BioRestorative Therapies, Inc. 10-Q

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 September 30, 2024 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) Nevada 30-1341024 (State or other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification No.) 40 Marcus Drive , Melville , New York 11747 (Address of Principal Executive Offices) (Zip Code) (631) 760-8100 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading symbol(s) Name of exchange on which registered Common Stock, $0.0001 par value BRTX Nasdaq Capital Market Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☐ 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: ☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒ Indicate by checkmark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☒ No ☐ As of November 12, 2024 there were 6,919,919 shares of the registrant’s Common Stock outstanding. BIORESTORATIVE THERAPIES, INC. FORM 10-Q FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023 TABLE OF CONTENTS Page PART I. FINANCIAL INFORMATION 3 ITEM 1. Financial Statements 3 Condensed Consolidated Balance Sheets as of September 30, 2024 (unaudited) and December 31, 2023 3 Unaudited Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2024 and 2023 4 Unaudited Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and Nine Months Ended September 30, 2024 and 2023 5 Unaudited Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023 6 Notes to Unaudited Condensed Consolidated Financial Statements 7 ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 19 ITEM 3. Quantitative and Qualitative Disclosures About Market Risk 27 ITEM 4. Controls and Procedures 27 PART II. OTHER INFORMATION 29 ITEM 1A. Risk Factors 29 ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 29 ITEM 6. Exhibits 29 SIGNATURES 30 2 PART I - FINANCIAL INFORMATION Item 1. Financial Statements BIORESTORATIVE THERAPIES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS September 30, December 31, 2024 2023 (unaudited) (As Restated) Assets Current Assets: Cash and cash equivalents $ 1,489,444 $ 884,377 Investments held in marketable securities 11,598,417 10,181,618 Accounts receivable 165,000 19,300 Prepaid expenses and other current assets 233,697 305,231 Deferred offering costs 22,381 - Total Current Assets 13,508,939 11,390,526 Property and equipment, net 378,434 356,055 Right-of-use assets 39,697 151,447 Intangible assets, net 646,381 713,692 Total Assets $ 14,573,451 $ 12,611,720 Liabilities and Stockholders’ Equity Current Liabilities: Accounts payable $ 401,379 $ 189,389 Accrued expenses and other current liabilities 682,237 711,686 Lease liability 42,414 162,317 Warrant liabilities 3,455,505 1,543,953 Total Current Liabilities 4,581,535 2,607,345 Total Liabilities 4,581,535 2,607,345 Commitments and contingencies - - Stockholders’ Equity: Preferred stock, $ 0.01 par value; 20,000,000 shares authorized; Series B Convertible Preferred Stock; 1,543,158 shares designated, 1,398,158 shares issued and outstanding at September 30, 2024 and December 31, 2023 13,982 13,982 Common stock, $ 0.0001 par value; 75,000,000 shares authorized; 6,919,919 and 4,706,917 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively 692 471 Additional paid-in capital 164,019,809 156,689,256 Accumulated deficit ( 154,042,567 ) ( 146,699,334 ) Total Stockholders’ Equity 9,991,916 10,004,375 Total Liabilities and Stockholders’ Equity $ 14,573,451 $ 12,611,720 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 3 BIORESTORATIVE THERAPIES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) 2024 2023 2024 2023 For the Three Months Ended For the Nine Months Ended September 30 September 30 2024 2023 2024 2023 (As Restated) (As Restated) Revenues $ 233,600 $ 30,700 $ 357,700 $ 126,500 Cost of goods sold 18,243 - 24,733 - Gross profit 215,357 30,700 332,967 126,500 Operating Expenses: Research and development 1,320,030 809,824 3,690,495 2,944,460 General and administrative 1,182,320 2,325,319 5,507,524 9,182,132 Total Operating Expenses 2,502,350 3,135,143 9,198,019 12,126,592 Loss From Operations ( 2,286,993 ) ( 3,104,443 ) ( 8,865,052 ) ( 12,000,092 ) Other (Income) Expense: Interest income ( 158,547 ) ( 61,667 ) ( 497,089 ) ( 176,070 ) Grant income - ( 83,333 ) - ( 83,333 ) Other income ( 566 ) ( 33,951 ) ( 150,498 ) ( 150,423 ) Gain on exchange of warrants - - ( 1,711,698 ) - Change in fair value of warrant liabilities ( 1,036,464 ) ( 7,693,753 ) 837,466 ( 3,476,556 ) Total Other (Income) Expense ( 1,195,577 ) ( 7,872,704 ) ( 1,521,819 ) ( 3,886,382 ) Net (Loss) Income $ ( 1,091,416 ) $ 4,768,261 $ ( 7,343,233 ) $ ( 8,113,710 ) Net (Loss) Income Per Share - Basic $ ( 0.13 ) $ 1.04 $ ( 0.96 ) $ ( 2.00 ) Net (Loss) Income Per Share - Diluted $ ( 0.13 ) $ 0.39 $ ( 0.96 ) $ ( 2.00 ) Weighted Average Common Shares Outstanding - Basic 8,121,499 4,570,843 7,643,437 4,061,975 Weighted Average Common Shares Outstanding - Diluted 8,121,499 12,324,766 7,643,437 4,061,975 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 4 BIORESTORATIVE THERAPIES, INC. CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (unaudited) Shares Amount Shares Amount Capital Deficit Total For the Nine Months Ended September 30, 2024 Series B Convertible Additional Preferred Stock Common Stock Paid-In Accumulated Shares Amount Shares Amount Capital Deficit Total Balance - January 1, 2024 (as restated) 1,398,158 $ 13,982 4,706,917 $ 471 $ 156,689,256 $ ( 146,699,334 ) $ 10,004,375 Common stock issued in connection with warrant exchange [1] - - 2,000,000 200 4,742,043 - 4,742,243 Return and cancellation of shares in lieu of payroll tax withholding - - ( 34,825 ) ( 4 ) ( 48,406 ) - ( 48,410 ) Stock-based compensation: Restricted share units - - 97,827 10 985,028 - 985,038 Options - - - - 1,043,336 - 1,043,336 Net loss (as restated) - - - - - ( 2,223,255 ) ( 2,223,255 ) Balance - March 31, 2024 1,398,158 $ 13,982 6,769,919 $ 677 $ 163,411,257 $ ( 148,922,589 ) $ 14,503,327 Common stock issued in connection with abeyance shares - - 150,000 15 ( 15 ) - - Stock-based compensation: Options - - - - 324,322 - 324,322 Net loss - - - - - ( 4,028,562 ) ( 4,028,562 ) Balance - June 30, 2024 1,398,158 $ 13,982 6,919,919 $ 692 $ 163,735,564 $ ( 152,951,151 ) $ 10,799,087 Stock-based compensation: Options - - - - 284,245 - 284,245 Net loss - - - - - ( 1,091,416 ) ( 1,091,416 ) Balance - September 30, 2024 1,398,158 $ 13,982 6,919,919 $ 692 $ 164,019,809 $ ( 154,042,567 ) $ 9,991,916 For the Nine Months Ended September 30, 2023 Series B Convertible Additional Preferred Stock Common Stock Paid-In Accumulated Shares Amount Shares Amount Capital Deficit Total (As Restated) (As Restated) (As Restated) Balance - January 1, 2023 (as restated) 1,518,158 $ 15,182 3,677,775 $ 369 $ 146,556,418 $ ( 136,281,630 ) $ 10,290,339 Return and cancellation of shares in lieu of payroll tax withholding - - ( 10,058 ) ( 1 ) ( 39,307 ) - ( 39,308 ) Stock-based compensation: Restricted share units - - 99,898 10 1,188,060 - 1,188,070 Options - - - - 2,190,428 - 2,190,428 Net loss (as restated) - - - - - ( 7,172,572 ) ( 7,172,572 ) Balance - March 31, 2023 (as restated) 1,518,158 $ 15,182 3,767,615 $ 378 $ 149,895,599 $ ( 143,454,202 ) $ 6,456,957 Stock-based compensation: Restricted share units - - 1,442 - 1,164,134 - 1,164,134 Options - - - - 321,534 - 321,534 Issuance of common stock - - 93,551 9 411,701 - 411,710 Conversion of Series B preferred to common stock ( 120,000 ) ( 1,200 ) 120,000 12 1,188 - - Net loss (as restated) - - - - - ( 5,709,399 ) ( 5,709,399 ) Balance - June 30, 2023 (as restated) 1,398,158 $ 13,982 3,982,608 $ 399 $ 151,794,156 $ ( 149,163,601 ) $ 2,644,936 Balance 1,398,158 $ 13,982 3,982,608 $ 399 $ 151,794,156 $ ( 149,163,601 ) $ 2,644,936 Stock-based compensation: Restricted share units - - - - 1,164,134 - 1,164,134 Options - - - - 