Current Report Filing (8-k)
06 Septembre 2022 - 02:11PM
Edgar (US Regulatory)
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2022-09-05 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 5, 2022
SYNTHETIC BIOLOGICS, INC.
(Exact name of registrant as specified in its charter)
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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,
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):
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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)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each
class |
Trading Symbol(s) |
Name of each exchange on which
registered |
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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 5, 2022, Synthetic Biologics, Inc. (the “Company”)
issued a press release announcing a presentation of initial data
from a Phase 1 investigator-sponsored study evaluating VCN-01 in
combination with durvalumab for patients with recurrent/metastatic
squamous cell carcinoma of the head and neck (R/M HNSCC). Data will
be featured in a poster presentation at the European Society for
Medical Oncology (ESMO) Congress, being held both virtually and in
Paris from September 9-13, 2022.
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 5, 2022, the Company issued a press release announcing
a presentation of initial data from a Phase 1
investigator-sponsored study evaluating VCN-01 in combination with
durvalumab for patients with recurrent/metastatic squamous cell
carcinoma of the head and neck (R/M HNSCC). Data will be featured
in a poster presentation at the European Society for Medical
Oncology (ESMO) Congress, being held both virtually and in Paris
from September 9-13, 2022.
Key data and conclusions featured in the ESMO presentation
include:
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· |
Safety: Treatment with VCN-01 had an
acceptable safety profile when administered with durvalumab in the
sequential regimen (single dose of VCN-01 administered 14 days
prior to the first dose of durvalumab; n=14). |
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o |
The most common treatment-related
adverse events (TRAEs) were pyrexia, flu-like symptoms and
increases in liver transaminases. |
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o |
TRAEs were dose-dependent,
reversible and consistent with TRAEs previously described for other
adenovirus-based products. |
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· |
Pharmacokinetics (PK) and
pharmacodynamics (PD): Based on toxicology and PK/PD analysis
the recommended Phase 2 dose is 1x1013 viral particles
(vp)/patient. |
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· |
Biological activity:
Sustained blood levels of VCN-01 viral genomes and increased serum
hyaluronidase levels were maintained for over six weeks. |
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o |
Observed an increase in CD8 T
cells, a marker of tumor inflammation and an upregulation of PD-L1
in tumors. |
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o |
Analysis of serial tumor biopsies
revealed differential gene expression profiles and downregulation
of matrix-related pathways after VCN-01 administration. |
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 6,
2022 |
SYNTHETIC BIOLOGICS,
INC. |
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By: |
/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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Synthetic Biologics (AMEX:SYN)
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De Jan 2023 à Fév 2023
Synthetic Biologics (AMEX:SYN)
Graphique Historique de l'Action
De Fév 2022 à Fév 2023
