Q2 2024 Liquidia Corp Earnings Call

August 7, 2024

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 are on a listen-only mode.

Operator: Financial Results and Corporate Update conference call.

Unknown Speaker: Adair. Thank you. Thank you. Thank you. Thank you.

Lisa: My name is Lisa, and I will be your conference operator today. Currently, I'll participate in a listen-only mode.

Lisa: My name is Lisa, 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 now like to remind everyone this conference call is being recorded. I will now hand the call over to Jason Adair, Chief Business Officer.

Lisa: Following the presentation, we will conduct a question and discussion. Instructions will be provided at that time for you to queue up for questions.

Speaker Change: 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 now like to remind everyone this conference call is being recorded.

Lisa: I would now like to remind everyone this conference call is being recorded.

Jason Adair: I will now hand the call over to Jason Adair, Chief Business Officer. Please go ahead.

Jason Adair: Thank you, Lisa.

Jason Adair: 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 Jeffs, Chief Operating Officer, and CFO, Michael Kaseta, Chief Medical Officer, Dr. Rajeev Saggar, Chief Commercial Officer, Scott Moomaw, 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.

Jason Adair: It's my pleasure to welcome everyone to the Liquidia Corporation 2nd 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 Kaseta, Chief Medical Officer Dr. Rajeev Saggar, Chief Commercial Officer Scott Moomaw, and General Counsel Rusty Schundler.

Speaker Change: Thank you, Lisa. It's my pleasure to welcome everyone to Liquidia Corporation's second quarter 2024 financial results and corporate update call.

Speaker Change: Joining the call today are Chief Executive Officer, Dr. Roger Jeffs, Chief Operating Officer and CFO , Michael Kaseta, Chief Medical Officer, Dr. Rajeev Saggar, Chief Commercial Officer, Scott Moomaw, and General Counsel, Rusty Schundler.

Jason Adair: 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 achievement. 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.

Jason Adair: 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 to your questions. Roger

Speaker Change: 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.

Jason Adair: For additional information, including a detailed discussion of our risk factors, please refer to the company's documents filed for the Securities and Exchange Commission, which can be accessed on our website.

Speaker Change: 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.

Jason Adair: 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.

Speaker Change: 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?

Roger Jeffs: Roger? Thank you, Jason.

Roger Jeffs: Thank you, Jason. Good morning, everyone.

Roger Jeffs: Good morning, everyone. Thank you for joining us today. While we, and patients, still anxiously await FDA action on the Utrepia NDA, so you can approval for both the AH and former NIH hypertension associated with an interstitial lung disease or PHID. We remain hopeful that we are close to achieving this. As a reminder, the FDA has said no legal impediments in April 1st to take action on the amendment as submitted, so you can approve for both the AH and the Childhood. What I can say today is that we have been in active and constructive communication with the FDA over these past four months, so will they not comment on the specifics of our conversations with the FDA?

Roger: Thank you, Jason. Good morning, everyone. Thank you for joining us today.

Roger Jeffs: Thank you for joining us today. While we and patients still anxiously await FDA action on the utrepia NDA and seek approval for both formulations, PAH, and Pulmonary Hypertension Associated with Interstitial Lung Disease, or PHILD.

Roger Jeffs: We remain hopeful that we are close to achieving this goal. 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 PHL. What I can say today is that we have been in active and constructive communication with the FDA over these past four months. But we will not comment on the specifics of our conversations with you.

Roger: 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.

Roger Jeffs: To be crystal clear, our medical and commercial teams remain on high, ready to launch Utrepia immediately upon approval. Our sales scheme continues to call on keep PH accounts, strengthening relationships, and educating them on Liquidia. And importantly, we are staging commercial product for rapid distribution, especially the promisey upon approval. Moving to our clinical programs, the Open Label of Sense Study of Utrepia, and PHID patients continues to ramp up, and 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 Utrepia to escalating therapeutic levels in these PHID patients.

Roger Jeffs: To be crystal clear, our medical and commercial teams remain on high alert and 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 utrepia in PHIL-B patients continues to ramp up, and the number of active clinical sites with parallel increases in patient screening and patient enrollment.

Roger: To be crystal clear, our medical and commercial teams remain on high alert and ready to launch utrepia immediately upon approval.

Roger: 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.

Roger Jeffs: We are pleased with the preliminary feedback from physicians suggesting that patients can readily titrate utrepia to escalating therapeutic levels in these PHLDs. While the assent data needs to mature more, our early patient experience today suggests that the benefits of print formulated repositories... delivered via a low effort inhaler... Parallel is a very good experience served in PAH.

Roger: We are pleased with the preliminary feedback from physicians suggesting that patients can readily titrate utrepia to escalating therapeutic levels in these PHLD patients.

Roger Jeffs: While the extent that it needs to mature more, our early patient experience today suggests that the benefits of print formula literature possible, delivered via low effort inhaler, parallels a very good experience observed in PH patients. For example, the median dose to be trapped here for patients currently enrolled beyond eight weeks in the end of the central is 185.5 micrograms per treatment. Session, or approximately 21 breath equivalence of tibesia per session, with a top dose of 318 micrograms or approximately 36 breath equivalence. These doses are several orders of magnitude beyond the recommended 9-12 breath dose target of tibesia, and exemplify the paradigm shifting potential of e-trepia for pH and pH ion depatient, especially as it relates to tolerability and potentially durability.

Roger: Delivered via low-effort inhaler. Parallel is a very good experience observed in PAH patients.

Roger Jeffs: For example, the median dose of utrepia for patients currently enrolled beyond eight weeks in the assent trial is 185.5 micrograms per treatment session, or approximately 21 breath equivalents of type asoprecession, 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 type A and exemplify the paradigm-shifting potential of utrepia for PH and PH IMD patients, especially as it relates to tolerability and potentially durability.

Roger: With a top dose of 318 micrograms, or approximately 36 breath equivalents.

Roger Jeffs: We plan to submit additional clinical data from the Central and Future Medical Conqueror to some more to come on that. With respect to our sustained release, like the similar formulation of inhaler Prosynil, L606, the preliminary safety data and exploratory efficacy data from the first 28 patients switching from Pivasos or Pivasodepi in our open label clinical study has been highly encouraging. We continue to observe favorable tolerability and titrateability for a while of twice daily dosing of L606, likely attributable to the seventh-fold lower c-mat, but with a similar systemic exposure over a 24-hour period compared with the four times a day dosing of inhaler prosynil, all volumes in a rapid portable handheld breath-actuated nebula.

Roger: especially as it relates to tolerability and potentially durability.

Roger Jeffs: We plan to submit additional clinical data from the Centrale at future medical conferences, and more to come on. With respect to our sustained release glycosomal formulation of inhaled proxenil L6s. The preliminary safety data and exploratory efficacy data from the first 28 patients. Switching from Tyvaso or Tyvaso DPI in our Open Label Clinical Study has been highly encouraged. We continue to observe favorable tolerability and titratability profiles of twice daily dosing of L606, likely attributable to the 7-fold lower Cmax, but with a similar systemic exposure over a 24-hour period compared with a 4-times-a-day dosing of inhaled troposinol, all while using a rapid, portable, hand-held breath-actuated nebulizer.

Roger: We plan to submit additional clinical data from the Accenture Allah Future Medical Conferences and more to come on that.

Roger: We continue to observe favorable tolerability and titratability profile of twice daily dosing of L6O6.

Roger Jeffs: The long-term safety data generated from this study has helped solicit favorable scientific advice from the European Medicine Agency, or the EMA, last month on our pivotal trial design, which was very consistent with the FDA feedback from our Type C meeting in December. While we continue to observe these patients in the open land of study, our focus will now shift to our efforts to initiate the registration.

Roger Jeffs: 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 labial study, our focus will now shift to our efforts to initiate the registration or global trial in patients with PHILD later this year. At this time, I'll turn the call over to Mike to summarize the second quarter.

Roger: 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 .

Roger Jeffs: Registration on global trial and patients with the IOT later this year.

Michael Kaseta: At this time, I will turn the call over to Mike to summarize the second quarter financial results.

Roger: At this time I'll turn the call over to Mike to summarize the second quarter financial results.

Michael Kaseta: Thank you, Roger, and good morning, everyone. I will briefly address our second quarter financial results found in today's press release. As you will see, revenue was $3.7 million for the second quarter of 2024 compared with $4.8 million in the same quarter of 2023. Revenue tied to our promotion agreement with Sanders to commercialize to prop known injection. The decreases primarily due to lower sales quantities in the current year as compared to the same period in the prior year. Cost of revenue increased to $1.5 million for the second quarter of 2024 compared to $0.7 million in the same quarter for 2023, with the increase being primarily due to our sales force expansion during the fourth quarter of 2023.

Mike: compared with 4.8 million dollars in the same quarter 2023.

Mike: Revenue is tied to our promotion agreement with Sandoz to commercialize troparosinol injection.

Michael Kaseta: The decrease is primarily due to lower sales quantities in the current year as compared to the same period in the prior year. Cost of revenue increased to $1.5 million for the second quarter of 2024 compared to $0.7 million in the same quarter of 2023, with the increase being primarily due to our sales force expansion during the fourth quarter of 2020. Research and development expenses were $9.4 million in the second quarter of 2024, compared with $17.7 million in 2Q2023, which included a $10 million upfront license fee to PhRMOSA for the exclusive license to L606 in North America.

Michael Kaseta: Research and development expenses were $9.4 million in the second quarter of 2024, compared with $17.7 million in 2Q 2023, which included a $10 million upfront license fee to Farmose for the exclusive license to L606 in North America. We saw a $1.4 million decrease in expenses related to our Uterpia program driven by expansion pre-launch inventory costs in the prior year. These decreases were offset by a $1.7 million increase in clinical expenses related to our L606 program and a $1.5 million increase in personal expenses related to increased headcount. General administrative expenses were $20 million in the second quarter of 2024 compared to $9.2 million in the same quarter for 2023.

