Financial Performance - The company reported net losses of approximately $5.0 million for the three months ended March 31, 2025, compared to $8.5 million for the same period in 2024, reflecting a decrease of $3.5 million [105][119]. - The company has incurred an accumulated deficit of approximately $42.8 million as of March 31, 2025 [105]. - The company expects to continue incurring significant losses as it advances product candidates through clinical development and seeks regulatory approvals [106]. - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future [110]. - Net cash used in operating activities was $5.3 million for the three months ended March 31, 2025, compared to $4.3 million for the same period in 2024 [136]. - The net cash provided by financing activities was $0 for the three months ended March 31, 2025, compared to $3.3 million for the same period in 2024 [138]. - The company incurred operating losses and expects such losses to continue as it builds infrastructure and conducts research and development activities [139]. Research and Development - Research and development expenses increased to $1.8 million for the three months ended March 31, 2025, from $1.0 million in 2024, an increase of $0.8 million [120]. - The company plans to initiate a twelve-week Phase 1/2 clinical trial for CYWC628 in Australia in the second half of 2025, with completion expected in the first quarter of 2026 [108]. - The company has completed the manufacturing of its master cell bank and working cell bank for CYWC628, which are certified for use in clinical trials [102]. - The company plans to seek a strategic partner for the development of CYMS101 either before or after the Phase 1/2 study, depending on its success [98]. - The company is in the early stages of research for human longevity and certain cancer applications, with plans to accelerate these programs as funding allows [101]. Financial Liabilities and Assets - The change in fair value of warrant liability resulted in a loss of $3.1 million for the three months ended March 31, 2024, while there was no loss for the same period in 2025 [122]. - The SEPA put option liability had a fair value of $543 thousand as of March 31, 2025, reflecting a loss of $0.1 million during the quarter due to changes in stock price [125]. - The company recognized a net loss of $180 thousand on the conversion of $3,600 thousand of convertible debt into Common Stock during the three months ended March 31, 2025 [127]. - The company had an accumulated deficit of approximately $42.8 million and cash and cash equivalents of approximately $8.7 million as of March 31, 2025 [132]. - The company has received aggregate proceeds of approximately $15.0 million from sales of convertible notes and $18.6 million from sales of preferred stock since inception [132]. - The SEPA allows the company to require the investor to purchase up to an additional $10,000 thousand of shares of Common Stock until December 20, 2026 [125]. Taxation - The effective income tax rate was 0.0% for all periods, with a full valuation allowance recorded against net deferred tax assets [131]. General and Administrative Expenses - General, administrative, and other expenses rose to $2.8 million for the three months ended March 31, 2025, compared to $2.5 million in 2024, an increase of $0.3 million primarily due to added personnel [121].

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 240 patents [1][5] - The company presented research on a scalable artificial thymus organoid at the ThymUS 2025 Meeting, which aims to recover the functionality of the thymus [2][3] Company Overview - Founded in 2001, FibroBiologics is based in Houston and is engaged in developing a pipeline of treatments for various chronic diseases, including multiple sclerosis, cancer, and wound healing [5] - The company emphasizes the unique immunomodulatory properties of fibroblasts, which are believed to enhance the functionality and durability of therapeutic organoids [3][5] Research and Development - The presented abstract details a method for developing transplantable and scalable thymus organoids that can generate functional T cells, indicating significant progress in the field [2][3] - The research highlights the potential of organoids to transform the study and treatment of chronic diseases, showcasing the innovative approaches being explored by the company [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 240 patents [1][5] - The company presented research on a scalable artificial thymus organoid at the ThymUS 2025 Meeting, which aims to recover the functionality of the thymus [2][3] Company Overview - Founded in 2001, FibroBiologics is based in Houston and is engaged in developing a pipeline of treatments for various chronic diseases, including multiple sclerosis, cancer, and wound healing [5] - The company emphasizes the unique immunomodulatory properties of fibroblasts in enhancing the functionality and durability of therapeutic organoids [3][5] Research and Development - The presented abstract details a method for developing transplantable and scalable thymus organoids that can generate functional T cells, showcasing the company's innovative approach in immunology [2][3] - The research indicates a significant advancement in understanding how organoids can be utilized to study and develop treatments for chronic diseases [3]

Core Insights - FibroBiologics, Inc. is a clinical-stage biotechnology company focused on developing therapeutics and potential cures for chronic diseases using fibroblast cells and materials [1][3] - The company holds over 240 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer [3] - Hamid Khoja, Ph.D., the Chief Scientific Officer, will present at The Cell & Gene Meeting On The Mediterranean in Rome, highlighting a fibroblast cell-based therapeutic approach targeting chronic inflammation-mediated diseases [1][2] Company Overview - FibroBiologics is based in Houston and represents a new generation of medical advancements in cell therapy and tissue regeneration [3] - The company is actively engaged in the development of a pipeline of treatments aimed at chronic diseases, leveraging its extensive patent portfolio [3] Conference Details - The presentation titled "Restoring Immune system homeostasis using a fibroblast cell-based therapeutic targeting three chronic inflammation-mediated diseases" will take place on April 16, 2025, at 9:00 AM CEST [2] - The event is a significant gathering for the Advanced Therapy Medicinal Products community from Europe and beyond [1][2]

Core Insights - FibroBiologics, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for chronic diseases using fibroblast cells and materials [1][3] - The company holds over 240 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, and cancer [3] - Hamid Khoja, Ph.D., the Chief Scientific Officer, will present at The Cell & Gene Meeting On The Mediterranean, highlighting a fibroblast cell-based therapeutic approach [1][2] Company Overview - FibroBiologics is based in Houston and is engaged in the development of a pipeline of treatments aimed at chronic diseases [3] - The company represents advancements in cell therapy and tissue regeneration, with a focus on innovative medical solutions [3] Conference Details - The presentation titled "Restoring Immune system homeostasis using a fibroblast cell-based therapeutic targeting three chronic inflammation-mediated diseases" will take place on April 16, 2025, at 9:00 AM CEST [2] - The event is a significant gathering for the Advanced Therapy Medicinal Products community in Europe [1][2]

HOUSTON, April 08, 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 the opening of a new laboratory facility that will expand the company's ability to pioneer additional candidates for chronic disease-focused indications leveraging its novel fibroblast-based ...

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 facili ...

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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K | (Mark One) | | | --- | --- | | ☒ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) | | | OF THE SECURITIES EXCHANGE ACT OF 1934 | | | For the fiscal year ended December 31, 2024. | | | or | | ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) | | | OF THE SECURITIES EXCHANGE ACT OF 1934 | | | For the transition period from [—Date—] to [—Date—] | | | Commission File Number: 001-41934 | FibroBiologics, Inc. (Exact name of reg ...

HOUSTON, March 27, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (NASDAQ:FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 160+ 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 2025 Annual Meeting of Stockholders will take place on June 12, 2025, at 11 a.m. CDT, exclusively through a virtual format. The record date for determination of stockholde ...