Amendment: SEC Form S-3/A filed by PLUS THERAPEUTICS Inc.

As filed with the Securities and Exchange Commission on April 23, 2025

Registration No. 333-286393

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

AMENDMENT NO. 1

TO

FORM S-3

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

 

PLUS THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware		33-0827593
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification Number)

2710 Reed Road, Suite 160

Houston, Texas 77051

(737) 255-7194

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

 

 

Marc H. Hedrick, M.D.

President and Chief Executive Officer

Plus Therapeutics, Inc.

2710 Reed Road, Suite 160

Houston, Texas 77051

(737) 255-7194

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

 

 

Copies to:

Andrew L. Strong

William I. Intner

Hogan Lovells US LLP

609 Main Street, Suite 4200

Houston, Texas 77002

(713) 632-1400

 

 

Approximate Date of Commencement of Proposed Sale to the Public: From time to time after the effective date of this registration statement.

If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box: ☐

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, other than securities offered only in connection with dividend or interest reinvestment plans, 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 registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ☐

If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ☐

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.

 

Large accelerated filer		☐		Accelerated filer		☐
Non-accelerated filer		☒		Smaller reporting company		☒
				Emerging growth company		☐

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 that specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

 

TABLE OF CONTENTS

 

ABOUT THIS PROSPECTUS			ii
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS			iii
PROSPECTUS SUMMARY			1
OUR COMPANY			1
THE OFFERING			2
RISK FACTORS			3
USE OF PROCEEDS			5
SELLING STOCKHOLDERS			8
PLAN OF DISTRIBUTION			13
LEGAL MATTERS			16
EXPERTS			16
WHERE YOU CAN FIND ADDITIONAL INFORMATION			16
INFORMATION INCORPORATED BY REFERENCE			16

 

 

You should rely only on the information provided in this prospectus, as well as the information incorporated by reference to exhibits to the registration statement of which this prospectus forms a part and any applicable prospectus supplement or amendment. Neither we nor the selling stockholders have authorized anyone to provide you with different information. Neither we nor the selling stockholders are making an offer of these securities in any jurisdiction where the offer is not permitted. You should not assume that the information in this prospectus or any applicable prospectus supplement is accurate as of any date other than the date of the applicable document. Since the date of this prospectus and the documents filed as exhibits to the registration statement of which this prospectus forms a part, our business, financial condition, results of operations and prospects may have changed.

 

i

ABOUT THIS PROSPECTUS

This prospectus is part of a registration statement that we filed with the Securities and Exchange Commission (the “SEC”) using a “shelf” registration process. Under this shelf registration process, the selling stockholders identified in this prospectus under the section entitled “Selling Stockholders,” may use the shelf registration statement to offer and resell, from time to time, up to an aggregate of 1,565,044,860 shares of our common stock through any means described in the section entitled “Plan of Distribution”.

A prospectus supplement may also add, update or change information included in this prospectus. Any statement contained in this prospectus will be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in such prospectus supplement modifies or supersedes such statement. Any statement so modified will be deemed to constitute a part of this prospectus only as so modified, and any statement so superseded will be deemed not to constitute a part of this prospectus. You should rely only on the information contained in this prospectus, any applicable prospectus supplement or any related free writing prospectus, including any information incorporated by reference. See “Where You Can Find More Information” and “Information Incorporated by Reference.”

We are not selling any shares of common stock under this prospectus, and we will not receive any proceeds from the sale of shares of common stock offered hereby by the selling stockholders, although we may receive cash from the exercise of the Warrants (as defined in this prospectus).

You should rely only on the information provided in this prospectus, including any information incorporated by reference. We have not authorized anyone to provide you with any other information and we take no responsibility for, and can provide no assurances as to the reliability of, any other information that others may give you. The information contained in this prospectus speaks only as of the date set forth on the cover page and may not reflect subsequent changes in our business, financial condition, results of operations and prospects.

Neither we nor the selling stockholders have authorized anyone to provide any information or to make any representations other than those contained in this prospectus, any accompanying prospectus supplement or any free writing prospectus we have prepared. We and the selling stockholders take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the shares of common stock offered hereby and only under circumstances and in jurisdictions where it is lawful to do so. No dealer, salesperson or other person is authorized to give any information or to represent anything not contained in this prospectus, any applicable prospectus supplement or any related free writing prospectus. This prospectus is not an offer to sell securities, and it is not soliciting an offer to buy securities, in any jurisdiction where the offer or sale is not permitted. You should assume that the information appearing in this prospectus or any prospectus supplement is accurate only as of the date of those documents and that any information incorporated by reference is accurate only as of the date of the document incorporated by reference (or, in each case, any earlier date specified for such information, unless we indicate otherwise), regardless of the time of delivery of this prospectus or any applicable prospectus supplement, or any sale of a security. Our business, financial condition, results of operations and prospects may have changed since those dates.

 

ii

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains “forward-looking statements” for purposes of the federal securities laws. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Words such as “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will” and “would,” as well as similar expressions which predict or indicate future events and trends or which do not relate to historical matters, are intended to identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. For example, we may use forward-looking statements when addressing topics such as:

 

•

our anticipated expenditures, including research and development, and general and administrative expenses;

 

•

our ability to enter into strategic arrangements and/or collaborations and to realize the potential benefits of such arrangements, including license agreements;

 

•

U.S. Food and Drug Administration and European Medicines Agency approvals and interactions and government regulation;

 

•

the potential size of the market for our product candidates;

 

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the timing or likelihood of regulatory filings and our ability to obtain and maintain regulatory approvals;

 

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any future commercialization of our product candidates and laboratory tests;

 

•

our ability to enroll patients in our clinical trials;

 

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our ability and the potential to successfully manufacture and supply our product candidates or laboratory tests for clinical trials and for commercial use;

 

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our estimates regarding the potential market size and market opportunity for our product candidates and laboratory tests;

 

•

our research and development efforts;

 

•

the timing of the initiation, progress, and expected results of our nonclinical studies, our pre-clinical and clinical trials, and our research and development programs;

 

•

our ability to advance product candidates into, and successfully complete, nonclinical studies and clinical trials;

 

•

results from our pre-clinical and clinical studies and the implications of such results regarding the efficacy or safety of our product candidates;

 

•

the safety profile, pathways, and efficacy of our product candidates and formulations;

 

•

the anticipated advantages of our product candidates and laboratory tests over other products available in the market and being developed;

 

•

the populations that will most benefit from our product candidates and indications that will be pursued with each product candidate;

 

•

the anticipated progress in our current and future clinical trials;

 

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plans and strategies to create novel technologies;

 

•

the scope of protection we are able to establish and maintain for intellectual property rights covering our technology platforms and product candidates, and the defense of such intellectual property rights;

 

iii

•

developments relating to our competitors and our industry, including competing product candidates, therapies and laboratory tests;

 

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future development and/or expansion of our product candidates, therapies and laboratory tests in our markets;

 

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sources of competition for any of our product candidates or laboratory tests;

 

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our ability to generate revenue and the sources of such revenue;

 

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our ability to effectively manage our gross profit margins;

 

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our potential need for additional financing and the availability thereof;

 

•

our ability to continue as a going concern;

 

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our ability to remain listed on Nasdaq;

 

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our estimates regarding expenses, capital requirements, and needs for additional financing and our ability to obtain additional capital;

 

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our ability to repay or refinance some or all of our outstanding indebtedness and our ability to raise capital in the future;

 

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our ability to integrate into our business and operations, develop, fully utilize and monetize acquired assets;

 

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our ability to transfer the drug product manufacturing to a contract drug manufacturing organization;

 

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the potential enhancement of our cash position through development, marketing, and licensing arrangements;

 

•

the implementation of our business model, strategic plans for our business, and product candidates;

 

•

our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;

 

•

our ability to prevent or timely detect a material security breach or cyber security attack affecting our operations and property;

 

•

our use of the proceeds from any exercise of the Warrants; and

 

•

other factors detailed under the section entitled “Risk Factors” in this prospectus.

