As filed with the Securities and Exchange Commission on October 19, 2017September 8, 2020

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-3 

FORM S-3

REGISTRATION STATEMENT

UNDER THE SECURITIES ACT OF 1933

DARIOHEALTH CORP.

(Exact Name of Registrant as Specified in Its Charter)

9 Halamish8 HaTokhen Street

Caesarea Industrial Park

3088900, Israel

Telephone: +(972)-(4) 770 4055

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.

9 Halamish8 HaTokhen Street

Caesarea Industrial Park

3088900, Israel

Telephone: +(972)-(4) 770 4055

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.

Robert V. Condon III,Ron Ben-Bassat, Esq.

Zysman, Aharoni, Gayer and

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 formForm are being offered pursuant to dividend or interest reinvestment plans, please check the following box.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.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 formForm 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 formForm 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, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging"emerging growth company”company" in Rule 12b-2 of the Exchange Act.  (Check one):

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.  ¨

CALCULATION OF REGISTRATION FEE

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 October 19, 2017September 8, 2020

PROSPECTUS

2,929,4463,825,441 SHARES OF COMMON STOCK

The selling stockholders identified in this prospectus may offer from time to time up to 2,929,4463,825,441 shares of our common stock, consisting of (i) 483,333 shares of our common stock; (ii) 2,307,654 shares of our common stock issuable upon conversion of our Series B Convertible Preferred Stock, $0.0001 par value per share the Series B Preferred Stock, and (iii) 138,459(the “Common Stock”), which includes 824,689 shares of our common stock representing a fixed 6% dividend to the holdersregistrant’s Common Stock issuable upon the exercise of the Series B Preferred Stock.pre-funded warrants.

This prospectus describes the general manner in which the shares may be offered and sold by the selling 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 stockholders. We will pay the expenses of registering these shares.

Our common stockCommon Stock is traded on the Nasdaq Capital Market under the symbol “DRIO.”

Investing in our common stockCommon Stock involves risks. See“Risk Factors”beginning on page 34 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                           , 2017.2020.

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 stockholders 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 doesdo not constitute an offer to sell, or a solicitation of an offer to purchase, the common stockCommon 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 stockCommon 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,” “we,” “our” and “us” refer to DarioHealth Corp., a Delaware corporation, collectively with its wholly-owned subsidiary, LabStyle Innovation Ltd., an Israeli corporation.

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

ABOUT THIS PROSPECTUS

This prospectus describes the general manner in which the selling stockholders identified in this prospectus may offer from time to time up to 2,929,4463,825,441 shares of our common stock.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.

OUR COMPANY

This summary highlights information contained in the documents incorporated herein by reference. Before making an investment decision, you should read the entire prospectus, and our other filings with the Securities and Exchange Commission, or the SEC, including those filings incorporated herein by reference, carefully, including the sections entitled “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements.”

We are a digitalleading global Digital Therapeutics, or DTx, company revolutionizing the way people manage their health (mHealth) companyacross the chronic condition spectrum to live a better and healthier life. By delivering personalized evidence-based interventions that is developingare driven by data, high quality software, easy-to-use medical devices and commercializingcoaching, we empower individuals to make healthy adjustments to their daily lifestyle choices in a patentedpersonalized way and proprietaryimprove their overall health. Our cross-functional team operates at the intersection of life sciences, behavioral science and software technology providing consumers with laboratory-testing capabilities using smart phones and other mobile devices. Our flagship product,to deliver highly engaging therapeutic interventions. The Dario^TM, which we also refer Blood Sugar Monitor is among the most downloaded healthcare apps, with 4.9/5.0 stars from 11,000+ reviews on the Apple Store as of July 2020. We are rapidly moving into new chronic conditions such as hypertension, using a performance-based approach to as our Dario^TM Smart Diabetes Management Solution, is a mobile, real-time, cloud-based, diabetes management solution based on an innovative, multi-feature software application combined with a stylish, ‘all-in-one’, pocket-sized, blood glucose monitoring device, which we callimprove the Dario^TM Smart Meter.health of users managing chronic disease.

