UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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): November 20, 2020

 

 

 

Onconova Therapeutics, Inc.

(Exact name of Registrant as specified in its charter)

 

 

 

Delaware 001-36020 22-3627252
(State or Other Jurisdiction (Commission (I.R.S. Employer
of Incorporation or Organization) File Number) Identification No.)

 

375 Pheasant Run

Newtown, PA 18940

(267) 759-3680

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive

Offices)

 

Not Applicable

(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:

 

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 (17CFR 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 $.01 per share   ONTX   The Nasdaq Stock Market LLC
Common Stock Warrants   ONTXW   The Nasdaq Stock Market LLC

 

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 ☐

 

 

 

 

 

 

Item 7.01. Regulation FD Disclosure.

 

On November 23, 2020, Onconova Therapeutics, Inc. (“Onconova” or the “Company”) issued a press release announcing that it has submitted an Investigational New Drug application for its product candidate ON 123300 to the U.S. Food and Drug Administration (“FDA”). A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

The information disclosed under this Item 7.01 (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 8.01. Other Events.

 

On November 20, 2020, Onconova submitted an Investigational New Drug application for its product candidate ON 123300 to the FDA. Following FDA review and Institutional Review Board approval, the Company plans to begin a Phase 1 study of ON 123300 in the United States.

 

Item 9.01 Financial Statements and Exhibits.

 

(d)    
     
Exhibit    
Number   Description
     
99.1   Press release of Onconova Therapeutics, Inc. issued on November 23, 2020  

 

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: November 23, 2020 Onconova Therapeutics, Inc.
   
  By: /s/ MARK GUERIN
    Name: Mark Guerin
    Title: Chief Financial Officer

 

 

 

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