BioRestorative Therapies, Inc. 10-Q

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated interim financial statements and related notes included in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2025 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, which was filed with the Securities and Exchange Commission (the “SEC”) on March 26, 2026. Note Regarding Forward-Looking Statements This Quarterly Report on Form 10-Q includes a number of forward-looking statements that reflect management’s current views with respect to future events and financial performance. Forward-looking statements are projections in respect of future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. These statements include statements regarding the intent, belief or current expectations of us and members of our management team, as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risk and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks set forth in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the SEC on March 26, 2026, any of which may cause our company’s or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied in our forward-looking statements. These risks and factors include, by way of example and without limitation: ● our ability to obtain financing needed to complete our clinical trials and implement our business plan; ● our ability to successfully develop and commercialize BRTX-100, our lead product candidate for the treatment of chronic lumbar disc disease, as well as our metabolic ThermoStem Program and commercial biocosmeceuticals platform; ● our ability to protect our proprietary rights; ● our ability to achieve and sustain profitability of the existing lines of business; ● our ability to attract and retain world-class research and development talent; ● our ability to attract and retain key science, technology and management personnel and to expand our management team; ● the accuracy of estimates regarding expenses, future revenue, capital requirements, profitability, and needs for additional financing; ● business interruptions resulting from geo-political actions, including war and terrorism or disease outbreaks; ● our ability to attract and retain customers; ● our ability to navigate through the increasingly complex therapeutic regulatory environment; ● our ability to successfully engage in any new business lines that we pursue; and ● risks related to our failure to meet the continued listing requirements of Nasdaq which could result in a delisting of our Common Stock. 18 Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity or performance. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to actual results. Readers are urged to carefully review and consider the various disclosures made by us in this report and in our other reports filed with the SEC. We undertake no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes in the future operating results over time, except as required by law. We believe that our assumptions are based upon reasonable data derived from and known about our business and operations. No assurances are made that actual results of operations or the results of our future activities will not differ materially from our assumptions. As used in this Quarterly Report on Form 10-Q and unless otherwise indicated, the terms “Company,” “we,” “us” and “our” refer to BioRestorative Therapies, Inc., a Nevada corporation (“BRT”), and its wholly-owned subsidiary, Stem Pearls, LLC, a New York limited liability company (“Stem Pearls”). Unless otherwise specified, all dollar amounts are expressed in United States dollars. Intellectual Property This report includes references to our federally registered trademarks, BioRestorative Therapies and Dragonfly design, BRTX-100, ThermoStem, and BRTX . The Dragonfly logo is also registered with the U.S. Copyright Office. This report may also include references to trademarks, trade names and service marks that are the property of other organizations. Solely for convenience, trademarks and trade names referred to in this report appear without the ®, SM or ™ symbols, and copyrighted content appears without the use of the symbol ©, but the absence of use of these symbols does not reflect upon the validity or enforceability of the intellectual property owned by us or third parties. Corporate History Our offices are located in Melville, New York where we have established a laboratory facility in order to increase our capabilities for the further development of possible cellular-based treatments, products and protocols, stem cell-related intellectual property and translational research applications. As of March 31, 2026, our accumulated deficit was $172,075,095 We have historically only generated a modest amount of revenue, and our losses have principally been operating expenses incurred in research and development, marketing and promotional activities in order to commercialize our products and services, plus costs associated with meeting the requirements of being a public company. We expect to continue to incur substantial costs for these activities over at least the next year. Business Overview We develop therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells. We are currently pursuing our Disc/Spine Program with our initial investigational therapeutic product being called BRTX-100 . In March 2022, a United States patent issued in our Disc/Spine Program . Pursuant to authorization received from the FDA, we are conducting