HOUSTON, Jan. 07, 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 issued the following letter to shareholders. Fellow Shareholders, Looking back on 2025, I'm reminded of something I've always believed: the best way to predict the future is to invent it. At ...

HOUSTON, Dec. 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 the filing of a Phase 1/2 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) seeking regulatory clearance to initiate clinical trials of CY ...

As filed with the Securities and Exchange Commission on December 23, 2025. Registration No. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification Number) 455 E. Medical Center Blvd. Suite 300 Houston, Texas 77598 (281) 671-5150 Delaware 2834 86-3329066 (Prim ...

Core Viewpoint - FibroBiologics has successfully repaid all outstanding convertible promissory notes, strengthening its balance sheet and eliminating further dilution from conversions [1][2][3] Financial Developments - The company has paid off the convertible promissory notes issued to Yorkville, which were part of a Standby Equity Purchase Agreement (SEPA) allowing the sale of up to $25 million in common stock [1][2] - The first $15 million was advanced in three equal tranches, and with the repayment, there will be no further conversions into shares [2] - The SEPA remains active until December 20, 2026, permitting the company to sell an additional $10 million of its common stock under certain conditions [2] Strategic Focus - The repayment of convertible debt allows the company to concentrate on advancing its clinical programs, particularly the initiation of first-in-human trials [3] - The company is preparing to start a Phase 1/2 clinical trial for its fibroblast-based product candidate CYWC628 in diabetic foot ulcer patients in early 2026 [4] - Additionally, the company plans to submit Investigational New Drug applications for treatments targeting psoriasis and multiple sclerosis [4] Company Overview - FibroBiologics is a clinical-stage biotechnology company based in Houston, focusing on developing therapeutics for chronic diseases using fibroblast cells [8] - The company holds over 270 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, and cancer [8]

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 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 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].