FibroBiologics CEO Issues Letter to Shareholders

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: [email protected].

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:

[email protected]

Investor Relations:

Nic Johnson

Russo Partners

(212) 845-4242

[email protected]

Media Contact:

Liz Phillips

Russo Partners

(347) 956-7697

[email protected]

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