FibroBiologics CEO Issues Letter to Shareholders

Rhea-AI Summary

FibroBiologics (Nasdaq: FBLG) outlined 2025 progress across clinical, manufacturing, IP, corporate and financing milestones.

Key items: opened a >10,000 sq ft Houston lab for discovery and in-house manufacturing; completed FDA cGMP master and working cell banks for CYWC628; received HREC approval in Australia for a 120-patient Phase 1/2 CYWC628 diabetic foot ulcer trial starting Q1 2026 with interim results potentially mid-2026 and topline before end-2026; filed an IND for CYPS317 on Dec 30, 2025; advanced remyelination and bone marrow organoid preclinical data; portfolio exceeds 270 issued and pending patents.

Financing: multiple registered direct offerings in Nov–Dec 2025 including $4M, $1.5M, $1.7M, closed two tranches of a $25M financing by Q2, and paid off all outstanding debt.

Positive

• HREC approval for 120-patient Phase 1/2 CYWC628 trial in Australia
• CYWC628 master and working cell banks manufactured under FDA cGMP and passed safety tests
• Filed IND for CYPS317 on Dec 30, 2025
• Raised capital via registered direct offerings totaling $7.2M in Nov–Dec 2025 and closed two tranches of a $25M financing
• Paid off all outstanding debt, improving balance sheet flexibility

Negative

• Company remains clinical-stage with no marketed products
• Key clinical readouts and commercialization dependent on successful 2026 trial milestones and IND approvals
• Ongoing funding and regulatory hurdles noted as continuing challenges

Key Figures

Lab size over 10,000 square feet New Houston laboratory facility

November financing $4 million Registered direct offering from existing shareholder

Second November financing $1.5 million Additional registered direct offering

December financing $1.7 million Registered direct offering in December 2025

Trial size 120 patients Phase 1/2 CYWC628 trial in diabetic foot ulcers

Trial sites 10 sites CYWC628 Phase 1/2 study in Australia

Patent portfolio 270+ patents issued and pending Global IP across multiple therapeutic areas

Financing facility $25 million Financing referenced as closed in two tranches by Q2 2025

Market Reality Check

$0.3380 Last Close

Volume Volume 1,994,651 is at 0.63x the 20-day average of 3,179,650 shares. low

Technical Shares at $0.26 are trading below the 200-day MA of $0.62 and far under the $2.335 52-week high.

Peers on Argus

FBLG was up 6.78% pre-news, while peers showed mixed, lower-magnitude moves (e.g., GDTC +0.72%, ICU +1.18%, LIXT -5.57%), indicating stock-specific dynamics.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Jan 05	Preclinical data	Positive	+1.5%	Positive FSdC spheroid preclinical results in degenerative disc disease models.
Dec 31	IND filing	Positive	-7.0%	Filed Phase 1/2 IND with FDA for CYPS317 in moderate to severe psoriasis.
Dec 16	Equity offering	Negative	-8.4%	Closed $1.7M registered direct offering with concurrent warrants at $0.33.
Dec 15	Equity offering	Negative	-33.1%	Announced $1.7M registered direct offering and related warrant financing.
Dec 10	Patent filing	Positive	+12.8%	Filed U.S. patent for fibroblast-based chondrocyte spheroid orthopedic platform.

Pattern Detected

News-driven moves generally align with headline tone; positive R&D/IP updates often saw gains, while financing announcements coincided with declines, with one divergence on an IND filing.

Recent Company History

Over the past month, FibroBiologics issued several R&D and financing updates. A patent filing on Dec 10, 2025 and positive FSdC preclinical data on Jan 5, 2026 were followed by share price gains, while registered direct offerings on Dec 15–16, 2025 aligned with notable declines. The psoriasis IND filing on Dec 31, 2025 drew a negative reaction despite its positive clinical implications. Today’s shareholder letter emphasizes 2025 execution and 2026 clinical milestones against this backdrop of recent dilution and ongoing scientific progress.

Market Pulse Summary

The stock surged +32.3% in the session following this news. A strong positive reaction aligns with FibroBiologics’ pattern of responding well to R&D and IP milestones, as seen after the Dec 10, 2025 patent news and Jan 5, 2026 preclinical update. However, recent financings and low-priced offerings have previously coincided with sharp declines, highlighting dilution risk. The shareholder letter’s emphasis on multiple 2026 trials and a portfolio of 270+ patents would have reinforced the growth narrative, but sustainability of any surge could depend on future capital needs and execution of planned studies.

