SNGX Soligenix

Filed: 7 May 21, 5:00pm





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): May 7, 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
incorporation or organization)
 (I.R.S. Employer
Identification Number)
29 Emmons Drive,
Suite B-10
Princeton, NJ

(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.


Soligenix, Inc. (the “Company”) recently had discussions with the U.S. Food and Drug Administration (“FDA”) regarding the HyBryte™ (SGX301) new drug application (“NDA”) submission.  Based upon these discussions and given delays in manufacturing, in part caused by the global COVID-19 pandemic, on May 7, 2021, the Company decided not to pursue a rolling NDA submission at this time, in order to provide additional supportive data for inclusion in the NDA filing.  The Company now plans to submit the NDA in the first half of 2022 with corresponding potential FDA approval adjusted to the first half of 2023.







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.


May 7, 2021 By:/s/ Christopher J. Schaber 

Christopher J. Schaber, Ph.D.

President and Chief Executive Officer

(Principal Executive Officer)