SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 1, 2021
SYNTHETIC BIOLOGICS, INC.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction of incorporation)||(Commission File No.)||(IRS Employer Identification No.)|
9605 Medical Center Drive, Suite 270
Rockville, MD 20850
(Address of principal executive offices) (Zip code)
Registrant’s telephone number, including area code: (301) 417-4364
(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 April 1, 2021, Synthetic Biologics, Inc. (the “Company”) issued a press release announcing that enrollment has been initiated and that the first six study participants were dosed in the Company’s Phase 1A clinical trial (the “Phase 1a Clinical Trial”) of SYN-020, a recombinant bovine intestinal alkaline phosphatase formulated for oral delivery to the small intestine. The Company also anticipates announcing topline results from this study as well as commencing a multiple-ascending dose study of SYN-020 during the third quarter of 2021.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 and in the press release attached 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. The information contained in this Item 7.01 and in the press release attached as Exhibit 99.1 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 attached as Exhibit 99.1 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. The Company undertakes no duty or obligation to update or revise the information contained in this Current Report on Form 8-K, although it may do so from time to time if its management believes it is appropriate. Any such updating may be made through the filing of other reports or documents with the Securities and Exchange Commission, through press releases or through other public disclosures.
|Item 8.01||Other Events.|
On April 1, 2021, the Company issued a press release announcing that enrollment has been initiated and that the first six study participants were dosed in the Company’s Phase 1A Clinical Trial of SYN-020, a recombinant bovine intestinal alkaline phosphatase formulated for oral delivery to the small intestine. The Company anticipates announcing topline results from this study as well as commencing a multiple-ascending dose study of SYN-020 during the third quarter of 2021.
|Item 9.01||Financial Statements and Exhibits.|
|99.1||Press Release issued by Synthetic Biologics, Inc., dated April 1, 2021|
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: April 1, 2021||SYNTHETIC BIOLOGICS, INC.|
|By:||/s/ Steven A. Shallcross|
|Name:||Steven A. Shallcross|
Chief Executive Officer and Chief Financial Officer