Valion Bio, Inc.

Table of Contents

As filed with the Securities and Exchange Commission on July 17, 2026.

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)

1305 E. Houston Street, Building 1, Suite 311

San Antonio, TX 78205

(888) 276-6888

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

Michael K. Handley

Chief Executive Officer

1305 E. Houston Street, Building 1, Suite 311

San Antonio, TX 78205

(888) 276-6888

(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: From time to time after the effective date of this Registration Statement.

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 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 becomes effective. This preliminary prospectus is not an offer to sell the securities and it is not soliciting an offer to buy the securities in any state where offers or sales are not permitted.

Up to 29,411,764 Shares of Common Stock

Up to 29,411,764 Pre-Funded Warrants to Purchase up to 29,411,764 Shares of Common Stock

Up to 29,411,764 Common Warrants to Purchase up to 29,411,764 Shares of Common Stock

Up to 1,764,705 Placement Agent Warrants to Purchase up to 1,764,705 Shares of Common Stock

Up to 29,411,764 Shares of Common Stock underlying the Pre-Funded Warrants

Up to 29,411,764 Shares of Common Stock underlying the Common Warrants

Up to 1,764,705 Shares of Common Stock underlying the Placement Agent Warrants

We are offering up to 29,411,764 shares of our common stock, par value $0.0001 per share, and up to 29,411,764 common warrants to purchase up to 29,411,764 shares of our common stock (the “Common Warrants”), to be sold together with each share of common stock, at an assumed combined public offering price of $0.51 per share and Common Warrant (based upon the last reported sale price of our common stock on The Nasdaq Capital Market on July 13, 2026). Each Common Warrant will have an assumed exercise price of $0.51 per share (100% of the assumed combined public offering price per share of common stock and Common Warrant), will become exercisable commencing on the date of issuance, and will expire five years from the date of issuance. The actual combined public offering price per share of common stock (or Pre-Funded Warrant) and Common Warrant will be determined among us, Dawson James Securities, Inc. (the “Placement Agent”), and the investors in the offering at the time of pricing, and may be at a discount to the then-current market price of our common stock. Therefore, the assumed combined public offering price used throughout this prospectus may not be indicative of the final offering price.

We are also offering to certain purchasers whose purchase of shares of common stock in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock immediately following the consummation of this offering, the opportunity to purchase, if any such purchaser so chooses, pre-funded warrants (“Pre-Funded Warrants”) to purchase shares of common stock, in lieu of shares of common stock. The purchase price of each Pre-Funded Warrant will be equal to the combined public offering price per share of common stock and Common Warrant sold in this offeringminus $0.0001, the exercise price of each Pre-Funded Warrant.

For each Pre-Funded Warrant we sell, the number of shares of common stock we are offering will be reduced on a one-for-one basis. Because we will issue a Common Warrant for each share of common stock and each Pre-Funded Warrant sold in this offering, the number of Common Warrants sold in this offering will not change as a result of a change in the mix of shares of common stock and Pre-Funded Warrants sold. The shares of common stock (or Pre-Funded Warrants) and the accompanying Common Warrants can only be purchased together in this offering, but the securities will be immediately separable upon issuance and will be issued separately. The shares of common stock issuable from time to time upon exercise of the Common Warrants and the Pre-Funded Warrants are also being offered by this prospectus. We collectively refer to the shares of common stock and Pre-Funded Warrants offered hereby and the shares of common stock underlying the Common Warrants and the Pre-Funded Warrants as the “Shares.”

This offering will terminate on August 14, 2026, 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 the securities purchased in this offering. The combined public offering price per share (or Pre-Funded Warrant) and accompanying Common Warrant will be fixed for the duration of this offering.

We have engaged the Placement Agent to act as our placement agent in connection with this offering. The Placement Agent has agreed to use its reasonable best efforts to arrange for the sale of the securities offered by this prospectus. The Placement Agent is not purchasing or selling any of the securities we are offering and the Placement Agent is not required to arrange the purchase or sale of any specific number of securities or dollar amount. We have agreed to pay to the Placement Agent the fees set forth in the table below, which assumes that we sell all of the securities offered by this prospectus. There is no arrangement for funds to be received in escrow, trust or similar arrangement. There is no minimum offering requirement as a condition of closing of this offering. We may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us. Because there is no escrow account and no minimum number of securities or amount of proceeds, investors could be in a position where they have invested in us, but we have not raised sufficient proceeds in this offering to adequately fund the intended uses of the proceeds as described in this prospectus. See “Risk Factors” for more information regarding risks related to this offering. We will bear all costs associated with the offering. See “Plan of Distribution” for more information regarding these arrangements.

Our common stock is traded on The Nasdaq Capital Market tier of The Nasdaq Stock Market, LLC under the symbol “VBIO.” The last reported sale price of our common stock on The Nasdaq Capital Market on July 13, 2026, was $0.51 per share. There is currently no established trading market for the offered Common Warrants or Pre-Funded Warrants. We do not intend to list the Common Warrants or Pre-Funded Warrants on The Nasdaq Capital Market or any other national securities exchange or nationally recognized trading system. Without an active trading market, the liquidity of the Common Warrants and Pre-Funded Warrants will be limited.

We are an “emerging growth company” and a “smaller reporting company,” each as defined under the federal securities laws and, as such, have elected to comply with certain reduced reporting requirements for this prospectus and may elect to do so in future filings. See the section titled “Implications of Being an Emerging Growth Company and a Smaller Reporting Company.”

Investing in our securities involves a high degree of risk. Before making an investment decision, please read the section titled “Risk Factors” beginning on page 8 of this prospectus.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

Dawson James Securities, Inc.

The date of this prospectus is , 2026.