BIO-PATH HOLDINGS INC

As filed with the Securities and Exchange Commission on January 17, 2025

Registration No. 333-

UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM****S-1

REGISTRATION STATEMENT UNDER

THE SECURITIES ACT OF 1933

(Exact name of registrant as specified in its charter)

4710 Bellaire Boulevard, Suite 210

Bellaire, Texas 77401

** (832) 742-1357**

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

Peter H. Nielsen

President and Chief Executive Officer

4710 Bellaire Boulevard, Suite 210

Bellaire, Texas 77401

** (832) 742-1357**

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

Copies To:

William R. Rohrlich, II

Winstead PC

600 Travis Street

Suite 5200

Houston, Texas 77002

Tel. (281) 681-5912

Fax (281) 681-5901

Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes 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, 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, a 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 Section Act of 1933, as amended, or until this registration statement shall become effective on such date as the Securities and Exchange Commission acting pursuant to said section 8(a), may determine.

The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This 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 of these securities is not permitted.

SUBJECT TO COMPLETION, DATED JANUARY 17, 2025

PRELIMINARY PROSPECTUS

UP TO SHARES OF COMMON STOCK

PRE-FUNDED WARRANTS TO PURCHASE UP TO SHARES OF COMMON STOCK

UP TO SHARES OF COMMON STOCK UNDERLYING THE PRE-FUNDED WARRANTS

SERIES A COMMON WARRANTS TO PURCHASE UP TO SHARES OF COMMON STOCK

UP TO SHARES OF COMMON STOCK UNDERLYING THE SERIES A COMMON WARRANTS

SERIES B COMMON WARRANTS TO PURCHASE UP TO SHARES OF COMMON STOCK

UP TO SHARES OF COMMON STOCK UNDERLYING THE SERIES B COMMON WARRANTS

PLACEMENT AGENT WARRANTS TO PURCHASE UP TO SHARES OF COMMON STOCK UP TO SHARES OF COMMON STOCK UNDERLYING THE PLACEMENT AGENT WARRANTS

This is a best efforts public offering of up to shares of our common stock, par value $0.001 per share, together with (i) Series A warrants to purchase up to an aggregate of shares of our common stock (the “Series A Warrants”) and (ii) Series B Warrants to purchase up to an aggregate of shares of our common stock (the “Series B Warrants” and together with the Series A Warrants, the “Common Warrants”) at an assumed combined public offering price of $ per share and one Series A Warrant and one Series B Warrant (the last reported sale price per share of our common stock on the Nasdaq Capital Market on, 2025). We are also offering pre-funded warrants to purchase up to shares of our common stock (the “Pre-Funded Warrants”) and the shares of common stock issuable upon exercise of the Pre-Funded Warrants, in lieu of shares of common stock, to those investors whose purchase of shares of our common stock in this offering would result in the investor, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the investor, 9.99%) of our outstanding common stock immediately following the consummation of this offering. Each Pre-Funded Warrant will be exercisable for one share of our common stock. Each Pre-Funded Warrant is being sold together with one Series A Warrant and one Series B Warrant. Each Pre-Funded Warrant and the accompanying Common Warrants will be offered at an offering price equal to the combined public offering price at which a share of common stock and accompanying Common Warrant is being offered, minus $0.001. The exercise price of the Pre-Funded Warrants will be $0.001 per share, and the Pre- Funded Warrants will be immediately exercisable and may be exercised at any time until exercised in full. For each Pre-Funded Warrant we sell, the number of shares of common stock 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 shares of our common stock and Pre-Funded Warrants sold. The exercise price of the Common Warrants will be $ per share. The Common Warrants will be exercisable immediately on the effective date of stockholder approval of the issuance of the shares upon exercise of the Common Warrants (the “Warrant Stockholder Approval Date” and such approval, the “Warrant Stockholder Approval”); provided, however, that, if and only if the Pricing Conditions (as defined below) are met, the Common Warrants will be exercisable upon issuance. As used herein “Pricing Conditions” means that the combined offering price per share and accompanying Common Warrants is such that the Warrant Stockholder Approval is not required under the rules of the Nasdaq Stock Market LLC because either (i) the offering is an at-the-market offering under the rules of the Nasdaq Stock Market LLC and such price equals or exceeds the sum of (a) the applicable “Minimum Price” per share under Nasdaq Rule 5635(d) plus (b) $0.125 per whole share of common stock underlying the Common Warrants or (ii) the offering is a discounted offering where the pricing and discount (including attributing a value of $0.125 per whole share underlying the Common Warrants) meet the pricing requirements under the Nasdaq Stock Market LLC’s rules. The Series A Warrants will expire five years from the Warrant Stockholder Approval Date, provided that if the Pricing Conditions are met, the Series A Warrants will expire five years from the date of issuance. The Series B Warrants will expire twenty-four months from the Warrant Stockholder Approval Date, provided that if the Pricing Conditions are met, the Series B Warrants will expire twenty-four months from the date of issuance. This offering also relates to the shares of common stock issuable upon the exercise of any Pre-Funded Warrants and any Common Warrants. The shares of common stock and Pre-Funded Warrants, as the case may be, 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.

Our common stock is currently listed on the Nasdaq Capital Market under the symbol “BPTH.” On, 2025, the last reported sales price per share of our common stock on the Nasdaq Capital Market was $. All share, Pre-Funded Warrant and Common Warrant numbers are based on an assumed combined public offering price of $per share and accompanying Common Warrants (or $per Pre-Funded Warrant and accompanying Common Warrants). The actual public offering price per share of common stock and accompanying Common Warrants and per Pre-Funded Warrant and accompanying Common Warrants, as the case may be, will be determined between us, the Placement Agent (as defined below) and the investors at the time of pricing, may be at a discount to the current market price, and 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. Therefore, the assumed combined public offering price used throughout this prospectus may not be indicative of the final offering price. There is no established public trading market for the Pre-Funded Warrants or the Common Warrants, and we do not expect a market to develop. In addition, we do not intend to list the Pre-Funded Warrants or the Common Warrants on the Nasdaq Capital Market, any other national securities exchange or any other nationally recognized trading system.

This offering will terminate on , 2025, unless we decide to terminate the offering (which we may do at any time in our discretion) prior to that date. We will have one closing for all securities purchased in this offering and the combined public offering price per share of common stock (or Pre-Funded Warrant) and accompanying Common Warrants will be fixed for the duration of this offering.

We have engaged as our exclusive placement agent (the “Placement Agent”) to use its reasonable best efforts to solicit offers to purchase our securities in this offering. The Placement Agent has no obligation to purchase any of the securities from us or to arrange for the purchase or sale of any specific number or dollar amount of the securities. Because there is no minimum offering amount required as a condition to closing in this offering the actual public offering amount, Placement Agent’s fee, and proceeds to us, if any, are not presently determinable and may be substantially less than the total maximum offering amounts set forth above and throughout this prospectus. We have agreed to pay the Placement Agent the Placement Agent fees set forth in the table above. See “Plan of Distribution” in this prospectus for more information. Because there is no minimum offering amount required as a condition to closing this offering, we may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us, and investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to pursue our business goals described in this prospectus. We will bear all costs associated with the offering.

Investing in our securities involves a high degree of risk. You should review carefully the risks and uncertainties described in the section titled “Risk Factors” on page11** of this prospectus.**

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

Delivery of the shares of common stock, Pre-Funded Warrants and Common Warrants offered hereby is expected to take place on , 2025, subject to satisfaction of certain conditions.

The date of this prospectus is , 2025.