FibroBiologics Reports Second Quarter 2025 Financial Results and Provides Corporate Update

Rhea-AI Summary

FibroBiologics (Nasdaq: FBLG), a clinical-stage biotech company, reported its Q2 2025 financial results and corporate updates. The company secured the third $5 million tranche of a $25 million financing round and appointed Jason D. Davis as CFO. For H1 2025, FibroBiologics reported a net loss of $9.6 million, with cash reserves of $8.8 million as of June 30, 2025.

The company presented promising pre-clinical evidence for fibroblast spheroids in psoriasis treatment and confirmed the use of CYWC628 master cell bank for CybroCell™ manufacturing. Key upcoming milestones include initiating a Phase 1/2 clinical trial for diabetic foot ulcers in Q1 2026 and completing pre-clinical IND-enabling studies for psoriasis treatment by end of 2025.

Positive

• Secured third $5M tranche of $25M total financing for R&D and clinical trials
• Expanded patent portfolio to 275+ issued and pending patents
• Promising pre-clinical evidence for psoriasis treatment with lower adverse effects
• Confirmed CYWC628 master cell bank for CybroCell manufacturing

Negative

• Net loss increased to $9.6M in H1 2025 from $7.6M in H1 2024
• R&D expenses doubled to $3.8M from $1.9M year-over-year
• G&A expenses increased to $5.2M from $4.7M year-over-year
• Cash position of $8.8M may require additional financing for operations

Insights

Biotechnology Financial Analyst

FibroBiologics shows R&D progress but widening losses as it advances fibroblast therapies toward clinical trials with adequate near-term funding.

FibroBiologics continues to advance its fibroblast-based therapeutic pipeline with notable pre-clinical progress, though at the cost of deepening financial losses. The company secured an additional $5 million tranche from its $25 million financing arrangement, providing essential capital for near-term operations. With approximately $8.8 million in cash as of June 30, and considering the $9.6 million net loss for the first half of 2025, the runway appears sufficient to reach their upcoming Q1 2026 clinical milestone for diabetic foot ulcers (DFUs).

The 100% year-over-year increase in R&D expenses to $3.8 million reflects intensified investment in clinical preparation, with significant allocations to contract research organizations ($0.9 million) and research materials ($0.5 million). This acceleration aligns with their timeline to initiate the Phase 1/2 DFU trial in Australia by Q1 2026. Meanwhile, G&A expenses grew more modestly by about 10.6% to $5.2 million, primarily driven by personnel costs.

Their intellectual property position has strengthened to 275+ patents issued or pending, providing potential long-term competitive advantages in the fibroblast therapy space. However, investors should note the widening losses ($9.6 million vs $7.6 million in the same period of 2024) and consider whether the current cash position will require additional financing before reaching clinical data readouts in Q3 2026. The appointment of an experienced CFO suggests preparation for future financial strategies as the company transitions toward clinical-stage operations.

The progress in both their lead DFU program and secondary psoriasis program (with pre-clinical data presented at scientific meetings) indicates execution against their stated development timeline, though commercial viability remains years away pending clinical validation of their fibroblast platform technology.

Regenerative Medicine Scientist

FibroBiologics advancing novel fibroblast-based therapies with promising preclinical data in psoriasis and preparation for DFU clinical trial.

FibroBiologics is making notable progress in advancing their fibroblast-based therapeutic platform toward clinical validation. Their fibroblast spheroid technology represents an innovative approach to chronic disease treatment with potential advantages over conventional therapies. The preclinical data presented at the Society for Investigative Dermatology Annual Meeting revealed particularly interesting findings for their psoriasis candidate, demonstrating not just efficacy in reducing disease severity but also sustained remission with lower relapse rates and fewer adverse effects compared to standard treatments.

The company's strategic focus on both diabetic foot ulcers (DFUs) and psoriasis represents a thoughtful dual-pathway approach to validate their platform technology. DFUs represent an excellent initial target for cell-based regenerative therapy due to the localized administration and clear endpoints for wound healing, while psoriasis validation would demonstrate broader immunomodulatory capabilities of their fibroblast technology.

The confirmation of the CYWC628 master cell bank for manufacturing CybroCell™ represents a crucial technical milestone that often goes underappreciated. Establishing a validated master cell bank is essential for manufacturing consistency and regulatory compliance for cell therapies. This development suggests they've overcome significant CMC (Chemistry, Manufacturing and Controls) hurdles that frequently delay cell therapy development.

Their timeline to complete IND-enabling studies for the psoriasis program (CYPS317) by year-end 2025 appears reasonable given their current preclinical evidence. The decision to conduct their initial clinical trial in Australia reflects a strategic approach to accelerate development timelines while potentially reducing costs compared to US-based trials. The projected completion of the Phase 1/2 DFU trial by Q3 2026 would represent a significant inflection point for validating their entire platform technology.

HOUSTON, July 31, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 275+ 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 second quarter 2025 financial results and provided a corporate update.

