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'Pivotal Topline Up Next' for Biotech's Phase 3 Cardiac Clinical Trial
Research Report

Source:

A study update and the next steps to advance the therapeutic were covered in a ROTH Capital Partners report.

In an April 25 research note, ROTH Capital Partners analyst Jotin Marango reported that the last required major adverse cardiac event, the 250th, occurred in Resverlogix Corp.'s (RVX:TSX) BETonMACE Phase 3 trial of apabetalone. The company expects to release corresponding topline data between mid-June and mid-August 2019.

"We remain bullish on the risk/reward of apabetalone into the Phase 3 readout, based on Phase 2 data and the Phase 3 design, the commercial opportunity and the lateral indication optionality of the drug," Marengo commented.

The next step, before the data readout, is conducting last study visits for all of the participating patients, noted Marango. Subsequently the database will be locked, and about two weeks after that, Resverlogix will announce the study results.

Should those data be positive, regulatory review and potential approval would follow, which would take place throughout this year and next, Marango explained. Commercialization of apabetalone then would begin in 2021, with a label for patients with type 2 diabetes and at high cardiovascular disease risk following hospitalization, a population consistent with that in the Phase 3 study.

The analyst noted that apabetalone would likely reach peak global sales of more than $1 billion by 2025, based on the market performance of the type 2 diabetes medication Jardiance (empagliflozin).

Also, Marango added, with its strong safety profile, Resverlogix could expand the use of apabetalone beyond the BETonMACE population.

ROTH has a Buy rating and a CA$10 per share target price on Resverlogix, whose stock is currently trading at around CA$3.97 per share.

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Disclosures from ROTH Capital Partners, Resverlogix Corp., Company Note, April 25, 2019

Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.




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