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Message: Near Term Events & Planning...

Near Term Events & Planning

 • The US FDA and Resverlogix have now confirmed the final BETonMACE2 clinical plans.

– Filing of a New Drug Application (NDA) with the FDA is possible following unequivocal efficacy at

an interim analysis of BETonMACE2 – potentially 2022

– All or most BETonMACE2 patients to receive top standard of care, including SGLT2 inhibitors

– BETonMACE2 to significantly increase enrichment of chronic kidney disease (CKD) patients

• Partnering Option - Resverlogix is advancing its ongoing negotiations with Major Pharmaceutical companies to determine a suitable partner, structure and trial design for co-developing apabetalone. Timing of completion is somewhat dependent on COVID-19, causing delays of large clinical trials globally. Co-development discussions with numerous pharma’s include the following:

Resverlogix expects to receive significant up front payment upon completion

▪ The Phase 3b clinical trial will be funded by a partnering company – Trial designs in discussion range in cost from $60MM to $150MM US dependent on the trial size, length and overall design. Backup options for funding include the sale of royalties or internal financing from current investors

• COVID-19 early clinical trial results could be available as early as Q1, 2021. The trial is being designed as a small fast program designed to confirm the recent scientific data regarding BETi and COVID-19

• Pulmonary Arterial Hypertension (PAH) clinical trial data should be available in the first half of 2021. This trial has been on and off again due to the strain of COVID 19 on pulmonary units. Data is still compiling and will continue to do so until the trial can be deemed completed

 

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