Mike: Research and development expenses were $9.4 million in the second quarter of 2024, compared with $17.7 million in 2Q2023, which included a $10 million upfront license fee to PhRMOSA for the exclusive license to L606 in North America.

Mike: We saw a $1.4 million decrease in expenses related to our UTREPIA program, driven by expensing pre-launch inventory costs in the prior year.

Mike: These decreases were offset by a $1.7 million increase in clinical expenses related to our L606 program and a $1.5 million increase in personnel expenses related to increased head count.

Michael Kaseta: We saw a $1.4 million decrease in expenses related to our UTREPIA program, driven by expensing pre-launch inventory costs in the prior year. These decreases were offset by a $1.7 million increase in clinical expenses related to our L606 program and a $1.5 million increase in personnel expenses related to increased headcount. General and administrative expenses were $20 million in the second quarter of 2024 compared to $9.2 million in the same quarter of 2023

Mike: General and administrative expenses were $20 million in the second quarter of 2024 compared to $9.2 million in the same quarter for 2023. The increase of $10.8 million is primarily due to a $6.3 million increase in personnel expenses, which includes stock-based compensation.

Michael Kaseta: The increase of $10.8 million is primarily due to a $6.3 million increase in personal expenses. expenses, which includes stock-based compensation, a $2.2 million increase in commercial and consulting expenses, and a $0.9 million increase in legal fees related to our ongoing Uterpia-related litigation.

Michael Kaseta: The increase of $10.8 million is primarily due to a $6.3 million increase in personnel expenses, which includes stock-based compensation. A $2.2 million increase in commercial and consulting expenses and a $0.9 million increase in legal fees related to our ongoing eutrophia-related litigation. In summary, we incurred a net loss for the three months ended June 30th, 2024, of $27.9 million, or $0.37 per basic and diluted chair, compared to a net loss of $23.5 million, or $0.36 per basic and diluted chair, for the three months ended March 31st, 2020. We ended the second quarter of 2024 with $133 million cash on hand and remain well positioned financially to achieve our corporate objectives this year. With that, I'd like to now turn the call back over to Roger.

Michael Kaseta: In summary, we incurred a net loss for the three months in June 30, 2024, of $27.9 million or $37 per basic and diluted share, compared to a net loss of $23.5 million or $36 per basic and diluted share for the three months ended March 31, 2023. We ended the second quarter, 2024, with $133 million cash on hand and remained well-positioned financially to achieve our corporate objectives this year.

Mike: compared to a net loss of $23.5 million, or $0.36 per basic undiluted share, for the three months ended March 31, 2023.

Mike: We ended the second quarter of 2024 with $133 million cash on hand and remain well positioned financially to achieve our corporate objectives this year.

Roger Jeffs: With that, I'd like to now throw in the call back over to Roger.

Roger Jeffs: Thank you, Mike. As you've just heard, it's been an active summer on several fronts since our last call. We were fully prepared for the potential launch of uTREPiO with a team of dedicated professionals who are poised to reshape and grow the market for in-the-outro personnel upon uTREPiO's approval. The market opportunity for inhaler prosthetics is currently at a $1.5 billion run rate, with the potential to grow in excess of $3 billion in the coming years.

Roger Jeffs: Thank you, Mike. As you've just heard, it's been an active summer on several fronts since our last call.

Speaker Change: Thank you Mike. As you've just heard, it's been an active summer on several fronts since our last call.

Roger Jeffs: We were fully prepared for the potential entrepreneurship uterpia with a team of dedicated professionals who were poised to reshape and grow the market for a neutral prognol on uterpia's approval. The market opportunity for a neutral prognol is currently at $1.5 billion run rate. With the potential to grow an excess of three billion in the coming years, this market remains keen for a competitive alternative, especially one with dosing and tolerability advantages that Uterpia can potentially provide once approved.

Speaker Change: We were fully prepared for the potential launch of Utrepio with a team of dedicated professionals who are poised to reshape and grow the market for in-outro personnel on Utrepio's approval.

Speaker Change: with the potential to grow in excess of $3 billion in the coming years. This market remains keen for a competitive alternative, especially one with the dosing and tolerability advantages that eutrophia can potentially provide once approved.

Roger Jeffs: This market remains keen for a competitive alternative, especially one with the dosing and tolerability advantages that Utrepia can potentially provide once approved. With that, I would now like to open the call to questions. Operator, first question, please.

Lisa: Thank you. If you would like to ask a question, please press star 1-1 on your telephone. You'll then hear an automated message to advise that your hand is raised. We also ask that you wait for your name and company to be announced before proceeding with your question. One minute while we prepare for the questions. And our first question today comes from Julian Harrison of BTIG. Your line is open. Hi, good morning. Thank you.

Roger Jeffs: With that, I would now like to open the call to question.

Operator: Operator, first question, please. Thank you. If you would like to ask a question, please press star 11 on your telephone. You'll then hear automated methods such advice that your hand is raised. We also ask that you wait for your name and company to be at Nile before proceeding with your question.

Speaker Change: With that, I would now like to open the call to questions.

Speaker Change: Operator, first question please. Thank you. If you would like to ask a question, please press star 1-1 on your telephone.

Operator: One minute while we prepare for the questions.

Julian Harrison: And our first question today comes from Julian Harrison of BTIG. Your line is open.

Roger Jeffs: Hi, good morning. Thank you for taking my questions, and congrats on the recent progress. I'm wondering if we could briefly review why higher and hiltrapossonal exposure should be beneficial both in pH and PHILD?

Julian Harrison: Hi, good morning. Thank you for taking my questions and congratulations on the recent progress. I'm wondering if we could briefly review why higher inhaled triposomal exposure should be beneficial both in people...

Speaker Change: Hi, good morning. Thank you for taking my questions and congrats on the recent progress. I'm wondering if we could briefly review why higher inhaled triposomal exposure should be beneficial both in PAH and PHILD.

Roger Jeffs: Yeah, Julian, thanks very much for the question. So I'll start, and then I'll answer you to add some additional color. So what we know historically from the use to process cycling is that in one of the beauties of process cycling in particular is the ability to continually titrate to affect over time. Because, unfortunately, these patients have an advancing disease that continues without relent. So the only way, the only therapeutic class that can address this progressive disease and remain a sort of an ability to tweak our process cycling. So if you look at troprosonal and various forms for entral, oral, inhaled, you can see that the ability to titrate is a hallmark of the therapy.

Speaker Change: Yeah Julian, thanks very much for the question. So I'll start and then I'll ask Rajeev to add some additional color.

Rajiv: So what we know historically from the use of prostacyclines, and one of the beauties of prostacyclines in particular, is the ability to continually titrate.

Speaker Change: because unfortunately these patients have an advancing disease that continues without relent. So the only way, the only therapeutic class that can address this progressive disease and remain a

Unknown Speaker: So the only way, the only therapeutic class that can address this progressive disease and remain a sort of ability to tweak our prostacyclin. So if you look at troprosinol in its various forms, parenteral, oral, and inhaled, you can see that the ability to titrate is a hallmark of the therapy, goes to effect, also while minimizing the side effects.

Roger Jeffs: But what has been limiting prior to uterapy in particular as you see with Taipei, so is the inability to titrate above a fairly low therapeutic seal. So what we Trepia have done, and this is why I say it's paradigm shifting, it's giving you all the benefits of the parental and oral products, but giving it directly to the side of action to limit the systemic side of that. So you now have a highly flexible... that can really be those two effects, also along minimizing the side effects.

Speaker Change: But what has been limiting prior to utropia in particular as you see with tybaso is the inability to titrate above a

Speaker Change: fairly low therapeutic ceiling.

Speaker Change: So what Utrepia has done, and this is why I say it's paradigm shifting, it's giving you all the benefits.

Speaker Change: of the parenteral and oral products.

Speaker Change: but giving it directly to the site of action to limit the systemic side effects. So you now have a highly flexible therapeutic with high utility that can really be dose to effect, also while minimizing the side effects.

Rajeev Saggar: So I think, you know, this is why we're so excited about Uteropia. We think it brings a different sort of utility to the marketplace in terms of the troposnell use. And we think this therapeutic profile will be needed to become both best in class and first in choice when considering starting a process like on the parental, oral, or inhaled.

Speaker Change: So I think, you know, this is why we're so excited about eutrophia. We think it brings a different

Speaker Change: sort of utility to the marketplace in terms of the troposinol use, and we think this therapeutic profile will lead it to become both best in class and first in choice when considering starting a process cycle, be it parenteral, oral, or inhaled.

Rajeev Saggar: Regis, I don't have any additional comments. Yeah, Julie and I think Roger answered most of it correctly. I would just sort of add is that, you know, we learned a lot from the increased study in Ph.L.D. I think in that study, the data highlighted that patients that achieved more than at least nine breaths. And especially as you get to higher doses, those patients, the clinical observations was that they walked further. And they had also improvements in many of the secondary outcomes. Also, I think you know this is a very heterogeneous group of patients, both in Ph.L.D.

Speaker Change: Rajeev, I don't know if you have any additional comments.

Rajeev: Yeah, Julian, yeah, I think Roger answered most of it correctly. I would just sort of add is that, you know, we learned a lot from the increased study in PHLD. I think in that study, the data highlighted that patients that achieve more than at least nine breaths

Unknown Speaker: The clinical observations were that they walked further, and they also had improvements in many of the secondary outcomes.

Speaker Change: The clinical observations was that they walked further and they had also improvements in many of the secondary outcomes.

Rajeev Saggar: with various degrees of severity. And in many of these patients, the disease is Roger highlighted. It's progressive.

