Current Report Filing (8-k)
November 23 2020 - 8:08AM
Edgar (US Regulatory)
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
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001-36020
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22-3627252
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(State or Other Jurisdiction
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(Commission
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(I.R.S. Employer
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of Incorporation or Organization)
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File Number)
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Identification No.)
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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:
☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17CFR 240.14a-12)
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☐
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐
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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:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, par value $.01 per share
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ONTX
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The Nasdaq Stock Market LLC
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Common Stock Warrants
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ONTXW
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The Nasdaq Stock Market LLC
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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.
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
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Onconova Therapeutics, Inc.
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By:
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/s/ MARK GUERIN
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Name: Mark Guerin
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Title: Chief Financial Officer
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