Results of Operations Revenues We expect that our research and development expenses will increase in subsequent fiscal periods. For the three months ended June 30, 2023, interest income was $96,187 compared to interest expense of $46,613 for the three months ended June 30, 2022. The change was primarily due to our investments in marketable securities during the three months ended 18 Revenues We expect that our higher level of research and development expenses will continue in subsequent fiscal periods. Inte ...

Securities registered pursuant to Section 12(g) of the Act: None (Title of Class) If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ As of June 30, 2022, the aggregate market value of the registrant's common stock held by non-affiliates of the registrant was $8,495,444 based on the closing sale price as repor ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading symbol(s) Name of exchange on which registered Common Stock, $0.0001 par value BRTX Nasdaq Capital Market Emerging growth company ☐ FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from _____ ...

Revenue Growth - For the three months ended June 30, 2022, revenues increased to $71,100 from $15,000 in the same period of 2021, representing a 374% increase[116]. - The company generated $87,100 in royalty revenue for the six months ended June 30, 2022, compared to $33,000 for the same period in 2021, indicating a significant increase[128]. Research and Development - Research and development expenses surged by 568% from $160,898 in Q2 2021 to $1,075,224 in Q2 2022, reflecting a recommencement of research initiatives[120]. - Research and development expenses increased by $1,524,409, or 467%, from $326,152 to $1,850,561 for the six months ended June 30, 2022, compared to the same period in 2021[131]. - The company has received FDA authorization to commence a Phase 2 clinical trial for BRTX-100, targeting chronic lower back pain from degenerative disc disease[111]. - The company is developing the ThermoStem Program, which focuses on treating type 2 diabetes and obesity using brown adipose tissue[111]. Expenses - General and administrative expenses rose by 6% from $3,401,497 in Q2 2021 to $3,588,809 in Q2 2022, primarily due to increased stock-based compensation[123]. - General and administrative expenses decreased by $10.5 million, or 57%, from $18.3 million to $7.8 million for the six months ended June 30, 2022, primarily due to a decrease in stock-based compensation[133]. - Total operating expenses for the six months ended June 30, 2022, decreased to $9,769,521 from $18,642,919 in the same period of 2021[127]. Net Loss and Financial Position - The net loss for the six months ended June 30, 2022, was $9,491,391, compared to a net loss of $19,715,925 for the same period in 2021[127]. - The accumulated deficit as of June 30, 2022, was $143.6 million, reflecting historical losses primarily from operating expenses[110]. - The accumulated deficit was $143,637,519 as of June 30, 2022, indicating a need for additional equity and/or debt financing to continue operations[140]. - The company reported a net cash used in operating activities of $2,845,756 for the six months ended June 30, 2022, primarily due to a net loss of $9,491,391[144]. Interest Expense - Interest expense decreased by 91% from $507,332 in Q2 2021 to $46,613 in Q2 2022, due to the exchange of convertible debt for equity[125]. - Interest expense decreased by $1,030,382, or 93%, for the six months ended June 30, 2022, compared to the same period in 2021, due to the exchange of convertible debt for common and preferred shares[135]. Cash and Working Capital - As of June 30, 2022, cash was $17,933,724, and working capital was $17,702,436, down from $21,026,727 and $21,104,086, respectively, as of December 31, 2021[139]. - Net cash used in investing activities was $247,247 for equipment purchases during the six months ended June 30, 2022, with no cash flows from investing activities in the same period of 2021[145]. Future Outlook - The company anticipates that general and administrative expenses will increase as it expands its staff and infrastructure to support business growth[134]. - The company may face challenges in raising sufficient additional capital on favorable terms, which could impact its operations[142].