Rajeev Saggar: The opportunity to continue to titrate and match disease severity and temper that down, I think, is going to be a clear advantage. And a great armamentarium for clinicians, as well as for the outcomes for patients.

Speaker Change: The opportunity to continue to titrate and match disease severity and temper that down I think is going to be a clear advantage and a great armamentarium for clinicians as well as for the outcomes for patients.

Rajeev Saggar: Thank you. Thank you for the question. Okay. Great.

Unknown Speaker: Thank you for the question.

Julian Harrison: Any one more, if I may? I was just curious if you have a good sense for when we might expect a comprehensive data disclosure from the Ascent trial. And can we maybe review, you know, what the key unanswered questions are that you plan to address with that trial?

Speaker Change: Thank you for the question. Okay.

Unknown Speaker: Yeah, maybe Rajeev, if you could comment on that.

Rajeev Saggar: Yeah, maybe we're safe if you could comment on that. Yeah, Julian. So, you know, again, just to remind everyone, you know, Ascent is a study studying the safety and tolerability, and the secondary outcomes would be exploratory efficacy of uterpia and patients with Ph.L.D. who have not been treated. That patients have to enroll with the baseline right heart catheterization. The study is actually for 24 months, and then we follow the patient out to one year.

Speaker Change: is a study studying the safety and tolerability and the secondary outcomes would be.

Rajeev Saggar: So, what is very important here in the study is that what we're looking for is to maintain the patients on the optimal dose of uterpia and also to show durability because what we do know is that after 16 weeks and increased study, many of these patients start to have a significant amount of instability. So, we wanted to show patients definitely have durability.

Speaker Change: the optimal dose of utropia, and also to show durability, because what we do know is that after 16 weeks of increased study, many of these patients start to have a significant amount of instability. So we wanted to show patients definitely have durability.

Rajeev Saggar: Our focus really coming out, you know, in the next set of conversations that are approaching here is really to highlight some of this exploratory clinical efficacy data. We are following clinical variables such as, you know, walk distance in terms of six-minute walk. We're also looking at various forms of questionnaires. And finally, we're also looking at a sex on the lung perankama and the lung voucher by using CT chest imaging, really to highlight, really where the effect is particularly on the pulmonary voucher with the use of uterpia. I just want to highlight, as Roger said, is that at least right now the median dose for those patients now past the eight-week mark is now 185.5 micrograms of uterpia.

Rajeev Saggar: And finally, we're also looking at effects on the lung parenchyma and the lung vasculature by using CT chest imaging, really to highlight exactly where the effect is, particularly on the pulmonary vasculature, with the use of utrepia. I just want to highlight, as Roger said, that at least right now, the median dose for those patients now past the eight-week mark is now 185.5 micrograms of This is just to highlight that if you compare this to our Sentinel-INSPIRE study in PAH, by two years, patients were on – about a third of the patients were on 159 micrograms.

Speaker Change: And finally, we're also looking at effects on the lung parenchyma and the lung vasculature by using...

Roger: CT chest imaging, really to highlight really where the effect is, particularly on the pulmonary vasculature with the use of utropia. I just want to highlight, as Roger said,

Rajeev Saggar: This is just to highlight that if you compare this to our Sentinel Inspire Study in PAH, by two years, patients were on about a third of the patients were on 159 mites. Grams. So, what we're seeing here is that providers and patients, in particular, are able to tolerate uterpia, and there's also, just to go back to our last question, a very clear understanding by providers that dose, the higher the dose, the potential, the benefit of the patient.

Roger: By two years, patients were on about a third of the patients were on 159 micrograms.

Speaker Change: So what we're seeing here is that providers and patients, in particular, are able to tolerate utrepia and there's also, just to go back to our last question, a very clear understanding by providers that dose...

Rajeev Saggar: And I think we look forward to highlighting some of these clinical parameters in the very near future.

Speaker Change: The higher the dose, the potential, the benefit of the patient. And I think we look forward to highlighting some of these clinical parameters in the very near future.

Rajeev Saggar: Thanks, Rajeev. So, Julian, as you can hear, a very robust study, trying to complete it.

Julian Harrison: By year end, specifically into your question, and then we'll look to publish that in 25. Excellent. Thank you, God.

Unknown Speaker: Operator. Excellent. Thank you again. Thank you.

Operator: Thank you. One moment for the next question.

Lisa: Thank you. Thank you. And our next question will be coming from Serge Belanger of Needham. Your line is open.

Serge Belanger: And our next question will be coming from Serge Belanger of Needham; your line is open. Good morning.

Speaker Change: And our next question will be coming from Serge Belanger of Needham. Your line is open.

Serge Belanger: Thanks for taking my question. I had a couple legal ones. First one on the U.P. case against FDA. I believe in the motion for dismissal, both the agency and Liquidia. Completely debris.

Serge Belanger: Good morning. Thanks for taking my question. I have a couple legal ones. First one on the

Rusty Schundler: So, just curious if you have any visibility on timelines for the next steps here, whether we'll get a hearing or judge-based rule on the brief. And related to this case, how closely is FDA following this, this little motion? And could that be a getting factor for them rendering a decision on the uterpia.

Speaker Change: Judge Bates will rule on the brief and related to this case

Serge Belanger: How closely is the FDA following this missile motion? How could that be a deciding factor for them rendering a decision?

Serge Belanger: How closely is the FDA following this missile motion and how could that be a getting factor for them rendering a decision?

Rusty Schundler: Thanks. Thanks for the question.

Rusty Schundler: Rusty. Yes, sir. Thanks for the question. So, on the. Take your first question first on the motion to dismiss next steps. You know, we don't know yet. The court could have an oral argument or could rule on the briefs. You know, we don't have an indication either way yet from the court. So, you know, we can't. Can't provide any guidance there just because we're waiting for the court to decide on that.

Speaker Change: Great, Serge. Thanks for the question. Rusty?

Rusty Schundler: On the second point, you know, obviously it's tough for us to comment on what's in the FDA's head. And I think, as Roger said in this opening remarks, I think we want to be careful, you know, not to comment on our communications with the FDA. So, you know, obviously once the FDA is taken into action, obviously we will announce that. But in the meantime, you know, we're not going to comment on our communications with the FDA.

Rusty Schundler: Thank you.

Serge Belanger: Thank you for the question, Sir. Thank you.

Unknown Speaker: Thank you for the question, Serge.

Speaker Change: Thank you for the question, Serge.

Operator: And one more for the next question. Our next question will be coming from.

Kambiz Yazdi: Kabir Yaza of Jeffries, your line is open. Good morning, team. For the registration study for L6O6, can you remind us the key features for that study design? And when is that slated to start? And then maybe just a few finer points on the spent study. How many more sites have you unhorted since the last update, and how many patients so far have you treated in the sense study?

Speaker Change: for that study design and when is that slated to start? And then maybe just a few finer points on the stent study. How many more sites have you onboarded since the last update? And how many patients so far have you treated in the stent study? Thank you.

Rajeev Saggar: Thank you for the questions.

Unknown Speaker: Questions. Rajeev, both of those are in your court.

Rajeev Saggar: We'll see if both of those are any. and your coordination.

Rajeev Saggar: Yeah, hi, Kambiz. So, you know, regarding the global single placebo control efficacy study with L606, specifically in patients with pomegranate tension associated with interstitial lung disease, we plan to initiate that study by the end of the year. I think we're working feverishly to, you know, do all the necessary steps to make sure that our protocols are properly submitted and viewed by agencies, as Roger highlighted. You know, we've had favorable feedback from both the type of meeting with the FDA and also from the scientific advice from the European Medicines Agency. So, I think we remain pretty confident in our plans.

Kambis: Yeah, hi Kambiz. So, you know, regarding the global

Speaker Change: I think we're working feverishly to, you know, do all the necessary steps to make sure that our protocols are properly implemented.

Speaker Change: submitted and and viewed by agencies as Roger highlighted. You know we've had favorable feedback from both the type C meeting with FDA and also from the scientific advice.

Rajeev Saggar: We've already highlighted the primary endpoint in the study is going to be six-minute walk distance, with a whole host of secondary efficacy end points that I think would be important to support our target profile. I think we were extremely confident based on the safety data that's emerging from the open level study in the United States. Again, just highlighting the liposomal technology on top of the tree proximal. I think Reli has shown to minimize costs and really support dosing and titrate ability of this drug, I think, which is going to be a game changer, along with a reduced frequency to twice a day.

Speaker Change: is going to be six minute walk distance with a whole host of secondary FCM points that I think would be important to support our target profile. I think we were extremely confident based on the safety data that's emerging from the open label study in the

Unknown Speaker: Technology on top of the triprocinol, I think, really has shown to minimize.

Speaker Change: United States. Again, just highlighting the liposomal.

Rajeev Saggar: So, we remain very, very excited about the feedback that KOLs throughout the global market has been showing for support of the study. This is an extremely significant amount of unmet need. I think definitely outside the US, in addition to the US, in that regard. In terms of a scent, we have, we're close to about tripling the number of sites by the end of this month, and we remain quite confident on completing the study by the end of the year. We anticipate to have close to about 15 patients by the end of this month. Just to highlight that the majority of the sites that have been just recently initiated have come on over the past 45 days, and we anticipate the remainder of sites to come on within the next 30 to 60 days as well.

Speaker Change: So we remain very very excited about about the feedback that KOLs

Speaker Change: There's an extremely significant amount of unmet need, I think, definitely outside the U.S. in addition to the U.S. in that regard.

Rajeev Saggar: Then, by that time, I think we'll be on full ramp to support the rest of the study.

Rajeev Saggar: All right, thank you, Regi, because thanks for your questions, Kombi.

