BioRestorative Therapies Reports Positive Phase 2 Blinded Data for BRTX-100 Demonstrating Meaningful Improvements in Pain and Function in Chronic Lumbar Disc Disease

Rhea-AI Summary

BioRestorative Therapies (Nasdaq:BRTX) reported blinded Phase 2 data for BRTX-100 in chronic lumbar disc disease showing meaningful, sustained pain and function improvements and no dose-limiting toxicity-related adverse events.

Key endpoints: >30% improvement required for success; many patients achieved >50% improvement on VAS, ODI, RMDQ and FRI at 26, 52 and 104 weeks. FDA Type B meeting aligned on Phase 3 design and CMC approach.

Positive

• VAS pain >50% improvement in 75% of patients at 52 weeks
• ODI >50% improvement in ~74.6% of patients at 52 weeks
• No dose-limiting toxicity-related adverse events reported
• FDA Type B meeting provided alignment on Phase 3 elements

Negative

• Small evaluable sample sizes at later timepoints (n=12 at 52 weeks, n=4 at 104 weeks)
• Primary Phase 2 efficacy endpoint is >30% improvement, lower than reported >50% responders

Market Reaction – BRTX

-11.64% $0.26

15m delay 16 alerts

-11.64% Since News

$0.26 Last Price

$0.25 $0.29 Day Range

-$881K Valuation Impact

$6.69M Market Cap

1.0x Rel. Volume

Following this news, BRTX has declined 11.64%, reflecting a significant negative market reaction. Our momentum scanner has triggered 16 alerts so far, indicating notable trading interest and price volatility. The stock is currently trading at $0.26. This price movement has removed approximately $881K from the company's valuation.

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Key Figures

VAS ≥50% improvement at 26 weeks: 53.57% (n=28) VAS ≥50% improvement at 52 weeks: 75% (n=12) ODI ≥50% improvement at 52 weeks: 74.63% (n=12) +5 more

8 metrics

VAS ≥50% improvement at 26 weeks 53.57% (n=28) Phase 2 BRTX-100 trial, Visual Analog Scale for pain

VAS ≥50% improvement at 52 weeks 75% (n=12) Phase 2 BRTX-100 trial, Visual Analog Scale for pain

ODI ≥50% improvement at 52 weeks 74.63% (n=12) Phase 2 BRTX-100 trial, Oswestry Disability Index

RMDQ ≥50% improvement at 26 weeks 57.14% (n=28) Phase 2 BRTX-100 trial, Roland-Morris Disability Questionnaire

FRI ≥50% improvement at 52 weeks 66.67% (n=12) Phase 2 BRTX-100 trial, Functional Rating Index

Composite ODI & VAS ≥50% at 52 weeks 55% (n=12) Phase 2 BRTX-100 trial, both pain and function thresholds

Primary efficacy threshold >30% improvement in VAS and ODI at 52 weeks Phase 2 BRTX-100 primary endpoint definition

Follow-up duration Up to 104 weeks Duration over which sustained responses were observed

Market Reality Check

Price: $0.2972 Vol: Volume 2,689,009 vs 20-da...

low vol

$0.2972 Last Close

Volume Volume 2,689,009 vs 20-day average 11,140,915 (relative volume 0.24x) suggests no heavy positioning ahead of this release. low

Technical Shares at $0.2972 are trading below the 200-day MA of $1.22 and sit 85.47% under the 52-week high.

Peers on Argus

BRTX showed a modest 0.41% gain pre-news while close biotech peers were mixed, w...

1 Up

BRTX showed a modest 0.41% gain pre-news while close biotech peers were mixed, with several (APM, XTLB, BCTX, PHGE) down and only BIVI up, pointing to a stock-specific rather than sector-driven setup.

