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EX-99.1 - EXHIBIT 99.1 - Aevi Genomic Medicine, Inc.v392952_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

 

November 3, 2014 (November 3, 2014)
Date of Report (Date of earliest event reported)

 

MEDGENICS, INC.
(Exact name of registrant as specified in its charter)

 

Delaware 1-35112 98-0217544
(State or other jurisdiction of
incorporation or organization)
(Commission File Number) (I.R.S. Employer
Identification No.)

 

435 Devon Park Drive, Building 700

Wayne, Pennsylvania 19087

(Address of principal executive offices, zip code)

 

(610) 254-4201
(Registrant’s telephone number, including area code)

 

Not Applicable
(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 (see General Instruction A.2. below):

¨ 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))

 

 
 

 

Item 7.01.Regulation FD Disclosure.

 

On November 3, 2014, the Company posted to its website at www.medgenics.com an updated slide presentation containing additional pipeline and development timelines, as well as initial clinical data from the ongoing MDGN-201 clinical trial, "Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in Chronic Kidney Disease Patients and End-Stage Renal Disease (ESRD) Dialysis Patients using TARGTEPO (formerly known as EPODURE BioPump).” A copy of this slide presentation is attached as Exhibit 99.1 and incorporated by reference herein. The slide presentation is available in the Investor section of the Company’s website

 

The information furnished in this report under this Item 7.01, including Exhibit 99.1attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such a filing.

 

This Current Report on Form 8-K, including the exhibits attached hereto, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company’s financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as “estimate,” “project,” “intend,” “forecast,” “anticipate,” “plan,” “planning, “expect,” “believe,” “will,” “will likely,” “should,” “could,” “would,” “may” or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. These risks and uncertainties include, but are not limited to, those discussed in the section titled “Risk Factors” of the Company’s Annual Report on Form 10-K for the year ended December 31, 2013, and any updates to those risk factors included in the Company’s Quarterly Reports on Form 10-Q. Should any of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this Current Report on Form 8-K, including the exhibits attached hereto, may not occur.

 

 
 

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits. The following exhibits are furnished herewith:

 

Exhibit No. Description
   
99.1 Slide Presentation dated November 2014 (furnished pursuant to Item 7.01).

 

 

 

 
 

 

SIGNATURES

 

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

 

  MEDGENICS, INC.
     
     
  By: /s/ John Leaman  
    Name: John Leaman
    Title: Chief Financial Officer

  

Date: November 3, 2014