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FibroBiologics Reports Full Year 2025 Financial Results and Provides Corporate Update

Key Takeaway: FibroBiologics reported its full year 2025 financial results and outlined plans for a Phase 1/2 clinical trial in Australia targeting diabetic foot ulcers in 2026. The company improved its financial standing through direct offerings and is focused on advancing its fibroblast-based therapies. CEO Pete O'Heeron emphasized the importance of generating critical data for chronic disease treatments.
Price reaction · baseline $5.35 (2026-02-24 close) · hit pre-market · 2 other FBLG headline(s) in the window, move may be shared
day 0 close
-1.6%

Market Sentiment Analysis

POSITIVE FACTORS

  • FibroBiologics is planning to initiate a Phase 1/2 clinical trial in Australia.
  • The company has improved its balance sheet through multiple direct offerings.
  • Key regulatory pathways have been established for rapid clinical study advancement.

CONCERNS & RISKS

  • Risks related to liquidity and maintaining sufficient capital resources.
  • Uncertainties regarding the relationship between R&D and clinical study results.
  • Potential challenges in manufacturing product candidates and conducting clinical trials.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Cash runway
~3 mo
High dilution risk
Lead asset
Tolerogenic Fibroblasts
Phase 1 · Multiple Sclerosis, Relapsing-Remitting

Full Press Release Details

Planning for phase 1/2 clinical trial initiation in Australia utilizing CYWC628 to treat diabetic foot ulcers in the first half of 2026
Improved balance sheet through multiple direct offerings; completed payments of outstanding debt
HOUSTON, Feb. 24, 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 announced full year 2025 financial results and provided a corporate update.

Recent Highlights

Upcoming Milestones

Pete O’Heeron, CEO and Founder of FibroBiologics commented, “Over the course of 2025, we focused on making steady, practical progress across the business. We advanced our fibroblast-based programs toward the clinic, expanded the intellectual property behind our platform, and improved our balance sheet. We also put key regulatory pathways in place, including approvals in Australia that allow us to rapidly move forward with our Phase 1/2 clinical study in early 2026. We are laser-focused on executing our clinical plans, initiating human studies, and advancing our IND programs for psoriasis and multiple sclerosis. We are generating the critical data needed to define where fibroblast-based therapies can make a meaningful therapeutic impact for patients with chronic diseases.”

Financial Highlights for the Year Ended December 31, 2025

For more information, please visit FibroBiologics’website, email FibroBiologics atinfo@fibrobiologics.comor follow FibroBiologics onLinkedIn,YouTube,FacebookorX.

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 status, timing and plans for manufacturing FibroBiologics’ product candidates, the potential clinical benefits of fibroblasts and fibroblast-derived materials, plans for, and the anticipated timing of the initiation and completion of, FibroBiologics’ current and future preclinical studies, clinical trials, and research and development programs, the robustness, progress, and momentum of FibroBiologics’ research and development program, the potential of product candidates as scalable platform technologies, the potential indications for FibroBiologics’ programs, and plans for, and the timing of, regulatory filings. 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 regain 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.

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, visitwww.FibroBiologics.com.

General Inquiries:info@fibrobiologics.com

Investor Relations:Nic JohnsonRusso Partners(212) 845-4242fibrobiologicsIR@russopr.com

Media Contact:Liz PhillipsRusso Partners(347) 956-7697Elizabeth.phillips@russopartnersllc.com

Frequently Asked Questions

What clinical trial is FibroBiologics planning?

FibroBiologics is planning a Phase 1/2 clinical trial in Australia for diabetic foot ulcers.

How has FibroBiologics improved its financial situation?

The company improved its balance sheet through multiple direct offerings.

What are the upcoming milestones for FibroBiologics?

FibroBiologics aims to initiate its clinical study in early 2026.

What focus areas does FibroBiologics target?

FibroBiologics focuses on chronic diseases using fibroblast-based therapies.

Who is the CEO of FibroBiologics?

Pete O'Heeron is the CEO and Founder of FibroBiologics.

Last updated: Feb 25, 2026