Good morning, ladies and gentlemen. My name is Delem, and I'll be your conference operator today. I would like to welcome everyone to the Liquidia conference call to discuss a regulatory update for LIQ861. At this time, 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. If anyone has any difficulties hearing the conference, please press star zero for operator assistance at any time. I would like to remind everyone that this conference is being recorded. I will now hand the conference over to Jason Adair, Vice President, Corporate Development and Strategy.
Thank you, and good morning, everyone. Welcome to Liquidia's conference call to discuss the regulatory update for LIQ861. Before we begin, let me remind you that today's call will include forward-looking statements pursuant to the Private Securities Litigation Reform Act of 1995 relating to, among other things, our expectations concerning next steps in the regulatory review and approval of LIQ861. Such statements represent management's judgment as of today and may involve significant risks and uncertainties that could cause actual results to differ materially from expected results. Please refer to our press release this morning and recent quarterly and annual filings with the SEC, which are available at sec.gov or from Liquidia's website at liquidia.com for information concerning risk factors that could cause such differences and otherwise affect the company. I'd now like to turn the call over to Neal Fowler , CEO of Liquidia.
Thanks, Jason. Thank you all for joining us this morning. On the call with me today is also Dr. Tushar Shah, Chief Medical Officer and Head of R&D, as well as other senior members of our company who are available to answer questions if needed. This morning, we announced that the FDA has issued a complete response letter related to the NDA for LIQ861 for the treatment of pulmonary arterial hypertension, or PAH. Consistent with the press release, the items that led to the CRL were related to the need for additional information and clarification of chemistry, manufacturing, and controls, or CMC data pertaining to the drug product and device biocompatibility, as well as a delay in the pre-approval inspections related to COVID-19.
Liquidia is confident in our ability to address the items raised in the CRL, and we do not believe they present a barrier to the ultimate approval of LIQ861. The FDA also reconfirmed the need to conduct on-site pre-approval inspections of two Liquidia manufacturing facilities located in the U.S. We do believe that some of the items raised in the CRL may have been addressed in the normal course of a pre-approval inspection. However, as previously disclosed, and has been the case for other companies in our industry, COVID-19 related travel restrictions have hindered the FDA's ability to conduct these inspections to date. It is important to highlight that the CRL did not cite the need for additional studies in areas related to toxicology or clinical pharmacology, nor did the FDA request additional clinical studies to further support the approval of the LIQ861 application.
As we recently shared during the third quarter earnings call, we are anticipating a launch in the second half of 2022. We remain confident in that timeline, as we do not believe that items in the CRL will change that projection. We remain fully committed to working closely with the FDA, and I am confident in our team's ability to provide them with the information required to support the approval of LIQ861. We continue to be excited about the opportunity in LIQ861. This excitement is supported by the strong set of clinical data that we have released over the last 18 months with now more than 70 patients who have received LIQ861 for more than two years and by their choosing. We will stay true to our course and firm in our commitment to advance LIQ861 to these patients. Now, operator, we are prepared to take questions.
Thank you, sir. As a reminder, to ask a question, you will need to press star one on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. I show our first question comes from the line of Serge Belanger from Needham & Company. Please go ahead.
Hi, good morning. Thanks for taking my questions.
Sure, Serge.
First one, Neal, can you just talk about the next steps here? Is it meeting with the FDA? Just getting clarity, and if you can provide any clarity on the CRL issues related to the drug product and device biocompatibility?
Sure. We'll be glad to, Serge. I will for all of the folks, I'll probably defer at the beginning here in the questions to Tushar, and I'll let Tushar take that, and I'll add as appropriate. Tushar, you want to take these?
Thanks, Neal. Serge , the kinds of items that they're asking when we talk about drug product and device biocompatibility are these are the typical sections of a CMC portion of an NDA where you have a drug and a device combination product involved. As you know, we've been working with the FDA through the information request that they have been providing on these CMC matters. We have been addressing them. Obviously, there are a few items that we weren't able to address to their satisfaction at this point. The challenge we have is there's no opportunity for dialogue in these discussions, right?
We now know where the areas are that are still open, and we will request an FDA meeting as quickly as we can and make sure that we have full understanding and clarity of what they want and that the information we're providing is going to address their concerns. As I said, these are all CMC-related matters. The good news is there's no clinical concerns. There's no areas on toxicology or Clin Pharm. These are the areas that typically take much longer in time to resolve. We're very confident that these CMC questions can be resolved within the timeframe that we've stipulated as to when we would expect to launch the product in late next year. Late in 2022.
Serge, the only other thing I would add to that, we'll move to get that meeting set up with the agency as quickly as possible. Obviously, we've got the holidays ahead of us here a little bit, so it'll be probably a little bit tricky navigating that, but we'll seek to do that as quickly as possible.
Okay. Just a couple follow-ups. It sounds like they've completed the clinical review portion of the data in the NDA?
Yes.
Any idea of when the pre-approval inspections can be completed?
