FibroBiologics Announces First Patients Dosed in Phase 1/2 Clinical Trial Evaluating CYWC628 for the Treatment of Diabetic Foot Ulcers

Rhea-AI Summary

FibroBiologics (Nasdaq:FBLG) announced first patients have been enrolled and dosed in its Phase 1/2 trial of CYWC628 for diabetic foot ulcers. The randomized multicenter study in Australia will enroll up to 120 patients and compare topical CYWC628 plus standard of care to standard care alone.

Participants receive up to 12 weeks of treatment, with wound-healing outcomes and safety assessed regularly and an interim analysis after six weeks to evaluate primary safety and efficacy endpoints.

Positive

• First patients dosed in Phase 1/2 CYWC628 diabetic foot ulcer trial
• Trial plans enrollment of up to 120 patients in Australia
• Randomized design compares CYWC628 plus standard care versus standard care alone
• Interim safety and efficacy analysis planned after six weeks of treatment
• Study aims to generate foundational data for broader fibroblast-spheroid therapies

Negative

• No clinical safety or efficacy results for CYWC628 reported yet
• CYWC628 remains an investigational therapy under evaluation in an early-stage trial

News Market Reaction – FBLG

+1.90%

2 alerts

+1.90% Session close to close

+4.2% Peak Tracked

-8.6% Trough Tracked

$5.47M Market Cap

0.2x Rel. Volume

In the Jun 3 session, FBLG gained 1.90%, reflecting a mild positive market reaction. Argus tracked a peak move of +4.2% during that session. Argus tracked a trough of -8.6% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement marks first-patient dosing in FibroBiologics’ Phase 1/2 CYWC628 trial for diabetic...

Analysis

This announcement marks first-patient dosing in FibroBiologics’ Phase 1/2 CYWC628 trial for diabetic foot ulcers, advancing from earlier HREC approvals, site onboarding and drug-product release. The study plans up to 120 patients with a 12‑week treatment window and a 6‑week interim analysis to assess safety and early efficacy. Investors may track upcoming clinical readouts, ongoing financing via at‑the‑market programs, and how these early data support broader fibroblast-spheroid applications.

Key Figures

Planned enrollment: up to 120 patients Treatment duration: up to 12 weeks Interim analysis timing: 6 weeks +5 more

8 metrics

Planned enrollment up to 120 patients Phase 1/2 CYWC628 DFU trial

Treatment duration up to 12 weeks CYWC628 plus standard of care vs. standard of care alone

Interim analysis timing 6 weeks Interim analysis after 6 weeks of treatment

Patent portfolio 270+ patents Issued and pending across fibroblast-based therapeutics

ATM capacity $7,500,000 Updated at-the-market program per May 5, 2026 prospectus supplement

Public float $47.0M Based on 5,399,112 non-affiliate shares as of May 5, 2026

Non-affiliate shares 5,399,112 shares Used in public float calculation on May 5, 2026

Annual equity plan evergreen up to 4% Potential annual share increase through 2036 under 2026 Equity Plan

Previous Clinical trial Reports

5 past events · Latest: May 04 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 04	Drug batch released	Positive	-5.5%	First cGMP CYWC628 batch released for clinical use in DFU trial.
Mar 31	Manufacturing update	Positive	+0.8%	Manufacturing completion of CYWC628 batch to support first-in-human trials.
Mar 05	Site onboarding	Positive	+11.6%	Completion of site onboarding for CYWC628 Phase 1/2 DFU trial.
Dec 31	Psoriasis IND filed	Positive	-7.0%	IND filing for CYPS317 Phase 1/2 trial in moderate to severe psoriasis.
Nov 20	HREC approval	Positive	-5.8%	Australian HREC approvals and TGA filing enabling CYWC628 DFU trial enrollment.

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

Pattern Detected

Clinical-trial announcements have often been followed by negative or muted next-day moves, with only 2 of 5 tagged events showing positive price alignment.