Beyond the benefitsWe attempt to drive behavioral change by creating highly personalized, closed-loop interactions that support our customers, who become members of individualour services, via connected FDA cleared monitoring devices, just-in-time health information and real-time coaching. This highly scalable infrastructure results in members with significant improvement in their health conditions at a modest price-point. The Dario solution is intended to stretch across various health conditions and ailments. We currently focus our efforts on diabetes management,and hypertension, and we envision the Dario^TM application becoming the centerpiece in a new era of interconnected devices and services, providing healthier and better lives for diabetic patients worldwide. With every single measurement captured and stored on a secure cloud data base,plan to expand our software driven, comprehensive data-management technology has the potential to deliver actionable insight and analytical tools to manage individual patients or large populations, as well as provide a complete and comprehensive “big data” solution for healthcare providers and payers.focus into additional chronic conditions during 2020, including hypertension.

Our address is 9 Halamish8 HaTokhen Street, Caesarea Industrial Park, 3088900, Israel and our telephone number is +(972)-(4) 770 4055. Our corporate website is: www.mydario.com. The contentscontent of our website shall not be deemed incorporated by reference in this prospectus.

About This OfferingABOUT THIS OFFERING

This prospectus relates to the resale by the selling stockholders identified in this prospectus of up to 2,929,4463,825,441 shares of our common stock, $0.0001 par value per share (the “Common Stock”) purchased in our private placement offering, which was closed on July 31, 2020 (the “July 2020 Private Placement”), consisting of (i) 483,3333,000,752 shares of our common stock,Common Stock; and (ii) 2,307,654824,689 shares of our common stockCommon Stock issuable upon conversionthe exercise of the Series B Preferred Stock, and (iii) 138,459 shares of our common stock representing a fixed 6% dividend to the holders of the Series B Preferred Stock.pre-funded warrants. All of the shares, when sold, will be sold by these selling stockholders. The selling stockholders may sell their shares of common stockCommon Stock from time to time at prevailing market prices. We will not receive any proceeds from the sale of the shares of common stockCommon Stock by the selling stockholders.

RISK FACTORS

An investment in our common stockCommon Stock involves significant risks. You should carefully consider the following risk factor, 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, 2016,2019 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.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 stockCommon Stock could decline as a result of any of these risks.  You could lose all or part of your investment in our common stock.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.

We may be subject to claims for rescission or damages in connection with certain sales of shares of our securities.

In March 2016, the Securities and Exchange Commission declared effective a registration statement that we filed to cover the sale of 1,333,333 shares of common stock, 1,533,333 warrants to purchase common stock, 1,533,333 shares of common stock underlying such warrants, and underwriters’ warrants to purchase up to 153,333 shares of common stock. Sales of approximately 55,555 shares of common stock, approximately 255,555 shares of common stock underlying warrants and approximately 25,555 shares of common stock underlying underwriters’ warrants may not have been made in accordance with Section 5 of the Securities Act of 1933, as amended. Accordingly, the purchasers of those securities may have rescission rights or be entitled to damages. The amount of such liability, if any, is uncertain.  In the event that we are required to make payments to investors as a result of these unregistered sales of securities, our liquidity could be negatively impacted.

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 of the proceeds from the sale of the 3,825,441 shares of our common stock being offered for saleCommon Stock subject to resale by the selling stockholders.stockholders 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 stockholders.

SELLING STOCKHOLDERS

The shares of Common Stock being offered by the selling stockholders acquiredlisted below (or their successors and assigns) were issued, or may be issued, as the common stock being registered for resale pursuant to this prospectus, pursuant to a contractual agreement or as remuneration for services rendered, as detailed below:case may be, in connection with our July 2020 Private Placement.

