BioRestorative Completes Patient Enrollment in Landmark Phase 2 Trial of BRTX-100 for Chronic Lumbar Disc Disease

Rhea-AI Summary

BioRestorative (NASDAQ:BRTX) announced on Feb 10, 2026 that it completed enrollment of 99 patients in its Phase 2 trial of BRTX-100 for chronic lumbar disc disease (cLDD). The randomized 2:1, double-blind, sham-controlled single-disc study has primary endpoints at week 52 for ODI and VAS improvements.

The company says this is the largest FDA-authorized Phase 2 cell-therapy trial in cLDD and that ~40% of enrollment occurred in the past six months, strengthening the pathway toward Phase 3 and a potential BLA discussion.

Positive

• Enrollment complete at 99 patients, meeting target for Phase 2
• Prospective randomized 2:1 double-blind, sham-controlled single-disc design
• Primary efficacy endpoints set at >30% ODI and >30% VAS improvement at week 52
• Approximately 40% of enrollment occurred in the past six months, indicating accelerating site productivity

Negative

• No efficacy or safety outcomes reported yet; results pending through week 52
• Single-disc enrollment criteria are restrictive and may limit generalizability to broader cLDD populations

Market Reaction

-42.58% $0.60 28.7x vol

15m delay 39 alerts

-42.58% Since News

$0.60 Last Price

$0.58 $0.89 Day Range

-$4M Valuation Impact

$5M Market Cap

28.7x Rel. Volume

Following this news, BRTX has declined 42.58%, reflecting a significant negative market reaction. Our momentum scanner has triggered 39 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $0.60. This price movement has removed approximately $4M from the company's valuation. Trading volume is exceptionally heavy at 28.7x the average, suggesting significant selling pressure.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.

Key Figures

Trial enrollment: 99 participants Clinical sites: 15 U.S. sites Randomization ratio: 2:1 BRTX-100:placebo +5 more

8 metrics

Trial enrollment 99 participants Phase 2 BRTX-100 trial in chronic lumbar disc disease

Clinical sites 15 U.S. sites Phase 2 BRTX-100 trial footprint

Randomization ratio 2:1 BRTX-100:placebo Prospective, randomized, double-blind, sham-controlled design

Function endpoint >30% ODI improvement Primary efficacy endpoint at week 52 vs. baseline

Pain endpoint >30% VAS reduction Primary efficacy endpoint at week 52 vs. baseline

Enrollment pace 40% in last six months Portion of total Phase 2 enrollment recently completed

Current price $1.045 Pre-news trading level vs. 52-week range

52-week range $0.9841–$2.50 Price sits 6.19% above low and 58.2% below high

Market Reality Check

Price: $1.04 Vol: Volume 17,857 is below 20...

normal vol

$1.04 Last Close

Volume Volume 17,857 is below 20-day average 22,862 (relative volume 0.78x). normal

Technical Price $1.045 is trading below 200-day MA $1.47 and 58.2% under 52-week high.

Peers on Argus

BRTX shows a modest 0.48% gain with subdued volume while only one peer in the mo...

1 Up

BRTX shows a modest 0.48% gain with subdued volume while only one peer in the momentum scan (PHIO) is up sharply (33.33%) and core peers show mixed moves (e.g., PHGE +19.21%, BIVI +6.42%, XTLB -9.18%). This points to stock-specific dynamics.

Previous Clinical trial Reports

2 past events · Latest: May 13 (Positive)

Same Type Pattern 2 events

Date	Event	Sentiment	Move	Catalyst
May 13	Phase 2 data update	Positive	-7.1%	Reported sustained positive blinded BRTX-100 efficacy with no serious adverse events.
Nov 13	Phase 2 data update	Positive	-6.1%	Shared promising preliminary Phase 2 BRTX-100 results showing strong pain and function gains.

Pattern Detected

Recent BRTX-100 clinical updates with positive blinded data have been followed by negative price reactions despite upbeat trial signals.

Recent Company History

Over the past year, BioRestorative’s key milestones have centered on its BRTX-100 Phase 2 program. Prior clinical updates on Nov 13, 2024 and May 13, 2025 highlighted strong pain and function improvements plus clean safety, yet shares fell about 6–7% after each release. Today’s completion of enrollment for the 99-patient Phase 2 trial advances the same program toward potential Phase 3/BLA discussions, extending this clinical narrative despite earlier adverse market reactions.

Historical Comparison

clinical trial

-6.6 %

Average Historical Move

Historical Analysis

In the past year, two BRTX-100 Phase 2 clinical updates averaged a -6.59% move despite positive data. Today’s enrollment-completion news continues the same trial’s progression and may be viewed against that history of weak tape responses.

Typical Pattern

Clinical news has progressed from early positive blinded Phase 2 data toward full enrollment completion in the same BRTX-100 cLDD trial, positioning the program for future Phase 3 and potential BLA discussions.

Market Pulse Summary

The stock is dropping -42.6% following this news. A negative reaction despite operational progress w...

