0001140361-15-034454.txt : 20150904 0001140361-15-034454.hdr.sgml : 20150904 20150904143754 ACCESSION NUMBER: 0001140361-15-034454 CONFORMED SUBMISSION TYPE: SC 13D/A PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20150904 DATE AS OF CHANGE: 20150904 GROUP MEMBERS: INTREXON CORP GROUP MEMBERS: NRM VII HOLDINGS I, LLC GROUP MEMBERS: THIRD SECURITY, LLC SUBJECT COMPANY: COMPANY DATA: COMPANY CONFORMED NAME: Synthetic Biologics, Inc. CENTRAL INDEX KEY: 0000894158 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133808303 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: SC 13D/A SEC ACT: 1934 Act SEC FILE NUMBER: 005-50777 FILM NUMBER: 151094362 BUSINESS ADDRESS: STREET 1: 617 DETROIT STREET, SUITE 100 CITY: ANN ARBOR STATE: MI ZIP: 48104 BUSINESS PHONE: (734) 332-7800 MAIL ADDRESS: STREET 1: 155 GIBBS STREET STREET 2: SUITE 412 CITY: ROCKVILLE STATE: MD ZIP: 20850 FORMER COMPANY: FORMER CONFORMED NAME: ADEONA PHARMACEUTICALS, INC. DATE OF NAME CHANGE: 20081027 FORMER COMPANY: FORMER CONFORMED NAME: PIPEX PHARMACEUTICALS, INC. DATE OF NAME CHANGE: 20061214 FORMER COMPANY: FORMER CONFORMED NAME: SHEFFIELD PHARMACEUTICALS INC DATE OF NAME CHANGE: 19970730 FILED BY: COMPANY DATA: COMPANY CONFORMED NAME: KIRK RANDAL J CENTRAL INDEX KEY: 0001091823 FILING VALUES: FORM TYPE: SC 13D/A MAIL ADDRESS: STREET 1: 1881 GROVE AVENUE CITY: RADFORD STATE: VA ZIP: 24141 SC 13D/A 1 formsc13da.htm RANDAL J. KIRK SC 13DA NO 4 9-2-2015 (SYNTHETIC BIOLOGICS)

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC  20549
 

SCHEDULE 13D
(Amendment No. 4)*
Under the Securities Exchange Act of 1934
 
SYNTHETIC BIOLOGICS, INC.
(Name of Issuer) 
 
Common Stock, par value $0.001 per share
(Title of Class of Securities) 
 
87163U102
(CUSIP Number) 
 
Third Security, LLC
1881 Grove Avenue
Radford, Virginia 24141
Attention: Marcus E. Smith, Esq.
(540) 633-7900
(Name, Address and Telephone Number of Person
Authorized to Receive Notices and Communications)
 
 
Copy to:
Intrexon Corporation
Attention: Legal
20374 Seneca Meadows Parkway
Germantown, Maryland 20876
(301) 556-9809
 
September 2, 2015
(Date of Event which Requires Filing of this Statement)
 
If the filing person has previously filed a statement on Schedule 13G to report the acquisition which is the subject of this Schedule 13D, and is filing this schedule because of Rule 13d-1(b)(3) or (4), check the following box    .
 
NOTE:  Schedules filed in paper format shall include a signed original and five copies of the schedule, including all exhibits.  See §240.13d-7 for other parties to whom copies are to be sent.
 
* The remainder of this cover page shall be filled out for a reporting person’s initial filing on this form with respect to the subject class of securities, and for any subsequent amendment containing information which would alter disclosures provided in a prior cover page.
 
The information required on the remainder of this cover page shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934 (“Act”) or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act (however, see the Notes).
 

