FibroBiologics Announces Positive Preclinical Results for a Fibroblast Spheroid-derived Chondrocyte (FSdC) Spheroid Therapy for Degenerative Disc Disease

Rhea-AI Summary

FibroBiologics (Nasdaq: FBLG) reported positive preclinical results for an investigational FSdC spheroid therapy in animal models of degenerative disc disease dated January 5, 2026. Key findings at 12 weeks showed the highest intervertebral disc height recovery versus 2D fibroblasts and fibroblast spheroids, with an unadjusted p-value of 0.00015 for FSdC (compared with 0.036 and 0.068 for comparators).

The study showed sustained highest average disc size index (%DHI) across six measurement periods over 12 weeks. The company says it will pursue regulatory engagement and advance FSdC toward clinical development.

Positive

• Disc height recovery statistically superior at 12 weeks (p=0.00015)
• Sustained highest %DHI across six time points
• Preclinical data supports mechanism, durability, efficacy
• Company intends to advance FSdC toward clinical development

Negative

• Results are from preclinical animal models, not human trials
• Comparator fibroblast spheroids showed p=0.068 (not significant)
• No clinical trial start date or regulatory milestones disclosed
• Translational risk remains between animal data and human outcomes

Key Figures

Disc height follow-up 12 weeks Timepoint for intervertebral disc height recovery comparison

p-value FSdC vs control p = 0.00015 Unadjusted p-value for disc height recovery vs vehicle control

p-value 2D fibroblasts p = 0.036 Unadjusted p-value for disc height recovery vs vehicle control

p-value fibroblast spheroids p = 0.068 Unadjusted p-value for disc height recovery vs vehicle control

Study duration 12 weeks Duration of degenerative disc disease animal model study

Disc measurements 6 time points Six disc height measuring periods during study

Market Reality Check

$0.3300 Last Close

Volume Volume 4,372,814 is 1.41x the 20-day average of 3,092,294 normal

Technical Price $0.2399 is trading below the 200-day MA at $0.63, reflecting a weak longer-term trend.

Peers on Argus 1 Up

FBLG showed a pre-news move opposite its momentum flag (“down”), while highlighted peer AKTX was up 12.41%. Among close peers, ICU gained 11.48%, most others were modestly positive, and LIXT declined, suggesting today’s setup is more stock-specific than a broad biotech move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 31	Clinical development	Positive	-7.0%	IND filing to start Phase 1/2 CYPS317 psoriasis trial with strong preclinical data.
Dec 16	Equity offering	Negative	-8.4%	Closing of $1.7M registered direct and concurrent warrant private placement.
Dec 15	Equity offering	Negative	-33.1%	Announcement of $1.7M registered direct offering with at-the-market pricing and warrants.
Dec 10	Intellectual property	Positive	+12.8%	Patent application for fibroblast-based chondrocyte spheroid platform for orthopedic uses.
Nov 26	Balance sheet action	Positive	+1.5%	Payoff of convertible notes under SEPA, leaving up to $10M equity capacity.

Pattern Detected

Equity offerings drew clearly negative price reactions, while clinical, IP, and balance-sheet updates generally aligned positively with sentiment, aside from one divergence on an IND filing.

Recent Company History

Over the last few months, FibroBiologics combined financing activity with pipeline and platform progress. In November–December 2025, multiple low-priced equity offerings and warrant deals coincided with sharp declines, notably a -33.06% move on the Dec 15 offering. In contrast, news on patent filings and debt payoff around Nov 26 and Dec 10 saw modest to strong gains. The Dec 31 IND filing for CYPS317 produced a negative reaction, diverging from its positive clinical implications. Today’s preclinical FSdC data extends the regenerative medicine narrative following the chondrocyte spheroid patent filing.