Analysis

The stock is dropping -42.6% following this news. A negative reaction despite operational progress would fit prior patterns, where positive BRTX-100 Phase 2 updates averaged about -6.59% in the following session. Completion of enrollment in a 99-patient gold-standard trial adds clinical value, but the market has previously focused on broader risk disclosures and capital-raising needs. Future volatility could hinge on full Phase 2 efficacy and safety data and how they support Phase 3 and BLA discussions.

Key Terms

autologous, mesenchymal stem cell, intradiscal, Oswestry Disability Index (ODI), +3 more

7 terms

autologous medical

"an autologous, hypoxically cultured mesenchymal stem cell therapy engineered"

Autologous describes a medical product or treatment made from a patient’s own cells or tissues rather than from a donor. For investors, autologous approaches matter because they can lower the risk of immune rejection and improve effectiveness, but they often require individualized manufacturing, complex logistics, and higher per-patient costs—factors that affect scalability, pricing, and regulatory hurdles in healthcare businesses.

mesenchymal stem cell medical

"hypoxically cultured mesenchymal stem cell therapy engineered for delivery"

Mesenchymal stem cells are adult cells that can act like a biological handyman, able to become bone, cartilage, fat or other tissue types and to support tissue repair and reduce inflammation. Investors care because these cells are the basis for many experimental therapies and medical products; their commercial potential, clinical trial results, manufacturing challenges and regulatory approvals directly affect the value and risk of companies developing them.

intradiscal medical

"through a minimally invasive outpatient intradiscal procedure"

Describes a treatment, device or procedure that is applied directly inside an intervertebral disc — the cushioning pad between spinal bones. Think of it as putting medicine or a tiny implant into the center of a car tire rather than around it: it’s highly targeted. For investors, “intradiscal” signals a specialized spine product or therapy with specific clinical, regulatory and reimbursement hurdles and a focused patient market, which can affect development cost, approval timeline and commercial potential.

Oswestry Disability Index (ODI) medical

"improvement in function in the Oswestry Disability Index (ODI) and a greater"

A patient questionnaire that measures how much back and leg pain affects daily activities, producing a score that ranges from minimal to severe disability. Think of it like a report card for a person’s functional ability: higher scores mean more limitation. Investors watch ODI results because they serve as a clinical trial endpoint and real-world outcome measure that can influence regulatory approval, payer coverage, market uptake, and the commercial value of treatments or devices.

Visual Analog Scale (VAS) medical

"reduction in pain on the Visual Analog Scale (VAS) vs. baseline"

A visual analog scale (VAS) is a simple measurement tool patients use to rate the intensity of symptoms—often pain—by marking a point along a straight line between two extremes (for example, 'no pain' and 'worst pain'). It acts like a thermometer for a subjective feeling, turning personal experience into a single number researchers and regulators can track. Investors care because VAS results frequently influence clinical trial success, product labeling, approval decisions and market acceptance, which affect a healthcare product’s commercial value.

sham-controlled medical

"prospective, randomized, double-blind, sham-controlled single-disc study"

A sham-controlled trial compares a real medical procedure or device to a fake version that looks and feels the same but has no therapeutic effect, much like a sugar pill for surgery or implants. For investors, sham control is a sign of rigorous testing because it helps separate true treatment benefits from placebo effects or patient expectations, making clinical results and regulatory prospects more reliable when assessing commercial potential.

Investigational New Drug (IND) regulatory

"conducted in cLDD under a Food and Drug Administration ("FDA") Investigational New Drug (IND)"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

AI-generated analysis. Not financial advice.

• Largest FDA-authorized Phase 2 cell therapy trial conducted in chronic lumbar disc disease
• The study has enrolled a total of 99 participants, each of whom was randomized to receive either BRTX-100 or placebo
• Prospective, randomized, double-blind, sham-controlled single-disc study — gold-standard clinical design
• Enrollment completion strengthens regulatory pathway toward Phase 3 and potential BLA filing

MELVILLE, N.Y., Feb. 10, 2026 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a late stage clinical regenerative medicine innovator focused on stem cell-based therapies and products, today announced completion of patient enrollment in its Phase 2 clinical trial evaluating the safety and efficacy of BRTX-100 for the treatment of chronic lumbar disc disease (“cLDD”).

BRTX-100 is BioRestorative’s lead clinical candidate — an autologous, hypoxically cultured mesenchymal stem cell therapy engineered for delivery into low-oxygen, low-nutrient disc environments.

With 99 patients enrolled across 15 leading U.S. clinical sites, the BRTX-100 Phase 2 study represents, the Company believes, the largest Phase 2 cell-therapy trial conducted in cLDD under a Food and Drug Administration (“FDA”) Investigational New Drug (IND) application and ranks among the largest controlled cell-therapy trials in spine medicine to date.

The trial utilizes a prospective, randomized, double-blind, sham-controlled design focused on single-disc disease, widely considered the gold standard for clinical rigor in spine intervention studies. Participants were randomized 2:1 to receive either BRTX-100 or placebo through a minimally invasive outpatient intradiscal procedure.

