BioRestorative Therapies Stock

BioRestorative Therapies, Inc. develops therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells.

The company is pursuing its Disc/Spine Program with its initial investigational therapeutic product being called BRTX-100. In March 2022, a United States patent issued in the company’s Disc/Spine Program. The company submitted an IND application to the U.S. Food and Drug Administration, or the FDA, to obtain authorization to commence a Phase 2 clinical trial investigating the use of BRTX-100 in the treatment of chronic lower back pain arising from degenerative disc disease. The company has received such authorization from the FDA and has commenced such clinical trial.

The company has obtained an exclusive license to use technology for investigational adult stem cell treatment of disc and spine conditions, including protruding and bulging lumbar discs.

The company is also developing its ThermoStem Program. This pre-clinical program involves the use of brown adipose (fat) in connection with the cell-based treatment of type 2 diabetes and obesity, as well as hypertension, other metabolic disorders and cardiac deficiencies. Patents related to the ThermoStem Program have been issued in the United States and other jurisdictions.

The company develops therapeutic products, using cell and tissue protocols, primarily involving adult stem cells. The company’s two core programs, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDisc): The company’s lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells, or MSCs, collected from the patient’s bone marrow. The company intends that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complimentary 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-surgical procedures and who potentially face the prospect of surgery. The company has received authorization from the FDA to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease. The company has commenced such clinical trial through the execution of a CRO agreement with PRC Clinical, the execution of clinical trial site agreements, patient enrollment, the commencement of patient procedures, the purchase of manufacturing equipment and the expansion of its laboratory to include capabilities for clinical production. In March 2022, a United States patent related to the company’s Disc/Spine Program was issued. The company has been granted exclusive license rights with regard to the patent.

Metabolic Program (ThermoStem): The company is developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells, or BADSC, to generate brown adipose tissue, or BAT. The company refers to this as its ThermoStem Program.

The company has also licensed an investigational curved needle device designed to deliver cells and/or other therapeutic products or material to the spine and discs (and other parts of the body). The company anticipates that FDA approval or clearance will be necessary for this device prior to commercialization.

The company has developed a mesenchymal stem cell product candidate, BRTX-100, derived from autologous (or a person’s own) human bone marrow, cultured and formulated, in a proprietary method, specifically for introduction into a painful lumbar disc. The product candidate was developed utilizing in part the exclusive license under Exclusive License.

The company submitted an IND application to the FDA to obtain authorization to commence a Phase 2 clinical trial investigating the use of BRTX-100, its lead cell therapy candidate, in the treatment of chronic lower back pain arising from degenerative disc disease. The company received such authorization from the FDA in February 2017. The company has commenced its Phase 2 clinical trial through the execution of a CRO agreement with PRC Clinical, the execution of clinical trial site agreements, patient enrollment, the commencement of patient procedures, the purchase of manufacturing equipment and the expansion of its laboratory to include capabilities for clinical production.

In addition to developing BRTX-100, the company seeks to sublicense the technology to a strategic third party, who may assist in gaining FDA approval for a lumbar disc indication, or third parties for use in connection with cellular-based developmental programs with regard to disc and spine related conditions.

The company has established a laboratory, which includes a clean room facility, to perform the production of cell products (including BRTX-100) for use in its clinical trials, for third party cell products or for general research purposes.

In March 2022, a United States patent related to BRTX-100, was issued. The company has been granted exclusive license rights with respect to the patent.

BRTX-100

The company’s lead product candidate, BRTX-100, is an autologous hypoxic (low oxygen) cultured mesenchymal stem cell product derived from a patient’s own bone marrow and formulated with a proprietary biomaterial carrier (platelet lysate) to increase potency, viability and survivability. The company has designed the cryopreserved sterile cellular product candidate to be provided in vials for injection into painful lumbar discs.

In September 2021, the company was awarded a National Institutes of Health Small Business Technology Transfer (STTR) Phase 1 grant to evaluate the therapeutic effects on its hypoxic cultured bone marrow derived mesenchymal stem cells (BRTX-100) after encapsulation with a PEG-peptide hydrogel. The work is being done in collaboration with Washington University of St. Louis.

Pursuant to the company’s license agreement with Regenerative Sciences, LLC, or Regenerative, that became effective in April 2012, or the Regenerative License Agreement, it has obtained, among other things, a worldwide (excluding Asia and Argentina), exclusive, royalty-bearing license from Regenerative to utilize or sublicense a certain method for culturing cells for use in its developmental program involving disc and spine conditions, including protruding or painful discs and the treatment of avascular zones. The investigational technology that has been licensed is an advanced stem cell culture and injection procedure that may offer relief from lower back pain, buttock and leg pain, and numbness and tingling in the leg and foot.

