BRTX

MKT CAP $41.3MP/E —DIV YIELD —FCF YIELD —REV TTM $358K −8.5%NET INCOME −$11.1MNET CASH $2.9M52W 0.14 – 4.94SEC XBRL · TTM TO Invalid Date

How BRTX rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

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Risks Related to Our Business Generally ● We have a limited operating history; we have incurred substantial losses since inception; we expect to continue to incur losses for the near term; there is substantial doubt about our ability to continue as a going concern within the next twelve months from the date of this filing; the report of our independent registered public accounting firm contains an explanatory paragraph that expresses substantial doubt about our ability to continue as a going concern. ● We will need to obtain a significant amount of financing to complete our clinical trials and implement our business plan. ● We will need to enter into agreements in order to implement our business strategy. ● We depend on our executive officers and on our ability to attract and retain additional qualified personnel. ● In the event that we are unable to utilize our current premises and need to relocate, we will be required to comply with regulatory requirements as to the operation of our laboratory, which could have had a material adverse effect on the conduct of our clinical trials and on our business.
Risks Related to Our Common Stock ● We pay no dividends. ● Stockholders who hold unregistered shares of our common stock are subject to resale restrictions pursuant to Rule 144 due to our former status as a “shell company.” ● Material weaknesses in our internal control over financial reporting may cause us to fail to timely and accurately report our financial results or result in a material misstatement of our consolidated financial statements. ● There may be significant future issuances or resales of our common stock which may materially and adversely dilute stockholders’ ownership interest and affect the market price of our securities. ● Our common stock is classified as a “penny stock;” the restrictions of the penny stock regulations of the SEC may result in less liquidity for our common stock. ● Anti-takeover provisions and the regulations to which we may be subject may make it more difficult for a third party to acquire control of us, even if the change in control would be beneficial to our securityholders.
As of December 31, 2025, our accumulated deficit was $169,920,690.
Our consolidated financial statements as of December 31, 2025 and 2024 and for the years then ended which are included in this Annual Report following Item 16 (“Form 10-K Summary”) have been prepared on the basis that we will continue as a going concern, which contemplates realization of assets and satisfying liabilities in the normal course of business.
For the year ended December 31, 2025, we had a net loss of $14.2 million and a 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.
Our current funds will not be sufficient to fund our development efforts for the twelve months following the issuance date of such financial statements or enable us to fully complete our development activities or attain profitable operations.
The report of our independent registered public accounting firm with respect to our financial statements as of December 31, 2025 and for the year then ended indicates that our financial statements have been prepared assuming that we will continue as a going concern.
The report states that, as of December 31, 2025 there is substantial doubt about our ability to continue as a going concern within one year after the issuance date of such financial statements.
Except for a certain license agreement with Regenerative Sciences, LLC and agreements relating to the conduct of our Phase 2 clinical trial, we do not have any material agreements or understandings in place with respect to the implementation of our business strategy.
The employment agreement for each of Messrs.
Alstodt and Silva expired in March 2026 and has not yet been extended.
In the event that we are unable to utilize our current premises and need to relocate, we will be required to comply with regulatory requirements as to the operation of our laboratory, which could have had a material adverse effect on the conduct of our clinical trials and on our business.
We are utilizing our laboratory, which includes a cGMP ISO-7 certified clean room, to provide the cell processing services necessary for the clinical production of BRTX-100 for our Phase 2 disc clinical trial and to manufacture our commercial product.
In the event that we are required to relocate our premises, whether due to a casualty event or otherwise, we will be required to comply with regulatory requirements as to the operation of our laboratory which could have a material adverse effect on the conduct of our clinical trials and on our business.
We are currently conducting a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain due to degenerative disc disease related to protruding/bulging discs.