The primary safety endpoint for the Phase 2 clinical trial of BRTX-100 in cLDD is the frequency and severity of adverse events (AEs). The primary efficacy endpoints of the trial are a greater than 30% improvement in function in the Oswestry Disability Index (ODI) and a greater than 30% reduction in pain on the Visual Analog Scale (VAS) vs. baseline at week 52.

Single-disc enrollment criteria are notably restrictive and historically challenging, underscoring the significance of completing full enrollment at this scale.

“Our manufacturing, quality control and clinical teams executed exceptionally well in completing enrollment in a highly selective, technically demanding study design,” said Francisco Silva, Vice President of Research and Development. “Interest from both investigators and patients was driven in part by the preliminary blinded data we presented at multiple leading scientific conferences, including ISSCR, ISCT, ORS, and the International Spine Research Symposium. We are deeply grateful to the patients and investigators whose participation made this milestone possible.”

Approximately 40% of total enrollment occurred within the past six months, reflecting accelerating site productivity and investigator engagement.

“This is a defining operational and clinical milestone for BioRestorative,” said Lance Alstodt, Chief Executive Officer. “Completing enrollment in what we believe is the largest and most rigorously designed Phase 2 cell-therapy trial in chronic lumbar disc disease represents years of disciplined execution and scientific focus.”

“This is not only a scale milestone — it is a quality milestone. A randomized, double-blind, sham-controlled, single-disc trial sets a high evidentiary bar and positions the program for meaningful regulatory dialogue and advancement,” added Mr. Alstodt. “Indeed, based on the compelling preliminary blinded Phase 2 data we have reported to date, together with constructive feedback from our recent FDA Type B meeting, we believe we have a clear and actionable pathway toward Phase 3 development and a potential BLA submission. We look forward to providing additional updates as we advance the program in the very near future.”

About Chronic Lumbar Disc Disease

cLDD is a common, often confounding problem for patients and physicians. In the United States, at least 80% of adults experience at least one episode of lower back pain during their lifetime. Low back pain is the most common cause of disability among Americans between 45 and 65 years of age and imposes the highest economic burden on the U.S. healthcare system. The standard of care for treating cLDD involves conservative non-surgical approaches or surgical interventions that target symptomatic relief and musculoskeletal stabilization. Currently, there is no clinical therapy targeting the reversal of disc degeneration or that addresses intervertebral disc cell homeostasis.

About BRTX-100

BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is BioRestorative’s lead clinical candidate. The safety and efficacy of BRTX-100 in treating cLDD is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study. A total of 99 eligible subjects have been enrolled at 15 clinical sites in the United States. Subjects included in the trial were randomized 2:1 to receive either BRTX-100 or placebo. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT04042844.

About BioRestorative Therapies, Inc.

BioRestorative (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we also operate a commercial BioCosmeceutical platform:

• Disc/Spine Program (brtxDISC^™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease. We have also obtained U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) clearance to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain.

• Metabolic Program (ThermoStem^®): We are developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells (“BADSC”) to generate brown adipose tissue (“BAT”), as well as exosomes secreted by BADSC. BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. BADSC secreted exosomes may also impact weight loss.

• BioCosmeceuticals: We operate a commercial BioCosmeceutical platform. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via IND-enabling studies, with the aim of pioneering FDA approvals in the emerging BioCosmeceuticals space.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K, as amended, filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:
Stephen Kilmer
Investor Relations
Direct: (646) 274-3580
Email: skilmer@biorestorative.com

FAQ

What did BioRestorative (BRTX) announce about its Phase 2 BRTX-100 trial on Feb 10, 2026?

They announced completion of enrollment for the Phase 2 study with 99 patients enrolled. According to the company, the study is randomized 2:1, double-blind, sham-controlled and focuses on single-disc cLDD with primary endpoints at week 52.

How is the BRTX-100 Phase 2 trial designed and what are its primary endpoints (BRTX)?

The trial is a prospective randomized 2:1, double-blind, sham-controlled single-disc study. According to the company, primary efficacy endpoints are >30% improvement in ODI and >30% reduction in VAS versus baseline at week 52.

Why does BioRestorative say completing enrollment in BRTX-100 Phase 2 is significant for BRTX shareholders?

Completing enrollment de-risks an operational milestone and enables data readouts. According to the company, it positions the program for regulatory dialogue toward Phase 3 and a potential BLA, subject to final trial results and FDA feedback.

When will results from the BRTX-100 Phase 2 trial (BRTX) be available and what endpoints matter most?

Primary readouts target week 52, when efficacy and safety will be assessed. According to the company, the key endpoints are >30% ODI improvement and >30% VAS pain reduction versus baseline at that timepoint.

How large and fast was enrollment for BioRestorative's BRTX-100 Phase 2 study (BRTX)?

Enrollment reached 99 patients across 15 U.S. sites, and about 40% of that occurred in the prior six months. According to the company, this reflects accelerating site productivity and investigator engagement.