FibroBiologics Advances Patient Dosing for Phase 1/2 Clinical Trial of CYWC628 for the Treatment of Diabetic Foot Ulcers

Rhea-AI Summary

FibroBiologics (Nasdaq:FBLG) reported first patient dosing in its Phase 1/2 clinical trial of CYWC628 for diabetic foot ulcers during the week of June 1, 2026. The company is advancing CYWC628 manufacturing with a second GMP drug product run released for shipment to Australia and a third run underway.

FibroBiologics has completed the first two batches of its third GMP run, supporting ongoing trial supply and potential future clinical use.

Positive

• First patients dosed with CYWC628 in Phase 1/2 DFU trial
• Second GMP drug product run released and scheduled to ship to Australia
• First two batches of third GMP manufacturing run completed
• Parallel progress in clinical development and manufacturing of CYWC628

Negative

• None.

News Market Reaction – FBLG

-9.29%

9 alerts

-9.29% Session close to close

+11.8% Peak Tracked

-7.6% Trough Tracked

$4.43M Market Cap

0.7x Rel. Volume

In the Jun 16 session, FBLG declined 9.29%, reflecting a notable negative market reaction. Argus tracked a peak move of +11.8% during that session. Argus tracked a trough of -7.6% from its starting point during tracking. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -9.3% in the session following this news. A negative reaction despite operational pr...

Analysis

The stock moved -9.3% in the session following this news. A negative reaction despite operational progress would fit prior instances where positive clinical updates still coincided with declines of 5.48% and 7.03%. The stock was already trading at $0.893, far below its 52-week high of $17.20, and under its $5.68 200-day MA, reflecting broader skepticism. Investors have previously faded good news around CYWC628 and CYPS317, so weakness following this update would be consistent with that pattern.

Key Figures

Intellectual property: 270+ patents Trial phase: Phase 1/2 Initial dosing timing: Week of June 1, 2026 +2 more

5 metrics

Intellectual property 270+ patents Patents issued and pending for fibroblast-based therapeutics

Trial phase Phase 1/2 CYWC628 clinical trial for diabetic foot ulcers

Initial dosing timing Week of June 1, 2026 First patients dosed in CYWC628 Phase 1/2 trial

Second GMP run 2nd manufacturing run Second CYWC628 GMP drug product run released for shipment to Australia

Third GMP run batches 2 batches First two batches of third CYWC628 GMP manufacturing run completed

Previous Clinical trial Reports

5 past events · Latest: Jun 03 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 03	CYWC628 first dosing	Positive	+1.9%	Announced first patients enrolled and dosed in CYWC628 Phase 1/2 DFU trial.
May 04	CYWC628 batch release	Positive	-5.5%	Released first cGMP CYWC628 batch for DFU trial after safety and quality testing.
Mar 31	CYWC628 manufacturing	Positive	+0.8%	Completed first CYWC628 drug product batch under CGMP for planned first‑in‑human trial.
Mar 05	CYWC628 site onboarding	Positive	+11.6%	Finished onboarding clinical sites for CYWC628 Phase 1/2 refractory DFU study.
Dec 31	CYPS317 IND filing	Positive	-7.0%	Filed Phase 1/2 IND with FDA for CYPS317 psoriasis trial based on preclinical data.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical trial updates have produced mixed reactions: three positive or flat moves and two notable selloffs, suggesting uneven investor confidence around trial and manufacturing milestones.

Recent Company History

Over the past six months, FibroBiologics has steadily advanced fibroblast-based programs. For CYWC628 in diabetic foot ulcers, it moved from successful manufacturing on Mar 31, 2026 to site onboarding on Mar 05, 2026, drug product release on May 04, 2026, and first patient dosing on Jun 03, 2026. A psoriasis program, CYPS317, advanced via an IND filing on Dec 31, 2025. Today’s update continues that CYWC628 dosing and manufacturing narrative within this clinical progression.

Key Terms

fibroblasts, fibroblast-derived materials, phase 1/2, good manufacturing practice (gmp), +2 more

6 terms

fibroblasts medical

"using fibroblasts and fibroblast-derived materials, announced that the first patients have been"

Fibroblasts are common cells in connective tissue that manufacture the structural proteins and fibers—like collagen—that form and repair the body's scaffolding, helping wounds heal and tissues hold their shape. For investors, fibroblasts matter because they are frequent targets or tools in drug development, regenerative medicine and safety testing: changes in their behavior can signal whether a therapy will work, cause side effects or enable new medical products, much like a construction crew determines the strength and finish of a building.

fibroblast-derived materials medical

"using fibroblasts and fibroblast-derived materials, announced that the first patients have been"

Materials produced or conditioned by fibroblasts—common connective‑tissue cells that secrete the structural proteins and other components tissues use as a scaffold. Investors should care because these biologically sourced materials are used in wound care, tissue engineering, cosmetic and regenerative products; their quality, scalability and regulatory path affect a product’s performance, manufacturing cost and commercial potential, much like the quality of bricks and mortar determines a building’s durability.

phase 1/2 medical

"announced that the first patients have been dosed in the Company’s Phase 1/2 clinical trial"

Phase 1/2 is a combined early-stage clinical trial that first tests a new drug or treatment for safety and the right dose, then quickly expands to check if it shows any signs of working in patients. For investors, results from a Phase 1/2 study offer an early read on both risk and potential reward—like a prototype test that both confirms a product won’t harm users and suggests whether it could sell—helping guide valuation and development decisions.

