Aerpio Pharmaceuticals, Inc. (NASDAQ:ARPO) Q4 2018 Earnings Conference Call - Final Transcript

Mar 05, 2019 • 08:30 am ET


Aerpio Pharmaceuticals, Inc. (NASDAQ:ARPO) Q4 2018 Earnings Conference Call - Final Transcript


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Good morning, ladies and gentlemen. Thank you for standing by and welcome to Aerpio Pharmaceuticals' Fourth Quarter and Full Year 2018 Financial Results and Business Update Conference Call.

It is now my pleasure to turn the call over to Michael Rogers, Aerpio's Chief Financial Officer. Please go ahead, sir.

Michael Rogers

Okay, Demetrius. Thank you. Good morning and thank you for joining us for Aerpio's Fourth Quarter and Full Year 2018 Earnings Call. Joining me on the call today is -- from Aerpio is Steve Hoffman, our Chief Executive Officer; Joseph Gardner, our President and Founder; Steve Pakola, our Chief Medical Officer and Kevin Peters, our Chief Scientific Officer.

This morning, Aerpio released financial results for the fourth quarter and full year ended December 31, 2018. If you have not received the news release or if you would like to be added to the company's distribution list, you can do so on our Investor Relations page of our website at

I'd also like to remind you that the remarks made on the call today include forward-looking statements about Aerpio. And such statements may include, but are not limited to, those related to Aerpio and its business and its product candidates, including their planned clinical development and therapeutic potential, as well as the announcement of top line results from Aerpio's TIME-2b clinical trial. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement.

A more complete description of these and other material risks can be found in Aerpio's periodic reports filed from time to time with the SEC. Aerpio does not undertake any obligation to update publicly any forward-looking statement whether as a result of new information, future events or otherwise.

With that, I will now turn the call over to our CEO, Steve Hoffman. Steve?

Steve Hoffman

Thanks, Mike and good morning, everyone. Thank you for joining us today. 2018 was a very productive year for Aerpio Pharmaceuticals, as we continued to advance our pipeline of first in class products that activate Tie2 to treat ocular diseases and diabetic complications. We remain on track to announce top line Phase 2b results from our TIME-2b study, evaluating our lead candidate AKB-9778 for patients with moderate to severe NPDR later this month.

The TIME-2b study was designed as a double mass placebo controlled multi-center trial where 157 patients were randomized to receive 48 weeks of treatment with either AKB-9778 50 milligrams once daily, twice daily or placebo. The primary endpoint of the TIME-2b study is the percentage of patients who improved by two steps or greater in their diabetic retinopathy severity score in the study high.

We have several secondary endpoints in the trial that are also very important. The first is assessment of DRSS or the Diabetic Retinopathy Severity Score, improvement in the fellow eye and patients that have bilateral disease. One distinct advantage of AKB-9778 is its systemic administration, which we believe is not only more convenient and less