Item 5. Other Information
ITEM 5. OTHER INFORMATION.
On November 9, 2020, we and CSMC mutually
agreed to terminate the exclusive license agreement that we and our subsidiary, Synthetic Biomics, Inc. entered into with CSMC
date December 5, 2013 and all amendments thereto and the clinical trial agreement relating to SYN-010. The determination to terminate
the SYN-010 license agreement was agreed following the completion of a planned interim futility analysis of the Phase 2b investigator-sponsored
clinical trial of SYN-010. On September 30, 2020, CSMC informed us that it discontinued the ongoing Phase 2b investigator-sponsored
clinical study of SYN-010 IBS-C patients. Based on the results of a planned interim futility analysis, it was concluded that although
SYN-010 was well tolerated, it was unlikely to meet its primary endpoint by the time enrollment is completed. The patent rights
previously licensed to us covering the use of SYN-010 will remain the property of CSMC.
ITEM 6. EXHIBITS
The exhibits filed or furnished as part
of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index, which Exhibit Index is incorporated herein by reference.
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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 thereunto duly authorized.
SYNTHETIC BIOLOGICS, INC.
By:
/s/ Steven A. Shallcross
Steven A. Shallcross
Chief Executive Officer, Chief Financial Officer
(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)
Date: November 10, 2020
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EXHIBIT INDEX
Exhibit
Number
Exhibit Title
10.1
Termination
of Exclusive License Agreement, effective November 9, 2020, by and among Cedars- Sinai Medical Center, Synthetic Biologics,
Inc. and Synthetic Biomics, Inc.*
31.1
Certification
of Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(a)/15d-14(a)*
32.1
Certification
of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002*
101.INS
XBRL Instance Document*
101.SCH
XBRL Taxonomy Extension Schema*
101.CAL
XBRL Taxonomy Extension Calculation Linkbase*
101.DEF
XBRL Taxonomy Extension Definition Linkbase*
101.LAB
XBRL Taxonomy Extension Label Linkbase*
101.PRE
XBRL Taxonomy Extension Presentation Linkbase*
*Filed herewith.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.