Moleculin Announces Polish Approval for Leukemia Clinical Trial

HOUSTON, TX--(Marketwired - December 21, 2017) - Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center ("MD Anderson"), announced that the Ethics Committee in Poland has approved the Company's Phase I/II clinical trial of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML").

"We have been highly focused on accelerating our clinical development of Annamycin," commented Walter Klemp, Chairman and CEO of Moleculin. "The protocol approved in Poland allows us to move more aggressively in identifying the optimum dosing for AML patients, which in turn should allow us to move into Phase II data generation more expeditiously."

Mr. Klemp added, "This approval should also increase our ability to recruit patients into our AML trial, which we expect to begin in a matter of weeks. Importantly, we believe the clinical data produced in Poland will be useful in our interactions with both the U.S. Food and Drug Administration ("FDA"), as well as with the European Medicines Agency ("EMA"), as we seek regulatory approval for Annamycin."

A site initiation visit for the first treatment site was completed this week and treatment of patients in Poland is now subject only to confirmation by the Polish National Office that all necessary forms have been properly filed. The Company expects the first patient to be enrolled in first quarter 2018.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our clinical stage drugs are Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, and WP1066, a modulator of hard-to-target tumor cell signaling mechanisms intended to attack tumor activity directly while also recruiting the patient's own immune system. We are also engaged in preclinical development of additional drug candidates, including compounds targeting the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company's Principal Investigators to enroll patients and the ability of Annamycin to demonstrate safety and efficacy in AML patients. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.