 

CUSIP No. 87163U102
Page 2 of 9
 
1
NAMES OF REPORTING PERSONS
 
 
I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS
 
 
 
RANDAL J. KIRK
 
 
 
 
 
2
CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP
(a)
 
(b)
 
 
3
SEC USE ONLY
 
 
 
 
 
 
 
4
SOURCE OF FUNDS
 
 
PF
 
 
 
 
5
CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)
 
 
 
 
 
 
6
CITIZENSHIP OR PLACE OF ORGANIZATION
 
 
United States
 
 
 
 
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH
7
SOLE VOTING POWER
 
 
3,625,000
 
 
 
 
8
SHARED VOTING POWER
 
 
9,613,268
 
 
 
 
9
SOLE DISPOSITIVE POWER
 
 
3,625,000
 
 
 
 
10
SHARED DISPOSITIVE POWER
 
 
9,613,268
 
 
 
 
11
AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
 
 
13,238,268
 
 
 
 
12
CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES
 
 
 
 
 
 
13
PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
 
 
14.6%
 
 
 
 
14
TYPE OF REPORTING PERSON
 
 
IN
 
 
 
 
 

CUSIP No. 87163U102
Page 3 of 9
 
1
NAMES OF REPORTING PERSONS
 
 
I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS
 
 
 
THIRD SECURITY, LLC
I.R.S. IDENTIFICATION NO.: 54-1923091
 
 
 
 
 
2
CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP
(a)
 
(b)
 
 
3
SEC USE ONLY
 
 
 
 
 
 
 
4
SOURCE OF FUNDS
 
 
WC
 
 
 
 
5
CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)
 
 
 
 
 
 
6
CITIZENSHIP OR PLACE OF ORGANIZATION
 
 
Virginia
 
 
 
 
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH
7
SOLE VOTING POWER
 
 
3,625,000
 
 
 
 
8
SHARED VOTING POWER
 
 
0
 
 
 
 
9
SOLE DISPOSITIVE POWER
 
 
3,625,000
 
 
 
 
10
SHARED DISPOSITIVE POWER
 
 
0
 
 
 
 
11
AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
 
 
3,625,000
 
 
 
 
12
CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES
 
 
 
 
 
 
13
PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
 
 
4.0%
 
 
 
 
14
TYPE OF REPORTING PERSON
 
 
OO – limited liability company
 
 
 
 
 

CUSIP No. 87163U102
Page 4 of 9
 
1
NAMES OF REPORTING PERSONS
 
 
I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS
 
 
 
NRM VII HOLDINGS I, LLC
I.R.S. IDENTIFICATION NO.: 27-1471440
 
 
 
 
 
2
CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP
(a)
 
(b)
 
 
3
SEC USE ONLY
 
 
 
 
 
 
 
4
SOURCE OF FUNDS (SEE INSTRUCTIONS)
 
 
WC
 
 
 
 
5
CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)
 
 
 
 
 
 
6
CITIZENSHIP OR PLACE OF ORGANIZATION
 
 
United States
 
 
 
 
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH
7
SOLE VOTING POWER
 
 
3,625,000
 
 
 
 
8
SHARED VOTING POWER
 
 
0
 
 
 
 
9
SOLE DISPOSITIVE POWER
 
 
3,625,000
 
 
 
 
10
SHARED DISPOSITIVE POWER
 
 
0
 
 
 
 
11
AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
 
 
3,625,000
 
 
 
 
12
CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES
 
 
 
 
 
 
13
PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
 
 
4.0%
 
 
 
 
14
TYPE OF REPORTING PERSON
 
 
OO – Limited Liability Company
 
 
 
 
 

CUSIP No. 87163U102
Page 5 of 9
 
1
NAMES OF REPORTING PERSONS
 
 
I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS
 
 
 
INTREXON CORPORATION
I.R.S. IDENTIFICATION NO.: 26-0084895
 
 
 
 
 
2
CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP
(a)
 
(b)
 
 
3
SEC USE ONLY
 
 
 
 
 
 
 
4
SOURCE OF FUNDS
 
 
WC
 
 
 
 
5
CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)
 
 
 
 
 
 
6
CITIZENSHIP OR PLACE OF ORGANIZATION
 
 
Virginia
 
 
 
 
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH
7
SOLE VOTING POWER
 
 
0
 
 
 
 
8
SHARED VOTING POWER
 
 
9,613,268
 
 
 
 
9
SOLE DISPOSITIVE POWER
 
 
0
 
 
 
 
10
SHARED DISPOSITIVE POWER
 
 
9,613,268
 
 
 
 
11
AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
 
 
9,613,268
 
 
 
 
12
CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES
 
 
 
 
 
 
13
PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
 
 
10.6%
 
 
 
 
14
TYPE OF REPORTING PERSON
 
 
CO
 
 
 
