FibroBiologics Completes Manufacturing of Third Batch of CYWC628 Drug Product for Phase 1/2 Diabetic Foot Ulcer Clinical Trial

Company expects existing supply will suffice to complete clinical trial and lead to cost savings

HOUSTON, July 7, 2026 /PRNewswire/ -- 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 completion of manufacturing of the third batch of its CYWC628 drug product for the ongoing Phase 1/2 clinical trial in patients with diabetic foot ulcers (DFUs).

The batch was manufactured in accordance with cGMP standards and is undergoing the required safety and quality testing ahead of release for clinical use. Upon release of the third batch, FibroBiologics expects to have sufficient drug product to complete the DFU clinical trial. The healing trend observed during the trial's early phase positions the Company to have surplus doses available for future research and development initiatives. This also translates into meaningful cost savings by eliminating the need for additional vial manufacturing. FibroBiologics anticipates reporting statistically significant interim data in Q3 2026.

"Producing sufficient drug product to complete our DFU clinical trial in only three batches is a significant achievement for the team," said Pete O'Heeron, Founder and CEO of FibroBiologics. "By not having to manufacture additional batches, we expect to reduce short-term cash outlays and experience significant cost savings."

For more information, please visit FibroBiologics' website, email FibroBiologics at [email protected] or follow FibroBiologics on LinkedIn, YouTube, Facebook or X. 

About CYWC628 
CYWC628 is an investigational topically administered allogeneic fibroblast cell-based therapy for wound healing. Preclinical data suggest CYWC628 may significantly accelerate wound healing compared to currently available treatments. 

FibroBiologics is conducting a prospective, multicenter, randomized clinical trial evaluating the safety, tolerability, and efficacy of CYWC628 in treating refractory diabetic foot ulcers with up to 12 weeks of treatment using either standard of care plus a low or high-dose of CYWC628, or standard of care only. 

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 sufficiency of drug product to complete the DFU clinical trial and support R&D activities, plans for, and the anticipated timing of the initiation and completion of, FibroBiologics' clinical trials, plans for, and the timing of, release of clinical trial results, a reduction in short-term cash outlays, and expected cost savings. 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) 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; (d) the ability of FibroBiologics to successfully prosecute its patent applications; (e) FibroBiologics' ability to manufacture its product candidates; (f) FibroBiologics' ability to conduct clinical trials; and (g) the Company's ability to maintain compliance with applicable Nasdaq rules. 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. 

General Inquiries:
[email protected]

Investor Relations:
Nic Johnson
Russo Partners
(212) 845-4242
[email protected]

Media Contact:
Liz Phillips
Russo Partners
(347) 956-7697
[email protected]

SOURCE FibroBiologics, Inc.