Key Terms

fibroblasts medical

"therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials"

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

"chronic diseases using fibroblasts and fibroblast-derived materials, today issued the following letter"

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.

cGMP regulatory

"cell banks with Charles River, manufactured under FDA cGMP standards and passing all safety tests"

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.

hrec regulatory

"we achieved a major win with HREC approval in Australia for our Phase 1/2 trial"

A Human Research Ethics Committee (HREC) is an independent review board that evaluates whether medical or social research involving people is safe, ethical and respects participants’ rights. For investors, HREC approval is a critical regulatory checkpoint—like a safety inspection for a new product—because it must be secured before clinical studies can proceed, and delays or refusals can affect a project’s timeline, costs and ultimate commercial value.

cdmo technical

"These steps, including our CDMO and CRO engagements, position us for multiple trials"

A contract development and manufacturing organization (CDMO) is a company that provides specialized services to help develop and produce pharmaceutical products for other businesses. Think of it as a contract factory that takes a company's recipe and makes the product on their behalf. For investors, CDMOs are important because they support the growth of pharmaceutical companies and can be key partners in bringing new medicines to market.

cro technical

"These steps, including our CDMO and CRO engagements, position us for multiple trials"

CRO stands for Contract Research Organization, a company that helps pharmaceutical and biotech firms manage and carry out clinical trials to test new medicines. For investors, CROs are important because they enable drug companies to develop new treatments more efficiently, potentially accelerating the path to market and affecting the company's growth prospects and success.

organoid medical

"Our bone marrow organoid platform showed promise in reducing tumor sizes in cancer models"

A lab-grown organoid is a tiny, three-dimensional cluster of human cells grown to mimic the structure and basic functions of a real organ or tissue, like a miniature, simplified organ in a dish. Investors care because organoids speed up and reduce the cost of testing drugs, predicting safety and effectiveness more reliably than flat cell cultures, and can de-risk development programs or create new markets for biotech products and services.

AI-generated analysis. Not financial advice.

HOUSTON, Jan. 07, 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 issued the following letter to shareholders.

Fellow Shareholders,

Looking back on 2025, I'm reminded of something I've always believed: the best way to predict the future is to invent it. At FibroBiologics, that's exactly what we've been doing by pushing the boundaries of science to create fibroblast-based therapies that may change lives. This year has been about relentless innovation and obsessing over science and long-term patient impact. Worldwide, patients are suffering from chronic diseases, and our mission is to deliver breakthroughs using fibroblast cells and fibroblast-derived materials. Let me share our progress in that spirit that’s straightforward, optimistic, and grounded in results.

First, let's talk about our major accomplishments. 2025 was a year of building momentum. We unveiled our new and expanded laboratory in Houston with a state-of-the-art facility over 10,000 square feet designed to fuel discovery and facilitate in-house manufacturing. This isn't just space; it's a launchpad for scaling our fibroblast-based platforms, allowing us to hire more scientists and accelerate R&D. Financially, we closed multiple registered direct offerings, raising essential capital like the $4 million in November from an existing shareholder, $1.5 million later that month, and $1.7 million in December. We also paid off all outstanding debt, giving us a cleaner balance sheet and more flexibility to invest in the future. Leadership-wise, we welcomed Jason D. Davis as CFO, bringing over 25 years of corporate finance, capital markets, and SEC reporting expertise to guide our growth. And we didn't stay quiet—we presented our work at over a dozen conferences, from BIO International to the H.C. Wainwright Global Investment Conference, sharing our vision with the world. Our team even authored an op-ed highlighting the scientific case for fibroblast cells' therapeutic advantages compared to stem cell therapies.