Rajeev Saggar: As you can see, really positive data flow from both the L606 open level study and the scent trial.

Speaker Change: Thank you, Rajeev. Thanks for your questions, Kambiz. As you can see,

Speaker Change: Really positive data from both the L606 open label study and the assent trial. You know, we're obviously very excited to get into the registrational study with L606 and PHIA patients, as Rajeev said. And I think the fact now that we're seeing the ability to titrate.

Rajeev Saggar: We're obviously very excited to get into the registration of study without the L606 and PHL. The patients, as Regi said, and I think the fact now that we're seeing the ability to titrate as easily as we are and as quickly as we are, as well as to see the durability of the two times a day format. That's an exciting phase-free program with a very positive predictive future.

Unknown Speaker: as easily as we are and as quickly as we are, as well as to see the durability of the two times a day format, you know, that's an exciting phase three program with a very high So thanks for the question, Kambiz. Next question, please.

Rajeev Saggar: Same for the scent trial, I think, when you see this rapid ability to to those these patients quite differentiating, and I think, you know, something that the market will lean on once we get to market. So thanks for the question. and Kambiz.

Speaker Change: quite differentiating, and I think, you know, something that the market will lean on once we get to market.

Operator: Next question, please. Thank you.

Speaker Change: So thanks for the question, Kambiz. Next question, please. Thank you.

Operator: And one moment for the next question.

Lisa: And one moment for the next question.

Matt Kaplan: Our next question will be coming from the line of Matt Kaplan of Layton Berg, Foundman.

Speaker Change: And one moment for the next question.

Matt Kaplan: Your line is open.

Unknown Attendee: Hi, good morning, guys. Thanks for taking the question. Um, I guess, since we're past the kind of legal impediments for FDA approval, I guess, with your interaction with the FDA, has the FDA identified any material differences which would prevent approval, and would, I guess, necessitate a CRL?

Matt Kaplan: Hi, good morning, guys. Thanks for taking the question. I guess, you know, since we're past the kind of legal impediments for FDA approval. I guess with your interaction with the FDA, has the FDA identified any material differences, which would prevent approval and would, I guess, necessitate the CRL.

Speaker Change: Hi. Good morning, guys. Thanks for taking the question. I guess, you know, since we're past the...

Speaker Change: kind of legal impediments for FDA approval. I guess with your interaction with the FDA, has the FDA identified any material differences which would prevent approval and would, I guess, necessitate a CRL?

Roger Jeffs: Hey, Matt, is Roger. Thanks for the question. So, you know, as I said in the interview, we're really not going to comment on specific discussions with the FDA. I think one way to look at this is, yes, we are past the time when there was no legal impediment for approval being April 1st, four months past that. And while that's frustrating, I think in, if you want to put a positive spin on that, it's four months is in the rearview mirror. So there's been four months to work to a solution. So we think we're that much closer to a decision and an action.

Roger: Hey Matt, it's Roger. Thanks for the question. So, you know, as I said in the intro, we're really not going to comment on specific discussions with the FDA.

Roger Jeffs: And we won't comment on directing communications with that, but we remain optimistic that we've had constructive discussions with the agency. And we remain highly focused on approval for both indications. So that's as we submitted it; we feel it was appropriate as amended. And we are seeking approval for both PAH and PHRD. We haven't backed away from that position, and that remains our focus.

Unknown Speaker: and we are seeking approval for both PAH and PHILD. We haven't backed away from that position, and that remains our focus.

Roger Jeffs: So apologies that I can't get specifics, but if we will have an action soon, we can talk about that in great detail with you.

Operator: Operator, next question. Yeah, no. Thank you.

Jason Gerberry: And one moment for the next question. Our next question will be coming from the line of Jason.

Unknown Speaker: and one moment for the next. Our next question will be coming from the line of Jason Gerberry of Bank of America. Your line is open.

Speaker Change: Operator, next question.

Jason Gerberry: Go very, I'll think of America. Your line is okay.

Jason Gerberry: Hey guys, good morning. Thanks for taking my questions. So two for me, just on the cash burn language and the 10-Q about roughly, you know, around a year of cash runway. I assume that that assumes an approval and launch cost.

Speaker Change: Hey guys, good morning. Thanks for taking my questions.

Michael Kaseta: Can you talk about, you know, in the alternative scenario, if there are delays, any flexibility to preserve the cash runway, any flexibility or levers, but you could pull.

Rusty Schundler: And then my second question is just on United Citizens petition. Is there any plans to submit any correspondence clarifying LGM's role as an importer? Or I assume that most of this is going to handle behind the scenes, if at all. But just curious if there's any plans to submit any response. Thanks.

Michael Kaseta: Yeah, great. Thanks, Jason.

Michael Kaseta: So Michael, you'll address the cash burn question and roughly if you could talk to the citizen. Citizen's petition, please. Yeah, so Jason, thanks for the, thanks for the question. I mean, I think where we sit now, we are sitting at $133 million of cash. We're very confident in our cash position. You know, we talked about all of our objectives for the rest of this year and going forward with a cent without getting L66 initiated. And also supporting a launch of Yetrepia, you know, we've always taken pride in having a strong balance sheet. We feel that we still have that.

Speaker Change: Yeah, great. Thanks, Jason. So, Michael, if you'll address the cash burn question, and Rusty, if you could talk to the citizen's petition, please.

Speaker Change: and also supporting the launch of Utrapia.

Michael Kaseta: And, you know, we're very confident in our ability to deliver. Now, with that being said, you know, we'll always focus on what's at hand and, you know, depending on where things stand, we will, we can make decisions. We will, we will be able to do that, but our focus right now really is to deliver on all three of those objectives of getting a trepia launched, getting L66 pivotal trial initiated, and continuing the essential. So, you know, when you look at our cash balance, I think our burn from, from year end to Q1 to Q2, you know, we've always been disciplined in how we invest.

Michael: We'll always focus on what's at hand, and depending on where things stand, we can make decisions. We will be able to do that, but our focus right now really is to deliver on all three of those objectives of getting Utrepia launched.

Michael: Getting L606 Pivotal Trial Initiated.

Michael Kaseta: We will continue to do that and look forward to hopefully a Yetrepia launch here in the in the next.

Michael Kaseta: Anderson Future.

Rusty Schundler: Jason, thanks for the question on the citizens petition.

Rusty Schundler: You know, we do not currently anticipate filing a public response to the citizens' petition.

Rusty Schundler: Obviously, you know, any issues that, you know, there would be direct communications, you know, from the FBA, which, you know, it's rather said before we were coming on.

Rusty Schundler: The other thing I had to point out is, I mean, even the United Therapeutics have to file an amended citizens petition to cure some of the statements on the original citizens petition. That is public, but, but again, we won't have a public response, or at least we're not anticipating one at this time. All right.

Roger: which, you know, as Roger said before, we won't comment on. The other thing I'd point out is, I mean, even United Therapeutics had to file an amended citizen's petition to cure some of the misstatements on the original citizen's petition. That is public, but again, we won't have a public response, or at least we're not anticipating one at this time.

Operator: Thank you.

Operator: Thank you, Jason. Thank you.

Roger Jeffs: And this is the close of today's Q&A session. I want to like to turn it back over to Roger for closing remarks. Please go ahead. Right. Well, again, I want to thank everybody for joining us today. As you've clearly heard, we remain confident in the approved ability to be trepid in the near term for both P.H. and P.H.L.D. and the competitive profile once launched. We look forward to updating you in the near future.

Roger: Thank you. Thank you, Jason.

Operator: Thank you.

Operator: Thank you for joining today's conference call. You made this connect.

Unknown Speaker: for both PAH and PHLD and the competitive profile ones. Thank you for joining today's conference call. ?? ?? ?? ?? ?? ?? ?? Written and Directed by Hassan Khashoggi ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music, Financial Results and Corporate Update Conference. My name is Lisa, and I will be your conference operator, follow the presentation, we will conduct a questionnaire. I would now like to remind everyone this conference call is being recorded. I will now hand the call over to Jason Adair.

Roger: Please see the complete disclaimer at https://sites.google.com

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Jason Adair: Joining the call today are Chief Executive Officer, Dr. Roger Jeffs, Chief Operating Officer, and CFO, Michael Kaseta, Chief Medical Officer, Dr. Rajeev Saggar, Chief Commercial Officer, Scott Moomaw, and General Counsel, Rusty Schundler. 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, see

Lisa: My name is Lisa, and I will be your conference operator today. Currently, I'll participate in a listen-only mode.

Speaker Change: Currently, all participants are in a listen-only mode.

Jason Adair: I will now hand the call over to Jason Adair, Chief Business Officer. Please go ahead. Thank you, Lisa.

Speaker Change: I will now hand the call over to Jason Adair, Chief Business Officer. Please go ahead.

Jason Adair: It's my pleasure to welcome everyone to the Liquidia Corporation, 2nd 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 Kaseta. Chief Medical Officer, Dr. Rajeev Saggar; Chief Commercial Officer, Scott Moomaw; and General Counsel, Rusty Schundler.

Jason Adair: 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 achievement. 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 its call.

Jason Adair: For additional information, including a detailed discussion of our risk factors, please refer to the company's document file for the Securities and Exchange Commission, which can be accessed on our website.

Jason Adair: 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.

Roger Jeffs: 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 eutrepia NDA, so you can approval for both former... The AH, and former NIH hypertension associated with an interstitial lung disease, or PHID. We remain hopeful that we are close to achieving this. As a reminder, the FDA has said no legal impediments in sample first to take action on the amendment as submitted, so you can approval for both the AH and PM childhood.

Jason Adair: 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 to your questions. Roger

Speaker Change: 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?

