BioRestorative Ends Q3 In 'Strong' Financial Position, Reports Positive Data For Its Phase 2 BRTX-100 Chronic Back Pain Trial

Detroit, Michigan

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By Meg Flippin, Benzinga

BioRestorative Therapies, Inc. BRTX, a regenerative medicine company focused on stem cell-based therapies and products, is advancing toward profitability, narrowing its loss in the third quarter and releasing favorable data for its BRTX-100 treatment for chronic back pain.

The third quarter was a busy period for BioRestorative, as it secured a new patent, released what it says is encouraging trial data and continued licensing discussions with a commercial-stage regenerative medicine company – while also reducing its losses.

For the three months ending Sept. 30, 2024, BioRestorative posted an operating loss of $2.3 million, marking a 26% year-over-year improvement from $3.1 million in the same period last year. The net loss for the third quarter was $1.1 million, or $0.13 per share. BioRestorative said it ended the quarter in a "very strong financial position" with $13 million in cash and short-term investments. The company had no debt as of the end of the third quarter.

"We have continued to execute well across all areas of our business and are looking forward to continuing to update investors on our progress as we close out the remainder of 2024," says Lance Alstodt, BioRestorative's chief executive officer. "From an operating perspective, we are thrilled with our third quarter results, as we are seeing initial progress on our path to sustainable profitability, driven by cost containment activities coupled with increased resources dedicated to our commercial programs."

Commercial Programs Making Inroads

BioRestorative's commercial programs got a boost late in the quarter when it announced it obtained a provisional license from the New York State Department of Health (NYSDOH) to process, isolate, expand and preserve allogeneic (non-autologous) donor tissue, including stem cells, for medical research. Previously BioRestorative was licensed by the NYSDOH to act as a tissue bank for the processing of mesenchymal stem cells derived from autologous donors only. "It will significantly enhance our ability to develop an unrivaled clinical pipeline of off-the-shelf cell-based biologic products," says Alstodt.

Meanwhile, the company's product, ThermoStem®, which uses adipose-derived (brown fat) stem cells to generate new brown fat tissue to target obesity and metabolic disorders, drew attention during the quarter. BioRestorative shared details of the ThermoStem platform at IFATS 2024, the annual industry conference focused on adipose therapeutics and science.

BioRestorative believes cell-based therapy candidates generated from its ThermoStem program may allow for lower dosing than GLP-1 obesity drugs or provide an alternative biologic-based treatment. Studies have shown brown fat activation in addition to weight loss, can lead to positive effects on several organs, including the heart, liver and muscle. The company competes with giants like Novo Nordisk NVO, Eli Lilly LLY and Pfizer PFE in the space.

During the quarter, the Israel Patent Office issued the company a Notice of Allowance for a new patent application covering several fundamental aspects of ThermoStem. It's the 14th international patent. In addition to all that, BioRestorative continued talks for a ThermoStem licensing deal with an undisclosed commercial-stage regenerative medicine company.

BRTX-100 Data Encouraging

In conjunction with third-quarter earnings, BioRestorative released clinical data for BRTX-100, its autologous stem cell product for chronic lower back pain. It uses a patient's stem cells, which are harvested, cultured and then injected directly into the affected disc to start the repair process. It's targeted at the more than 25 million people in the U.S. who suffer from chronic lower back pain each year.

Safety and efficacy endpoints from an ongoing phase 2 trial for the treatment of chronic lumbar disc disease (cLDD) were encouraging, BioRestorative reported. The company said no serious adverse events (SAEs) were reported in any of the 10 first patients of the prospective, randomized, double-blinded and controlled study. BioRestorative said there was also no dose limiting toxicity at 26-52 weeks.

"Blinded preliminary clinical data of safety and efficacy endpoints from the ongoing phase 2 clinical trial of BRTX-100 in the treatment of cLDD are very encouraging, with patient-reported pain and function outcomes demonstrating a positive trend," said Alstodt. "Most importantly, at 26 weeks, 70% of the patients are reporting a greater than 30% increase in function and a more than 30% decrease in pain. If data continues with this trend, we are confident that we will hit our efficacy endpoints for the phase 2 trial."

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 will be randomized 2:1 to receive either BRTX-100 or a placebo. The new blinded preliminary safety and efficacy data from the ongoing phase 2 clinical trial of BRTX-100 was described in a podium presentation at the Orthopaedic Research Society (ORS) Philadelphia Spine Research Society (PSRS) 7th International Spine Research Symposium.

From posting encouraging data to narrowing its losses, BioRestorative seems to be making strides on its path to profitability. With more news to come, this may be a story worth paying attention to. To learn more about BioRestorative's stem cell therapies, click here.

Featured photo by National Cancer Institute on Unsplash.

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