Recent Highlights

• Successfully closed third $5 million tranche of a $25 million total financing, with proceeds used to advance research and development efforts and support the upcoming Phase 1/2 clinical trial in diabetic foot ulcers (DFUs).
• Strengthened leadership team with the appointment of Jason D. Davis, CPA, as Chief Financial Officer, who brings over 25 years of experience in building and leading organizations.
• Presented pre-clinical evidence at the Society for Investigative Dermatology Annual Meeting supporting the potential of fibroblast spheroids to reduce psoriasis severity. Findings showcased the fibroblast-based candidate’s ability to enable sustained remission and reduce relapse, accompanied by a significantly lower adverse side effects profile.
• Highlighted potential of fibroblast-based therapies for chronic disease treatments at the BIO International Convention 2025.
• Confirmed the use of the CYWC628 master cell bank for the manufacturing of CybroCell™, FibroBiologics’ investigational intradiscal administered allogeneic fibroblast cell-based therapy in development for degenerative disc disease.
  

Upcoming Milestones

• Initiate Phase 1/2 clinical trial in Australia evaluating fibroblast-based spheroids product candidate, CYWC628, in DFU patients in the first quarter of 2026.
• Complete Phase 1/2 clinical trial in Australia in DFU patients in the third quarter of 2026.
• Complete pre-clinical IND-enabling studies for the treatment of psoriasis with CYPS317, FibroBiologics’ fibroblast spheroid product candidate, by the end of 2025.
  

Pete O'Heeron, Founder and Chief Executive Officer of FibroBiologics, said, “Backed by our strong research and development efforts, we are continuing to progress toward entering the clinic with our Phase 1/2 trial evaluating CYWC628 in diabetic foot ulcer patients, while simultaneously advancing IND-enabling studies for CYPS317 in psoriasis. Our robust intellectual property portfolio, which now includes more than 275 issued or pending patents, is reinforced by the growing pre-clinical evidence supporting the potential of our fibroblast-based therapies. We believe this expanding IP position enhances our competitive advantage and supports our long-term strategy for innovation. As always, we remain focused on executing our clinical milestones and delivering meaningful value to both patients and shareholders as we advance toward our goal of transforming chronic disease treatments.”

Financial Highlights for the Six Months Ended June 30, 2025

• Research and development expenses were approximately $3.8 million for the six months ended June 30, 2025, compared to approximately $1.9 million for the same period in 2024. The increase was primarily due to increased chemistry, manufacturing and control costs of $0.2 million for cell manufacturing activities; increased CRO costs of $0.9 million to prepare for a clinical trial; increased personnel related expenses of $0.3 million due to hiring additional research scientists; and increased research materials and supplies expenses of $0.5 million due to increased laboratory personnel and preclinical studies.
• General and administrative expenses were approximately $5.2 million for the six months ended June 30, 2025, compared to approximately $4.7 million for the same period in 2024. The increase was primarily due to increased expenses of $0.5 million for added personnel in 2025, which includes stock-based compensation expense; increased professional fees of $0.3 million for accounting, legal and marketing expenses; increased travel expenses of $0.1 million; and decreased Direct Listing related expenses of $0.4 million.
• For the six months ended June 30, 2025, FibroBiologics reported a net loss of approximately $9.6 million compared to a net loss of approximately $7.6 million for the same period in 2024. The net loss for the six months ended June 30, 2025, was primarily due to the increase in both research and development expenses and general and administrative expenses discussed above.
• Cash and cash equivalents totaled approximately $8.8 million at June 30, 2025.

For more information, please visit FibroBiologics’ website or email FibroBiologics at info@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 potential of fibroblast spheroids to reduce psoriasis severity, the potential of fibroblast-based therapies for chronic disease treatments, plans for, and the anticipated timing of the initiation and completion of, FibroBiologics’ clinical trials, and the robustness, progress, timing, and momentum of FibroBiologics’ research and development program. 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; and (e) FibroBiologics’ ability to manufacture its product candidates. 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 275+ 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 were FibroBiologics (FBLG) key financial results for H1 2025?

FibroBiologics reported a net loss of $9.6 million, with R&D expenses of $3.8 million and G&A expenses of $5.2 million. The company held $8.8 million in cash as of June 30, 2025.

What is the status of FibroBiologics' diabetic foot ulcer clinical trial?

FibroBiologics plans to initiate a Phase 1/2 clinical trial in Australia evaluating CYWC628 for diabetic foot ulcer patients in Q1 2026, with expected completion in Q3 2026.

How much funding did FibroBiologics (FBLG) secure in their latest financing?

FibroBiologics closed the third $5 million tranche of a larger $25 million total financing round, with proceeds directed toward R&D efforts and upcoming clinical trials.

What progress has FibroBiologics made in psoriasis treatment development?

FibroBiologics presented pre-clinical evidence showing their fibroblast spheroids reduce psoriasis severity with sustained remission and lower side effects. They expect to complete pre-clinical IND-enabling studies for CYPS317 by end of 2025.

How many patents does FibroBiologics currently have?

FibroBiologics maintains a robust intellectual property portfolio with 275+ issued and pending patents related to fibroblasts and fibroblast-derived materials for chronic disease treatments.