Roger Jeffs: Thank you, Jason. Good morning, everyone. Thank you for joining us today. While we and patients still anxiously await FDA action on the utrepia NDA, seeking approval for both the former... What I can say today is that we have been in active and constructive communication with the FDA over these past four months. But we will not comment on the specifics of our conversations with you.

Roger Jeffs: What I can say today is that we have been in active and constructive communication with the FDA over these past four months, so 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, ready to launch Eutrepia immediately upon approval. Our sales team continues to call on keep PH accounts, strengthening relationships, and educating them on the podium. And importantly, we are staging commercial product for rapid distribution, especially the promises upon approval. Moving to our clinical programs, the open label of the sense that eutrepia NPHRD patients continues to ramp up, and the number of active clinical sites with parallel increases in patient screening and patient enrollment.

Roger: What I can say today is that we have been in active and constructive communication with the FDA over these past four months, but we will not comment on the specifics of our conversations with the FDA.

Roger Jeffs: 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 utrepia in PHIL-B patients continues to ramp up in the number of active clinical sites, with parallel increases in patient screening and patient enrollment.

Roger: To be crystal clear, our medical and commercial teams remain on high alert and ready to launch utrepia immediately upon approval.

Roger Jeffs: We are pleased with the preliminary feedback from physicians, suggesting that patients can readily titrate eutrepia to escalating therapeutic levels in these PHID patients. While the extent that it needs to mature more, our early patient experience today suggests that the benefits of print formula to tribusional, delivered via low effort inhaler, parallels a very good experience observed in PA. Page Patient. For example, the median dose to be trepid for patients currently enrolled beyond 8 weeks in the central is 185.5 micrograms per treatment session, or approximately 21 breath equivalence of tibesa per session, with a top dose of 318 micrograms or approximately 36 breath equivalence.

Roger Jeffs: We are pleased with the preliminary feedback from physicians suggesting that patients can readily titrate utrepia to escalating therapeutic levels in these PHLD patients delivered via a low effort inhaler. Parallel is a very good experience served in PAH. For example, the median dose of utrepia for patients currently enrolled beyond eight weeks in the assent trial is 185.5 micrograms per treatment session, or approximately 21 breadth equivalents of Type A supersession. These doses are several orders of magnitude beyond the recommended 9 to 12 breath dose targeted at Type A. We plan to submit additional clinical data from the Accenture Allah Future Medical Conferences, and more to come.

Roger: We are pleased with the preliminary feedback from physicians suggesting that patients can readily titrate utrepia to escalating therapeutic levels in these PHLD patients.

Roger: With a top dose of 318 micrograms, or approximately 36 breath equivalents.

Roger Jeffs: These doses are several orders of magnitude beyond the recommended 9-12 breath dose target of Tibesa. And exemplify the paradigm-shifting potential of the trepid for pH and pH ion D patients, especially as it relates to tolerability and potentially durability.

Roger: and exemplify the paradigm-shifting potential of utrepia for PH and PH-IoD patients.

Roger Jeffs: We plan to submit additional clinical data from the central and future medical conferences, and more to come on that. With respect to our sustained release, like the similar formulation of inhaler proximal, L606, the preliminary safety data and exploratory efficacy data from the first 28 patients switching from tibesa or tibesa DPI in our open label clinical study has been highly encouraging. We continue to observe favorable tolerability and titratability profile of twice daily dose in the VL606, L606, likely attributable to the seventh-fold lower CMAT, but with a similar systemic exposure over a 24-hour period compared with the four times a day dose. In the long-term safety data generated from this study, it has helped solicit favorable scientific advice from the European Medicine Agency or the EMA last month on our pivotal trial design, which was very consistent with the FDA feedback from our type C meeting in December.

Roger: Especially as it relates to tolerability and potentially durability.

Roger: With respect to our sustained release glycosamone formulation of inhaled droproxenil L606.

Roger: Attributable to the 7-fold lower Cmax, but with a similar systemic exposure over a 24-hour period compared with a 4-times-a-day dosing of inhaled traprosanol, all while using a rapid portable handheld breath-actuated nebulizer.

Roger Jeffs: While we continue to observe these patients in the open land of study, our focus will now shift to our efforts to initiate the registration, registration on global trial and patients with the IOT later this year.

Michael Kaseta: At this time, I will turn the call over to Mike to summarize the second quarter financial results. Thank you, Roger, and good morning, everyone. I will briefly address our second quarter financial results found in today's press release. As you will see, revenue was $3.7 million for the second quarter of 2024 compared with $4.8 million in the same quarter of 2023. Revenue is tied to our promotion agreement with Sanders to commercialize to a profitable injection. The decreases primarily due to lower sales quantities in the current year as compared to the same period in the prior year.

Roger: Thank you, Roger, and good morning, everyone. I will briefly address our second quarter financial results found in today's press release.

Michael Kaseta: As you will see, revenue was $3.7 million for the second quarter of 2024, compared with $4.8 million in the same quarter of 2023. Revenue is tied to our promotion agreement with Sandoz to commercialize toprofenol injection.

Roger: As you will see, revenue was $3.7 million for the second quarter of 2024.

Roger: Revenue is tied to our promotion agreement with Sandoz to commercialize troparacanol injection.

Michael Kaseta: The decrease is primarily due to lower sales quantities in the current year as compared to the same period in the prior year. Cost of revenue increased to $1.5 million for the second quarter of 2024 compared to $0.7 million in the same quarter of 2023, with the increase being primarily due to our Salesforce expansion during the fourth quarter of 2020. Research and development expenses were $9.4 million in the second quarter of 2024, compared with $17.7 million in 2Q2023, which included a $10 million upfront license fee to Pharmosa for the exclusive license to L606 in North America.

Speaker Change: The decrease is primarily due to lower sales quantities in the current year as compared to the same period in the prior year.

Michael Kaseta: Cost of revenue increased to $1.5 million for the second quarter of 2024 compared to $0.7 million in the same quarter for 2023, with the increase being primarily due to our sales force expansion during the fourth quarter of 2023. Research and development expenses were $9.4 million in the second quarter of 2024 compared with $17.7 million in 2Q 2023, which included a $10 million upfront license fee to farm most of for the exclusive license to L606 in North America. We saw a $1.4 million decrease in expenses related to our Uterpia program driven by expensive pre-launch inventory costs in the prior year.

Speaker Change: Cost of revenue increased to 1.5 million dollars for the second quarter 2024 compared to 0.7 million dollars in the same quarter for 2023, with the increase being primarily due to our Salesforce expansion during the fourth quarter 2023.

Michael Kaseta: We saw a $1.4 million decrease in expenses related to our UTREPIA program, driven by expensing pre-launch inventory costs in the prior year. We ended the second quarter of 2024 with $133 million cash on hand and remain well positioned financially to achieve our corporate objectives this year. With that, I'd like to now turn the call back over to Roger.

Speaker Change: We saw a $1.4 million decrease in expenses related to our UTREPIA program, driven by expensing pre-launch inventory costs in the prior year.

Michael Kaseta: These decreases were offset by a $1.7 million increase in clinical expenses related to our L606 program and a $1.5 million increase in personal expenses related to it. and Increase Headcount. General administrative expenses were $20 million in the second quarter of 2024, compared to $9.2 million in the same quarter for 2023. The increase of $10.8 million is primarily due to a $6.3 million increase in personal expenses, which includes stock-based compensation. A $2.2 million increase in commercial and consulting expenses, and a $0.9 million increase in legal fees related to our ongoing Uterpia-related litigation. In summary, we incurred a net loss for the three months ended June 30th, 2024, of $27.9 million or $37 per basic and diluted share, compared to a net loss of $23.5 million or $36 per basic and diluted share for the three months ended March 31st, 2023.

Speaker Change: These decreases were offset by a $1.7 million increase in clinical expenses related to our L606 program and a $1.5 million increase in personnel expenses related to increased headcount.

Speaker Change: General and administrative expenses were $20 million in the second quarter of 2024 compared to $9.2 million in the same quarter for 2023. The increase of $10.8 million is primarily due to a $6.3 million increase in personnel expenses, which includes stock-based compensation.

Speaker Change: A $2.2 million increase in commercial and consulting expenses, and a $0.9 million increase in legal fees related to our ongoing utrepia-related litigation.

Michael Kaseta: We ended the second quarter, 2024, with $133 million cash on hand and remained well-positioned financially to achieve our corporate objectives this year.

Speaker Change: We ended the second quarter of 2024 with $133 million cash on hand and remain well positioned financially to achieve our corporate objectives this year.

Roger Jeffs: With that, I'd like to now turn the call back over to Roger. Thank you, Mike. As you've just heard, it's been an active summer on several fronts since our last call. We were fully prepared for the potential entrepreneur uterpia with a team of dedicated professionals who were poised to reshape and grow the market for an uterproprocino on uterpia's approval. The market opportunity for an uterproprocino is currently at $1.5 billion rent rate, with the potential to grow an excess of three billion in the coming years. This market remains keen for a competitive alternative, especially one with a dosing and tolerability advantages Uterpia can potentially provide once approved.

Roger Jeffs: Thank you, Mike. As you just heard, it's been an active summer on several fronts since our last call.

Speaker Change: With that, I'd like to now turn the call back over to Roger.

Roger Jeffs: We were fully prepared for the potential launch of uTREPiO with a team of dedicated professionals who are poised to reshape and grow the market for inhaler prostones on uTREPiO's approval. The market opportunity for inhaler prostones is currently at a 1.5 billion dollar run rate, with the potential to grow in excess of three billion in the coming years. This market remains keen for a competitive alternative, especially one with the dosing and tolerability advantages Utrepia can potentially provide once approved. With that said, I would now like to open the call to questions. Operator, first question please.

Roger: We were fully prepared for the potential launch of Utrepia with a team of dedicated professionals who are poised to reshape and grow the market for Neotroposinol on Utrepia's approval.

