Company: BIAF
Filing Date: 2025-05-02
Form Type: S-1
Source: 0001641172-25-008170
Chunk: 29

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-02
Form: S-1
Chunk 29
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Fundamental Transaction” (as defined in the related warrant agreement, which generally includes any merger with another entity, the sale, transfer or other disposition of all or substantially all of our assets to another entity, or the acquisition by a person of more than 50% of our Common Stock), each warrant holder will have the right at any time prior to the consummation of the Fundamental Transaction to require us to repurchase the warrant for a purchase price in cash equal to the Black-Scholes value (as calculated under the warrant agreement) of the then remaining unexercised portion of such warrant on the date of such Fundamental Transaction, which may materially adversely affect our financial condition and/or results of operations and may prevent or deter a third party from acquiring us.

If the April 2025 Warrants are exercised after the exercise price is reset stockholders will suffer substantial dilution.

If the April 2025 Warrants are exercised after a reverse stock split is effected and/or after the price reset, assuming receipt of Warrant Stockholder Approval, such exercising holder will receive 7.1 shares of Common Stock for each April 2025 Warrant they exercise and a total of 75,074,993 shares of Common Stock would be issuable upon exercise of all of the April 2025 Warrants if the exercise price is reset to the floor price of $0.10.

Risks Related to our Diagnostic Product

Until we secure FDA clearance for CyPath ®Lung as a Class II in vitro diagnostic, we may encounter physicians who will not order an LDT.

In order to market our CyPath ®Lung as an IVD medical device, we must receive de novoclassification from the FDA as a Class II in vitro diagnostic. Subject to obtaining necessary financing, we intend to launch a pivotal trial later this year in an effort to attain such classification; however, there can be no assurance that the trial will have favorable results or that it will generate the results necessary to obtain such classification. Until such time as we receive de novoclassification, which we may never receive, our marketing efforts are limited to the marketing and sale of CyPath ®Lung as an LDT. Without clearance of CyPath ®Lung by the FDA, some physicians may not order the test.

If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.

We may not be able to initiate or continue clinical trials if we are unable to locate and enroll a sufficient