We anticipate that we will not be able to commercialize our BRTX-100 product candidate for at least five years; however, due to the unknowns relating to the FDA regulatory process, such time period may be longer or shorter.
The recent extensive use of both FDA-approved and compounded version of glucagon-like peptide-1 (GLP-1) receptor agonist drug products, such as Wegovy and Ozempic (semaglutide), including the launch of FDA-approved oral Wegovy in January 2026, for the treatment of obesity has significantly increased the competition in the obesity market.
Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA until 12 years after the original branded product is approved under a BLA.
We may also face competition from unapproved stem cell therapies performed by treatment centers that do not comply with FDA requirements.
Despite FDA’s successful enforcement against unapproved stem cell treatments in the federal courts ( United States v.
Stem Cell Clinic LLC (2021 11 th Cir.) and United States v.
California Stem Cell Treatment Center, Inc.
(2024 9 th Cir. cert. denied ) thousands of clinics continue to offer unapproved stem cell therapies due to high demand, FDA enforcement limitations, and tactical rebranding to avoid FDA enforcement action.
FDA lacks the resources to bring enforcement actions against thousands of individual small-office clinics simultaneously.
Therefore, we could face competition from stem cell clinics that would not be required to undergo the costly and time-consuming FDA approval and compliance process.
To the extent that any disruption, theft of information, or security breach were to result in a loss of or damage to data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the clinical development and future development of our product candidates could be delayed.
We manufactured a commercial product as a contract manufacturer for a third-party company.
While we believe the product we manufactured for the third party was intended for cosmetic uses, we (as the contract manufacturer) did not ultimately have control over how the product was marketed.
It is possible that the FDA could determine, based on how the product was marketed (among other considerations), that it was 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 the third party or us in connection with this product, or against others for whom we may serve in the future as a contract manufacturer, it could have an adverse impact on our operations and/or harm our reputation as a biologics company.
See “Risks Associated with Our Nasdaq Listing.” Stockholders who hold unregistered shares of our common stock are subject to resale restrictions pursuant to Rule 144 due to our former status as a “shell company.” We previously were a “shell company” pursuant to Rule 144, promulgated under the Securities Act, or Rule 144, and, as such, sales of our securities pursuant to Rule 144 cannot be made unless, among other things, we continue to remain subject to Section 13 or 15(d) of the Exchange Act, and we file all of our required periodic reports with the SEC under the Exchange Act.
Our material weaknesses related to the following control deficiencies: ● Lack of adherence to formal policies and procedures; ● Lack of risk assessment procedures on internal controls to detect financial reporting risks on a timely manner; ● Lack of design and implementation of effective controls to achieve complete and accurate financial reporting and disclosures, including documented controls over the preparation and review of journal entries, account reconciliations and income taxes.
We currently have authorization to issue up to 75,000,000 shares of common stock of which, as of March 23, 2026, 25,478,170 shares were issued and outstanding.
Until May 2026, we will be restricted from issuing additional shares of our common stock in the future, including securities convertible into, or exchangeable or exercisable for, shares of our common stock, subject to certain exceptions.
Beginning in May 2026, we will no longer be so restricted.
Pursuant to our November 2021 public offering of securities, we issued warrants for the purchase of an aggregate of 2,645,000 shares of common stock (of which warrants for the purchase of an aggregate of 1,675,000 shares of common stock have been exercised and warrants for the purchase of 970,000 shares of common stock remain outstanding) as well as underwriter warrants for the purchase of 235,970 shares of common stock.
In addition, in February 2024, in connection with certain warrant exercises, we issued warrants for the purchase of an aggregate of 2,513,686 shares of common stock.
We also have effective registration statements on Form S-8 under the Securities Act registering an aggregate of 9,850,000 shares of our common stock issuable under our 2021 Stock Incentive Plan, or the 2021 Plan (of which 349,046 shares have been issued).
As of March 23, 2026, options to purchase 5,229,325 shares of our common stock were outstanding under the 2021 Plan and 4,271,629 shares of our common stock were available for grant under the 2021 Plan.

