MEI Pharma Inc (MEIP) 2017 Q4 法說會逐字稿

-- ladies and gentlemen, and welcome to the MEI Pharma Fiscal Year 2017 Results Conference Call. (Operator Instructions) As a reminder this conference call may be recorded. (inaudible) Pete De Spain, Vice President Investor Relations, you may begin.

Thank you Nicole. On behalf of our entire management team, I'd like to welcome you all to our fiscal year-end conference call. Before we get started, I want to call your attention to the fact that this conference call may contain certain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in its forward-looking statements which are based on management's current expectations and are subject to a number of risks and uncertainties as discussed in our SEC filings, including our most recent annual report on Form 10-K filed earlier today.

On our call today we intend to discuss the results from our fiscal year ended June 30, 2017, as well as some recent progress we've made in the clinic. A copy of our fiscal year 2017 results, press release is now available on our website. A replay of this call will also be available on our website approximately an hour after its conclusion.

With that said, I'd like to introduce you to our speakers for today. With me I have Dan Gold, our President and Chief Executive Officer; along with Brian Drazba, our Chief Financial Officer. Richard Ghalie, our Senior Vice President of Clinical Development is also with us and available to answer questions. Brian will start with a summary of our financial results after which Dan will provide an update on our clinical programs. Following the prepared remarks, we will open the line for your question. With that, I'll turn the call over to Brian.

Thank you Pete and good morning everyone. I recognize that many of you are eager to hear more about our progress we made in the last year, so I'll keep my remarks brief. For more detailed information regarding our financial results, I invite you to review our 10-K filed earlier today.

I'm pleased to report that we finished fiscal year 2017 with more cash on hand than when we started, due in large part to the $20 million in near-term payments we received in connection with our license development and commercialization agreement with Helsinn, plus another $5 million in a related equity transaction combined with tightly-managed spend. Our cash expenditures decreased from $17.9 million in fiscal 2016 to $16.5 million in 2017. Similarly, our cash expenditures decreased from $3.5 million in the fourth quarter ended June 30, 2016, to $3.1 million last quarter.

R&D expenses decreased from $13.4 million in fiscal 2016 to $7.2 million in 2017, primarily due to a reduction in expenses related to pracinostat pursuant to our license agreement with Helsinn. We had a slight increase in G&A expenses from $7.6 million in fiscal 2016 to $8.6 million in 2017 primarily due to professional service costs. Fiscal 2017 also marked a first for our company in that we reported revenues, due again to our license agreement with Helsinn which totaled $23.2 million.

Costs of research and development revenue consisting primarily of reimbursable third-party pass-through cost was $5 million. Our net income was $2.7 million or $0.07 per share for the fiscal year ended June 2017 compared to a net loss of $20.9 million or $0.61 per share in 2016. As of June 30, 2017, we had cash, cash equivalents, and short-term investments of $53.6 million. We have no outstanding debt.

In summary, we start fiscal year 2018 with a solid balance sheet. We believe our cash on hand will be sufficient to fund operations into calendar year 2019, and on that note I'll turn the call over to Dan.

Thanks Brian, and thank you all for joining us bright and early this morning. I'd like to spend a few minutes highlighting some important advancements we've made with our programs over the last few months.

Let's begin with pracinostat, our most advanced drug candidate, now partnered with Helsinn. In July after months of diligent preparation and site recruitment, the first patient was dosed in the highly anticipated phase III study of pracinostat in combination with azacitidine in adults with newly diagnosed acute myeloid leukemia who are unfit to receive intensive induction chemotherapy. This pivotal double-blinded, placebo-controlled study will enroll approximately 500 eligible patients worldwide. The primary endpoint of the study is overall survival. We believe it is a well-powered rigorously designed study, and we look forward to tracking its progress in the months ahead.

As we have discussed previously, Helsinn is responsible for the conduct and funding of this entire phase III program.

Meanwhile our clinical team here at MEI is actively managing our phase II dose optimization study of pracinostat plus azacitidine in patients with high and very high-risk myelodysplastic syndrome who were previously untreated with a hypomethylating agent. Based on our clinical experience with this combination, we believe that a reduced dose of pracinostat has the potential to improve tolerability in patients with high-risk MDS. Our experience suggests that prolonged exposure to this combination may translate to greater efficacy compared to azacitidine alone.

The 2-stage study will be conducted at approximately 25 sites and is expected to enroll up to 120 patients. The first patient was dosed in June. While we're responsible for the conduct of this study, the cost is being shared with Helsinn. We look forward to reporting data from the first stage of this study in the first quarter of 2018.

