Kairos Pharma, LTD.

As filed with the Securities and Exchange Commission on January 28, 2025.

Registration No. 333-[*]

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORMS-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

(Exact name of registrant as specified in its charter)

2355 Westwood Blvd.,#139

Los Angeles CA 90064

(310) 948-2356

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

John S. Yu, M.D.

Chief Executive Officer

2355 Westwood Blvd.,#139

Los Angeles CA 90064

(310) 948-2356

(Name, address, including zip code, and telephone number, including area code, of agent for service)

With Copies to:

Megan J. Penick, Esq. Dorsey & Whitney LLP 51 West 52nd Street New York, New York 10019 Tel: (212) 415-9200

**Approximate date of commencement of proposed sale to the public:**From time to time after this Registration Statement is declared effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box: ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.☐

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the U.S. Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

Preliminary Prospectus

2,500,000 shares** of Common Stock Issuable Upon Exercise of the Pre-Funded Warrants**

3,750,000 shares of Common Stock Issuable Upon Exercise of the Common Warrants

175,000 shares of Common Stock Issuable Upon Exercise of the Placement Agent Warrants

This prospectus relates to the offer for sale of an aggregate of 6,425,000 shares of common stock, par value $0.001 per share (“common stock”), of Kairos Pharma, Ltd. (the “Company”), consisting of (i) 2,500,000 shares of common stock underlying the pre-funded warrants (the “Pre-Funded Warrants,” and the shares of common stock underlying the Pre-Funded Warrants, the “Pre-Funded Warrant Shares”), exercisable for $0.001 per share, and (ii) 3,750,000 shares of common stock underlying common stock purchase warrants (the “Common Warrants,” and the shares of common stock underlying the Common Warrants, the “Common Warrant Shares”)all of which were issued to the investor (the “Investor”) in a private placement offering which closed on January 16, 2025 (the “PIPE Offering”), In addition, we are registering 175,000 shares of common stock, exercisable at $1.40 per share, underlying common stock purchase warrants (the “Placement Agent Warrants,” andthe shares of common stock underlying the Placement Agent Warrants, the “Placement Agent Warrant Shares”) issued to Boustead Securities, LLC (“Boustead”) and D. Boral Capital LLC (“D. Boral”) for their services as co-placement agents for the PIPE Offering(the “Placement Agents,” and together with the Investor, the “Selling Stockholders”).

In this prospectus, we sometimes refer to the Pre-Funded Warrants, Common Warrants and the Placement Agent Warrants as the “Warrants,” and we refer to the Pre-Funded Warrant Shares, Common Warrant Shares and the PA Warrant Shares as the “Warrant Shares” or “shares.”

We will not receive any proceeds from the resale of any of the shares of common stock being registered herein. We would, however, receive proceeds of up to approximately $5.5 million upon the exercise for cash of the Warrants held by the Selling Stockholders. Proceeds, if any, received from the exercise of such Warrants will be used to fund our ongoing Phase 1 and Phase 2 clinical trials of our product candidates, including ENV 105 and preclinical product candidates including KROS 101, potential acquisition or in-licensing activities, and working capital and general corporate purposes or for other purposes that our board of directors, in their good faith, deem to be in the best interest of our Company. No assurances can be given that any Warrants will be exercised or that we will receive any cash proceeds upon such exercise if cashless exercise is available.

The Selling Stockholders are “underwriters” within the meaning of Section 2(a)(11) of the Securities Act of 1933, as amended (the “Securities Act”). The Selling Stockholder may offer all or part of the shares for resale from time to time through public or private transactions, at either prevailing market prices or at privately negotiated prices. Our registration of the shares of common stock covered by this prospectus does not mean that the Selling Stockholders will offer or sell any of the shares. With regard only to the shares each Selling Stockholders sells for its own behalf, the Selling Stockholder may be deemed an “underwriter” within the meaning of the Securities Act. The Company has paid all of the registration expenses incurred in connection with the registration of the shares. We will not pay any of the selling commissions, brokerage fees and related expenses.

Our common stock is listed on NYSE American under the symbol “KAPA.” On January 27, 2025, the last reported sale price of our common stock was $1.53 per share. We recommend that you obtain current market quotations for our common stock prior to making an investment decision.

We will pay the expenses incurred in registering the shares, including legal and accounting fees. See “Plan of Distribution” beginning on page 136 of this prospectus.

We are an “emerging growth company,” as that term is used in the Jumpstart Our Business Startups Act of 2012, and as such, have elected to comply with certain reduced public company reporting requirements for the registration statement of which this prospectus forms a part and future filings. See “Prospectus Summary—Implications of Being an Emerging Growth Company.”

Neither the U.S. Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

We may amend or supplement this prospectus from time to time by filing amendments or supplements as required. We urge you to read the entire prospectus, any amendments or supplements, any free writing prospectuses, and any documents incorporated by reference carefully before you make your investment decision.

Investing in our securities involves a high degree of risk. See “Risk Factors” beginning on page 11 of this prospectus for a discussion of certain risks that you should consider in connection with an investment in our securities.

The date of this prospectus is , 2025.

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