329,570 - 329,570 Issuance of common stock - - 685,033 69 1,853,921 - 1,853,990 Net income (as restated) - - - - - 4,768,261 4,768,261 Net income (loss) (as restated) - - - - - 4,768,261 4,768,261 Balance - September 30, 2023 (as restated) 1,398,158 $ 13,982 4,667,641 $ 468 $ 155,141,781 $ ( 144,395,340 ) $ 10,760,891 Balance 1,398,158 $ 13,982 4,667,641 $ 468 $ 155,141,781 $ ( 144,395,340 ) $ 10,760,891 [1] Represents the aggregate fair value of 3,351,580 shares of common stock, which includes 2,150,000 that have been issued and 1,201,580 shares held in abeyance. See Note 4 - Stockholders’ Equity - Warrant Exercise and Issuance and Note 6 - Fair Value Measurement for additional details. The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 5 BIORESTORATIVE THERAPIES, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) 2024 2023 For the Nine Months Ended September 30, 2024 2023 (As Restated) Cash Flows From Operating Activities: Net loss $ ( 7,343,233 ) $ ( 8,113,710 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 138,687 123,022 Dividend and interest income ( 492,476 ) ( 166,866 ) Stock-based compensation 2,636,941 6,318,562 Non-cash lease expense 111,750 87,034 Gain on exchange of warrants ( 1,711,698 ) - Change in fair value of warrant liabilities 837,466 ( 3,476,556 ) Changes in operating assets and liabilities: Accounts receivable ( 145,700 ) ( 23,300 ) Prepaid expenses and other current assets 23,124 37,151 Accounts payable 211,990 56,453 Accrued expenses and other current liabilities ( 29,449 ) 418,882 Lease liability ( 119,903 ) ( 102,921 ) Net Cash Used In Operating Activities ( 5,882,501 ) ( 4,842,249 ) Cash Flows From Investing Activities: Sale of marketable securities 17,370,243 18,089,372 Purchase of marketable securities ( 18,294,566 ) ( 14,651,512 ) Purchases of equipment ( 93,755 ) ( 101,019 ) Net Cash (Used In) Provided By Investing Activities ( 1,018,078 ) 3,336,841 Cash Flows From Financing Activities: Net proceeds from issuance of common stock in at-the-market offering - 411,710 Net proceeds from issuance of common stock in direct-offering - 1,853,990 Proceeds from exchange and issuance of warrants, net [1] 7,528,027 - Deferred offering costs ( 22,381 ) - Net Cash Provided By Financing Activities 7,505,646 2,265,700 Net Increase In Cash and Cash Equivalents 605,067 760,292 Cash and Cash Equivalents - Beginning of the Period 884,377 1,676,577 Cash and Cash Equivalents - End of the Period $ 1,489,444 $ 2,436,869 Supplemental Disclosures of Cash Flow Information: Cash paid during the period for: Interest $ - $ - Income taxes $ - $ - Non-cash investing and financing activities: Issuance of common stock held in abeyance $ 15 $ - Return and cancellation of shares in lieu of payroll tax withholding $ 48,410 $ 39,308 [1] Includes gross proceeds of $ 8,123,391 , less issuance costs of $ 595,364 . The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 6 NOTE 1 – BUSINESS ORGANIZATION, NATURE OF OPERATIONS, BASIS OF PRESENTATION AND LIQUIDITY Corporate History BioRestorative Therapies, Inc. has one wholly-owned subsidiary, Stem Pearls, LLC (“Stem Pearls”). BioRestorative Therapies, Inc. and its subsidiary are referred to collectively as “BRT” or the “Company”. On December 23, 2022, the Company reincorporated from Delaware to Nevada by filing Articles of Incorporation with the state of Nevada. The reincorporation was structured as a statutory merger. Business Operations BRT develops therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells. BRT’s website is at www.biorestorative.com. The information contained in the website or connected thereto is not intended to be incorporated by reference into this Quarterly Report. BRT is currently developing a Disc/Spine Program referred to as “brtxDISC”. Its lead cell therapy candidate, BRTX-100 , is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. The product is intended to be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complimentary therapeutic to a surgical procedure. BRT is also engaging in research efforts with respect to a platform technology utilizing brown adipose (fat) for therapeutic purposes to treat type 2 diabetes, obesity and other metabolic disorders and has labeled this initiative its ThermoStem Program. In addition, in continuation of BRT’s mission of developing and commercializing cell-based biologics, it is seeking to develop a biologics-based cosmetic products business. Pursuant to such business, BRT would formulate, manufacture and sell products designed for cosmetic and aesthetic uses. Further, BRT has licensed a patented curved needle device that is a needle system designed to deliver cells and/or other therapeutic products or material to the spine and discs or other potential sites. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. The December 31, 2023 consolidated balance sheet data were derived from audited financial statements but do not include all disclosures required by U.S. GAAP. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) that are considered necessary for a fair presentation of the unaudited condensed consolidated financial statements of the Company as of September 30, 2024 and for the three and nine months then ended. The results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the operating results for the full year ending December 31, 2024 or any other period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and related disclosures of the Company as of December 31, 2023 and for the year then ended, which were filed with the Securities and Exchange Commission (“SEC”) on June 11, 2024 as part of the Company’s Amendment No. 1 to the Annual Report on Form 10-K/A (the “Form 10-K/A”), which includes the restatement of the Company’s consolidated financial statements, including periods that are included in this Quarterly Report on Form 10-Q. Refer to Note 2 - Summary of Significant Accounting Policies - Restatement of Previously Issued Consolidated Financial Statements and Note 3 - Restatement of Previously Issued Unaudited Interim Condensed Consolidated Financial Statements in the Form 10-K/A for additional information. 7 Liquidity For the nine months ended September 30, 2024, the Company had a net loss of $ 7.3 million, negative cash flows from operations of $ 5.9 million and working capital of $ 8.9 million. The Company’s operating activities consume the majority of its cash resources. The Company anticipates that it will continue to incur net losses and negative cash flows from operations as it executes its development plans for 2024 and beyond, as well as other potential strategic and business development initiatives. The Company has previously funded, and plans to continue funding, these losses primarily through current cash on hand, investments in marketable securities and additional infusions of cash from equity and debt financing. During the nine months ended September 30, 2024, the Company raised net proceeds of approximately $ 7.5 million in connection with a warrant exercise program which is further discussed in Note 4 – Stockholders’ Equity. On November 6, 2024, the Company entered into an at-the-market offering agreement pursuant to which the Company has an ability to issue and sell shares of its common stock up to an aggregate offering price of $ 3,614,170 . See Note 7 – Subsequent Events for additional details. Based on cash on hand and investments as of the date these unaudited condensed consolidated financial statements were issued, which includes $ 7.5 million of net proceeds from the warrant exercise program, the Company believes it has sufficient cash to fund operations for at least 12 months after the issuance date of these unaudited condensed consolidated financial statements. However, the Company’s current funds will not be sufficient to enable the Company to fully