BioRestorative to Provide a Positive FDA Update on Clinical Pipeline

Rhea-AI Summary

BioRestorative Therapies (NASDAQ:BRTX) has announced it will provide a positive clinical pipeline update before market open on Thursday, February 27, 2025. The regenerative medicine company, which focuses on stem cell-based therapies, will share what CEO Lance Alstodt describes as "meaningful key developments" regarding their clinical pipeline.

Alstodt expressed enthusiasm about the upcoming announcement, noting that it reflects "the very solid work of our scientific team over the last several years come to fruition" and mentioned additional positive events related to BRTX-100, one of the company's products.

The company will host a webcasted conference call at 8:00am EST on February 27, 2025, accessible by dialing 888-506-0062 (US) or 973-528-0011 (International) with participant access code 440089. The call will also be broadcast live and archived on the Investor section of BioRestorative's website.

Positive

• Upcoming positive clinical pipeline update announcement
• Positive developments related to BRTX-100 product
• Years of scientific work coming to fruition according to CEO

Negative

• Specific details of the positive developments not yet disclosed
• Actual impact on company financials remains unknown until full announcement

MELVILLE, N.Y., Feb. 25, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage regenerative medicine innovator focused on stem cell-based therapies and products, is pleased to announce that it expects to provide a positive clinical pipeline update before market open on Thursday, February 27, 2025.

“We very much look forward to updating investors on some recent meaningful key developments with respect to our clinical pipeline and review some additional positive events related to BRTX-100 on Thursday,” said Lance Alstodt, Chief Executive Officer of BioRestorative. “We are thrilled to be in a position that reflects the very solid work of our scientific team over the last several years come to fruition and excited to see that positive momentum continue.”

Clinical Pipeline Update Conference Call & Webcast Details

BioRestorative management will host a webcasted conference call at 8:00am EST on Thursday, February 27, 2025. To participate in the conference call by telephone, please dial 888-506-0062 (United States) or 973-528-0011 (International), participant access code 440089. The call will also be broadcast live and archived on the Investor section of the Company’s website at https://www.biorestorative.com/investor-relations/.

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 have also recently begun offering BioCosmeceutical products:

• 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.

• 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 Investigational New Drug (IND)-enabling studies, with the aim of pioneering U.S. Food and Drug Administration (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, and Form 10-Q 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 positive clinical pipeline update will BioRestorative Therapies (BRTX) announce on February 27, 2025?

The specific details of the positive clinical pipeline update haven't been disclosed yet. CEO Lance Alstodt indicated there will be "meaningful key developments" regarding their clinical pipeline and additional positive events related to BRTX-100. The full announcement will be made before market open on February 27, 2025.

What is BRTX-100 and how might it impact BioRestorative Therapies' stock?

BRTX-100 is one of BioRestorative Therapies' stem cell-based therapy products in development. While specific details about BRTX-100 weren't provided in the announcement, the company indicated there will be positive developments related to this product on February 27, 2025, which could potentially impact the stock depending on the nature of the update.

How can investors participate in BioRestorative Therapies' (BRTX) February 27, 2025 conference call?

Investors can participate in BioRestorative's conference call on February 27, 2025, at 8:00am EST by dialing 888-506-0062 (US) or 973-528-0011 (International) with participant access code 440089. The call will also be broadcast live and archived on the Investor section of the company's website at biorestorative.com/investor-relations.

What areas of regenerative medicine does BioRestorative Therapies (BRTX) focus on?

BioRestorative Therapies focuses on stem cell-based therapies and products in the regenerative medicine space. While the press release doesn't detail specific treatment areas, the company is a clinical stage innovator developing therapies that likely target tissue regeneration applications.

What has been the recent progress of BioRestorative Therapies' (BRTX) scientific team?

According to CEO Lance Alstodt, the upcoming announcement reflects "the very solid work of our scientific team over the last several years come to fruition." This suggests significant progress in their research and development efforts, though specific achievements will be detailed during the February 27, 2025 update.