Now I'd like to turn our attention to our PI3 delta inhibitor, MEI 401, an asset that continues to exceed our high expectations. For those of you less familiar with this space, PI3K delta inhibitors have demonstrated clear activity in the treatment of chronic lymphocytic leukemia and follicular lymphoma, but unfortunately at the expense of well-documented toxicities. We believe this provides an opportunity for a drug that is both effective and safe. ME-401 has several attributes suggesting it is a highly differentiated PI3K delta inhibitor, attributes that we believe could lead to significant efficacy with diminished toxicity.

As we reported back in May, an independent safety review committee completed its review of the first cohort of 6 evaluable patients ongoing in our phase Ib dose escalation study of 401 in relapsed refractory CLL and follicular lymphoma. The committee found no dose-limiting toxicities with a response rate well in excess of 50%, and declared 60 milligrams daily as a minimal biologic effective dose with a recommendation to escalate to 120 milligrams daily dose cohort.

The 2-month safety and efficacy of this second cohort has recently been reviewed by the safety committee. Seeing no safety concerns and a response rate again well in excess of 50%, the committee recommended escalation to a third cohort of 180 milligrams. Meanwhile the study has enrolled an additional 6 patients into a 60 milligram expansion cohort, raising the total number of patients today to 18. While 4 patients are still too early for response assessment, all 18 are evaluable for safety, having been on study for a median of nearly 3 months with a range of 1 to 10 months.

Notably no patients have discontinued to adverse events or disease progression. Grade 3 adverse events associated with ME-401 were reported in 2 patients, one neutropenia, and one rash, neither of which were unexpected. In fact in both cases the problem was resolved and both patients continue on study. We are very excited by the response and safety data that continued to emerge from its -- this open-label study and await the opportunity to present detailed results in an upcoming scientific meeting.

In the meantime we are now expanding this study to evaluate the combination of ME-401 with an anti-CD20 antibody such as rituxan. Our goal at this time is to submit a briefing package to the FDA regarding our registrational plan for ME-401 during the first quarter of 2018.

For the sake of time, I won't delve into our clinical stage mitochondrial drug candidate ME 344 except to say that we remain very excited by its prospects and anxiously await the results of the hypothesis testing, randomized study underway in Madrid evaluating ME-344 in combination with Avastin in women recently diagnosed with HER2 negative breast cancer.

With that, I believe we're now ready for questions.

(Operator Instructions) Our first question comes from the line of Stephen Willey at Stifel.

This is Philomena Kamya in for Stephen Willey. Could you please just confirm again for the ME-401 trial what the expanded dose escalation trial would be? Is it 180 milligram or 120 milligram dose cohort?

Hi Philomena, could you ask that again? I'm not quite sure I understood what you were driving to.

For the recommended dose escalation in terms of (inaudible) safety review, is it to 180 milligram dose cohort or 120 milligram dose cohort?

I see. So yes, so the 120 milligram cohort of 6 patients was fully enrolled and the safety review committee met, as I mentioned. We're now open for 180 milligrams and as soon as that cohort is enrolled we will then go back and expand the 120 milligram. That's sort of how we've been doing this, is escalating and then back expanding so we can get larger cohorts of at least a dozen patient per cohort for both safety and efficacy.

Great. And so that leads me to my second question, for the combination trial of ME-401 plus anti-CD20, what dose will the combination patients for ME-401 be dosed at? What is the dose regimen for ME-401 with the combination?

Good question. I'm going to let Richard Ghalie, our Head of Clinical answer that question for you.

Yes, for this combination regimen the starting dose for ME-401 is 60 milligram, that dose that was defined as the minimum biologic effective dose as single agent. And then from that 60 milligram dose level we will go up to 120 milligrams if 60 milligram reduction is shown to be safe.

(Operator Instructions) Our next question comes from the line of Leah Cann of Oppenheimer.

So Dan, a quick question on the 401 program, have you disclosed your site locations and your primary investigator on that study?

Yes, the primary investigators are first [Andy Zelmet] at Memorial and John Pagel at Swedish in Seattle.

(Operator Instructions) And I'm showing no further questions at this time. I'd like to hand the call back over to management for any closing remarks.

Thank you.

On behalf of the entire board and the management team at MEI Pharma, I'd like to thank you for your continued support. We begin our new fiscal year with strong momentum, a deep pipeline of clinical stage oncology drug candidates and a healthy cash balance. We are more excited about our prospects than ever and we look forward to updating you on our progress at every opportunity. In the meantime I invite you to follow up with Pete, Brian or myself if you have any further questions. Thanks again and have a great day.

Ladies and gentlemen, thank you for participating in today's conference. That does conclude today's program. You may all disconnect. Everyone have a great day.