0001213900-21-025167.txt : 20210507 0001213900-21-025167.hdr.sgml : 20210507 20210507170015 ACCESSION NUMBER: 0001213900-21-025167 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20210507 ITEM INFORMATION: Other Events FILED AS OF DATE: 20210507 DATE AS OF CHANGE: 20210507 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SOLIGENIX, INC. CENTRAL INDEX KEY: 0000812796 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 411505029 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-14778 FILM NUMBER: 21903729 BUSINESS ADDRESS: STREET 1: 29 EMMONS DRIVE STREET 2: SUITE B-10 CITY: PRINCETON STATE: NJ ZIP: 08540 BUSINESS PHONE: 609-538-8200 MAIL ADDRESS: STREET 1: 29 EMMONS DRIVE STREET 2: SUITE B-10 CITY: PRINCETON STATE: NJ ZIP: 08540 FORMER COMPANY: FORMER CONFORMED NAME: DOR BIOPHARMA INC DATE OF NAME CHANGE: 20020329 FORMER COMPANY: FORMER CONFORMED NAME: ENDOREX CORP DATE OF NAME CHANGE: 19960916 FORMER COMPANY: FORMER CONFORMED NAME: IMMUNOTHERAPEUTICS INC DATE OF NAME CHANGE: 19920703 8-K 1 ea140526-8k_soligenix.htm CURRENT REPORT

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): 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		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.

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.

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.

May 7, 2021

By:

/s/ Christopher J. Schaber

Christopher J. Schaber, Ph.D.

President and Chief Executive Officer

(Principal Executive Officer)