HOUSTON, Sept. 30, 2024 (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 fibroblastderived materials, today announced that Chief Scientific Officer, Hamid Khoja, Ph.D., will present at the 2024 Cell & Gene Meeting on the Mesa Conference taking place October 7-9 in Phoenix, Arizona. "We always look ...

HOUSTON, Sept. 12, 2024 (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 fibroblastderived materials, announced the filing of a patent application with the United States Patent Office covering the use of fibroblast cell-based technology in generating three-dimensional hemopoietic organoids that ca ...

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 has over 150 patents issued and pending, covering various clinical pathways including disc degeneration, orthopedics, multiple sclerosis, psoriasis, wound healing, reversing organ involution, and cancer [3] Company Overview - FibroBiologics is based in Houston and represents the next generation of medical advancement in cell therapy [3] - The company has filed its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, with the U.S. Securities and Exchange Commission [1]

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 has over 150 patents issued and pending, covering various clinical pathways including disc degeneration, orthopedics, multiple sclerosis, psoriasis, wound healing, reversing organ involution, and cancer [1][3] Company Overview - FibroBiologics is based in Houston and represents the next generation of medical advancement in cell therapy [3] - The company has filed its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, with the U.S. Securities and Exchange Commission [1]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024. or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41934 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) Delaware 86-3329066 (State or other jurisdict ...

HOUSTON, July 15, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 150+ 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 Founder and Chief Executive Officer, Pete O'Heeron, will present at the JonesTrading Healthcare Seaside Summit occurring July 14-16, 2024, in San Diego, California. Details of ...

HOUSTON, July 15, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 150+ 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 Founder and Chief Executive Officer, Pete O'Heeron, will present at the JonesTrading Healthcare Seaside Summit occurring July 14-16, 2024, in San Diego, California. About Fibr ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024. or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41934 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) Delaware 86-3329066 (State or other jurisdic ...

