Liquidia Corporation (NASDAQ:LQDA) Q3 2023 Earnings Call Transcript

Roger Jeffs: Great. Thank you, Scott. Thank you, Rajeev. Operator next question.

Operator: Thank you. One moment. Our next question comes from Serge Belanger from Needham.

Serge Belanger: Hi. Good morning. Thanks for the updates. First one on the L606 program. So going into the Type C meeting next month, what are your expectations in terms of what is needed to get to filing the open label — the ongoing open-label trial, would that support a filing, or do you think you’ll need to conduct placebo-controlled studies in both PAH and PH-ILD? And then second question maybe for Scott, maybe kind of a follow-up on the previous PH-ILD question. Maybe just talk about how different the prescriber base is for PAH and PH-ILD and how much overlap there is between the two?

Roger Jeffs: Yeah. Thank you, Serge. Rajeev, if you wouldn’t mind talking about our at least preliminary L606 registration strategy and kind of what we see as the path forward and what we’re discussing with the FDA, ILD.

Rajeev Saggar: Sure. Thanks, Serge. So as we’ve discussed on prior calls the goal of this Type C meeting with the FDA, our overall clinical program is to discuss with them, what is the path to regulatory approval. We believe that our proposed clinical paradigm of advancing a single Phase 3 study in PH-ILD that’s placebo-controlled using L606 achieving a robust primary endpoint will lead to the ultimate approval of both PAH and PH-ILD in the near future. And that will be inclusive of adding the safety profile of open-label ongoing study of L606 that’s currently enrolling to date. Scott?

Scott Moomaw: Yeah. So the PH-ILD HCP market, it’s as you might expect The PH centers, the centers of excellence, the Dukes, the Mayos, et cetera, not only treat PAH, but they treat PH-ILD as well as the other forms of pulmonary hypertension. And then you have what’s usually just labeled the community physicians, mostly pulmonologists that are treating ILD, but may not be diagnosing or treating PH-ILD. Some of the numbers that we see if you think about us having 5,000 targets overall, it would be maybe 2,000 of those targets would be doctors who do not prescribe prostacyclins or the more serious PAH meds. So you would infer from that that they are not treating PAH PH-ILD. So we’re sized to cover all of those more than adequately.

And so the goal in the two different segments is a little bit different obviously. When you’re in centers you want to make sure that they’re reaching our drug. But when you’re in the community, you want to make sure that they are aware of the severity of PH-ILD and the probability of PH-ILD and then that they’re diagnosing it and if they’ll treat it that’s great, and if they won’t let’s make sure that that patient gets to a center of excellence that can.

Serge Belanger: Thank you.

Scott Moomaw: Thank you, Serge. Operator, next question.

Operator: Thank you for the question. Our next question comes from Kambiz Yazdi from Jefferies. Your line is open.

Kambiz Yazdi: Good morning, team. Roger in the past you’ve, kind of, discussed YUTREPIA potentially being kind of a prostacyclins at first choice. Maybe you could expand on that thought, especially ahead of a potential launch. And then as a second question, can you remind us what is the status of the ‘061 method of use patent? Thank you.

Roger Jeffs: Yeah. Thanks for the question Kambiz. So maybe Rajeev maybe if you could talk about the pillars of YUTREPIA that will help position it as the potential process second or first choice. And then Rusty you can talk about the status question if you will. Rajeev?