Previous Clinical trial Reports

4 past events · Latest: Mar 19 (Positive)

Same Type Pattern 4 events

Date	Event	Sentiment	Move	Catalyst
Mar 19	Phase 2 data preview	Positive	+11.9%	Announced upcoming presentation of positive blinded Phase 2 BRTX-100 efficacy and safety data.
Feb 10	Enrollment completed	Positive	-38.9%	Reported completion of 99-patient enrollment in randomized Phase 2 BRTX-100 cLDD trial.
May 13	Preliminary Phase 2 data	Positive	-7.1%	Presented preliminary blinded Phase 2 data showing strong ODI/VAS responses without serious safety issues.
Nov 13	Early Phase 2 results	Positive	-6.1%	Disclosed promising early 10-patient blinded data with >30% ODI and VAS improvements and no SAEs.

Pattern Detected

Clinical-trial headlines for BRTX have generally been positive but often followed by negative price reactions, with 3 of 4 past events selling off despite favorable data.

Recent Company History

Over the past year, BioRestorative has repeatedly reported encouraging blinded Phase 2 data for BRTX-100 in chronic lumbar disc disease, including early 10‑patient results in Nov 2024 and larger preliminary datasets through May 2025. Enrollment of 99 patients in the randomized Phase 2 trial was completed by Feb 10, 2026. A Mar 19, 2026 release previewed the same blinded efficacy and safety themes now detailed in this article, highlighting consistent pain and function improvements and reinforcing the trial’s Phase 3 path.

Historical Comparison

-10.0% avg move · In the past, BRTX’s clinical-trial headlines averaged a -10.03% move. Today’s modest 0.41% gain ahea...

clinical trial

-10.0%

Average Historical Move clinical trial

In the past, BRTX’s clinical-trial headlines averaged a -10.03% move. Today’s modest 0.41% gain ahead of detailed Phase 2 data looks far more muted than prior reactions.

Clinical updates show a steady progression: from early 10-patient blinded improvements, to larger preliminary datasets with durable ODI/VAS gains, through full enrollment of 99 patients and repeated confirmations of safety and functional benefit for BRTX-100.

Market Pulse Summary

The stock is dropping -11.6% following this news. A negative reaction despite positive blinded effic...

Analysis

The stock is dropping -11.6% following this news. A negative reaction despite positive blinded efficacy and safety data would fit the pattern where past clinical updates averaged a -10.03% move. The market has previously sold off on encouraging BRTX-100 results, possibly reflecting concerns about funding, development timelines, or prior dilution. Even with strong ≥50% improvement rates at 52 weeks, traders may have focused on longer-term execution and capital requirements.

Key Terms

hypoxic-cultured mesenchymal stem cells, visual analog scale, oswestry disability index, roland-morris disability questionnaire, +2 more

6 terms

hypoxic-cultured mesenchymal stem cells medical

"evaluating hypoxic-cultured mesenchymal stem cells for the treatment of chronic"

Mesenchymal stem cells are a type of adult cell used in experimental therapies, and when they are grown in the lab under low-oxygen conditions (“hypoxic-cultured”), they tend to behave more like they would inside the body. For investors, this matters because hypoxic culture can make these cells survive better, work more effectively, and scale differently for manufacturing, which affects a therapy’s safety, effectiveness, production costs, and regulatory pathway—key factors for commercial value.

visual analog scale medical

"improvement in both the Visual Analog Scale (VAS) and Oswestry Disability Index"

A visual analog scale is a simple patient-reported tool that lets someone mark how intense a symptom feels along a straight line anchored by two extremes (for example, “no pain” to “worst imaginable pain”). It turns subjective feelings into a numerical score so researchers and regulators can compare results consistently. Investors watch VAS scores because they’re often used as trial endpoints or to measure treatment benefit, affecting regulatory approval, labeling, and market acceptance.

oswestry disability index medical

"Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) at 52 weeks"

A standardized questionnaire used to measure how much back pain limits a person’s everyday activities, like lifting, walking or sleeping; patients answer a set of simple questions and receive a score that reflects their level of disability. Investors pay attention because changes in this score are often used in clinical trials and regulatory reviews to demonstrate whether a treatment or device meaningfully improves patients’ quality of life, which can affect approval, market adoption and commercial value.

