UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
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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
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 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.
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Exhibit No. |
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Description |
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10.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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.
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Oncternal Therapeutics, Inc. |
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Date: January 23, 2024 |
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/s/ Richard G. Vincent |
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Name: Richard G. Vincent |
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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:
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