Financial Performance - For the three months ended March 31, 2022, the company generated $16,000 in revenue, a decrease of 11.1% from $18,000 in the same period in 2021[115]. - Total operating expenses for the three months ended March 31, 2022, were $5,069,793, down 66.3% from $15,072,656 in the same period in 2021[114]. - The company reported a net loss of $4,816,150 for the three months ended March 31, 2022, compared to a net loss of $15,653,330 in the same period in 2021[114]. - The net loss for the three months ended March 31, 2022, was $4,816,150, a decrease from the net loss of $15,653,330 in the same period of 2021[131]. Expenses - Research and development expenses increased by $610,083, or 369%, from $165,254 in Q1 2021 to $775,337 in Q1 2022[118]. - General and administrative expenses decreased by $10,688,497, or 72%, from $14,896,413 in Q1 2021 to $4,207,916 in Q1 2022[120]. - Non-cash expenses related to stock-based compensation amounted to $3,430,925 for the three months ended March 31, 2022[131]. Cash Flow - As of March 31, 2022, the company's cash balance was $19,322,520, down from $21,026,727 as of December 31, 2021[126]. - Net cash used in operating activities was $1,594,634 for the three months ended March 31, 2022, compared to $813,701 for the same period in 2021, reflecting a significant increase in cash outflow[131]. - Net cash used in investing activities was $109,573 for the three months ended March 31, 2022, due to equipment purchases, with no cash flows from investing activities in the same period of 2021[133]. - There were no cash flows from financing activities for the three months ended March 31, 2022, while financing activities in 2021 included $250,000 from a loan under the Paycheck Protection Program[134]. - The net decrease in cash for the three months ended March 31, 2022, was $1,704,207, compared to a decrease of $563,701 in the same period of 2021[130]. - Changes in operating assets and liabilities provided $40,591 in cash for the three months ended March 31, 2022, primarily due to increases in accounts payable and accrued expenses[131]. Financial Position - The accumulated deficit as of March 31, 2022, was $138,962,278, indicating ongoing financial challenges[127]. - The company anticipates needing additional equity and/or debt financing to continue operations and fund clinical trials[129]. Clinical Trials and Operations - The company expects to incur substantial costs for clinical trials and operational activities over the next year[109]. - The company has received FDA authorization to commence a Phase 2 clinical trial for BRTX-100, targeting chronic lower back pain[110]. Market and Risk Factors - The company does not believe that inflation has had a material impact on its business or operating results during the periods presented[135]. - There are no off-balance sheet arrangements that could materially affect the company's financial condition or results of operations[137]. - The company is not required to provide quantitative and qualitative disclosures about market risk as a smaller reporting company[138].