We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. Forward-looking statements are not guarantees of future performance, conditions or results, and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, actual results may differ materially and adversely from those anticipated in any forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this prospectus. While we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information.

We undertake no obligation to update or revise any forward-looking statements contained in this prospectus, whether as a result of new information, future events or otherwise.

 

iv

 

1

 

2

RISK FACTORS

An investment in our shares of common stock involves a high degree of risk. In addition to the risks and uncertainties discussed below, and above under “Cautionary Note Regarding Forward-Looking Statements,” you should carefully consider the risk factors incorporated by reference to our most recent Annual Report on Form 10-K and all other information contained or incorporated by reference into this prospectus, as updated by our subsequent filings under the Exchange Act, and the risk factors and other information contained in any applicable prospectus supplement, before making an investment decision. Our business, prospects, financial condition or operating results could decline due to any of these risks and, as a result, you may lose all or part of your investment. The occurrence of any of these risks might cause you to lose all or part of your investment in the offered securities. We may face additional risks and uncertainties that are not presently known to us, or that we currently deem immaterial.

We are registering for resale an aggregate of 1,565,044,860 shares of common stock, including an aggregate of 1,542,317,700 shares of common stock issuable upon exercise of the Warrants, and the issuance and sale of these shares (or the perception that such sales may occur) may depress the market price of our common stock and cause immediate and substantial dilution to our existing stockholders.

As of March 21, 2025, we had 16,999,626 shares of common stock issued and outstanding. We are registering for resale an aggregate of 1,565,044,860 shares of our common stock, which represents approximately 9,206% of the 16,999,626 shares of our common stock outstanding and approximately 99% of our total shares of common stock outstanding assuming the exercise of all of the Warrants and issuance of the maximum number of shares of common stock that may be issuable upon exercise of the Warrants. The Series B Common Stock Warrants are subject to a zero exercise price provision, pursuant to which the Series B Common Stock Warrants can be exercised without further payment to us and for three times the number of shares of common stock issuable upon exercise of the Series B Common Stock Warrants for cash. The Common Warrants include a reset provision described below under “Private Placement,” pursuant to which the exercise price of the Common Warrants may be reduced to a price not lower than $0.132 (the “Floor Price”). On April 21, 2025, the closing sale price of our common stock was $0.641 per share.

If the exercise price of the Series A Common Stock Warrants is reduced to the Floor Price pursuant to the reset provision, the 28,042,138 outstanding Series A Common Stock Warrants would become exercisable for an aggregate of up to 280,421,380 shares of common stock. The 28,042,138 outstanding Series B Common Stock Warrants would be exercisable for an aggregate of up to 84,126,414 shares of common stock assuming the Series B Common Stock Warrants are exercised pursuant to the zero exercise price provision. In the event that the exercise price of the Series B Common Stock Warrants is reduced to the Floor Price pursuant to the reset provision, the Series B Common Stock Warrants would become exercisable for an aggregate of up to 420,632,070 shares of common stock, or an aggregate of up to 1,261,896,210 shares of common stock assuming the Series B Common Stock Warrants are exercised pursuant to the zero exercise price provision.

Any sale of such shares may depress the market price of our common stock. Sales of a substantial number of shares of our common stock by the selling stockholders in the public market could occur at any time. Whether as a result of sales of a substantial number of shares of our common stock by the selling stockholders or the perception that such sales may occur, the market price of shares of our common stock could decline significantly and the volatility of the market price of our shares of common stock could increase significantly. In addition, the issuance of shares upon exercise of the Warrants will cause immediate and substantial dilution to our stockholders. For example, if the maximum aggregate of 1,542,317,700 shares of common stock issuable upon exercise of the Warrants were issued, the ownership interest of our existing stockholders, other than the holders of the Warrants whose ownership interests would materially increase, would be correspondingly diluted by approximately 99%.

 

3

The price of our common stock may decline or be depressed as a result of short sales. There is an increased potential for short sales of our common stock due to the sale of shares of our common stock pursuant to the Purchase Agreement, which could materially and adversely affect the market price of our common stock.

When an investor sells stock that it does not own, it is known as a short sale. The short selling investor, anticipating that the price of the stock will go down, intends to buy stock to cover its sale at a later date. If the price of the stock goes down, the short selling investor will profit to the extent of the difference between the price at which it originally sold it less its later purchase price. The Purchase Agreement does not contain a prohibition against short sales by the selling stockholders, including between the date that the March PIPE Financing was consummated and the date that the Warrant Stockholder Approval (as defined below) is obtained, if at all. As such, receipt of the Warrant Stockholder Approval and, in particular the large number of shares of common stock then issuable upon exercise of the Common Warrants and the exercise price adjustment provisions in the Common Warrants, could encourage short sales of our common stock by the selling stockholders. When and if the Warrant Stockholder Approval is obtained, significant amounts of such short selling could place further downward pressure on the market price of our common stock. Any significant downward pressure on the price of our common stock as the selling stockholders sell their shares of our common stock could encourage other stockholders to sell as well as short sales by the selling stockholders or others. Any such short sales could place further downward pressure on the price of our common stock.

There is no assurance that we will be able to continue to comply with Nasdaq’s minimum bid price requirement, and as a result our common stock may become delisted, which could have a material adverse effect on the liquidity of our common stock and our ability to raise capital.

To maintain the listing of our shares of common stock on the Nasdaq, our common stock must maintain a minimum bid price of $1.00 as set forth in Nasdaq Rule 5550(a)(2). If the closing bid price of our common stock is below $1.00 for 30 consecutive trading days, Nasdaq will send a deficiency notice to us, advising us that we have been afforded a “compliance period” of 180 calendar days to regain compliance with the applicable requirements. The closing bid price for our common stock fell below the minimum $1.00 per share required for continued listing on Nasdaq pursuant to Rule 5550(a)(2), starting on April 2, 2025.

There is no assurance that we will be able to meet Nasdaq’s listing requirements or comply with the requisite Nasdaq requirements to maintain our listing of common stock on Nasdaq. If Nasdaq delists our securities from trading on its exchange and we are not able to list our securities on Nasdaq or any other national securities exchange, we could face significant material adverse consequences, including:

 

•

a limited availability of market quotations for our common stock;

 

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reduced liquidity for our common stock;

 

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a determination that our common stock is a “penny stock,” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities;

 

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a limited amount of news and analyst coverage for us;

 

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a decreased ability to issue additional securities or obtain additional financing in the future; and

 

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the incurring of additional costs under state blue sky laws in connection with any sales of our securities.

