Liquidia Corporation

Good morning and welcome everyone to Liquidia Corporation third quarter 2024 financial results on corporate update conference call. My name is Michelle 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 would now like to hand the conference over to Jason Adair, Chief Business Officer. Please go ahead.

Thank you, Michelle. It's my pleasure to welcome everybody today to the Liquida Corporation Third Quarter 2024 Financial Results and Corporate Update Call. Joining the call today are Chief Executive Officer Dr. Roger Jeffs, Chief Operating Officer and CFO Michael Cassetta, Chief Medical Officer Dr. Rajiv Sagar, Chief Commercial Officer Scott Lumaw, and General Counsel Rusty Schundler. 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 you will open the call for your questions.

Good morning, everyone. We're pleased to be speaking with you today. With the significant progress made over the last few months, we now have a clear line of sight to seeking final approval of eutrapia for both PAH and PHILD patients. Final approval could occur following the expiration of Tyvaso DPI's clinical exclusivity on May 23, 2025, or in just a six-month time. Critical wins that underpinned this significant milestone included the following. First, the FDA confirmed that the amended NDA to add PHLD to the tentatively approved label for eutrepia was proper, and therefore has determined that we have met the regulatory requirements for approval for PAH and PHLD pending the expiration of Tyvesa DPI's clinical exclusivity. And second, with the Supreme Court's decision in September to deny SIRT, The legal process with respect to the three patents originally asserted against us has been fully exhausted, and these three patents no longer provide any impediment to the commercialization of eutrapia. As mentioned, the sole item cited by the FDA that is blocking final approval of eutrapia is the new clinical investigation exclusivity that was granted to Tyves and DPI, which will expire in May of 25, or earlier if we are successful in our lawsuit against the FDA. Rusty will speak more specifically about this lawsuit in a minute. On the clinical front, we remain active and productive in advancing our clinical programs that we have developed to prospectively demonstrate the differentiated value of eutropia in PHILD patients, as well as advancing our next generation sustained release program, L606. We feel the combination of eutropia and L606 gives us a compelling portfolio of treatment options for the delivery of inhaled tryprosinol to treat PAH and PHILD patients both now and in the future. On a related business front, in this quarter we have expanded our relationship with Pharmosa with respect to L606, amending our license agreement to include the EU and other territories outside of North America. We have also entered into a device license agreement with Pharmosa to secure rights to proprietary next generation nebulizers for administration of L606 in a small portable breath actuated nebulizer the size of an iPhone. Rajiv will speak to the clinical progress of both programs and share excitement that is building within the community based on our prospective studies. And finally, we have also strengthened our balance sheet, having closed several simultaneous financings in September. Mike will offer more insight on our balance sheet later in the call, but there is no doubt in my mind that we have the team, capital, the products, the vision, and especially the determination to change the treatment landscape for pulmonary hypertension patients in the near and long term. With that, I will ask Rusty to share some more details.