a Phase 2 clinical trial investigating the use of BRTX-100 in the treatment of chronic lower back pain arising from degenerative disc disease. We have received a license from the New York State Department of Health to act as a tissue bank for mesenchymal stem cell processing. In June 2023, we received a unanimous recommendation from the Data Safety Monitoring Board to continue our Phase 2 clinical trial without any changes. We have obtained a worldwide (excluding Asia and Argentina) exclusive license to use technology for investigational adult stem cell treatment of disc and spine conditions, including protruding and bulging lumbar discs. The technology is an advanced stem cell injection procedure that may offer relief from lower back pain, buttock and leg pain, and numbness and tingling in the leg and foot. We are investigating the expansion of the clinic application of BRTX-100 to other indications within the body. 19 We are also developing our 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. United States patents related to the ThermoStem Program were issued in September 2015, January 2019, March 2020, March 2021, July 2021, June 2023 and December 2023; Australian patents related to the ThermoStem Program were issued in April 2017, October 2019, and August 2021; Japanese patents related to the ThermoStem Program were issued in December 2017, June 2021, February 2022, June 2023, July 2024 and September 2025; Israeli patents related to our ThermoStem Program were issued in October 2019, May 2020, March 2022, and March 2025; European patents related to the ThermoStem Program were issued in April 2020, January 2021, July 2023, and March 2025. We have obtained a license for a patented curved needle device that is a needle system designed to deliver cells and/or other therapeutic products or materials to the spine and discs or other potential sites. We anticipate that FDA approval or clearance will be necessary for this device prior to commercialization. We do not intend to utilize this device in connection with our Phase 2 clinical trial with regard to BRTX-100 . In addition, in continuation of our mission of developing and commercializing cell-based biologics, we have developed a biologics-based cosmetic products business through which we formulate, manufacture and sell products designed for cosmetic and aesthetic uses. Our biocosmeceutical product offerings consist of two product lines: ExoCR, which is sold pursuant to a supply agreement with Cartessa Aesthetics, LLC (“Cartessa”), a North American aesthetic company, and BioX, which we commenced selling commercially during the three months ended March 31, 2026 to multiple customers in the ordinary course of business. Revenue We derive royalty revenue pursuant to a license agreement with a stem cell treatment company (the “SCTC”) entered into in January 2012, as amended in November 2015 and November 2022. Pursuant to the license agreement, the SCTC granted to us an exclusive license to use certain intellectual property related to, among other things, stem cell disc procedures and we have granted to the SCTC a sublicense to use, and the right to sublicense to third parties the right to use, in certain locations in the United States and the Cayman Islands, certain of the licensed intellectual property. In consideration of the sublicenses, the SCTC has agreed to pay us royalties on a per disc procedure basis. We also derive product revenue from sales of our biocosmeceutical product offerings. During the three months ended March 31, 2026, we derived $11,870 of product revenue, all of which was generated from sales of our BioX product line. We did not derive any revenue from our supply agreement with Cartessa during the three months ended March 31, 2026. We did not generate any product revenue during the three months ended March 31, 2025. 20 Results of Operations Comparison of the Three Months Ended March 31, 2026 to the Three Months Ended March 31, 2025 Our financial results for the three months ended March 31, 2026 are summarized as follows in comparison to the three months ended March 31, 2025: For the Three Months Ended March 31 2026 2025 Revenues $ 23,170 $ 25,000 Cost of goods sold 7,385 2,909 Gross profit 15,785 22,091 Operating Expenses: Research and development 1,926,311 2,646,900 General and administrative 1,475,207 2,182,725 Total Operating Expenses 3,401,518 4,829,625 Loss From Operations (3,385,733 ) (4,807,534 ) Other Income (Expense): Dividend and interest income, net 5,479 100,608 Other income 5,728 1,246 Change in fair value of warrant liabilities 1,220,121 (634,119 ) Total Other Income (Expense) 1,231,328 (532,265 ) Net Loss $ (2,154,405 ) $ (5,339,799 ) Revenues For the three months ended March 31, 2026, we generated total revenues of $23,170, comprised of $11,870 of product revenue and $11,300 of royalty revenue, as compared to total revenues of $25,000, comprised entirely of royalty revenue, for the three months ended March 31, 2025. Royalty revenue, which is derived from our sublicense agreement with the SCTC, decreased by $13,700, or 54.8%, to $11,300 from $25,000, primarily due to a decrease in disc procedures performed by the SCTC. Product revenue, which is derived from sales of our biocosmeceutical product offerings, increased by $11,870 to $11,870 from $0, due to the commencement of commercial sales of our BioX product line during the three months ended March 31, 2026. Research and Development Research and development expenses include cash compensation of (a) our Vice President of Research and Development; (b) our Scientific Advisory Board members; and (c) laboratory staff and costs related to our brown fat and disc/spine initiatives. Research and development expenses are expensed as they are incurred. For the three months ended March 31, 2026, research and development expenses decreased by $720,589 or 27.2%, as compared to the three months ended March 31, 2025. The decrease is primarily attributed to a decrease in stock-based compensation expense of $799,983, a decrease in general lab supplies expense of $83,447, and a decrease in bonus expense of $61,625, partially offset by an increase in recruitment and other costs for our Phase 2 clinical trial of $230,824. 