complete its development activities or attain profitable operations. If the Company is unable to obtain such needed additional financing on a timely basis, the Company may have to curtail its development, marketing and promotional activities, which would have a material adverse effect on the Company’s business, financial condition and results of operations, and ultimately the Company could be forced to discontinue its operations and liquidate. The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with U.S. GAAP, which contemplate continuation of the Company as a going concern and the realization of assets and satisfaction of liabilities in the normal course of business. The carrying amounts of assets and liabilities presented in the unaudited condensed consolidated financial statements do not necessarily purport to represent realizable or settlement values. The accompanying unaudited condensed consolidated financial statements do not include any adjustments that might be necessary should the Company be unable to continue as a going concern. NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES See Amendment No. 1 to the Annual Report on Form 10-K/A for the year ended December 31, 2023 for a complete listing of the Company’s significant accounting policies. Reclassifications Certain prior period statements of operations, changes in stockholders’ equity and cash flows amounts have been reclassified to conform to the Company’s fiscal 2024 presentation. These reclassifications have no impact on the Company’s previously reported net (loss) income. 8 Cash and Cash Equivalents Financial instruments that potentially subject the Company to concentrations of credit risk consist of a cash account in a financial institution. The Company maintains deposits in its accounts that hold cash and cash equivalents in excess of the Federal Depository Insurance Corporation (“FDIC”) coverage of $ 250,000 per banking institution. The Company had deposits in excess of FDIC coverage of $ 1,220,350 and $ 604,226 as of September 30, 2024 and December 31, 2023, respectively. As of September 30, 2024, the Company has not experienced losses on this account. Customer and Revenue Concentrations All of the Company’s contract service revenue is derived from one customer. Additionally, all of the Company’s product sales revenue is derived from one customer. Accounts Receivable Accounts receivable are carried at their contractual amounts, less an estimate for credit losses. As of September 30, 2024 and 2023, no allowances for credit losses were determined to be necessary. Management estimates the allowance for credit losses based on existing economic conditions, the financial conditions of the customers, and the amount and age of past due accounts. Receivables are considered past due if full payment is not received by the contractual due date. Past due accounts are generally written off against the allowance for credit losses only after all collection attempts have been exhausted. Deferred Contract Costs The Company defers costs associated with fulfilling its contracts if those costs meet all of the following criteria: (i) the costs relate directly to a contract, (ii) the costs generate or enhance resources of the Company that will be used in satisfying performance obligations in the future, and (iii) the costs are expected to be recovered. Deferred contract costs are recognized as cost of revenues in the period when the related revenue is recognized. Deferred contract costs consist of consumables and labor costs and are included in prepaid and other current assets in the unaudited condensed consolidated balance sheets. The Company had $ 8,333 and $ 0 deferred contract costs as of September 30, 2024 and December 31, 2023, respectively. Derivative Financial Instruments The Company evaluates all of its agreements to determine if such instruments have derivatives or contain features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in the statements of operations. For stock-based derivative financial instruments, the Company uses a weighted-average Black-Scholes option pricing model to value the derivative instruments at inception and on subsequent valuation dates. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is evaluated at the end of each reporting period. 9 Fair Value of Financial Instruments Fair value is defined as the amount that would be received for selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date and is measured using inputs in one of the following three categories: Level 1 measurements are based on unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability to access. Valuation of these items does not entail a significant amount of judgment. Level 2 measurements are based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active or market data other than quoted prices that are observable for the assets or liabilities. Level 3 measurements are based on unobservable data that are supported by little or no market activity and are significant to the fair value of the assets or liabilities. The Company considers cash and cash equivalents, investments held in marketable securities, accounts receivable, accounts payable and warrant liabilities to meet the definition of financial instruments. As of September 30, 2024 and December 31, 2023, the carrying amount of cash and cash equivalents, investments held in marketable securities, accounts receivable, and accounts payable approximate their fair value due to the relatively short period of time between their origination and their expected realization or payment. The warrant liabilities are measured at fair value (see Note 6 – Fair Value Measurement for additional details). Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” (“ASC 606”). The core principle of ASC 606 requires that an entity recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. ASC 606 defines a five-step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within the revenue recognition process, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. The Company recognizes revenue primarily from the following different types of contracts: ● Product sales - Revenue is recognized at the point in time the customer obtains control of the goods and the Company satisfies its performance obligation. ● Royalty revenue - Revenue is recognized as a usage-based royalty from customers’ usage of intellectual property pursuant to a license agreement at the point in time in which the underlying sale occurs. 10 The Company recognizes bill-and-hold revenue from its sale of cosmetic vials warehoused at a Company location for a specified period of time in accordance with directions received from the Company’s customer. Even though the vials are held at a Company location, a sale is recognized at the point in time when the customer obtains control of the product. Control is transferred to the customer in a bill-and-hold arrangement when: (i) customer acceptance specifications have been met, (ii) legal title has transferred, (iii) the customer has a present obligation to pay for the product and (iv) the risks and rewards of ownership have transferred to the customer. Additionally, all the following bill-and-hold criteria have to be met in order for control to be transferred to the customer: ● the reason for the bill-and-hold arrangement is substantive ● the customer has requested the product be warehoused ● the product has been identified as separately belonging to the customer ● the product is currently ready for physical transfer to the customer ● the Company does not have the ability to use the product or direct it to another customer. The following table summarizes the Company’s revenue recognized in its unaudited condensed consolidated statements of operations: SCHEDULE OF REVENUE RECOGNIZED 2024 2023 2024 2023 For the Three