BioRestorative is back on track with stem cell therapy programs
“Stop Sign” Removal
BioRestorative Therapies, Inc., a life sciences company focused on stem cell-based therapies to address unmet needs in patients with highly prevalent conditions, has filed its Annual Report on Form 10-K for the year ended December 31, 2020. As a result, the company 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, meaning that BioRestorative now has current public information available.
According to Lance Alstodt, chairman and CEO, “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.
He added, “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, commented, “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.”
BioRestorative Therapies is actively developing programs that aim to dramatically increase quality of care for both chronic back pain caused by disc degeneration and metabolic disorders including obesity and diabetes. It is initiating expansion of its Melville, New York based research laboratories to include capabilities for the clinical production of the company’s pipeline of clinical and investigational cell therapy candidates.
“We look forward to expanding our current research and development operations to include clinical manufacturing, a necessary step to initiate our Phase 2 clinical trial for our novel Disc/Spine program,” Alstodt said. “The ability to control internal clinical grade cell manufacturing capacity is critical in order to support multiple product manufacturing for our two programs: BRTX -100 and our allogeneic ThermoStem® metabolic program. Additionally, this capability will allow us to advance our proprietary technologies and begin first in man clinical studies with our collaborative clinical partners.”
The cGMP facility will include process development space, ISO 7 cleanrooms and state-of-the-art scientific equipment. As the manufacturing facility becomes fully operational, the Company expects to hire additional full-time employees. The new facility is being designed to provide cGMP manufacturing according to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations and guidelines to support clinical grade cell production.
In November BioRestorative’s amended joint plan of reorganization became effective, and it emerged from Chapter 11 reorganization. Pursuant to the confirmed plan of reorganization, the company received $3,848,000 in financing. The confirmed plan of reorganization also provides for additional funding, subject to certain conditions, of $3,500,000 less the sum of the debtor-in-possession financing provided to the company during the reorganization (approximately $1,227,000) and the costs incurred by the debtor-in-possession lender.
Alstodt was appointed the company’s president, chief executive officer and chairman of the board. He said, “This process has been a long and challenging journey for the Company. I’m inspired by the great resolve and execution from our employees, professionals and investors. We are very pleased that all requirements have been met for us to emerge. Allowed creditor claims have been fully satisfied and, as importantly, our equity holders have retained their shares in this exciting new opportunity. We were able to preserve all of our intellectual property assets and look forward to initiating our Phase 2 clinical trial.”
Based upon the company’s emergence from Chapter 11 reorganization, FINRA removed the “Q” at the end of its trading symbol. Shareholders did not need to exchange their shares for new shares.
BioRestorative Therapies develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Its lead cell therapy candidate, BRTX-100, is a product formulated from autologous cultured mesenchymal stem cells collected from the patient’s bone marrow. The product will be used for the non-surgical treatment of painful lumbosacral disc disorders.
The BRTX-100 production process uses 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. BioRestorative has received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs.
The company is also developing a cell-based therapy 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 the body 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.
BioRestorative received a Notice of Allowance on its patent application for a method of generating brown fat stem cells from the Israeli Patent Office in 2019. This is the eighth patent issued, in the United States and other countries, for the company’s brown fat technology related to BioRestorative’s metabolic program (ThermoStem® Program).
Once issued in Israel, the final patent will allow for a method of isolating and differentiating a non-embryonic human brown adipose-derived stem cell into functional human brown adipocytes and a method of identifying compounds that modifies metabolic activity of human brown adipocytes. The technology is applicable for potential therapeutic uses for treating a wide range of degenerative and metabolic disorders, including but not limited to diabetes, obesity, hypertension and cardiac deficiency.