Milestone Pharmaceuticals Inc Q2 2019 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Chris Howerton - Jefferies LLC - Analyst : Hey, good morning. Thanks for the update and hope all is well with you guys. For the first question, I guess, just so I fully understand it, the initial plan was that you want to kind of make sure that you have the minimum event number for each arm. And the change in the upsizing essentially just gives you the confidence that you will meet that minimum number without a statistical adjudication. Is that the basic rationale?

Question: Chris Howerton - Jefferies LLC - Analyst : Okay, got it, got it. And so when you think about the regulatory path in the EMA, will the NODE-301 trial serve as a single efficacy trial in that territory as well? Or is that still an open discussion with the EMA?

Question: Chris Howerton - Jefferies LLC - Analyst : Excellent, okay, great. And maybe just another one in terms of the conduct of the NODE-301 trial. And kind of any information or color you can give us around the event rate or the things that give you confidence that you will still be able to meet that deadline in the first half of next year for top-line results?

Question: Chris Howerton - Jefferies LLC - Analyst : Awesome. Okay, well, great. And then maybe the other one. I think that I have some ideas, but I'd love to hear your thoughts as well is in terms of what the implications are for the 303 design modifications and the lack of the requirement for the test dose and potentially on the patient population. How does that change your view of the commercial opportunity if at all?

Question: Chris Howerton - Jefferies LLC - Analyst : Got it. Okay. All right. Well, thank you so much for the updates and look forward to the continued progress.

Question: Ritu Baral - Cowen and Company - Analyst : Good morning, guys. Thanks for taking the question and the updates. If you had to rank order the reasons behind why the trial is enrolling faster than previously expected, if you had to rank order screening rates, randomization rates, and event rates, like what is the most important driving factor here?

Question: Ritu Baral - Cowen and Company - Analyst : Sorry to interrupt. So should we assume that that was kind of like a low-single-digit screen failure rate for the test dose?

Question: Ritu Baral - Cowen and Company - Analyst : Got it. Thanks. Sorry, keep going.

Question: Ritu Baral - Cowen and Company - Analyst : And to confirm, your sort of patient interest, patient input rate is at least what you expected? Obviously, it has ramifications for patient prevalence.

Question: Ritu Baral - Cowen and Company - Analyst : Got it. And then the second question. You mentioned that upsizing the events gives you additional powering on some key subpopulation analysis and key pharmacoeconomic analyses. Can you give us a little more detail on the most important subpopulations and why? And which pharmacoeconomic analyses you were referring to in particular?

Question: Ritu Baral - Cowen and Company - Analyst : Great. Thanks for taking all the questions. I will get back in the queue with my others.

Question: Ted Tenthoff - Piper Jaffray & Co. - Analyst : Great. Thank you very much and thanks for the updates. Joe, just want to make sure. Did you actually say what percentage of patients have been enrolled? And to this concept of kind of getting patients who have events earlier, remind me. Once they have one event, they go into the open-label study; it is not like they can be counted more than once in the 301, right? Thanks. without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. AUGUST 13, 2019 / 12:00PM, MIST.OQ - Q2 2019 Milestone Pharmaceuticals Inc Earnings Call

Question: Ted Tenthoff - Piper Jaffray & Co. - Analyst : That's super helpful. I appreciate the additional color.

Question: Leland Gershell - Oppenheimer & Co. - Analyst : Hey, good morning, Joe. Thanks for taking my questions and for the good update. I wanted to ask with the 301 data still on track for first half of next year, then the safety study seeming like that may go a bit faster, given your comments, just want to ask if you could maybe qualify for us a bit the NDA and approval timing following the 301 data with 303 filling in. If that could be moved up from prior expectations or how we should think about timelines until approval. Thanks.

Question: Leland Gershell - Oppenheimer & Co. - Analyst : Got you. And then just one more, if I may. As you are now going to expand the scope of the safety study and include elderly patients, older patients, patients who may be or have been more reluctant to, let's say, go for ablations and would prefer a pharmacologic intervention but who also may be on many more concomitant meds -- calcium channel blockers, other cardiac active medications -- if you could just again qualify for us what the picture looks like for those older patients in terms of what you see in terms of the meds they are coming on with that may also affect their cardiovascular system. Thanks.

Question: Leland Gershell - Oppenheimer & Co. - Analyst : Great. Thanks for the clarification. It's very helpful.

Question: Ritu Baral - Cowen and Company - Analyst : Hey, guys. Thanks for taking the follow-up. One more trial conduct question. I know that you guys somewhere in the protocol will be adjudicating the patient events just to make sure that they are true PSVT events. Is that happening real-time or is that sort of adjudication of the true event something that happens after database lock? Remind me again.

Question: Ritu Baral - Cowen and Company - Analyst : Got it. So basically by the time you lock the database and you count your events, you won't lose any events to classification of real or adjudication, put it that way.

Question: Ritu Baral - Cowen and Company - Analyst : Got it. And can you remind me, do you have any plans on changing the maximum number of doses in 302 and 303? I believe one of them is like 7 max and the other was 11 max. Any changes to that?

Question: Ritu Baral - Cowen and Company - Analyst : Got it. And then last question. Can you just confirm that Europe didn't have any other suggestions for the 301 trial design? Or are there potential other small protocol changes to either 301, 302, or 303 that they requested?

Question: Ritu Baral - Cowen and Company - Analyst : But nothing that would jeopardize the acceptability of the current 301 study?

Question: Ritu Baral - Cowen and Company - Analyst : Got it. Okay, thanks for taking the follow-up.