BioRestorative Therapies, Inc.

Previous wording

We have 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 toBRTX-100.

Current wording

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 toBRTX-100.

Previous wording

As of December 31, 2023, our accumulated deficit was $167,056,381. 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.

Current wording

As of December 31, 2024, our accumulated deficit was $155,678,715. 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.

Previous wording

In April 2023, we entered into a Capital on Demand Sales Agreement with JonesTrading Institutional Services LLC, or the Sales Agent, under which we currently have the ability to issue and sell shares of our common stock, from time to time, through the Sales Agent, up to an aggregate offering price of approximately $6,109,000 in what is commonly referred to as an “at-the-market”, or ATM, program. During the year ended December 31, 2023, we sold 132,827 shares of our common stock under the ATM program with the Sales Agent at a weighted-average gross price of approximately $4.68 per share and raised approximately $622,000 of gross proceeds. The total commissions and related legal fees were approximately $127,000, and we received net proceeds of approximately $495,000. As of December 31, 2023, we had remaining capacity to sell up to an additional $5,487,000 of common stock under the ATM program.

Current wording

In November 2024, we entered into an At The Market Offering Agreement with Rodman, under which we currently have 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. Subsequent to the year ended December 31, 2024, we sold 492,000 shares of our common stock under the ATM program with Rodman at a weighted-average gross price of approximately $2.20 per share and raised approximately $1,084,000 of gross proceeds. The total commissions and related legal fees were approximately $178,000, and we received net proceeds of approximately $906,000. As of March 24, 2025, we had remaining capacity to sell up to an additional $2,530,000 of common stock under the ATM program with Rodman.

Previous wording

The net proceeds received from our November 2021 public offering, the ATM program and the registered direct offering are sufficient for us to complete our Phase 2 clinical trial with regard toBRTX-100; however, we will require significant additional funding to complete our contemplated Phase 3BRTX-100 clinical trial (assuming the receipt of no revenues). We will also 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 metabolicThermoStem 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.

Current wording

For the year ended December 31, 2024, we had a net loss of $9.0 million and negative cash flows from operations of $8.2 million and as of December 31, 2024, we had working capital of $7.4 million. We anticipate that we will continue to incur net losses and negative cash flows from operations as we execute our development plans for 2025 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 usingBRTX-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 metabolicThermoStem 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.

Previous wording

For the years ended December 31, 2023 and 2022, we generated $145,800 and $119,800, respectively, of royalty revenue in connection with our sublicense agreement.

Current wording

For the years ended December 31, 2024 and 2023, we generated $401,000 and $145,800, respectively, of royalty revenue in connection with our sublicense agreement and sales revenue in connection with our cosmeceuticals business.

Previous wording

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, 2023, research and development expenses increased by $521,239, or 15%, to $4,034,591 compared to $3,513,352 for the year ended December 31, 2022. The increase was primarily driven by increased compensation of $857,294 due to salary increases and bonuses, increased lab supplies expenses of $193,298, increased repair and maintenance expenses of $30,521, increased license agreements and fees expenses of $25,155 and increased consulting fees of $112,581, offset by a decrease in lab site fees of $53,029, and a decrease in PRC service expenses of $644,245 as the result of non-recurring start-up and execution expenses incurred during the year ended December 31, 2022.

Current wording

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, 2024, research and development expenses increased by $1,314,118, or 33%, to $5,348,709 compared to $4,034,591 for the year ended December 31, 2023. The increase was primarily driven by headcount costs of $323,025 and general lab supplies expense of $1,041,952, partially offset by the reversal of a 2023 bonus accrual of $257,873.

Previous wording

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, 2023, general and administrative expenses decreased by $4,248,490, or 27% to $11,331,983 from $15,580,473 for the year ended December 31, 2022. The decrease was primarily driven by a $4,753,377 decrease in stock-based compensation, decreased franchise tax expense of $130,850, decreased amortization expense of $104,630, decreased travel expense of $84,122, and decreased insurance expense of $53,858, all offset by an increase in compensation of $775,678 due to salary increases and bonuses, increased investor relations expense of $80,957, increased professional fees of $44,056 and an increase in office supplies expense of $10,616.

Current wording

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, 2024, general and administrative expenses decreased by $4,752,570, or 42% to $6,579,413 from $11,331,983 for the year ended December 31, 2023. The decrease was primarily driven by a decrease in stock-based compensation expense of $4,970,401 and a decrease in headcount costs of $111,363, offset by an increase in professional fees of $229,273.

Previous wording

For the year ended December 31, 2023, interest income increased $540,643, or 4641%, to $552,293 from $11,650 for the year ended December 31, 2022. The increase was due to the interest and dividend income of the investments held in marketable securities.

Current wording

For the year ended December 31, 2024, interest income increased $63,784, or 12%, to $616,077 from $552,293 for the year ended December 31, 2023. The increase was due to the interest and dividend income of the investments held in marketable securities.