and 31 more.

Gone since FY2024

Risks Related to Our Business Generally ● We have a limited operating history; we have incurred substantial losses since inception; we expect to continue to incur losses for the near term; there is substantial doubt about our ability to continue as a going concern within the next twelve months from the date of this filing; the report of our independent registered public accounting firm contains an explanatory paragraph that expresses substantial doubt about our ability to continue as a going concern. ● We will need to obtain a significant amount of financing to complete our clinical trials and implement our business plan. ● We will need to enter into agreements in order to implement our business strategy. ● We depend on our executive officers and on our ability to attract and retain additional qualified personnel.
Risks Relating to Late Filing of our Periodic Report ● Our failure to prepare and timely file our Quarterly Report on Form 10-Q for the period ended March 31, 2024 with the SEC limits our access to the public markets to raise debt or equity capital.
Risks Related to Our Common Stock ● We pay no dividends. ● Stockholders who hold unregistered shares of our common stock are subject to resale restrictions pursuant to Rule 144 due to our former status as a “shell company.” ● Material weaknesses in our internal control over financial reporting may cause us to fail to timely and accurately report our financial results or result in a material misstatement of our consolidated financial statements. ● There may be significant future issuances or resales of our common stock which may materially and adversely dilute stockholders’ ownership interest and affect the market price of our securities. ● Anti-takeover provisions and the regulations to which we may be subject may make it more difficult for a third party to acquire control of us, even if the change in control would be beneficial to our securityholders.
As of December 31, 2024, our accumulated deficit was $155,678,715.
Our consolidated financial statements as of December 31, 2024 and 2023 and for the years then ended which are included in this Annual Report following Item 16 (“Form 10-K Summary”) have been prepared on the basis that we will continue as a going concern, which contemplates realization of assets and satisfying liabilities in the normal course of business.
For the year ended December 31, 2024, we had a net loss of $9.0 million and a 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.
Our current funds will not be sufficient to enable us to fully complete our development activities or attain profitable operations.
The report of our independent registered public accounting firm with respect to our financial statements as of December 31, 2024 and 2023 and for the years then ended indicates that our financial statements have been prepared assuming that we will continue as a going concern.
The report states that, as of December 31, 2024 there is substantial doubt about our ability to continue as a going concern within one year after the issuance date of such financial statements.
Except for a certain license agreement with Regenerative Sciences, LLC, a product manufacturing agreement with Cartessa Aesthetics, LLC, and agreements relating to the conduct of our Phase 2 clinical trial, we do not have any material agreements or understandings in place with respect to the implementation of our business strategy.
Alstodt and Silva is subject to an employment agreement with us.
Risks Relating to Late Filing of our Periodic Report Our failure to prepare and timely file our Quarterly Report on Form 10-Q for the period ended March 31, 2024 with the SEC limits our access to the public markets to raise debt or equity capital for a period of time.
We filed our Quarterly Report on Form 10-Q for the period ended March 31, 2024 with the SEC late on June 11, 2024; therefore, at such time, we were not current in our reporting requirements with the SEC.
We are not currently eligible, without receiving a waiver from the SEC, to register our securities pursuant to a short-form registration statement on Form S-3 or a “shelf” registration statement until June 2025.
After such date, we must maintain status as a current filer.
If we wish to pursue an offering now, we would be required to conduct the offering on an exempt basis or file a registration statement on Form S-1.
Using a Form S-1 registration statement for a public offering could take significantly longer than using a registration statement on Form S-3 and increase our transaction costs, and could, to the extent we are not able to conduct offerings using alternative methods, adversely impact our ability to raise capital or complete acquisitions of other companies in a timely manner.
Our lead product candidate, BRTX-100 , is in early stages of development and we have just recently commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain due to degenerative disc disease related to protruding/bulging discs.
We anticipate that we will not be able to commercialize our BRTX-100 product candidate for at least five years.
We have just recently commenced the clinical trials necessary to obtain FDA approval to market our product candidate, BRTX-100 .
Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA until 12 years after the original branded product is approved under a biologics license application, or BLA.
We may also face increased competition from stem cell therapies performed by treatment centers that do not require FDA premarket approval.
In August 2022, a federal District Court in the case of United States v.
California Stem Cell Treatment Center, Inc. held that certain autologous adipose stem cell treatments were not “biological products” and therefore did not require FDA approval.
Court of Appeals for the Ninth Circuit, but may be appealed to the U.S.
Should it be reversed by the Supreme Court, we could face competition from stem cell clinics that would not be required to undergo the costly and time-consuming FDA approval process.
To the extent that any disruption, theft of information, or security breach were to result in a loss of or damage to data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the clinical development and the future development of our product candidates could be delayed.
We manufacture a commercial product as a contract manufacturer for a third-party company, 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.
Stockholders who hold unregistered shares of our common stock are subject to resale restrictions pursuant to Rule 144 due to our former status as a “shell company.” We previously were a “shell company” pursuant to Rule 144, promulgated under the Securities Act, or Rule 144, and, as such, sales of our securities pursuant to Rule 144 cannot be made unless, among other things, we continue to remain subject to Section 13 or 15(d) of the Exchange Act, and we file all of our required periodic reports with the SEC under the Exchange Act.
Our material weaknesses related to the following control deficiencies: ● Lack of adherence to formal policies and procedures; ● Lack of risk assessment procedures on internal controls to detect financial reporting risks on a timely manner; ● Lack of design and implementation of effective controls to achieve complete and accurate financial reporting and disclosures, including documented controls over the preparation and review of journal entries, account reconciliations and income taxes. ● Lack of design and implementation of effective controls over the accounting for warrants issued in connection with equity financings.
We currently have authorization to issue up to 75,000,000 shares of common stock of which, as of March 26, 2025, 7,504,780 shares were issued and outstanding.
In addition, as discussed in Item 1 (“Business – Business Development – Material Events During 2024”), we are obligated to issue an additional 1,138,055 shares of common stock.
We are not restricted from issuing additional shares of our common stock in the future, including securities convertible into, or exchangeable or exercisable for, shares of our common stock.
In addition, there are 1,398,158 shares of Series B preferred stock issued and outstanding.
Such shares are convertible under certain circumstances into an equal number of shares of common stock.
Pursuant to our November 2021 public offering of securities, we issued warrants for the purchase of an aggregate of 2,645,000 shares of common stock (of which warrants for the purchase of an aggregate of 1,675,000 shares of common stock have been exercised) as well as underwriter warrants for the purchase of 235,970 shares of common stock.

and 11 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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