BioRestorative Confirms No Material Impact from Reciprocal Tariffs; All BRTX-100 Production & Manufacturing Performed in the United States

Rhea-AI Summary

BioRestorative Therapies (NASDAQ:BRTX) confirms no material impact from new U.S. tariffs due to its domestic production strategy for BRTX-100, its lead cell-based therapeutic targeting areas with blood flow. The company reports significant clinical progress with:

• FDA Fast Track designation for BRTX-100 in treating chronic lumbar disc disease (cLDD), following positive Phase 2 preliminary data
• FDA clearance of IND application for BRTX-100 in treating chronic cervical discogenic pain (cCDP)
• Strong financial position with over $10 million in cash, cash equivalents, and marketable securities at the end of 2024

Positive

• FDA Fast Track designation received for BRTX-100 in treating cLDD
• FDA IND clearance obtained for BRTX-100 in treating cCDP, expanding treatment pipeline
• Strong cash position of over $10 million as of end-2024
• No exposure to tariff impacts due to domestic production strategy

Negative

• None.

MELVILLE, N.Y., April 10, 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 confirm that it currently faces no material exposure to newly imposed U.S. tariffs.

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 chronic lumbar disc disease (“cLDD”) is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study. The U.S. Food and Drug Administration (“FDA”) recently granted Fast Track designation to the BRTX-100 program for the treatment of cLDD, reflecting the positive preliminary Phase 2 safety and efficacy data reported to date. Also in February, the FDA cleared the Company’s Investigational New Drug (“IND”) application for BRTX-100 for the treatment of chronic cervical discogenic pain (cCDP), expanding BioRestorative’s advanced clinical pipeline for BRTX-100 to include the treatment of both chronic lower back and neck pain.

“Our ‘made-in-America’ production and manufacturing strategy, combined with our use of domestic inputs, enables us to effectively manage costs amid global supply chain shifts,” said Lance Alstodt, BioRestorative’s Chief Executive Officer. “We ended 2024 in a very strong financial position with cash, cash equivalents, marketable securities of over $10 million. We plan on continuing to efficiently manage our cash reserves while executing upon all of our strategic goals.”

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. 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 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

How will the new U.S. tariffs affect BRTX's BRTX-100 production costs?

BRTX confirms no material impact from tariffs as all production and manufacturing is performed in the United States.

What recent FDA designations has BRTX-100 received for chronic lumbar disc disease?

BRTX-100 received FDA Fast Track designation for treating chronic lumbar disc disease (cLDD) following positive Phase 2 preliminary data.

What is BRTX's current cash position as of end-2024?

BioRestorative reported over $10 million in cash, cash equivalents, and marketable securities at the end of 2024.

What new treatment indication has BRTX-100 received FDA IND clearance for?

BRTX-100 received FDA IND clearance for treating chronic cervical discogenic pain (cCDP), expanding its clinical pipeline to include neck pain treatment.