ONCT Oncternal Therapeutics Inc

 

 

 

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) January 22, 2024

Oncternal Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware		000-50549		62-1715807
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

12230 El Camino Real Suite 230 San Diego, CA 92130 (858) 434-1113

(Address and zip code; telephone number, including area code, of registrant’s principal executive offices)

 

N/A

(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 (see General Instruction A.2. below):

☐	Written communication 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 $0.001 per share		ONCT		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 ☐

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. ☐

 

 

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Item 1.01. Entry into a Material Definitive Agreement.

 

On January 22, 2024, Oncternal Therapeutics, Inc. ("Oncternal") entered into Amendment No. 4 (the "Amendment") to the Amended and Restated License Agreement between Oncternal and the Regents of the University of California, represented by UC San Diego dated February 5, 2024. The Amendment extends the deadlines by which Oncternal is required to meet certain diligence milestones for naked antibodies, including Oncternal's zilovertamab product candidate. A copy of the Amendment is attached as Exhibit 10.1 hereto and is incorporated herein by reference. The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
10.1		Amendment #4 to the Amended and Restated License Agreement between Oncternal Therapeutics, Inc. and UC San Diego dated August 31, 2018
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

1

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SIGNATURES

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.

 

	Oncternal Therapeutics, Inc.
Date: January 23, 2024	By:	/s/ Richard G. Vincent
		Name: Richard G. Vincent
		Title: Chief Financial Officer

 

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Exhibit 10.1

AMENDMENT NO. 4

TO THE AMENDED AND RESTATED LICENSE AGREEMENT

BETWEEN ONCTERNAL THERAPEUTICS, INC.

AND THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

FOR UC CASE NUMBERS SD2005-212, SD2020-036, SD2011-178, SD2012-143, SD2012-403, SD2015-027, SD2015-200, SD2018-253 AND SD2019-278

 

This Amendment No. 4 (this “Amendment”) is made as of the date of the last signature below by and between Oncternal Therapeutics, Inc. having an address at 12230 El Camino Real, Suite 230, San Diego, California 92130 (“LICENSEE”) and The Regents of the University of California, a California public corporation having its statewide administrative offices at 1111 Franklin Street, Oakland, California 94607-5200 (“UNIVERSITY”), represented by its San Diego campus having an address at University of California San Diego, Office of Innovation and Commercialization (“OIC”), Mail Code 0910, 9500 Gilman Drive, La Jolla, California 920930910 (“UC San Diego”).

 

WHEREAS, LICENSEE and UNIVERSITY entered into an Amended and Restated License Agreement, UC Control Number 2019-03-0137 effective August 31, 2018, which was amended by Amendment No. 1, UC Control Number 2019-03-0137(R501) effective March 25, 2019, Amendment No. 2, UC Control Number 2019-03-0137(R502) effective May 15, 2019 and Amendment No. 3, UC Control Number 2019-03-0137(R503) effective February 5, 2021 (collectively, the “Agreement”); and

 

WHEREAS, LICENSEE and UNIVERSITY wish to further amend the Agreement to make certain changes.

 

NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants set forth below, the parties amend the Agreement and otherwise agree as follows:

 

 

 

 

 

 

 

 

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Exhibit 10.1

“Phase III Clinical Trial” shall mean a pivotal human clinical trial in any country the results of which could be used to establish safety and efficacy of Licensed Product as a basis for a BLA or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

 

“BLA” means a Biologics License Application as described in 21 C.F.R. § 601.2, including any amendments thereto, or any corresponding application in a country or jurisdiction outside the U.S.

 

 

 

 

IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to be executed by their duly authorized representatives, as of the latest date written below.

 

ONCTERNAL THERAPEUTICS, INC.: THE REGENTS OF THE

UNIVERSITY OF CALIFORNIA:

 

By: /s/ James Breitmeyer, M.D., Ph.D. By: /s/ Victoria Cajipe, Ph.D.

Name: James Breitmeyer, M.D., Ph.D. Name: Victoria Cajipe, Ph.D.

Title: President and Chief Executive Officer Title: Associate Director

Date: 1/22/2024 Date: 1/19/2024

 

 

 

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v3.23.4

Document and Entity Information	Jan. 22, 2024
Document Information [Line Items]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 22, 2024
Entity Registrant Name	Oncternal Therapeutics, Inc.
Entity Central Index Key	0001260990
Entity Emerging Growth Company	false
Securities Act File Number	000-50549
Entity Incorporation State Country Code	DE
Entity Tax Identification Number	62-1715807
Entity Address, Address Line One	12230 El Camino Real
Entity Address, Address Line Two	Suite 230
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92130
City Area Code	858
Local Phone Number	434-1113
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Security 12b Title	Common Stock, par value $0.001 per share
Trading Symbol	ONCT
Security Exchange Name	NASDAQ

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