NEW YORK, NY / ACCESSWIRE / September 22, 2016 / SeeThruEquity, the leading independent equity research firm focused on smallcap and microcap public companies, today announced it has initiated coverage on Moleculin Biotech, Inc. (MBRX).
The report is available here: MBRX Initiation Report.
We initiate coverage of Moleculin Biotech Inc. (Nasdaq: MBRX, “Moleculin”) with a price target of $9.26. Based in Houston, TX, Moleculin is a pre-clinical and clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates. Moleculin became a publicly traded company in June 2016, having raised $9.2mn in gross proceeds from its initial public offering. Moleculin has three core development programs, which are largely based on anti-cancer technologies discovered at MD Anderson Cancer Center (MD Anderson), the world’s largest cancer research facility. The company’s development pipeline is led by liposomal Annamycin, an anthracycline intended for the treatment of relapsed or refractory acute myeloid leukemia (AML), which also holds promise for pediatric leukemia given that it has been shown to avoid multi-drug resistance without cardiotoxicity. AML is a form of cancer that starts in blood stem cells and for which first line induction therapy (designed to qualify patients for bone marrow transplants) has limited efficacy and for which there are no approved second line therapies. Moleculin is in the process of preparing for expanded Phase clinical 2 trials for Annamycin for AML and is also seeking Orphan Drug Designation, which, if granted, could entitle the company to market exclusivity for seven to ten years from the date of approval in the US and Europe.
Moleculin is also pursuing two other clinical development programs licensed from the University of Texas System in concert with MD Anderson: WP1066, an anti-cancer small molecule program designed to stimulate the natural immune response and to induce tumor cell death; and WP1122, a prodrug of glucose decoy with potential applications in a number of tumors dependent on glucose to survive, initially focused on the treatment of central nervous system malignancies and glioblastoma. We see several potential catalysts ahead for Moleculin over the next 12-18 months as the company expands it Phase 2 clinical trials for Annamycin for AML in the United States, and advances its WP1066 and WP1122 technologies from preclinical stages into Phase 1/ Phase 2. We see Moleculin as a rising new company in the biopharmaceutical sector seeking to advance what it believes is a promising lineup of pre-clinical / clinical anti-cancer technologies with “game changing” potential.
Highlights from the report are as follows:
Annamycin a promising Phase 2 second line therapeutic for AML
Moleculin’s lead candidate Annamycin is now ready for expanded Phase 2 clinical trials as a second line therapeutic for refractory/relapsed AML. Annamycin addresses a key unmet need in AML treatment, which is the ineffectiveness of existing induction therapy chemotherapeutics to eliminate enough cancerous white blood cells to allow for a bone marrow transplant. Among the approximately 19,000 US adults diagnosed with AML each year, only approximately 20% of patients treated with induction therapy qualify for a bone marrow transplant. Annamycin promises to improve this results, as it was designed to avoid multi-drug resistance mechanisms that have plagued other anthracyclines used to treat AML, such as doxorubicin, and has also shown no cardiotoxicity in 114 patients over multiple clinical studies – eliminating a critical side effect. Moleculin is exploring an accelerated regulatory pathway for Annamycin and is also preparing an application for an Orphan Drug Designation, which could entitle the company to market exclusivity for 7-10 years from the date of new drug approval in the US and Europe.
WP1122, WP1066 novel small molecules targeting difficult cancers
Beyond Annamycin, Moleculin is also pursuing two other promising clinical development programs with their roots in research from MD Anderson. These include WP1122, a prodrug of glucose decoy with potential applications in a number of tumors dependent on glucose to survive, initially being investigated for glioblastoma, and WP1066, an anti-cancer small molecule program designed to stimulate the natural immune response and to induce tumor cell death. Moleculin’s management team expects to initiate proof-of-concept trials on WP1122 and WP1066 in the next 12-18 months, and has high hopes for these anti-cancer technologies.
Initiate coverage with a price target of $9.26
We see several potential catalysts ahead for Moleculin over the next 12-18 months as it begins expanded clinical trials of Annamycin for AML, and advances its WP1066 and WP1122 technologies from preclinical into proof of concept Phase 1/2. We see Moleculin as a rising new biopharmaceutical company developing what it believes will be an impactful lineup of anti-cancer technologies with “game changing” potential. We note that promising drug candidates in this space which are supported by strong clinical results have attracted significant valuation premiums by strategic players in the industry – as evinced by Jazz Pharmaceuticals’ recent acquisition of late-stage oncology player Celator Pharmaceuticals, whose Phase 3 candidate Vyxeos for AML was the centerpiece of the $1.5Bn deal, which closed in July 2016. If achieved, the price target of $9.26 suggests potential upside of 55.4% from the recent price of $5.96 on September 19, 2016.
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Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system. The other portfolio targets the metabolism of tumors. www.moleculin.com.
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