Current Report Filing (8-k)
September 27 2022 - 8:18AM
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2022-09-27
2022-09-27
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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): September 27, 2022
SYNTHETIC BIOLOGICS, INC.
(Exact name of registrant as specified in its charter)
| Nevada |
|
001-12584 |
|
13-3808303 |
|
(State or other jurisdiction of
incorporation) |
|
(Commission File No.) |
|
(IRS Employer Identification
No.) |
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
(Address of principal executive offices and zip
code)
(301) 417-4364
Registrant’s telephone number, including
area code
N/A
(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)) |
Securities registered pursuant to Section 12(b)
of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which
registered |
| Common stock, par value $0.001 per share |
SYN |
NYSE American |
Indicate by check mark whether the registrant
is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by checkmark
if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01. Regulation
FD Disclosure.
On September 27, 2022,
Synthetic Biologics, Inc. (the “Company”) issued a press release announcing positive outcome from the Data and Safety Monitoring
Committee (“DSMC”) review of results from the first Cohort of the Company’s Phase 1b/2a randomized, double-blinded,
placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention
of acute graft-versus-host-disease (aGVHD).
The information in this
Item 7.01 and in the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section
or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended and shall not be incorporated by reference into any filing with
the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general
incorporation language in such filing.
The press release furnished
as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities Litigation
Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.
Item 8.01. Other
Events.
On September 27, 2022,
the Company issued a press release announcing positive outcome from the DSMC review of results from the first Cohort of the Company’s
Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant
(HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD).
Key data and conclusions disclosed in the press release include:
Cohort 1 enrolled 19 patients who received at
least 1 dose of study drug (SYN-004 or Placebo randomized 2:1). Sixteen patients received at least one dose of intravenous (IV) meropenem
and 12 of these patients completed sufficient doses of IV meropenem to be evaluable towards the study endpoints. The study is on-going
and remains blinded; however, key findings from blinded data for Cohort 1 are included below:
| · | Adverse events (AEs) and serious adverse events
(SAEs) observed in Cohort 1 were typical of those observed in allo-HCT patients and no AEs or SAEs were determined to be related to study
drug treatment by the investigators. |
| o | A total of 13 SAEs were reported among 10 patients, with the most common SAE being infections and infestations
including sepsis. |
| o | One patient died 14 days after the last dose of study drug (within the 30-day reporting period) due to
sepsis that was not related to study drug. |
| · | Consistent with previous studies of SYN-004 in
healthy volunteers, SYN-004 was not observed in blood samples from the majority of the evaluable patients. |
| o | A total of 3 plasma samples (~2% of all analyzed samples) had low but
quantifiable levels of SYN-004 using a sensitive ECL assay. |
| o | None of the 3 ECL positive plasma samples was found to contain active SYN-004 using a functional enzyme
activity assay. |
| · | Meropenem pharmacokinetics were as expected for
this patient population. |
Based on a review of the safety and pharmacokinetic
data, the DSMC has recommended that the study may proceed to enroll Cohort 2 in which study drug (SYN-004 or Placebo) will be administered
in combination with the IV beta-lactam antibiotic piperacillin/tazobactam.
Item 9.01. Financial
Statements and Exhibits.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the
undersigned hereunto duly authorized.
| Dated: September 27, 2022 |
SYNTHETIC BIOLOGICS, INC. |
| |
|
|
|
| |
By: |
/s/ Steven A. Shallcross |
| |
|
Name: |
Steven A. Shallcross |
| |
|
Title: |
Chief Executive Officer and Chief Financial Officer |
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