...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: Final Checklist for Management

Below is the final draft. I have sent along to Don McCaffrey, Sarah Zapotichny, general IR, and Clayton Paradis at Resverlogix (don@resverlogix.com, sarah@resverlogix.com, ir@resverlogix.com, and clayton@zenithepigenetics.com). I invite you to do the same. Please copy and paste the message below the dotted line and send along as it. We kindly request that you do not alter it. Stockhouse was offline when I tried to post the final. Will someone please post this entire message (text above and below dotted line) to Stockhouse and Investor Village?

Best regards,

BearDownAZ

P.S. Thanks to SanFran, Kelsee, KayakerBC and others who helped out in the composition of this document.

--------------------------------------------------

In consideration of all RVX shareholders and on behalf of the RVX forum from which the idea for this presentation began, we deliver to the company a collective list of concerns of shareholders. In past webcasts by the company, we have been told that an effort would be made to keep us, the shareholders, better informed of the goings-on with the company. Although some progress has been made, much has been left untouched with respect to priority news items of investor interest, thus the following list was hatched.

1. Citibank Loan: The $68.8 million Citibank loan is currently due for repayment on August 28, 2017. The fiscal 2016 year end documents stated that "The Company is in discussions regarding extending the loan." This is perhaps the most important concern amongst current shareholders and thus should be prioritized by management. Please provide an update regarding plans for renegotiating continuation terms or replacing this loan.

2. Improve the Annual General Meeting (AGM): For future AGMs, including the upcoming October 5, 2016 AGM, change the AGM into a "shareholder summit" by webcasting the AGM, giving shareholders (both in Calgary and on the Webcast) ample time to ask questions and preparing more than a cursory presentation that mirrors everything we've seen before and repeatedly.

3. Financial Update: The fiscal 2016 year end documents stated "We believe our cash as of April 30, 2016 will be insufficient to fund our contractual commitments for the next year and our planned business operations over the next year (based on anticipated patient enrollment for BETonMACE). We will have to raise additional capital.....We will also require additional capital to fund research, development and corporate activities beyond the next year. The Company will continue to explore alternatives to generate additional cash including raising additional equity and product licensing; however, there is no assurance that these initiatives will be successful. We intend to raise capital from equity and/or debt offering and partnering in the future." What additional funds will need to be raised to complete the BETonMACE trial and to fund the proposed renal, PNH/complement-mediated disease or other future trial(s)? Please cover in detail the additional funds that will need to be raised and approximately when those funds will be raised - including for the Citibank loan mentioned previously. Please review cash on hand, burn rate, and expected cash needs going forward over the next 3 years. Please include notation of changes in burn rate due to activities.

4. Update on Business Arrangements: The fiscal 2016 year end documents stated "Given the high cost, long development times and high attrition rates associated with drug development, many biotechnology companies partner with or license with a pharmaceutical partner to advance their products through clinical trials. We will seek to partner or license our drug candidate at the stage that will provide our shareholders with the optimal value for their investment. Should such partnering or licensing be successful, a pharmaceutical company will provide some or all of the funding and expertise to complete the latter stages of drug development and commercialization." Please provide an overview of the types of partnerships, joint ventures, newco's or other business arrangements that the company is or will be having with pharma to move current or new molecules into the clinic. Please provide a status report of where those discussions are at currently (just beginning, well underway, close to fruition, etc.)

5. IP and Patent Protection: The fiscal 2016 year end documents briefly summarized the patent position of Resverlogix. However, many shareholders have legitimate concerns about patent protection after what happened with Zenith with their first lead molecule ZEN-3365 that was withdrawn due to potential IP conflict. Resverlogix and Zenith each have very large compound libraries. Please review IP coverage for us including status of patents for RVX-208, ZEN-3694, ZEN-3717 and other lead/backup molecules and the lifetime of these patents. Are the vast compound libraries of Resverlogix and Zenith covered by granted patents at this time or are these patents pending? Although Resverlogix has a several year lead on other competitors with RVX-208, the term of the RVX-208 patents is limited. What other patents for RVX-208 or other molecules have been filed to expand the breadth of the patent protection? How does the synergy (or lack of synergy) of RVX-208 with rosuvastatin in BETonMACE affect patent protection and life of patent for RVX-208?

6. Licensing Deals: What are the updates on the second licensing deal that we have been told will be announced in 2016? Update us in a detailed fashion about HepaLink and other licensing deal(s). What are their activities? When will the all-important revenue spigot be turned on? Do they have skin in the game? Corporate documents state that "Hepalink will be responsible for all clinical and development costs in the Territories, including a patient population that is expected to be included in the Company’s Phase 3 BETonMACE trial." Is Hepalink paying for the Taiwan sites for the BETonMACE trial?

7. Update on Analyst Coverage: The most recent 2016 milestone checklist in the Q2 update indicated that 3 new analyst coverage programs were to be added in 2016. What is the status of these and when are the new analyst reports expected? Are any of the coverages provided by Marcel Wijma (Van Leeuwenhoeck Institute), John D. Vandermosten (Zacks Small Cap Research), or Stonegate Capital considered "new analyst coverage programs" or are other new analyst coverages expected in 2016?

8. Nasdaq listing: Please update on projected timeline and circumstances for a Nasdaq listing.

9. Long range plans: Resverlogix and Zenith each have very large compound libraries, which have the potential to give rise to numerous licensing deals, sale of IP, or spin offs. In past AGMs, it has been suggested that this large compound library may give rise to future spin-offs for different indications or classes of molecules, kind of like a "Star Factory." Please provide an overview of the long range plan for Resverlogix (and Zenith if applicable). If future spin-offs (Star Factories) do happen, what defines an individual "Star"? Is a Star a single molecule, a sub-family of related compounds from their big library, a BET inhibitor scaffold, a disease target, etc.? What would actually be spun off as an independent entity?

