Liquidia Corporation

Good morning and welcome everyone to the Liquidia Corporation third quarter 2023 financial results and corporate update conference call. My name is Therese and I will be your conference operator today. Currently, all participants are in a listen only mode. Following the presentation, we will conduct a question and answer session. Instructions will be provided at that time for you to queue up for questions. I would like to remind everyone that this conference call is being recorded. I will now hand the call over to Jason Adair, Chief Business Officer.

Thank you, Teresa. It's my pleasure to welcome everyone to the Quiddius Third Quarter 2023 Financial Results and Corporate Update Call. Joining the call today are Chief Executive Officer Dr. Roger Jeffs, Chief Financial Officer Michael Cassetta, Chief Commercial Officer Scott Mumaw, Chief Medical Officer Dr. Rajiv Sagar, and General Counsel Rusty Shundler. Before we begin, please note that today's conference call will contain forward-looking statements, including those statements regarding future results, unaudited and forward-looking financial information, as well as the company's future performance and or achievements. These statements are subject to known and unknown risks and uncertainties, which may cause our actual results or performance to be materially different from any future results or performance expressed or implied on this call. For additional information, including a detailed discussion of our risk factors, please refer to the company's documents filed with the Securities and Exchange Commission, which can be accessed on our website. I'd now like to turn the call over to Roger for our prepared remarks, after which he will open up the call for your questions.

Thank you, Jason. Good morning, everyone, and thank you for joining us. The third quarter was marked by continued and positive steps to change the future of the company, the pH market, and the lives of patients we are committed to serve. We have built a portfolio that we believe includes the most promising products in the fastest-growing area of the pH marketplace, inhaled tryprosinol for the treatment of pulmonary arterial hypertension, or PAH, and pulmonary hypertension associated with interstitial lung disease, or PHILD. Many of you know already that eutrapia, our dry powder formulation of tryprosinol, using a low-effort, simple-to-use, pocket-sized dry powder inhaler, has the potential to be the first and best choice when adding naprostocycline to a patient's treatment regimen. In support of this, a recent summary from our open-label clinical experience shows how durable and titratable eutropia treatment can be, where we've treated patients for as long as five and a half years and have titrated to doses now equivalent to 30 breaths of Tyveso four times per day. I want to emphasize dose matters. as it has been demonstrated across all routes of prostacyclin use that higher doses equate with better patient outcomes. Utrepia's ability to dose higher has the potential to significantly broaden and improve upon the therapeutic index and utility of inhaled tryprosinol administration as it currently exists. At the same time, we've seen promising early evidence of clear benefits in our sustained release inhaled tryprosinol program called L606, This liposomal formulation, delivered in two administrations per day, offers more consistent drug exposure throughout the day, including during sleeping hours. Each dose is delivered in approximately one minute using simple tidal breathing with a portable next-generation breath-activated nebulizer. We have plans to share data at conferences in 2024, but our preliminary data suggests that patients in the open-label study who have transitioned from Tyveso have been able to safely titrate to higher doses, including daily doses comparable to 25 breaths of Tyveso four times per day without any reported throat pain to date and only mild to moderate and expected adverse events in a minority of patients. We very much look forward to sharing more details on the development and registration path for this program during our future earnings calls, which will be informed by our Type C meeting scheduled with the FDA next month. While we are very excited about our L606 program, we recognize that most of our investors' attention is focused on near-term legal events. The good news is that legal story has now become greatly simplified. There's just a single patent, the 793 patent, that currently supports the injunction preventing the FDA from granting full approval of Futrevia. All claims of that patent were found to be invalid by the Patent Travel Appeal Board, or PTAB. The PTAB's favorable decision is currently being appealed by United Therapeutics. with oral arguments scheduled for December 4th. We expect the decision could be issued as quickly as a few days after oral argument, if some reaffirmance is granted, or within just a few months after oral argument if a formal written decision is provided. Regardless, if the PTAP's decision is affirmed, we will immediately seek to have the injunction lifted and request final approval from the FDA. In the event of such an approval, we will execute on our plan to change the landscape of the pH market as quickly as possible. For this reason, I have asked Scott Mumaw, our Chief Commercial Officer, to introduce himself broadly to our investors and to provide an update regarding our commercial preparations. Scott?