Liquidia Corporation (NASDAQ:LQDA) Q2 2023 Earnings Call Transcript

Roger Jeffs: Yeah. I’ll ask Rajeev, our Chief Medical officer, who’s overseeing the development to address that question.

Rajeev Saggar: So, first and foremost, just to highlight the L606 program has one current ongoing open-label study that’s active in the United States, with the inclusion of the following patients. These are WHO Group 1 PAH patients that are either naive to prostacyclins or they could be transitioned from inhaled Tyvaso, either the DPI or nebulized, as well as patients that have PH-ILD that can be transitioned from Tyvaso DPI or Tyvaso nebulizer to open-label L606. That study is already recruiting. And we have patients that have already achieved up to one year of exposure. The priority now based on our understanding is, is that we are going to be seeking a type B discussion with the FDA, that is our — that’s first and foremost priority to just confirm that the requirement from my understanding is a single placebo controlled study with L606, specifically in PH-ILD.

We believe that that study in particular plus our Phase 1 study, that combination will be enough for to seek NDA approval for both indications of PAH and PH-ILD. Roger, back to you.

Roger Jeffs: Yeah. Thanks Rajeev. And Matt, that’s the timeline. We’re a little bit silent. We want to get through the type B meeting. Again, there’s a good proxy for what we need to do just from the Tyvaso ILD study that was done. So, there’s precedent in terms of sample size time to get that study enrolled. And I think given its PH-ILD and it will be sort of unencumbered by background therapies, I think it’d be potentially faster than what you’ve seen previously, particularly if somebody was doing a PAH only study. So, again, it’ll take us a few years, but I think we have the chance to become the first — less than four times a day option for patients. Operator, next question please.

Operator: Thank you. And I see no further questions in the Q&A queue at this time. I’ll now turn the call back over to you, Dr. Jeffs, for any closing remarks.

End of Q&A:

Roger Jeffs: Thank you, operator. So, with no further questions, again, I’d like to thank you for joining us today. We look forward to reporting on our continued progress in the coming quarters. Goodbye.

Operator: Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation. You may now disconnect.