10. New molecules and new indications: At the Q1 update, it was stated that several follow on molecules have gone through various animal studies for different indications. We know that Resverlogix is very interested in renal and complement-mediated diseases. Additionally, at the NYAS symposium it was indicated that other applications of RVX-208 may include muscular dystrophy and liver fibrosis. Please give us more detail on the backup/follow-on molecules for Resverlogix and Zenith, which indication(s) they are targeting, and how and when they will be moved forward into the clinic. Is Resverlogix still on track to confirm an RVX-208 follow on candidate in 2016? Will this be for similar indications as for RVX-208 or for different indication(s)? Is Resverlogix pursuing the autoimmune molecule RVX-297, or another follow on molecule, for autoimmune indications such as rheumatoid arthritis, multiple sclerosis, Crohn’s disease, psoriasis, Sjogren’s syndrome, and lupus? Or has the autoimmune program being pursued by Zenith and not Resverlogix?

11. What distinguishes Resverlogix from Zenith?: Both companies command their own extensive BET inhibitor compound libraries. At the time Zenith was formed in 2013, it seemed that apoAI modulation defined Resverlogix and Zenith got everything else licensed to it from Resverlogix. But Zenith terminated this license on January 31, 2015 to pursue its own IP. What now differentiates Zenith's compounds from Resverlogix's compounds? It would seem that Resverlogix and Zenith could each go after any disease they want. Although Zenith is currently going after oncology indications and Resverlogix is going after cardiovascular, renal and complement-mediated diseases, what is stopping Resverlogix and Zenith from directly competing for the same indications? Both companies have substantial overlap in Senior Management and Board of Directors. Please provide a better idea of what differentiates Resverlogix from Zenith currently and in the future.

12. Update on BETonMACE enrollment and study sites: In the most recent Fiscal 2016 year end disclosure documents, it was stated that "All planned countries, namely Argentina, Belgium, Bulgaria, Croatia, Germany, Hungary, Israel, Mexico, Poland, Serbia, and Slovakia had received regulatory approval to open clinical investigator sites and are currently enrolling and randomizing patients." Are all of the planned BETonMACE study sites in each of these 11 countries now active as well? If not, what is the timeline for their activation? Is the overall patient recruitment rate still on schedule with the original estimates? Corporate documents state that "Hepalink will be responsible for all clinical and development costs in the Territories, including a patient population that is expected to be included in the Company’s Phase 3 BETonMACE trial." At the Q2 update we were told that Taiwan BETonMACE involvement should be launching by end of 2016. Will there be any other China study sites involved in BETonMACE other than Taiwan? It was also mentioned in a past update that Australia was a possible BETonMACE site for more patients if needed. Is there any update on this, or is it still too early to know? Is the 125 MACE event futility analysis still on track for mid-2017?

13. Update on US sites in BETonMACE: At the Q2 update, we were told that by end of 2016 Resverlogix will have a Type C meeting with the FDA to discuss adding BETonMACE centers in US and review any outstanding requests from the FDA. We were told that "At the time of this meeting safety data from over 1,000 patients in the BETonMACE trial will be available, additional dose response work, MOA and liver biology work will be complete." Assuming that this meeting goes well, when is the earliest that US sites could be actively recruiting and how does this affect the original BETonMACE timeline? Resverlogix will also have a Type C meeting with the FDA by years end to discuss toxicology issues and go forward carcinogenicity program. Is there any update on the immunotoxicity rat study that was requested by the FDA? What concerns, if any, are there about the current BETonMACE protocol meeting FDA expectations?

14. Status of Orphan Indication Trials: At the Q1 webcast, we were told that a PNH trial consisting of 30-40 patients at an estimated cost of 2-3 MM is still planned to launch in 2016. What is the timeline and estimated launch date of the RVX-208 Phase 2 PNH trial? What other orphan disease trials or complement-mediated disease trials are going to be moved forward and when? What are the projected primary and secondary endpoints for these complement-mediated disease or orphan disease trials?

15. Update on renal program: At the Q2 update we were told that by the end of 2016 that Resverlogix will have a Type B meeting with the FDA, pre IND for the new renal program, to review of top line PK data of the Phase 1 trial. Assuming that the Phase 1 New Zealand pharmacokinetic trial and FDA meeting go well, what is the plan and timeline for Phase 2/3 renal trial(s) going forward? BETonRENAL was mentioned at the Q2 update. Will this be a Phase 2 or Phase 3? What are the projected primary and secondary endpoints for BETonRENAL?

16. Update on Blood Bank and SomaScan Analysis: The analysis of blood samples from patients in ASSERT, SUSTAIN and ASSURE with the SomaScan (SomaLogic, Boulder, CO) has been emphasized during recent scientific presentations such as the NYAS webcast. What new exciting insights has Resverlogix obtained from this data and how does Resverlogix plan to use this data going forward? Will this data be published?

17. Update on manuscripts: The 2016 milestone checklist most recently shown at the Q2 update indicated that 4 manuscripts were to be published in 2016. In addition to the January Atherosclerosis article and the May Metabolism article, what other peer-review publications are in the works or planned?

We, as a group of shareholders representing collectively what could be considered a somewhat significant retail share block, are intending to make the practice of forwarding to you the company, on a semi-annual basis, a list of our concerns that we would appreciate having addressed in upcoming webcasts, news releases, blog updates, quarterlies, or any other form of media you choose to go with. We of course look forward to hearing back from the Investor Relations Department or from our CEO himself, Don McCaffrey, about our many concerns.

Share
New Message
Please login to post a reply