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EX-99.1 - InspireMD, Inc.ex99-1.htm

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): July 8, 2020

 

InspireMD, Inc.

 

(Exact name of registrant as specified in its charter)

 

Delaware   001-35731   26-2123838

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

4 Menorat Hamaor St.

Tel Aviv, Israel

  6744832
(Address of principal executive offices)   (Zip Code)

 

(888) 776-6804

(Registrant’s telephone number, including area code)

 

N/A

(Former Name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

[  ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
[  ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
[  ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
[  ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)  

Name of exchange on

which registered

Common Stock, par value $0.0001 per share   NSPR   NYSE American
Warrants, exercisable for one share of Common Stock   NSPR.WS   NYSE American
Series B Warrants, exercisable for one share of Common Stock   NSPR.WSB   NYSE American

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

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 13(a) of the Exchange Act. [  ]

 

 

 

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Item 7.01 Regulation FD Disclosure

 

Non-Deal Roadshow Presentation

 

Beginning on or about July 8, 2020, InspireMD, Inc. (the “Company”) will make presentations to potential institutional and other investors as part of an ordinary course, non-deal “road show,” during which the Company will provide an overview of its business. A copy of the presentation materials to be shown to potential institutional and other investors is furnished herewith as Exhibit 99.1.

 

The current investor presentation materials reflect certain updates relative to the last such presentation materials that had been furnished by the Company to the Securities and Exchange Commission (the “SEC”), as Exhibit 99.1 to the Company’s Current Report on Form 8-K (a “Form 8-K”) furnished on May 26, 2020. In particular, the current presentation updates the following:

 

  Trial Results: The current presentation reflects, in slide 13, a reduced 30-day rate of Death Stroke and Myocardial Infarction (“DSM”) of 1.80% in the ongoing clinical trials for the Company’s CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease treatment. The 30-day DSM had been 1.86% in the previous investor presentation materials. The reduction reflects the inclusion of the results of the SIBERIA randomized clinical trial of CGuard™ EPS, which were released on June 25, 2020 (as reported in the Form 8-K filed by the Company on that day). In that trial, none of the 50 patients treated with the CGuard™ EPS displayed any post-procedural evidence of DSM 30 days following the procedure, thereby reducing the overall 30-day DSM rate for the CGuard™ EPS.
     
  Increased Cash Balances as of end of Q2 2020: As a result of the public offering that the Company consummated on June 5, 2020, and the subsequent exercise of pre-funded warrants and a portion of ordinary warrants sold in that offering, the Company’s cash balances stood at $13.9 million as of June 30, 2020, as reflected in slide 21 of the current investor presentation.
     
  Increased Outstanding Share Capital as of end of Q2 2020: The current presentation updates, in slide 21, the number of outstanding shares of the Company’s common stock to 33,358,994 as of June 30, 2020. That reflects an increase relative to the previous investor presentation, resulting from the Company’s issuance of additional shares of common stock (i) in the June 2020 public offering, as well as (ii) subsequently, upon the exercise of pre-funded warrants and a portion of ordinary warrants also sold in that public offering.

 

In addition to the foregoing updates, the current presentation materials contain certain projections of the Company’s anticipated results of operations, or assumptions or estimates as to future events or outcomes. Those materials are intended to speak only as of the date of this report and should not be construed as representing projections of the Company’s anticipated results of operations, or assumptions or estimates as to future events or outcomes, as of any subsequent date. By furnishing the projections and other information in the presentation materials, the Company is not undertaking, and the Company expressly disclaims, any obligation to furnish updated or revised projections of the Company’s projected results of operations, or assumptions or estimates as to future events or outcomes, to reflect any events or circumstances occurring or existing at any time after the date hereof (irrespective in any such case of whether the projections, assumptions or estimates set forth in the presentation materials, in light of events or circumstances occurring or existing at any time after the date hereof, shall have ceased to have a reasonable basis). Consequently, the projections of the Company’s anticipated results of operations, assumptions and estimates set forth in the presentation materials furnished hereby should not be regarded as a representation by the Company that the projected results of operations can or will be achieved, only that the Company has concluded in good faith that they may be achieved based on many assumptions. The Company’s regular annual and quarterly financial statements, and the accompanying discussions and analyses of its financial condition and results of operations, contained in the Company’s Annual Reports on Form 10-K and its Quarterly Reports on Form 10-Q filed with the SEC after the date of this report will contain disclosure regarding the Company’s actual results of operations for fiscal periods covered by the projections in the presentation materials. The Company’s actual results could, and likely will, vary significantly from the potential results projected in the presentation materials, as a result of, among other things, changes in operations, factors affecting the Company’s business and industry, and the degree and timing to which management is able to execute its currently proposed business plan.

 

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Please refer to page 2 of Exhibit 99.1 for a cautionary note regarding certain forward-looking statements included therein and the risks and uncertainties related thereto.

 

This information is being furnished pursuant to Item 7.01 of this report, and the exhibit being furnished as Exhibit 99.1 hereto shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, and will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended, unless specifically identified as being incorporated therein by reference and regardless of any general incorporation language in such filing. The inclusion of that information in this report will not be deemed an admission as to the materiality of any information in this report that is being disclosed pursuant to Regulation FD.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit Number   Description
99.1   Presentation of InspireMD, Inc., as furnished on July 8, 2020

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

InspireMD, Inc.
     
Date: July 8, 2020 By: /s/ Craig Shore
Name: Craig Shore
Title: Chief Financial Officer