HOUSTON, May 05, 2026 (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 issued the following letter to shareholders.
Dear Fellow Shareholders,
This year, FibroBiologics achieved a milestone we have been working toward over the past few years. We initiated our clinical trial for our lead program, CYWC628, an investigational fibroblast-based therapy for diabetic foot ulcers (DFUs).
After years of building the technology and infrastructure to support it, progressing into the clinic is a critical step for us. It demonstrates the dedicated work across the team and signifies an important transition from development into clinical execution.
DFUs remain an underserved condition in medicine. More than 33 million patients worldwide are affected, yet current treatment options continue to fall short, with amputation and recurrence rates that have seen little improvement over time. CYWC628 is designed to address this by harnessing the unique regenerative and immune-modulating properties of fibroblasts. We are now evaluating its clinical benefit potential in patients. This program represents not only a near-term opportunity, but also a first step in demonstrating the broader applicability of our platform and the potential to derisk for future indications and applications.
We have a clear set of imminent clinical milestones that will guide this program. We have completed initial site activation and will begin patient enrollment in Q2 of 2026. Our focus will be on generating data that validates the efficacy and safety as the trial progresses, resulting in a topline data readout that can inform the next phase of clinical development by the end of 2026. Each of these steps is designed to reduce risk and build a strong clinical foundation for CYWC628.
Our current capital plan provides us with the resources to operate through topline data from this trial. This allows our team to remain focused on disciplined execution by advancing the study, generating high-quality data, and reaching a meaningful clinical readout.
While CYWC628 is our priority, we continue to progress across the broader pipeline. Our programs in multiple sclerosis and psoriasis are advancing, supported by ongoing preclinical work, and our artificial thymus organoid platform continues to generate data that we believe may support an entirely new approach to restoring immune function. Each of these programs reflects our strategy of targeting diseases where cellular dysfunction plays a central role and where our technology may offer a differentiated approach.
Last year, I said we were building something enduring. This year, we are beginning to demonstrate it with a clear clinical pathway, a focused strategy, and the resources to execute.
Thank you for your continued support and confidence in what we are building.
Best regards,
Pete O’Heeron
Founder, Chief Executive Officer, and Chairman
FibroBiologics
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, please visit FibroBiologics' website, email FibroBiologics at [email protected] or follow FibroBiologics on LinkedIn, YouTube, Facebook or X.
Cautionary Statement Regarding Forward-Looking Statements
This letter contains "forward-looking statements." Forward-looking statements include information concerning plans for, the anticipated timing of the initiation of, and reporting of results from, FibroBiologics’ clinical trials, the robustness, progress, timing, and momentum of FibroBiologics’ research and development program, the potential, capabilities, and potential applications of fibroblasts and fibroblast-derived materials, the potential of FibroBiologics’ platform, indications of interest, and the sufficiency of capital resources. 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; and (f) FibroBiologics’ ability to conduct clinical trials. 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]
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f3ebedd0-66f2-4e20-b298-4b52bbb42404