Recent Updates
Recently added Catalysts
FBLG Positive Sentiment

FibroBiologics Reports Third Quarter 2025 Financial Results and Provides Corporate Update

Key Takeaway: FibroBiologics reported its third quarter 2025 financial results, highlighting preparations for the Phase 1/2 clinical trial of CYWC628 for diabetic foot ulcers. The company is also preparing to submit Investigational New Drug applications for treatments targeting psoriasis and multiple sclerosis. CEO Pete O'Heeron emphasized the focus on advancing their fibroblast platform as a scalable technology.
Price reaction · baseline $7.866 (2025-10-31 close) · hit after-hours · clean, no other FBLG news in the window
day 0 close
+0.3%

Market Sentiment Analysis

POSITIVE FACTORS

  • FibroBiologics is advancing preparations for clinical trials.
  • The company is focusing on scalable fibroblast technology.
  • They have multiple product candidates in development for various diseases.

CONCERNS & RISKS

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

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

Advancing preparations to begin manufacturing of fibroblast-based spheroids product candidate, CYWC628, for the Phase 1/2 clinical trial evaluating CYWC628 in diabetic foot ulcers (DFU) patients
Preparing to submit Investigational New Drug applications for the treatment of psoriasis with CYPS317 and the treatment of multiple sclerosis with CYMS101
HOUSTON, Oct. 31, 2025 (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 third quarter 2025 financial results and provided a corporate update.

Recent Highlights

Upcoming Milestones

“This quarter brought our strategy into greater focus,” said Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics. “We are efficiently moving our most advanced product candidates towards the clinic while laying the groundwork to demonstrate that fibroblasts can be a scalable platform and not simply a single-asset bet. Our fibroblast platform will enter the clinic with our Phase 1/2 trial in diabetic foot ulcer patients in the first quarter next year, as we execute against defined milestones to validate its biology, the technology, and the regulatory and commercial path forward.”

Financial Highlights for the Nine Months Ended September 30, 2025

For more information, please visit FibroBiologics’websiteor email FibroBiologics atinfo@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 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; 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.

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 is CYWC628 used for?

CYWC628 is being developed for the treatment of diabetic foot ulcers.

What other treatments is FibroBiologics developing?

FibroBiologics is also preparing IND applications for psoriasis and multiple sclerosis.

When will the Phase 1/2 trial for CYWC628 start?

The Phase 1/2 trial for CYWC628 is expected to begin in the first quarter of next year.

How many patents does FibroBiologics hold?

FibroBiologics holds over 270 patents issued and pending.

Last updated: Oct 31, 2025