MEI Pharma, Inc. (MEIP)

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MEI Pharma, Inc. (MEIP)

Cowen and Company 33rd Annual Health Care Conference Call

March 6, 2013 10:40 am ET


Dan Gold - President & CEO


Nic Bishop - Cowen and Company


Nic Bishop - Cowen and Company

Okay. Sir, you're ready?

Dan Gold

I'm ready. Yeah, sure.

Nic Bishop

All right. It's being webcast. Well good morning everybody and welcome to our session this morning with MEI Pharma. I'm Nic Bishop, one of the biotech analysts at Cowen and Company, and we're very happy to have with us today Dan Gold, the company's President and CEO to tell us more about the MEI story and there will be a breakout. If you have further questions for Dan in the AMOT room next door. Dan?

Dan Gold

Thanks very much, Nic. Thanks. I want to extend my thanks to Cowen for giving us the opportunity to update you all on the evolving MEI story. We're very excited. I think this is going to be a great year for us and we're really happy to be able to tell you our story in this wonderful city of Boston, holds fondness in my heart certainly from my early years of training and certainly a hub of biotechnology.

Before we get started the -- I've to mention there my state, my talk could contain forward-looking statements and the risks associated with those statements can be found in our SEC filings that you can access on our website.

So, MEI Pharma is a clinical oncology company with a diversified pipeline of drug candidates housed in San Diego, as our headquarters. Our lead drug candidate is called Pracinostat a potential best-in-class orally available HDAC inhibitor that we're currently developing for the treatment of myelodysplastic syndrome, MDS, and acute myelogenous leukemia or AML. We hold worldwide rights to all of our drug candidates and have a very strong IP worldwide patent portfolio that extends well out and past 2025. We're well funded with a high-quality syndicate of institutional investors and plan on really using that newly acquired funding to aggressively move into the clinic this year.

This is our team and our directors. I just want to point out one new addition to our board; Dr. Tom Reynolds has just recently joined us. Tom was the Chief Medical Officer recently at Seattle Genetics, and Tom was responsible for leading the initiative that led to the approval of Seattle Genetics first-in-class drug conjugated antibody for treatments of Hodgkin's disease and we really welcome Tom and his expertise in to our board.

This is our pipeline. We have three drug candidates currently in the clinic for various indications in cancer. The first two, I'll just point out and then move on from our homegrown isoflavone-based drug candidates, ME-143 and ME-344. Both of these drug candidates are isoflavone-based small molecules. We've spoken before about 143, it's a second generation of a drug Phenoxodiol, which we believe have shown evidence of clinical activity when used in combination with platinum. That drug has completed its Phase I dose finding studies and we've established a Phase II dose that we'll be testing hopefully in the future.

ME-344 is a mitochondrial inhibitor, very similar to ME-143, but with a very distinct mechanism of action. ME-344 is first-in-human for us and is currently completing its Phase I dose escalation study as soon as we establish the maximum tolerated dose we'll be by putting together a development plan for both 143 and 344 in most likely ovarian and breast cancer.

So, I'd like to spend the rest of the time telling you about and giving you an update on Pracinostat, our selective HDAC inhibitor or pan-HDAC inhibitor. As I mentioned, we're currently developing this drug for myelodysplasia and acute myelogenous leukemia. So, little bit about Pracinostat.

Pracinostat has been tested in now over 200 patients to-date both in solid and hematologic tumors in multiple Phase I and Phase II clinical trials, as well as in pediatric patients in the solid tumor setting. It has readily manageable side effects that are very consistent with drugs of this class such as primarily fatigue, some noxiousness, and some suppression, but these are all quite manageable.

I'll show you a little bit of data concerning single-agent activity of this drug. It has well demonstrated single-agent activity in AML as well as in myelofibrosis. And I'll show you evidence of synergistic activity in the clinic when we use in combination with Vidaza the hypomethylating agent used in the setting of myelodysplastic syndrome.

Then I'll show you a little bit of data concerning the synergism of this drug with various other combinations, which greatly expand our universal potential to use utility of the drug in the future. Pracinostat lacks any P450 interactions and it allows us to use in -- considered in combination with many drugs indeed.

So a little bit about Pracinostat and its pharmacokinetics and its potency. So we talk about HDAC inhibitors, but actually HDACs are a class of molecules. These are isoenzymes that are highly related, they're broken up into four families or four classes based on their homologies with yeast homologs.

HDAC I contains the isoforms, class 1 is contains HDAC-1, 2, 3, 4, and 8, and as shown HDAC II contains the isoforms 4, 5, 6, 7, 9, and 10. HDAC IV is a single member and then there are the SIRTs and the SIRTs are a completely different class of HDAC inhibitors and our compound is volatile, the majority of the others and their development have no activity against the III. So we're really a class I, II, and IV pan-HDAC inhibitor.

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