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]

Core Insights - FibroBiologics, Inc. has opened a new laboratory facility to enhance its research capabilities for chronic disease therapeutics using fibroblast technology [1][2][3] - The new facility spans over 10,000 square feet and will support in-house GMP manufacturing for drug product candidates [2][3] - The expansion aims to accelerate innovation, increase research efficiency, and reduce reliance on external partners [3] Company Overview - FibroBiologics is a clinical-stage biotechnology company based in Houston, focusing on developing treatments and potential cures for chronic diseases through fibroblast cells and materials [6] - The company holds over 240 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, and cancer [6] Future Plans - The company plans to hire additional researchers to support the new laboratory and its mission to combat chronic diseases [2][3] - The expansion is expected to facilitate the exploration of a broader pipeline of therapeutic candidates and enhance collaboration among research teams [3]

Core Insights - FibroBiologics has made significant advancements in neurodegenerative disease research, demonstrating that intravenous fibroblasts can facilitate remyelination using the Cuprizone animal model [1][2][3] Company Overview - FibroBiologics is a clinical-stage biotechnology company based in Houston, focusing on developing therapeutics and potential cures for chronic diseases through fibroblasts and fibroblast-derived materials [6][7] - 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 [6][7] Research Findings - The study using the Cuprizone animal model showed a statistically significant increase in myelin expression within seven weeks after both single and multiple dose fibroblast treatments [2] - This finding confirms previous reports of remyelination in the Experimental Autoimmune Encephalomyelitis (EAE) animal model, highlighting the critical role of the myelin sheath in nerve function and its importance in neurodegenerative diseases like multiple sclerosis [2][3] Leadership Statements - The Chief Scientific Officer emphasized that the confirmation of fibroblasts supporting myelin sheath regeneration marks a significant step in cell-based therapeutics for regenerative medicine [3] - The CEO stated that these findings provide hope for patients with demyelinating diseases and reflect the company's commitment to developing transformative therapies that address the root causes of chronic diseases [4]

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].

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 ...

HOUSTON, March 21, 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 Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics, will present on FibroBiologics' unique fibroblast cell-based approach for the potential treatment of chronic di ...

This innovative method has the potential to unlock new treatment options for chronic conditions driven by mitochondrial dysregulation. HOUSTON, March 04, 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, announced the filing of a patent application with the Unite ...

Core Insights - FibroBiologics has completed its proprietary master cell bank for the CYWC628 drug product, which will support upcoming clinical trials for diabetic foot ulcers [1][3][4] - The master cell bank was manufactured in compliance with FDA Good Manufacturing Practices (cGMP) and has passed all required safety testing [1][3] - The CYWC628 therapy targets diabetic foot ulcers, a condition affecting millions globally, and aims to provide effective long-term treatment solutions [3][4] Company Overview - FibroBiologics is a clinical-stage biotechnology company focused on developing therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, holding over 160 patents [2][8] - The company is exploring treatments for various conditions, including wound healing, multiple sclerosis, degenerative disc disease, psoriasis, human longevity, and cancer [2][8] Collaboration and Manufacturing - Charles River Laboratories will manufacture the CYWC628 cell banks and drug product at its state-of-the-art cGMP facilities, facilitating the upcoming phase I/II clinical trial [3][4] - The partnership between FibroBiologics and Charles River aims to expedite the development of advanced therapies and ensure readiness for scaling the CYWC628 product [4]

FibroBiologics to also present at the BIO CEO & Investor ConferenceHOUSTON, Feb. 05, 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, announced that it will host an in-person analyst day at the New York Marriott Marquis on February 12, 2025, at 2:00 p.m. ET. The ...