Current Report Filing (8-k)
30 Septembre 2022 - 02:11PM
Edgar (US Regulatory)
0000894158 false 0000894158 2022-09-30
2022-09-30 iso4217:USD xbrli:shares iso4217:USD xbrli:shares
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
|
Synthetic Biologics (AMEX:SYN)
Graphique Historique de l'Action
De Jan 2023 à Fév 2023
Synthetic Biologics (AMEX:SYN)
Graphique Historique de l'Action
De Fév 2022 à Fév 2023