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BioRestorative Therapies Inc (OTCMKTS: BRTX) Surges Over a Penny on Renewed Interest

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BioRestorative Therapies Inc (OTCMKTS: BRTX) is amking a strong move up the charts in recent days since a brief dip below the $0.01 mark after successfully emerging from chapter 11 reorganization.

BioRestorative Therapies 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. BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow.

BioRestorative Therapies Inc (OTCMKTS: BRTX) 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™): Its 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.

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. The Company 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.

BioRestorative owns a valuable intelectual property portfolio including  unique international Stem Cell patents as well as 8 patents issued, in the United States and other countries, for the Company’s brown fat technology related to BioRestorative’s metabolic program (ThermoStem® Program).

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In a letter to shareholders on January 5 BRTX CEO Lance Alstodt stated to shareholders:  As you may already know, on November 16, 2020, we successfully emerged from chapter 11 reorganization. This process was 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 were met for us to emerge. Allowed creditor claims have been 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.

Focus and intensity will be the way we approach all of our corporate activities. In our immediate future, we will focus on setting realistic, measurable goals and executing upon them. Looking ahead, we have identified three critical strategic goals: getting current with our SEC filings; advancing our scientific programs; and streamlining our organization to maximize efficiencies.

Our first priority is to become current with our SEC filings. Our latest filed periodic report is the September 30, 2019 10-Q; therefore, we will need to file our 2019 10-K, our 2020 10-Qs and our 2020 10-K (which is not due until March 31, 2021). Much work needs to be done, but with our team of accountants, auditor and attorneys, we expect to return to a current status by early next year. Discussions with the SEC have provided us with the information necessary to create a clear and thoughtful pathway to executing on this process. We expect to file our 2019 10-K in February 2021, our 2020 10-Qs in March 2021 and our 2020 10-K timely in 2021 (giving effect to the 15 day extension afforded by the SEC’s rules). Not only would that bring us current, but it would also trigger, pursuant to the confirmed plan of reorganization, a milestone funding obligation from the company that provided the debtor-in-possession (DIP) financing to us during the chapter 11 process. The amount of the funding is to be $3.5 million less the sum of the approximately $1.2 million of DIP financing provided during the reorganization and the costs incurred by the DIP funder.

At the same time, we are looking to advance our scientific programs. We hope to have our cGMP manufacturing facility completed during the first half of 2021. This facility will be used to manufacture BRTX-100, our lead clinical product for our Phase 2 clinical trial. With in-house cGMP manufacturing capabilities, we will be able to coordinate with our contract research organization (CRO) and initiate our trial, transitioning us into a clinical stage company. During 2021 we expect to finalize the pre-clinical work for our brown fat program and file a drug master file (DMF) with the FDA. This would allow us to file an investigational new drug (IND) application giving BioRestorative Therapies two active clinical programs.

Although we remain focused on our efforts to take BRTX-100 to the clinical trials, we plan on leveraging our cellular therapy platform by working with our product pipeline and expanding our programs, targeting new indications that address unmet medical needs.

In terms of streamlining our operations, we have begun to renegotiate key contracts with service vendors, both operational and professional, that impact our overhead. We have analyzed our human resource needs and will outsource some of the key positions to better match the resource with the business need. We intend to reduce near-term executive cash-based salaries to better align our team with investors. The successful implementation of such programs will ensure that we are operating more characteristically like a start up emerging growth biotech company, all with a healthier and cleaner balance sheet affording us a slower burn and an optimized infrastructure.

We are committed to making 2021 a landmark year by developing our programs, including the initiation of our Phase 2 clinical trial with BRTX-100. We will continue to focus on bringing our products to market as quickly as possible.  We will also continue to seek to solidify our relationships within the industry, and build upon our existing strong research collaborations with academic leaders.

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According to management: “Our first priority is to become current with our SEC filings. Our latest filed periodic report is the September 30, 2019 10-Q; therefore, we will need to file our 2019 10-K, our 2020 10-Qs and our 2020 10-K (which is not due until March 31, 2021). Much work needs to be done, but with our team of accountants, auditor and attorneys, we expect to return to a current status by early next year. Discussions with the SEC have provided us with the information necessary to create a clear and thoughtful pathway to executing on this process. We expect to file our 2019 10-K in February 2021, our 2020 10-Qs in March 2021 and our 2020 10-K timely in 2021 (giving effect to the 15 day extension afforded by the SEC’s rules). Not only would that bring us current, but it would also trigger, pursuant to the confirmed plan of reorganization, a milestone funding obligation from the company that provided the debtor-in-possession (DIP) financing to us during the chapter 11 process. The amount of the funding is to be $3.5 million less the sum of the approximately $1.2 million of DIP financing provided during the reorganization and the costs incurred by the DIP funder.” We will be updating on BioRestorative when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with BioRestorative.

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Disclosure: we hold no position in BRTX either long or short and we have not been compensated for this article.

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