Liquidia Corporation

Good morning and welcome everyone to the liquidia corporation second quarter 2024 financial results and corporate update conference call. My name is Lisa and I will be your conference operator today currently all participants on a listen only mode. Following the presentation, we will conduct a question answer session instructions will be provided at that time for you to queue up for questions, I would now like to remind everyone this conference call is being recorded. I will now hand the call over to Jason Elliott, Chief Business Officer. Please go ahead.

Thank you, Lisa. It's my pleasure to welcome everyone to Liquidia Corporation's second quarter 2024 financial results and corporate update call. Joining the call today are Chief Executive Officer, Dr. Roger Jeff, Chief Operating Officer and CFO, Michael Cassetta, Chief Medical Officer, Dr. Rajiv Sagar, Chief Commercial Officer Scott Mumaw, 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 would now like to turn the call over to Roger for our prepared remarks, after which he will open the call for your questions.

Roger? Thank you, Jason. Good morning, everyone. Thank you for joining us today. While we, and patients, still anxiously await FDA action on the eutrapia NDA, seeking approval for both pulmonary PAH and pulmonary hypertension associated with interstitial lung disease, or PHILD. We remain hopeful that we are close to achieving this. As a reminder, the FDA has had no legal impediments since April 1st to take action on the amendment as submitted, seeking approval for both PH and PHILD. What I can say today is that we have been in active and constructive communication with the FDA over these past four months though we will not comment on the specifics of our conversations with the FDA. To be crystal clear, our medical and commercial teams remain on high alert, ready to launch Utrepia immediately upon approval. Our sales team continues to call on key pH accounts, strengthening relationships and educating them on liquidia. And importantly, we are staging commercial product for rapid distribution to specialty pharmacies upon approval. Moving to our clinical programs, The open-label assent study of eutrepia in PHILD patients continues to ramp up in the number of active clinical sites, with parallel increases in patient screening and patient enrollment. We are pleased with the preliminary feedback from physicians, suggesting that patients can readily titrate eutrepia to escalating therapeutic levels in these PHILD patients. While the assent data needs to mature more, our early patient experience today suggests that the benefits of print-formulated tryprosinol delivered via a low-effort inhaler parallels a very good experience observed in PAH patients. For example, the median dose of butyrepia for patients currently enrolled beyond eight weeks in the ASCENT trial is 185.5 micrograms per treatment session, or approximately 21 breath equivalents of Tybaso per session, with a top dose of 318 micrograms, or approximately 36 breath equivalents. These doses are several orders of magnitude beyond the recommended 9 to 12 breath dose targeted Tybaso, and exemplify the paradigm-shifting potential of Utrepia for pH and pH Ion B patients, especially as it relates to tolerability and potentially durability. We plan to submit additional clinical data from the ECCENT trial at future medical conferences. Some more to come on that. With respect to our sustained-release liposomal formulation of inhaled naproxenil, L606, the preliminary safety data and exploratory efficacy data from the first 28 patients switching from Tyveso or Tyveso DPI in our open-label clinical study has been highly encouraging. We continue to observe favorable tolerability and titratability profile of twice-daily dosing of L606, likely attributable to the seven-fold lower CMAX, but with a similar systemic exposure over a 24-hour period compared with a four-times-a-day dosing of inhaled tryprosinol, all while using a rapid, portable, handheld breath-actuated nebulizer. The long-term safety data generated from this study has helped solicit favorable scientific advice from the European Medicines Agency, or the EMA, last month on our pivotal trial design, which was very consistent with the FDA's feedback from our Type C meeting in December. While we continue to observe these patients in the open-lambda study, our focus will now shift to our efforts to initiate the registration registration on global trial in patients with the ILD later this year. At this time, I will turn the call over to Mike to summarize the second quarter financial results.