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Moleculin Biotech, Inc. Reports Financial Results for the First Quarter Ended March 31, 2019

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Wednesday, May 15, 2019

HOUSTON, USA -- 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.

Management Discussion
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 preclinical 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.

"Also, during the quarter, the FDA granted Orphan Drug Designation for WP1066 for the treatment of glioblastoma, one of the most aggressive forms of brain tumors. The FDA grants Orphan Drug Designation to drugs and biologics that are intended for the treatment of rare diseases. In addition to glioblastoma, WP1066 could be effective in the treatment of a range of highly resistant tumors including acute myeloid leukemia ("AML") and pancreatic cancer."

Mr. Klemp concluded, "This just completed first quarter yielded a number of important developments that set the stage for a successful 2019 and the years ahead. As we continue through our various clinical trials and preclinical research, we are heartened with the tangible progress being made and that we are advancing toward our goal of developing effective treatments for rare and difficult cancers that eclipse the outcomes of the standard of care. Providing hope to patients, where it might have been lost, is a driving force for the entire Moleculin team."

Recent milestones and accomplishments include:

Next Generation Anthracycline - Annamycin

  • Announcement of additional positive interim safety and efficacy data from our ongoing study of Annamycin in Poland. After receiving a single starting dose of 120 mg/m2 in the first cohort of the dose escalation phase of the trial, 2 of 3 patients treated responded sufficiently to qualify for a potentially curative bone marrow transplant. Additionally, no patients in the U.S. or in the European trials, to date, have shown any signs of cardiotoxicity. The results for all 3 patients were reviewed by the Safety Review Committee, which determined that no drug-related adverse events were observed that would prevent advancing the trial to the next higher dose level of 150 mg/m2.
  • FDA grants Fast Track Designation of our drug Annamycin for the treatment of relapsed or refractory acute myeloid.
  • Announcement that we have found Annamycin to be active against metastases to the lungs in preclinical testing. Annamycin significantly improved survival in an aggressive form for triple negative breast cancer metastasized to the lungs in animal models.
  • U.S. clinical trial completed the first cohort and is currently recruiting patients for the second cohort to be given a dose level of 120 mg/m2.

Immune/Transcription Modulators - WP1066 Portfolio

  • Agreement with Emory University to conduct pediatric brain tumor trial. This will be a Phase 1 clinical trial of WP1066 in children with recurrent or refractory malignant brain tumors. The study will be conducted at the Aflac Cancer & Blood Disorders Center at Children's Healthcare of Atlanta.
  • Announcement that preclinical data supporting activity of our STAT3-inhibiting Immune/Transcription Modulators was presented by Dr. Waldemar Priebe, Founder and Chair of the Scientific Advisory Board of Moleculin, Inc. at the 2019 Annual Meeting of the American Association for Cancer Research ("AACR") in Atlanta, GA. The presentation included data resulting from preclinical evaluation in pancreatic cancer models of STAT3 inhibitors WP1066 and WP1732. WP1066 is an orally bioavailable drug with significant brain uptake that is currently in Phase I clinical studies in patients with brain tumors. Complementary to WP1066, we believe STAT3 inhibitor WP1732 may be suitable for IV administration and demonstrates high uptake by the pancreas without uptake to the brain.
  • Announcement of the first two patients enrolled in our European clinical trial of WP1220 for the topical treatment of cutaneous T-Cell Lymphoma (CTCL).
  • FDA granted Orphan Drug Designation for our drug candidate WP1066 for the treatment of glioblastoma, the most aggressive form of brain tumor.
  • Announcement that we have shown that WP1066, an Immune/Transduction Modulator, appears to counteract resistance to checkpoint blockade therapy (specifically, immune checkpoint target PD-L1) in our own sponsored research.

General

  • Announcement of Dr. Martin Tallman, Chief of Leukemia for Memorial Sloan Kettering Cancer Center has joined the Company's Science Advisory Board (SAB).

Jonathan Foster, Executive Vice president and Chief Financial Officer of Moleculin, stated, "We finished the first quarter with cash of approximately $8.8 million and we received additional gross proceeds of $16.6 million subsequent to the quarter end from a public offering and the exercise of various warrants. The strengthening of our balance sheet provides us the ability to fund our ongoing research programs and clinical trials. We believe our existing cash and cash equivalents will be sufficient to fund our planned operations well into 2020. Currently, we have four clinical trials ongoing, and we will continue to carefully focus on being capital efficient through this important developmental process."

Source: moleculin
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