If our common stock is delisted by Nasdaq, our common stock may be eligible to trade on an over-the-counter quotation system where an investor may find it more difficult to sell our stock or obtain accurate quotations as to the market value of our common stock. In the event our common stock is delisted from Nasdaq, we may not be able to list our common stock on another national securities exchange or obtain quotation on an over-the-counter quotation system.

Furthermore, any efforts we take to maintain our listing on Nasdaq, including pursuing a reverse stock split, may not be sufficient.

 

4

USE OF PROCEEDS

We will not receive any proceeds from any sale of shares of our common stock by the selling stockholders or their permitted transferees. All proceeds from the sale of shares of common stock will be for the accounts of the selling stockholders or their permitted transferees.

We will only receive net proceeds to the extent that the Warrants are exercised for cash. We expect to use any such net proceeds from the exercise of the Warrants for general corporate purposes.

Our expected use of proceeds described above represents our current intentions based on our present plans and business condition. The amounts and timing of our actual expenditures will depend on numerous factors, including the time and cost necessary to conduct our planned clinical trials, the results of our planned clinical trials, and other factors described in “Risk Factors” in this prospectus, as well as the amount of cash used in our operations and any unforeseen cash needs.

We will bear the out-of-pocket costs, expenses, and fees incurred in connection with the registration of the shares of common stock to be sold by the selling stockholders pursuant to this prospectus. Other than registration-related expenses, the selling stockholders will bear their own broker or similar commissions payable with respect to any sales of their shares of common stock and any legal fees or other costs of the selling stockholders related thereto.

 

5

PRIVATE PLACEMENT

The shares of common stock, Pre-Funded Warrants and Common Warrants being registered hereunder were issued in the March PIPE Financing pursuant to the Purchase Agreement, among us and the Purchasers.

Exercise Price. The exercise price of each Prefunded Warrant is $0.001 per share of common stock.

The initial exercise price of each Series A Common Stock Warrant is $1.32 per share of common stock, subject to the “reset” provision described below.

The initial exercise price of each Series B Common Stock Warrant is $1.98 per share of common stock, subject to the “reset” provision described below, or pursuant to a zero exercise price option, which is referred to in the Series B Warrant as an “alternative cashless exercise.”

Reset Provision. The exercise price of the Common Warrants will reset to a price equal to the greater of (i) the Floor Price, and (ii) the lowest volume weighted average price during the period commencing on the first trading day immediately following the later of (x) the earlier of (A) the first (1^st) trading day after the registration statement of which this prospectus forms a part is declared effective, or (B) the first (1^st) trading day after the date on which the holder of those securities can sell them pursuant to Rule 144 without restriction or limitation, or (y) the first (1^st) trading day after the Warrant Stockholder Approval is obtained, and the number of shares issuable upon exercise will be proportionately adjusted such that the aggregate exercise price will remain unchanged. The Floor Price is subject to appropriate adjustment for any stock dividend, stock split, stock combination, reclassification or similar transaction.

The number of shares issuable upon exercise of the Common Warrants will increase in proportion to the amount by which the exercise price is reduced below the initial exercise price of the applicable Common Warrant. In the event that the exercise price of the Series A Common Stock Warrants is reduced to the Floor Price pursuant to the reset provision, the 28,042,138 outstanding Series A Common Stock Warrants would become exercisable for an aggregate of up to 280,421,380 shares of common stock at the Floor Price. The 28,042,138 outstanding Series B Common Stock Warrants would be exercisable for an aggregate of up to 84,126,414 shares of common stock assuming the Series B Common Stock Warrants are exercised pursuant to the zero exercise price provision. In the event that the exercise price of the Series B Common Stock Warrants is reduced to the Floor Price pursuant to the reset provision, the Series B Common Stock Warrants would become exercisable for an aggregate of up to 420,632,070 shares of common stock, or an aggregate of up to 1,261,896,210 shares of common stock assuming the Series B Common Stock Warrants are exercised pursuant to the zero exercise price provision.

Adjustment for Subsequent Issuances. Subject to certain exceptions, if the Company sells any common stock (or securities convertible into or exercisable into common stock) at a price per share (or conversion or exercise price, as applicable) less than the exercise price of the Series A Common Stock Warrants then in effect, then the exercise price of the Series A Common Stock Warrants will be reduced to such lower price, but no lower than the Floor Price, and the number of shares issuable upon exercise will be proportionately adjusted such that the aggregate exercise price will remain unchanged.

Share Combination Event Adjustment. If at any time on or after the date of issuance there occurs any share split, share dividend, share combination recapitalization or other similar transaction involving our common stock and the lowest daily volume weighted average price during the period commencing on the trading day immediately following the applicable date of share combination event and ending on the fifth (5^th) trading day immediately following such date is less than the exercise price of the Warrants then in effect, then the exercise price of the Warrants will be reduced to the lowest daily volume weighted average price during such period (subject to a minimum exercise price of the Floor Price), and the number of shares issuable upon exercise will be proportionately adjusted such that the aggregate exercise price will remain unchanged.

 

6

Warrant Stockholder Approval. Under Nasdaq listing rules, the Warrants may not be exercised unless and until we obtain the approval of our stockholders (the “Warrant Stockholder Approval”). While we intend to promptly seek stockholder approval, there is no guarantee that the Warrant Stockholder Approval will ever be obtained. If we are unable to obtain the Warrant Stockholder Approval, the Warrants may not be exercised and will have substantially less value. In addition, we will incur substantial cost, and management will devote substantial time and attention, in attempting to obtain the Warrant Stockholder Approval.

 

7

SELLING STOCKHOLDERS

The selling stockholders listed in the table below may from time to time offer and sell up to an aggregate of 1,565,044,860 shares of common stock offered and issued in the March PIPE Financing pursuant to this prospectus and the applicable prospectus supplements, which consists of:

 

•

up to 3,077,270 shares of common stock;

 

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up to 19,650,000 shares of common stock issuable upon exercise of Pre-Funded Warrants;

 

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up to 280,421,380 shares of common stock that could become issuable upon exercise of Series A Common Stock Warrants; and

 

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up to 1,261,896,210 shares of common stock that could become issuable upon exercise of Series B Common Stock Warrants.

The number of shares issuable upon the Common Warrants has been calculated assuming the exercise price of the Common Warrants has been reduced to the Floor Price as discussed under Private Placement above. The selling stockholders have not had any material relationship with us within the past three years, except for the ownership of our equity or debt securities.

As used in this prospectus, the term “selling stockholders” includes the selling stockholders listed in the table below, together with any additional selling stockholders listed in a subsequent amendment to this prospectus, and their respective donees, pledgees, assignees, transferees or other successors-in-interest selling shares of common stock or interests in shares of common stock received after the date of this prospectus from a selling stockholder as a gift, pledge, partnership distribution or other transfer.