At this stage, because we've received a CRL, when we submit the response is when they would anticipate they would look to do the inspections. I think with the pandemic, as you know, they've been very challenged to do these. We anticipate a lot of companies are struggling, and in the best-case scenario, we would have anticipated sometime mid-next year would have been the earliest they would probably get to an inspection. It's hard to project exactly, but that would be our expectation, that once we submit the response, we would be then in the queue to get the inspection done.
Okay.
Thank you.
Thank you. Our next question comes from the line of Georgi Yordanov of Cowen and Company. Please go ahead.
Thank you so much, guys, for taking my question. I just have a couple from us. Yes, can you also remind us, following up on the previous question, where the manufacturing sites are located? Are they in the U.S.?
Sure.
I have just a follow-up on the CRL and the litigation.
Sure. I'll take the first one, and we'll stand by for your second one. Sure. The two sites are indeed in the U.S. One of those sites is at our facility here, where we manufacture particles and active ingredient to create the powder. That's here at Research Triangle Park in North Carolina. The other site is in Florida, where we conduct all of our packaging. They're both domestic here in the U.S.
Got it. Do you anticipate the resubmission to be a type 1 or a type 2?
Maybe I can take that, Neal.
Sure. Take it, Rusty
We anticipate, obviously, normally you wouldn't know until you submit the response, the FDA takes a look at it, then determines what classification they're going to grant. We anticipate it's a type 2 response, that's our expectation, but we won't know for certain until we submit the information and the FDA reviews it.
Got it. Just for the, I guess, upcoming litigation in court, can you just remind us of your confidence in your manufacturing process and how it's different from the patents that are being asserted by United?
Yeah. I know [Schundler] , who's our counsel, is on the line here. Schun would you like to handle that question?
Yeah, sure. Hey, Georgi. This is Schun. We have not given, obviously, with the private information and the litigation and our litigation strategy, we need to keep a lot of that information very quiet. To the details of your question, we have not released that information to this time. We will point you to the fact that this is treprostinil. It's a drug that was designed and developed in the '70s and '80s by Upjohn, and then it's worked its way through GlaxoSmithKline and finally into the treatment of PH later on in the early 2000s. This drug has a lot of history, and there's a lot of prior art on the drug itself. That is about the extent of the information that we're giving at this point. Thank you.
Thank you so much. This is helpful. Thank you.
Thank you. I show no further questions in the queue at this time. I'd like to turn the call back over to Mr. Adair. Please go ahead.
Thanks.
Thanks.
I'm sorry, Neal. One of our analysts-
No, go ahead.
was able to stay on the call, so I'm going to ask a couple questions on his behalf, just to be transparent. One of the questions was, how long does it typically take for the FDA to accept a revised NDA and take an action? I guess that's Tushar might be the best to answer.
Right. Just to clarify, we're not resubmitting an NDA here, right? It's just a response to the CRL. As I explained, we believe this will be considered a class 2 resubmission. We would anticipate that it would be about a six-month review for the FDA, though we won't know for certain whether it's class 1 or 2 until they receive the response and they have a chance to review the materials.
Thanks, Tushar. One other question was relating just to further clarify what is meant by the phrase device biocompatibility?
Sure. Device biocompatibility refers to data that we provide in an NDA describing how a device and the materials of the device specifically perform when in contact with the human body. As you know, this device has been developed and approved for other products for 20-plus years and is still available globally for use in inhaled products. The FDA's requirements on biocompatibility is evolving as many times things do, as we learn more about different aspects of drugs and devices. The FDA is just wanting to ensure that we are up to date with the information we're providing around biocompatibility, and we're working with our device manufacturer to provide the information they're requesting.
Thanks, Tushar. One last question was how does Liquidia plan to communicate with investors from this point going forward related to the regulatory interactions?
Maybe, Neal, you want to take that one?
Yeah. Listen, clearly, as we continue to learn and evolve, Tushar's hit on several things here today around is this going to be one or two in terms of review cycles, things like that. Those things will remain to be kind of seen as we go. Like we always try to do, we will be very consistent in handling any investor questions that come up and to the extent that we can handle those live time and answer them, we always will seek to do that. The only thing I'd say is we're obviously digesting the process here right now ourselves. We'll seek to meet with FDA as quickly as possible, as we mentioned, and begin to dive in. Again, I want to bring it back around. We feel all of these items are addressable.
It does not impact our timeline for launch on the back half of 2022, and we look forward to bringing LIQ861 to the market.
Thanks, Neal. I didn't have any other questions from our analysts that couldn't stay on the call, so I think that concludes the questions section.
Okay, terrific. I guess I'll just close by saying thanks to those of you who joined the call today. We appreciate the interest and investment in Liquidia in some cases. We'll continue, as I just mentioned, to update everyone on our progress. I will take this chance to say I hope everyone has a safe and great Thanksgiving. Thanks for your time this morning. Bye.
Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect. Good day.