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): December 22, 2015 (December 18, 2015)

 

Medgenics, Inc.

(Exact Name of Issuer as Specified in Charter)

 

Delaware

(State or Other Jurisdiction of Incorporation or Organization)

1-35112

(Commission File Number)

98-0217544

(I.R.S. Employer Identification Number)

 

435 Devon Park Drive, Building 700

Wayne, Pennsylvania

(Address of Principal Executive Offices)

19087

(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 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
   
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act
   
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act
   
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act

 

 

 

 

Item 1.01. Entry Into a Material Definitive Agreement.

 

On December 18, 2015, Medgenics, Inc., a Delaware corporation, through its wholly owned subsidiary Medgenics Medical Israel Ltd., a company organized under the laws of the State of Israel (collectively, the “ Company ”), entered into an amendment (the “ Amendment ”) of the Sponsored Research Agreement by and between the Company and The Children’s Hospital Of Philadelphia, a Pennsylvania nonprofit corporation (“ CHOP ”), dated November 12, 2014 (the “ Research Agreement ”).

 

The Amendment extends the term of the Research agreement for a second year, through November 10, 2016, and the Company has the unilateral right to extend the term of the Research Agreement for an additional year, and to provide additional funding for such an extension. Pursuant to the Amendment, the Company is obligated to pay CHOP 4,475,765 in 2016 (which is equal to the funding that the Company paid to CHOP in 2015), and $1,856,023 in the first quarter of 2017, for a total of $6,331,788.

 

Under the terms of the Research Agreement, the Company agreed to sponsor research at CHOP with respect to the recruitment and genetic analysis of patents with rare Mendelian diseases to accelerate discovery of diagnostic and therapeutic targets. In exchange for the Company’s sponsorship of the research program, CHOP has granted the Company options over certain intellectual property created in the course of the research.

 

The Amendment is filed as Exhibit 10.1 to this Current Report on Form 10-K and is incorporated herein by reference. The description of the material terms of the Amendment is qualified in its entirety by reference to such exhibit. The Research Agreement (with certain portions redacted pursuant to a confidential treatment order) was included as Exhibit 10.28 to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2014 filed with the Securities and Exchange Commission on February 13, 2015.

 

Item 7.01. Regulation FD Disclosure.

 

The Company issued a press release on December 22, 2015, announcing the extension of the Research Agreement. A copy of such press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits:
   
10.1

Amendment #1 to Sponsored Research Agreement, dated December 18, 2015, by and between Medgenics Medical Israel Ltd. and the Children’s Hospital of Philadelphia 

   
99.1

Press Release dated December 22, 2015 

 

 

 

 

 

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.
     
     
Date:  December 22, 2015 By:  /s/ John Leaman
    John Leaman
    Chief Financial Officer

 

 

 

 

EXHIBIT INDEX

 

Exhibit
Number 		Exhibit
   
10.1 Amendment #1 to Sponsored Research Agreement, dated December 18, 2015, by and between Medgenics Medical Israel Ltd. and the Children’s Hospital of Philadelphia
   
99.1 Press Release dated December 22, 2015

 

 

 

 

 

Exhibit 10.1

 

Amendment #1 to Sponsored Research Agreement

 

This Amendment #1 to Sponsored Research Agreement, executed on November 12, 2014 (“Agreement”), is made and entered into as of December 18, 2015 (“Amendment #1 Effective Date”) by and between Medgenics Medical Israel, Ltd. (“SPONSOR”) and The Children’s Hospital of Philadelphia (“CHOP”).

 

RECITALS

Whereas SPONSOR and CHOP desire to amend the Sponsored Research Agreement to extend the term of the Agreement and to increase the Budget of the Research Program by $6,331,788 for a new total of $10,807,553;

 

Whereas any capitalized term not separately defined in this Amendment #1 shall have the meaning ascribed to it in the Agreement.

 

Now, therefore, in consideration of the mutual agreements, promises and covenants contained herein SPONSOR and CHOP hereby agree to amend the Sponsored Research Agreement as follows:

 

1. Section 3.1 of the Agreement is hereby replaced in its entirety with the following:

“Term. The initial term of this AGREEMENT shall begin on the EFFECTIVE DATE and shall end on the second anniversary of the EFFECTIVE DATE unless terminated sooner pursuant to Section 2.2 or ARTICLE 9. SPONSOR shall have the option to extend the term of this AGREEMENT through the third anniversary of the EFFECTIVE DATE by giving CHOP written notice of such extension no later than sixty (60) days before the second anniversary of the EFFECTIVE DATE. This AGREEMENT may be extended or renewed beyond the third anniversary of the EFFECTIVE DATE only with the PARTIES’ mutual written agreement.”

 

2. Invoice and Payment Schedule of Attachment B (Budget) is hereby replaced in its entirety with the attached Invoice and Payment Schedule of Attachment B (Budget).

3. Section 4.b. (Timelines) of the Statement of Work of Attachment A is hereby replaced in its entirety with the following: “Phase II extends from November 11, 2015 to November 10, 2016.”

 

4. Section 4.c. (Timelines) of the Statement of Work of Attachment A is hereby replaced in its entirety with the following: “Phase III extends from November 11, 2016 to November 10, 2017. ”

 

All other terms and conditions of the Sponsored Research Agreement not amended herein shall remain in full force and effect.

 

In witness whereof, SPONSOR and CHOP have caused this Amendment #1 to be duly executed as of the Effective Date.

