OTHER INFORMATION.
−Removed: Not applicable
+Added: On November 9, 2020, we and CSMC mutually
+Added: agreed to terminate the exclusive license agreement that we and our subsidiary, Synthetic Biomics, Inc.
+Added: entered into with CSMC
+Added: date December 5, 2013 and all amendments thereto and the clinical trial agreement relating to SYN-010.
+Added: The determination to terminate
+Added: the SYN-010 license agreement was agreed following the completion of a planned interim futility analysis of the Phase 2b investigator-sponsored
+Added: clinical trial of SYN-010.
+Added: On September 30, 2020, CSMC informed us that it discontinued the ongoing Phase 2b investigator-sponsored
+Added: clinical study of SYN-010 IBS-C patients.
+Added: Based on the results of a planned interim futility analysis, it was concluded that although
+Added: SYN-010 was well tolerated, it was unlikely to meet its primary endpoint by the time enrollment is completed.
+Added: The patent rights
+Added: previously licensed to us covering the use of SYN-010 will remain the property of CSMC.
The exhibits filed or furnished as part
6 unchanged sentences
(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)
−Removed: August 6, 2020
+Added: November 10, 2020
EXHIBIT INDEX
Exhibit Title
−Removed: Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(a)/15d-14(a)*
−Removed: Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C.
−Removed: Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
+Added: of Exclusive License Agreement, effective November 9, 2020, by and among Cedars- Sinai Medical Center, Synthetic Biologics,
+Added: and Synthetic Biomics, Inc.*
+Added: Certification
+Added: of Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(a)/15d-14(a)*
+Added: Certification
+Added: of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C.
+Added: Section 1350, as adopted pursuant to
+Added: Section 906 of the Sarbanes-Oxley Act of 2002*
XBRL Instance Document*
6 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.