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FibroBiologics Reports Q1 2026 Financial Results and Provides Corporate Update

(Positive)
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FibroBiologics (Nasdaq: FBLG) reported Q1 2026 results and a corporate update on April 30, 2026. Key items: completed cGMP manufacture of initial CYWC628 batches, completed site onboarding, positive preclinical data in burn and degenerative disc programs, regained Nasdaq compliance, and raised capital via direct offerings.

Financials: R&D $3.0M, G&A $2.1M, net loss ~$5.0M, cash $1.5M at March 31, 2026; $2.5M net raised after quarter.

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Positive

  • Completed cGMP manufacture of first CYWC628 drug-product batches
  • Site onboarding complete to support Q2 2026 first-patient dosing
  • Positive preclinical data in burn and degenerative disc programs
  • Raised $3.0M in a direct offering and $2.5M net post-quarter
  • Regained compliance with all Nasdaq listing requirements
  • Expanded patent portfolio with new U.S. and Canadian patents

Negative

  • Net loss of approximately $5.0M for Q1 2026
  • Cash and cash equivalents of approximately $1.5M at March 31, 2026
  • R&D spend increased to $3.0M due to $1.8M higher CRO costs

News Market Reaction – FBLG

+10.61%
5 alerts
+10.61% Session close to close
+19.0% Peak in 3 hr
$6.81M Market Cap
0.6x Rel. Volume

In the May 1 session, FBLG gained 10.61%, reflecting a significant positive market reaction. Argus tracked a peak move of +19.0% during that session. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock surged +10.6% in the session following this news. A strong positive reaction aligns with F...
Analysis

The stock surged +10.6% in the session following this news. A strong positive reaction aligns with FibroBiologics’ pattern of earnings-linked catalysts, where prior updates sometimes produced sizable moves such as 22.67%. However, the pre-news backdrop includes a share price far below the $22.60 52‑week high and cash of only $1.5M at March 31, 2026, supplemented by recent offerings. Investors reviewing such a surge might weigh dilution risk, going-concern language in the latest 10-Q, and whether upcoming CYWC628 and psoriasis milestones justify sustained strength.

Key Figures

R&D expenses: $3.0M R&D expenses prior year: $1.8M G&A expenses: $2.1M +5 more
8 metrics
R&D expenses $3.0M Three months ended March 31, 2026
R&D expenses prior year $1.8M Three months ended March 31, 2025
G&A expenses $2.1M Three months ended March 31, 2026
G&A expenses prior year $2.8M Three months ended March 31, 2025
Net loss $5.0M Three months ended March 31, 2026
Net loss prior year $5.0M Three months ended March 31, 2025
Cash and cash equivalents $1.5M Balance at March 31, 2026
Capital raised $2.5M Net proceeds from registered direct offering after March 31, 2026

Previous Earnings Reports

5 past events · Latest: Feb 24 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Feb 24 Full-year 2025 results Positive -1.6% Reported 2025 results, debt repayment, financing and CYWC628/IND milestones.
Oct 31 Q3 2025 earnings Neutral +0.3% Nine‑month 2025 results with CYWC628, psoriasis and organoid platform updates.
Jul 31 Q2 2025 earnings Positive +1.8% Q2 2025 results plus $25M financing tranche and psoriasis preclinical data.
May 14 Q1 2025 earnings Positive +22.7% Q1 2025 results with CYWC628 trial plans and neurodegenerative data.
Mar 31 Full-year 2024 results Neutral -4.4% 2024 results, CYWC628 master cell bank completion and $25M equity agreement.

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

Pattern Detected

Earnings updates often see price moves that broadly align with the news tone; only one of the last five earnings events showed a clear divergence between positive messaging and a negative next-day move.

Recent Company History

Over the last five earnings-related updates, FibroBiologics has repeatedly tied financial reports to CYWC628 progress and broader pipeline milestones. Prior releases highlighted HREC approvals, IND filings, cost controls, and use of a $25M financing structure, alongside cash levels between $4.9M and $14.0M. Stock reactions ranged from a -4.44% decline to a 22.67% gain. Today’s Q1 2026 update continues this pattern, pairing financials with clinical timelines in diabetic foot ulcers, psoriasis, and multiple sclerosis.