 

MEDGENICS MEDICAL ISRAEL, LTD. THE CHILDREN’S HOSPITAL OF PHILADELPHIA
By: /s/ Michael Cola By: /s/ Mary Tomlinson
Name:    Michael Cola Name:    Mary Tomlinson
Title: Chief Executive Officer Title:   Senior VP, Research Administration
Date:

12/18/2015

Date: 12/10/2015

 

AGREED AND ACKNOWLEDGED
BY: /s/ Hakon Hakonarson
Name:     Hakon Hakonarson, MD
Title: Principal Investigator, Director, CAG
Date: 12/09/2015

 

 

 

 

Attachment B

Invoice and Payment Schedule Year 2, Phase 2

November 11, 2015 – November 10, 2016

 

Budget remains the same

 

Invoice and Payment Schedule

CHOP will invoice Sponsor on a monthly basis for work/efforts completed during the past 30 days. The invoices will be itemized in accordance with staff efforts, supplies and processing services. Monthly pass through costs of Sequencer lease payments and AWS will similarly be included. The average monthly payments for Year 2, Phase 2 will be $527,649 (with the exception of August 2016) and will be paid through March 2017, not to exceed $6,331,788 in total.

 

Date Payment Due   Amount of Payment Due  
       
December 11, 2015   $ 527,649  
January 11, 2015   $ 527,649  
February 11, 2016   $ 527,649  
March 11, 2016   $ 527,649  
April 11, 2016   $ 527,649  
May 11, 2016   $ 527,649  
June 11, 2016   $ 527,649  
July 11, 2016   $ 527,649  
August 11, 2016   $ 254,573  
January 11, 2017   $ 527,649  
February 11, 2017   $ 527,649  
March 11, 2017   $ 800,725  
         
Total Year 2   $ 6,331,788  

 

Unobligated funds from the previous budget period can be carried forward into the new budget period.

 

 

 

Exhibit 99.1

 

 

NEWS RELEASE

 

Medgenics Announces Annual Renewal of Rare and Orphan Disease Research Collaboration with The Children’s Hospital of Philadelphia

· Annual option exercised to extend collaboration
· First development candidate advancing to Phase 2/3 development in 2016
· Additional programs expected in 2016

 

PHILADELPHIA, PA (December 22, 2015) - Medgenics, Inc. (NYSE MKT: MDGN) today announced the annual renewal of its major research collaboration with the Center for Applied Genomics (CAG) at The Children’s Hospital of Philadelphia (CHOP) focused on pediatric rare and orphan genetic diseases. The goal of the collaboration is to accelerate the development of transformational new therapies for these underserved patients.

 

“We are excited to enter the second year of our relationship with CAG following an incredibly productive first year,” stated Michael Cola, Chief Executive Officer of Medgenics. “Working with CAG, we have the opportunity to leverage novel genetic discoveries to progress our genomic medicine strategy. These insights provide us the ability to identify unique populations of rare and orphan disease patients, and to acquire and develop therapeutics that are likely to benefit these patients. We look forward to announcing one or more additional development candidates arising from the collaboration in 2016.”

 

The research collaboration leverages the unique strengths of both organizations. The biobank at CAG is home to one of the largest biorepositories of pediatric genetic data in the world. Access to the rich genetic information in the CAG biobank uniquely enables CHOP and Medgenics researchers to work rapidly and efficiently to identify new rare and orphan disease targets and accelerate the development of novel therapies into clinical stage programs.

 

“CHOP created its Center for Applied Genomics, led by Hakon Hakonarson, M.D., Ph.D., to better understand the genetic basis for disease, and we continue to broaden this vision through important collaborations such as this one with Medgenics,” said Bryan A. Wolf, M.D., PhD, Chief Scientific Officer and Executive Vice President at CHOP. “With our pediatric biobank, we bring to this collaboration access to one of the world’s largest libraries of novel targets and insights into rare genetic diseases affecting children everywhere.”

 

“The mission of Medgenics is to rapidly deliver transformational therapies to those suffering from serious rare and orphan diseases around the world, especially sick children. Our collaboration with CHOP and their impressive scientific, genomic and clinical resources enables us to focus our efforts and technology to translate the latest data and insights into new treatments,” stated Garry Neil, MD, Chief Scientific Officer of Medgenics. “The research collaboration has already led to Medgenics’ decision earlier this year to acquire the NFC-1 program, which is currently in development for mGluR-positive Attention Deficit Hyperactivity Disorder (ADHD) and 22q Deletion Syndrome.”

 

About Medgenics, Inc.

Medgenics is dedicated to unlocking the potential of genomic medicine to identify and treat patients with life-altering conditions. Its efforts, including its internal research and development and ongoing sponsored research and licensing agreements with a well-respected pediatric academic medical center, give Medgenics the ability to focus on the underlying genetic pathway of pediatric diseases with the goal of finding therapeutic solutions for subpopulations of both children and adults living with rare and other difficult-to-treat diseases. Medgenics is the developer of TARGT TM (Transduced Autologous Restorative Gene Therapy), a proprietary platform for the sustained production and delivery of therapeutic proteins, monoclonal antibodies and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases. For more information, visit the Company's website at www.medgenics.com.

 

 

 

 

Forward-looking Statements

This release 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. 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 release may not occur.

 

Contacts:

 

Medgenics, Inc.
John Leaman
john.leaman@medgenics.com

 

Brian Piper

Brian.piper@medgenics.com

Stern Investor Relations

Beth DelGiacco

212-362-1200

Beth@sternir.com