Market Pulse Summary

This announcement highlights statistically significant preclinical efficacy of FSdC spheroids in preserving intervertebral disc structure over a 12-week study, with an unadjusted p-value of 0.00015 versus control. It builds on December’s chondrocyte spheroid patent filing and prior IND work, reinforcing FibroBiologics’ fibroblast-based regenerative focus. Investors may watch for progression toward clinical trials, updates on broader pipeline candidates, and how ongoing capital-structure and Nasdaq compliance initiatives intersect with future development milestones.

Key Terms

fibroblast medical

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

A fibroblast is a common type of cell in connective tissue that acts like the body’s construction crew, producing the protein scaffolding and glue that hold tissues together and help wounds heal. Investors watch fibroblast-related science because these cells are central to developing treatments for scarring, chronic fibrotic diseases, wound repair and cosmetic or regenerative therapies, so changes in research, approvals or commercial products can affect company value.

spheroid medical

"an investigational FSdC spheroid-based therapy, demonstrating superior improvement"

A spheroid is a tiny, three-dimensional clump of living cells grown in the lab that mimics the structure and behavior of tissue better than flat cell layers; think of it as a miniature, simplified version of an organ or tumor. For investors, spheroids matter because they can make early drug testing more predictive of how a treatment will work in humans, potentially lowering the risk of costly late-stage failures and shortening development timelines.

chondrocyte medical

"Fibroblast Spheroid-derived Chondrocyte (FSdC) spheroid therapy for degenerative"

A chondrocyte is a specialized cell that produces and maintains cartilage, the flexible, cushioning tissue in joints and other parts of the body; think of it as the builders and maintenance crew that keep cartilage intact. Investors track chondrocyte-related science because drugs, implants, or regenerative treatments that protect, restore, or replace cartilage can affect markets for orthopedics, sports medicine, and chronic joint diseases by changing demand for procedures, devices, and therapies.

intervertebral disc medical

"recovering intervertebral disc integrity and preventing degeneration in animal models"

An intervertebral disc is the soft, flexible cushion sitting between the bones of the spine that absorbs shock and lets the spine bend and twist, like a small shock absorber or rubber pad separating stacked blocks. It matters to investors because many medical products and treatments—implants, surgical procedures, biologic therapies and imaging tools—target disc damage or degeneration, so advances, approvals or clinical setbacks can directly affect company value and market opportunity.

extracellular matrix medical

"integrating extracellular matrix remodeling with targeted tissue support, and inflammation"

A network of proteins and other molecules that sits outside cells and gives tissues their shape, strength and a medium for cells to send signals and move — like the scaffolding and wiring inside a building. Investors care because changes to this matrix play a major role in diseases, wound healing and tissue repair, making it a common target for drugs, medical devices and diagnostics that can drive regulatory decisions and commercial value.

pharmacology medical

"The data includes comprehensive preclinical pharmacology and efficacy assessments"

Pharmacology is the science of how drugs affect the body and how the body affects drugs — including what a drug does, how much is needed, how long it lasts, and possible side effects. For investors, pharmacology matters because it determines whether a medicine is likely to work safely, how it will be dosed, what risks regulators and doctors will see, and therefore how big its market and approval chances might be — like testing a recipe to see if it will reliably satisfy customers.

p-value technical

"with an unadjusted p-value of 0.00015 as compared to 0.036 for 2D fibroblasts"

A p-value is a number that helps determine how likely it is that a result or pattern happened by chance rather than because of a real effect. For investors, a low p-value suggests that the findings in a study or analysis are probably meaningful and not just random noise—like noticing a pattern in coin flips that’s unlikely to occur by chance. This helps in assessing the reliability of information used to make financial decisions.

degenerative disc disease medical

"therapy for degenerative disc disease. These preclinical findings represent a major"

Degenerative disc disease is the gradual breakdown of the soft, cushion-like discs between spinal bones, which can cause chronic back or neck pain and reduced mobility. Like the worn-out shock absorbers on a car, failing discs lead to compensating repairs and replacements, creating sustained demand for treatments such as medications, medical devices, surgeries and rehabilitation; that demand, regulatory approvals and long-term care costs are what make the condition important to investors.

AI-generated analysis. Not financial advice.

