Core Insights - FibroBiologics has successfully completed the manufacturing of its proprietary CYWC628 drug product, which is set to support upcoming first-in-human clinical trials [1][3] - The CYWC628 therapy targets diabetic foot ulcers, a condition affecting millions globally with no effective long-term treatment options [2] - This marks the first large-scale CGMP manufacturing of a fibroblast-based spheroid therapeutic candidate, allowing the company to proceed with planned Phase 1/2 clinical trials in DFU patients in the first half of 2026 [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] - The company holds over 270 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer [5]

As filed with the Securities and Exchange Commission on March 27, 2026. Registration No. 333- 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) Delaware 2834 86-3329066 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer 455 E. Medical Center Blvd. Suite 300 Houst ...

Core Insights - FibroBiologics is expanding its wound care platform to include treatments for acute and chronic burn injuries, leveraging its proprietary fibroblast spheroid technology [1][2] Company Overview - FibroBiologics is a clinical-stage biotechnology company based in Houston, holding over 270 patents related to various therapeutic areas, including wound healing and chronic diseases [6] Technology and Research Findings - The proprietary fibroblast spheroid treatment (CYWC628) demonstrated nearly a four-fold increase in tissue-level IL-10, which supports tissue repair, and a significant reduction in IL-1B, an inflammatory marker in burn wounds [3][4] - These findings suggest that CYWC628 may enhance wound closure and improve the quality of healed tissue by promoting regeneration and reducing inflammation [4] Market Potential - The global burn care market is estimated to be $2.55 billion and is projected to grow to $3.35 billion by 2030, driven by increasing incidence and demand for advanced wound care solutions [5]

Core Viewpoint - FibroBiologics has completed onboarding clinical sites for its Phase 1/2 clinical trial of CYWC628, aimed at treating refractory diabetic foot ulcers (DFUs) [1][2]. Group 1: Clinical Trial Details - The clinical trial is a prospective, multicenter, open-label study designed to evaluate the safety, tolerability, and efficacy of CYWC628, which is a topically administered allogeneic fibroblast spheroid-based therapy [2][8]. - Participants will undergo up to 12 weeks of treatment, receiving either standard of care (SoC) plus a low or high dose of CYWC628, or SoC alone [2][8]. - An interim analysis will be conducted after a predefined number of participants complete six weeks of treatment to assess primary safety and efficacy endpoints [3]. Group 2: Company Statements and Management - The successful engagement of all clinical trial sites is seen as a critical step towards trial initiation, with a focus on disciplined execution to demonstrate the potential of fibroblast spheroid-based therapies [4]. - Southern Star Research, a full-service Australian CRO, is managing all aspects of the CYWC628 trial, emphasizing the program's fit within Australia's clinical research ecosystem [4][10]. Group 3: Product Information - CYWC628 is an investigational therapy that may significantly accelerate wound healing compared to currently available treatments, based on preclinical data [7][8]. - FibroBiologics holds over 270 patents issued and pending, focusing on developing therapeutics for chronic diseases using fibroblast cells and fibroblast-derived materials [9].

Core Insights - FibroBiologics, Inc. is preparing to initiate a Phase 1/2 clinical trial in Australia for CYWC628, aimed at treating diabetic foot ulcers, expected to start in the first half of 2026 [1][4] - The company has improved its balance sheet by raising $7.2 million through direct offerings and has repaid all outstanding debt [4][9] - FibroBiologics reported a net loss of approximately $18.6 million for the year ended December 31, 2025, compared to a net loss of approximately $11.2 million in 2024, primarily due to increased research and development expenses [9] Recent Highlights - The company secured Human Research Ethics Committee (HREC) approvals in Australia for the clinical trial, allowing the enrollment of 120 patients across 10 sites [4] - An investigational new drug (IND) application was filed with the FDA for CYPS317, targeting psoriasis [4] - The patent portfolio was expanded with a new application covering a fibroblast-derived therapy platform for orthopedic and musculoskeletal conditions [4] Upcoming Milestones - Completion of manufacturing CYWC628 in accordance with FDA Good Manufacturing Practices (cGMP) is scheduled for Q1 2026 [4] - Enrollment of clinical sites and dosing of the first patient is expected in the first half of 2026, with interim results to be reported in the same timeframe [4] - The company plans to submit an IND application for multiple sclerosis treatment with CYMS101 in the first half of 2026 [4] Financial Highlights - Research and development expenses increased to approximately $7.4 million in 2025 from $4.5 million in 2024, driven by higher costs related to clinical trial preparations and personnel [9] - General and administrative expenses remained stable at approximately $9.2 million for 2025, with minor fluctuations in personnel and professional fees [9] - Cash and cash equivalents were approximately $4.9 million as of December 31, 2025 [9]

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]

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, Inc. has submitted a new patent application for a fibroblast-derived therapy platform aimed at orthopedic and musculoskeletal conditions, which could enhance its competitive position in the market [1][2]. Group 1: Patent Application - The new patent application covers a proprietary fibroblast-derived therapy platform for degenerative disc repair, cartilage repair, and joint restoration [1]. - If granted, the patent will strengthen the protection for the company's fibroblast technology, which utilizes fibroblast cells and spheroids for orthopedic tissue repair [2]. Group 2: Preclinical Studies and Patents - Preclinical studies indicate that fibroblast-based constructs and chondrocyte spheroids can integrate with native tissue, promote extracellular matrix remodeling, and encourage regeneration in models of disc and joint degeneration [3]. - FibroBiologics holds over 270 U.S. and internationally issued patents or patents pending across various clinical pathways, including wound healing and orthopedics [3]. Group 3: Recent Events - In November, FibroBiologics closed a registered direct offering of 4.48 million shares at $0.335 per share, raising approximately $1.5 million [4]. - The company received approvals in Australia for a Phase 1/2 trial of CYWC628 for refractory diabetic foot ulcers, allowing enrollment of 120 patients [5]. - Following these developments, FBLG stock increased by 13.61% to $0.335 [5].

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 Viewpoint - FibroBiologics has received necessary regulatory approvals for a Phase 1/2 clinical trial of CYWC628 aimed at treating refractory diabetic foot ulcers, marking a significant milestone in the company's development of fibroblast-based therapies [1][5]. Company Overview - FibroBiologics is a clinical-stage biotechnology company based in Houston, focusing on developing therapeutics for chronic diseases using fibroblast cells and fibroblast-derived materials. The company holds over 270 patents issued and pending across various clinical pathways [1][11]. Clinical Trial Details - The approved clinical trial is a prospective, multicenter, randomized study designed to evaluate the safety, tolerability, and efficacy of CYWC628, a topically administered allogeneic fibroblast cell-based therapy for refractory diabetic foot ulcers. The trial will enroll 120 patients across 10 sites in Australia [1][3]. - Participants will receive treatment for up to 12 weeks, either with standard of care plus a low or high dose of CYWC628, or standard of care alone [3][10]. Trial Management - Southern Star Research, a full-service Australian CRO, will manage all aspects of the CYWC628 trial, continuing its partnership with FibroBiologics [2]. Expected Outcomes - The trial will assess wound healing outcomes, efficacy of response, and safety parameters through regular clinical and imaging evaluations. An interim analysis will be conducted after a predefined number of participants complete six weeks of treatment to evaluate primary safety and efficacy endpoints [4][10]. - The study aims to provide key clinical data supporting CYWC628 as a novel therapy for chronic wound management, addressing a significant unmet need in this area [5].