21 General and Administrative General and administrative expenses consist primarily of salaries, bonuses, payroll taxes and stock-based compensation to employees, as well as corporate expenses such as legal and professional fees, investor relations and occupancy-related expenses. For the three months ended March 31, 2026, general and administrative expenses decreased by $707,518, or 32.4%, as compared to the three months ended March 31, 2025. The decrease is primarily attributed to a decrease in stock-based compensation expense of $918,928, partially offset by an increase in professional fees of $141,428, an increase in headcount costs of $64,583 and an increase in consulting expense of $17,019. Dividend and Interest Income, net For the three months ended March 31, 2026, dividend and interest income, net of interest expense decreased by $95,129, or 95%, to $5,479 as compared to interest income of $100,608 for the three months ended March 31, 2025. The change was primarily due to a decrease in interest income from the investments held in marketable securities due to a lower average balance of the marketable securities during 2026 as compared to 2025. Other Income For the three months ended March 31, 2026, other income was $5,728, as compared to other income of $1,246 for the three months ended March 31, 2025. Change in Fair Value of Warrant Liabilities For the three months ended March 31, 2026, we recognized a gain on the change in fair value of warrant liabilities of $1,220,121, primarily reflecting the decrease in our stock price between January 1, 2026 and February 24, 2026, the date on which the warrants previously classified as derivative liabilities were reclassified to equity. For the three months ended March 31, 2025, we recognized a loss on the change in fair value of warrant liabilities of $634,119 related to the increase in our stock price during that period. Liquidity and Capital Resources Liquidity We measure our liquidity in a number of ways, including the following: March 31, 2026 December 31, 2025 Cash and cash equivalents $ 3,112,679 $ 1,511,188 Investments held in marketable securities $ 479,351 $ 1,441,734 Working capital (deficiency) $ 2,185,071 $ (586,029 ) 22 Working capital increased by $2,771,100, from a working capital deficiency of $586,029 at December 31, 2025 to working capital of $2,185,071 at March 31, 2026. The increase in working capital was driven primarily by a $1,399,349 reduction in current liabilities resulting from the reclassification of warrant liabilities to equity in connection with the conversion of the Series B Convertible Preferred Stock, a $674,597 decrease in accounts payable, and a net increase in current assets, of which cash and cash equivalents increased by $1,601,491 (partially offset by a $962,383 decrease in investments held in marketable securities). The net increase in cash and cash equivalents reflected $4,440,836 of cash provided by financing activities and $968,447 of cash provided by investing activities, partially offset by $3,807,792 of cash used in operating activities. Availability of Additional Funds For the three months ended March 31, 2026, we had a net loss of $2.2 million and negative cash flows from operations of $3.8 million, and as of March 31, 2026, we had working capital of $2.2 million. We anticipate that we will continue to incur net losses and negative cash flows from operations as we execute our development plans during 2026 and beyond, as well as other potential strategic and business development initiatives. Based on these conditions, we believe we do not have sufficient cash for at least twelve months after the issuance date of the financial statements included in this Quarterly Report which raises substantial doubt about our ability to continue as a going concern. Our operating needs include the planned costs to operate our business, including amounts required to fund our clinical trials, working capital and capital expenditures. Our future capital requirements and the adequacy of our available funds will depend on many factors, including our ability to successfully commercialize our products and services, competing technological and market developments, and the need to enter into collaborations with other companies or acquire other companies or technologies to enhance or complement our product and service offerings. We may be unable to raise sufficient additional capital when we need it or raise capital on favorable terms. Future financing may require us to pledge certain assets and enter into covenants that could restrict certain business activities or our ability to incur further indebtedness and may contain other terms that are not favorable to our stockholders or us. If we are unable to obtain adequate funds on reasonable terms, we may be required to significantly curtail or discontinue operations or obtain funds by entering into financing agreements on unattractive terms. Nasdaq Listing Compliance On March 26, 2026, we received a notification letter from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that we are not in compliance with the minimum bid price requirement of Nasdaq Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum closing bid price of $1.00 per share. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we have an initial compliance period of 180 calendar days, or until September 22, 2026, to regain compliance. We intend to monitor the closing bid price of our Common Stock and consider available options to resolve the noncompliance, including effecting a reverse stock split of our Common Stock. There can be no assurance that we will regain compliance with the minimum bid price requirement or otherwise be in compliance with the Nasdaq listing criteria. See Note 1 to the unaudited condensed consolidated financial statements for additional information. 23 Cash Flows During the three months ended March 31, 2026 and 2025, our sources and uses of cash were as follows: Three Months Ended March 31, 2026 2025 Net Cash Used In Operating Activities $ (3,807,792 ) $ (2,778,786 ) Net Cash Provided By Investing Activities $ 968,447 $ 2,366,967 Net Cash Provided By Financing Activities $ 4,440,836 $ 1,092,718 Net Increase in Cash $ 1,601,491 $ 680,899 Operating Activities Net cash used in operating activities was $3,807,792 for the three months ended March 31, 2026, primarily due to cash used to fund the net loss of $2,154,405, adjustments to net non-cash expenses of $883,576, and $769,811 of cash used in changes in operating assets and liabilities. Net cash used in operating activities was $2,778,786 for the three months ended March 31, 2025 , primarily due to cash used to fund the net loss of $5,339,799 and $31,214 of cash used in changes in operating assets and liabilities, partially offset for adjustments to net non-cash expenses of $2,592,227. Investing Activities Net cash provided by investing activities was $968,447 for the three months ended March 31, 2026 primarily due to sales of marketable securities which provided $1,043,367 of cash, partially offset by purchases of marketable securities which used $74,920 of cash. Net cash provided by investing activities was $2,366,967 for the three months ended March 31, 2025 primarily due to sales of marketable securities which provided $3,456,535 of cash, partially offset by purchases of marketable securities which used $1,053,168 of cash and a purchase of equipment which used $36,400 of cash. Financing Activities Net cash provided by financing activities was $4,440,836 for the three months ended March 31, 2026 due to the issuance of Common Stock and pre-funded warrants in the Rodman public offering which provided gross proceeds of $5,000,000 of cash, partially offset by the payment of issuance costs which used $559,164 of cash. Net cash provided by financing activities was $1,092,718 for the three months ended March 31, 2025 due to the issuance of Common Stock in an at-the-market offering which provided $1,083,915 of cash and the exercise of stock options which provided $42,411 of cash, partially offset by the payment of issuance costs which used $33,608 of cash. Effects of Inflation We do not believe that inflation had a material impact on our business, revenues or operating results during the periods presented. Critical Accounting Policies and Estimates We prepare our unaudited condensed consolidated financial statements in accordance with U.S. generally accepted accounting principles, which require our management to make estimates that affect the reported amounts of assets, liabilities and disclosures of contingent assets and liabilities at the balance sheet dates, as well as the reported amounts of revenues and expenses during the reporting periods. To the extent that there are material differences between these estimates and actual results, our financial condition or results of operations would be affected. We base our estimates on our own historical experience and other assumptions that we believe are reasonable after taking account of our circumstances and expectations for the future based on available information. We evaluate these estimates on an ongoing basis. 24 We consider an accounting estimate to be critical if: (i) the accounting estimate requires us to make assumptions about matters that were highly uncertain at the time the accounting estimate was made, and (ii) changes in the estimate that are reasonably likely to occur from period to period or use of different estimates that we reasonably could have used in the current period, would have a material impact on our financial condition or results of operations. There are items within our unaudited condensed consolidated financial statements that require estimation but are not deemed critical, as defined above. For a detailed discussion of our significant accounting policies and related judgments, see Note 2 of the Notes to Unaudited Condensed Consolidated Financial Statements in “Item 1. Financial Statements” of this report. Item 3. Quantitative and Qualitative Disclosures about Market Risk Not applicable. As a smaller reporting company, we are not required to provide the information required by this Item.