In accordance with the terms of the Registration Rights Agreement, this prospectus covers the resale of the maximum number of shares of common stock issuable upon exercise of the Warrants without regard to any limitations on the exercise of such warrants. Under the terms of the Pre-Funded Warrants and Common Warrants held by selling stockholders, a selling stockholder may elect to the extent such exercise would cause such selling stockholder, together with its affiliates and attribution parties, to beneficially own a number of shares of common stock which would exceed 4.99% or 9.99%, as applicable, of our then outstanding shares common stock following such exercise, excluding for purposes of such determination shares of common stock issuable upon exercise of such Warrants that have not been exercised, to instead receive a Pre-Funded Warrant in lieu of shares of common stock. The shares of common stock reported under “Number of Shares Owned” and “Number of Shares Being Offered” in the table below do not give effect to any such beneficial ownership limitation.

The table below lists the selling stockholders and other information regarding the beneficial ownership of the shares of common stock by each of the selling stockholders as of April 2, 2025, assuming the full exercise of the Warrants held by the selling stockholders on that date, without regard to any limitations on exercises. As of March 21, 2025, we had 16,999,626 shares of common stock issued and outstanding. The following table also provides the number of shares of common stock that may be sold by each selling stockholder under this prospectus and that each selling stockholder will beneficially own assuming all the shares of common stock that may be offered pursuant to this prospectus are sold. Because each selling stockholder may dispose of all, none or some portion of their shares of common stock, no estimate can be given as to the number of shares of common stock that will be beneficially owned by a selling stockholder upon termination of this offering. For purposes of the table below, however, we have assumed that after termination of this offering none of the shares of common stock covered by this prospectus will be beneficially owned by the selling stockholders and further assumed that the selling stockholders will not acquire beneficial ownership of any additional securities during the offering. In addition, the selling stockholders may have sold, transferred or otherwise disposed of, or may sell, transfer or otherwise dispose of, at any time and from time to time, our securities in transactions exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), after the date on which the information in the table is presented. See the section entitled “Plan Of Distribution.”

 

8

Certain selling stockholders currently hold and may acquire shares of common stock in addition to those registered hereby. In accordance with the rules of the SEC, beneficial ownership includes voting or investment power with respect to securities and includes any shares of common stock issuable pursuant Warrants that are exercisable within 60 days of March 21, 2025, except that the numbers presented in the table below do not give effect to the beneficial ownership limitations discussed above. These shares of common stock are deemed to be outstanding and beneficially owned by the person holding those Warrants for the purpose of computing the percentage ownership of that person, but they are not treated as outstanding for the purpose of computing the percentage ownership of any other person. The information contained in the following table is not necessarily indicative of beneficial ownership for any other purpose.

 

		Beneficial Ownership Before this Offering								Beneficial Ownership After this Offering
Selling Stockholder		Number of Shares Owned				Number of Shares Being Offered				Number of Shares Owned				Percentage of Outstanding Shares
AIGH Investment Partners, L.P.(1)			91,995,312				91,041,775				953,537				5.31	%
WVP Emerging Manager Onshore Fund, LLC – AIGH Series(2)			31,692,024				31,361,880				330,144				1.91	%
AIGH Investment Partners, LLC(3)			10,323,940				10,200,300				123,640					*
Iroquois Master Fund Ltd.(4)			32,123,750				31,708,875				414,875				2.39	%
Iroquois Capital Investment Group LLC(5)			49,059,762				48,442,900				616,862				3.51	%
The Hewlett Fund LP(6)			47,390,013				46,921,270				468,743				2.68	%
Aramas Capital Management LLC(7)			8,258,241				8,160,130				98,111					*
Pinz Capital Special Opportunities Fund lp(8)			8,258,241				8,160,130				98,111					*
Globis Capital Partners, L.P.(9)			16,320,480				16,320,480				—				—
Altium Healthcare Long Short Master Fund LP(10)			254,545,424				254,545,424				—				—
Bigger Capital Fund, LP(11)			254,545,424				254,545,424				—				—
Great Point Capital, LLC(12)			254,545,424				254,545,424				—				—
L1 Capital Global Opportunities Master Fund(13)			254,545,424				254,545,424				—				—
S.H.N Financial Investments Ltd.(14)			254,545,424				254,545,424				—				—

 

*	Represents beneficial ownership of less than one percent (1%) of the outstanding shares of our common stock.

(1)

The shares reported under “Beneficial Ownership Before this Offering” consist of the following securities: (i) 16,553,050 shares of common stock issuable upon the exercise of Series A Common Stock Warrants; (ii) 74,488,725 shares of common stock issuable upon the exercise of Series B Common Stock Warrants; and (iii) 953,537 shares of common stock issuable upon the exercise of Series B common stock purchase warrants (“May 2024 Warrants”) issued in a private placement on May 9, 2024. The Common Warrants and May 2024 Warrants are subject to a beneficial ownership limitation of 9.99%, which limitation restricts the selling stockholder from exercising that portion of the Common Warrants and May 2024 Warrants that would result in the selling stockholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. Mr. Orin Hirschman is the managing member of AIGH Capital Management, LLC, a Maryland limited liability company (“AIGH CM”), which is an advisor with respect to the securities held by AIGH Investment Partners, L.P. (“AIGH LP”). Mr. Hirschman has voting and investment control over the securities indirectly held by AIGH CM, directly held by AIGH LP and directly held by Mr. Hirschman and his family. The address of Mr. Hirschman and the entities listed is 6006 Berkeley Avenue, Baltimore, Maryland 21209.

 

9

(2)

The shares reported under “Beneficial Ownership Before this Offering” consist of the following securities: (i) 5,702,160 shares of common stock issuable upon the exercise of Series A Common Stock Warrants; (ii) 25,659,720 shares of common stock issuable upon the exercise of Series B Common Stock Warrants; and (iii) 330,144 shares of common stock issuable upon the exercise of May 2024 Warrants. The Common Warrants and May 2024 Warrants are subject to a beneficial ownership limitation of 9.99%, which limitation restricts the selling stockholder from exercising that portion of the Common Warrants and May 2024 Warrants that would result in the selling stockholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. Mr. Hirschman is the managing member of AIGH CM, which is a sub-advisor with respect to the securities held by WVP Emerging Manager Onshore Fund, LLC – AIGH Series. Mr. Hirschman has voting and investment control over the securities indirectly held by AIGH CM and directly held by Mr. Hirschman and his family directly. The address of Mr. Hirschman and the entities listed is 6006 Berkeley Avenue, Baltimore, Maryland 21209.

(3)

The shares reported under “Beneficial Ownership Before this Offering” consist of the following securities: (i) 1,854,600 shares of common stock issuable upon the exercise of Series A Common Stock Warrants; (ii) 8,345,700 shares of common stock issuable upon the exercise of Series B Common Stock Warrants; and (iii) 123,640 shares of common stock issuable upon the exercise of May 2024 Warrants. The Common Warrants and May 2024 Warrants are subject to a beneficial ownership limitation of 9.99%, which limitation restricts the selling stockholder from exercising that portion of the Common Warrants and May 2024 Warrants that would result in the selling stockholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. Mr. Hirschman is the managing member of AIGH Investment Partners, LLC, a Delaware limited liability company (“AIGH LLC”). Mr. Hirschman has voting and investment control over the securities indirectly held by AIGH LLC and directly held by Mr. Hirschman and his family directly. The address of Mr. Hirschman and the entities listed is 6006 Berkeley Avenue, Baltimore, Maryland 21209.

