Annual Report for Fiscal Year Ending DECEMBER 31, 2025 (Form 10-K)

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

The following discussion and analysis of the consolidated results of operations and financial condition of BioRestorative Therapies, Inc. as of December 31, 2025 and 2024 and for the years ended December 31, 2025 and 2024 should be read in conjunction with our financial statements and the notes to those financial statements that are included elsewhere in this Annual Report following Item 16 ("Form 10-K Summary"). References in this "Management's Discussion and Analysis of Financial Condition and Results of Operations" to "us," "we," "our," and similar terms refer to BioRestorative Therapies, Inc. This Annual Report contains forward-looking statements as that term is defined in the federal securities laws. The events described in forward-looking statements contained in this Annual Report may not occur. Generally, these statements relate to business plans or strategies, projected or anticipated benefits or other consequences of our plans or strategies, projected or anticipated benefits from acquisitions that may be made by us, or projections involving anticipated revenues, earnings or other aspects of our operating results. The words "may," "will," "expect," "believe," "anticipate," "project," "plan," "intend," "estimate," and "continue," and their opposites and similar expressions, are intended to identify forward-looking statements. We caution you that these statements are not guarantees of future performance or events and are subject to a number of uncertainties, risks and other influences, many of which are beyond our control, which may influence the accuracy of the statements and the projections upon which the statements are based. Reference is made to Item 1A of this Annual Report ("Risk Factors") for a discussion of some of the uncertainties, risks and assumptions associated with these statements.

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 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 obtained an exclusive license to use technology for investigational adult stem cell treatment of disc and spine conditions, including protruding and bulging lumbar discs. The 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 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; and European patents related to the ThermoStem Program were issued in April 2020, January 2021, July 2023 and March 2025.

We operate a commercial biocosmeceutical platform. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via IND-enabling studies, with the aim of pioneering FDA approvals in the emerging biocosmeceuticals space.

We have also licensed 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.

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 December 31, 2025, our accumulated deficit was $169,920,690. 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.

In November 2024, we entered into an At The Market Offering Agreement with Rodman & Renshaw, LLC, or Rodman, under which we had the ability to issue and sell shares of our common stock, from time to time, through Rodman, up to an aggregate offering price of approximately $3,614,000 in an ATM program. During the year ended December 31, 2025, we sold 965,424 shares of our common stock under the ATM program with Rodman at a weighted-average gross price of approximately $2.08 per share and raised approximately $2.0 million of gross proceeds. We received net proceeds of approximately $1.8 million. We currently may not sell any shares of common stock under the ATM program with Rodman.

In October 2025, we sold 678,125 shares of our common stock in a registered direct offering. We received net proceeds of approximately $0.9 million from the offering.

In February 2026, we sold 12,560,715 shares of our common stock, pre-funded warrants to purchase 1,725,000 shares of our common stock (which have been exercised in full) and warrants for the purchase of 14,285,715 shares of our common stock in a public offering. We received net proceeds of approximately $4.5 million from the offering.

For the year ended December 31, 2025, we had a net loss of $14.2 million and negative cash flows from operations of $10.8 million and, as of December 31, 2025, we had a working capital deficit of $0.6 million. We anticipate that we will continue to incur net losses and negative cash flows from operations as we execute our development plans for 2026 and beyond, as well as other potential strategic and business development initiatives. These conditions raise substantial doubt about our ability to continue as a going concern for at least twelve months after the issuance date of the financial statements included in this Annual Report. We will require significant additional funding to complete our clinical trials using BRTX-100. We will require a substantial amount of additional funding to implement our other programs as discussed in this Annual Report under the caption Item 1 ("Business"), including our metabolic ThermoStem Program, and fund general operations. No assurance can be given that the amount of funding that we anticipate may be required for such purposes is correct or that we will be able to accomplish our goals within the timeframes projected. In addition, no assurance can be given that we will be able to obtain any required financing on commercially reasonable terms or otherwise.

