MELVILLE, N.Y., Dec. 20, 2021 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (the “Company” or “BioRestorative”) (NASDAQ:BRTX), a life sciences company focused on adult stem cell-based therapies, today released the following year-end message.
As we reach the end of 2021, we are inspired by the many healthcare workers and biopharmaceutical companies that have worked to combat the COVID-19 pandemic. This year has been environmentally difficult, but we have seen incredible advancements in our sector which have reinforced the importance of our mission to become a clinical stage company. Since our emergence from Chapter 11 in 2020, we have sought to take positive steps at BioRestorative Therapies with the goal of making it a preeminent cell therapy company. During 2021, we achieved important transformational milestones, which created meaningful intrinsic value and advanced us toward our stated strategic goals.
In November of this year, we closed on a $23 million capital raise and concurrently listed our securities on the Nasdaq Capital Market. This is a very significant development as we are now fully funded to complete our Phase 2 trial for our lead clinical candidate, BRTX-100, for the treatment of chronic lumbar disc disease (CLDD.) During this process, we have attracted many new institutional fundamental investors as well as some retail investors. With that accomplished, I would like to briefly discuss the status of our programs and the opportunities that lie ahead of us.
BRTX-100 is our lead program for the treatment of CLDD, one of the leading causes of lower back pain. Our solution is a one-time injection of 40 million mesenchymal stem cells derived from a patient’s own bone marrow and expanded ex vivo before re-injection. Two things make us optimistic about this program. First, in connection with our IND filing, we referred the FDA to prior human clinical studies from different institutions that demonstrated the safety/feasibility of using mesenchymal stem cells to treat disc orders. This data not only enabled us to accelerate our clinical program and initiate a Phase 2 trial, but we believe it substantially reduces risk in offering compelling guidance on the use of cell-based interventions to treat lower back pain. Second, our manufacturing of BRTX-100 involves the use of low oxygen conditions, which ensures that the cells have enhanced survivability after introduction into the harsh avascular environment of the injured disc which has little or no blood flow. The benefits of this process are significant and are illustrated well in our recent Journal of Translational Medicine publication. Our approach is akin to transplant medicine in which specific cell types are used to replace the ones which have been lost to disease. We believe that transplanting targeted cells can offer a more attractive safety profile and potentially an improved clinical outcome. We remain optimistic that we will see significant positive clinical outcomes as we proceed with our clinical trial.
The most significant milestones we achieved in 2021 include:
- Raised $23 million of capital in a public offering, the proceeds of which will be used to execute the Phase 2 trial for CLDD, for pre-clinical research and development with respect to our ThermoStem® Program and for working capital.
- Uplisted to the Nasdaq Capital Market.
- Emerged and finalized our Chapter 11 process.
- Restructured our balance sheet, eliminating all debt and historical warrant overhang
- Became a “current” filer of SEC documents (two 10-Ks and six 10-Qs, all in 8 months)
- Renegotiated all our key vendor agreements, streamlining operations and reducing historical cash burn rates
- Were granted 6 new patents protecting novel technology for stem cell-based therapeutics
- Filed 10 new patent applications to protect novel technology related to BRTX-100
- Expanded our manufacturing facility to comply with FDA Good Manufacturing Practices (GMP) for clinical manufacturing
- Expanded our management team to provide us with the resources we need to support our growth and programs
- Expanded our Board of Directors to include a diverse set of executives with strong domain expertise and experience
- Initial research report published by analyst Elemer Piros, Ph.D., of Roth Capital Partners
Our 2022 objectives include the initiation of enrollment for our BRTX-100 clinical trial, the development of our overall product profiles via manufacturing and delivery system improvements, and the entering into of technology validation and enabling partnerships to accelerate our clinical timelines.
Some of the events and milestones that we hope to accomplish in 2022 include:
- Sign a CRO agreement with PRC Clinical related to our Phase 2 clinical trial targeting CLLD
- Complete BRTX-100 engineering runs for our Phase 2 clinical study during the first quarter of 2022
- Complete the recruitment of approximately 15 US clinical sites in the first quarter of 2022
- Complete first patient recruitment for our Phase 2 clinical study during the second quarter of 2022
- Meet with the FDA to discuss further development of the off-the-shelf brown adipose stem cell program during the first half of 2022
- Evaluate opportunities throughout 2022 for new brown adipose stem cell product candidates based on pre-clinical animal data
- Evaluate throughout 2022 partnership opportunities, the expansion of existing external collaborations and the identification of new collaborations for our off-the-shelf brown adipose stem cell program, ThermoStem®, as well as BRTX-100
- Participate in key investor and scientific industry conferences to broaden the exposure of our platforms and our strategic objectives
This is an exciting time to be part of the BioRestorative family. As we enter 2022 with a well-capitalized balance sheet to fully fund our Phase 2 trial, we look to accelerate our research and development pipeline. We do not take for granted that our technologies give us an opportunity to make a profound impact on the everyday lives of many people. We are grateful for the opportunity to validate such technologies; it is what we do and what we believe is the center of our core competencies.
Visit our website at www.biorestorative.com for more information about BioRestorative.
Thank you to the BioRestorative family for your loyalty and ongoing support.
I wish you and all those near and dear to you a wonderful Holiday Season and the very best for 2022 and beyond.
Very truly yours,
President, CEO and Chairman of the Board
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.
This letter 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 (SEC) and other filings made with the SEC. 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 letter are made as of the date hereof and the Company undertakes no obligation to update such statements.
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