As filed with the Securities and Exchange Commission on December 30, 2022April 22, 2024

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-3

REGISTRATION STATEMENT

UNDER THE SECURITIES ACT OF 1933

DARIOHEALTH CORP.

(Exact Name of Registrant as Specified in Its Charter)

18

322 W. 18th St, 5th Floor

57th St. #33B
New York, New York 10011
Telephone: (646) 665-4667(972) 4-770-6377

Facsimile: +(972)-(4) 770 4060

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal
Executive Offices)

Mr. Erez Raphael

Chief Executive Officer

DarioHealth Corp.

18322 W. 18th St, 5th Floor

57th St. #33B
New York, New York 10011
Telephone: (646) 665-4667(972) 4-770-6377

Facsimile: +(972)-(4) 770 4060

(Name, address, including zip code, and telephone number,

including area code, of agent for service)

Copies to:

Oded Har-Even, Esq.

Ron Ben-Bassat, Esq.

Sullivan & Worcester LLP

1633 Broadway

New York, NY 10019

Telephone: (212) 660-5000

Facsimile: (212) 660-3001

Approximate date of commencement of proposed sale to the public: From time to time after the effective date of this registration statement, as determined by market and other conditions.

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: x

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, 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 Securities Act. ¨

THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION ACTING PURSUANT TO SAID SECTION 8(a), MAY DETERMINE.

The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

Subject to completion, dated December 30, 2022April 22, 2024

PROSPECTUS

UP TO 107,40915,727,223 SHARES OF COMMON STOCK

The selling stockholderstockholders identified in this prospectus may offer from time to time up to 107,40915,727,223 shares of our common stock, $0.0001 par value per share or(the “Common Stock”), consisting of (i) 8,345,097 shares of our Common Stock issuable upon the conversion of our Series C Preferred Stock; (ii) 1,980,200 shares of our Common Stock issuable upon the conversion of our Series C-1 Preferred Stock; (iii) 521,031 shares of our Common Stock issuable upon the conversion of our Series C-2 Preferred Stock and (iv) 4,880,895 shares of our Common Stock issuable as dividends to our Series C Preferred Stock, Series C-1 Preferred Stock and Series C-2 Preferred Stock.

This prospectus describes the general manner in which the shares may be offered and sold by the selling stockholder.stockholders. If necessary, the specific manner in which the shares may be offered and sold will be described in a supplement to this prospectus.

WeWhile we will not receive any proceeds from the sale of the shares by the selling stockholder. See “Use of Proceeds.”stockholders. We will pay the expenses of registering these shares. The selling stockholder may sell all or a portion of the shares from time to time in market transactions through any market on which our shares are then traded, in negotiated transactions or otherwise, and at prices and on terms that will be determined by the then prevailing market price or at negotiated prices directly or through a broker or brokers, who may act as agent or as principal or by a combination of such methods of sale. See “Plan of Distribution.”

Our Common Stock is traded on the Nasdaq Capital Market under the symbol “DRIO.” The last reported sale price of our Common Stock on Nasdaq on April 19, 2024 was $1.16 per share.

Investing in our Common Stock involves risks. See “Risk Factors” beginning on page 64 of this prospectus.

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

The date of this prospectus is December , 2022.2024.

TABLE OF CONTENTS

You should rely only on the information contained in this prospectus, any prospectus supplement and the documents incorporated by reference, or to which we have referred you. Neither we nor the selling stockholderstockholders have authorized anyone to provide you with different information. If anyone provides you with different or inconsistent information, you should not rely on it. This prospectus and any prospectus supplement dodoes not constitute an offer to sell, or a solicitation of an offer to purchase, the Common Stock offered by this prospectus and any prospectus supplement in any jurisdiction to or from any person to whom or from whom it is unlawful to make such offer or solicitation of an offer in such jurisdiction. You should not assume that the information contained in this prospectus, any prospectus supplement or any document incorporated by reference is accurate as of any date other than the date on the front cover of the applicable document.

Neither the delivery of this prospectus nor any distribution of Common Stock pursuant to this prospectus shall, under any circumstances, create any implication that there has been no change in the information set forth or incorporated by reference into this prospectus or in our affairs since the date of this prospectus. Our business, financial condition, results of operations and prospects may have changed since such date.

When used herein, unless the context requires otherwise, references to the “Company,” “Dario,” “we,” “our” and “us” refer to DarioHealth Corp., a Delaware corporation, collectively with our subsidiariesits wholly-owned subsidiary, LabStyle Innovation Ltd., an Israeli company, andcorporation, PsyInnovations Inc., a Delaware company. “Dario” is registered ascompany, DarioHealth India Services Pvt. Ltd., an Indian company and Twill, Inc., a trademark in the United States, Israel, China, Canada, Hong Kong, South Africa, Japan, Costa Rica and Panama. “DarioHealth” is registered as a trademark in the United States and Israel.Delaware company.

