A few musings
posted on
May 02, 2017 02:58PM
ATVB Resverlogix presents at the ATVB conference in Minneapolis this week. Oral Presentation on Thursday May 4th 4:45-5PM (CST) - "Selective BET inhibitors are useful for normalizing inflammation leading to reduced cardiovascular disease (CVD) in humans". Poster Presentation on morning of Saturday May 6 - "Apabetalone (RVX-208), A Selective Bet Protein Inhibitor, Reduces Expression Of Acute Phase Response Markers In Vitro And In Patients With Cardiovascular Disease And Chronic Kidney Disease."
Bloom & Burton slides had no new info. Very disappointing. However, it was not webcast so we don't know what DM said at the conference or at any potential one on one meetings.
BETonMACE will have been dosing for 18-months as of May 11th 2017. Patients are to be dosed up to 24 months. So first patients in trial only have ~6 months of dosing to go (assuming they are still alive). DSMB reports have been every 3-4 months with the last one being March 17th 2017. Assuming that the futility analysis is not triggered before the next DSMB report, then I would expect the next DSMB report to be mid-June at the earliest. Also, the 2400 patient enrollment is expected to be completed H2 2017. The latest official communication from RVX indicates that over 1200 have been enrolled; however, the recent Van Leeuwenhoeck report states that "Resverlogix has enrolled in more than 1,400 of the planned 2,400 patients." In my opinion, if US sites are to be included then this needs to happen in the next 6-7 months before the 2400 patient count is reached.
BETonRENAL What is the hold up to the start of Phase 2 BETonRENAL? Is the delay all due to funding issues or what? We were told last year that the trial would begin early 2017. Q1 has come and gone. Now the slides in recent presentations indicate "New Cardio/Renal IND on track for H1 2017." Have they even filed the IND yet? Based on that statement in the slide, I don't think so. Plus, in the latest Van Leeuwenhoeck analyst report, it states "Resverlogix intends to file an official Investigative New Drug (IND) application and proceed with the planned Phase IIa clinical trial in 2017 Q2." Should we expect a news release upon IND filing/approval?
Analyst Reports I agree with many posters here that the valuation of $12.50 CAD the recent Van Leeuwenhoeck Institute analyst report seems a bit high. However, their previous report was from May 2016 and had a valuation of $8.50 CAD. There have been 3 positive DSMB reports since that report and enrollment is going well. And the new Van Leeuwenhoeck is including valuation for CKD/renal as well, which should be launching Phase 2 very soon. Do these positive events warrant the 47% increase in valuation? Maybe, maybe not. Perhaps the better question is why does the Zacks valuation differ so much from the Van Leeuwenhoeck valuation? Zacks went from $5 in late June 2016 to $6.50 in late March 2017 for a 30% increase. So over a similar timeframe, Zacks went from $5 to $6.50 (30%) and Van Leeuwenhoeck went from $8.50 to $12.50 (47%). Zacks doesn't include renal/CKD. But renal/CKD alone doesn't explain the big discrepancy in valuations. Whatever happened to the 2 new analysts that were supposed to be coming on board that DM referred to numerous times last year?
Best regards,
BearDownAZ