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 ...

Reverse Split Expected to Take Effect March 30, 2026HOUSTON, March 25, 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 that its Board of Directors has approved a 1-for-20 reverse stock split of the Company’s issued and outstanding common stock. T ...

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 Viewpoint - FibroBiologics has received a new U.S. patent for fibroblast cell therapy aimed at treating osteoporosis, enhancing its intellectual property in regenerative medicine and bone disorders [1][2]. 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. The company holds over 270 patents issued and pending across various clinical pathways, including wound healing, multiple sclerosis, and cancer [5]. Patent Details - The newly issued U.S. Patent No. 12,544,407 B2 covers methods for treating bone diseases, particularly osteoporosis, through the administration of fibroblast cells. This includes both systemic and local administration to modulate bone remodeling by inhibiting osteoclast activity and promoting osteoblast activity [2][3]. - The patent supports the use of fibroblasts as therapeutic agents capable of modulating bone resorption and formation pathways, specifically through the inhibition of RANK ligand-mediated osteoclast activation [2]. Strategic Importance - The issuance of this patent is viewed as a significant milestone for FibroBiologics, reinforcing its strategy to develop proprietary fibroblast cell therapies that address unmet medical needs in the treatment of osteoporosis and other bone-related disorders [3].

Core Insights - FibroBiologics, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for chronic diseases using fibroblasts and fibroblast-derived materials, holding over 270 patents [1] - The company has a market capitalization of approximately $11 million and has experienced significant stock price fluctuations, with a yearly high of $1.53 and a low of $0.22 [4][5] Stock Performance - H.C. Wainwright maintained a "Buy" rating for FibroBiologics, with the stock priced at approximately $0.26, despite a recent decrease of 1.57% [2][5] - The stock has shown volatility, fluctuating between $0.25 and $0.28 on the day of the report [2] Upcoming Events - FibroBiologics is scheduled to present at the BIO Investment & Growth Summit on March 2-3, 2026, which may enhance the company's exposure and networking opportunities [3][5]

Core Insights - FibroBiologics, Inc. is a clinical-stage biotechnology company focused on developing therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials [1][3] - 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 [3] Company Presentation - The CEO, Pete O'Heeron, will present at the BIO Investment & Growth Summit on March 2-3, 2026, in Miami Beach, FL [1] - The company will have a presentation scheduled for 10:15 a.m. ET on March 2 and will be available for one-on-one meetings throughout the event [2] Company Overview - FibroBiologics is based in Houston and represents the next generation of medical advancement in cell therapy and tissue regeneration [3] - The company is actively developing a pipeline of treatments aimed at chronic diseases [3]

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 ...

Financial Performance - The company has incurred net losses of approximately $18.6 million and $11.2 million for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of approximately $54.2 million as of December 31, 2025[504]. - The net loss for 2025 was $18.6 million, compared to a net loss of $11.2 million in 2024, reflecting a deterioration of 66.1%[538]. - Net cash used in operating activities was $16.4 million in 2025, compared to $11.9 million in 2024, an increase of 37.6%[538]. - Net cash provided by financing activities decreased to $7.6 million in 2025 from $16.9 million in 2024, a decline of 55.0%[540]. - The effective income tax rate was 0.0% for all periods, with a full valuation allowance recorded against net deferred tax assets[534]. Funding and Capital Requirements - The company has funded operations through $15.0 million in convertible promissory notes, $18.6 million in preferred stock, and $10.4 million from common stock sales[503]. - The company expects to incur significant losses for the foreseeable future and will need substantial additional funding to support operations and growth strategy[505]. - The company is dependent on raising additional capital to continue as a going concern, with potential financing through equity offerings or other arrangements[543]. - Future funding requirements will be influenced by various factors, including unforeseen expenses and operational needs for clinical trials and R&D expenditures[544]. - The company has material cash requirements and contractual obligations related to office and lab rent[547]. - The company initiated a Standby Equity Purchase Agreement (SEPA) for a total principal amount of $15.0 million, with net proceeds of $4.3 million from the first tranche and $4.4 million from the second tranche of short-term convertible notes[551]. Research and Development - The company has completed IND-enabling pre-clinical studies for CYWC628, showing statistically significant acceleration in wound closure rates and planning to initiate a twelve-week Phase 1/2 clinical trial in Australia for diabetic foot ulcers in Q1 2026[495]. - CYMS101 has received approval from a U.S.-based IRB for clinical investigations in Mexico, with a Phase 1 study conducted on five participants showing no adverse events during a 16-week monitoring period[496][497]. - The company filed a Phase 1/2 IND application for CYPS317 with the FDA on December 30, 2025, after completing preliminary IND-enabling pre-clinical studies[499]. - The manufacturing of the master cell bank for CYWC628 is complete, and the company plans to amend the IND clearance with the FDA to replace single-cell fibroblasts with fibroblast-derived chondrocyte spheroids[501]. - The company plans to expand research and development activities and hire additional personnel to support the advancement of its product candidates[507]. - Research and development expenses increased to $7.4 million in 2025 from $4.5 million in 2024, representing a growth of 64.4%[519]. Operating Expenses - Total operating expenses rose to $16.6 million in 2025, up from $13.7 million in 2024, an increase of 21.0%[518]. - General and administrative expenses are expected to increase due to compliance with SEC regulations and the growth of the administrative function[514]. - Interest expense increased to $0.2 million in 2025 from approximately $20,000 in 2024, a significant rise due to the payoff of convertible notes[533]. Risks and Uncertainties - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future[506]. - The company has not generated any revenue from product sales and expects to continue incurring operating losses as it develops its product candidates[541]. - The company is subject to risks related to the development of new product candidates, which may lead to unforeseen expenses and delays[544]. - The company may need to relinquish certain rights or grant licenses on unfavorable terms if additional capital is raised through collaborations or licensing arrangements[543]. - The company evaluates its critical accounting estimates based on historical experience and other factors, which may lead to differences in actual results[548]. Company Classification - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to delay adopting new accounting standards[557]. - The company will remain an emerging growth company until certain revenue or market value thresholds are met, including total annual gross revenue of at least $1.235 billion[559]. Fair Value and Liabilities - The change in fair value of SEPA put option liability resulted in a gain of $0.4 million in 2025, compared to a loss of $0.5 million in 2024[524]. - The fair value of the SEPA put option liability was estimated at $0.5 million at inception and $0.1 million as of December 31, 2025[555].

Core Viewpoint - FibroBiologics, Inc. has received an extension from a Nasdaq Hearings Panel to regain compliance for continued listing on The Nasdaq Capital Market, providing a clear path for the company to maintain its stock listing [1][2]. Group 1: Compliance Conditions - The company must meet an equity standard of $2.5 million under Nasdaq Listing Rule 5550(b)(1) by February 27, 2026, as an alternative to the $35 million minimum Market Value of Listed Securities under Listing Rule 5550(b)(2) [2]. - FibroBiologics is required to meet the minimum bid price requirement of $1.00 per share by April 13, 2026, as per Nasdaq Listing Rule 5550(a)(2) [2]. - The company must comply with all applicable criteria for continued listing on Nasdaq by April 13, 2026 [2]. Group 2: 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 [4]. - The company holds over 270 patents issued and pending in the US and internationally, covering various clinical pathways including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer [4]. - FibroBiologics represents a new generation of medical advancements in cell therapy and tissue regeneration [4].