Financing and Grants - The company completed a $23,000,000 public offering of securities, issuing 2,300,000 shares of common stock and warrants for 2,645,000 shares[25]. - The company received a National Institutes of Health STTR Phase 1 grant for $256,000 to evaluate therapeutic effects on hypoxic cultured bone marrow derived mesenchymal stem cells[22]. - The company anticipates requiring approximately $35,000,000 in additional financing to complete the Phase 3 clinical trial for BRTX-100[43]. Clinical Trials and Research - The company has initiated a Phase 2 clinical trial for BRTX-100, which is aimed at treating chronic lower back pain from degenerative disc disease[32]. - The Phase 2 clinical trial for BRTX-100 involves 99 patients randomized 2:1, with a primary efficacy endpoint at 12 months, focusing on improvement in function and reduction in pain[68]. - The FDA authorized the Phase 2 clinical trial in February 2017, and the company has commenced the trial with a CRO agreement and expanded laboratory capabilities[49][66]. - A National Institutes of Health STTR Phase 1 grant of $256,000 was awarded to evaluate the therapeutic effects of BRTX-100 after encapsulation with a PEG-peptide hydrogel[57]. - The company has established a laboratory with clean room facilities for the production of cell products, including BRTX-100, for clinical trials and research purposes[52]. - The company plans to initiate additional preclinical animal studies in 2022 to optimize delivery and explore additional indications[103]. - The company is pursuing its Disc/Spine Program with the investigational therapeutic product BRTX-100, which has received FDA authorization to commence a Phase 2 clinical trial[210]. Product Development and Technology - The company has obtained five United States patents and nine foreign patents related to the ThermoStem Program, along with three United States patent applications and eight foreign patent applications[41]. - The company has licensed a curved needle device for delivering therapeutic products, pending FDA approval[35]. - BRTX-100 is an autologous hypoxic cultured mesenchymal stem cell product derived from a patient's own bone marrow, designed to enhance viability and therapeutic potential with an expected cell count of approximately 40 million per dose[54][55]. - The anticipated cost of a single treatment using BRTX-100 is expected to be less expensive than common surgical procedures, which can range from $20,000 to $150,000[46]. - The company is focused on developing therapies for disc/spine disease and metabolic disorders using adult stem cells[32]. - The ThermoStem Program is focused on utilizing brown adipose-derived stem cells for metabolic diseases, with initial success in animal models[78][81]. - The company is developing a bioengineered implantable brown adipose tissue construct to target obesity and metabolic disorders using BADSCs[83]. - The next generation BAT is expected to have a higher purity of BADSC and a greater percentage of functional brown adipocytes, enhancing therapeutic effects compared to the first generation product[85]. - The company has developed a promising encapsulation technology for therapeutic delivery, which may prevent immune response and increase safety[85]. Regulatory and Compliance - The FDA issued guidance in July 2020 regarding HCT/P Regulations, with enforcement discretion until May 31, 2021, after which non-compliant products may face immediate action[138]. - If regulated under HCT/P provisions, the company must meet several requirements, including registration, donor eligibility, and adverse event reporting[139]. - Non-compliance with FDA regulations could lead to enforcement actions such as fines, recalls, or criminal prosecution, which could materially affect the company[142]. - If products are regulated as drugs or biologics, significant resources will be required for compliance, and the approval process can take many years[158]. - The FDA may expedite review processes for NDAs and BLAs through programs like Fast Track, Breakthrough Therapy, and Priority Review[161][163]. - The FDA's accelerated approval pathway allows products to be approved based on clinical trials showing effects on surrogate endpoints, which may predict clinical benefits[165]. - The company intends to comply with all applicable foreign governmental requirements for products developed outside the U.S.[143]. - The FDA has broad regulatory authority over drugs and biologics, impacting research, clinical testing, and marketing[144]. Financial Performance and Operations - The company incurred $729,058 and $876,829 in research and development expenses for the years ended December 31, 2021 and 2020, respectively, indicating a decrease of approximately 17%[119]. - The company has historically generated a modest amount of revenue, primarily incurring losses from research and development and marketing expenses[213]. - As of December 31, 2021, the accumulated deficit of the company was $134,146,129[213]. - The company currently has seven full-time employees, indicating a small workforce[191]. - The principal executive offices occupy 6,800 square feet under a lease expiring in December 2024, with annual base rental costs ranging from $153,748 to $173,060[194]. - The company did not receive any proceeds from the issuance of unregistered securities during the three months ended December 31, 2021[203]. Intellectual Property and Competition - The company has filed twelve patent applications related to the Disc/Spine Program and has been issued a patent for a curved needle therapeutic delivery device[111]. - The company has multiple active patent applications in the U.S. related to its Disc/Spine and Metabolic programs, including U.S. Patent No. 11,278,573 B2 for methods to facilitate repair of avascular tissue[114]. - The company has secured registrations for trademarks including BRTX-100 and THERMOSTEM, and has an allowed application for the trademark BRTX[117]. - The company believes that its product BRTX-100 has competitive advantages over Mesoblast's adult stem cell biologic due to the use of autologous cells, which results in a lower risk of rejection and a greater safety profile[130]. - The company faces competition from various pharmaceutical and biotechnology companies, many of which have greater resources[125]. - The company is focused on developing and protecting its proprietary technology through a combination of patents, trade secrets, and other legal protections[118]. Strategic Partnerships and Collaborations - The company is engaged in a Research and Development Agreement with Rohto Pharmaceutical Co., Ltd., which has now expired upon completion of the services[115]. - The company has established a Scientific Advisory Board to provide guidance on scientific matters, including a Disc Advisory Committee focused on the Disc/Spine Program[120]. - The collaboration with the University of Utah has resulted in the acquisition of rights to two provisional patent applications related to human brown fat cell lines[86]. - The company is exploring potential sublicensing of BRTX-100 technology to strategic partners to facilitate FDA approval and commercialization[51][70]. Market Potential - The total annual healthcare costs related to pain in the U.S. are estimated at $600 billion, highlighting the potential market for BRTX-100[77]. - The company intends to market its cell product candidates to healthcare professionals, hospitals, and research institutions upon regulatory approval, targeting physicians skilled in spinal injections[131]. - The company plans to explore opportunities for establishing stem cell therapy clinics internationally as they arise[189].

