Clinical Trials and Product Development - The company received FDA authorization to commence a Phase 2 clinical trial for BRTX-100, targeting chronic lower back pain from degenerative disc disease[17]. - The company submitted an IND application to the FDA for a Phase 2 clinical trial of BRTX-100, targeting chronic lower back pain from degenerative disc disease, with authorization received in February 2017[48]. - The Phase 2 clinical trial will involve 99 patients, randomized 2:1 for BRTX-100 to control, with a primary efficacy endpoint at 12 months[64]. - BRTX-100 is designed to deliver approximately 40 million mesenchymal stem cells per dose, with a focus on enhancing viability and therapeutic potential[52]. - The production process for BRTX-100 takes approximately five weeks, including three weeks for cell culturing and two weeks for quality control testing[55]. - The animal study showed BRTX-100 resulted in a statistically significant increase in disc height and improvement in disc histology compared to the control group at day 120[62]. - The company is pursuing its Disc/Spine Program with the investigational therapeutic product BRTX-100, for which it has received FDA authorization to commence a Phase 2 clinical trial[200]. Financial Overview and Funding Needs - The company anticipates requiring approximately $12 million in financing to complete the Phase 2 clinical trial for BRTX-100 and an additional $45 million for further clinical trials[42]. - The company has received a total of $5,038,961 in financing, including $1,189,413 in debtor-in-possession financing during Chapter 11 reorganization[22]. - As of December 31, 2020, the accumulated deficit of the company was $89,842,833 and the stockholders' deficit was $1,331,492[203]. - The company anticipates requiring approximately $12,000,000 in financing to complete a Phase 2 clinical trial for its Disc/Spine Program, and an additional $45,000,000 for further clinical trials[207]. - The company reported a loss from operations of $(2,752,076) for the year ended December 31, 2020, compared to a loss of $(8,432,005) in 2019[210]. Market Opportunity and Competitive Landscape - Approximately 25 million American adults suffer from chronic lower back pain, with 12 million diagnosed with disc degeneration, highlighting a substantial market opportunity[45]. - The total annual healthcare costs related to pain in the U.S. are estimated at $600 billion, highlighting the market potential for effective treatments like BRTX-100[72]. - The competitive landscape includes companies developing therapies for obesity and diabetes, indicating a broad market for regenerative medicine[116]. - The company believes its product candidate BRTX-100 has competitive advantages over Mesoblast's product due to its use of autologous cells and a streamlined regulatory path[122]. Intellectual Property and Research Development - The company has obtained five U.S. patents and seven foreign patents related to the ThermoStem Program, indicating significant progress in intellectual property development[40]. - The company has secured multiple patents related to its ThermoStem Program, including patents issued in the United States, Australia, Japan, and Europe[84][85][86][87][88][89][90][92][93][94]. - The company is developing a cell-based therapy candidate targeting obesity and metabolic disorders through its ThermoStem Program, utilizing brown adipose-derived stem cells[33]. - The company has developed the ThermoStem Program, which involves the use of brown adipose tissue for treating type 2 diabetes, obesity, hypertension, and other metabolic disorders[200]. Regulatory Compliance and Challenges - The company must comply with stringent FDA regulations regarding the manufacturing and marketing of its products, which could affect its operational costs[136]. - The FDA requires that all clinical trials comply with regulations and protocols to ensure data reliability for regulatory purposes[144]. - The FDA's approval process for drugs and biologics involves multiple phases, including non-clinical tests and human clinical trials, which the company must navigate[137]. - The company is at risk of regulatory enforcement actions if it fails to comply with applicable requirements, which could materially impact its operations[134]. - The company anticipates that its cellular therapy products may be regulated as HCT/Ps under FDA regulations, which could impact its operational strategy[129]. Research Collaborations and Facilities - The company has entered into various research agreements with institutions such as the University of Utah and Pfizer, receiving initial payments totaling $250,000 and up to an additional $525,000[82]. - The company has established a laboratory facility to further develop cellular-based treatments and stem cell-related intellectual property[41]. - The company has established a laboratory in Melville, New York, for research and potential production of cell-based product candidates[98]. - The company aims to expand its laboratory capabilities to include cellular characterization, protocol development, and therapeutic outcome analysis[99]. Marketing and Revenue Generation - The company has historically generated a modest amount of revenue, primarily incurring losses from research and development, marketing, and public company compliance costs[203]. - For the year ended December 31, 2020, the company generated revenues of $77,000, a decrease of 40.8% from $130,000 in 2019[213]. - Marketing and promotion expenses decreased by 91% from $321,280 in 2019 to $28,281 in 2020 due to reduced spending during the Chapter 11 reorganization[214]. - The company expects marketing and promotion expenses to increase in the future as it ramps up marketing activities following the full commercialization of its products and services[215].
BioRestorative Therapies(BRTX) - 2020 Q4 - Annual Report