BioRestorative Therapies Announces Filing of 2023 Annual Report on Form 10-K

MELVILLE, N.Y., April 01, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, announced today the filing of its Form 10-K annual report with the Securities and Exchange Commission ("SEC") for the year ended December 31, 2023.

The annual report can be accessed on the SEC's website at www.sec.gov, and on the Company's website at www.biorestorative.com under "SEC Filing" in the Investors and Media section.

2023 and Recent Pipeline Developments

BioRestorative’s two primary platform technologies include: its lead clinical-stage cell therapy candidate, BRTX-100, which consists of 40 million autologous bone marrow-derived, hypoxic-cultured transitional stem cells combined with an autologous platelet lysate, and is engineered to be injected into targeted areas of the body that have little blood flow; and ThermoStem, a preclinical program that aims to use allogeneic brown adipose-derived, or brown fat, stem cells to address major metabolic diseases such as obesity and Type 2 diabetes.

BRTX-100

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. A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States. Subjects included in the trial are being randomized 2:1 to receive either BRTX-100 or placebo.

While previous clinical studies have demonstrated that the harsh microenvironment of the disc could impact stem cell dose viability and result in a non-efficacious or the worsening of clinical outcomes, BRTX-100 has been designed to potentially overcome this challenge by culturing and expanding these highly potent cells under hypoxic conditions to mimic and condition them to the unforgiving, low oxygen environment of the disc in order to maximize cell survivability.

In June 2023, BioRestorative announced that the independent Data Safety Monitoring Board, which is overseeing the ongoing Phase 2 clinical trial of BRTX-100 in cLDD, unanimously recommended the continuation of the study in accordance with the current version of the protocol with no changes. There were no dose limiting toxicities (DLTs) observed in the patients within the initial safety run-in segment of the study.