods of generating multipotent cells from fibroblasts found in donor tissue for clinical applications. Published a leadership-authored article in the Opinion Pages presenting the scientific case for fibroblast cells' therapeutic advantages compared to stem cell therapies. Presented recent updates on fibroblast-based therapies for chronic disease treatments at the Cell & Gene Meeting on the Mesa, H.C. Wainwright 27th Annual Global Investment Conference, and the 2025 ThinkEquity Conference. Implemented cost efficient measures to reduce operating expenses and focus resources on near-term pipeline priorities. Upcoming Milestones Complete manufacturing training runs for CYWC628 and confirm sterility of the manufacturing process by the end of 2025. Complete the manufacturing of CYWC628 in accordance with FDA Good Manufacturing Practices (cGMP). Initiate Phase 1/2 clinical trial in Australia evaluating fibroblast-based spheroids product candidate, CYWC628, in diabetic foot ulcers (DFU) patients in the first quarter of 2026. Complete Phase 1/2 clinical trial in Australia in DFU patients in the third quarter of 2026. Complete pre-clinical IND-enabling studies for the treatment of psori...

HOUSTON, July 31, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 275+ 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 second quarter 2025 financial results and provided a corporate update. Recent Highlights Successfully closed third $5 million tranche of a $25 million total financing, with proceeds used to advance research and development efforts and support the upcoming Phase 1/2 clinical trial in diabetic foot ulcers (DFUs). Strengthened leadership team with the appointment of Jason D. Davis, CPA, as Chief Financial Officer, who brings over 25 years of experience in building and leading organizations. Presented pre-clinical evidence at the Society for Investigative Dermatology Annual Meeting supporting the potential of fibroblast spheroids to reduce psoriasis severity. Findings showcased the fibroblast-based candidate’s ability to enable sustained remission and reduce relapse, accompanied by a significantly lower adverse side effects profile. Highlighted potential of fibroblast-based therapies for chronic disease treatments at the BIO International Convention 2025. Confirmed the use of the CYWC628 master cell bank for the manufacturing of CybroCell™, FibroBiologics’ investigational intradiscal administered allogeneic fibroblast cell-based therapy in development for degenerative disc disease. Upcoming Milestones Initiate Phase 1/2 clinical trial in Australia evaluating fibroblast-based spheroids product candidate, CYWC628, in DFU patients in the first quarter of 2026. Complete Phase 1/2 clinical trial in Australia in DFU patients in the third quarter of 2026. Complete pre-clinical IND-enabling studies for the treatment of psoriasis with CYPS317, FibroBiologics’ fibroblast spheroid product candidate, by the end of 2025. Pete O'Heeron, Founder and Chief Executive Officer of FibroBiologics, said, “Backed by our strong research and development efforts, we are continuing to progress toward entering the clinic with our Phase 1/2 trial evaluating CYWC628 in diabetic foot ulcer patients, while simultaneously advancing IND-enabling studies for CYPS317 in psoriasis. Our robust intellectual property portfolio, which now includes more than 275 issued or pendi...

Preparations for Phase 1/2 clinical trial in Australia utilizing fibroblast-based spheroids product candidate, CYWC628, to treat diabetic foot ulcers are proceeding with plans to initiate in the third quarter of 2025 HOUSTON, May 14, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 240+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced first quarter 2025 financial results and provided a corporate update. Recent Highlights Announced the completion of FibroBiologics’ proprietary master cell bank that will support upcoming clinical trials. Manufactured in accordance with FDA Good Manufacturing Practices (cGMP), the cell bank has successfully passed all required safety testing. Announced the opening of a new laboratory facility in Houston that will expand the company’s ability to pioneer additional candidates for chronic disease-focused indications leveraging its novel fibroblast-based technology. Announced a significant advancement in neurodegenerative disease research. Leveraging the well-established Cuprizone animal model, FibroBiologics has demonstrated that intravenous fibroblasts can facilitate remyelination. FibroBiologics’ Cuprizone animal model study demonstrated a statistically significant increase in myelin expression within seven and nine weeks after both single and multiple dose fibroblast treatments. This confirms FibroBiologics’ previous report of remyelination with the Experimental Autoimmune Encephalomyelitis (EAE) animal model. Presented at a number of investor and science conferences including the ThymUS 2025 Meeting, The Cell & Gene Meeting on the Mediterranean, and The German-Nordic Joint Extracellular Matrix Meeting. Announced the filing of a patent application with the United States Patent and Trademark Office covering methods employing fibroblasts to improve mitochondrial performance in cells. Upcoming Milestones Initiate Phase 1/2 clinical trial in Australia utilizing fibroblast-based spheroids product candidate, CYWC628, in diabetic foot ulcer (DFU) patients in the third quarter of 2025. Complete Phase 1/2 clinical trial in Australia in DFU patients in the first quarter of 2026. Determine the potential of using the CYWC628 master cell bank fo...