Item 1. Business FibroBiologics is a clinical-stage cell therapy company developing fibroblast-based therapies for chronic diseases and life extension applications [Overview](index=5&type=section&id=Overview) FibroBiologics, formed in April 2021, is a clinical-stage cell therapy company developing fibroblast-based therapies for chronic diseases and life extension applications - FibroBiologics is a clinical-stage cell therapy company developing fibroblast-based therapies for chronic diseases including degenerative disc disease, multiple sclerosis, wound healing, and certain cancers, with potential for life extension applications[17](index=17&type=chunk) - The company was formed in April 2021 as a spinout from FibroGenesis, acquiring rights to certain intellectual property through patent assignment and cross-licensing agreements[18](index=18&type=chunk) [Fibroblasts Technology Platform](index=5&type=section&id=Fibroblasts%20Technology%20Platform) FibroBiologics leverages fibroblasts as a cell therapy platform, highlighting their regenerative capabilities, immune-privileged nature, and cost-effectiveness - Fibroblasts are considered favorable over stem cells for cell therapy due to several advantages[21](index=21&type=chunk) - Can be non-invasively harvested from skin donors - Have a faster doubling time in culture than stem cells - Possess superior immune modulatory activity compared with stem cells - Exhibit enhanced ability to produce regenerative cytokines and growth factors compared with stem cells - Are more economical to isolate, culture and expand compared with stem cells because fibroblasts do not require the use of expensive tissue culture media - Allogeneic fibroblasts are immune-privileged and do not provoke an immune response, allowing for off-the-shelf treatments - The company plans to build its own cGMP manufacturing facility to source allogeneic fibroblast cells for clinical testing and commercial sales[21](index=21&type=chunk) [Our Strategy](index=6&type=section&id=Our%20Strategy) FibroBiologics aims to become a world leader in regenerative medicine by prioritizing clinical development, investing in manufacturing, and protecting intellectual property - Key strategic pillars include[23](index=23&type=chunk) - Attract and retain skilled scientists for preclinical and clinical studies - Prioritize clinical development on product candidates with significant unmet needs, lower risk, and market potential - Partner with Clinical Research Organizations (CROs) for successful clinical trial execution - Invest in critical capabilities for fibroblast production and supply for clinical trials and initial commercialization - Protect, expand, and defend the intellectual property portfolio around fibroblasts - Expand development efforts for product candidates with longer timelines and greater risk as funding allows - Available Capital and Planned R&D Funding (as of Dec 31, 2023) | Metric | Amount (approx.) | | :------------------------------------------------ | :----------------- | | Cash and cash equivalents (Dec 31, 2023) | $9.2 million | | **Expected R&D Initiatives (next 12 months):** | | | Capital expenditures for lab equipment | $0.1 - $0.2 million| | Acquire clinical skin samples | $0.3 - $0.4 million| | Tissue and fibroblast cell characterization/optimization | $0.2 - $0.3 million| | Develop master cell bank | $0.2 - $0.4 million| | Develop working cell bank | $0.1 - $0.3 million| | Develop processes for transfer to CDMO | $0.1 - $0.3 million| | Submit IND for CYWC628 (wound healing) | $0.1 million | | Complete preclinical animal study for CYMS101 (MS) | $0.2 - $0.3 million| | Initiate preclinical animal study for CYTER915 (thymic involution) | $0.1 million | [Our People](index=7&type=section&id=Our%20People) FibroBiologics has an experienced executive leadership team and a scientific advisory board guiding its research and development efforts - The executive leadership team has successful track records in startup entrepreneurial companies and the life sciences industry[27](index=27&type=chunk) - A scientific advisory board of world-renowned scientists guides the company's research and development efforts[27](index=27&type=chunk) [Our Current Pipeline](index=7&type=section&id=Our%20Current%20Pipeline) FibroBiologics has a pipeline of fibroblast-based product candidates in various development stages, targeting degenerative disc disease, multiple sclerosis, wound healing, and early-stage research for other conditions - The company's pipeline includes product candidates for degenerative disc disease, multiple sclerosis, wound healing, and early-stage research for extension of life, psoriasis, and certain cancers[28](index=28&type=chunk)[52](index=52&type=chunk)[69](index=69&type=chunk)[80](index=80&type=chunk)[89](index=89&type=chunk)[92](index=92&type=chunk) [CybroCell for Degenerative Disc Disease](index=7&type=section&id=CybroCellfor%20Degenerative%20Disc%20Disease) CybroCell is an allogeneic fibroblast cell-based therapy for degenerative disc disease, with IND clearance for a Phase 1/2 study in the US - CybroCell™ is an allogeneic fibroblast cell-based therapy for degenerative disc disease, aiming to repair intervertebral disc cartilage[44](index=44&type=chunk) - The therapy uses Human Dermal Fibroblasts (HDFs) forced to differentiate into chondrocyte-like cells in vivo[44](index=44&type=chunk) - Received IND clearance from the FDA on November 7, 2018 (IND number 18151) for a Phase 1/2 study in the US, conditional on master cell bank approval[44](index=44&type=chunk)[49](index=49&type=chunk) - Preclinical animal studies demonstrated positive outcomes[47](index=47&type=chunk)[48](index=48&type=chunk) - **10% increase in disk height index** after eight weeks with nHDFs (p<.05) - Reduced expression of inflammatory markers - Higher ratio of collagen type II over collagen type I gene expression - Increased proteoglycan contents [CYMS101 for Multiple Sclerosis](index=12&type=section&id=CYMS101%20for%20Multiple%20Sclerosis) CYMS101 is an allogeneic fibroblast cell-based therapy for Multiple Sclerosis, with a completed Phase 1 study in Mexico showing no adverse effects - CYMS101 is an allogeneic fibroblast cell-based therapy under development for Multiple Sclerosis (MS)[63](index=63&type=chunk) - A completed Phase 1 study in Mexico (5 participants) showed no adverse effects and general improvement in PASAT score (cognitive function) and Nine-Hole Peg Test completion time (upper extremity function)[63](index=63&type=chunk)[64](index=64&type=chunk) - No general improvement or deterioration was noted with the Timed 25-Foot Walk Test or EDSS test in the Phase 1 study[65](index=65&type=chunk)[66](index=66&type=chunk) - The company is conducting further research to determine the mode of action of fibroblasts in oligodendrocyte expansion and plans to file an IND application for a Phase 2 clinical trial in the US[67](index=67&type=chunk) - The company may seek a strategic partner for CYMS101 development before or after the Phase 2 study[67](index=67&type=chunk) [CYWC628 for Wound Healing](index=15&type=section&id=CYWC628%20for%20Wound%20Healing) CYWC628 is an early-stage allogeneic fibroblast cell-based therapy for wound healing, with an IND application planned for 2024 - CYWC628 is an early-stage allogeneic fibroblast cell-based therapy for wound healing[77](index=77&type=chunk) - Current studies focus on using fibroblasts and fibroblast-derived cells to treat wounds in diabetic mice and rats[77](index=77&type=chunk) - An IND submission with the FDA for wound healing is planned as early as **2024**, based on achieved results[77](index=77&type=chunk) [Our Early-Stage Research](index=17&type=section&id=Our%20Early-Stage%20Research) FibroBiologics is conducting early-stage research on CYTER915 for life extension, CYPS317 for psoriasis, and TCB190 for certain cancers - CYTER915 research aims to regenerate or reinvigorate the thymus and/or spleen using activated or inactivated fibroblasts, potentially combined with nucleic acids, cytokines, growth factors, and hormones[86](index=86&type=chunk) - Preclinical studies are planned to demonstrate thymic or splenic involution reversal in animal models[86](index=86&type=chunk) - CYPS317 is being developed for psoriasis, utilizing fibroblasts' immunomodulatory and anti-inflammatory properties, offering a scalable and cost-effective alternative to mesenchymal stem cells (MSCs)[91](index=91&type=chunk) - Early-stage research is also underway for TCB190 for the treatment of certain cancers[92](index=92&type=chunk) [Manufacturing and Supply](index=18&type=section&id=Manufacturing%20and%20Supply) FibroBiologics currently produces cell therapy candidates in its Houston lab and is contracting with a CDMO for cell bank production to support clinical trials - Cell therapy product candidates are currently produced at the company's Houston laboratory facility[93](index=93&type=chunk) - The company is contracting with a CDMO for the transfer of its experimental cell bank to produce master and working cell banks for clinical trials[93](index=93&type=chunk) - Future manufacturing for commercial sales will either be in-house (cGMP facility) or outsourced to a CDMO[93](index=93&type=chunk) [Intellectual Property](index=18&type=section&id=Intellectual%20Property) FibroBiologics' IP portfolio includes 48 issued patents and 109 pending applications, with exclusive rights in spinal diseases, certain cancers, orthopedic diseases, and multiple sclerosis - The company's IP portfolio includes **48 issued patents** and **109 pending patent applications**, with patent protections generally expiring from **2027 to 2043**[97](index=97&type=chunk) - Exclusive rights for fibroblast development are granted in fields including spinal diseases, certain cancers, orthopedic diseases, and multiple sclerosis[95](index=95&type=chunk)[96](index=96&type=chunk) - CybroCell™ does not have composition of matter patents due to patent ineligibility laws, but patents related to its production exist[99](index=99&type=chunk)