Financial Performance - For the three months ended September 30, 2021, the company generated revenues of $8,000, a decrease of 47% compared to $15,000 for the same period in 2020[175]. - For the nine months ended September 30, 2021, the company reported revenues of $41,000, down 32% from $60,000 for the same period in 2020[187]. - The net loss for the three months ended September 30, 2021 was $4,184,232, compared to a net loss of $836,263 for the same period in 2020[174]. - The net loss for the nine months ended September 30, 2021 was $23,900,157, compared to a net loss of $5,511,375 for the same period in 2020[186]. Operating Expenses - Total operating expenses for the three months ended September 30, 2021 were $3,696,687, an increase of 492% from $625,265 in the same period of 2020[174]. - General and administrative expenses for the nine months ended September 30, 2021 increased to $21,756,887, a significant rise of 1,826% from $1,129,218 in the same period of 2020[186]. - Research and development expenses for the three months ended September 30, 2021 were $237,410, a decrease of 5% from $251,036 in the same period of 2020[178]. - Marketing and promotion expenses for the nine months ended September 30, 2021 decreased by 68% to $9,120 from $28,131 in the same period of 2020[188]. - Consulting expenses decreased by $91,158, or 90%, from $101,195 to $10,037 for the nine months ended September 30, 2021, compared to the same period in 2020[190]. - Research and development expenses decreased by $135,355, or 19%, from $698,917 to $563,562 for the nine months ended September 30, 2021, compared to the same period in 2020[191]. - General and administrative expenses increased by $20,627,669, or 1,827%, from $1,129,218 to $21,765,887 for the nine months ended September 30, 2021, compared to the same period in 2020[193]. - Interest expense increased by $189,089, or 13%, for the nine months ended September 30, 2021, compared to the same period in 2020[196]. Cash and Financing - As of September 30, 2021, cash was $1,129,716, down from $3,064,610 as of December 31, 2020[200]. - Working capital decreased from $2,142,229 to $296,200 as of September 30, 2021[200]. - The company required additional equity and/or debt financing due to an accumulated deficit of $113,742,990 as of September 30, 2021[201]. - The company completed a public offering on November 9, 2021, issuing 2,300,000 units at a public offering price of $10.00 per unit, raising approximately $20,772,000[206][208]. - Net cash used in operating activities was $2,184,894 for the nine months ended September 30, 2021, compared to $1,392,145 for the same period in 2020[210]. - The company anticipates needing at least $12,000,000 to complete Phase 2 clinical trials for its Disc/Spine Program[214]. Clinical Trials - The company intends to commence a Phase 2 clinical trial for BRTX-100 in 2022, pending necessary funding[169]. - The company has received FDA authorization to commence the clinical trial for BRTX-100, targeting chronic lower back pain from degenerative disc disease[169].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from _________ to _________ Commission file number: 001-37603 BIORESTORATIVE THERAPIES, INC. (Exact name of registrant as specified in its charter) | --- | --- | --- | --- | | ...

Financial Performance - For the three months ended March 31, 2021, the company generated $18,000 in revenue, a decrease of 30.77% from $26,000 in the same period of 2020[151]. - Total operating expenses for the three months ended March 31, 2021, were $15,072,656, an increase of 1,776.5% from $844,989 in the same period of 2020[150]. - The company reported a net loss of $15,653,330 for the three months ended March 31, 2021, compared to a net loss of $7,550,772 for the same period in 2020[150]. Expenses Breakdown - General and administrative expenses increased by $14,293,772, or 2,372%, from $602,641 to $14,896,413, primarily due to an increase in stock-based compensation[158]. - Research and development expenses decreased by $21,075, or 11%, from $186,328 to $165,254, attributed to a reduction in stock compensation[156]. - Interest expense decreased by $104,412, or 37%, for the three months ended March 31, 2021, compared to the same period in 2020[160]. Cash and Working Capital - As of March 31, 2021, the company had cash of $2,500,909, down from $3,064,610 as of December 31, 2020[166]. - Working capital surplus decreased to $1,302,698 as of March 31, 2021, from $2,142,229 as of December 31, 2020[166]. - The net cash used in operating activities for the three months ended March 31, 2021, was $813,702, primarily due to a net loss of $15,653,330[175]. Financing Needs and Activities - The company required additional equity and/or debt financing to continue operations due to an accumulated deficit of $105,496,163 as of March 31, 2021[167]. - The company anticipates needing at least $12,000,000 to complete a Phase 2 clinical study of BRTX-100[172]. - The company secured $1,189,413 in DIP financing and $3,848,548 in debt financing as part of its Chapter 11 reorganization[172]. - Net cash provided by financing activities for the three months ended March 31, 2021, was $250,000, primarily from a loan under the Paycheck Protection Program[176]. - Approximately $14,700,000 in outstanding debt and other liabilities were exchanged for shares of common stock and new convertible notes during the reorganization[172]. - The company has sufficient cash to fund operations for the twelve months following the filing date due to recent financing efforts[172]. - The company may face challenges in raising additional capital on favorable terms due to existing security interests in its assets[170]. Future Expectations - The company expects marketing and promotion expenses to increase in the future as it ramps up marketing activities following full commercialization of its products[153]. - The company does not believe inflation has materially impacted its business or operating results during the reported periods[178].

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].