HOUSTON, April 02, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics”), a clinical-stage biotechnology company with 240+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced a significant advancement in neurodegenerative disease research. Leveraging the well-established Cuprizone animal model, FibroBiologics has demonstrated that intravenous fibroblasts can facilitate remyelination. FibroBiologics’ Cuprizone animal model study demonstrated a statistically significant increase in myelin expression within seven weeks after both single and multiple dose fibroblast treatments. This confirms FibroBiologics’ previous report of remyelination with the Experimental Autoimmune Encephalomyelitis (EAE) animal model. Myelin sheath, the insulating layer around nerve fibers, is critical for proper nerve function and is often damaged in neurodegenerative diseases like multiple sclerosis. In the brain, the myelin sheath plays a critical role in speeding up communications between neurons. This is especially important in the brain, where rapid and precise signaling is needed for functions like thinking, memory, movement, and coordination. “This confirmation by our talented team of researchers demonstrates that fibroblasts can support the regeneration of myelin sheath, marking a potentially significant step in the utilization of a cell-based therapeutic in regenerative medicine,” said Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics. “Our team’s findings advance our understanding of fibroblasts’ regenerative capabilities,” said Pete O'Heeron, Founder & Chief Executive Officer of FibroBiologics. “Confirming remyelination in a second validated animal model is an important step in our research and development efforts, offering fresh hope for patients with demyelinating diseases, including multiple sclerosis. These findings advance our mission to develop transformative fibroblast-based therapies that address the root causes of chronic disease, not just their symptoms, and reflect our dedication to pushing the frontiers of regenerative medicine." For more information, please visit FibroBiologics' website or email FibroBiologics at: [email protected]. Cautionary Statement Regarding Forward-Looking Statements This commun...

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. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 240+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced full year 2024 financial results and provided a corporate update. Recent Highlights Established a master services agreement with Charles River Laboratories to develop and manufacture FibroBiologics’ therapeutic master cell bank, working cell bank, and fibroblast-based spheroids product, CYWC628, for utilization in a Phase 1/2 clinical trial to treat diabetic foot ulcers (DFUs). Completed FibroBiologics’ proprietary master cell bank that will support upcoming clinical trials. Manufactured in accordance with FDA Good Manufacturing Practices (cGMP), the cell bank has successfully passed all required safety testing. Engaged Southern Star Research to provide clinical research organization (CRO) services in Australia in connection with FibroBiologics’ planned Phase 1/2 clinical trial utilizing CYWC628 to treat DFUs. Presented at a number of investor and science conferences including the 2024 Jones Healthcare and Innovation Conference, HC Wainright Global Investment Conference, 2024 Maxim Virtual Summit, BIO San Diego, Cell and Gene Meeting on the Mesa, ThinkEquity Conference, BIO CEO Conference, and The Extracellular Matrix Pharmacology Congress, Copenhagen, Denmark. Announced early-stage research and development efforts in FibroBiologics’ human longevity program covering potential extension of life applications including recovery of lost thymic functionality by using transplanted artificial thymic organoids in animal models, which has demonstrated the generation of a diverse array of mature T-cells, and 60+ days of vascularization and persistence at the transplantation site. Moved discovery phase project, CY...