BRTX stock moved 35% higher in early trade on December 22, 2021, after the company announced plans to start a phase 2 clinical trial for its degenerative disc diseases product.
BioRestorative Therapies Announces CRO Agreement with PRC Clinical for its BRTX-100 Phase 2 Clinical Trial to Treat Chronic Lumbar Disc Disease
On December 21, 2021, BioRestorative Therapies, Inc. (NASDAQ:BRTX), a life sciences company focused on adult stem cell-based therapies, today announced it has entered into a Master Service Agreement with PRC Clinical, a contract research organization (CRO) specializing in clinical trial management to conduct BioRestorative’s Phase 2 clinical trial.
PRC Clinical is an all-inclusive CRO and has specialized expertise across regenerative medicine, CNS, ophthalmology, pulmonary and COVID-19, rare and orphan disease and more complex indications. Their innovative approach to executing studies for biotech and pharmaceutical companies combines high-touch human elements and cutting-edge technology with extensive experience and deep therapeutic knowledge. Pursuant to the agreement, PRC Clinical will manage BioRestorative’s Phase 2 clinical study of BRTX-100, the Company’s lead clinical product to treat chronic lumbar disc disease.
“This is a significant milestone in our mission to develop cell-based therapeutics and to become a clinical stage company. We believe that PRC’s renowned expertise in conducting clinicals trials and their use of innovative technology makes them an excellent CRO to partner with,” said Lance Alstodt, Chief Executive Officer of BioRestorative Therapies. “This is the most meaningful step the Company has taken to initiate our clinical trial. We should now expect a host of developments pertaining to the advancement of our clinical trial, ultimately leading to the read out of our primary endpoints.”
📺 VIDEO Regenerative Biology For Healthier Lives | 1:1 w/ Lance Alstodt, BioRestorative, CEO
BioRestorative Therapies, Inc. (NASDAQ:BRTX) was on the James Hicks “NewMedia Show” on December 21, 2021.
“It’s an honor to be invited on the NewMedia Show with James Hicks. I have followed his programming and I’m very impressed with the format of the show and the reach that he has within his community. I look forward to the opportunity to tell our story, review our 2021 accomplishments as well as provide an update for the coming year,” said Lance Alstodt, CEO of BioRestorative Therapies.
BioRestorative Therapies files ten patent applications for lumbar disc disease
On December 2, 2021, BioRestorative Therapies has filed ten patent applications related to its BRTX-100 program for treating chronic lumbar disc disease with the USPTO. These patent applications cover methodologies used to generate BRTX-100, a stem cell-based therapeutic engineered to treat patients suffering from chronic lumbar disc disease. BioRestorative currently is authorized by the FDA to commence a Phase 2 clinical trial using BRTX-100.
BioRestorative Therapies, Inc. Releases Year-End Message
On December 20, 2021, BioRestorative Therapies, Inc. 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 sheetThe balance sheet is a snapshot of a company's financial position at a specific point in time. It shows the company's assets, liabilities, and equity., 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
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