Calidi Biotherapeutics, Inc.

As filed with the Securities and Exchange Commission on August 15, 2025

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORMS-1

REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

Calidi Biotherapeutics, Inc.

(Exact name of registrant as specified in its charter)

4475 Executive Drive, Suite 200,

San Diego, California 92121

Telephone:(858) 794-9600

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

Dr. Eric Poma

Chief Executive Officer

Calidi Biotherapeutics, Inc.

4475 Executive Drive, Suite 200,

San Diego, CA 92121

Telephone:(858) 794-9600

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

Copies to:

Approximate date of commencement of proposed sale to the public: As soon as practicable 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 Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

Up to 1,197,605 Common Stock Units

Each Common Stock Unit Consisting of One Share of Common Stock and

Up to 1,197,605 Pre-Funded Warrant Units

Each Pre-Funded Warrant Unit Consisting of One Pre-Funded Warrant to Purchase One Share of Common Stock and

Up to 1,197,605 Shares of Common Stock Underlying the Pre-Funded Warrants

Up to 1,197,605 Shares of Common Stock Underlying the Series I Warrants

59,880** Representative Warrants to purchase Shares of Common Stock**

Up to 59,880 Shares of Common Stock Issuable Upon Exercise of Representative Warrants

We are offering up to 1,197,605 common stock units (the “Common Stock Units”), each consisting of: (i) one share of our common stock, par value $0.0001 (“common stock” or “Common Stock”), and (ii) a Series I warrant to purchase one share of our common stock (or pre-funded warrants to purchase one share of our Common Stock in lieu thereof) (the “Common Warrant”). The assumed purchase price for each Common Stock Unit is $5.01 (equal to the last sale price of our common stock as reported by the NYSE American on August 8, 2025). The Common Warrants will have an initial exercise price of $5.01 per share or $5.009 per pre-funded warrant, which prices are equal to 100% of the price per Common Stock Unit and price per PFW Unit (defined below), respectively, sold in the offering. The Common Warrants are exercisable immediately, subject to certain limitations described herein. The Common Warrants will expire five (5) years from the closing date of this offering. We are also offering shares of our common stock or the pre-funded warrants that are issuable from time to time upon exercise of the Common Warrants.

We are also offering to each purchaser whose purchase of Common Stock Units in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% of our outstanding common stock immediately following the consummation of this offering, the opportunity to purchase, if the purchaser so chooses, up to 1,197,605 pre-funded warrant units (the “PFW Units” and together with the Common Stock Units, the “Units”), in lieu of Common Stock Units that would otherwise result in the purchaser’s beneficial ownership exceeding 4.99% of our outstanding common stock. Each PFW Unit consists of: (i): one pre-funded warrant to purchase one share of our common stock (the “Pre-Funded Warrants”), and (ii) a Common Warrant to purchase one share of our common stock. The Common Warrants included in the PFW Units are identical to the Common Warrants included in the Common Stock Units. Subject to limited exceptions, a holder of Pre-Funded Warrants will not have the right to exercise any portion of its Pre-Funded Warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99% (or, at the election of the holder, 9.99%, 14.99%, or 19.99%) of the number of shares of common stock outstanding immediately after giving effect to such exercise. Each Pre-Funded Warrant will be exercisable for one share of common stock at an exercise price of $0.001 per share of common stock. Each Pre-funded Warrant will be immediately exercisable and may be exercised at any time until all of the Pre-funded Warrants are exercised in full. The public offering price per PFW Unit is equal to the public offering price per Common Stock Unit less $0.001. We are also offering the shares of our common stock that are issuable from time to time upon exercise of the Pre-Funded Warrants. For each PFW Unit we sell, the number of Common Stock Units we are offering will be decreased on a one-for-one basis.

The number of Common Warrants sold in this offering will not change as a result of a change in the mix of the Common Stock Units and PFW Units sold. The shares of common stock in the Common Stock Units or the Pre-Funded Warrants in the PFW Units, as applicable, and the accompanying Common Warrants, can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance.

We anticipate that certain of our officers and directors will participate in the offering and purchase up to $0.5 million of the Common Stock Units or PFW Units. Because these indications of interest are not a binding agreement or commitment to purchase any securities in this offering, such officer or director may determine to purchase more, less, or no securities in this offering or the underwriters may determine to sell more, less, or no securities to such officers and directors. The underwriters will receive the same underwriting discounts and commissions on any securities purchased by our officers and directors as they would from any other securities sold to the public in this offering.

Neither the Common Stock Units nor the PFW Units will be issued or certificated. The common stock and Pre-Funded Warrants, and the accompanying Common Warrants, as the case may be, can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance. The Common Stock Units, the PFW Units, the shares of common stock, the Common Warrants, the Pre-Funded Warrants, shares of common stock or the pre-funded warrants underlying the Common Warrants, the shares of common stock underlying the Pre-Funded Warrants and Pre-Funded Warrants are sometimes collectively referred to herein as the “securities.”

Our common stock is listed on the NYSE American under the symbol “CLDI”. On August 8, 2025, the closing price of our common stock was $5.01 per share. There is no established trading market for the Pre-Funded Warrants or Common Warrants and we do not expect a market to develop. In addition, we do not intend to list the Pre-Funded Warrants or Common Warrants on the NYSE American, any other national securities exchange or any other trading system. Without an active trading market, the liquidity of the Pre-Funded Warrants and Common Warrants may be limited.

The number of Common Stock Units, PFW Units and the accompanying Common Warrants, offered by this prospectus and all other applicable information has been determined based on an assumed public offering price of $5.01, which is the closing price of our common stock on August 8, 2025. The public offering price per Common Stock Unit and any PFW Units, and the accompanying Common Warrants will be determined by us at the time of pricing, may be at a discount to the current market price of our common stock, and the recent market price of our common stock used throughout this prospectus may not be indicative of the final public offering price of the Common Stock Units or PFW Units. The actual public offering price may be based upon a number of factors, including our history and our prospects, the industry in which we operate, our past and present operating results, the previous experience of our executive officers and the general condition of the securities markets at the time of this offering.

We are an “emerging growth company” and a “smaller reporting company” under applicable Securities and Exchange Commission (“SEC”) rules and, as such, have elected to comply with certain reduced public company disclosure requirements for this prospectus and future filings. See the discussions in the section titled “Summary – Implications of Being an Emerging Growth Company and a Smaller Reporting Company.”

Investing in our securities involves a high degree of risk. You should review carefully the risks and uncertainties described in the section entitled “Risk Factors” beginning on page 12 of this prospectus, and under similar headings in any amendments or supplements to this prospectus.

Neither the 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 have granted a 45-day option to the underwriters to purchase up to 179,640 additional shares of common stock and/or up to 179,640 Pre-funded warrants and/or up to an additional 179,640 Common Warrants solely to cover over-allotments or any combination thereof, if any.

The underwriters expect to deliver the securities to purchasers on or about , 2025.

Sole Bookrunner

Ladenburg Thalmann

Co-Manager

Laidlaw & Company (UK) Ltd.

The date of this prospectus is , 2025.

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