SNGX Soligenix

Filed: 29 Oct 21, 4:05pm



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):  October 29, 2021


Commission File No. 000-16929


Soligenix, Inc.

(Exact name of small business issuer as specified in its charter)





(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




The Nasdaq Capital Market

Common Stock Purchase Warrants




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.



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 


/s/ Christopher J. Schaber 



Christopher J. Schaber, Ph.D.

President and Chief Executive Officer

(Principal Executive Officer)