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 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 Founder and CEO, Pete O'Heeron, will present at the 9th Annual BFC Global Healthcare Business Development and Investment Conference on January 11, 2026, at 4:30 p.m. PT [1][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]

Core Insights - FibroBiologics has announced positive preclinical results for FSdC, a spheroid-based therapy, showing significant improvement in intervertebral disc integrity and degeneration prevention in animal models of degenerative disc disease [1][2] Group 1: Preclinical Findings - FSdC spheroids demonstrated the highest level of intervertebral disc height recovery at 12 weeks post-treatment, outperforming 2D fibroblasts and fibroblast spheroids [5] - The study revealed an unadjusted p-value of 0.00015 for FSdC spheroids in disc height recovery, indicating exceptional statistical superiority compared to 0.036 for 2D fibroblasts and 0.068 for fibroblast spheroids [5] - FSdC spheroids maintained the highest average disc size index across all time points during the 12-week study, suggesting a breakthrough potential in regenerative therapies for degenerative disc disease [5] Group 2: Company Overview - FibroBiologics is a clinical-stage biotechnology company focused on developing therapeutics for chronic diseases using fibroblast cells and materials, holding over 270 patents [4] - The company aims to advance FSdC spheroids into clinical trials, supported by comprehensive preclinical pharmacology and efficacy assessments [3] - Degenerative disc disease is a significant cause of chronic back pain and disability, affecting millions in the U.S., highlighting the unmet needs in long-term disc preservation and regeneration [2]

Core Viewpoint - FibroBiologics has filed a Phase 1/2 Investigational New Drug (IND) application with the FDA for CYPS317, a fibroblast spheroid-based therapy aimed at treating moderate to severe psoriasis, marking a significant step in its chronic inflammatory disease pipeline [1][2][3] Group 1: Company Developments - The IND filing is a major advancement for FibroBiologics, following positive preclinical results that indicate CYPS317 can significantly reduce psoriasis severity and relapse [2] - The IND submission includes comprehensive data on pharmacology, safety, and manufacturing, supporting the therapeutic's mechanism of action and safety profile [3] - The company aims to advance first-in-human clinical trials for CYPS317 after FDA review [3] Group 2: Market Context - Psoriasis affects over eight million adults in the U.S., significantly impairing quality of life and productivity, with existing therapies still leaving unmet needs [4] - The filing of the IND application is seen as a pivotal transition from preclinical research to clinical development for CYPS317, with the potential to redefine treatment for chronic inflammatory disorders [5] Group 3: Scientific Insights - Preclinical data suggest that CYPS317 combines extracellular matrix signaling with immunomodulation, potentially restoring tissue homeostasis in chronic inflammatory conditions like psoriasis [5] - The therapy's single dose has shown effects that match or exceed those of multiple doses of existing anti-IL-23 monoclonal antibodies, indicating its durability and immunomodulatory capacity [2]

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 successfully closed a registered direct offering of 5,227,275 shares of common stock at $0.33 per share, raising approximately $1.7 million in gross proceeds, with additional potential proceeds from unregistered warrants [1][3]. Group 1: Offering Details - The registered direct offering involved 5,227,275 shares priced at $0.33 each, with concurrent private placement of unregistered warrants for the same number of shares at the same exercise price [1]. - The total gross proceeds from the offering are approximately $1.7 million before deducting fees and expenses, with potential additional proceeds of $1.7 million from the unregistered warrants if fully exercised [3]. - The unregistered warrants will be exercisable upon stockholder approval and will expire five years after such approval [1]. Group 2: Regulatory and Legal Aspects - The shares offered in the registered direct offering were made under a "shelf" registration statement filed with the SEC, which became effective on February 10, 2025 [4]. - The unregistered warrants and shares from the private placement were offered under Section 4(a)(2) of the Securities Act and have not been registered, thus cannot be sold in the U.S. without registration or an exemption [5]. Group 3: Company Overview - FibroBiologics is a clinical-stage biotechnology company focused on developing therapeutics for chronic diseases using fibroblast cells, holding over 270 patents [9]. - The company aims to advance medical treatments in areas such as wound healing, multiple sclerosis, and cancer through its innovative cell therapy and tissue regeneration approaches [9].

Core Viewpoint - FibroBiologics, Inc. has announced a registered direct offering of 5,227,275 shares of common stock at $0.33 per share, along with a concurrent private placement of unregistered warrants for the same number of shares at the same exercise price, aiming to raise approximately $1.7 million in gross proceeds [1][3]. Group 1: Offering Details - The company will issue 5,227,275 shares of common stock at an offering price of $0.33 per share in a registered direct offering [1]. - Concurrently, unregistered warrants will be issued to purchase up to 5,227,275 shares at an exercise price of $0.33 per share, which will be exercisable upon stockholder approval [1]. - The closing of the offering is expected on or about December 16, 2025, subject to customary closing conditions [1]. Group 2: Financial Implications - The aggregate gross proceeds from the offering are expected to be approximately $1.7 million before deducting fees and expenses [3]. - If the unregistered warrants are fully exercised, additional gross proceeds of approximately $1.7 million could be realized [3]. - The net proceeds from the offering will be used for working capital and general corporate purposes [3]. Group 3: Regulatory Information - The shares offered in the registered direct offering are being made under a "shelf" registration statement that became effective on February 10, 2025 [4]. - The unregistered warrants and shares issuable upon their exercise are being offered in a private placement and have not been registered under the Securities Act [5]. Group 4: Company Overview - FibroBiologics is a clinical-stage biotechnology company focused on developing therapeutics for chronic diseases using fibroblast cells and materials, holding over 270 patents [9]. - The company is involved in various clinical pathways, including wound healing, multiple sclerosis, and cancer, representing advancements in cell therapy and tissue regeneration [9].

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 Insights - FibroBiologics has submitted a new patent application for a fibroblast-derived therapy platform aimed at orthopedic and musculoskeletal conditions, which includes degenerative disc repair and cartilage repair [1][2][3] - The application, if granted, will enhance the protection of the company's innovative fibroblast technology, which has shown promise in preclinical studies for integrating with native tissue and promoting regeneration [2][3] - The CEO of FibroBiologics emphasized that this patent application is a significant advancement in expanding the company's focus from chronic wounds to the structural repair of the musculoskeletal system, targeting large markets in degenerative disc disease and joint disease [3] Company Overview - FibroBiologics is a clinical-stage biotechnology company based in Houston, specializing in developing treatments and potential cures for chronic diseases using fibroblast cells and materials [4] - The company holds over 270 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, and orthopedics [4] - FibroBiologics aims to be at the forefront of medical advancements in cell therapy and tissue regeneration [4]

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]