MOLECULIN BIOTECH, INC. (NASDAQ:MBRX) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01 Entry into a Material Definitive Agreement.
MOLECULIN BIOTECH, INC. (NASDAQ:MBRX) Files An 8-K Entry into a Material Definitive Agreement
On May 20, 2020, Moleculin Biotech, Inc. (the “Company”) entered into an amendment (the “Amendment”) to the Patent and Technology License Agreement dated April 2, 2012 entered into by and between Intertech Bio Corporation and The Board of Regents (the “Board”) of The University of Texas System on behalf of The University of Texas M. D. Anderson Cancer Center (“UTMDACC”), as previously amended on October 19, 2015 (“Amendment 1”) and November 1, 2018 (“Amendment 2” and collectively, the “WP122 Agreement”). The WP1122 Agreement was assigned to the Company on November 17, 2015. to the WP1122 Agreement, the Company obtained a royalty-bearing, worldwide, exclusive license to intellectual property, including patent rights, related to its WP1122 portfolio and to the drug product candidate, WP1122. In consideration, the Company must make payments to UTMDACC including an up-front payment, license documentation fee, annual maintenance fee, milestone payments and minimum annual royalty payments for sales of products developed under the WP1122 Agreement. to the WP1122 Agreement, the Board and UTMDACC have the right to terminate the WP1122 Agreement if the Company does not, within certain time periods: (i) file an Investigational New Drug Application with the FDA for a Phase I Study for a Licensed Product (“IND filing requirement”); and (ii) commence a Phase I Study for a Licensed Product (“Phase I study requirement”). to the Amendment, the Company is required to meet the IND filing requirement within nine months of the date of the Amendment (the previous requirement was three years from the date of Amendment 1 and 18 months from the date of Amendment 2) and the Phase I study requirement within 2.5 years of the date of the Amendment (the previous requirement was five years from the date of Amendment 1 and 3.5 years from the date of Amendment 2); provided the Company has the right to extend such time periods for up to an additional 18 months by the payment of certain extension payments to UTMDACC.
Item 8.01 Other Events.
On May 27, 2020, Moleculin Biotech, Inc. (the “Company”) issued a press release announcing that the US Food and Drug Administration (“FDA”) has granted the Company’s request for a Pre-IND Meeting to provide guidance regarding the Company’s plan to study its drug candidate, WP1122, in a clinical trial for patients with COVID-19 (the disease caused by the SARS-CoV-2 coronavirus), in addition to providing a general update on the WP1122 development efforts.
A copy of the press release is attached to this report as Exhibit 99.1 and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
99.1 Press Release dated May 27, 2020
Moleculin Biotech, Inc. Exhibit
EX-99.1 2 exh991-pressreleasemolecul.htm EXHIBIT 99.1 Exhibit Exhibit 99.1 Moleculin Provides Update on Coronavirus Drug Development FDA grants Pre-IND Meeting requestHOUSTON,…
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EX-99.1 2 exh991-pressreleasemolecul.htm EXHIBIT 99.1 Exhibit Exhibit 99.1 Moleculin Provides Update on Coronavirus Drug Development FDA grants Pre-IND Meeting requestHOUSTON,…
To view the full exhibit click
hereAbout MOLECULIN BIOTECH, INC. (NASDAQ:MBRX)
Moleculin Biotech, Inc. is a preclinical and clinical-stage pharmaceutical company. The Company is focused on the development of anti-cancer drug candidates. Its lead drug candidate is liposomal Annamycin, which it refers to as Annamycin, an anthracycline intended for the treatment of relapsed or refractory acute myeloid leukemia (AML). Annamycin is a Phase II clinical-stage anthracycline and liposome formulated anthracycline that has been designed to eliminate cardiotoxicity and avoid the multidrug resistance mechanisms. It has over two other drug development projects in progress, one involving a portfolio of small molecules, which it refers to as the WP1066 Portfolio, focused on the modulation of key oncogenic transcription factors involved in the progression of cancer, and the WP1122 Portfolio, a suite of molecules targeting the metabolic processes involved in cancer in general, and glioblastoma. As of September 30, 2016, it had not generated any revenue from its operations.
