MELVILLE, NY / ACCESSWIRE / September 18, 2023 / BioRestorative Therapies Inc. (NASDAQ:BRTX) ('BioRestorative') is a clinical-stage biotech company that is developing cell-based therapies to treat chronic lumbar disc disease and metabolic conditions such as obesity and diabetes. The company is focusing on developing BRTX-100, its lead therapeutic candidate for the treatment of patients with chronic lower back pain caused by degenerative disc disease. This technology involves using the patient's own stem cells to regenerate damaged discs in the lower back, potentially reducing pain and improving mobility. BioRestorative is also developing ThermoStem(R), an off-the-shelf cell-based therapeutic designed to help people with metabolic disorders such as obesity and diabetes.
Roth MKM recently released a report highlighting the company and sharing that they believe the company has an undeserved low valuation and they project that the company's stock price will hit $15 over the next 12 months, as compared to the current $2.59 as of the report's publication.
As of the second quarter of 2023, the company had pro forma cash of $13.4 million, which is projected to be sufficient to fund operations. Additionally, the company has an at-the-market facility in place, with $3.7 million available for use. However, as of mid-2023, only $3.3 million of this facility remains unused.
In June, BioRestorative received a unanimous recommendation from the DSMB (Data and Safety Monitoring Board) to continue its Phase 2 trial for evaluating BRTX-100 in patients with chronic lumbar disc disease (cLDD). Importantly, no dose-limiting toxicities were observed among the four safety run-in patients. This positive outcome paves the way for enrolling the next 95 cLDD patients, allowing for a meaningful evaluation of the therapy's efficacy.
According to the report by Roth MKM, BioRestorative has positioned itself well for future growth. The company has made significant efforts to ramp up its manufacturing and quality control capacity, hiring four senior scientists for these important roles. This move indicates that the company expects a substantial increase in demand for its product pipeline, especially BRTX-100.
The increased demand is expected to come from several sources. BioRestortative anticipates an acceleration in Phase 2 enrollment starting in the second half of 2023. Additionally, the company plans to file Investigational New Drug (IND) applications for other indications and collaborate with highly enthusiastic investigators for investigator-initiated trials (IITs) in indications outside of cLDD. While some IIT sites may overlap with Phase 2 sites, they will focus on different indications, ensuring that patients who qualify for the cLDD trial are not diverted to other studies.
Furthermore, Roth MKM believes that BioRestorative will be able to expand its intellectual property rights by making advancements in generating stem cells through a more proprietary method. This progress would enhance the company's commercial economics, pending approval.
In May, the company obtained a license from the New York State Department of Health to serve as a tissue bank for processing mesenchymal stem cells from autologous donors. In 2022, the global mesenchymal stem cell market was worth $2.7 billion, and it is expected to grow at a CAGR of 12.8% from 2023 to 2030. The granted license positions BioRestorative as even more of a leader in the stem cell space - in a market growing by a double-digit percentage.
BioRestorative can expand its clinical operations to meet the demand for investigator-initiated trials of BRTX-100 and potential 'right to try' uses of autologous cellular therapy. The company has made significant strides in New York, including an agreement with Northwell Health to add its sites as trial sites for cLDD, demonstrating progress within the state.
Overall, Roth MKM's report indicates that BioRestorative Therapies is strategically positioning itself for future growth by expanding manufacturing capacity, anticipating increased demand for BRTX-100, and making advancements in intellectual property. The company's licensing agreement with the New York State Department of Health and collaboration with Northwell Health further enhance its clinical operations and potential for advancement in the BRTX-100 Phase 2 trial.
Other companies competing in the cell-based biologics or chronic pain treatment space include Mesoblast, Brainstorm Cell Therapeutic and Longeveron.
To learn more about BioRestorative, visit its website.
SOURCE: BioRestorative Therapies, Inc.
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