Roger: This market remains keen for a competitive alternative.

Speaker Change: Especially one with the dosing and tolerability advantages that uTREPIA can potentially provide once approved. With that, I would now like to open the call to questions. Operator, first question please. Thank you. If you would like to ask a question, please press star 11 on your telephone.

Lisa: Thank you. If you would like to ask a question, please press star 1-1 on your telephone. One minute while we prepare for the questions. And our first question today comes from Julian Harrison of BTIG. Your line is open. Hi, good morning. Thank you.

Operator: With that, I would now like to open the call to question. Operator, first question, please. Thank you. If you would like to ask a question, please press star 11 on your telephone. You'll then hear the automated message such advise that your hand is raised. We also ask that you wait for your name and company to be announced before proceeding with your question.

Operator: One minute while we prepare for the questions, and our first question today comes from Julian Harrison of BTIG. Your line is open. Hi. Good morning. Thank you for taking my questions, and congrats on the recent progress. I'm wondering if we could briefly review why higher and hiltroposinal exposure should be beneficial both in pH and PHILD. Hi, Julian. Thanks very much for the question. So I'll start, and then I'll ask for you to add some additional color. So what we know historically from the use of process cyclones is that, in one of the beauties of process cyclones in particular, is the ability to continually titrate to affect over time because, unfortunately, these patients have an advancing disease that continues without relent.

Speaker Change: One minute while we prepare for the questions. And our first question today comes from Julian Harrison of BTIG. Your line is open.

Unknown Speaker: So what we know historically from the use of prostacyclines, and one of the beauties of prostacyclines in particular, is the ability to continually titrate to effect over time because, unfortunately, these patients have an advancing disease that continues without relent, goes to effect, also while minimizing.

Speaker Change: So what we know historically from the use of prostacyclines that and one of the beauties of prostacyclines in particular is the ability to continually titrate

Speaker Change: to affect over time.

Speaker Change: Unfortunately, these patients have an advancing disease that continues without relent.

Julian Harrison: So the only way, the only therapeutic class that can address this progressive disease and remain a sort of an ability to tweak our process cyclones. So if you look at troprosinal and various forms for entral, oral, inhaled, you can see that the ability to titrate is a hallmark of the therapy. But what has been limiting prior to trippy in particular, as you see with Taipei, is the inability to try to treat above. Alba, Barely Loved, Ariputic Seal. So what we trepid have done, and this is why I say it's paradigm shifting, it's giving you all the benefits of the parental and oral products, but giving it directly to the side of action to limit the systemic side of that.

Speaker Change: So the only way, the only therapeutic class that can address this progressive disease and remain a

Speaker Change: fairly low therapeutic ceiling.

Roger Jeffs: So you now have a highly flexible, therapeutic with high utility that can really be, goes to effect, also all minimizing the side of that. So I think in the this is why we're so excited about eutrophia, we think it brings a different sort of utility to the marketplace in terms of the troposnell use. And we think this therapeutic profile, we lead it to become both best in class and first in choice when considering starting a process like on the parental, oral, or inhaled. Regime, I don't know if you have any additional comments. Yeah, Julie, India, I think Roger answered most of it quickly.

Speaker Change: Rajeev, I don't know if you have any additional comments.

Rajeev Saggar: I would just sort of add is that, you know, we learned a lot from the increased study in Ph.L.D. I think in that study, the data highlighted that patients that achieve more than at least nine breaths, and especially as you get to higher doses, those patients. The clinical observations was that they walked further, and they had also improvements in many of the secondary outcomes. Also, I think, you know, this is a very heterogeneous group of patients both in Ph.L.D. with various degrees of severity. And in many of these patients, the disease is, Roger highlighted, it's progressive.

Julian Harrison: Thank you for the question. Great. And one more, if I may. I was just curious if you have a good sense for when we might expect a comprehensive data disclosure from the Ascent trial. And can we maybe review, you know, what the key unanswered questions are that you plan to address with that trial? Yeah, maybe Regime, if you could comment on that. Yeah, Julian. So, you know, again, just to remind everyone, you know, Ascent is a study studying the safety and controllability, and the secondary outcomes would be exploratory efficacy of uterpia and patients with Ph.L.D.

Unknown Speaker: Okay, thank you for the question.

Speaker Change: Thank you for the questions.

Unknown Speaker: Yeah, maybe Rajeev, if you could comment on that.

Speaker Change: Julian, so you know again just to remind everyone you know a cent is a is a

Rajeev Saggar: The study studying safety and tolerability and the secondary outcomes would be exploratory efficacy of utrepia in patients with PHLD who have not been treated. The patients have to enroll with baseline right heart catheterization.

Rajeev Saggar: who have not been treated. That patients have to enroll with the baseline right heart catheterization. The study is actually for 24 months. And then we follow the patient out to one year. So, what is very important here in the study is that what we're looking for is to maintain the patients on the optimal dose of Uterpia and also to show durability. Because what we do know is that after 16 weeks and increased study, many of these patients start to have a significant amount of instability. So, we wanted to show patients definitely have durability. Our focus really coming out, you know, in the next set of congresses that are approaching here is really to highlight some of this exploratory clinical efficacy data.

Speaker Change: Phl.D. who have not been treated.

Rajeev Saggar: The study is actually for 24 months, and then we follow the patient out to one year. So, what is very important here in this study is that what we're looking for is to maintain the patients on the optimal dose of utrepia and also to show durability, because what we do know is that after 16 weeks of increased study, many of these patients start to have a significant amount of instability. So we wanted to show patients definitely have durability.

Rajeev Saggar: Our focus really coming out, you know, the next set of Congresses that are approaching here is really to highlight some of this exploratory clinical efficacy data. We are following clinical variables such as, you know, walk distance in terms of a six minute walk. We're also looking at various forms of questionnaires.

Speaker Change: Our focus really coming out, you know, the next set of Congresses that are approaching here is really to highlight some of this exploratory

Rajeev Saggar: We are following clinical variables such as, you know, walk distance in terms of six-minute walk. We're also looking at various forms of questionnaires. And finally, we're also looking at effects on the lung parenchyma and the lung vascular chair by using CT chest imaging, really to highlight, really where the effect is particular, particularly on the pulmonary vascular chair with the use of uterpia. I just want to highlight, as Roger said, is that at least right now the median dose for those patients now past the eight-week mark is now 185.5 micrograms of uterpia. This is just to highlight that if you compare this to our Sentinel Inspire Study in PAH, by two years, patients were on about a third of the patients were on 159 mites.

Speaker Change: And finally, we're also looking at effects on the lung parenchyma and the lung vasculature by using...

Rajeev Saggar: of Rams. So what we're seeing here is that providers and patients in particular are able to tolerate uterpia, and there's also, just to go back to our last question, a very clear understanding by providers that dose, the higher the dose, the potential, the benefit of the patient, and I think we look forward to highlighting some of these clinical parameters in the very near future. Thanks, Rajeev. So Juleen, as you can hear, very robust study.

Rajeev Saggar: So what we're seeing here is that providers and patients, in particular, are able to tolerate utrepia, and there's also, just to go back to our last question, a very clear understanding by providers that the higher the dose, the potential benefit of the patient, and I think we look forward to highlighting some of these clinical parameters in the very near future.

Speaker Change: The higher the dose, the potential, the benefit of the patient, and I think we look forward to highlighting some of these clinical parameters in the very near future.

Unknown Speaker: Thanks, Rajeev. So, Julian, as you can hear, a very robust study. We're trying to complete it by year-end to specifically answer your question, and then we'll look to publish that in 2025.

Rajeev Saggar: We're trying to complete it by year end, specifically into your question, and then we'll look to publish that in '25. Excellent. Thank you; you got welcome. Thank you. One moment for the next question.

Rajiv: Thanks, Rajeev. So, Julian, as you can hear, a very robust study. We're trying to complete it by year-end to specifically answer your question, and then we'll look to publish that in 2025.

Unknown Speaker: Excellent. Thank you again. Thank you.

Lisa: Thank you. One moment for the next question, and our next question will be coming from Serge Belanger of Needham. Your line is open.

Serge Belanger: And our next question was becoming from Serge Belanger of Needham. Your line is open. Good morning. Thanks for the question. I had a couple legal ones. First one on the UPC case against FDA, I believe in emotion for dismissal, both the agency and Liquidia, completely debris. So just curious if you have any visibility on timelines for the next steps here, whether we'll get a hearing or a judge-based rule on the brief, and related to this case, how closely is FDA following this dismissal emotion, and could that be a getting factor for them rendering a decision on the utopia and VA?

Speaker Change: And our next question will be coming from Serge Belanger of Needham. Your line is open.

Serge Belanger: Hey, good morning. Thanks for taking my question. I have a couple legal ones.

Serge Belanger: First one on the UT case against FDA. I believe in the motion for dismissal, both the agency and Liquidia completed their briefs. So just curious if you have any visibility on timelines for the next steps here, whether we'll get a hearing or Judge Bates will rule on the brief, and related to this case. And how closely is the FDA following this missile motion? Could that be a gating factor for them rendering a decision? Unknown Speaker, Unknown Speaker, Unknown Speaker, Great, Serge. Thanks for the question.

Speaker Change: The UT case against FDA.

Speaker Change: completed their briefs to

Serge Belanger: I'm just curious if you have any visibility on timelines for the next steps here, whether we'll get a hearing or Judge Bates will rule on the brief. And related to this case.

Speaker Change: How closely is the FDA following this missile motion and could that be a gating factor for them rendering a decision?