 
 

CUSIP No. 87163U102
Page 6 of 9
 
This Amendment No. 4 (the “Amendment”) amends and supplements the Statement on Schedule 13D, dated December 7, 2011 and filed on December 12, 2011 as amended by Amendment No. 1 dated October 16, 2012 and filed on October 19, 2012, as amended by Amendment No. 2 dated October 29, 2012 and filed on November 1, 2012 and as amended by Amendment No. 3 dated December 17, 2013 and filed December 19, 2013 (the “Original Schedule 13D”), relating to the Common Stock, par value $0.001 per share (the “Common Stock”), of Synthetic Biologics, Inc. a Nevada corporation (the “Company”).  Mr. Randal J. Kirk (“Mr. Kirk”), NRM VII Holdings I, LLC (“NRM VII Holdings”), a Virginia limited liability company that is managed by an affiliate that is managed by Third Security, LLC (“Third Security”), a Virginia limited liability company that is managed by Mr. Kirk, and  Intrexon Corporation, a Virginia corporation (“Intrexon” and, together with Mr. Kirk, NRM VII Holdings and Third Security, the “Reporting Persons”), are filing this Amendment to disclose the acquisition by Intrexon of 937,500 shares of Common Stock received in connection with a Stock Issuance Agreement, dated August 10, 2015 between the Company and Intrexon (as further described below).  Mr. Kirk could be deemed to have indirect beneficial ownership of the shares of Common Stock directly beneficially owned by NRM VII Holdings and Intrexon.
 
Except as set forth below, there are no changes to the information set forth in the Original Schedule 13D.

Item 3. Source and Amount of Funds or Other Consideration.
 
Item 3 of the Original Schedule 13D is hereby amended and supplemented as follows:
 
On August 10, 2015, the Company expanded its relationship with Intrexon and entered into an Exclusive Channel Collaboration Agreement (the “Channel Agreement”) with Intrexon that governs a “channel collaboration” arrangement in which the Company will use Intrexon’s technology for development of biotherapeutic products (a “Collaboration Product”) for the treatment of phenylketonuria (PKU) in humans by direct administration of a viral construct containing a gene to alter genetic expression of phenyalanine hydroxylase and/or administration of genetically modified bacteria that express an effector directed to the metabolic conversion of phenyalanine (the “Field”).  The Channel Agreement establishes committees comprised of Company and Intrexon representatives that will initially govern activities related to the collaboration in the areas of project establishment and intellectual property and optionally, chemistry, clinical and regulatory matters and commercialization efforts.

The Channel Agreement grants the Company a worldwide exclusive license to use the patents and other intellectual property of Intrexon in connection with the research, development, use, importing, manufacture, sale, and offer for sale of Collaboration Products in the Field.  Such license is exclusive to both parties within the Field, and otherwise is non-exclusive.  The Company may not sublicense the rights described without Intrexon’s written consent other than under limited circumstances to third party contractors performing contract manufacturing services or in the case of certain late stage clinical product candidates.

Under the Channel Agreement, and subject to certain exceptions, the Company is responsible for, among other things, the development, commercialization and manufacturing of products.
 

CUSIP No. 87163U102
Page 7 of 9
 
The Company agreed to pay Intrexon a technology access fee by the issuance of 937,500 shares of its Common Stock having a value equal to $3 million as of August 7, 2015 within ten days of approval of the issuance by the NYSE MKT.  These shares were issued on September 2, 2015, upon satisfaction of customary closing conditions, including the approval for the listing on the NYSE MKT.

Item 4. Purpose of Transaction.
 
Item 4 of the Original Schedule 13D is hereby amended and supplemented as follows:
 
Intrexon acquired the shares disclosed hereunder for investment purposes and as partial consideration for the execution and delivery of the Channel Agreement.
 
Item 5. Interest in Securities of the Issuer.
 
Items 5(a) and (b) of the Original Schedule 13D are hereby amended and restated to read in its entirety as follows:
 
(a) and (b)                              See Items 11 and 13 of the cover pages to this Statement for the aggregate number of shares and percentage of issued and outstanding shares of Common Stock of the Company owned by the Reporting Persons. The percentage ownership is calculated based on 88,515,086 shares of Common Stock outstanding as of August 6, 2015 as disclosed in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015 and filed on August 10, 2015, increased by the number of shares issued (i) by the Company on August 31, 2015 as disclosed in the Company’s filing of Form 8-K on September 3, 2015 and (ii) to and purchased by Intrexon in partial consideration for the execution of the Channel Agreement.
 
