Preparations for Phase 1/2 clinical trial in Australia utilizing fibroblast-based spheroids product candidate, CYWC628, to treat diabetic foot ulcers are proceeding with plans to initiate in the second quarter of 2025
HOUSTON, Nov. 12, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 160+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced third quarter 2024 financial results and provided a corporate update.
Third Quarter 2024 and Recent Highlights
Upcoming Milestones
“We continue to experience strong momentum in our clinical programs and are making significant breakthroughs in our core science,” said Pete O’Heeron, Founder and Chief Executive Officer. “We are enthusiastic about the progress of our preclinical research and our product candidates, particularly our wound care product candidate, CYWC628, which is on track to enter a phase 1/2 clinical trial to treat diabetic foot ulcers in the second quarter of 2025. I am also enthused by our human longevity program and pleased to report that, to date, we have demonstrated over 60 days of T-cell generation, vascularization, and durable fixation at the transplantation site in animal models using transplanted artificial organoids. This momentum not only reflects our commitment to innovation but also positions us strategically for future advancements in cell therapy.”
Financial Highlights for the Nine Months Ended September 30, 2024
For more information, please visit FibroBiologics' website or email FibroBiologics at [email protected].
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 plans for, and the anticipated timing of the initiation of, FibroBiologics’ clinical trials, the robustness, progress and momentum of FibroBiologics’ research and development program, being positioned strategically for future advancements in cell therapy, and the potential and capabilities of fibroblasts and artificial thymus organoids to persist and function post-transplantation, with vascularization and the generation of a diverse array of mature T cells. 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. When used in this communication, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. 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) expectations regarding the initiation, progress and expected results of FibroBiologics’ R&D efforts and preclinical studies; (b) the unpredictable relationship between R&D and preclinical results and clinical study results; (c) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; 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.
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 160+ US and internationally issued patents/patents pending across various clinical pathways, including disc degeneration, orthopedics, multiple sclerosis, wound healing, reversing organ involution, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy and tissue regeneration. For more information, visit www.FibroBiologics.com.