Months Ended For the Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Product revenue $ 230,700 $ - $ 300,000 $ - Royalty revenue 2,900 30,700 57,700 126,500 Revenues $ 233,600 $ 30,700 $ 357,700 $ 126,500 Net (Loss) Income Per Common Share Net (loss) income per share is computed by dividing net (loss) income by the weighted average number of shares of common stock outstanding during the year. All outstanding options and warrants are considered potential common stock. The Company has 1,201,580 shares held in abeyance included in basic loss per share given that they are issuable for no additional consideration (see Note 4 – Stockholders’ Equity for additional details). The dilutive effect, if any, of stock options and warrants are calculated using the treasury stock method. All outstanding convertible preferred stock is considered common stock at the beginning of the period or at the time of issuance, if later, pursuant to the if-converted method. Since the effect of common stock equivalents is anti-dilutive with respect to losses, options, warrants, restricted stock units (“RSUs”) and convertible preferred stock have been excluded from the Company’s computation of diluted net (loss) income per common share for the three months ended September 30, 2024 and the nine months ended September 30, 2024 and 2023. 11 The following table summarizes the securities that were excluded from the diluted per share calculation because the effect of including these potential shares was antidilutive due to the Company’s net loss position even though the exercise or conversion price could be less than the average market price of the common shares: SCHEDULE OF WEIGHTED AVERAGE DILUTIVE COMMON SHARES For the Three Months Ended For the Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Stock options 3,401,608 - 3,401,608 1,466,890 Warrants 3,952,504 - 3,952,504 4,791,048 Unvested RSUs - - - 97,827 Convertible Preferred Stock 1,398,158 - 1,398,158 1,398,158 8,752,270 - 8,752,270 7,753,923 Recently Issued Accounting Pronouncements In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, “Improvements to Reportable Segments Disclosures (Topic 280)” (“ASU 2023-07”), which updates reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses on both an annual and interim basis. The guidance becomes effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. Since this new ASU addresses only disclosures, the Company does not expect the adoption of this ASU to have any material effects on its financial condition, results of operations or cash flows. The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-07. In December 2023, the FASB issued ASU No. 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures,” (“ASU 2023-09”). The amendments in ASU 2023-09 are designed to enhance the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of this update on its consolidated financial statements and related disclosures. In November 2024, the FASB issued ASU No. 2024-03, “Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses,” (“ASU 2024-03”), which is intended to require more detailed disclosures about specified categories of expenses (including employee compensation, depreciation, and amortization) included in certain expense captions presented on the face of the income statement. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The amendments may be applied either (1) prospectively to financial statements issued for reporting periods after the effective date of ASU 2024-03 or (2) retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating the potential impact of this update on its consolidated financial statements and related disclosures. NOTE 3 - ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES Accrued expenses and other current liabilities consist of: SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES September 30, December 31, 2024 2023 Accrued bonuses $ 584,250 $ 638,000 Accrued general and administrative expenses 97,987 73,686 Total accrued expenses and other current liabilities $ 682,237 $ 711,686 12 NOTE 4 - STOCKHOLDERS’ EQUITY 2021 Stock Incentive Plan On July 23, 2024, the Company’s Board of Directors approved an amendment to the Company’s 2021 Stock Incentive Plan (the “2021 Plan”) to increase the number of shares of common stock authorized to be issued under the 2021 Plan from 3,850,000 to 6,850,000 . On September 19, 2024, the Company held its Annual Meeting of Stockholders (the “Annual Meeting”). At the Annual Meeting, the Company’s stockholders approved the amendment to the 2021 Plan to increase such number of authorized shares. Warrant Exercise and Issuance On February 6, 2024, the Company entered into agreements with certain holders of its existing warrants exercisable for an aggregate of 3,351,580 shares of its Common Stock (collectively, the “Existing Warrants”), to exercise their warrants at a reduced exercise price of $ 2.33 per share, in exchange for the issuance of new warrants (the “New Warrants”) as described below (the “Warrant Exercise and Issuance”). The aggregate gross proceeds from the exercise of the Existing Warrants and the payment of the New Warrants, as described below, was approximately $ 8.1 million, before deducting cash issuance costs in the amount of $ 595,364 . The reduction of the exercise price of the Existing Warrants and the issuance of the New Warrants was structured as an at-market transaction under Nasdaq rules. Of the 3,351,580 shares of Common Stock issuable upon the exercise of the Existing Warrants, through September 30, 2024, the Company had issued an aggregate of 2,150,000 shares of Common Stock. The remaining 1,201,580 shares of Common Stock, which are issuable to Auctus Fund, LLC (“Auctus”), are being held in abeyance due to Auctus’ maximum beneficial ownership limitation (the “Abeyance Shares”) . Such Abeyance Shares have been fully paid for and are issuable upon notice from Auctus to the Company. In consideration for the immediate exercise of the Existing Warrants for cash and the payment of $ 0.125 per share underlying the New Warrants, the exercising holders received the New Warrants to purchase shares of Common Stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The New Warrants will be exercisable for a period of five years into an aggregate of 2,513,686 shares of Common Stock at an exercise price of $ 2.43 per share. The securities offered in the private placement have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. As part of the transaction, the Company agreed to file a resale registration statement with the SEC to register the resale of the shares of Common Stock underlying the New Warrants issued in the private placement. Such resale registration statement was filed and was declared effective by the SEC on April 18, 2024. In connection with the transaction described above, the Company entered into a financial advisory services agreement, dated February 5, 2024, with Roth Capital Partners, LLC (“Roth”), pursuant to which the Company has paid Roth a cash fee of approximately $ 528,000 for its services, in addition to reimbursement for certain expense. During the nine months ended September 30, 2024, the Company incurred an aggregate of $ 595,364 of cash issuance costs related to the Warrant Exercise and Issuance. Prior to the Warrant Exercise and Issuance, the Existing Warrants were classified as derivative liabilities. Additionally, the Company analyzed the form of the New Warrants and determined that they should be classified as derivative liabilities in accordance with ASC 815-40, Derivatives and Hedging — Contracts in Entity’s Own Equity. Under the New Warrants, the Company does not control the occurrence of events, such as a tender offer or exchange, that may trigger cash settlement of the New Warrants and not result in a change of control of the Company. As a result, such New Warrants do not meet the criteria for equity treatment. Additionally, certain New Warrants contain adjustments to the settlement amount based on a variable that is not an input to the fair value of a “fixed-for-fixed” option as defined under ASC 815-40 and, accordingly, such New Warrants are not considered indexed to the Company’s own stock and are not eligible for an exception from derivative accounting. See Note 6 – Fair Value Measurement for details regarding the valuation of the Existing Warrants and New Warrants. 