good manufacturing practice (gmp) regulatory

"second good manufacturing practice (GMP) manufacturing run has been released and is scheduled"

Good Manufacturing Practice (GMP) is a set of government-enforced standards that ensure medicines, medical devices, and related products are produced consistently, safely, and with the quality claimed on the label. Think of it as a strict recipe and hygiene checklist for a factory that prevents contamination, errors, and product variations. Investors care because GMP compliance affects a company’s ability to sell products, avoid costly recalls or regulatory shutdowns, and maintain reliable revenue and reputation.

gmp manufacturing run technical

"the Company's second good manufacturing practice (GMP) manufacturing run has been released"

A GMP manufacturing run is a production batch made under Good Manufacturing Practice standards, which are government-backed rules ensuring consistent quality, cleanliness, and traceability in making drugs, medical devices, or related products. For investors, a successful GMP run is like a chef proving they can reliably follow a certified recipe: it reduces regulatory and quality risk, supports product approvals, and signals that a company can supply the market as claimed.

diabetic foot ulcers medical

"clinical trial evaluating CYWC628 for the treatment of diabetic foot ulcers (DFUs)."

A diabetic foot ulcer is an open sore or wound on the foot that occurs when high blood sugar and nerve damage prevent normal healing, much like a small pothole that keeps widening because the road can’t be properly repaired. It matters to investors because these wounds drive demand for treatments, medical devices, wound-care drugs and hospital services, and they carry risks of infection and amputation that can shape healthcare costs, reimbursement decisions and clinical trial opportunities.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Company continues to advance CYWC628 manufacturing with second GMP drug product run released for shipment to Australia and a third run nearing completion

HOUSTON, June 16, 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, announced that the first patients have been dosed in the Company’s Phase 1/2 clinical trial evaluating CYWC628 for the treatment of diabetic foot ulcers (DFUs). Initial dosing took place during the week of June 1, 2026.

In parallel with clinical progress, FibroBiologics continues to advance manufacturing of CYWC628 to support ongoing trial activity. Drug product from the Company's second good manufacturing practice (GMP) manufacturing run has been released and is scheduled to ship to Australia during the week of June 15, 2026. FibroBiologics has also completed the manufacturing of the first two batches of its third GMP manufacturing run.

“Initiating treatment in our first patients marks the moment our science transitions from the laboratory into the lives of the people in need,” said Pete O'Heeron, Founder and Chief Executive Officer of FibroBiologics. “Fibroblasts are the body's own architects of repair, and CYWC628 is designed to restore the underlying biology that chronic wounds have lost rather than managing symptoms. Successfully advancing our clinical and manufacturing operations in parallel reflects the disciplined execution we set out to deliver.”

“Producing consecutive GMP runs of CYWC628 demonstrates that our fibroblast manufacturing platform is reproducible and ready to supply the ongoing clinical trial and beyond,” said Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics. “This consistency is foundational. It provides us confidence both in the integrity of the product reaching patients and our ability to scale for clinical use.”

For more information, please visit FibroBiologics' website, email FibroBiologics at info@fibrobiologics.com 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 FibroBiologics’ clinical trials and research and development programs, and the potential clinical benefits of fibroblasts and fibroblast-derived materials. 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. 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:
info@fibrobiologics.com

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

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

FAQ

What did FibroBiologics (NASDAQ:FBLG) announce about CYWC628 on June 16, 2026?

FibroBiologics announced first patient dosing in its Phase 1/2 trial of CYWC628 for diabetic foot ulcers. According to FibroBiologics, dosing began the week of June 1, 2026, alongside continued GMP manufacturing to support the ongoing clinical study.

When were the first patients dosed with CYWC628 for diabetic foot ulcers?

The first patients were dosed with CYWC628 during the week of June 1, 2026. According to FibroBiologics, this marks the transition of its fibroblast-based science from laboratory work into treating people with chronic diabetic foot ulcers in a Phase 1/2 study.

What is CYWC628 and how is it being tested by FibroBiologics (FBLG)?

CYWC628 is a fibroblast-derived therapeutic being evaluated for diabetic foot ulcers in a Phase 1/2 trial. According to FibroBiologics, CYWC628 is designed to restore underlying wound biology, with patient dosing underway and GMP manufacturing runs supplying the clinical program.

How advanced is FibroBiologics' GMP manufacturing for CYWC628 as of June 2026?

FibroBiologics has completed a second GMP drug product run and started a third for CYWC628. According to FibroBiologics, the second run is released for shipment to Australia, and the first two batches of the third run are manufactured to support ongoing clinical use.

Where is CYWC628 being supplied for the Phase 1/2 diabetic foot ulcer trial?

CYWC628 from the second GMP manufacturing run is scheduled to ship to Australia. According to FibroBiologics, drug product released from this run will support the ongoing Phase 1/2 clinical trial, with additional supply coming from a third GMP manufacturing campaign.

What does the CYWC628 Phase 1/2 trial mean for FibroBiologics (FBLG) investors?

The CYWC628 trial represents early-stage clinical testing of a fibroblast-based therapy for diabetic foot ulcers. According to FibroBiologics, first patient dosing and consecutive GMP runs demonstrate operational progress that may inform future development, but no efficacy or financial outcomes are reported yet.