Clinical trial milestones represent the heart of our progress—where ideas meet real-world impact. Early in the year, we completed and released the CYWC628 master and working cell banks with Charles River, manufactured under FDA cGMP standards and passing all safety tests. This was the first step in unlocking manufacturing for our wound healing program. In November, we achieved a major win with HREC approval in Australia for our Phase 1/2 trial of CYWC628 in diabetic foot ulcers—a 120-patient study across 10 sites evaluating safety, tolerability, and efficacy. The clinical trial is scheduled to start in Q1 2026, with interim results potentially by mid-year and topline results expected before the end of 2026. For psoriasis, positive IND-enabling data from our CYPS317 spheroids showed efficacy matching biologics in acute models and reducing relapse in chronic ones, with preclinical studies wrapping up by year-end resulting in a new IND filed on December 30, 2025. In multiple sclerosis, we're advancing CYMS101 toward an IND submission, building on remyelination data. These steps, including our CDMO and CRO engagements, position us for multiple trials in 2026.

On the scientific front, we made exciting strides. We confirmed remyelination in brain tissue repair models, supporting our approach for demyelinating diseases such as multiple sclerosis. Our bone marrow organoid platform showed promise in reducing tumor sizes in cancer models and addressing age-related immune decline for our human longevity program. These aren't abstract ideas; they're tangible steps toward therapies that can potentially extend healthy lifespans and fight tough diseases.

Turning to patents and intellectual property— this is where we fortify our moat, much like high tech companies investments in technology. Our portfolio now exceeds 270 issued and pending patents across the U.S. and internationally, covering everything from wound healing to orthopedics and human longevity. Key advancements this year include filing for methods to generate multipotent cells from donor fibroblasts, enabling scalable production for diverse applications like cartilage repair and organ regeneration. We also patented a novel approach to modulate mitochondrial activity using fibroblasts, potentially boosting cellular energy for aging-related therapies. In December, we filed for a fibroblast-based chondrocyte spheroid platform to treat musculoskeletal conditions, including degenerative disc disease and joint restoration—backed by preclinical data showing tissue integration and regeneration. These filings build on earlier ones, like those for cancer treatments and preventing blood clotting in cell therapies. Our IP isn't just defensive; it's a roadmap for turning science into cures.

Financially, our quarterly reports reflect disciplined execution. Q1 saw R&D expenses focused on the lab expansion and master cell bank. By Q2, we closed two tranches of our $25 million financing. Q3 emphasized cost efficiencies while advancing priorities.

Looking ahead, 2026 will be about execution which includes completing a clinical trial, submitting INDs, and strengthening our financial position. We'll continue obsessing over science, while fostering a sense of urgency for clinical validation. Challenges remain, like regulatory hurdles and funding, but our team's grit and your support as shareholders make me confident that we will continue to conquer any challenges that stand between our science and patient relief.

Thank you for believing in this journey.

Let's keep inventing the future…patients are counting on us!

Best regards,

Pete O'Heeron
Founder/CEO, FibroBiologics

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. For more information, please visit FibroBiologics' website or email FibroBiologics at: info@fibrobiologics.com.

Cautionary Statement Regarding Forward-Looking Statements

This letter contains "forward-looking statements." Forward-looking statements include information concerning the potential clinical benefits of fibroblasts and fibroblast-derived materials, plans for, the anticipated timing of the initiation and completion of, and reporting of results from, 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, plans for, and the timing of, regulatory filings, plans for hiring, and potential value creation of ongoing efforts. 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.

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

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/fb808b9d-ebc2-4ee6-b466-d865ec01e264

FAQ

What clinical trial did FibroBiologics (FBLG) get approval for on January 7, 2026?

FibroBiologics obtained HREC approval for a 120-patient Phase 1/2 CYWC628 diabetic foot ulcer trial in Australia.

When will the FibroBiologics (FBLG) CYWC628 trial start and when are results expected?

The CYWC628 trial is scheduled to start Q1 2026 with interim results potentially mid-2026 and topline results expected before end-2026.

What manufacturing milestone did FibroBiologics (FBLG) announce for CYWC628?

FibroBiologics completed CYWC628 master and working cell banks manufactured under FDA cGMP standards that passed all safety tests.

Did FibroBiologics (FBLG) file any INDs in 2025?

Yes, FibroBiologics filed an IND for CYPS317 on December 30, 2025.

How did FibroBiologics (FBLG) strengthen its financial position in late 2025?

The company completed multiple registered direct offerings in Nov–Dec 2025 (including $4M, $1.5M, $1.7M) closed two tranches of a $25M financing by Q2 and paid off all outstanding debt.

How large is FibroBiologics' (FBLG) intellectual property portfolio as of January 7, 2026?

The company's portfolio exceeds 270 issued and pending patents across the U.S. and internationally.