Recent Company History

Recent history shows FibroBiologics methodically advancing fibroblast-based therapies into the clinic. Prior CYWC628 updates covered manufacturing completion, site onboarding, and drug product release for the Phase 1/2 DFU trial, while a Dec 31, 2025 IND filing advanced psoriasis candidate CYPS317. Market reactions to these clinical milestones were mixed, frequently negative despite positive operational progress. Today’s first-patient dosing update fits this ongoing execution narrative and continues the DFU program’s stepwise progression.

Key Terms

phase 1/2, diabetic foot ulcers, allogeneic, fibroblast-spheroid, +4 more

8 terms

phase 1/2 medical

"first patients have been enrolled and 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.

diabetic foot ulcers medical

"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.

allogeneic medical

"topically administered allogeneic fibroblast-spheroid cell-based therapy"

Allogeneic describes a process or material involving different individuals of the same species, such as cells, tissues, or organs donated from one person to another. It is important to investors because products or treatments based on allogeneic sources can enable scalable, off-the-shelf solutions, potentially reducing costs and increasing accessibility in healthcare and biotech industries.

fibroblast-spheroid medical

"fibroblasts and fibroblast-derived materials, today announced ... fibroblast-spheroid cell-based therapy"

A fibroblast-spheroid is a tiny, three-dimensional cluster of fibroblasts — the connective-tissue cells that help form skin, tendons and scar tissue — grown in the lab to mimic how cells behave inside real tissue. Think of it as a mini, spherical piece of tissue used for testing drugs or materials instead of flat cell layers; it matters to investors because these more realistic models can improve early-stage screening, reduce costly late-stage failures, and speed development of therapies or medical products.

standard of care medical

"compared to standard of care (SoC) alone"

Standard of care is the accepted medical treatment or clinical approach that most qualified doctors would use for a given condition today, based on available evidence, guidelines and common practice. For investors, it acts like the baseline product customers expect: a new therapy or device must match or improve on the standard of care to win market share, gain reimbursement and limit legal or regulatory risk.

human research ethics committee regulatory

"following receipt of both public and private Human Research Ethics Committee (HREC) approvals"

A human research ethics committee is an independent group that reviews and approves medical or social studies involving people to make sure participants are treated safely, understand the risks, and give proper consent. Think of it as a safety and fairness check before a study can run. For investors, these committees matter because their approval is often required for clinical trials and product testing, and delays or rejection can affect development timelines, regulatory risk and potential returns.

therapeutics goods administration regulatory

"and completion of the required Therapeutics Goods Administration (TGA) filing"

The Therapeutic Goods Administration is the national regulator that evaluates and approves medicines, medical devices and related products for safety, quality and effectiveness. For investors, its decisions are like a gatekeeper’s stamp of approval: they determine whether a drug or device can be sold, how quickly it reaches customers, and what claims can be made, which directly affects a company’s sales prospects and risk profile.

cell-based therapy medical

"investigational topically administered allogeneic fibroblast-spheroid cell-based therapy"

Cell-based therapy uses living cells as the active treatment, delivering them into a patient to replace, repair or instruct damaged tissue or immune responses—think of sending a living repair crew into the body. For investors this matters because these therapies can offer high-value, potentially long-lasting medicines but also come with unique risks and costs tied to complex manufacturing, strict regulation, clinical trial success, and scalability.

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

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HOUSTON, June 03, 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 that the first patients have been enrolled and dosed in the Company’s Phase 1/2 clinical trial evaluating CYWC628 for the treatment of diabetic foot ulcers (DFUs).

A Media Snippet accompanying this announcement is available by clicking on this link.