13 The Company determined the Warrant Exercise and Issuance to be an exchange by investors of Existing Warrants with an aggregate fair value of $ 1,115,334 along with aggregate cash consideration of $ 8,123,392 (consisting of $ 7,809,181 paid to exercise the Existing Warrants and $ 314,211 paid for the New Warrants) for an aggregate of 3,351,580 shares of common stock with an aggregate fair value of $ 4,742,244 , New Warrants with an aggregate fair value of $ 2,189,420 and aggregate cash issuance costs of $ 595,364 and, accordingly, the Company recorded a gain on extinguishment of $ 1,711,698 during the nine months ended September 30, 2024. Warrants See Note 6 – Fair Value of Financial Instruments for details regarding the valuation of the New Warrants. A summary of the Company’s warrant activity and related information follows: SCHEDULE OF WARRANT ACTIVITY Weighted Weighted Average Average Remaining Number of Exercise Life Warrants Price In Years Outstanding, January 1, 2024 4,791,019 $ 10.57 Granted 2,513,686 2.43 Exercised ( 3,351,580 ) 2.33 Expired ( 622 ) 3,126 Outstanding, September 30, 2024 3,952,504 $ 3.84 3.55 Exercisable, September 30, 2024 3,952,504 $ 3.84 3.55 As of September 30, 2024, the warrants exercisable and outstanding had an intrinsic value of $ 0 . Stock Options On February 13, 2024, the Company granted options to purchase an aggregate 1,934,716 shares of the Company’s Common Stock at an exercise price of $ 1.45 per share to employees, the Company’s board of directors and a member of the Company’s Scientific Advisory Board. The options had an aggregate grant date fair value of $ 2,140,000 and vest as follows: (i) options to purchase an aggregate 513,663 shares of common stock vest monthly over one year, and (ii) options to purchase an aggregate of 1,421,053 shares of common stock vest to the extent of 50 % immediately with the remainder vesting quarterly over two years commencing one year from the date of grant. The Company will recognize the grant date fair value of the options proportionate to the vesting period. In applying the Black-Scholes option pricing model to stock options granted, the Company used the following assumptions: SCHEDULE OF STOCK OPTION GRANTED ASSUMPTIONS For the Nine Months Ended September 30, 2024 2023 Risk free interest rate 4.14 - 4.30 % 4.22 % Expected term (years) 2.77 - 5.38 3.5 Expected volatility 101 - 102 % 175 % Expected dividends 0.00 % 0.00 % 14 There were no stock options granted during the three months ended September 30, 2024 and 2023. Options granted during the nine months ended September 30, 2024 and 2023 had a weighted average grant date fair value per share of $ 1.11 and $ 2.77 per share, respectively. A summary of the stock option activity during the nine months ended September 30, 2024 is presented below: SCHEDULE OF STOCK OPTION ACTIVITY Weighted Weighted Average Average Remaining Number of Exercise Life Intrinsic Options Price In Years Value Outstanding, January 1, 2024 1,466,892 $ 4.11 Granted 1,934,716 1.45 Exercised - - Forfeited - - Outstanding, September 30, 2024 3,401,608 $ 2.60 7.8 $ - Exercisable, September 30, 2024 2,351,081 $ 3.03 7.4 $ - Restricted Stock Units (“RSUs”) Pursuant to the 2021 Plan, the Company may grant RSUs to employees, consultants or non-employee directors (“Eligible Individuals”). The number, terms and conditions of the RSUs that are granted to Eligible Individuals are determined on an individual basis by the 2021 Plan administrator. On the distribution date, the Company shall issue to the Eligible Individual one unrestricted, fully transferable share of the Company’s common stock (or the fair market value of one such share in cash) for each vested and nonforfeitable RSU. A summary of the Company’s unvested RSUs as of September 30, 2024 is as follows: SCHEDULE OF UNVESTED RESTRICTED STOCK UNITS Number of Shares Non-vested at January 1, 2024 97,827 Granted - Vested ( 97,827 ) Forfeited - Non-vested at September 30, 2024 - 15 Stock-Based Compensation Expense The following table presents information related to stock-based compensation expense: SCHEDULE OF STOCK OPTION EXPENSE For the Three Months Ended For the Nine Months Ended Unrecognized at Weighted Average Remaining Amortization September 30, September 30, September 30, Period 2024 2023 2024 2023 2024 (Years) General and administrative $ 284,245 $ 1,493,704 $ 2,636,941 $ 6,318,562 $ 1,060,129 1.64 Total $ 284,245 $ 1,493,704 $ 2,636,941 $ 6,318,562 $ 1,060,129 1.64 The following table presents stock-based compensation by award type: SCHEDULE OF STOCK COMPENSATION BY AWARD TYPE For the Three Months Ended For the Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Options $ 284,245 $ 329,570 $ 1,651,903 $ 2,802,224 RSUs - 1,164,134 985,038 3,516,338 Total $ 284,245 $ 1,493,704 $ 2,636,941 $ 6,318,562 NOTE 5 - LEASES The Company is a party to a lease for 6,800 square feet of space located in Melville, New York (the “Melville Lease”) with respect to its corporate and laboratory operations. The Melville Lease was scheduled to expire in March 2020 (subject to extension at the option of the Company for a period of five years) and provided for an annual base rental during the initial term ranging between $ 132,600 and $ 149,260 . In June 2019, the Company exercised its option to extend the Melville Lease and entered into a lease amendment with the lessor whereby the five-year extension term commenced on January 1, 2020 with annual base rent ranging between $ 153,748 and $ 173,060 . When measuring lease liabilities for leases that were classified as operating leases, the Company discounted lease payments using its estimated incremental borrowing rate at August 1, 2019. The weighted average incremental borrowing rate applied was 12 % . 16 The following table presents net lease cost and other supplemental lease information: SCHEDULE OF NET LEASE COST AND OTHER SUPPLEMENTAL LEASE INFORMATION 2024 2023 For the Nine Months Ended September 30, 2024 2023 Lease Costs Operating lease cost (cost resulting from lease payments) $ 129,795 $ 126,021 Net lease costs $ 129,795 $ 126,021 Operating lease - operating cash flows (fixed payments) $ 129,795 $ 126,021 Operating lease - operating cash flows (liability reduction) $ 119,903 $ 102,921 Non-current leases - right of use assets $ 39,697 $ 154,726 Current liabilities - operating lease liabilities $ 42,414 $ 156,310 Non-current liabilities - operating lease liabilities $ - $ 42,414 Future minimum payments under non-cancellable leases for operating leases for the remaining terms of the leases as of September 30, 2024: SCHEDULE OF FUTURE MINIMUM PAYMENTS UNDER NON-CANCELABLE LEASES FOR OPERATING LEASES Fiscal Year Operating Leases 2024 $ 43,265 Total future minimum lease payments 43,265 Amount representing interest ( 851 ) Present value of net future minimum lease payments $ 42,414 NOTE 6 – FAIR VALUE MEASUREMENT On February 8, 2024, in connection with the Warrant Exercise and Issuance, the Company estimated the aggregate fair value of the Existing Warrants (see Note 4 - Stockholders’ Equity for details) to be $ 1,115,334 using the Black-Scholes option pricing model (Level 3 inputs). The following table shows the detail of the valuation assumptions used: SCHEDULE OF FAIR VALUE VALUATION ASSUMPTIONS