Re: ... AGM thoughts...
posted on
Nov 28, 2017 12:39PM
AGM 2 weeks away. I revisited the checklist for management and made up a revised list of questions. Shorter and more focused. Please edit/add on as you see fit.
1. Citibank Loan: What is the status of Pending Hepalink $87.7 M deal, TSX application for financial hardship exemption, and remedial delisting review.
2. Financial Update/Business Arrangements: How to fund clinical trial and R&D activities in 2018 and beyond? Status of potential licensing, partnering, sale of IP, spin out plans (i.e. Star Factory). What are the updates/details of the “Strategic Transaction: The Company also announces that it has received a letter of intent regarding a significant potential regional licensing arrangement (the "License") for apabetalone (RVX-208), and/or a significant equity investment in the Company” announced in the August 28, 2017 news release?
3. New molecules: It’s been over a year since Resverlogix “confirmed” a second clinical compound IND candidate and informed us that seven compounds have been chosen for follow-on testing (including RVX-206, RVX-641, RVX-2101, RVX-2113). What differentiates these seven additional compounds from RVX-208? Are they all bromodomain-2 selective BET inhibitors? If so, are they “improved” versions of RVX-208? If not, what are their unique properties and what indications are being pursued (see below)?
4. New indications: We’ve heard some teasers of potential indications including: Neurofibromatosis/Malignant Peripheral Nerve Sheath Tumors (MPNST), Pulmonary Arterial Hypertension, Muscular Dystrophy/Facio Scapulo Humeral Dystrophy, Calciphylaxis/Calcification, Neuroinflammation, Autoimmune. When are we going to see pre-clinical data for these new indications? What are the plans for presenting/publishing this data? Which of these indications are for RVX-208 and which are for one or more of the seven additional compounds?
5. Update on BETonMACE enrollment and study sites: There were ~2000 patients enrolled as of November 2017. Is the total enrollment target still 2400 patients? When do you anticipate reaching 2400 patients? When will US patients start enrolling? Is the target number of MACE still 250? When will the futility analysis occur? Will there still be a sample size estimate analysis at 175 events? Is there a minimum length that the US patients will need to be dosed in BETonMACE before the trial can end? What is the realistic best and worst case timeline scenario for completing BETonMACE?
6. Status of Renal, Fabry and PNH Clinical Trials: What is the timeline and estimated launch date of the Paroxysmal Nocturnal Hemoglobinuria (PNH) trial? When will the Fabry trial start enrolling? When will the Phase 2 Renal trial start enrolling?