Reporting Person
 
Amount of
Common Stock
Beneficially
Owned
 
Percent
of Class
 
Sole Power
to Vote or
Direct
the Vote
 
Shared
Power to
Vote or
Direct
the Vote
 
Sole Power to
Dispose or to
Direct the
Disposition
 
Shared Power to
Dispose or to
Direct the
Disposition
Randal J. Kirk
   
13,238,268
     
14.6
%
   
3,625,000
     
9,613,268
     
3,625,000
     
9,613,268
 
Third Security, LLC
   
3,625,000
     
4.0
%
   
3,625,000
     
     
3,625,000
     
 
NRM VII Holdings I, LLC
   
3,625,000
     
4.0
%
   
3,625,000
     
     
3,625,000
     
 
Intrexon Corporation
   
9,613,268
     
10.6
%
   
     
9,613,268
     
     
9,613,268
 
 
Mr. Kirk could be deemed to have indirect beneficial ownership of the shares of Common Stock directly beneficially owned by NRM VII Holdings and Intrexon.
 
Item 6. Contracts, Arrangements, Understandings or Relationships with Respect to Securities of the Issuer.
 
The Reporting Persons’ responses to Items 3 and 4 are incorporated herein by reference.
 

CUSIP No. 87163U102
Page 8 of 9
 
Item 7. Material to be Filed as Exhibits.
 
Exhibit 1
Stock Issuance Agreement between the Company and Intrexon dated August 10, 2015 (filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K, dated and filed August 10, 2015 and incorporated herein by reference)
 
Exhibit 2
Joint Filing Agreement, dated as of September 4, 2015, by and among Mr. Kirk, Third Security, NRM VII Holdings and Intrexon
 

CUSIP No. 87163U102
Page 9 of 9
 
SIGNATURES
 
After reasonable inquiry and to the best of their knowledge and belief, the undersigned certify that the information set forth in this statement is true, complete and correct.
 
Date:  September 4, 2015

 
/s/ Randal J. Kirk
 
Randal J. Kirk
     
 
THIRD SECURITY, LLC
     
 
By:
/s/ Randal J. Kirk
   
Randal J. Kirk
   
Manager
     
 
NRM VII HOLDINGS I, LLC
     
 
By:
/s/ Randal J. Kirk
   
Randal J. Kirk
   
Manager
     
 
INTREXON CORPORATION
     
 
By:
/s/ Randal J. Kirk
   
Randal J. Kirk
   
Chief Executive Officer
 

EXHIBIT INDEX
 
Exhibit 1
Stock Issuance Agreement between the Company and Intrexon dated August 10, 2015 (filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K, dated and filed August 10, 2015 and incorporated herein by reference)
 
Joint Filing Agreement, dated as of September 4, 2015, by and among Mr. Kirk, Third Security, NRM VII Holdings and Intrexon
 
 

EX-2 2 ex2.htm EXHIBIT 2

Exhibit 2
 
Joint Filing Agreement
 
In accordance with Rule 13d-1(k) promulgated under the Securities Exchange Act of 1934, as amended, the persons named below agree to the joint filing on behalf of each of them a Statement on Schedule 13D (including amendments thereto) with regard to the common stock of Synthetic Biologics, Inc. and further agree that this Joint Filing Agreement be included as an exhibit to such joint filings. In evidence thereof, the undersigned, being duly authorized, hereby execute this agreement as of the 4th day of September, 2015.
 
 
/s/ Randal J. Kirk
 
Randal J. Kirk
     
 
THIRD SECURITY, LLC
     
 
By:
/s/ Randal J. Kirk
   
Randal J. Kirk
   
Manager
     
 
NRM VII HOLDINGS I, LLC
     
 
By:
/s/ Randal J. Kirk
   
Randal J. Kirk
   
Manager
     
 
INTREXON CORPORATION
     
 
By:
/s/ Randal J. Kirk
   
Randal J. Kirk
   
Chief Executive Officer