All dollar amounts refer to U.S. dollars unless otherwise indicated.

ABOUT THIS PROSPECTUS

This prospectus describes the general manner in which the selling stockholderstockholders identified in this prospectus may offer from time to time up to 107,40915,727,223 shares of our Common Stock. If necessary, the specific manner in which the shares may be offered and sold will be described in a supplement to this prospectus, which supplement may also add, update or change any of the information contained in this prospectus. To the extent there is a conflict between the information contained in this prospectus and the prospectus supplement, you should rely on the information in the prospectus supplement, provided that if any statement in one of these documents is inconsistent with a statement in another document having a later date—for example, a document incorporated by reference in this prospectus or any prospectus supplement—the statement in the document having the later date modifies or supersedes the earlier statement.

ABOUT THIS OFFERING

This prospectus relates to the resale by the selling stockholder, an affiliate of one of our board members,stockholders identified in this prospectus of up to 107,40915,727,223 shares of our Common, which were issued following a mandatory conversion of our previously designated Series A Convertible Preferred Stock,common stock, $0.0001 par value per share or(the “Common Stock”), consisting of (i) 8,345,097 shares of our Common Stock issuable upon the conversion of our Series A ConvertibleC Preferred Stock; (ii) 1,980,200 shares of our Common Stock issuable upon the conversion of our Series C-1 Preferred Stock; (iii) 521,031 shares of our Common Stock issuable upon the conversion of our Series C-2 Preferred Stock includingand (iv) 4,880,895 shares of our Common Stock issuable as dividends issued to the holders ofour Series A ConvertibleC Preferred Stock, Series C-1 Preferred Stock and Series C-2 Preferred Stock. All of the shares, when sold, will be sold by these selling stockholders. The selling stockholderstockholders may sell itstheir shares of Common Stock from time to time at prevailing market prices. We will not receive any proceeds from the sale of the shares of Common Stock by the selling stockholder.stockholders.

Unless we indicate otherwise, all information in this prospectus supplement is based on 25,679,410 shares of Common Stock outstanding as of December 28, 2022, and excludes:

RISK FACTORS

An investment in our Common Stock involves significant risks. You should carefully consider the risk factors contained in any prospectus supplement and in our filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, 20212023, our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2022, our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2022, as well as all of the information contained in this prospectus, any prospectus supplement and the documents incorporated by reference herein or therein, before you decide to invest in our Common Stock. Our business, prospects, financial condition and results of operations may be materially and adversely affected as a result of any of such risks. The value of our Common Stock could decline as a result of any of these risks. You could lose all or part of your investment in our Common Stock. Some of our statements in sections entitled “Risk Factors” are forward-looking statements. The risks and uncertainties we have described are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our business, prospects, financial condition and results of operations.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This prospectus, any prospectus supplement and the documents we incorporate by reference contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, regarding our business, clinical trials, financial condition, expenditures, results of operations and prospects. Words such as “expects,” “anticipates,” “intends,” “plans,” “planned expenditures,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements, but are not deemed to represent an all-inclusive means of identifying forward-looking statements as denoted in this prospectus, any prospectus supplement and the documents we incorporate by reference. Additionally, statements concerning future matters are forward-looking statements.

Although forward-looking statements in this prospectus, any prospectus supplement and the documents we incorporate by reference reflect the good faith judgment of our management, such statements can only be based on facts and factors known by us as of such date. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. Factors that could cause or contribute to such differences in results and outcomes include, without limitation, those specifically addressed under the heading “Risk Factors” herein and in the documents we incorporate by reference, as well as those discussed elsewhere in this prospectus and any prospectus supplement. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this prospectus, any prospectus supplement or the respective documents incorporated by reference, as applicable. Except as required by law, we undertake no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of such forward-looking statements. Readers are urged to carefully review and consider the various disclosures made throughout the entirety of this prospectus, any prospectus supplement and the documents incorporated by reference, which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operations and prospects.

USE OF PROCEEDS

We will not receive any proceeds from the sale of the 107,40915,727,223 shares of Common Stock subject to resale by the selling stockholderstockholders under this prospectus. We will incur all costs associated with the preparation and filing of the registration statement of which this prospectus is a part. Brokerage fees, commissions and similar expenses, if any, attributable to the sale of shares offered hereby will be borne by the applicable selling stockholder.stockholders.

