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Moleculin Announces Submission to Expand Clinical Sites in European AML Trial

Submits regulatory requests to open two additional clinical sites in Poland


HOUSTON, June 4, 2020 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates, today announced that it has submitted requests to Polish regulatory authorities for approval to open two additional clinical sites for its Phase 1/2 clinical study of Annamycin for the treatment of acute myeloid leukemia ("AML").


"We are pleased to report that the Annamycin trial in AML continues forward despite the disruptions from the COVID-19 pandemic," commented Walter Klemp, Chairman and CEO of Moleculin.  "Two additional hospitals in Poland, one in Szczecin and one in Kielce, have been moving quickly to participate in this trial.  Assuming these requests are granted in a timely manner, we expect both sites to begin recruiting in the third quarter."


Moleculin currently has 5 clinical sites for the Annamycin AML clinical trial operating in Europe.  The addition of sites in Szczecin and Kielce would bring this total to 7.


About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses. The Company's clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity, being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML; WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, being studied for brain tumors, pancreatic cancer and hematologic malignancies; and WP1220, an analog to WP1066, being studied for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition, such as WP1122.


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 Annamycin to be shown safe and effective for the treatment of AML and the ability to receive regulatory approval to add additional hospitals to its AML clinical trial. Although Moleculin 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.


Contacts James Salierno / Carol Ruth The Ruth Group 646-536-7028 / 7000 jsalierno@theruthgroup.com cruth@theruthgroup.com


SOURCE Moleculin Biotech, Inc.


Source: https://www.prnewswire.com/news-releases/moleculin-announces-submission-to-expand-clinical-sites-in-european-aml-trial-301070425.html

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