(4)

The shares reported under “Beneficial Ownership Before this Offering” consist of the following securities: (i) 30,525 shares of common stock; (ii) 5,765,250 shares of common stock issuable upon the exercise of Series A Common Stock Warrants; (iii) 25,943,625 shares of common stock issuable upon the exercise of Series B Common Stock Warrants; and (iv) 384,350 shares of common stock issuable upon the exercise of May 2024 Warrants. The Common Warrants and May 2024 Warrants are subject to a beneficial ownership limitation of 4.99%, which limitation restricts the selling stockholder from exercising that portion of the Common Warrants and May 2024 Warrants that would result in the selling stockholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. Iroquois Capital Management L.L.C. is the investment manager of Iroquois Master Fund, Ltd. Iroquois Capital Management, LLC has voting control and investment discretion over securities held by Iroquois Master Fund. As Managing Members of Iroquois Capital Management, LLC. Richard Abbe and Kimberly Page make voting and investment decisions on behalf of Iroquois Capital Management, LLC in its capacity as investment manager to Iroquois Master Fund Ltd. As a result of the foregoing, Mr. Abbe and Mrs. Page may be deemed to have beneficial ownership (as determined under Section 13(d) of the Securities Exchange Act) of the securities held by Iroquois Capital Management and Iroquois Master Fund. The address for Iroquois Master Fund Ltd., Mr. Abbe and Mrs. Page is c/o Iroquois Capital Management, LLC, 2 Overhill Road, Suite 400, Scarsdale, New York 10583.

(5)

The shares reported under “Beneficial Ownership Before this Offering” consist of the following securities: (i) 29,875 shares of common stock; (ii) 8,807,800 shares of common stock issuable upon the exercise of Series A Common Stock Warrants; (iii) 39,635,100 shares of common stock issuable upon the exercise of Series B Common Stock Warrants; and (iv) 586,987 shares of common stock issuable upon the exercise of May 2024 Warrants. The Common Warrants and May 2024 Warrants are subject to a beneficial ownership limitation of 4.99%, which limitation restricts the selling stockholder from exercising that portion of the Common Warrants and May 2024 Warrants that would result in the selling stockholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. Mr. Richard Abbe is the managing member of Iroquois Capital Investment Group LLC. Mr. Abbe has voting control and investment discretion over securities held by Iroquois Capital Investment

 

10

Group LLC. The address for Iroquois Capital Investment Group LLC and Mr. Abbe is 2 Over Hill Rd., Suite 500, Scarsdale, New York 10583.

(6)

The shares reported under “Beneficial Ownership Before this Offering” consist of the following securities: (i) 8,531,140 shares of common stock issuable upon the exercise of Series A Common Stock Warrants; (ii) 38,390,130 shares of common stock issuable upon the exercise of Series B Common Stock Warrants; and (v) 468,743 shares of common stock issuable upon the exercise of May 2024 Warrants. The Common Warrants, and May 2024 Warrants are subject to a beneficial ownership limitation of 4.99%, which limitation restricts the selling stockholder from exercising that portion of the Common Warrants and May 2024 Warrants that would result in the selling stockholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. Mr. Martin Chopp, the general partner of the The Hewlett Fund LP (“Hewlett”), has voting and investment control over the securities held by Hewlett. The address for Hewlett and Mr. Chopp is 100 Merrick Road, Suite 400W, Rockville Centre, New York 11570.

(7)

The shares reported under “Beneficial Ownership Before this Offering” consist of the following securities: (i) 1,483,660 shares of common stock issuable upon the exercise of Series A Common Stock Warrants; (ii) 6,676,470 shares of common stock issuable upon the exercise of Series B Common Stock Warrants; and (iii) 98,111 shares of common stock issuable upon the exercise of May 2024 Warrants. The Common Warrants and May 2024 Warrants are subject to a beneficial ownership limitation of 4.99%, which limitation restricts the selling stockholder from exercising that portion of the Common Warrants and May 2024 Warrants that would result in the selling stockholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. Mr. Sam Ginzburg has sole voting and dispositive power over the shares held by Aramas Capital Management LLC. The address for Aramas Capital Management LLC and Mr. Ginzburg is c/o Aramas Capital Holdings LLC, 19 Orchard Street, Manhasset, New York 11030.

(8)

The shares reported under “Beneficial Ownership Before this Offering” consist of the following securities: (i) 1,483,660 shares of common stock issuable upon the exercise of Series A Common Stock Warrants; (ii) 6,676,470 shares of common stock issuable upon the exercise of Series B Common Stock Warrants; and (iii) 98,111 shares of common stock issuable upon the exercise of May 2024 Warrants. The Common Warrants and May 2024 Warrants are subject to a beneficial ownership limitation of 4.99%, which limitation restricts the selling stockholder from exercising that portion of the Common Warrants and May 2024 Warrants that would result in the selling stockholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. Mr. Matthew L. Pinz has sole voting and dispositive power over the shares held by Pinz Capital Special Opportunities Fund. The address for Pinz Capital Special Opportunities Fund and Mr. Pinz is 80 Dogwood Avenue, Roslyn Harbor, New York 11576.

(9)

The shares reported under “Beneficial Ownership Before this Offering” consist of the following securities: (i) 2,967,360 shares of common stock issuable upon the exercise of Series A Common Stock Warrants; and (ii) 13,353,120 shares of common stock issuable upon the exercise of Series B Common Stock Warrants. The Common Warrants are subject to a beneficial ownership limitation of 4.99%, which limitation restricts the selling stockholder from exercising that portion of the Common Warrants that would result in the selling stockholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. Mr. Paul Packer is the managing member of Globis Capital Partners, L.P. and has voting and investment control over the securities held by Globis Capital Partners, L.P. The address for Globis Capital Partners, L.P. and Mr. Packer is 7100 W. Camino Real, Suite 302-48, Boca Raton, FL 33433.

(10)

The shares reported under “Beneficial Ownership Before this Offering” consist of the following securities purchased by Altium Healthcare Long Short Master Fund LP in the March PIPE Financing: (i) 435,454 shares of common stock; (ii) 4,110,000 shares of common stock issuable upon the exercise of Pre-Funded Warrants; (iii) 45,454,540 shares of common stock issuable upon the exercise of Series A Common Stock Warrants; and (iv) 204,545,430 shares of common stock issuable upon the exercise of Series B Common Stock Warrants. The Pre-Funded Warrants and Common Warrants are subject to a beneficial ownership limitation of 4.99%, which limitation restricts the selling stockholder from exercising that portion of the Pre-Funded Warrants and Common Warrants that would result in the selling stockholder owning, after

 

11

exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The address for Altium Healthcare Long Short Master Fund LP is Altium Capital Management LLC, 152 West 57th Street, 20th Floor, New York, New York 10019.

(11)

The shares reported under “Beneficial Ownership Before this Offering” consist of the following securities purchased by Bigger Capital Fund, LP in the March PIPE Financing: (i) 435,454 shares of common stock; (ii) 4,110,000 shares of common stock issuable upon the exercise of Pre-Funded Warrants; (iii) 45,454,540 shares of common stock issuable upon the exercise of Series A Common Stock Warrants; and (iv) 204,545,430 shares of common stock issuable upon the exercise of Series B Common Stock Warrants. The Pre-Funded Warrants and Common Warrants are subject to a beneficial ownership limitation of 4.99%, which limitation restricts the selling stockholder from exercising that portion of the Pre-Funded Warrants and Common Warrants that would result in the selling stockholder owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The address for Bigger Capital Fund, LP is 11700 W Charleston Blvd. 170-659, Las Vegas, Nevada 89135.