roland-morris disability questionnaire medical

"observed on the RMDQ, with 57.14% of patients experiencing greater than 50%"

A short patient questionnaire that measures how much lower back pain limits everyday activities, using a checklist of common tasks and symptoms. Investors care because it is a widely accepted clinical measure used in trials to show whether a treatment meaningfully improves patients’ daily function; better scores can support regulatory approvals, marketing claims and the commercial value of a therapy, much like a clear test result can prove a product works.

dose-limiting toxicities medical

"No adverse events related to dose-limiting toxicities associated with hypoxic-cultured"

Dose-limiting toxicities are the harmful side effects seen in early clinical trials that are severe enough to stop researchers from raising a drug’s dose. Like a car’s speed limiter marking the safe top speed, DLTs define the maximum tolerable dose, and they matter to investors because they determine whether a medicine can reach effective levels, influence development timelines, costs, and regulatory chances, and thus affect a drug’s commercial prospects.

type b meeting regulatory

"following our recent Type B meeting with the U.S. Food and Drug Administration"

A Type B meeting is a formal, scheduled discussion between a drug or medical-device developer and a health regulator to resolve key mid‑ or late‑stage development issues such as clinical trial plans, interpretation of results, or steps needed for approval. Like a mid‑project review with an inspector, the meeting’s outcome can meaningfully change the timeline, cost and risk for a candidate: a clear, positive outcome lowers uncertainty for investors, while requests for more data or changes can signal delays and extra expense.

AI-generated analysis. Not financial advice.

Data showed 50% or more of patients reporting >50% improvement in key pain and function scales 

No adverse events related to dose-limiting toxicities associated with hypoxic-cultured mesenchymal stem cells

Presented at the 2026 Orthopaedic Research Society Annual Meeting

MELVILLE, N.Y., March 30, 2026 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative,” “BRTX,” or the “Company”) (Nasdaq:BRTX), a late-stage clinical regenerative medicine company focused on stem cell-based therapies and products, today announced blinded data from its Phase 2 clinical trial evaluating hypoxic-cultured mesenchymal stem cells for the treatment of chronic lumbar disc disease, with 50% or more of treated patients reporting improvements >50% across key pain and functional outcome measures and no adverse events related to dose-limiting toxicities. Importantly, the Phase 2 study efficacy endpoint is a greater than a 30% improvement in both the Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) at 52 weeks, which is the minimum improvement needed to meet clinical efficacy success. Chronic lumbar disc disease is a leading cause of chronic lower back pain and disability, affecting millions of patients globally and representing a significant unmet need for non-surgical regenerative therapies.

These data were presented at the 2026 Orthopaedic Research Society Annual Meeting on March 28, 2026 at the Charlotte Convention Center in Charlotte, North Carolina. The Company delivered these data in a presentation titled, “Late-Stage Phase 2 Clinical Safety and Efficacy Data on Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells: Study Update.”

“These blinded data further support the therapeutic potential of our hypoxic-cultured mesenchymal stem cell technology, with patients demonstrating meaningful improvements across key pain and functional outcome measures,” said Lance Alstodt, BioRestorative Therapies President, Chief Executive Officer, and Chairman. “Even with blinded data, this signal provides us with confidence in the ultimate outcome of the study, and optimism moving forward with regard to the ultimate potential for meeting a medical need that has, to date, been inadequately addressed.

“Importantly, the results also continue to reinforce the favorable safety and tolerability profile observed to date. In addition, following our recent Type B meeting with the U.S. Food and Drug Administration, we achieved alignment on key elements of a potential Phase 3 clinical trial for BRTX-100, including primary endpoints, statistical powering assumptions, dosing strategy, and the overall development framework. The agency did not raise safety concerns and confirmed that our CMC framework is appropriate for late-stage development.

“Taken together, these developments position the Company to transition from clinical evaluation toward registrational planning. As we move toward the planned unblinding of the Phase 2 study, we have begun preparing for the next stage of clinical development, including protocol planning and other Phase 3 readiness activities, while continuing to generate additional clinical data that may support the advancement and potential commercialization of BRTX-100,” concluded Mr. Alstodt.