The prospective, multicenter, randomized study is being conducted across multiple sites in Australia following receipt of both public and private Human Research Ethics Committee (HREC) approvals and completion of the required Therapeutics Goods Administration (TGA) filing. The trial is designed to enroll up to 120 patients and will evaluate the safety, tolerability, and efficacy of CYWC628, FibroBiologics' investigational topically administered allogeneic fibroblast-spheroid cell-based therapy, compared to standard of care (SoC) alone. Participants will receive up to 12 weeks of treatment using either SoC plus a low or high dose of CYWC628, or SoC alone.

“With the first patients enrolled and dosed, FibroBiologics has reached a significant milestone in advancing CYWC628 into the clinic,” said Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics. “Most chronic wound therapies are designed to manage symptoms of chronic wounds rather than actively restore the underlying biology required for repair. Our approach is different – CYWC628 is built on the idea that fibroblasts play a central role in the wound healing process, and we believe their therapeutic potential has been largely overlooked in chronic wound care. Dosing the first patients is an important step in evaluating how our platform can shift the approach to care for patients living with diabetic foot ulcers.”

“This trial represents a meaningful opportunity to demonstrate what fibroblast-spheroid-based therapies can do for patients with some of the most difficult-to-treat chronic wounds,” said Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics. “The data we generate from this study will be foundational, not only for CYWC628, but for our broader understanding of how fibroblast-spheroid cell therapy can be applied across chronic disease indications.”

The trial will assess wound healing outcomes and safety parameters through regular clinical and imaging evaluations. An interim analysis will be conducted after participants complete six weeks of treatment to assess primary safety and efficacy endpoints. In addition to confirming safety and therapeutic potential, the study is expected to generate key clinical data supporting CYWC628 as a novel cell therapy addressing a significant unmet need in chronic wound management.

For more information, please visit FibroBiologics' website, email FibroBiologics at info@fibrobiologics.com or follow FibroBiologics on LinkedIn, YouTube, Facebook or X.

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 plans for, and the anticipated timing of the initiation of and results from, 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.

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.

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 3, 2026?

FibroBiologics announced that the first patients have been enrolled and dosed in its Phase 1/2 trial of CYWC628 for diabetic foot ulcers. According to FibroBiologics, the study will evaluate safety, tolerability and efficacy versus standard of care alone across multiple Australian sites.

What is CYWC628 in FibroBiologics' Phase 1/2 diabetic foot ulcer trial for FBLG?

CYWC628 is an investigational, topically administered allogeneic fibroblast-spheroid cell-based therapy for diabetic foot ulcers. According to FibroBiologics, the trial will test low and high CYWC628 doses plus standard care compared with standard care alone over up to 12 weeks of treatment.

How is FibroBiologics' CYWC628 Phase 1/2 trial for FBLG designed?

The CYWC628 trial is a prospective, multicenter, randomized Phase 1/2 study in Australia enrolling up to 120 patients. According to FibroBiologics, participants receive up to 12 weeks of treatment and undergo regular clinical and imaging assessments of wound healing and safety outcomes.

When will interim results from FibroBiologics' CYWC628 diabetic foot ulcer trial be assessed?

An interim analysis is planned after participants complete six weeks of treatment in the CYWC628 Phase 1/2 trial. According to FibroBiologics, this analysis will focus on primary safety and efficacy endpoints, helping guide further development of the fibroblast-spheroid therapy platform.

Why is FibroBiologics studying CYWC628 for diabetic foot ulcers in FBLG investors' view?

FibroBiologics is studying CYWC628 to address an unmet need in chronic wound management by targeting fibroblast-driven wound healing. According to FibroBiologics, data from this trial may support CYWC628 as a novel cell therapy and inform broader chronic disease applications for fibroblast-spheroid treatments.

Where is FibroBiologics' CYWC628 Phase 1/2 trial for FBLG being conducted?

The CYWC628 Phase 1/2 trial is being conducted at multiple sites across Australia. According to FibroBiologics, the study began after receiving approvals from public and private Human Research Ethics Committees and completing the required Therapeutics Goods Administration filing for the investigational therapy.