(12)

The shares reported under “Beneficial Ownership Before this Offering” consist of the following securities purchased by Great Point Capital, LLC in the March PIPE Financing: (i) 885,454 shares of common stock; (ii) 3,660,000 shares of common stock issuable upon the exercise of Pre-Funded Warrants; (iii) 45,454,540 shares of common stock issuable upon the exercise of Series A Common Stock Warrants; and (iv) 204,545,430 shares of common stock issuable upon the exercise of Series B Common Stock Warrants. The Pre-Funded Warrants and Common Warrants are subject to a beneficial ownership limitation of 9.99%, which limitation restricts the selling stockholder from exercising that portion of the Pre-Funded Warrants and Common Warrants that would result in the selling stockholder owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The address for Great Point Capital, LLC is 12301 Research Blvd, Bldg 4-270, Austin, Texas 78759.

(13)

The shares reported under “Beneficial Ownership Before this Offering” consist of the following securities purchased by L1 Capital Global Opportunities Master Fund in the March PIPE Financing: (i) 435,454 shares of common stock; (ii) 4,110,000 shares of common stock issuable upon the exercise of Pre-Funded Warrants; (iii) 45,454,540 shares of common stock issuable upon the exercise of Series A Common Stock Warrants; and (iv) 204,545,430 shares of common stock issuable upon the exercise of Series B Common Stock Warrants. The Pre-Funded Warrants and Common Warrants are subject to a beneficial ownership limitation of 4.99%, which limitation restricts the selling stockholder from exercising that portion of the Pre-Funded Warrants and Common Warrants that would result in the selling stockholder owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The address for L1 Capital Global Opportunities Master Fund is 161A Shedden Road, 1 Artillery Court, PO Box 10085, Grand Cayman KY1-1001, Cayman Islands.

(14)

The shares reported under “Beneficial Ownership Before this Offering” consist of the following securities purchased by S.H.N Financial Investments Ltd. in the March PIPE Financing: (i) 885,454 shares of common stock; (ii) 3,660,000 shares of common stock issuable upon the exercise of Pre-Funded Warrants; (iii) 45,454,540 shares of common stock issuable upon the exercise of Series A Common Stock Warrants; and (iv) 204,545,430 shares of common stock issuable upon the exercise of Series B Common Stock Warrants. The Pre-Funded Warrants and Common Warrants are subject to a beneficial ownership limitation of 9.99%, which limitation restricts the selling stockholder from exercising that portion of the Pre-Funded Warrants and Common Warrants that would result in the selling stockholder owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The address for S.H.N Financial Investments Ltd. is Arik Einstein 3, Herzliya, Israel.

 

12

PLAN OF DISTRIBUTION

The selling stockholders, which as used in this prospectus includes the selling stockholders listed in the section of this prospectus entitled “Selling Stockholders,” together with any additional selling stockholders listed in a subsequent amendment to this prospectus, and their respective donees, pledgees, assignees, transferees or other successors-in-interest selling shares of common stock or interests in shares of common stock received after the date of this prospectus from a selling stockholder as a gift, pledge, partnership distribution or other transfer, may, from time to time, sell, transfer or otherwise dispose of any or all of their shares of common stock or interests in shares of common stock on any stock exchange, market or trading facility on which the shares are traded or in private transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale, or at negotiated prices. The selling stockholders may use any one or more of the following methods when disposing of their shares of common stock or interests therein:

 

•

on any national securities exchange or quotation service on which the shares of common stock may be listed or quoted at the time of sale;

 

•

in the over-the-counter market;

 

•

ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

 

•

block trades in which the broker-dealer will attempt to sell the shares of common stock as agent but may position and resell a portion of the block as principal to facilitate the transaction;

 

•

through brokers, dealers or underwriters that may act solely as agents;

 

•

purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

 

•

an exchange distribution in accordance with the rules of the applicable exchange;

 

•

privately negotiated transactions;

 

•

delivery of shares in settlement of short sales;

 

•

in transactions through broker-dealers that agree with the selling stockholders to sell a specified number of such shares of common stock at a stipulated price per security;

 

•

through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;

 

•

a combination of any such methods of disposition; or

 

•

any other method permitted pursuant to applicable law.

The selling stockholders may also sell the shares of common stock under Rule 144 or any other exemption from registration under the Securities Act, if available, rather than under this prospectus.

Broker-dealers engaged by the selling stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers, underwriters and other agents may receive commissions or discounts from the selling stockholders (or, if any broker-dealer acts as agent for the purchaser of shares of common stock, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this prospectus, in the case of an agency transaction not in excess of a customary brokerage commission in compliance with Financial Industry Regulatory Authority (“FINRA”) Rule 2121, and in the case of a principal transaction a markup or markdown in compliance with FINRA Rule 2121.

The selling stockholders may from time to time pledge or grant a security interest in some or all of the shares of common stock owned by them and the pledgee or other secured party, transferee or other successor in interest may sell shares of common stock from time to time under this prospectus, or under a supplement or amendment

 

13

to this prospectus under Rule 424(b)(3) under, or other applicable provision of, the Securities Act amending the list of selling stockholders to include the pledgee, secured party, transferee or other successors-in-interest as selling stockholders under this prospectus. The selling stockholders also may transfer the shares of common stock in other circumstances in which case the donees, pledgees, assignees, transferees or other successors-in-interest may be the selling beneficial owners for purposes of this prospectus and may sell such shares of common stock from time to time under this prospectus after an amendment or supplement has been filed under Rule 424(b)(3) under, or another applicable provision of, the Securities Act, amending, if necessary, the list of selling stockholders to include the donees, pledgees, assignees, transferees or other successors-in-interest as selling stockholders under this prospectus.

Upon being notified in writing by the selling stockholder that any material arrangement has been entered into with a broker-dealer for the sale of shares of common stock through a block trade, special offering, exchange distribution or secondary distribution or a purchase by a broker or dealer, a supplement to this prospectus, if required, pursuant to Rule 424(b) under the Securities Act will be filed, disclosing (i) the name of each such selling stockholder and of the participating broker-dealer(s), (ii) the number of shares of common stock involved, (iii) the price at which such shares of common stock were sold, (iv) the commissions paid or discounts or concessions allowed to such broker-dealer(s), where applicable, (v) that such broker-dealer(s) did not conduct any investigation to verify the information set out or incorporated by reference in this prospectus, if applicable, and (vi) other facts material to the transaction.

The selling stockholders also may transfer the shares of common stock in other circumstances, in which case the donees, pledgees, assignees, transferees or other successors-in-interest will be the selling beneficial owners for purposes of this prospectus.