Consolidated Results of Operations

Year Ended December 31, 2025 Compared with Year Ended December 31, 2024

The following table presents selected items in our consolidated statements of operations for the years ended December 31, 2025 and 2024, respectively:

		For the Years Ended
		December 31,
		2025				2024
Revenues		$	359,700			$	401,000
Cost of goods sold			23,844				28,072
Gross profit			335,856				372,928
Operating Expenses:
Research and development			10,094,671				6,706,913
General and administrative			5,888,317				5,221,209
Total Operating Expenses			15,982,988				11,928,122
Loss From Operations			(15,647,132	)			(11,555,194	)
Other Income (Expense):
Interest income, net			266,207				616,077
Other income			17,448				150,850
Gain on exchange of warrants			-				1,711,698
Change in fair value of warrant liabilities			1,121,502				97,188
Total Other Income			1,405,157				2,575,813
Net Loss		$	(14,241,975	)		$	(8,979,381	)

Revenues

For the years ended December 31, 2025 and 2024, we generated $59,700 and $101,000, respectively, of royalty revenue in connection with our sublicense agreement with the stem cell treatment company. The decrease was primarily due to a decrease in disc procedures.

For each of the years ended December 31, 2025 and 2024, we generated $300,000 of cosmetic product sales revenue in connection with our supply agreement with Cartessa Aesthetics, LLC.

Research and development

Research and development expenses include cash and non-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 year ended December 31, 2025, research and development expenses increased by $3,387,758, or 51%, to $10,094,671 compared to $6,706,913 for the year ended December 31, 2024. The increase was primarily the result of an increase in recruitment and other costs for our Phase 2 clinical trial of $2,682,474, an increase of general lab supplies expense of $485,166, and an increase in stock-based compensation expense of $165,849, partially offset by a decrease in bonus expense of $33,996 and a decrease in headcount costs of $9,851.

We expect that our research and development expenses will continue to increase with the continuation of the aforementioned initiatives.

General and administrative

General and administrative expenses consist primarily of salaries, bonuses, payroll taxes and stock-based compensation to employees (excluding any cash or non-cash compensation of our Vice President of Research and Development and our laboratory staff), as well as corporate expenses such as legal and professional fees, investor relations and occupancy related expenses. For the year ended December 31, 2025, general and administrative expenses increased by $667,108, or 13%, to $5,888,317 from $5,221,209 for the year ended December 31, 2024. The increase was primarily driven by an increase in stock-based compensation expense of $347,212, an increase in headcount costs of $212,274, an increase in consulting expense of $130,453, and an increase in professional fees of $31,241.

We expect that our general and administrative expenses related to operations will continue to increase as we expand our staff, develop our infrastructure and incur additional costs to support the growth of our business.

Interest income, net

For the year ended December 31, 2025, interest income, net of interest expense decreased $349,870, or 57%, to $266,207 from $616,077 for the year ended December 31, 2024. 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 2025 as compared to 2024.

Other income

For the year ended December 31, 2025, other income decreased $133,402, or 88%, to $17,448 from $150,850 for the year ended December 31, 2024. The change was primarily due to a one-time payment received in the 2024 period in connection with the development of our biocosmeceuticals product line.

Gain on Exchange of Warrants

For the year ended December 31, 2024, we recognized a gain on exchange of warrants of $1,711,698 related to the issuance of warrants and common stock in exchange for the cancellation of existing warrants. There was no gain on exchange of warrants for the year ended December 31, 2025.

Change in fair value of warrant liabilities

For the year ended December 31, 2025, we recognized a gain on the change in fair value of warrant liabilities of $1,121,502 related to the reduction in the fair value of the warrants that are accounted for as warrant liabilities. For the year ended December 31, 2024, we recognized a gain on the change in fair value of warrant liabilities of $97,188 related to the reduction in the fair value of the warrants that are accounted for as warrant liabilities.

