In May 2016 and April 2017, Moleculin disclosed in its S-1 and Form 10-K that its rights to WP1122 could be terminated by MD Anderson if certain development milestones were not met within prescribed periods of time. Thereafter, the company removed the disclosure from its financial statements and has since made no reference to the possibility of the termination of the license rights.
The staff obtained from MD Anderson a more recent amendment to the license agreement between Moleculin and MD Anderson, which was signed in November 2018. This amendment modifies MD Anderson’s termination rights. Although Moleculin has disclosed the underlying license agreement with MD Anderson as an exhibit to its annual 10-K filings with the Commission, it has not disclosed the November 2018 amendment. That amendment affords MD Anderson the right to terminate the license if Moleculin does not file an IND with the FDA for a Phase I clinical trial by May 1, 2020