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Moleculin Biotech, Inc. Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2016
Recently Received Orphan Drug Designation for Annamycin
HOUSTON – April 3, 2017 – Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical 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 M.D. Anderson Cancer Center (“MD Anderson”), today announced its financial and operating results for the fourth quarter and year ended December 31, 2016.
2016 Accomplishments & Recent Highlights:
|·||Received Orphan Drug Designation for Annamycin by the U.S. Food and Drug Administration (“FDA”) for the treatment of acute myeloid leukemia (“AML”). The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trial costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval;|
|·||Recently the Company filed its investigative new drug (“IND”) application, with a Phase I/II approach with the intent of increasing the Maximum Tolerable Dose (“MTD”), for Annamycin. In subsequent discussions, the FDA requested certain revisions to the protocol, additional information, and additional data related to Chemistry, Manufacturing and Controls (“CMC”). The Company indicates it has the additional information, has made the requested revisions to the protocol, and is working on developing the CMC data. In the interim, Moleculin has withdrawn the IND application, in order to resubmit it when the requested data is available. The Company believes that the resubmission of the IND application will occur in time for the IND to go into effect and allow for clinical trials to begin in the first half of 2017. However, if the Company is unable to obtain the required CMC data on a timely basis, it will be delayed in resubmitting its IND application, which will delay the commencement of its clinical trials beyond the first half of 2017;|
|·||Announced the closing of an underwritten public offering of securities for net proceeds of approximately $4.4 million. Roth Capital Partners and National Securities Corporation acted as joint book-running managers. Subsequently, approximately $0.8 million of additional funds have been received through the exercise of associated warrants to the transaction bringing the total net raised in excess of $5 million;|
|·||Announced that Drs. Sandra Silberman and Paul Waymack have joined the Company's Scientific Advisory Board (“SAB”). The Company's current SAB also includes Dr. Waldemar Priebe (Chair) and Dr. Madeleine Duvic;|
|·||Updated the Annamycin clinical strategy to add a Phase I arm to its next Phase II trial that leverages a potential increase in the MTD, which could increase the chance for positive outcomes. The Company believes that it will be able to publicly announce results from its Phase I/II clinical trial sometime in 2018;|
The following information was filed by Moleculin Biotech, Inc. (MBRX) on Monday, April 3, 2017 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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