Clinically meaningful improvements in both pain and functional outcomes were observed across multiple validated pain and function measures, including the Visual Analog Scale (“VAS”), Oswestry Disability Index (“ODI”), Roland-Morris Disability Questionnaire (“RMDQ”), and Functional Rating Index (“FRI”), with responses sustained for up to two years in patients with longer-term follow-up.

On the VAS for pain, 53.57% of patients reported greater than 50% improvement at 26 weeks (n=28), with the percentage of patients that reported greater than 50% improvement increasing to 75% at 52 weeks (n=12) and remaining 75% at 104 weeks (n=4).

Similar improvements were observed on the ODI, a widely used measure of functional impairment associated with spinal disorders. Blinded results from the abstract showed 53.57% of patients achieved greater than 50% improvement at 26 weeks (n=28), increasing to 74.63% of patients at 52 weeks (n=12), with 50% of patients maintaining that level of improvement at 104 weeks (n=4).

Improvements were also observed on the RMDQ, with 57.14% of patients experiencing greater than 50% improvement at 26 weeks (n=28), 50% of patients at 52 weeks (n=12), and 75% of patients at 104 weeks (n=4).

FRI demonstrated continued improvement over time, with 35.71% of patients achieving greater than 50% improvement at 26 weeks (n=28), increasing to 66.67% of patients at 52 weeks (n=12) and 50% of patients at 104 weeks (n=4).

Finally, at 26 weeks (n=28) 41% of patients reported a 50% improvement in both ODI and VAS, 55% of patients achieved a 50% improvement in both ODI and VAS at 52 weeks (n=12), and at 104 weeks (n=4) 57% of patients met a 50% improvement in both ODI and VAS.

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 products are formulated and manufactured in our cGMP, ISO-7 certified clean room facility. Each product features a cell-based secretome enriched with exosomes, proteins, growth factors, peptides, and other carefully selected active ingredients. This proprietary biologic portfolio has been thoughtfully engineered to support skin health and longevity while addressing visible signs of aging and enhancing overall cosmetic performance. 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:
Investors
CORE IR
investors@biorestorative.com

FAQ

What blinded Phase 2 results did BioRestorative Therapies (BRTX) report for BRTX-100 on March 30, 2026?

BRTX reported blinded Phase 2 data showing many patients achieved >50% improvement in pain and function measures. According to the company, results included VAS, ODI, RMDQ and FRI improvements sustained to 104 weeks in some patients.

How did BRTX-100 perform on the VAS pain scale in the Phase 2 trial (BRTX)?

On VAS, 53.57% of patients reported >50% improvement at 26 weeks and 75% at 52 weeks. According to the company, the >50% responder rate persisted in available 104-week follow-up patients.

Did BioRestorative (BRTX) report any serious safety issues or dose-limiting toxicities for BRTX-100?

No adverse events related to dose-limiting toxicities were reported in the blinded Phase 2 data. According to the company, safety and tolerability remained favorable in evaluated patients through available follow-up.

What regulatory feedback did BioRestorative (BRTX) receive about BRTX-100 development after Phase 2?

Following a Type B meeting, the FDA aligned on primary endpoints, statistical powering, dosing strategy and CMC framework for Phase 3. According to the company, the agency raised no safety concerns for late-stage development.

What were the Phase 2 functional outcome results for ODI and combined ODI+VAS responders for BRTX-100?

Blinded ODI results showed ~53.57% >50% improvement at 26 weeks and ~74.63% at 52 weeks; combined ODI+VAS responders were 41% at 26 weeks and 55% at 52 weeks. According to the company, some patients sustained responses to 104 weeks.

What limitations should investors note about the BRTX-100 Phase 2 blinded data from BioRestorative (BRTX)?

Later-timepoint sample sizes were small (n=12 at 52 weeks, n=4 at 104 weeks), limiting statistical certainty. According to the company, these are blinded interim data while the study moves toward planned unblinding and Phase 3 readiness.