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): October 29, 2021
Commission File No. 000-16929
Soligenix, Inc.
(Exact name of small business issuer as specified in its charter)
DELAWARE |
| 41-1505029 |
(State or other jurisdiction of |
| (I.R.S. Employer |
|
|
|
29 Emmons Drive, Suite B-10 Princeton, NJ |
| 08540 |
(Address of principal executive offices) |
| (Zip Code) |
(609) 538-8200
(Issuer’s telephone number, including area code)
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 $.001 per share |
| SNGX |
| The Nasdaq Capital Market |
Common Stock Purchase Warrants |
| SNGXW |
| The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark 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.
Due to disruptions caused by the global COVID-19 pandemic resulting in delays by the commercial active pharmaceutical ingredient contract manufacturer, Soligenix, Inc. (the “Company”) is unable to provide the pre-requisite amount of accrued stability data required to file its HyBryte™ (SGX301) new drug application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) by the first half of 2022. Therefore, the timeline for anticipated NDA filing with the FDA is being adjusted to the second half of 2022 with corresponding potential FDA approval adjusted to the second half of 2023.
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SIGNATURE
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.
| Soligenix, Inc. | |
| | |
October 29, 2021 | By: | /s/ Christopher J. Schaber |
|
| Christopher J. Schaber, Ph.D. |
| | President and Chief Executive Officer |
| | (Principal Executive Officer) |
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