In connection with the sale of the shares of common stock or interests therein, the selling stockholders may enter into hedging transactions after the effective date of the registration statement of which this prospectus is a part with broker-dealers or other financial institutions, which may in turn engage in short sales of the shares of common stock in the course of hedging the positions they assume. The selling stockholders may also sell the shares of common stock short after the effective date of the registration statement of which this prospectus forms a part and deliver these shares of common stock to close out their short positions, or loan or pledge the shares of common stock to broker-dealers that in turn may sell these shares of common stock. The selling stockholders may also enter into option or other transactions after the effective date of the registration statement of which this prospectus forms a part with broker-dealers or other financial institutions or create one or more derivative securities that require the delivery to such broker-dealer or other financial institution of shares of common stock offered by this prospectus, which securities such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction), including in the short sale transactions.

The selling stockholders and any broker-dealers or agents that are involved in selling the shares of common stock may be deemed to be “underwriters” within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the shares of common stock purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Each selling stockholder has informed the Company that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the shares of common stock. Any compensation paid to underwriters, broker-dealers or agents in connection with the offering of the shares of common stock, and any discounts, concessions or commissions allowed by underwriters to participating dealers will be provided in the applicable prospectus supplement and shall comply with the rules and requirements of FINRA.

The Company is required to pay certain fees and expenses incurred by the Company incident to the registration of the shares of common stock. The Company has agreed to indemnify the selling stockholders against certain losses, claims, damages and liabilities to which they may become subject, including liabilities under the Securities Act.

 

14

We agreed to keep this prospectus effective until the earlier of (i) the date that such shares of common stock become eligible for resale without volume or manner-of-sale restrictions and without current public information pursuant to Rule 144 and certain other conditions have been satisfied, or (ii) all of the shares of common stock have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect.

There can be no assurance that any selling stockholder will sell any or all of the shares of common stock registered pursuant to the registration statement of which this prospectus forms a part.

Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously engage in market-making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the selling stockholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the common stock by the selling stockholders or any other person. Regulation M may also restrict the ability of any person engaged in the distribution of the shares of common stock to engage in market-making activities with respect to the shares of common stock. All of the foregoing may affect the marketability of the shares of common stock and the ability of any person or entity to engage in market-making activities with respect to the shares of common stock.

 

15

LEGAL MATTERS

Hogan Lovells US LLP, Houston, Texas, will pass upon the validity of the shares of our common stock offered by this prospectus.

EXPERTS

The consolidated financial statements of Plus Therapeutics, Inc. as of December 31, 2024 and 2023 and for the years then ended incorporated by reference in this prospectus and in the Registration Statement have been so incorporated in reliance on the report of BDO USA, P.C., an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting. The report on the consolidated financial statements contains an explanatory paragraph regarding the Company’s ability to continue as a going concern.

WHERE YOU CAN FIND ADDITIONAL INFORMATION

This prospectus is part of the registration statement on Form S-3 that we filed with the SEC under the Securities Act and does not contain all the information set forth or incorporated by reference in the registration statement. Whenever a reference is made in this prospectus to any of our contracts, agreements or other documents, the reference may not be complete and you should refer to the exhibits that are a part of the registration statement or the exhibits to the reports or other documents incorporated by reference into this prospectus for a copy of such contract, agreement or other document. You may obtain copies of the registration statement and its exhibits via the SEC’s EDGAR database.

We file annual, quarterly and current reports, proxy statements and other information with the SEC under the Exchange Act. The SEC maintains a website that contains reports, proxy and information statements and other information regarding issuers, including us, that file electronically with the SEC. You may obtain documents that we file with the SEC at www.sec.gov.

Our website address is www.plustherapeutics.com. We do not incorporate the information on or accessible through our website into this prospectus or any prospectus supplement, and you should not consider any information on, or that can be accessed through, our website as part of this prospectus or any prospectus supplement. Our website address is included in this prospectus as an inactive textual reference only.

INFORMATION INCORPORATED BY REFERENCE

The registration statement of which prospectus is a part incorporates by reference important business and financial information about our company that is not included in or delivered with this document. The information incorporated by reference is considered to be part of this prospectus, and the SEC allows us to “incorporate by reference” the information we file with it, which means that we can disclose important information to you by referring you to those documents instead of having to repeat the information in this prospectus. Any statement contained in any document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in or omitted from this prospectus or any accompanying prospectus supplement, or in any other subsequently filed document which also is or is deemed to be incorporated by reference herein, modifies or supersedes such statement. Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus. We incorporate by reference:

 

•

Our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025;

 

16

•

Our Current Reports on Form 8-K filed with the SEC on  February  18, 2025, March  4, 2025, March  10, 2025, and April 18, 2025; and

 

•

The description of our shares of common stock contained in the registration statement on 10/A, filed with the SEC on July 16, 2001 (File No. 000-32501), as updated by Exhibit 4.1 to our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 30, 2021, as well as any additional amendments or reports filed for the purpose of updating such description.

We also incorporate by reference into this prospectus any further filings we make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act (other than portions of those made pursuant to Item 2.02 or Item 7.01 of a Current Report on Form 8-K or other information “furnished” and not filed with the SEC), including all filings filed after the date hereof and prior to the completion of an offering of securities under this prospectus.

We have filed with the SEC this registration statement under the Securities Act, covering the shares of common stock to be offered and sold pursuant to this prospectus and any applicable prospectus supplement. This prospectus does not contain all of the information included in the registration statement, some of which is contained in exhibits to the registration statement. The registration statement, including the exhibits, can be read at the SEC website referred to above under “Where You Can Find More Information.” Any statement made in this prospectus or any prospectus supplement concerning the contents of any contract, agreement or other document is only a summary of the actual contract, agreement or other document. If we have filed any contract, document, agreement or other document as an exhibit to the registration statement or any other document incorporated herein by reference, you should read the exhibit for a more complete understanding of the document or matter involved. Each statement regarding a contract, agreement or other document is qualified in its entirety by reference to the actual document.

You may request a free copy of any of the documents incorporated by reference in this prospectus by writing to us at Plus Therapeutics, Inc., 2710 Reed Road, Suite 160, Houston, Texas 77051. Exhibits to the filings will not be sent, however, unless they have specifically been incorporated by reference in this prospectus or any accompanying prospectus supplement.

 

17

PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 14. Other Expenses of Issuance and Distribution.

The following table sets forth an estimate of the fees and expenses payable by us in connection with the issuance and distribution of the shares of common stock hereby. All the amounts shown are estimates, except for the SEC registration fee.

 

		Amount
SEC registration fee		$	194,083
Accountants’ fees and expenses		$	25,000
Legal fees and expenses		$	50,000
Miscellaneous fees and expenses		$	10,917
Total expenses		$	280,000

Discounts, concessions, commissions and similar selling expenses attributable to the sale of shares of common stock covered by this prospectus will be borne by the selling stockholders. We will pay all expenses (other than discounts, concessions, commissions and similar selling expenses) relating to the registration of the resale of the shares of common stock with the SEC, as estimated in the table above.

Item 15. Indemnification of Directors and Officers.

The Company is a Delaware corporation. Section 145(a) of the General Corporation Law of the State of Delaware (“DGCL”) provides that a Delaware corporation may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, other than an action by or in the right of the corporation, by reason of the fact that such person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with such action, suit or proceeding if the person acted in good faith and in a manner the person reasonably believed to be in or not opposed to the best interests of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful.