The patents that are the subject of the Regenerative License Agreement have been assigned to Regenexx, LLC which the company has been advised by Regenerative is an affiliate of Regenerative.

The company submitted an IND application to the FDA to obtain authorization to commence a Phase 2 clinical trial investigating the use of BRTX-100, its lead cell therapy candidate, in the treatment of chronic lower back pain arising from degenerative disc disease. The company has received such authorization from the FDA. The company has commenced its Phase 2 clinical trial through the execution of a CRO agreement with PRC Clinical, the execution of clinical trial agreements with 11 sites, patient enrollment, the commencement of patient procedures, the purchase of manufacturing equipment and the expansion of its laboratory to include capabilities for clinical production.

In March 2018, the company engaged Defined Health, a business development and strategy consulting firm, to conduct an independent review of BRTX-100. Defined Health has worked with many of the leading companies in the pharmaceutical, biotech and healthcare industries for over 25 years.

Since June 2011, the company has been engaging in pre-clinical research efforts with respect to an investigational platform technology utilizing brown adipose (fat) derived stem cells, or BADSCs, for therapeutic purposes. The company has labeled this initiative its ThermoStem Program.

The company is developing a cell-based product candidate to target obesity and metabolic disorders using BADSCs. The company has isolated and characterized a human multipotent stem cell population that resides within BAT depots. The company focuses on the development of treatment protocols that utilize allogeneic cells.

In June 2012, the company entered into an Assignment Agreement with the University of Utah Research Foundation, or the Foundation, and a Research Agreement with the University of Utah, or the Utah Research Agreement. Pursuant to the Assignment Agreement, which provides for royalty payments, the company acquired the rights to two provisional patent applications that relate to human brown fat cell lines.

In February 2019, the company entered into a Services Agreement with the University of Utah pursuant to which the university has been retained to provide research services with regard to the ThermoStem Program. Pursuant to this agreement, the company will initiate preclinical models to study the efficacy of its generation 2 encapsulated brown adipose tissue construct.

In February 2014, the company’s research with regard to the identification of a population of brown adipose derived stem cells was published in Stem Cells, a respected stem cell journal.

In March 2014, the company entered into a Research Agreement with Pfizer Inc., a global pharmaceutical company. Pursuant to the Research Agreement with Pfizer, the company was engaged to provide research and development services with regard to a joint study of the development and validation of a human brown adipose cell model.

In August 2015, the company entered into a one year research collaboration agreement with the University of Pennsylvania with regard to the understanding of brown adipose biology and its role in metabolic disorders. In September 2018, the company entered into a one year research collaboration agreement with the University of Pennsylvania pursuant to which the university was provided access to its proprietary brown adipose tissue cells for research purposes.

In September 2015, a United States patent related to the ThermoStem Program was issued to the company.

In April 2017, an Australian patent related to the ThermoStem Program was issued to the company.

In December 2017, a Japanese patent related to the ThermoStem Program was issued to the company.

In January 2019, a United States patent related to the ThermoStem Program was issued to the company.

In October 2019, an Australian patent related to the ThermoStem Program was issued to the company.

In October 2019, an Israeli patent related to the ThermoStem Program was issued to the company.

In March 2020, a United States patent related to the company ThermoStem Program was issued to it.

In March 2020, the company’s collaboration with the University of Pennsylvania resulted in a publication in Cell Reports, a respected peer reviewed journal, with regard to its ThermoStem Program.

In April 2020, a European patent related to the company’s ThermoStem Program was issued to it. This European patent was validated in Belgium, France, Germany, Italy, Poland, Spain, Sweden, Switzerland, and the United Kingdom.

In May 2020, an Israeli patent related to the company’s ThermoStem Program was issued to it.

In January 2021, a European patent related to the company’s ThermoStem Program was issued to it. This European patent was validated in France, Germany, Italy, Spain, and the United Kingdom.

In March 2021, a United States patent related to the company’s ThermoStem Program was issued to it.

In June 2021, a Japanese patent related to the company’s ThermoStem Program was issued to it.

In July 2021, a United States patent related to the company’s ThermoStem Program was issued to it.

In August 2021, an Australian patent related to the company’s ThermoStem Program was issued to it.

In February 2022, a Japanese patent related to the company’s ThermoStem Program was issued.

In March 2022, an Israeli patent related to the company’s ThermoStem Program was issued.

In December 2022, the company announced that it was awarded a Small Business Innovation Research (SBIR) Phase 1 grant from Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health to enable the development and the evaluation of its ThermoStem Program for the treatment of polycystic ovary syndrome (PCOS).

