Current Report Filing (8-k)
September 30 2022 - 8:11AM
Edgar (US Regulatory)
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2022-09-30
2022-09-30
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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 30, 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 30, 2022, Synthetic Biologics, Inc. (the “Company”) issued a press release announcing an oral presentation
entitled “Topotecan enhances oncolytic adenovirus infection, replication and antitumor activity in retinoblastoma,” featuring
Dr. Victor Burgueño, Professor at Fundació Sant Joan de Déu at the SIOP 2022 Congress of the International Society
of Pediatric Oncology (the “SIOP”), being held in Barcelona, Spain from September 28-October 1, 2022. The new data further
support evaluation of VCN-01, an oncolytic adenovirus expressing hyaluronidase, and topotecan for the treatment of refractory retinoblastoma.
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
30, 2022, the Company issued a press release announcing an oral presentation entitled “Topotecan enhances oncolytic adenovirus
infection, replication and antitumor activity in retinoblastoma,” featuring Dr. Victor Burgueño, Professor at Fundació
Sant Joan de Déu at the SIOP 2022 Congress of the International Society of Pediatric Oncology, being held in Barcelona, Spain from
September 28-October 1, 2022. The new data from the study for which Dr. Victor Burgueño is the lead investigator further support
evaluation of VCN-01, an oncolytic adenovirus expressing hyaluronidase, and topotecan for the treatment of refractory retinoblastoma.
Key data and conclusions showcased in the SIOP presentation include:
| • | VCN-01 treatment in combination with topotecan, but not with carboplatin or melphalan, significantly increased VCN-01 infection and
replication in retinoblastoma cells (p=0.0007) in vitro. |
| • | In athymic mice engrafted with human retinoblastomas, topotecan administered systemically after intratumoral VCN-01 increased viral
genome replication and the number of VCN-01 infected cells when compared to administration of VCN-01 alone (p = 0.0002). |
| • | Sequential administration of intratumoral VCN-01 followed by systemic topotecan significantly increased median ocular survival, compared
to VCN-01 alone (p =0.0364). |
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 30, 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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