FSdC demonstrated statistically significant and superior improvement in disc preservation and structural integrity compared to other treatments

HOUSTON, Jan. 05, 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 positive preclinical results for FSdC, an investigational FSdC spheroid-based therapy, demonstrating superior improvement in recovering intervertebral disc integrity and preventing degeneration in animal models of degenerative disc disease.

These preclinical findings represent a major advancement for FibroBiologics’ regenerative medicine pipeline and highlight the potential of FSdC spheroids to address unmet needs in spinal health. Key results from the degenerative disc disease animal model study include:

• Significantly Improved Disc Height Recovery: FSdC spheroids exhibited the highest level of intervertebral disc height recovery at 12 weeks after treatment as compared to 2D fibroblasts and fibroblast spheroids, demonstrating superior long-term structural integrity.
• Highly Significant Statistical Superiority: Study data revealed FSdC spheroids exceptional performance in disc height recovery 12 weeks after treatment, achieving the most compelling statistical difference from vehicle control with an unadjusted p-value of 0.00015 as compared to 0.036 for 2D fibroblasts, and 0.068 for fibroblast spheroids—positioning it as the leading innovative approach.
• Breakthrough Potential for Spinal Health: By sustaining the highest average disc size index (%DHI) across all time points during the six disc height measuring periods of the 12 week study, FSdC spheroids significantly outperformed single cell fibroblasts and fibroblast spheroids, heralding a potential new era in regenerative therapies for the treatment of degenerative disc disease and joint-cartilage damage.
  

“These compelling preclinical results for FSdC mark a significant step forward in our regenerative pipeline and advance our goal of bringing innovative fibroblast-based therapies to patients,” said Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics. “Degenerative disc disease impacts millions who face ongoing pain and limited mobility with current options. We believe FSdC spheroids have the potential not only to enhance structural integrity but also to transform how spinal degenerative conditions are managed. This data reinforces our commitment to innovation, scientific excellence, and meaningful patient impact.”

Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics, added: “Our preclinical findings indicate that FSdC spheroids leverage unique, multi-faceted regenerative activity, integrating extracellular matrix remodeling with targeted tissue support, and inflammation control which may help restore spinal disc homeostasis in degenerative states. We are enthusiastic about collaborating with regulatory authorities as we move this promising program toward clinical development.”

Degenerative disc disease is a leading cause of chronic back pain and disability, affecting millions of adults in the United States and significantly impairing quality of life and productivity. Despite available treatments, unmet needs remain, particularly in achieving long-term disc preservation and regeneration with minimal invasiveness.

FibroBiologics is pursuing a development program for FSdC spheroids with the goal of advancing to clinical trials. The data includes comprehensive preclinical pharmacology and efficacy assessments supporting the therapy’s mechanism of action, durability of effect, and potential for regenerative outcomes.

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 communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning the potential indications for FibroBiologics’ programs, 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, 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. 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; and (c) the unpredictable relationship between R&D and preclinical results and clinical study results. 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

FAQ

What did FibroBiologics (FBLG) announce on January 5, 2026 about FSdC?

FibroBiologics announced positive preclinical animal-model results showing FSdC spheroids improved disc height recovery and sustained %DHI over 12 weeks.

How statistically significant was the FSdC result in the FBLG preclinical study?

FSdC achieved an unadjusted p-value of 0.00015 for disc height recovery at 12 weeks versus vehicle control.

Does the January 2026 FBLG news mean FSdC is in clinical trials now?

No; the announcement reports preclinical results and states the company plans to pursue regulatory engagement to move toward clinical development.

What clinical benefit did FBLG claim for FSdC spheroids in degenerative disc disease?

The company reported FSdC spheroids significantly recovered intervertebral disc height and preserved structural integrity in animal models over 12 weeks.

How did FSdC compare to 2D fibroblasts and fibroblast spheroids in the FBLG study?

FSdC showed the highest disc height recovery and the most favorable statistical difference versus 2D fibroblasts (p=0.036) and fibroblast spheroids (p=0.068).