BioRestorative Therapies to Present 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) will present new blinded Phase 2 data for BRTX-100 on March 28, 2026, at the Orthopaedic Research Society meeting.

The update covers approximately 45 patients, reports meaningful improvements in pain and function scales, and confirms safety and tolerability. A pre-market press release will detail the results. Following a Type B meeting with FDA, the company said regulators raised no safety concerns and aligned on Phase 3 design elements, subject to final IND review.

Positive

• Blinded Phase 2 data from ~45 patients showing improvements in pain and function
• FDA Type B meeting alignment on Phase 3 endpoints and statistical powering
• Agency raised no safety concerns for BRTX-100 development

Negative

• Small dataset of only ~45 patients limits statistical certainty
• Data currently blinded; full unblinded results and details pending
• Phase 3 start subject to final IND review and regulatory clearance

News Market Reaction – BRTX

+11.93%

11 alerts

+11.93% News Effect

+20.0% Peak in 28 hr 38 min

+$663K Valuation Impact

$6M Market Cap

0.1x Rel. Volume

On the day this news was published, BRTX gained 11.93%, reflecting a significant positive market reaction. Argus tracked a peak move of +20.0% during that session. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $663K to the company's valuation, bringing the market cap to $6M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Phase 2 patients (blinded): ≈45 patients Phase 2 enrollment: 99 patients ODI/VAS improvement threshold: >30% improvement +5 more

8 metrics

Phase 2 patients (blinded) ≈45 patients New blinded data to be presented March 28, 2026

Phase 2 enrollment 99 patients Completed enrollment in BRTX-100 cLDD trial (Feb 10, 2026)

ODI/VAS improvement threshold >30% improvement FDA requirement exceeded in prior Phase 2 data

High responders at week 52 70% of subjects Achieved >50% improvement in both ODI and VAS

Maintained responders to week 104 66.66% of subjects Maintained >50% ODI and VAS improvement

Serious adverse events 0 SAEs No SAEs or dose-limiting toxicity reported in prior Phase 2 data

Price change -9.24% 24h move ahead of March 19, 2026 news

52-week range $0.19–$2.10 Shares <b>20.47%</b> above low and <b>89.1%</b> below high

Market Reality Check

Price: $0.3269 Vol: Volume 1.72M vs 20-day av...

low vol

$0.3269 Last Close

Volume Volume 1.72M vs 20-day average 22.89M (relative volume 0.08x) ahead of data presentation. low

Technical Shares at $0.23 are trading below the $1.28 200-day MA, and 89.1% below the 52-week high.

Peers on Argus

BRTX fell 9.24% while at least 2 biotech peers (e.g., BIVI, PHGE) also traded do...

2 Down

BRTX fell 9.24% while at least 2 biotech peers (e.g., BIVI, PHGE) also traded down about 3.6–4.2%, indicating broader sector pressure rather than a BRTX-only move.

Previous Clinical trial Reports

3 past events · Latest: Feb 10 (Positive)

Same Type Pattern 3 events

Date	Event	Sentiment	Move	Catalyst
Feb 10	Phase 2 enrollment	Positive	-38.9%	Completion of enrollment of 99 patients in Phase 2 BRTX-100 cLDD trial.
May 13	Positive blinded data	Positive	-7.1%	Encouraging Phase 2 BRTX-100 data with no SAEs and strong ODI/VAS improvements.
Nov 13	Preliminary Phase 2 data	Positive	-6.1%	Promising early Phase 2 BRTX-100 results showing >30% pain/function improvement.

Pattern Detected

Clinical BRTX-100 headlines have consistently been followed by negative 24h moves despite positive blinded efficacy/safety signals.

Recent Company History

Recent clinical news for BRTX has highlighted steady progress in its BRTX-100 program. On Feb 10, 2026, the company completed enrollment of 99 patients in its Phase 2 cLDD trial, yet the stock fell 38.87%. Earlier updates in May 2025 and Nov 2024 reported strong blinded pain and function improvements and no serious adverse events, but saw -7.09% and -6.1% price reactions. Today’s positive Phase 2 blinded data announcement fits this pattern of constructive clinical signals against weak share performance.

Historical Comparison

-17.4% avg move · Prior BRTX-100 clinical trial updates (3 events) averaged a -17.35% 24h move. Today’s -9.24% reactio...

clinical trial

-17.4%

Average Historical Move clinical trial

Prior BRTX-100 clinical trial updates (3 events) averaged a -17.35% 24h move. Today’s -9.24% reaction is negative but somewhat milder than that recent pattern.

Clinical updates show progression from early preliminary blinded data to positive longer-term ODI/VAS outcomes and, most recently, full Phase 2 enrollment completion toward a potential Phase 3 path.

Market Pulse Summary

The stock surged +11.9% in the session following this news. A strong positive reaction aligns with a...

Analysis

The stock surged +11.9% in the session following this news. A strong positive reaction aligns with a pipeline de‑risking narrative, given repeated positive blinded BRTX-100 data and FDA alignment on Phase 3 elements. Historically, however, prior clinical updates saw average 24h moves of -17.35%, and recent financings disclosed in S-1 and 424B4 filings underscored going-concern risks. Investors would have weighed these capital needs and past dilution alongside the new efficacy and safety signals.