February 8, 2024 Risk free interest rate 4.20 - 4.28 % Expected term (years) 2.75 - 2.76 Expected volatility 102 % Expected dividends 0.00 % On February 8, 2024, the Company estimated the aggregate issuance date fair value of the warrant liability related to the New Warrants (see Note 4 - Stockholders’ Equity for details) as $ 2,189,420 using the Black-Scholes option pricing model (Level 3 inputs). The following table shows the detail of the valuation assumptions used: February 8, 2024 Risk free interest rate 4.12 % Expected term (years) 5.00 Expected volatility 101 % Expected dividends 0.00 % 17 On September 30, 2024, the Company estimated the aggregate fair value of warrants that are accounted for as warrant liabilities to be $ 3,455,505 using the Black-Scholes option price model (Level 3 inputs) and, accordingly, recognized a loss on the change in fair value of these warrant liabilities of $ 837,466 during the nine months ended September 30, 2024. The following table shows the detail of the valuation assumptions used: September 30, 2024 Risk free interest rate 3.58 % - 3.64 % Expected term (years) 2.11 - 4.36 Expected volatility 99 % - 109 % Expected dividends 0.00 % The following table sets forth a summary of the changes in the fair value of Level 3 liabilities that are measured at fair value on a recurring basis during the nine months ended September 30, 2024: SCHEDULE OF FAIR VALUE MEASURED ON RECURRING BASIS Balance, January 1, 2024 (as restated) $ 1,543,953 Issuance of warrants 2,189,420 Exercise of warrants ( 1,115,334 ) Change in fair value of warrant liability 837,466 Balance, September 30, 2024 $ 3,455,505 Assets and liabilities measured at fair value on a recurring basis are as follows: SCHEDULE OF FAIR VALUE RECURRING BASIS Fair value measurements at reporting date using: Quoted prices in active markets for identical liabilities (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Total Fair Value Assets: Marketable securities as of September 30, 2024 $ 11,598,417 $ - $ - $ 11,598,417 Marketable securities as of December 31, 2023 $ 10,181,618 $ - $ - $ 10,181,618 Liabilities: Warrant liabilities as of September 30, 2024 $ - $ - $ 3,455,505 $ 3,455,505 Warrant liabilities as of December 31, 2023 (as restated) $ - $ - $ 1,543,953 $ 1,543,953 NOTE 7 – SUBSEQUENT EVENTS On November 6, 2024, the Company entered into an at-the-market offering agreement pursuant to which the Company has an ability to issue and sell shares of its common stock up to an aggregate offering price of $ 3,614,170 . 18 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, 2023 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K/A (Amendment No. 1) for the fiscal year ended December 31, 2023, which was filed with the Securities and Exchange Commission (the “SEC”) on June 11, 2024. 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/A (Amendment No. 1) for the fiscal year ended December 31, 2023, as filed with the SEC on June 11, 2024, 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 (such as the recent outbreak of COVID-19); ● 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 the restatement of our previously issued financial statements. 19 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 September 30, 2024, our accumulated deficit was $154,042,567. 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 . We have received authorization from the FDA 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. We have commenced such clinical trial through the execution of a CRO agreement with Professional Research Consulting, Inc., d/b/a 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 our laboratory to include capabilities for clinical production. 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. 20 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, and July 2024; Israeli patents related to our ThermoStem Program were issued in October 2019, May 2020, and March 2022; European patents related to the ThermoStem Program were issued in April 2020, January 2021, and July 2023 . 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 are seeking to develop a biologics-based cosmetic products business. Pursuant to such business, we would formulate, manufacture and sell products designed for cosmetic and aesthetic uses. In April 2024, we announced that we have entered into a five-year exclusive supply agreement with Cartessa Aesthetics, LLC (“Cartessa”), a leading North American based aesthetic company, to supply to Cartessa our first commercial product. Revenue We derived some of our 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 derived our initial product revenue from our five-year exclusive supply agreement with Cartessa entered into in April 2024. 21 Results of Operations Comparison of the Three Months Ended September 30, 2024 to the Three Months Ended September 30, 2023 Our financial results for the three months ended September 30, 2024 are summarized as follows in comparison to the three months ended September 30, 2023: For the Three Months Ended September 30 2024 2023 (As Restated) Revenues $ 233,600 $ 30,700 Cost of goods sold 18,243 - Gross profit 215,357 30,700 Operating Expenses: Research and development 1,320,030 874,824 General and administrative 1,182,320 2,260,319 Total Operating Expenses 2,502,350 3,135,143 Loss From Operations (2,286,993 ) (3,104,443 ) Other Income: Interest income (158,547 ) (61,667 ) Grant income - (83,333 ) Other income (566 ) (33,951 ) Change in fair value of warrant liabilities (1,036,464 ) (7,693,753 ) Total Other Income (1,195,577 ) (7,872,704 ) Net (Loss) Income $ (1,091,416 ) $ 4,768,261 Revenues For the three months ended September 30, 2024 and 2023, we generated $2,900 and $30,700, respectively, of royalty revenue in connection with our sublicense agreement with the SCTC. The decrease was primarily due to a decrease in disc procedures. For the three months ended September 30, 2024 and 2023, we generated $230,700 and $0, respectively, of cosmetic product sales revenue in connection with our exclusive supply agreement with Cartessa. 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 September 30, 2024, research and development expenses increased by $510,206, or 63%, as compared to the three months ended September 30, 2023. The increase was primarily the result of an increase in lab supply expense of $246,384, an increase in recruitment costs for our Phase 2 clinical trial of $73,194, an increase in payroll expense of $141,079 and an increase in consulting expense of $12,680. We expect that our research and development expenses will continue to increase in subsequent fiscal periods. 22 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 September 30, 2024, general and administrative expenses decreased by $1,142,999, or 49%, as compared to the three months ended September 30, 2023, primarily driven by a decrease in stock-based compensation expense of $1,209,459 related to the vesting of awards, partially offset by an increase in cash compensation to employees of $40,075 and an increase in professional fees of $11,836 primarily related to the recent restatement of our historical financial statements. Interest Income For the three months ended September 30, 2024, interest income was $158,547, as compared to interest income of $61,667 for the three months ended September 30, 2023. The change was primarily due to interest and dividend income on the investments held in marketable securities. Grant income Grant income of $83,333 during the three months ended September 30, 2023 consists of funding received under a National Institutes of Health Small Business Technology Transfer (STTR) Phase 1 grant, offset by related expenses. There was no grant income received during the three months ended September 30, 2024. Other Income For the three months ended September 30, 2024 