Re: Questions for Q1 webcast
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posted on
Mar 05, 2016 12:07PM
Here are some notes I took during the webcast organized for each question submitted. In my opinion, they did a decent job touching on most of the questions submitted. Of course, some questions they didn't address at all and some questions we didn't get too much depth of an answer. Despite the whining of several on this board (including myself to a certain degree) and Stockhouse, I think Resverlogix did a good job of telling us what they can at this point. I have a hunch (of course I could be completely wrong) that any bigger news (if any at all) will be released in the next couple of months around the time of one or more of the events listed in Q12.
1) What is the status of BETonMACE study site activation and enrollment? It is hard to tell from ClinicalTrials.gov or EU Clinical Trials register what the actual status is since these are infrequently updated.
Mike Sweeney did a great job covering this. Even if you didn't like DM's presentation, you should listen to Sweeney's presentation. He comprehensively covered the logistics of this huge endeavor. Half of total study sites should be active by end of March 2016. Enrollment is slow now, but as most study sites become active, enrollment will increase exponentially. 125 MACE event target by mid 2017, at which time futility analysis will occur; 250 MACE event target by mid 2018. There will be a sample size estimate analysis at 175 MACE events at which time the trial could be adjusted to continue until 375 MACE events. Austrailia had been added as a study site and will be used if additional patients are necessary. Taiwan will be included and should launch soon. US still possible pending FDA required animal work.
2) What is the timeline and estimated launch date of the RVX-208 Phase 2 PNH trial? Is a H1 2016 trial start still a possibility?
We didn't get much info here. A PNH trial consisting of 30-40 patients as an estimated cost of 2-3 MM is still planned to launch in 2016.
3) What is the number of and timeline for other RVX-208 orphan disease trials as alluded to in the recent blog video? Will these happen concurrent with the PNH trial?
In addition to the above PNH trial, a kidney dialysis trial is planned to launch in 2016 consisting of 20 patients at a cost of 1-2 MM. No other comment on any other RVX-208 trials.
4) What are the plans for the Alzheimer's trial that seems to keep getting kicked down the road? In the September Corporate Update, RVX discussed how the complement pathway is now being appreciated to be involved in Alzheimer's progression, so seems like there should be renewed interest.
No new Alzheimer's trial is planned any time soon. However, there are 800 of the 2400 patients in BETonMACE who will have MOCA cognitive test performed. If I remember the webcast correctly, these 800 patients are age 70 or older.
5) How is the collaboration going with university in Colorado (can't remember which one) to analyze up to 1300 plasma proteins in the ASSERT trial samples? Ewalina Kulikowski talked about this in the September Corporate Update.
Did not discuss.
6) What are the plans for RVX-208 follow on molecules? Will these be for MACE/Athero or other indications? What kind of pre-clinical data has been collected on these?
Goal for 2016 is to confirm an RVX-208 follow on candidate. DM did indicate that several follow on molecules have gone through various animal studies for different indications, but was quite vague.
7) What are the plans for Nasdaq listing?
Did not discuss.
8) Are there other licensing deals in the works?
Second licensing/partering deal to be announced in 2016.
9) Can you provide a financial update: How will upcoming trials be financed? How will the Citibank/Eastern Capital loan will be paid off next year? Will there be any future dilution? If so, when and how much? What is the current employee count, cash on hand and cash burn rate?
Other than brief financial overview in beginning of webcast, this was not discussed.
10) What is status of Hepalink agreement. For example, will China still have patients in BETonMACE? How is China economy affecting things if at all?
No specific comment on Hepalink agreement. DM did indicate that Taiwan will be launching soon (I presume this related to BETonMACE). However, no other China BETonMACE study sites were mentioned.
11) How are discussion with FDA for BETonMACE going? Still ongoing? Finished? Any chance for US study sites/patients in BETonMACE?
Resverlogix is working to complete some FDA-required animal work that is requisite for FDA consideration to include US sites in BETonMACE. However, even if FDA is happy with animal work, there is a chance that FDA may not approve of the BETonMACE trial design. So US study sites are still possible, but no guarantee.
12) What conferences are Resverlogix planning to attend in 2016?
Did not discuss other than mentioning that they are presenting at the European Society of Cardiology (ESC) in Rome in August. I think DM mentioned August 28th. I also think he mentioned that Resverlogix is organizing a session at this meeting. I didn't catch it all. As for other events, here is what we know so far.
Mar. 13-16: 28th Annual ROTH Conference. Orange County, CA.
Mar. 21-22: Alberta Epigenetics Network. Banff, AB.
Mar. 23: The Richmond Club. Toronto, ON.
Apr. 19: Epigenetics Inhibitor Discovery, San Diego, CA
Apr. 28: Epigenetics: Cancer and Beyond, The New York Academy of Sciences, New York, NY
13) Are there scientific manuscripts in preparation?
Yes. Four manuscripts to be submitted in 2016. One has already been published (the Atherosclerosis article).
14) What is the estimate for when the BETonMACE 125 event interim analysis might occur?
See Question #1. Mid-2017.
15) What is management's plan for increasing shareholder knowledge and interest in this stock? What is management doing to get the word out regarding BetOnMace, the company, the formula, etc.?
Did not specifically address. However, DM did indicate that there will be 3 new analyst coverages in 2016.
Best regards,
BearDownAZ