BioRestorative Therapies Announces Compliance with SEC Reporting Requirements and “Stop Sign” Removal

Rhea-AI Summary

BioRestorative Therapies, Inc. (OTC: BRTX) announced the filing of its Annual Report on Form 10-K for 2020, achieving compliance with SEC requirements. This filing removed the 'stop sign' from its OTC profile, indicating current public information availability. CEO Lance Alstodt expressed optimism regarding the company's positioning for funding opportunities for its phase 2 clinical trial and advances in its metabolics program. The company emphasizes a focus on clinical programs to drive future value for shareholders.

Positive

• Achieved SEC compliance, removing the 'stop sign' from OTC Markets.
• Positioned to pursue funding for phase 2 clinical trial approved by FDA.
• Reduced monthly burn rate through organizational restructuring.
• Recapitalized balance sheet for flexible future funding opportunities.

Negative

• None.

MELVILLE, N.Y., May 03, 2021 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the “Company” or “BioRestorative”) (OTC: BRTX), a life sciences company focused on stem cell-based therapies, today announced that it has filed its Annual Report on Form 10-K for the year ended December 31, 2020 and, as a result, is now current in its SEC periodic filings. The filing of the Form 10-K has resulted in the removal of the “stop sign” from the OTC Markets website with regard to the Company, indicating that BioRestorative now has current public information available.

Lance Alstodt, Chairman and CEO, stated “I am very excited that, after only 5 months post- Chapter 11, we are now current in all of our reporting requirements with the SEC. It is a testament to the execution of our team and advisors, having met an aggressive timetable in achieving this meaningful milestone. We believe that we are now very well positioned to pursue funding opportunities to initiate our phase 2 clinical trial, which the FDA has granted us approval to begin. Additionally, we will advance our metabolics program simultaneously, continuing to build fundamental value within our two platform technologies.

The Company is now at a critical inflection point where value creation should largely be tied to the advancement of our clinical programs. I’m pleased with our team’s discipline and focus, accomplishing so much in a short period of time. Among the many goals we have met: we have right sized the organization with a more efficient infrastructure reducing our monthly burn rate; we have recapitalized our balance sheet to include a more flexible set of future funding opportunities; and we have added to our team of experts and advisors to match our challenges with the right set of human resources. Leveraging all of these corporate activities will position BioRestorative as a biotechnology company with many future operational/clinical catalysts to drive value to our shareholders. I’m passionate about our technology and our ability to prove and validate what could be paradigm shifting events in the sectors where we focus.”

Francisco Silva, Vice President of Research and Development, added, “Achieving full reporting compliance was an important milestone for the company; we can now turn our attention to initiating our clinical programs. We expect to address in-house clinical manufacturing capabilities for both our ThermoStem® metabolic and BRTX-100® disc/spine programs. We look forward to achieving our clinical targets and driving value based on clinical catalysts”.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

• 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 received authorization from the Food and Drug Administration to commence 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 a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). 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.

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 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:
Email: ir@biorestorative.com

FAQ

What does the filing of the Form 10-K mean for BRTX?

The filing indicates that BioRestorative Therapies has achieved current compliance with SEC reporting, which positively impacts its market standing.

What clinical trial is BRTX planning to initiate?

BRTX plans to initiate a phase 2 clinical trial for its lead product BRTX-100, targeting chronic lower back pain.

How has the financial position of BioRestorative Therapies improved?

The company has recapitalized its balance sheet and reduced its monthly burn rate, enhancing its financial stability.

What are the main focuses of BioRestorative Therapies post-10-K filing?

The company will focus on advancing its clinical programs and seeking funding opportunities.

What technologies are being developed by BioRestorative Therapies?

The company is developing therapies targeting disc/spine disease with BRTX-100 and obesity/metabolic disorders with ThermoStem®.