Current Report Filing (8-k)
January 07 2020 - 7:06AM
Edgar (US Regulatory)
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): January 6, 2020
SYNTHETIC BIOLOGICS, INC.
(Exact name of registrant as specified in
its charter)
Nevada
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001-12584
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13-3808303
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(State or other jurisdiction of incorporation)
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(Commission File No.)
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(IRS Employer Identification No.)
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9605 Medical Center Drive, Suite 270
Rockville, MD 20850
(Address of principal executive offices
and zip code)
Registrant’s telephone number, including
area code: (301) 417-4364
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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section
12(b) of the Act:
Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common stock, par value $0.001 per share
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SYN
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NYSE American
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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 8.01. Other Events
On January 6, 2020, Synthetic Biologics,
Inc. (the “Company”) received official meeting minutes from the U.S. Food and Drug Administration (the “FDA”)
following a Type C meeting held on December 2, 2019 at the Company’s request to discuss the development of SYN-004 (ribaxamase)
in allogeneic hematopoietic cell transplant (HCT) recipients who are administered intravenous (IV) beta-lactam antibiotics in response
to fever. Based on the final meeting minutes, the Phase 1b/2a study will comprise a single center, randomized, double-blinded,
placebo-controlled clinical trial of oral SYN-004 (ribaxamase) in up to 36 evaluable adult allogeneic HCT recipients. The goal
of this study is to evaluate the safety, tolerability and potential absorption into the systemic circulation (if any) of 150 mg
oral SYN-004 (ribaxamase) administered to allogeneic HCT recipients who receive an IV beta-lactam antibiotic to treat fever. Study
participants will be enrolled into three sequential cohorts administered a different study-assigned IV beta-lactam antibiotic.
Eight participants in each cohort will receive SYN-004 (ribaxamase) and four will receive placebo. Safety and pharmacokinetic data
for each cohort will be reviewed by an independent Data and Safety Monitoring Committee, which will make a recommendation on whether
to proceed to the next IV beta-lactam antibiotic. The study will also evaluate potential protective effects of SYN-004 (ribaxamase)
on the gut microbiome as well as generate preliminary information on potential therapeutic benefits and patient outcomes of SYN-004
(ribaxamase) in allogeneic HCT recipients. Enrollment is expected to begin during the first quarter of 2020 contingent upon approval
of the clinical study protocol by the Washington University School of Medicine’s Institutional Review Board.
The press release attached as Exhibit 99.1
to this Current Report on Form 8-K, which is incorporated herein by reference, includes “safe harbor” language pursuant
to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained in the slide
presentation are “forward-looking” rather than historical.
The Company undertakes no duty or obligation
to update or revise information included in this Current Report on Form 8-K or the press release attached as Exhibit 99.1 hereto.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
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.
Dated: January 7, 2020
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SYNTHETIC BIOLOGICS, INC.
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By:
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/s/ Steven A. Shallcross
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Name: Steven A. Shallcross
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Title: Chief Executive Officer
and Chief Financial Officer
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