In February 2023, a notice of allowance was issued by the European Patent Office for a patent application related to the company ThermoStem Program.

In February 2023, a notice of allowance was issued by the United States Patent Office for a patent application related to the company’s ThermoStem Program.

The company has completed proof of concept preclinical animal studies using its first generation brown adipose derived stem cells.

In the company’s Disc/Spine Program, twelve patent applications have been filed with regard to technology that is the subject of the Regenerative License Agreement. Regenerative has been issued a patent from one of these applications with regard to its curved needle therapeutic delivery device. This patent expires in March 2031. In addition, in March 2022, a United States patent related to BRTX-100 was issued. This patent expires in December 2029. The other ten applications remain pending. The patents that are the subject of the Regenerative License Agreement have been assigned to Regenexx, LLC which the company has been advised is an affiliate of Regenerative.

In its ThermoStem Program, the company has three pending United States patent applications and five United States patents within three patent families. Three of the patents expire in June 2032 and two of the patents expire in April 2034. With regard to the first patent family in the ThermoStem Program, patent applications have been filed in five foreign jurisdictions (of which four applications have been granted as foreign patents and one application has lapsed). The patents expire in June 2032. With regard to the second patent family in the ThermoStem Program, patent applications have been filed in four foreign jurisdictions (of which four applications have been granted as foreign patents). The patents expire in April 2034. With regard to the third patent family in the ThermoStem Program, patent applications have been filed in four foreign jurisdictions.

The company’s patent applications and those of Regenexx, LLC are in prosecution (i.e.,it and Regenexx, LLC are seeking issued patents).

In March 2014, the company entered into a Research and Development Agreement with Rohto Pharmaceutical Co., Ltd., a Japanese pharmaceutical company, or Rohto. Pursuant to the Research and Development Agreement with Rohto, it was engaged to provide research and development services with regard to stem cells. The agreement with Rohto expired upon the completion of the services provided for therein.

The company has secured registrations in the U.S. Patent and Trademark Office for various trademarks. Including BRTX-100, THERMOSTEM, and BRTX.

The Dragonfly Logo is also registered with the U.S. Copyright Office.

The company also has federal common law rights in the trademark BioRestorative Therapies and other trademarks and trade names used in the conduct of its business that are not registered.

Research and Development

During the year ended December 31, 2022, the company incurred $3,513,352 in research and development expenses.

Material Events During 2022

In February 2022, the company announced that it had initiated the site selection process for its active Phase 2 clinical trial targeting chronic lumbar disc disease. As of December 31, 2022, the company had identified 17 sites in various cities in the United States and clinical trial agreements with 11 of such sites are in place.

In March 2022, an Israeli patent related to the company’s ThermoStem Program was issued to it.

In March 2022, a United States patent related to BRTX-100, the company’s lead cell therapy candidate, was issued. The company has been granted exclusive license rights with regard to the patent.

In April 2022, the company announced that it had completed the testing and certification of its clinical grade cell therapy manufacturing facility.

In June 2022, the company announced that the first patient had been enrolled in its Phase 2 clinical trial evaluating the safety and efficacy of BRTX-100.

In December 2022, the company entered into an agreement with Regenexx, LLC pursuant to which the license rights granted by Regenexx to it for intellectual property developed to address chronic lumber disc disease have been made exclusive.

In December 2022, the company announced that it were awarded a Small Business Innovation Research (SBIR) Phase 1 grant from Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health to enable the development and evaluation of its ThermoStem Program for the treatment of polycystic ovary syndrome (PCOS).

Materials Events During 2023

In February 2023, a notice of allowance was issued by the European Patent Office for a patent application related to the company’s ThermoStem Program.

In February 2023, a notice of allowance was issued by the United States Patent Office for a patent application related to the company’s ThermoStem Program.

Governmental Regulation

The laws and regulations pertaining to the company’s business include FDA regulation of stem cell treatment and products; human cells, tissues, and cellular and tissue-based products regulation; drug and biological product regulation; FDA expedited review programs; medical device regulation; current good manufacturing practices and other FDA regulations of cellular therapy products; Federal Regulation of Clinical Laboratories; Health Insurance Portability and Accountability Act—Protection of Patient Health Information; and Foreign Government Regulation.

History

The company was incorporated in Nevada in 1997. The company was formerly known as Columbia River Resources Inc. and changed its name to Traxxec Inc. in 2008; and then to Stem Cell Assurance, Inc. in 2009. Further, the company changed its name to BioRestorative Therapies, Inc. in 2011. Effective January 1, 2015, the company reincorporated in Delaware.