bioAffinity Technologies, Inc.

In addition to other information set forth in this Quarterly Report, you should carefully consider the “Risk Factors” discussed in the 2025 Form 10-K for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in this Quarterly Report. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial might materially adversely affect our actual business, financial condition, and operating results. The following information updates and should be read in conjunction with the information disclosed in Part I, Item 1A, “Risk Factors,” contained in our 2025 Form 10-K. Except as disclosed below, there have been no material changes from the risk factors disclosed in our 2025 Form 10-K.

Risks Related to Our Financial Position

Our business plan relies upon our ability to obtain additional sources of capital and financing. If the amount of capital we are able to raise from financing activities, together with our revenues from operations, is not sufficient to satisfy our capital needs, we may be required to cease operations.

Prior to 2022, we had not generated any revenue. During the six months ended June 30, 2026, we generated revenue of approximately $2.9 million, and $6.2 million during the year ended December 31, 2025.

To become and remain profitable, we must succeed in generating additional laboratory revenue and developing and commercializing our diagnostic tests and therapeutic products that we expect will generate significant income in the planned timeframe. This will require us to be successful in a range of challenging activities, including completing preclinical testing and clinical trials of our diagnostic and therapeutic technologies, obtaining regulatory approval for our diagnostic and therapeutic technologies, manufacturing, marketing, and selling any diagnostic tests and therapeutic products for which we may obtain regulatory approval, and establishing and managing our collaborations at various phases of each diagnostic test and therapeutic product candidate’s development. We are in the preliminary phases of these activities. We may never succeed in these activities and, even if we do, may never generate sufficient income to achieve profitability.

To become profitable, we must develop our diagnostic tests and therapeutic products, which will depend in large part on our ability to:

Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress our value and could impair our ability to raise capital, expand our business, maintain the research and development efforts, diversify our diagnostic tests and therapeutic product offerings, or even continue operations. A decline in our value could also cause you to lose all or part of your investment.

As of June 30, 2026, we had an accumulated deficit of $75.6 million and $2.4 million cash on hand. As of August 3, 2026, our cash and cash equivalents were $1.0 million. Despite our recent financings, we will need to raise further capital through the sale of additional equity or debt securities or other debt instruments, strategic relationships or grants, or other arrangements to support our future operations. Our business plan includes expansion for our commercialization efforts which will require additional funding. If we are unable to improve our liquidity position, we may not be able to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to generate revenue and raise capital from financing transactions. Without funding from the proceeds of a capital raise or strategic relationship or grant, management anticipates that our cash resources are sufficient to continue operations through August 2026. Based on our current expected level of operating expenditures, current expected levels of revenue, and the cash and cash equivalents on hand at June 30, 2026, of $2.4 million, management concludes that there is substantial doubt about our ability to continue as a going concern for a period of at least twelve (12) months subsequent to the issuance of the accompanying unaudited condensed consolidated financial statements contained in this Quarterly Report. Our future is dependent upon our ability to obtain financing and upon future profitable operations from the development of new business opportunities. There can be no assurance that we will be successful in accomplishing these objectives. Without such additional capital, we may be required to curtail or cease operations and be required to realize our assets and discharge our liabilities other than in the normal course of business which could cause investors to suffer the loss of all or a substantial portion of their investment. WithumSmith+Brown, PC, our independent registered public accounting firm for the fiscal year ended December 31, 2025, has included an explanatory paragraph in its opinion that accompanies our audited consolidated financial statements as of and for the year ended December 31, 2025, indicating that our current liquidity position raises substantial doubt about our ability to continue as a going concern.

We are unable to precisely estimate when we will begin to generate significant profit from revenue, if ever, from PPLS’ services, the amount of profit or revenue that will be generated, or the expenses that will be incurred.

We do not expect to immediately derive profit from revenue from PPLS’ services. Since its acquisition in September 2023, we have generated $2.5 million in 2023, $9.4 million in 2024, $6.2 million in 2025, and $2.9 million in 2026 in revenue from PPLS. Once we begin to generate such profit, there is no guarantee that it will be sufficient to realize the expected financial benefits of the acquisition. In addition, since we have limited experience operating a clinical laboratory, we may not accurately estimate the expenses we will incur.

We have received a notice of delisting from Nasdaq due to our failure to maintain the minimum bid price requirement, and there can be no assurance that we will be able to regain compliance or maintain our listing on The Nasdaq Capital Market.

On July 30, 2026, we received written notice from the Listing Qualifications Department of Nasdaq indicating that the bid price of our listed securities had closed at less than $1.00 per share over the previous thirty consecutive business days, and that, as a result, we are not in compliance with the Minimum Bid Price Requirement for continued listing on The Nasdaq Capital Market set forth in Nasdaq Listing Rule 5550(a)(2). Pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iv), we are not eligible for the standard 180-calendar day compliance period because we effected a 1-for-30 reverse stock split on September 19, 2025, which occurred within the prior one-year period.

We have submitted an appeal to Nasdaq and intend to present our plans to regain compliance with the Minimum Bid Price Requirement at a hearing before a Nasdaq Hearings Panel (the “Panel”). However, there can be no assurance that the Panel will grant us any extension period within which to regain compliance, or that, if any such extension period is granted, we will be able to regain compliance within such period.

If we are unable to regain compliance with the Minimum Bid Price Requirement or otherwise satisfy Nasdaq’s continued listing requirements, our securities could be delisted from The Nasdaq Capital Market. A delisting of our securities could have material adverse consequences, including, but not limited to: a limited availability of market quotations for our securities; reduced liquidity for our securities, making it more difficult for stockholders to buy or sell our securities; a determination that our common stock is a “penny stock,” which would require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities; a limited amount of news and analyst coverage; a decreased ability to issue additional securities or obtain additional financing in the future; potential loss of confidence by investors, employees, and business partners; and potential negative reputational effects that could impair our business, financial condition, and results of operations.

In addition, we may be required to take actions to regain compliance with the Minimum Bid Price Requirement, such as effecting an additional reverse stock split, which could result in further dilution to our stockholders and may not result in a sustained increase in the per-share price of our common stock. We previously effected a 1-for-30 reverse stock split on September 19, 2025, and there can be no assurance that any future reverse stock split, if undertaken, would result in a lasting increase in the market price of our common stock sufficient to regain or maintain compliance with the Minimum Bid Price Requirement.