UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C FORM 8-K CURRENT REPORT

Transcription

1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED): February 15, 2018 MOLECULIN BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) DELAWARE (State or Other Jurisdiction of Incorporation (Commission File No.) (I.R.S. Employer Identification No.) or Organization) 2575 WEST BELLFORT, SUITE 333, HOUSTON TX (Address of principal executive offices and zip code) (713) (Registrant s telephone number, including area code) (Former name or former address, if changed from last report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): [ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR ) [ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR a-12) [ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR d-2(b)) [ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR e-14(c)). Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 ( of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 ( b-2 of this chapter). Emerging growth company [X] If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [X]

2 Item Other Events. On February 15, 2018, Moleculin Biotech, Inc., (the "Company") issued a press release announcing that, pursuant to its con nued collabora on with MD Anderson it has developed and licensed what it believes is a major breakthrough in immune-s mula ng STAT3 inhibitors. A copy of the press release is a ached to this report as Exhibit 99.1 and is incorporated by reference herein. Item 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press release dated February 15, 2018 SIGNATURE Pursuant to the requirements of the Securi es and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. MOLECULIN BIOTECH, INC. Date: February 15, 2018 By: /s/ Jonathan Foster Jonathan Foster Chief Financial Officer 2

3 EXHIBIT INDEX Exhibit No. Description 99.1 Press release dated February 15,

4 Exhibit 99.1 Moleculin Announces Breakthrough Discovery of a New Molecule for Cancer Treatment Cutting Edge Science Suggests New Molecule is Capable of Shutting Down Tumor Activity HOUSTON - February 15, Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceu cal company focused on the development of an -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 ), today announced that, pursuant to its con nued collabora on with MD Anderson it has developed and licensed what it believes, based on preclinical tes ng, is a major breakthrough in its effort to develop a new cancer treatment that selectively kills highly resistant tumors. We believe our unique approach to develop immuno-s mula ng STAT3 inhibitors just took a major step forward, commented Walter Klemp, Chairman and CEO of Moleculin. Our WP1066 por olio has already resulted in mul ple collabora ons with some of the most pres gious cancer centers in the world and now this new discovery could drama cally improve our ability to treat a broader range of the most difficult cancers, and especially pancrea c cancer. Dr. Don Picker, Moleculin s Chief Science Officer, explained, The scien fic community recognizes the poten al for small molecule immuno-s mula ng STAT3 inhibitors to become a game-changer for trea ng cancer pa ents. We believe this discovery may not only drama cally improve our ability to develop and deliver such therapies, it may also help support a new mechanis c understanding of oncogenic transcrip onal ac vity. Specifically, we now have preclinical evidence to suggest we are capable of controlling a process known as ubiquitination to block the activated form of STAT3, an important oncogenic transcrip on factor. The study of the role of ubiqui na on in cancer is cu ng edge science and appears to hold great promise. And, given the desperate lack of treatment op ons for indica ons like pancrea c cancer, we believe clinical researchers across the country have been eagerly awai ng a breakthrough like this. In developing our current lead STAT3 inhibitor, WP1066, for brain tumors, we have focused on its oral bioavailability and brain uptake, con nued Dr. Picker, but at the same me we have con nued our quest to expand this por olio by the crea ng alterna ve inhibitors with increased bioavailability and altered ssue and organ distribu on that are not affected by first-pass metabolism. The lead molecule resulting from this new discovery is called WP1732 and it not only appears to share the same key mechanis c proper es with WP1066, it has markedly different organ distribu on and its dramatically increased solubility makes it ideal for administration via

5 standard IV injec on. Importantly, preclinical tes ng has also shown that WP1732 s proper es make it a promising candidate for treating pancreatic cancer, one of the most resistant and deadly forms of cancer. So much has happened in the past few months, it s important to recap where we are, added Mr. Klemp. Moleculin has three poten al breakthrough disrup ve technologies - (1) Annamycin, an an cancer agent that is ac ve against mul drug resistant tumor cells and has been designed to be non-cardio toxic (unlike currently approved drugs in this class), (2) immuno-s mula ng STAT3 inhibitors like WP1066 and, now, WP1732, and (3) WP1122, a metabolic inhibitor that has been shown in preclinical tes ng to effec vely block the energy supply required by cancer cells to function and proliferate. Since our IPO in June 2016, we have accelerated to the point of having two drugs, Annamycin and WP1066, beginning clinical trials in the near term. Mr. Klemp concluded, We are now demonstra ng the breadth of our drug pipeline and the benefits of collabora ng with world-class cancer research centers. In the AML space, we expect pa ent dosing either in the United States or Poland to begin with Annamycin yet this quarter and we have begun to work with researchers at MD Anderson on using our immuno-s mula ng STAT3 inhibitors to target AML as well. A second clinical trial targe ng brain tumors with WP1066 should begin dosing within the first half of the year. In Poland, we are about to request a clinical trial authoriza on for WP1220 for the topical treatment of Cutaneous T-Cell Lymphoma (CTCL), which we expect will become our third clinical trial this year. WP1220 is our patented STAT3 inhibitor designed to be compa ble with topical formula ons and was selected based on its preclinical ac vity in CTCL cell lines and based on the need for be er topical treatments for CTCL. Addi onally, we just announced posi ve data for WP1122, our glycolysis inhibitor, in a pancrea c cancer mouse model. Along with the newly licensed discovery of WP1732, this sets the course for establishing the base for two more Inves ga onal New Drug (IND) applica ons over the coming year and posi ons us as a leader in developing new approaches for pancrea c cancer. Our highly experienced leadership and expanding team is looking forward to sharing more progress on all of this activity as we move forward into About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a clinical stage pharmaceu cal company focused on the development of an -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 a ack tumor ac vity directly while also recrui ng the pa ent's own immune system. We are also engaged in preclinical development of addi onal drug candidates, including compounds targe ng the metabolism of tumors. For more information about the Company, please visit

6 Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Sec on 27A of the Securi es Act of 1933, Sec on 21E of the Securi es Exchange Act of 1934 and the Private Securi es Li ga on Reform Act of 1995, which involve risks and uncertain es. Forward-looking statements in this press release include, without limita on, the ability of Annamycin, WP1066 and WP1220 to demonstrate safety and efficacy in clinical trials and the ming of the commencement of such trials, and the ability of WP1732 and WP1122 to achieve IND status and to demonstrate safety and efficacy in human pa ents. These statements relate to future events, future expecta ons, plans and prospects. Although Moleculin Biotech believes that the expecta ons reflected in such forward-looking statements are reasonable as of the date made, expecta ons may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has a empted to iden fy forward-looking statements by terminology including ''believes,'' ''es mates,'' ''an cipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''poten al,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to iden fy these forward-looking statements. These statements are only predic ons and involve known and unknown risks, uncertain es, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securi es and Exchange Commission ( SEC ) and updated from me to me 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 obliga on to update any forward-looking statements contained in this release to reflect events or circumstances occurring a er its date or to reflect the occurrence of unanticipated events. Contacts Joe Dorame, Robert Blum or Joe Diaz Lytham Partners, LLC mbrx@lythampartners.com