Key Terms

phase 1/2, cGMP, cytokine, registered direct offering, +3 more
7 terms
phase 1/2 medical
"On track for first patient dosed in phase 1/2 clinical trial evaluating CYWC628..."
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.
cGMP medical
"Completed manufacturing of the first two batches of the CYWC628 drug product in accordance with ... cGMP..."
cGMP (current Good Manufacturing Practice) are government-enforced quality standards that manufacturers must follow to ensure drugs, medical devices, and related products are made consistently, safely, and meet specified quality tests. For investors, cGMP compliance is like a restaurant passing health inspections: it reduces the risk of product recalls, regulatory fines, or production stoppages that can hurt revenue and company value, and it supports market access and long-term trust.
cytokine medical
"indicating increases in a cytokine known to support tissue repair and wound healing..."
Small proteins produced by cells that act as chemical messengers to coordinate immune and inflammatory responses, like text messages or traffic signals telling cells when to activate, calm down, or move. Investors care because cytokines are common drug targets and biomarkers; changes in cytokine activity can determine a therapy’s effectiveness, safety, regulatory approval, and market potential, so trial results or safety signals tied to cytokines often drive stock moves.
registered direct offering financial
"Subsequent to March 31, 2026, the Company raised approximately $2.5 million net, in a registered direct offering."
A registered direct offering is a way for a company to sell new shares of its stock directly to select investors with regulatory approval. This method allows the company to raise funds quickly and efficiently without needing a public auction, similar to offering exclusive access to a limited number of buyers. For investors, it often provides an opportunity to purchase shares at a favorable price, while giving the company immediate access to capital.
Nasdaq listing requirements regulatory
"Successfully regained compliance with all Nasdaq listing requirements."
NASDAQ listing requirements are the financial, governance and disclosure rules a company must meet to have its shares traded on the NASDAQ stock exchange. Think of them as the standards a business must pass to join an exclusive marketplace — they affect whether a stock can be bought easily, how much public information the company must provide, and how investors judge its credibility and risk. Meeting these rules can boost liquidity and investor confidence.
clinical trial medical
"phase 1/2 clinical trial evaluating CYWC628 in diabetic foot ulcers..."
A clinical trial is a carefully controlled study in which a new medicine, medical device, or treatment is tested on people to see if it is safe and effective. For investors it matters because trial results determine whether a product can win regulatory approval and reach patients, much like a road test decides if a new car can be sold; positive or negative results can sharply change a company’s prospects and stock value.
multiple sclerosis medical
"Submit an IND application with the FDA for the treatment of multiple sclerosis with..."
A chronic neurological disease in which the immune system damages the protective coating (like insulation on electrical wires) around nerves, disrupting signals between the brain and body and causing symptoms such as numbness, weakness, vision problems, fatigue and mobility issues. It matters to investors because the unpredictability and long-term nature of the condition drive ongoing demand for treatments, influence the value of companies developing therapies, affect healthcare costs and shape regulatory and reimbursement decisions.

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On track for first patient dosed in phase 1/2 clinical trial evaluating CYWC628 in diabetic foot ulcers in Q2 of 2026

HOUSTON, April 30, 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 reported financial results for the first quarter ended March 31, 2026, and provided a corporate update.

Recent Highlights 

  • Completed manufacturing of the first two batches of the CYWC628 drug product in accordance with Food & Drug Administration (FDA) Good Manufacturing Practices (cGMP) for the phase 1/2 clinical trial for the treatment of diabetic foot ulcers (DFUs).
  • Completed site onboarding for the phase 1/2 clinical trial for CYWC628.
  • Reported positive preclinical results for the burn program, using proprietary fibroblast spheroid technology, indicating increases in a cytokine known to support tissue repair and wound healing in skin and a significant reduction in a cytokine that is a key driver of inflammation in burn wounds.​
  • Announced positive preclinical results for a fibroblast spheroid-derived chondrocyte spheroid therapy for degenerative disc disease, demonstrating significant improvement in recovering intervertebral disc integrity versus single cell fibroblasts and fibroblast spheroids in animal models of degenerative disc disease.
  • Raised $3M through a direct offering.
  • Successfully regained compliance with all Nasdaq listing requirements.
  • Expanded the patent portfolio with the issuance of a patent from the United States Patent and Trademark Office covering fibroblast cell therapy for the treatment of osteoporosis and with the Canadian Intellectual Property Office covering a novel fibroblast-based treatment for cachexia.
  • Presented recent updates on fibroblast-based therapies for chronic disease treatments at the 9th Annual BFC Global Healthcare Business Development and Investment Conference, DealFlow Discovery Conference, and BIO Investment & Growth Summit.