SELLING STOCKHOLDERSTOCKHOLDERS

The shares of Common Stockcommon stock being offered by the selling stockholderstockholders listed below (or itstheir successors and assigns) were issued, following a mandatoryor may be issued, as the case may be, in connection with the February 2024 Private Placement.

On February 15, 2024 and February 16, 2024, we entered into securities purchase agreements with accredited investors relating to an offering and the sale of up to 15,727,223 shares of our common stock, $0.0001 par value per share (the “Common Stock”), consisting of (i) 8,345,097 shares of our Common Stock issuable upon the conversion of our previously designated Series A ConvertibleC Preferred Stock; (ii) 1,980,200 shares of our Common Stock issuable upon the conversion of our Series C-1 Preferred Stock; (iii) 521,031 shares of our Common Stock issuable upon the conversion of our Series C-2 Preferred Stock includingand (iv) 4,880,895 shares of our Common Stock issuable as dividends to our Series C Preferred Stock, Series C-1 Preferred Stock and Series C-2 Preferred Stock. Aegis Capital Corp. served as the placement agent for the February 2024 Private Placement. In connection with the February 2024 Private Placement, we agreed to file this registration statement covering the resale of the shares of Common Stock sold in the offering by April 21, 2024.

Pursuant to the terms of the placement agency agreement between us and Aegis Capital Corp., or Aegis, dated December 23, 2023, and as amended on January 31, 2024, with respect to the offering of the Series C Preferred stock, we agreed to pay Aegis an aggregate cash fee representing 10% of aggregate proceeds raised in the offering (and fees representing 5% and 1.5% for certain company introduced investors), non-accountable expense allowance representing 3% of aggregate proceeds raised in the offering (and fees representing 1.5% and none for certain Company introduced investors). In addition, we issued to Aegis or its designees warrants (the “Placement Agent Warrant”) to purchase shares of common stock representing 14.5% of the holdersequivalent shares of Common Stock issuable upon initial conversion of the Series A ConvertibleC Preferred Stock.Stock at an exercise price equal to the consolidated bid price of the common stock as of the date of such closing. The Placement Agent Warrant provides for a cashless exercise feature and are exercisable for a period of five years from the date of closing. We also granted the Placement Agent the right of first refusal, for a twelve (12) month period after the final closing of the offering, to serve as the Company’s lead or co-placement agent for any proposed private placement of our securities (equity or debt) that is proposed to be consummated to investors in the United States with the assistance of a registered broker dealer. Mr. Adam Stern, a member of our Board of Directors, is a control person of Aegis. Mr. Stern, a member of our Board of Directors, has an interest, and will receive fees due to, Aegis.

The selling stockholderstockholders may sell all, some or none of their shares in this offering. See “Plan of Distribution.”

Mr. Adam Stern, a member of our Board of Directors, is an affiliate of the selling stockholder. Pursuant to the terms of the placement agency agreement between us and Aegis Capital Corp., or Aegis, dated October 22, 2019, we granted Aegis the right to nominate an individual to the Board for a period of three years, which resulted in the appointment of Mr. Stern to serve on our Board. Other than the relationships described herein, to our knowledge, none of the selling stockholder is not an employeestockholders are employees or suppliersuppliers of ours or our affiliates. Within the past three years, other than the relationships described herein, none of the selling stockholderstockholders has not held a position as an officer a director of ours, nor has theany selling stockholder had any material relationship of any kind with us or any of our affiliates. All information with respect to share ownership has been furnished by the selling stockholder,stockholders, unless otherwise noted. The shares being offered are being registered to permit public secondary trading of such shares and theeach selling stockholder may offer all or part of the shares it owns for resale from time to time pursuant to this prospectus. TheNone of the selling stockholder does not havestockholders has any family relationships with our officers, other directors or controlling stockholders.

To the extent theAny selling stockholder is an affiliatestockholders who are affiliates of broker-dealers and any participating broker-dealers are deemed to be “underwriters” within the meaning of the Securities Act of 1933, as amended, or the Securities Act, and any commissions or discounts given to any such selling stockholder or broker-dealer may be regarded as underwriting commissions or discounts under the Securities Act.

The term “selling stockholder”stockholders” also includes any transferees, pledgees, donees, or other successors in interest to the selling stockholderstockholders named in the table below. Unless otherwise indicated, to our knowledge, theeach person named in the table below has sole voting and investment power (subject to applicable community property laws) with respect to the shares of Common Stock set forth opposite such person’s name. We will file a supplement to this prospectus (or a post-effective amendment hereto, if necessary) to name successors to any named selling stockholderstockholders who are able to use this prospectus to resell the Common Stock registered hereby.