Rusty Schundler: Thanks. Thanks for the question. Resty. Yes, sir. Thanks for the question. So on the, take your first question first. On the motion to dismiss, next steps, we don't know yet; the court could have an oral argument or could rule on the briefs. We don't have an indication either way yet from the court, so really can't provide any guidance there just because we're waiting for the court to decide on that. On the second point, obviously it's tough for us to comment on what's in the FDA's head. And I think, as Roger said in this opening remarks, I think we want to be careful not to comment on our communications with the FDA.

Unknown Speaker: Thanks for the question. Rest. Yes, sir.

Rusty: Great, Serge. Thanks for the question. Rusty?

Russell Schundler: Taking your first question first, on the motion to dismiss Next Steps, you know, we don't know yet. The court could hear an oral argument, or it could rule on the briefs.

Speaker Change: Thanks for the question. So on the.

Rusty Schundler: So obviously, once the FDA is taken definitive action, obviously we will announce that. But in the meantime, we're not going to comment on our communications with the FDA. Thank you for the question, Serge.

Russell Schundler: You know, we don't have an indication either way yet from the court. So, you know, really can't, can't provide any guidance there just because we're waiting for the court to decide on that. On the second point, you know, obviously it's tough for us to comment on what's in the FDA's head. And, I think, as Roger said in his opening remarks, I think we want to be careful not to comment on our communications with the FDA. So, you know, obviously, once the FDA has taken definitive action, we will obviously announce that. But in the meantime, you know, we're not going to comment on our communications with the FDA.

Kambiz Yazdi: Thank you, and one more for the next question. Our next question will be coming from Cabiz, Yaza of Jeffries, Yelena. It's open. Morning, team. For the registrational study for L606, can you remind us the key features for that study design and one of that's plated to start? And then maybe just a few finer points on the STEM study. How many more sites have you onboarded since the last update, and how many patients so far have you treated in the STEM study? Thank you. Carter. Yeah, hi, Kambiz. So, you know, regarding the global single placebo control, efficacy study with L-606, specifically in patients with pomegranate tension associated with interstitial lung disease, we plan to initiate that study by the end of the year.

Unknown Speaker: Thank you for the question, Serge.

Lisa: Thank you. And one moment for the next question. Our next question will be coming from... Kabez. Yazda of Jeffrey's, your line is open.

Kambiz Yazdi: Morning team, for the registrational study for L606, can you remind us the key features of that study design and when is that slated to start? And then maybe just a few finer points on the stent study. How many more sites have you onboarded since the last update? And how many patients so far have you treated in the center? Thank you.

Speaker Change: Morning, team. For the registrational study for L606, can you remind us the key features

Unknown Speaker: Questions. Rajeev, both of those are in your court.

Rajeev Saggar: Yeah, hi Kambiz. So, you know, regarding the global... I think we're working feverishly to, you know, do all the necessary steps to make sure that our protocols are properly submitted and viewed by agencies, as Roger highlighted. You know, we've had favorable feedback from both the Type C meeting with FDA and also from the scientific advice from the European Medicines Agency. So I think we remain pretty confident in our plans.

Speaker Change: Yeah, hi, Kambiz. So, you know, regarding the global...

Rajeev Saggar: I think we're working feverishly to, you know, do all the necessary steps to make sure that our protocols are properly submitted and viewed by agencies. As Roger highlighted, you know, we've had favorable feedback from both the type of meeting with the FDA and also from the scientific advice from the European Medicines Agency. So, I think we remain pretty confident in our plans. We've already highlighted the primary end point in the study is going to be six minute walk distance, with a whole host of secondary efficacy end points that I think would be important to support our target profile.

Speaker Change: from the European Medicines Agency. So, I think we remain pretty confident in our plans. We've already highlighted the primary endpoint in this study is going to be six minute walk distance with a whole host of secondary efficacy endpoints that I think would be important.

Rajeev Saggar: We've already highlighted the primary endpoint in this study is going to be the six-minute walk distance, with a whole host of secondary efficacy endpoints that I think would be important to support our target profile. I think we're extremely confident based on the safety data that's emerging from the Open Label Study in the United States, again, just highlighting the liposomal Technology on top of the triprocinol, which I think really has Koff, and really support dosing and titratability of this drug, which is going to be a game changer, along with a reduced frequency to twice a day.

Rajeev Saggar: I think we were extremely confident based on the safety data that's emerging from the open level study in the United States. Again, just highlighting the liposomal technology on top of the three proximal. I think Rally has shown to minimize cough and really support dosing anti-treatability of the drug, I think, which is going to be a game changer, along with a reduced frequency to twice a day. So, we're very, very excited about the feedback that KOLs throughout the global market has been showing for support of the study. This is an extremely significant amount of unmet need.

Speaker Change: to support our target profile. I think we're extremely confident based on the safety data that's emerging from the Open Label Study in the United States. Again, just highlighting the liposomal.

Rajeev Saggar: So we remain very, very excited about the feedback that KOLs throughout the global market have been showing for support of the study. There's an extremely significant amount of unmet need, I think, definitely outside the US in addition to the US in that regard. In terms of ascent, we're close to tripling the number of sites by the end of this month, and we remain quite confident of completing the study by the end of the year.

Speaker Change: So we remain very very excited about about the feedback that KOLs

Speaker Change: Throughout the global market has been showing for for support of the study

Rajeev Saggar: I think definitely outside the U.S. in addition to the U.S. in that regard. In terms of a scent, we have, we're close to about tripling the number of sites by the end of this month, and we remain quite confident on completing the study by the end of the year. We anticipate to have close to about 15 patients by the end of this month, just to highlight that the majority of the sites that have been just recently initiated have come on over the past 45 days. And we anticipate the remainder of sites to come on within the next 30 to 60 days as well.

Speaker Change: There's an extremely significant amount of unmet need, I think, definitely outside the U.S., in addition to the U.S. in that regard.

Speaker Change: In terms of ascent, we're close to about tripling the number of sites by the end of this month. And we remain quite confident on...

Speaker Change: completing the study by the end of the year. We anticipate to have close to about 15 patients by the end of the year.

Rajeev Saggar: We anticipate to have close to about 15 patients by the end of this month. Just to highlight that the majority of the sites that have just recently initiated have come on over the past 45 days, and we anticipate the remainder of sites to come on within the next 30 to 60 days as well. Then, by that time, I think we'll be on full ramp to support the rest of the sites.

Speaker Change: by the end of this month. Just to highlight that the majority of the sites that have been...

Speaker Change: Just recently initiated, have come on over the past 45 days, and we anticipate the remainder of sites to come on within the next 30 to 60 days as well. Then by that time, I think we'll be on full ramp to support the rest of the study.

Rajeev Saggar: Then, by that time, I think we'll have, we'll be on full ramp to support the rest of the study.

Rajeev Saggar: Right. Thank you, Rishi. Thanks for your questions, Combs. As you can see, really positive data flow from both the L606 open label study and the scent trial. We're obviously very excited to get into the registration of study with L606 and PHL. The patients, as Rishi said, and I think the fact now that we're seeing the ability to titrate as easily as we are and as quickly as we are, as well as to see the durability of the two times a day format. That's an exciting phase for reprogram with a very positive, predictive future. Same for the scent trial, I think, when you see this rapid ability to dose these patients, quite differentiating, and I think, you know, something that the market will lean on once we get to market.

Unknown Speaker: Great. Thank you. Thank you, Rajeev. Thanks for your questions, Kambiz.

Speaker Change: Great. Thank you, Rajeev. Thanks for your questions, Kambiz. As you can see,

Speaker Change: really positive data flow from both the L606 open label study and the assent trial. We're obviously very excited to get into the registrational study with L606 and PHI-LD patients as Rajeev said, and I think the fact now that we're seeing the ability to titrate

Roger Jeffs: As you can see, really positive data flow from both the L6-O6 open label study and the assent trial. You know, we're obviously very excited to get into the registrational study with L6-O6 and PHI-LD patients, as Rajeev said, and I think the fact now that we're seeing the ability to titrate As easily as we are and as quickly as we are, as well as to see the durability of the two times a day format, you know, that's, that's an exciting phase three program with a very, Positive Predictive Future.

Speaker Change: As easily as we are and as quickly as we are, as well as to see the durability of a two-times-a-day format, you know, that's an exciting phase three program with a very

Roger Jeffs: Same for the offense trial, I think when you see this rapid ability to treat these patients, it's quite differentiating, and I think, you know, something that the market will lean on once we get to market. So thanks for the question, Kambiz. Next question, please.

Speaker Change: positive predictive future. Same for the event trial. I think when you see these this rapid ability to to those these patients quite differentiating and I think you know something that that the market will lean on once we get to market.

Rajeev Saggar: So thanks for the question. and Kambiz.

Operator: Thanks, questions, please. Thank you. And one moment for the next question.

Lisa: and one moment for the next question. Our next question will be coming from the line of Matt Kaplan of Leidenberg.

Operator: Our next question will be coming from the line of Matt Kaplan of Layton Berg, Falman. Your line is open. Hi, good morning, guys. Thanks for taking the question. I guess, you know, since we're past the legal impediments for FDA approval, I guess, with your interaction with the FDA, has the FDA identified any material differences, which would prevent approval, and would, I guess, necessitate the CRL? Hey, Matt, Roger, thanks for the question. You know, as I said in the interview, we're really not going to comment on specific discussions with the FDA. I think one way to look at this is, yes, we are past the time when there was no legal impediment for approval, being April 1st, four months past that, and while that's frustrating, I think in, if you want to put a positive spin on that, it's four months is in the rearview mirror, so there's been four months to work to a solution.

Matthew Kaplan: Hi, good morning, guys. Thanks for taking the question. Um, I guess, since we're past the kind of legal impediments for FDA approval, I guess, with your interaction with the FDA, has the FDA identified any material differences which would prevent approval, and would, I guess, necessitate a CRL? Amen. Roger.

Speaker Change: Bowman, your line is open.