Section 145(b) of the DGCL provides that a Delaware corporation may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the corporation to procure a judgment in its favor by reason of the fact that such person acted in any of the capacities set forth above, against expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit if the person acted in good faith and in a manner the person reasonably believed to be in, or not opposed to, the best interests of the corporation, except that no indemnification shall be made in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to the corporation, unless and only to the extent that the Court of Chancery or the court in which such action or suit was brought shall determine, upon application, that, despite the adjudication of liability but in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which the court shall deem proper.

Further subsections of DGCL Section 145 provide that:

 

(1)

to the extent a present or former director or officer of a corporation has been successful on the merits or otherwise in the defense of any action, suit or proceeding referred to in subsections (i) and (ii) of

 

II-1

Section 145 or in the defense of any claim, issue or matter therein, such person shall be indemnified against expenses, including attorneys’ fees, actually and reasonably incurred by such person in connection therewith;

 

(2)

the indemnification and advancement of expenses provided for pursuant to Section 145 shall not be deemed exclusive of any other rights to which those seeking indemnification or advancement of expenses may be entitled under any bylaw, agreement, vote of shareholders or disinterested directors or otherwise; and

 

(3)

the corporation shall have the power to purchase and maintain insurance of behalf of any person who is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against any liability asserted against such person and incurred by such person in any such capacity, or arising out of such person’s status as such, whether or not the corporation would have the power to indemnify such person against such liability under Section 145.

As used in this Item 15, the term “proceeding” means any threatened, pending or completed action, suit or proceeding, whether or not by or in the right of the Company, and whether civil, criminal, administrative, investigative or otherwise.

Section 145 of the DGCL makes provision for the indemnification of officers and directors in terms sufficiently broad to indemnify officers and directors of the Company under certain circumstances from liabilities (including reimbursement for expenses incurred) arising under the Securities Act. The Company’s organizational documents provide, in effect, that, to the fullest extent and under the circumstances permitted by Section 145 of the DGCL, the Company will indemnify any and all of its officers and directors. The Company has entered into indemnification agreements with its officers and directors. The Company may, in its discretion, similarly indemnify its employees and agents. The Company’s certificate of incorporation, as amended, also relieves its directors from monetary damages to the Company or its stockholders for breach of such director’s fiduciary duty as a director to the fullest extent permitted by the DGCL. Under Section 102(b)(7) of the DGCL, a corporation may relieve its directors from personal liability to such corporation or its stockholders for monetary damages for any breach of their fiduciary duty as directors except (i) for a breach of the duty of loyalty, (ii) for failure to act in good faith, (iii) for intentional misconduct or knowing violation of law, (iv) for willful or negligent violations of certain provisions in the DGCL imposing certain requirements with respect to stock repurchases, redemptions and dividends or (v) for any transactions from which the director derived an improper personal benefit.

The Company has purchased insurance policies that, within the limits and subject to the terms and conditions thereof, cover certain expenses and liabilities that may be incurred by directors and officers in connection with proceedings that may be brought against them as a result of an act or omission committed or suffered while acting as a director or officer of the Company.

We have entered into the Registration Rights Agreement with the selling stockholders of the shares of common stock registered hereby which obligates the parties to indemnify, under certain circumstances, the other party, its officers, directors, and controlling persons within the meaning of the Securities Act against certain liabilities.

 

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Item 16. Exhibits.

 

				Incorporated by Reference
Exhibit Number		Description		Form				File Number				Exhibit				Filing Date
3.1		Composite Certificate of Incorporation.			10-K				001-34375				3.1				03/11/2016
3.2		Certificate of Amendment to Amended and Restated Certificate.			8-K				001-34375				3.1				05/10/2016
3.3		Certificate of Amendment to Amended and Restated Certificate.			8-K				001-34375				3.1				05/23/2018
3.4		Certificate of Amendment to Amended and Restated Certificate.			8-K				001-34375				3.1				07/29/2019
3.5		Certificate of Amendment to Amended and Restated Certificate.			8-K				001-34375				3.1				08/06/2019
3.6		Certificate of Amendment to Amended and Restated Certificate.			8-K				001-34375				3.1				04/28/2023
3.7		Amended and Restated Bylaws of Plus Therapeutics, Inc.			8-K				001-34375				3.1				09/21/2021
3.8		Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock.			8-K				001-34375				3.1				11/28/2017
3.9		Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock.			8-K				001-34375				3.1				07/25/2018
4.1		Form of Common Stock Certificate.			10-K				001-34375				4.33				03/09/2018
4.2		Form of Pre-Funded Warrant.			8-K				011-34375				4.1				03/04/2025
4.3		Form of Series A Warrant.			8-K				011-34375				4.2				03/04/2025
4.4		Form of Series B Warrant.			8-K				011-34375				4.3				03/04/2025
5.1**		Opinion of Hogan Lovells US LLP.
23.1*		Consent of Independent Registered Public Accounting Firm.
23.2**		Consent of Hogan Lovells US LLP (included in Exhibit 5.1 hereto).
24.1		Power of Attorney.			S-3				333-286393				24.1				04/04/2025
24.2*		Power of Attorney.
107.1		Filing Fee Table.			S-3				333-286393				107.1				04/04/2025

 

*	Filed herewith.

**	To be filed by amendment.

Item 17. Undertakings

(a) The undersigned registrant hereby undertakes:

(1) To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

 

(i)

to include any prospectus required by Section 10(a)(3) of the Securities Act;

 

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(ii)

to reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation of Filing Fee Table” in the effective registration statement; and

 

(iii)

to include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;

provided, however, that Paragraphs (a)(1)(i), (a)(1)(ii), and (a)(1)(iii) of this section do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the SEC by the registrant pursuant to Section 13 or Section 15(d) of the Exchange Act that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.

(2) That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof;

(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering;

(4) That, for the purpose of determining liability under the Securities Act to any purchaser:

 

(i)

Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and

 

(ii)

Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.

(5) That, for the purpose of determining liability of the registrant under the Securities Act to any purchaser in the initial distribution of the securities: The undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

 

(i)

Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;

 

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(ii)

Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;

 

(iii)

The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and

 

(iv)

Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.

(b) that, for purposes of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

(c) Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

 

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SIGNATURES

Pursuant to the requirements of the Securities Act, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Houston, State of Texas, on April 23, 2025.

 

PLUS THERAPEUTICS, INC.
By:		/S/ Marc H. Hedrick
		Marc H. Hedrick, M.D.
		President and Chief Executive Officer

Pursuant to the requirements of the Securities Act, this registration statement has been signed by the following persons in the capacities held and on the dates indicated.

 

Signature		Title		Date
/S/ Marc H. Hedrick MARC H. HEDRICK, M.D.		President, Chief Executive Officer and Director (Principal Executive Officer)		April 23, 2025
/S/ Andrew Sims ANDREW SIMS		Chief Financial Officer (Principal Financial and Accounting Officer)		April 23, 2025
* RICHARD J. HAWKINS		Chair of the Board of Directors		April 23, 2025
* HOWARD CLOWES		Director		April 23, 2025
* KYLE GUSE		Director		April 23, 2025
* AN VAN ES-JOHANSSON, M.D.		Director		April 23, 2025
* ROBERT LENK, PH.D		Director		April 23, 2025

 

*BY:		/S/ Marc H. Hedrick
		MARC H. HEDRICK, M.D.
		Attorney-in-fact

 

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