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Thursday, October 29, 2020

Moleculin Biotech Inc (NASDAQ:MBRX) Pulls Back Despite AML Prospects

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Moleculin Biotech Inc (NASDAQ:MBRX) is a biopharma name that has been making huge waves for small-cap traders over the past couple months. MBRX has powered higher from well under a buck/share to over $3/share just in that time. Management recently commented on several recent FDA approvals for new drugs for the treatment of acute myeloid leukemia (AML).

Walter Klemp, CEO of Moleculin commented: “the recent approvals of three new drugs (Rydapt, Vyxeos and Idhifa) for the treatment of AML are exciting, since they provide additional options for treatments in defined subpopulations, and because they help underscore the magnitude of the potential opportunity for Annamycin, which we will be studying for relapsed or refractory AML. With regard to AML, Rydapt is approved only for patients with a specific gene mutation, and for use in combination with the standard of care chemotherapy. Vyxeos is approved as an option to the standard of care, but only for specific AML patients, namely those with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Jazz Pharmaceuticals purchased this drug in their $1.5 billion acquisition of Celator Pharmaceuticals.”

Moleculin Biotech Inc (NASDAQ:MBRX) trumpets itself as a preclinical-stage pharmaceutical company that focuses on the development of anti-cancer drug candidates.

MBRX’s lead drug candidate is liposomal Annamycin, an anthracycline intended for the treatment of relapsed or refractory acute myeloid leukemia. The company also develops other drugs, including WP1066 Portfolio that focuses on the modulation of regulatory transcription factors involved in the progression of cancer; and WP1122 Portfolio, a suite of molecules targeting the metabolic processes involved in cancer and glioblastoma.

MBRX has an agreement with Mayo Clinic to enable additional research on its WP1066 molecule for the possible treatment of a rare form of pediatric brain tumor. Moleculin Biotech, Inc. was founded in 2015 and is headquartered in Houston, Texas.

According to company materials, “Moleculin Biotech, Inc. is a preclinical 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, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical 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.”

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As noted above, MBRX shares have been truly on fire. One of the likely catalysts driving the action is the perception that recent trends in biopharmaceutical regulatory behavior presents favorable potentialities for this company, in particular. Management has been very vocal on this dimension of things.

Mr. Klemp continued: “although FDA approval of both of those drugs was based on overall survival comparisons with a standard of care, Idhifa was approved based on an accelerated clinical trial design that showed a 19% response rate in patients with relapsed or refractory AML and IDH2 mutation. What’s interesting is that Idhifa was approved with a single Phase 1/2 clinical trial based on response rate, not overall survival, and a relatively low response rate at that. Also, the patient population for which it is approved represents only 13% of all AML patients. We look forward to working with FDA on a similar approach for Annamycin — reliance on response rate in an accelerated path — but for a larger population of AML patients.”

“While these new drugs make valuable incremental improvements in AML therapy,” concluded Mr. Klemp, “most AML patients will still fail to respond to (or relapse from) initial therapy; therefore, our initial clinical development plan will attempt to address the significant unmet need of patients who relapse from, or are refractory to, initial therapy. We also believe that, if Annamycin can demonstrate superior efficacy and safety to the current standard of care, the drug may be able to fill major areas for first-line AML treatment. In the meantime, these transactions serve to remind us of the opportunity for our company if Annamycin shows significant activity in our planned clinical trials.”

Recent action has seen 70% tacked on to share pricing for the stock in the past month. The situation may be worth watching. MBRX is a stock whose past is littered with sudden rips. In addition, the listing has registered increased average transaction volume recently, with the past month seeing 120% beyond what we have been seeing over the larger time frame.

Now commanding a market cap of $48.12M, MBRX has a significant war chest ($8.9M) of cash on the books, which compares with about $108K in total current liabilities. The company is pre-revenue at this point. This may be a very interesting story and we will look forward to updating it again soon. For continuing coverage on shares of $MBRX stock, as well as our other hot stock picks, sign up for our free newsletter today and get our next breakout pick!

Disclosure: we hold no position in $MBRX, either long or short, and we have not been compensated for this article.

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