Liquidity and Capital Resources

Liquidity

We measure our liquidity in a number of ways, including the following:

		December 31,
		2025				2024
Cash and cash equivalents		$	1,511,188			$	547,890
Investments held in marketable securities		$	1,441,734			$	10,184,701
Working capital (deficit)		$	(586,029	)		$	7,395,815

Working capital decreased by $7,981,844 primarily due to $10,788,963 of cash used to fund our operations and a $8,742,967 decrease in marketable securities, offset by $8,897,470 of cash provided by investing activities and $2,854,791 of cash provided by financing activities.

Availability of Additional Funds

For the year ended December 31, 2025, we had a net loss of $14.2 million and negative cash flows from operations of $10.8 million and, as of December 31, 2025, we had a working capital deficit of $0.6 million. We anticipate that we will continue to incur net losses and negative cash flows from operations as we execute our development plans for 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 Annual 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.

Public Offerings

In October 2025, we sold 678,125 shares of our common stock in a registered direct offering. We received net proceeds of approximately $0.9 million from the offering.

In February 2026, we sold 12,560,715 shares of our common stock, pre-funded warrants to purchase 1,725,000 shares of our common stock (all of which have been exercised) and warrants for the purchase of 14,285,715 shares of our common stock in a public offering. We received net proceeds of approximately $4.5 million from the offering.

Cash Flows

During the years ended December 31, 2025 and 2024, our sources and uses of cash were as follows:

		Year Ended December 31,
		2025				2024
Net Cash Used In Operating Activities		$	(10,788,963	)		$	(8,230,346	)
Net Cash Provided By Investing Activities		$	8,897,470			$	514,529
Net Cash Provided By Financing Activities		$	2,854,791			$	7,379,330
Net Increase (Decrease) in Cash		$	963,298			$	(336,487	)

Net Cash Used in Operating Activities

Net cash used in operating activities was $10,788,963 for the year ended December 31, 2025, primarily due to cash used to fund the net loss of $14,241,975, partially offset by net non-cash expenses of $2,143,536 and $1,309,476 of cash provided by changes in our operating assets and liabilities. Net cash used in operating activities was $8,230,346 for the year ended December 31, 2024, primarily due to cash used to fund the net loss of $8,979,381 partially offset by net non-cash expenses of $720,382 and $28,653 of cash provided by changes in operating assets and liabilities.

Net Cash Provided by Investing Activities

Net cash provided by investing activities was $8,897,470 for the year ended December 31, 2025 primarily due to the sale of marketable securities which provided $11,692,686 of cash, offset by the purchase of marketable securities which used $2,679,147 of cash and purchases of equipment which used $116,069 of cash. Net cash provided by investing activities was $514,529 for the year ended December 31, 2024 primarily due to the sale of marketable securities which provided $21,508,641 of cash, offset by the purchase of marketable securities which used $20,887,923 of cash and purchases of equipment which used $106,189 of cash.

Net Cash Provided by Financing Activities

Net cash provided by financing activities was $2,854,791 for the year ended December 31, 2025 due to net proceeds of $2,918,297 received in connection with the issuance of common stock pursuant to the 2024 ATM offering and an October 2025 registered direct offering and $41,165 due to the exercise of stock options, partially offset by the payment of deferred offering costs of $99,973 and repayment of financed insurance premiums of $4,698, compared to $7,379,330 net cash provided by financing activities for the year ended December 31, 2024 due to net proceeds of $7,528,027 received in connection with the exercise and issuance of warrants, partially offset by the payment of deferred offering costs of $148,697.

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 Estimates

We prepare our consolidated financial statements in accordance with U.S. generally accepted accounting principles, or GAAP, 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 the 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 financial statements that require estimation but are not deemed critical, as defined above.

Recently Issued Accounting Pronouncements

See Note 2 to our consolidated financial statements for the years ended December 31, 2025 and 2024 included elsewhere in this Annual Report following Item 16 ("Form 10-K Summary").

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.