HOUSTON, Nov. 24, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics” or the “Company”), 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 it has entered into definitive agreements for the issuance and sale of an aggregate of 4,477,614 shares of its common stock at an offering price of $0.335 per shar ...

HOUSTON, Nov. 20, 2025 (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 it has received both public and private Human Research Ethics Committee (HREC) approvals in Australia for a Phase 1/2 clinical trial evaluating CYWC628 for the Treatment of Re ...

Core Viewpoint - FibroBiologics, Inc. has successfully closed a registered direct offering, raising approximately $4 million through the issuance of common stock and pre-funded warrants, with a unique payment method involving gold coins [1][2][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 270 patents [1][10]. - The company is engaged in various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer [10]. Offering Details - The company issued 3,540,000 shares of common stock and pre-funded warrants to purchase 8,570,203 shares at a price of $0.3303 per share [1]. - The purchase price was paid with sovereign-issued .9999 fine gold coins valued at $4,069.18 per ounce [2]. - In a concurrent private placement, unregistered warrants were issued to purchase up to 12,110,203 shares of common stock, with an exercise price of $0.3303 per share [3]. Financial Implications - The gross proceeds from the offering were approximately $4 million, intended for general corporate purposes, including debt satisfaction [4]. - If the unregistered warrants are fully exercised for cash following stockholder approval, the company could receive an additional $4 million [4]. Regulatory Compliance - The shares and pre-funded warrants were offered under a shelf registration statement previously filed with the SEC [5]. - The unregistered warrants were offered in a private placement and have not been registered under the Securities Act [6].

HOUSTON, Nov. 19, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics” or the “Company”), 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 it has entered into a definitive agreement for the issuance and sale to an existing shareholder of 3,540,000 shares of its common stock and pre-funded warrants to ...

Core Insights - FibroBiologics is advancing preparations for the manufacturing of its fibroblast-based spheroids product candidate, CYWC628, for a Phase 1/2 clinical trial targeting diabetic foot ulcers (DFU) patients [1] - The company is also preparing to submit Investigational New Drug (IND) applications for treatments of psoriasis with CYPS317 and multiple sclerosis with CYMS101 [1] Recent Highlights - The CEO emphasized the strategic focus on moving advanced product candidates towards clinical trials while establishing fibroblasts as a scalable platform [4] - Positive updates from the psoriasis research program indicate the potential of human dermal fibroblast spheroids as a novel therapeutic approach [6] - The Bone Marrow Organoid platform has been advanced, presenting new treatment options for hematopoietic cancers and age-related immune decline [6] Financial Highlights - Research and development expenses for the nine months ended September 30, 2025, were approximately $6.6 million, up from $3.1 million in the same period of 2024, primarily due to increased contract research costs and personnel-related expenses [5] - General and administrative expenses were approximately $7.4 million for the same period, compared to $6.9 million in 2024, driven by increased personnel and professional fees [10] - The net loss for the nine months ended September 30, 2025, was approximately $15.4 million, compared to a net loss of $8.1 million in 2024 [10] Upcoming Milestones - The company plans to complete manufacturing training runs for CYWC628 and confirm the sterility of the manufacturing process by the end of 2025 [6] - The initiation of the Phase 1/2 clinical trial in Australia for CYWC628 is expected in the first quarter of 2026, with completion anticipated in the third quarter of 2026 [6] - Pre-clinical IND-enabling studies for psoriasis and multiple sclerosis treatments are also set to be completed, with IND submissions planned [6]