and 2023, other income primarily related to gains from settlements of certain accrued expenses and realized and unrealized gain on investments. Change in Fair Value of Warrant Liabilities For the three months ended September 30, 2024 and 2023, we recognized a gain on the change in fair value of warrant liabilities of $1,036,464 and $7,693,753, respectively, related to the decrease in fair value of warrants that are accounted for as warrant liabilities. Comparison of the Nine Months Ended September 30, 2024 to the Nine Months Ended September 30, 2023 Our financial results for the nine months ended September 30, 2024 are summarized as follows in comparison to the nine months ended September 30, 2023: For the Nine Months Ended September 30 2024 2023 (As Restated) Revenues $ 357,700 $ 126,500 Cost of goods sold 24,733 - Gross profit 332,967 126,500 Operating Expenses: Research and development 3,690,495 2,944,460 General and administrative 5,507,524 9,182,132 Total Operating Expenses 9,198,019 12,126,592 Loss From Operations (8,865,052 ) (12,000,092 ) Other (Income) Expense: Interest income (497,089 ) (176,070 ) Grant income - (83,333 ) Other income (150,498 ) (150,423 ) Gain on exchange of warrants (1,711,698 ) - Change in fair value of warrant liabilities 837,466 (3,476,556 ) Total Other (Income) Expense (1,521,819 ) (3,886,382 ) Net Loss $ (7,343,233 ) $ (8,113,710 ) Revenues For the nine months ended September 30, 2024 and 2023, we generated $57,700 and $126,500, respectively, of royalty revenue in connection with our sublicense agreement with the SCTC. The decrease was primarily due to a decrease in disc procedures. For the nine months ended September 30, 2024 and 2023, we generated $300,000 and $0, respectively, of cosmetic product sales revenue in connection with our exclusive supply agreement with Cartessa. 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 nine months ended September 30, 2024, research and development expenses increased by $746,035, or 25%, as compared to the nine months ended September 30, 2023. The increase was primarily the result of increased lab supply expense of $532,268 and increased payroll expense of $271,388, all partially offset by a decrease in bonus expense of $196,878. We expect that our research and development expenses will continue to increase in subsequent fiscal periods. 23 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 nine months ended September 30, 2024, general and administrative expenses decreased by $3,674,608, or 40%, as compared to the nine months ended September 30, 2023, primarily driven by a decrease in stock-based compensation expense of $3,681,621 related to the vesting of awards and a decrease in payroll expense of $170,434 all partially offset by an increase in professional fees of $179,273 primarily related to the recent restatement of our historical financial statements. Interest Income For the nine months ended September 30, 2024, interest income was $497,089, as compared to interest income of $176,070 for the nine months ended September 30, 2023. The change was primarily due to interest and dividend income on the investments held in marketable securities. Grant income Grant income of $83,333 during the nine months ended September 30, 2023 consists of funding received under a National Institutes of Health Small Business Technology Transfer (STTR) Phase 1 grant, offset by related expenses. There was no grant income received during the nine months ended September 30, 2024. Other Income For the nine months ended September 30, 2024 and 2023, other income primarily related to gains from settlements of certain accrued expenses and realized and unrealized gain on investments. Gain on Exchange of Warrants For the nine months ended September 30, 2024, we recognized a gain on exchange of $1,711,698 related to the issuance of warrants and common stock in exchange for the cancellation of existing warrants. Change in Fair Value of Warrant Liabilities For the nine months ended September 30, 2024, we recognized a loss on the change in fair value of warrant liabilities of $837,466 related to the increase in fair value of warrants that are accounted for as warrant liabilities. For the nine months ended September 30, 2023, we recognized a gain on the change in fair value of warrant liabilities of $3,476,556 related to the decrease in fair value of warrants that are accounted for as warrant liabilities. 24 Liquidity and Capital Resources Liquidity We measure our liquidity in a number of ways, including the following: September 30, 2024 December 31, 2023 (As Restated) Cash and cash equivalents $ 1,489,444 $ 884,377 Investments held in marketable securities $ 11,598,417 $ 10,181,618 Working capital $ 8,927,404 $ 8,783,181 Working capital increased by $144,223 primarily due to the $7,505,646 of cash provided by financing activities which was partially offset by $5,882,501 of cash used to fund our operations and $1,018,078 of cash used to fund our investments. Availability of Additional Funds Based upon our accumulated deficit of $154,042,567 as of September 30, 2024, along with our forecast for continued operating losses and our need for financing to fund our current and contemplated clinical trials, we will eventually require additional equity and/or debt financing to continue our operations. However, based on cash and cash equivalents and investments on hand, we believe we have sufficient cash to fund operations for at least 12 months after the issuance date of these financial statements. 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. On November 6, 2024, we entered into an at-the-market offering agreement pursuant to which we have an ability to issue and sell shares of our common stock up to an aggregate offering price of $3,614,170. Cash Flows During the nine months ended September 30, 2024 and 2023, our sources and uses of cash were as follows: Nine Months Ended September 30, 2024 2023 (As Restated) Net Cash Used In Operating Activities $ (5,882,501 ) $ (4,842,249 ) Net Cash (Used In) Provided By Investing Activities $ (1,018,078 ) $ 3,336,841 Net Cash Provided By Financing Activities $ 7,505,646 $ 2,265,700 25 Operating Activities Net cash used in operating activities was $5,882,501 for the nine months ended September 30, 2024, primarily due to cash used to fund the net loss of $7,343,233, adjusted for net non-cash expenses of $1,520,670, and $59,938 of cash used in changes in operating assets and liabilities. Net cash used in operating activities was $4,842,249 for the nine months ended September 30, 2023, primarily due to cash used to fund the net loss of $8,113,710, adjusted for non-cash expenses of $2,885,196, and $386,265 of cash provided by changes in operating assets and liabilities. Investing Activities Net cash used in investing activities was $1,018,078 for the nine months ended September 30, 2024 primarily due to a purchase of marketable securities which used $18,294,566 of cash and a sale of marketable securities which provided $17,370,243 of cash. Net cash provided by investing activities was $3,336,841 for the nine months ended September 30, 2023 primarily due to a sale of marketable securities which provided $18,089,372 of cash and a purchase of marketable securities which used $14,651,512 of cash. Financing Activities Net cash provided by financing activities was $7,505,646 for the nine months ended September 30, 2024 due to net proceeds received in connection with the exercise and issuance of warrants, compared to $2,265,700 net cash provided by financing activities for the nine months ended September 30, 2023 due to the net proceeds from the at-the-market offering of our common stock. 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. 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. 