Upcoming Milestones 

Wound Healing:

  • Phase 1/2 clinical trial evaluating fibroblast-based spheroids product candidate, CYWC628, in DFU patients:
    • GMP batch 1 clinical drug product release and shipping to Australia
    • Dose first patient in the second quarter of 2026. 
    • Report interim results in the third quarter of 2026.
    • Complete and report primary safety and efficacy results by the end of 2026. 

Psoriasis

  • Receive IND clearance for the treatment of psoriasis with CYPS317, the Company's fibroblast spheroid product candidate, in the third quarter of 2026.

Multiple Sclerosis

  • Submit an IND application with the FDA for the treatment of multiple sclerosis with FibroBiologics’ fibroblast spheroid product candidate, CYMS101, in the second half of 2026.

Degenerative Disc Disease

  • Amend the IND clearance with the FDA to replace single-cell fibroblasts with fibroblast-derived chondrocyte spheroids derived from the CYWC628 master cell bank by the end of 2026.

Pete O’Heeron, CEO, and Founder of FibroBiologics commented, “During the first quarter of 2026, we made important progress initiating our phase 1/2 clinical trial, including completing cGMP manufacturing of the first batch of the CYWC628 drug product and site onboarding to support dosing the first patient in the second quarter. We continued to build momentum across our pipeline, with positive preclinical data in both our burn and degenerative disc disease programs, further supporting the potential of our fibroblast-based platform. We also strengthened our cash position with additional capital. As we move into the next phase of execution, our focus is on initiating our clinical study, generating meaningful data, and advancing our pipeline programs in psoriasis and multiple sclerosis.”

Financial Highlights for the Quarter Ended March 31, 2026

  • Research and development expenses were approximately $3.0 million for the three months ended March 31, 2026, compared to approximately $1.8 million for the same period in 2025. The increase was primarily due to increased CRO costs of $1.8 million to prepare for a clinical trial; decreased contract research costs of $0.3 million; and decreased supplies expenses of $0.3 million.
  • General and administrative expenses were approximately $2.1 million for the three months ended March 31, 2026, compared to approximately $2.8 million for the same period in 2025. The primary areas of net change are decreased personnel expenses of $0.2 million; decreased professional fees of $0.4 million for accounting, legal and marketing expenses; decreased travel expenses of $0.1 million; and increased listing expenses of $0.1 million
  • For the three months ended March 31, 2026 and 2025, FibroBiologics reported a net loss of approximately $5.0 million. The net loss for the three months ended March 31, 2026, was primarily due to research and development expenses and general and administrative expenses discussed above. 
  • Cash and cash equivalents totaled approximately $1.5 million at March 31, 2026. Subsequent to March 31, 2026, the Company raised approximately $2.5 million net, in a registered direct offering.

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 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 maintain 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, 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

When will FibroBiologics (FBLG) dose the first patient in the CYWC628 DFU trial?

FibroBiologics plans to dose the first patient in Q2 2026. According to the company, GMP batch 1 was released and sites are onboarded to enable first dosing in the second quarter of 2026.

What are the key Q1 2026 financial figures for FibroBiologics (FBLG)?

FibroBiologics reported R&D of $3.0M, G&A of $2.1M, and net loss of ~$5.0M for Q1 2026. According to the company, cash and cash equivalents were about $1.5M at March 31, 2026.

How much capital did FibroBiologics (FBLG) raise recently and when?

FibroBiologics raised $3.0M via a direct offering and $2.5M net after March 31, 2026. According to the company, the $2.5M net amount came from a registered direct offering completed after the quarter.

What near-term clinical milestones does FibroBiologics (FBLG) expect in 2026?

Key 2026 milestones include interim CYWC628 results in Q3 and primary results by year-end. According to the company, IND submissions and amendments for psoriasis, MS, and disc disease are planned in H2 2026.

What preclinical progress did FibroBiologics (FBLG) report in Q1 2026?

FibroBiologics reported positive preclinical results for burn and degenerative disc programs using fibroblast spheroid technologies. According to the company, studies showed cytokine changes supporting repair and improved disc integrity in animal models.