Previous wording

Grant income of $83,333 during the year ended December 31, 2023 consisted of funding received under a National Institutes of Health Small Business Technology Transfer (STTR) Phase 1 grant, offset by related expenses. Grant income of $110,518 during the year ended December 31, 2022 consisted of funding received under a $256,000 National Institutes of Health Small Business Technology Transfer (STTR) Phase 1 grant, which we were awarded in September 2021.

Current wording

There was no grant income for the year ended December 31, 2024. Grant income of $83,333 during the year ended December 31, 2023 consisted of funding received under a National Institutes of Health Small Business Technology Transfer (STTR) Phase 1 grant, offset by related expenses.

Previous wording

For the year ended December 31, 2023, other income, net of $169,664 primarily related to an Employee Retention Tax Credit, gains from settlements of certain accrued expenses and realized and unrealized gain on investments. For the year ended December 31, 2022, Other income, net of $107,088 primarily related to gains from settlements of certain accrued expenses and unrealized gain on investments.

Current wording

For the year ended December 31, 2024, other income of $150,850 primarily related to investment dividend income and other miscellaneous income. For the year ended December 31, 2023, other income of $169,664 primarily related to an Employee Retention Tax Credit, gains from settlements of certain accrued expenses and realized and unrealized gain on investments.

Previous wording

In April 2023, we entered into a Capital on Demand Sales Agreement with JonesTrading Institutional Services LLC, or the Sales Agent, under which we currently have the ability to issue and sell shares of our common stock, from time to time, through the Sales Agent, up to an aggregate offering price of approximately $6,109,000 in what is commonly referred to as an “at-the-market”, or ATM, program. During the year ended December 31, 2023, we sold 132,827 shares of our common stock under the ATM program with the Sales Agent at a weighted-average gross price of approximately $4.68 per share and raised approximately $622,000 of gross proceeds. The total commissions and related legal fees were approximately $127,000, and we received net proceeds of approximately $495,000. As of December 31, 2023, we had remaining capacity to sell up to an additional approximately $5,487,000 of common stock under the ATM program.

Current wording

In November 2024, we entered into an At The Market Offering Agreement with Rodman, under which we currently have 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. Subsequent to the year ended December 31, 2024, we sold 492,000 shares of our common stock under the ATM program with Rodman at a weighted-average gross price of approximately $2.20 per share and raised approximately $1,084,000 of gross proceeds. The total commissions and related legal and accounting fees were approximately $178,000 and we received net proceeds of approximately $906,000. As of March 26, 2025, we had remaining capacity to sell up to an additional $2,530,000 of common stock under the ATM program with Rodman.

Previous wording

Net cash used in operating activities was $6,430,211 for the year ended December 31, 2023, primarily due to cash used to fund the net loss of $14,415,484, which was partially offset by non-cash expenses of $7,469,947 related primarily to stock-based compensation and $515,326 of cash provided by changes in our operating assets and liabilities. Net cash used in operating activities was $5,913,100 for the year ended December 31, 2022, primarily due to cash used to fund the net loss of $18,494,769 and a non-cash gain of $250,000 on forgiveness of our PPP loan, which was partially offset by non-cash expenses of $12,567,525 related primarily to stock-based compensation and $14,144 of cash provided by changes in operating assets and liabilities.

Current wording

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 which gives effect to net non-cash expenses of $720,382, partially offset by $28,653 of cash provided by changes in operating assets and liabilities. Net cash used in operating activities was $6,430,211 for the year ended December 31, 2023, primarily due to cash used to fund the net loss of $10,417,704 which gives effect to net non-cash expenses of $3,472,167, partially offset by $515,326 of cash provided by changes in our operating assets and liabilities.

Previous wording

Net cash provided by investing activities increased by $16,731,432 for the year ended December 31, 2023 compared to the year ended December 31, 2022, primarily due to the initial use of cash in the amount of $16,000,000 for the purchase of investments held in marketable securities made in 2022 for which there was no corresponding activity in 2023.

Current wording

Net cash provided by investing activities decreased by $2,737,514 for the year ended December 31, 2024 compared to the year ended December 31, 2023, primarily due to the purchase of marketable securities.

Previous wording

Net cash provided by financing activities increased by $2,351,343 for the year ended December 31, 2023 compared to the year ended December 31, 2022 due to the net proceeds from the ATM and registered direct public offerings of our common stock.

Current wording

Net cash provided by financing activities increased by $5,030,557 for the year ended December 31, 2024 compared to the year ended December 31, 2023 due to the gross proceeds from the exchange and issuance of warrants of $8,123,391, less issuance costs of $595,364, all partially offset by $2,348,773 of gross proceeds from the sale of common stock pursuant to an ATM and direct offering undertaken during the year ended December 31, 2023.