Between August 16, 2017 and August 22, 2017,On July 28, 2020, we executed Securities Purchase Agreements, or the Securities Purchase Agreements,entered into subscription agreements (each, a “Subscription Agreement”) with a total of 23 accredited and non-U.S. investors relating to two concurrent private placement offerings, oran offering with respect to the Offering,sale of 483,333an aggregate of (i) 2,969,266 shares of our common stock at a purchase price of $1.80 per share, and 2,307,654 shares of Series B PreferredCommon Stock at a purchase price of $1.80$7.47 per share, orand (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase 824,689 shares of Common Stock (collectively, the Securities.“First Closing”), at a purchase price of $7.4699 per Pre-Funded Warrant, which represents the per share offering price per share, less a $0.0001 per share exercise price for each such Pre-Funded Warrant. In addition, on July 30, 2020, we entered into a Subscription Agreement with an accredited investor for the purchase of 31,486 shares of Common Stock at a purchase price per share of $7.94 (the “Second Closing” and together with the First Closing, the “Offering”). The closing of the Offering took place on August 22, 2017.July 31, 2020.

Pursuant toIn connection with the Certificate of Designation of Preferences, Rights and Limitations of the Series B Preferred Stock, or the Certificate of Designation, the shares of Series B Preferred Stock are convertible into an aggregate of 2,307,654 shares of common stock based on a conversion price of $1.80 per share. Such conversion price is not subject to any future price-based anti-dilution adjustments but does carry customary stock-based anti-dilution protection. The holders of the Series B Preferred Stock will not be entitled to convert such preferred stock into shares of our common stock untilJuly 2020 Private Placement we obtain stockholder approval for such issuance and upon obtaining such stockholder approval the Series B Preferred Stock shall automatically convert into shares of common stock. In addition, the holders of the Series B Preferred Stock are entitled to a 6% fixed dividend, payable in shares of common stock, which shall be payable upon the automatic conversion of the Series B Preferred Stock. The holders of the Series B Preferred Stock do not possess any voting rights but the Series B Preferred Stock does carry a liquidation preference for each holder equal to the investment made by such holder in the Offering, and such liquidation preference applies in certain deemed liquidation events such as a change in control of the Company. In addition, the holders of Series B Preferred Stock are eligible to participate in dividends and other distributions by us on an as converted basis.

We have agreed to file this registration statement covering the resale of the shares of common stockCommon Stock sold in the Offering,offering by October 29, 2020.

The Pre-Funded Warrants are exercisable at any time after the date of issuance. A holder of Pre-Funded Warrants may not exercise the warrant if the holder, together with any group that the holder is a member, would beneficially own more than 4.99% (or, at the election of the purchaser, 9.99%) of the number of shares of common stock underlyingoutstanding immediately after giving effect to such exercise. A holder of Pre-Funded Warrants may terminate, increase or decrease this percentage by providing at least 61 days’ prior notice to the Series B Preferred Stock andCompany. A holder of Pre-Funded Warrant is also subject to a limitation on exercise of the Pre-Funded Warrant if such exercise would result in such holder, together with any group that the holder is a member, beneficially owning more 19.99% of the number of shares of common stock issuable upon the paymentCommon Stock outstanding immediately before giving effect to such exercise, unless shareholder approval is obtained. The selling stockholders may sell all, some or none of the Series B Preferred Stock dividend, within 60 daystheir shares in this offering. See “Plan of closing.Distribution.”

Other than the relationships described herein, to our knowledge, none of the selling stockholders are employees or suppliers of ours or our affiliates. Within the past three years, other than the relationships described herein, none of the selling stockholders has held a position as an officer a director of ours, nor has any selling stockholder had any material relationship of any kind with us or any of our affiliates, except that certain selling stockholders acquired shares of our common stock and registration rights pursuant to the transactions described above.affiliates.  All information with respect to share ownership has been furnished by the selling stockholders, unless otherwise noted.  The shares being offered are being registered to permit public secondary trading of such shares and each selling stockholder may offer all or part of the shares it owns for resale from time to time pursuant to this prospectus. In addition, except for Shehnee Lawrence Farhi, who is a first degree cousin of our Board member, Yalon Farhi, noneNone of the selling stockholders has any family relationships with our officers, other directors or controlling stockholders.

Any selling stockholders 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 stockholders” also includes any transferees, pledgees, donees, or other successors in interest to the selling stockholders named in the table below. Unless otherwise indicated, to our knowledge, each 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 stockCommon 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 stockholders who are able to use this prospectus to resell the common stockCommon Stock registered hereby.