Moleculin Biotech, Inc. Reports Financial Results for the First Quarter Ended March 31, 2019
HOUSTON - May 14, 2019 - Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"),
a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced its financial results for the first quarter ended March 31, 2019. Additionally, the Company announced potential upcoming milestones and recent corporate developments.
Walter Klemp, Chairman and CEO of Moleculin, said, "We are off to a very good start in 2019, as we have achieved significant milestones with the development of our oncology portfolio. This time last year we had just commenced our first clinical trial for one drug. Today, we have three drugs in four clinical trials under way with a fifth clinical trial that may start before year end. We are excited with the progress that has been achieved and we expect that 2019 will be the ‘year of data’ where we provide progress reports as our various drug candidates proceed through their respective clinical trials."
"One of the highlights of the just completed quarter was FDA ‘Fast Track’ designation for Annamycin, our drug candidate for the treatment of adults with relapsed or refractory acute myeloid leukemia. Fast Track represents an important first step toward accelerated approval. We presented the FDA a proposal for the designation, and they determined that Annamycin should be eligible for accelerated approval. This potentially cuts years off our development timeline and should make Annamycin attractive to development partners much sooner. We also announced pre-clinical data supporting the expansion of Annamycin indications to include lung cancer."
"It bears noting we announced last week that our Annamycin clinical trial in Poland is generating very encouraging results," continued Mr. Klemp. "We have completed the first cohort of the trial and 2 out of 3 patients treated responded sufficiently to qualify for a potentially curative bone marrow transplant. Although we are still early in the trial, we believe this small sample size is indicative of what Annamycin is designed to produce. The standard of care failed these relapsed or refractory patients, and we believe Annamycin has provided new hope for an improved quality of life, and, or possibly, an extension of life.
"We continue to see strong anti-tumor activity with WP1066, our flagship Immune/Transduction Modulator in a wide range of animal models. The data is showing positive results of combining our drug candidate WP1066 with checkpoint inhibitors, suggesting that WP1066 may have the ability to improve the outcome of immune checkpoint therapy in tumors that have been resistant to these therapies. We believe this represents an important new approach to treating many types of cancer. We are extremely excited with the ongoing results of this preclinical research. These important developments, along with regulatory approvals, complement our vision of developing numerous drugs that support our ‘multiple shots on goal’ strategy.
The following information was filed by Moleculin Biotech, Inc. (MBRX) on Tuesday, May 14, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.