Armed With Its Patent Portfolio, BioRestorative Therapies Has Success In The Laboratory And At The Negotiating Table: Is Profitability Close Behind?

September 11, 2024 at 08:35 AM EDT

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By Anthony Termini

BioRestorative Therapies (NASDAQ: BRTX) is a clinical-stage biotechnology company involved in various clinical trials involving its patented approach for using stem cell therapy to treat a number of disorders. The company has, in recent months, issued updates on its earnings and operations, and it is developing a promising treatment program to treat diabetes and obesity.

Quarterly Report Highlights

The company issued its second quarter 2024 business update in August, and a number of announcements accompanied their reported financials.

BioRestorative announced that preliminary clinical data related to its “Disc/Spine Program” showed meaningful signals and no notable safety markers in patients enrolled in a clinical study of BRTX-100 as a treatment for chronic lumbar disc disease.

Also, following manufacturing/clinical process enhancements made by BioRestorative that tripled its monthly trial capacity, it guided that it was targeting completion of patient enrollment in the phase 2 BRTX-100 study in chronic lumbar disc disease (cLDD) by the end of 2024. The company also plans to provide additional preliminary data updates by then.

Furthermore, BioRestorative said that it has also laid the foundation for the commercialization of its BioCosmeceuticals business, which could begin generating significant revenues this year. The company noted that it inked an agreement to supply its proprietary cell-based biologic serum to Cartessa Aesthetics, LLC.

An analysis of the company’s June 30, 2024 Form 10-Q revealed a 19% improvement in year-over-year operations, with net loss narrowed to $2.5 million compared to a $3.1 million loss in the prior period. BioRestorative’s balance sheet showed some $14.7 million on hand at the end of June.

Lance Alstodt, BioRestorative’s Chief Executive Officer, noted that these accomplishments “will provide additional financial flexibility” and bolster the company’s strategy to execute and accomplish important long-term goals.

The quarterly report also discussed BioRestorative’s expansion of its core preclinical program for ThermoStem®.

“Metabolic Program” Addresses Important And Lucrative Markets

One of the more significant opportunities that BioRestorative is pursuing is related to its ThermoStem platform. Currently in preclinical testing, the intended therapy is to target obesity and metabolic disorders (like diabetes) using stem cells to generate a type of body fat that regulates metabolic homeostasis.

A recent report from the Centers for Disease Control and Prevention demonstrates that nearly 42% of adults in the United States suffer from obesity. Those diagnosed with severe obesity were just over 9%.

Furthermore, research conducted at Harvard University and George Washington University concluded that “adults with obesity spend an average of $1,861 more a year on medical costs than someone who doesn’t have obesity. People with severe obesity spend an average of $3,097 more.”

According to investment firm Goldman Sachs, the worldwide market for obesity drugs could be $100 billion by 2030. And there is a link between obesity and diabetes.

The American Heart Association says that obesity contributes to up to half of new diabetes cases annually in the United States. Treating this disease also represents a significant market opportunity for BioRestorative.

Precedence Research expects the global diabetes drug market to reach about $132 billion by 2034. The combined market for obesity and diabetes drugs creates a significant opportunity for BioRestorative’s ThermoStem over the next decade.

It is important to note that ThermoStem is not restricted to being only a standalone treatment. It may be used with drugs like Novo Nordisk’s (NYSE: NVO) Ozempic or Wegovy, or Eli Lilly’s (NYSE: LLY) Mounjaro, which are already approved for use to treat both obesity and diabetes.

“We believe that ThermoStem has immense potential to develop both best-in-class and first-in-class therapies,” said Alstodt.

Other Developments Related To BioRestorative’s Intellectual Property Portfolio

Also accompanying BioRestorative’s business update announcement were comments related to its broad intellectual property portfolio.

Previously published data from a study conducted at the University of Utah School of Medicine showed significant reductions in weight, triglyceride, and blood glucose levels compared to controls. The study also demonstrated that BioRestorative’s 3D scaffold was capable of retaining viable transplanted cells for at least five weeks post-implantation.

In June, BioRestorative published a press release announcing that it had received notice of allowance from the Japanese Patent Office for a patent application related to ThermoStem. This is the fifth Japanese patent issued for the ThermoStem technology platform.

“We are proactively expanding the already formidable ThermoStem intellectual property estate to help ensure long-term market exclusivity…” and “…this is demonstrated by this new patent allowance,” Alstodt remarked.

The company also announced that it is currently involved in substantive discussions with at least one (undisclosed) regenerative medicine company regarding ThermoStem licensing. This, along with the Cartessa agreement, is why the company said that it “is poised to potentially enter into a stage of anticipated rapid growth.”

Featured photo by qimono on Pixabay.

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