FibroBiologics Granted European Patent Covering Gene Therapy for the Regeneration of Cartilage

The granted patent, European Patent No. EP 3043825 B1, contains 12 claims directed to compositions comprising one or more expression vectors encoding therapeutic polynucleotides, including Sox9, for use in treating individuals in need of cartilage repair. The patent will be validated across selected designated contracting states of the European Patent Convention, extending the Company's protection for this technology into major European markets.

Some of the granted claims include:

• Compositions comprising one or more expression vectors encoding therapeutic polynucleotides that include Sox9, for use in producing chondrocytes or cartilage-type cells in the joint of an individual in need of cartilage repair.
• Delivery of those expression vectors to fibroblast cells, which then differentiate into chondrocytes or cartilage-type cells, either before or after delivery to the joint.
• Use of viral and non-viral vectors for genetic modification.
• Combinations of Sox9 with additional therapeutic genes on a single or multiple vectors.

Cartilage does not meaningfully repair itself, leaving patients with only the therapeutic options of tissue grafting and joint replacement. The granted claims cover an approach that works with the biology already present at the site of injury, instructing fibroblasts to take on a chondrocyte phenotype and produce cartilage matrix components rather than replacing damaged tissue with hardware or donor material. The patent supports FibroBiologics' fibroblast-based approach to cartilage regeneration for orthopedics and disc degeneration indications.

"Cartilage loss sits behind an enormous amount of pain and disability worldwide, and the treatments available today largely manage the consequences rather than rebuild the tissue," said Pete O'Heeron, Founder and Chief Executive Officer of FibroBiologics. "Securing this patent in Europe extends protection for our cartilage regeneration work into a major market and reinforces a strategy we have followed from the beginning, which is to build a global intellectual property position around the therapeutic potential of fibroblasts."

"Sox9 is a master regulator of chondrogenesis, and the claims recognize the use of this gene to direct fibroblasts toward a cartilage-producing phenotype," said Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics. "Cartilage is avascular, aneural, and low in oxygen, which is what has made it so difficult to reach. The granted claims cover the practical elements that allow a gene therapy approach to work in an avascular, low-oxygen cartilage environment."

For more information, please visit FibroBiologics' website, email FibroBiologics at info@fibrobiologics.com or follow FibroBiologics on LinkedIn, YouTube, Facebook or X.

About FibroBiologics

Based in Houston, FibroBiologics is a clinical-stage biotechnology company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 270+ US and internationally issued patents/patents pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy and tissue regeneration. For more information, visit www.FibroBiologics.com.

Cautionary Statement Regarding Forward-Looking Statements

This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning the scope and strength of the Company's intellectual property portfolio, the potential indications for FibroBiologics' programs, FibroBiologics' research and development programs, and the potential clinical benefits of fibroblasts and fibroblast-derived materials. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections and beliefs, as well as a number of assumptions concerning future events. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, www.sec.gov. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (b) expectations regarding the initiation, progress and expected results of FibroBiologics' R&D efforts and preclinical studies; (c) the unpredictable relationship between R&D and preclinical results and clinical study results; and (d) the ability of FibroBiologics to successfully prosecute its patent applications. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update, or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations.

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SOURCE FibroBiologics, Inc.