Key Terms

mesenchymal stem cells, chronic lumbar disc disease, phase 2, phase 3, +4 more

8 terms

mesenchymal stem cells medical

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

Mesenchymal stem cells are adult cells that can develop into bone, cartilage, fat and other connective tissues and act like a versatile repair crew in the body. Investors watch them because they are the basis for many experimental therapies and regenerative medicines: successful clinical results could create large markets, while manufacturing complexity, safety concerns and regulatory hurdles make development costly and risky.

chronic lumbar disc disease medical

"stem cells for the treatment of chronic lumbar disc disease will be presented at"

A long-lasting condition in which the cushioning pads between the lower vertebrae (lumbar discs) degenerate, bulge, or tear, often causing ongoing back pain, numbness, or weakness. Think of the discs as worn-out shock absorbers that no longer protect the spine. Investors track it because it drives demand for drugs, surgical implants, and rehabilitation services, affects healthcare costs and insurance payouts, and can influence regulatory approvals and sales for medical-device and pharmaceutical companies.

phase 2 medical

"from its Phase 2 clinical trial evaluating hypoxic-cultured mesenchymal stem cells"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

phase 3 medical

"alignment on key elements of a future Phase 3 clinical trial for BRTX-100"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue 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.

investigational new drug (ind) regulatory

"review of a Phase 3 investigational new drug (IND) application submission"

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.

cmc framework technical

"The agency did not raise safety concerns and confirmed that our CMC framework"

A CMC framework is the set of technical documents, standards and procedures that describe how a drug or biologic is made, tested and kept consistent from batch to batch — like a detailed recipe plus the factory checklist and quality controls. It matters to investors because a strong, clear CMC reduces regulatory hurdles, production delays and cost surprises; weak or incomplete CMC work can derail approvals, slow revenue and create supply risks.

intradiscal injections medical

"Safety and Efficacy Data on Intradiscal Injections of Hypoxic Cultured Mesenchymal"

Intradiscal injections are medical procedures that deliver a drug, biological material, or other therapeutic directly into the soft cartilage-like cushions (intervertebral discs) between vertebrae to relieve pain or slow degeneration. For investors, these treatments matter because their clinical success, safety profile, regulatory approval, and reimbursement determine market size and revenue potential for drug developers, device makers and clinics—think of it as patching a worn-out cushion inside the spine, where outcomes and costs drive commercial value.

AI-generated analysis. Not financial advice.

New blinded data from ~45 patients to date in key pain and function scales and safety and tolerability of the Company’s proprietary hypoxic-cultured mesenchymal stem cells to be unveiled on March 28th at the 2026 Orthopaedic Research Society Annual Meeting

MELVILLE, N.Y., March 19, 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 that new blinded data on approximately 45 patients from its Phase 2 clinical trial evaluating hypoxic-cultured mesenchymal stem cells for the treatment of chronic lumbar disc disease will be presented at the 2026 Orthopaedic Research Society Annual Meeting. The meeting will be held March 27-31, 2026, at the Charlotte Convention Center in Charlotte, North Carolina.

Francisco Silva, BioRestorative’s Vice President of Research and Development, will present its poster, titled, “Late-Stage Phase 2 Clinical Safety and Efficacy Data on Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells: Study Update,” on March 28, 2026. The Company will issue a press release pre-market that day, detailing the newly reported data. 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.

“The highly anticipated presentation of these blinded data will continue to generate interest around the therapeutic potential of our hypoxic-cultured mesenchymal stem cell technology,” said Lance Alstodt, BioRestorative Therapies President, Chief Executive Officer, and Chairman. “Following our recent Type B meeting with the U.S. Food and Drug Administration, we achieved alignment on key elements of a future Phase 3 clinical trial for BRTX-100, including primary endpoints, statistical powering assumptions, dosing strategy, and the overall development framework (subject to final review of a Phase 3 investigational new drug (IND) application submission). The agency did not raise safety concerns and confirmed that our CMC framework is appropriate for late-stage development. Therefore, we believe that the discussion around these blinded data, combined with our planned unblinding of the Phase 2 study, continues our progress towards the next stage of clinical development, including protocol planning and other Phase 3 readiness activities, which may support the advancement and potential commercialization of BRTX-100.”

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

When will BioRestorative Therapies (BRTX) present the Phase 2 BRTX-100 data?

The company will present the blinded Phase 2 data on March 28, 2026 at the Orthopaedic Research Society meeting. According to the company, the poster presentation will be given by Francisco Silva and a pre-market press release will detail the new data the same day.

How many patients are included in the presented BRTX-100 Phase 2 dataset for BRTX?

The presented dataset covers approximately 45 patients in the Phase 2 study. According to the company, these are blinded safety and efficacy data on pain and function scales, with full unblinded results planned to follow the presentation.

What did the FDA Type B meeting mean for BRTX-100 development (BRTX)?

According to the company, the FDA aligned on primary endpoints, powering, dosing, and development framework for Phase 3. The agency reportedly raised no safety concerns, but Phase 3 plans remain subject to final IND review and regulatory approvals.

Did BioRestorative report any safety issues with BRTX-100 in Phase 2 (BRTX)?

The company reported safety and tolerability with no safety concerns raised following the FDA meeting. According to the company, the blinded Phase 2 data to be presented include safety assessments supporting late-stage development.

What investor impact should be expected from the March 28, 2026 BRTX presentation?

The presentation could influence investor sentiment depending on the level of efficacy detail released. According to the company, a pre-market press release will provide specifics, but unblinded data and regulatory steps will determine material next-stage decisions.