Financial Performance - The company has incurred net losses of $15.4 million and $8.1 million for the nine months ended September 30, 2025 and 2024, respectively, with an accumulated deficit of $50.9 million as of September 30, 2025[116]. - The net loss for Q3 2025 was $5.8 million, significantly higher than the $0.5 million loss in Q3 2024, reflecting an increase of 1,056%[132]. - The net loss for the nine months ended September 30, 2025, was $15.4 million, compared to $8.1 million in 2024, reflecting an increase of 90.5%[147]. - The company reported a net cash used in operating activities of $13.2 million for the nine months ended September 30, 2025, compared to $8.8 million in 2024, a 49.5% increase[163]. - The company recognized a net loss of approximately $0.9 million on the conversion of $9.7 million of convertible debt into shares of Common Stock during the nine months ended September 30, 2025[155]. - As of September 30, 2025, the company had cash and cash equivalents of $4.9 million and an accumulated deficit of $50.9 million[161]. - The company expects to continue incurring operating losses as it builds infrastructure and conducts research and development activities, raising substantial doubt about its ability to continue as a going concern[169]. Research and Development - The company expects to initiate a twelve-week Phase 1/2 clinical trial for CYWC628 in Australia in Q1 2026, with completion anticipated in Q3 2026[118]. - The company has completed IND-enabling pre-clinical studies for CYWC628, showing statistically significant acceleration in wound closure compared to a marketed product[106]. - The company plans to file an IND application for a Phase 1/2 clinical trial for CYMS101 in the U.S. in Q4 2025, following a successful Phase 1 study in Mexico[107]. - The company has completed two animal studies for CybroCell™, supporting its IND application for a "first in human" trial[108]. - The company expects research and development expenses to increase substantially as it advances product candidates into later clinical stages[124]. - Research and development expenses increased to $2.8 million for the three months ended September 30, 2025, up from $1.2 million in 2024, representing a 130% increase[133]. - For the nine months ended September 30, 2025, research and development expenses totaled $6.6 million, up from $3.1 million in 2024, a 111% increase[148]. Operating Expenses - General, administrative and other expenses rose to $2.2 million in Q3 2025 from $2.1 million in Q3 2024, a 4.7% increase attributed to added personnel costs[134]. - Total operating expenses for Q3 2025 were $5.0 million, compared to $3.4 million in Q3 2024, marking a 50.3% increase[132]. - Total operating expenses for the nine months ended September 30, 2025, were $14.1 million, compared to $10.0 million in 2024, an increase of 40.5%[147]. 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[113]. - The company anticipates needing substantial additional funding to support ongoing operations and growth strategy[117]. - Future funding requirements will depend on various factors, including the progress and costs of clinical trials and regulatory requirements[170]. - The company may seek additional capital through public or private equity offerings, debt financings, collaborations, and licensing arrangements, which may involve relinquishing certain rights[169]. Cash Flow - Net cash used in operating activities was $13.2 million for the nine months ended September 30, 2025, compared to $8.8 million for the same period in 2024, primarily due to net losses of $15.4 million and $8.1 million, respectively[165]. - Net cash used in investing activities was $0.3 million for the nine months ended September 30, 2025, compared to $0.1 million in 2024, mainly for laboratory equipment purchases[166]. - Net cash provided by financing activities was $4.4 million for the nine months ended September 30, 2025, down from $7.6 million in 2024, with a principal balance of $5.0 million in short-term convertible debt issued[167]. Operational Risks - The company is subject to risks related to the development of new product candidates, which may lead to unforeseen expenses and operational needs[171]. - Material cash requirements and contractual obligations are related to office and lab rent[172]. - The company has implemented measures to reduce operating expenses, including delaying certain research and development projects and limiting administrative costs[169].

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-Europe 2025 conference from November 3-5, 2025, in Vienna, Austria [1] - FibroBiologics is scheduled to deliver a company presentation on November 4 at 4:15 p.m. CET and will be available for one-on-one investor meetings during 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, leveraging its extensive patent portfolio [3]

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 2025 ThinkEquity Conference on October 30 at 4:30 p.m. ET [2] - FibroBiologics will also be available for one-on-one investor meetings during 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]

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][4] - The company will present updates on its fibroblast-based technologies at the 2025 Cell & Gene Meeting on the Mesa Conference scheduled for October 6-8, 2025 [2] - A clinical trial for diabetic foot ulcers is planned to be initiated in the first quarter of 2026 [2] Company Overview - FibroBiologics is based in Houston and is developing a pipeline of treatments targeting chronic diseases, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer [4] - The company represents advancements in cell therapy and tissue regeneration [4] Event Details - The presentation at the 2025 Cell & Gene Meeting on the Mesa will take place on October 7, 2025, at 2:15 p.m. MST in FLW Ballroom F [2]

Core Viewpoint - FibroBiologics presents fibroblast cells as a superior alternative to stem cells for chronic disease therapies, highlighting their therapeutic advantages and potential to transform treatment outcomes [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 using fibroblast cells and fibroblast-derived materials [5][6]. - The company holds over 270 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, and cancer [5][6]. Research and Findings - The editorial authored by company leadership reviews extensive research indicating that fibroblast cells have faster proliferation rates, better sourcing capabilities, and enhanced immune modulation properties compared to stem cells [2][3]. - The evidence suggests that fibroblasts may not only match but potentially exceed the efficacy of mesenchymal stem cells in clinical applications [3]. Future Implications - The leadership at FibroBiologics believes that the transition from stem cell therapies to fibroblast-based solutions represents a paradigm shift in medicine, aiming for long-term improvements in patient outcomes [3]. - The company emphasizes the scalability and effectiveness of fibroblast therapies, which could fundamentally change how chronic diseases are treated [3].