26 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. Item 4. Controls and Procedures Evaluation of Disclosure Controls and Procedures We maintain disclosure controls and procedures as that term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (“the Exchange Act”), that are designed to ensure that information required to be disclosed in our reports under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosures. In designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance of achieving the desired control objectives. Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we are required to perform an evaluation of our disclosure controls and procedures, as such term is defined in Rule 13a-15(e) under the Exchange Act, as of September 30, 2024. Management has completed such evaluation and has concluded that our disclosure controls and procedures were not effective to provide reasonable assurance that information required to be disclosed by us in reports we file or submit under the Exchange Act is appropriate to allow timely decisions regarding required disclosures. As a result of the material weaknesses in internal controls over financial reporting described below, we concluded that our disclosure controls and procedures as of September 30, 2024 were not effective. Material Weaknesses in Internal Control over Financial Reporting A material weakness, as defined in the standards established by Sarbanes-Oxley, is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements will not be prevented or detected on a timely basis. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with U.S. GAAP. The following material weaknesses in our internal control over financial reporting were present as of December 31, 2023 and continued to exist as of September 30, 2024: ● Lack of adherence to formal policies and procedures; ● Lack of risk assessment procedures on internal controls to detect financial reporting risks in a timely manner; ● Lack of sufficient formal management testing over documented formal procedures and controls, and time to evaluate continuous effectiveness of controls to achieve complete and accurate financial reporting and disclosures, including documented controls over the preparation and review of journal entries and account reconciliations; and ● Lack of design and implementation of effective controls over the accounting for warrants issued in connection with equity financings. 27 Management’s Plan to Remediate the Material Weaknesses Management has been implementing and continues to implement measures designed to ensure that control deficiencies contributing to the material weaknesses are remediated, such that these controls are designed, implemented, and operating effectively. The remediation actions include: ● Management personnel, including our Chief Financial Officer, are overseeing the financial reporting process and implementation of enhanced controls and governance; ● Engagement of external financial consulting firm with expertise in accounting for significant and complex non-routine transactions to continue to enhance financial reporting, financial operations and internal controls; and ● Documentation of key procedures and controls using a risk-based approach. Management is committed to maintaining a strong internal controls environment and implementing measures designed to help ensure that control deficiencies contributing to the material weaknesses are remediated as soon as possible. We have documented key procedures and controls using a risk-based approach and have, therefore, made progress toward remediation. We continue to implement our remediation plan, which includes continued engagement of an external financial consulting firm to enhance financial reporting and operations as well as design and implementation of controls. We will consider the material weaknesses remediated after the applicable controls operate for a sufficient period of time, and management has concluded, through testing, that the controls are operating effectively. Management will continue to monitor and evaluate the effectiveness of our internal controls and procedures over financial reporting on an ongoing basis and is committed to taking further action and implementing additional enhancements or improvements, as necessary and as funds allow. Changes in Internal Control Over Financial Reporting Other than described above, there have been no changes in our internal control over financial reporting that occurred during our third quarter of 2024 that have materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting. 28 PART II - OTHER INFORMATION Item 1A. Risk Factors An investment in our common stock involves a number of very significant risks. You should carefully consider the risk factor set forth below, the risk factors included in the “Risk Factors” section of Amendment No. 1 to our Annual Report on Form 10-K/A for the year ended December 31, 2023, as filed with the SEC on June 11, 2024, and the other information contained in that report and in this quarterly report in evaluating the Company and its business before purchasing shares of our common stock. The Company’s business, operating results and financial condition could be adversely affected due to any of those risks. Risks Related to Our Cell Therapy Product Development Efforts Our activity as a contract manufacturer of biologic-based cosmetics could result in FDA enforcement for reasons outside of our control, which could disrupt the development of our own product candidates or harm our reputation. We manufacture a commercial product as a contract manufacturer for a third-party company, Cartessa Aesthetics, LLC (“Cartessa”). While we believe the product we manufacture for Cartessa is intended for cosmetic uses, we (as the contract manufacturer) do not ultimately have control over how the product is marketed. It is possible that the FDA could determine, based on how the product is marketed (among other considerations), that it is intended for unapproved therapeutic use(s), which could result in the temporary or permanent suspension of manufacturing and/or commercialization of the product and/or a wide range of enforcement actions, such as warning letters, recall, ‘dear doctor’ letters, and others. If the FDA takes enforcement action against Cartessa or us in connection with this product, it could have an adverse impact on our operations and/or harm our reputation as a biologics company. Item 2. Unregistered Sales of Equity Securities and Use Of Proceeds During the three months ended September 30, 2024, we did not have any unregistered sales of equity securities. Item 6. Exhibits Incorporated by Reference Exhibit Number Exhibit Description Form Exhibit Filing Date 3.1 Amended and Restated Articles of Incorporation 8-K 3.3 1/5/2023 3.2 Certificate of Designations of Preferred Stock (Series B) 8-K 3.4 1/5/2023 3.3 Bylaws 8-K 3.5 1/5/2023 10.1* BioRestorative Therapies, Inc. 2021 Stock Incentive Plan, as amended 31.1* Certification of Principal Executive Officer 31.2* Certification of Principal Financial Officer 32.1** Section 1350 Certification of Principal Executive Officer and Principal Financial Officer 101.INS Inline XBRL Instance Document 101.SCH Inline XBRL Taxonomy Extension Schema Document 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document 104 Cover Page Interactive Date File (embedded within the Inline XBRL document) * Filed herewith. ** In accordance with SEC Release 33-8238, Exhibit 32.1 is being furnished and not filed. 29 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. BIORESTORATIVE THERAPIES, INC. By: /s/ Lance Alstodt Lance Alstodt Chief Executive Officer, President, and Chairman of the Board (Principal Executive Officer) Date: November 12, 2024 By: /s/ Robert E. Kristal Robert E. Kristal Chief Financial Officer (Principal Financial Officer) Date: November 12, 2024 30