Bowman: Hi, good morning, guys. Thanks for taking the question. Um, I guess, you know, since we're past the

Bowman: kind of legal impediments for FDA approval. I guess with your interaction with the FDA, has the FDA identified any material differences which would prevent approval and would, I guess, necessitate a CRL?

Roger Jeffs: Hey Matt, it's Roger. Thanks for the question. So, you know, as I said in the introduction, we're really not going to comment on specific discussions with the FDA. I think one way to look at this is, yes, we are past the time when there was no legal impediment for approval, that being April 1st, four months past that, and while that's frustrating, I think if you want to put a positive spin on that, it's four months are in the rear view mirror, so there's been four months to work out a solution.

Roger: Hey Matt, it's Roger. Thanks for the question. So, you know, as I said in the intro, we're really not going to comment on specific discussions with the FDA.

Speaker Change: I think one way to look at this is, yes, we are past the time when there was no legal impediment for approval, that being April 1st.

Speaker Change: Four months past that, and while that's frustrating, I think if you want to put a positive spin on that, it's four months is in the rearview mirror, so there's been four months to work to a solution. So we think we're that much closer to a decision and an action, and we won't come in on.

Roger Jeffs: So, we think we're that much closer to a decision and an action, and we won't come on direct communications with that, but we remain optimistic that we've had constructive discussions with the agency, and we remain highly focused on approval for both indications. So, as we submitted it, we feel it was appropriate as amended, and we are seeking approval for both PAH and PHRD. We haven't backed away from that position, and that remains our focus. So, apologies that I can't get specific, but if we will have an action soon, we can talk about that in great detail with you.

Roger Jeffs: So we think we're that much closer to a decision and action, and we won't come in on direct communications with that, but we remain optimistic that we've had constructive discussions with the agency, and we remain highly focused on approval for both indications. So that's how we submitted it, we feel it was appropriate as amended, and we are seeking approval for both PAH and PHILD. We haven't backed away from that position, and that remains our focus. So apologies that I can't get specifics, but hopefully we'll have an action soon and we can talk about that in great detail with you. Operator.

Bowman: director of communications for that but we remain optimistic that we've had constructive discussions with the agency. Thank you.

Bowman: And we remain highly focused on approval for both indications. So as we submitted it, we feel it was appropriate as amended, and we are seeking approval for both PAH and PHILD. We haven't backed away from that position, and that remains our focus.

Speaker Change: So apologies that I can't get specifics, but we will have an action soon and we can talk about that in great detail with you.

Operator: Operator, next question. Yeah, no. Thank you, and moment for the next question.

Speaker Change: Operator, next question.

Speaker Change: Thank you. And one moment for the next question.

Operator: Our next question will be coming from the line of Jason. Go very, think of America; your line is okay. Hey guys, good morning. Thanks for taking my questions. To for me, just on the cash burn language in the 10-Q about roughly, you know, around a year of cash runway, I assume that that assumes an approval and launch cost. Can you talk about, you know, in the alternative scenario if there are delays, any flexibility to preserve the cash runway, any flexibility or levers that you could pull? And then my second question is just on United Citizens petition.

Lisa: and one moment for the next. Our next question will be coming from the line of Jason Gerberry of Bank of America. Your line is open.

Speaker Change: Our next question will be coming from the line of Jason Gerberry of Bank of America. Your line is open.

Jason Gerberry: Hey guys, good morning. Thanks for taking my questions. So two for me, just on the cash burn language in the 10-Q about roughly around a year of cash runway. I assume that that assumes approval and launch costs. Can you talk about, you know, in the alternative scenario, if there are delays, any flexibility to preserve the cash runway, any flexibility or levers that you could pull? And then my second question is just about the United Citizens petition.

Jason Gerberry: Hey guys, good morning. Thanks for taking my questions.

Jason Gerberry: So, two for me, just on the cash burn language in the 10-Q, about roughly, you know, around a year of cash runway.

Speaker Change: I assume that that assumes an approval and launch cost.

Speaker Change: Can you talk about, you know, in the alternative scenario, if there are delays?

Speaker Change: Any flexibility to preserve the cache runway, any flexibility or levers that you could pull.

Jason Gerberry: Is there any plan to submit any correspondence clarifying LGM's role as an importer? Or I assume that most of this is going to be handled behind the scenes, if at all. But just curious if there's any plans to submit any response. Thanks. Yeah, great, thanks.

Michael Kaseta: Is there any plans to submit any correspondence clarifying LGM's role as an importer? Or I assume that most of this is going to handle behind the scenes, if at all, but just curious if there's any plans to submit any response. Thanks. Yeah, great. Thanks, Jason. So, Mike, if you'll address the cash burn question and roughly if you could talk to the citizen, citizen's petition, please. Yeah, so Jason, thanks for the, thanks for the question. I mean, I think where we sit now, we are sitting at $133 million of cash. We're very confident in our cash position.

Speaker Change: And then my second question is just.

Speaker Change: on United Citizens petition. Is there any plans to submit any correspondence clarifying LGM's role as an importer? I assume that most of this is going to handle behind the scenes, if at all, but just curious if there's any plans to submit any response. Thanks.

Unknown Speaker: Yeah, great. Thanks, Jason. So, Michael, if you'd address the cash burn question and, roughly, if you could talk about the citizen's petition.

Speaker Change: Yeah, great. Thanks, Jason. So, Michael, if you'll address the cash burn question, and the rest of you could talk to the citizen's petition, please.

Michael Kaseta: Yeah, so Jason, thanks for the thanks for the question. I mean, I think where we sit now, we are sitting at $133 million in cash. We're very confident in our cash position. You know, we talked about all of our objectives for the rest of this year and going forward with Ascent with getting L606 initiated and also supporting the launch of Utrepia. We've always taken pride in having a strong balance sheet; we feel that we still have that.

Michael: Yeah, so Jason, thanks for the question. I mean, I think where we sit now, we are sitting at $133 million of cash. We're very confident in our cash position. You know, we talked about all of our objectives for the rest of this year and going forward with Ascent, with getting L6.06 initiated.

Michael Kaseta: You know, we talked about all of our objectives for the rest of this year and going forward with a cent without getting L66 initiated and also supporting a launch of Yatrepia. You know, we've always taken pride of having a strong balance sheet. We feel that we still have that. And, you know, we're very confident in our ability to deliver. Now, with that being said, you know, we'll always focus on what's at hand. And, you know, depending on where things stand, we can make decisions. We will be able to do that. But our focus right now really is to deliver on all three of those objectives of getting Yatrepia launched, getting L66 Pivill trial initiated, and continuing the essential trial.

Speaker Change: and also supporting a launch of Utrapia.

Michael: We've always taken pride of having a strong balance sheet. We feel that we still have that, and we're very confident in our ability to deliver. Now with that being said...

Michael Kaseta: And, you know, we're very confident in our ability to deliver. Now, with that being said, we'll always focus on what's at hand. And, you know, depending on where things stand, we will be able to make decisions; we will be able to do that. But our focus right now really is to deliver on all three of those objectives of getting Utrepia launched, getting the L606 pivotal trial initiated, and continuing the Ascent trial.

Speaker Change: We'll always focus on what's at hand, and depending on where things stand, we can make decisions. We will be able to do that, but our focus right now really is to deliver on all three of those objectives of getting Utrepia launched.

Rusty Schundler: So, you know, when you look at our cash balance, I think our burn from, you know, year-end to Q1 to Q2, you know, we've always been disciplined in how we invest. We will continue to do that and look forward to hopefully Yatrepia launch here in the nuts. Anderson Future. Jason, thanks for the question on the citizens' petition. You know, we do not currently anticipate filing a public response to the citizens' petition. Obviously, you know, any issues that, you know, there would be direct communications, you know, from the FDA, which, you know, as Roger said before, we won't comment on.

Michael Kaseta: So, you know, when you look at our cash balance, I think our burn rate from, you know, year end to Q1 to Q2, you know, we've always been disciplined in how we invest, and we will continue to do that and look forward to, hopefully, a Utrepia launch here in the not too distant future.

Russell Schundler: And Jason, thanks for the question on the citizen's petition. You know, we do not currently anticipate filing a public response to the citizen's petition. Obviously, you know, any issues that, you know, there would be direct communications between us and the FDA, which, you know, as Roger said before, we won't comment on. The other thing I'd point out is that, I mean, even United Therapeutics had to file an amended citizen's petition to cure some of the misstatements in the original citizen's petition. That will be public, but again, we won't have a public response, or at least we're not anticipating one at this time.

Michael: And Jason, thanks for the question on the citizen's petition. You know, we do not currently anticipate filing a public response to the citizen's petition. Obviously, you know, any issues that, you know, there would be direct communications between us and the FDA.

Rusty Schundler: The other thing I'd point out is, I mean, even the United Therapeutics have to file an amended citizens petition to cure some of the statements on the original citizens petition. That is public, but, but again, we won't have a public response, or at least we're not anticipating one at this time. All right, thank you. Thank you, Jason. Thank you.

Speaker Change: Which, as Roger said before, we won't comment on. The other thing I'd point out is, even United Therapeutics had to file an amended citizen's petition to cure some of the misstatements on the original citizen's petition. That is public, but again, we won't have a public response, or at least we're not anticipating one at this time.

Unknown Speaker: Thank you.

Roger Jeffs: And the fiscal close today is Q&A session.

Operator: I want to like to turn it back over to Roger for closing remarks. Please go ahead. Right. Well, again, I want to thank everybody for joining today. As you clearly heard, we remain confident in the approved ability to be treppy in the near term for both the age and the competitive profile once launched. We look forward to updating you in the near future. Thank you. Thank you for joining today's conference.

Q2 2024 Liquidia Corp Earnings Call

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