Full Year 2024 Liquidia Corp Earnings Call & Business Update
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Shannon: Good morning and welcome everyone to the Liquidia Corporation full year 2024 Financial Result and Corporate Update Conference call. My name is Shannon and I will be your conference I've read here today. Currently all participants are in a
Speaker Change: Following the presentation, we will conduct the questioning at the session. Instructions will be provided at the time for you to queue up for your questions. I would like to remind everyone that this conference call has been recorded. I will now hand the call over to Jason Adair, Chief Business Officer.
Jason Adair: Thank you, Shannon. It's my pleasure to welcome everyone to the Liquidia Corporation for your 2020 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.
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.
Speaker Change: The statements are subject to known and unknown risks and uncertainties which may cause our actual results of performance to be materially different for many future results or performance expressed or implied on this call.
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.
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: Thank you Jason. Good morning everyone and thank you for joining us today.
Roger: We believe that 2025 has the potential to be a transformational year for the company, as we further build upon the success of 2024, which resulted in the broadening of the tentatively approved label for intravia to include both the treatment of patients with pulmonary arterioids retention or BAH.
and Pulmonary Hypertension Associates with the Nurse of Chalone Disease, for PHILD.
Roger: There are four strategic comparatives that will drive our success and growth in the near and long term.
Roger: Continuing to leverage our development expertise to advance treatment options that have the potential to further improve the lives of patients like our phase III ready nextgen sustained release like the simple therapy.
Roger: Six.
Roger: I'd like to take a few minutes to expand on each of these strategic goals.
Roger: With regard to the first imperative is seeking to launch into the marketplace as soon as soon as possible.
Roger: I'm happy to say that based on the favorable legal decisions a lot.
Roger: Yes.
Roger: There are no legal barriers that currently impacts the FDA issued final approval of the trip here after may 23rd when they exclusive exclusivity granted to our competitor will expire.
Roger: It's also important to remember that when the FDA issued a tentative approval of an NDA. The MBA has met all requirements for approval.
Roger: It cannot reapproved into existing legal or regulatory barriers.
Roger: In our case, so Barry are identified by the FDA, what's new clinical exclusivity granted it's a deep yard which expires on May 23 2025.
Roger: As directed in the tentative approval label, we plan to submit the request for final approval in the coming weeks.
Roger: Yes.
Roger: With regards to the second imperative.
Roger: To advance our studies to establish the clinical profile of your trip yet.
Roger: The medical community's interest in your traffic is increasing with particular interest in the data being generated from our ascent trial.
Roger: The open label safety study of contribute in ph ILD patients.
Roger: Yeah.
Roger: I'm happy to report.
Roger: Yeah.
Roger: Sorry, I haven't asked this morning.
Roger: I'm happy to report that we are on track to complete enrollment in the coming weeks.
Roger: With 50 or more patients in total to be enrolled.
Roger: We continue to be encouraged by the positive patient response.
Roger: The escalating doses if you trip here.
Roger: <unk> at the J P. Morgan JP Morgan Health Care Conference in January we shared that dosing and Tolerability profile.
Roger: The first 20 patients that completed eight weeks of treatment.
Roger: We noted that the ph ILD patients on your trip yet we're able to titrate. The doses that are three times, the comparable therapeutic target of nebulizer today Sir.
Roger: And today, we're happy to share some new information from the ascent study.
Roger: We've also been looking at exploratory efficacy measures of efficacy.
Roger: One such measure is the change in six minute walk test at week eight.
Roger: We are pleased to report in this same 20 patient cohort the main change in baseline improved by 26 four meters.
Roger: While it is difficult to draw.
Roger: Strong conclusions from some cross study comparisons it is worth noting in the phase III Registrational study of nebulous today, certainly in ph ILD patients the increase study.
Roger: Group patients had an observed improvements in six minute walk distance at 16 meters at week, eight and 22 meters at week 16.
Roger: We are highly encouraged by this early efficacy data from ascent as it demonstrates that you're trapping supports the key therapeutic attributes in ph ILD, we aspired for it specifically being well tolerated.
Roger: Amenable to rapid dose escalation dose as well beyond historical standards, leading to an accelerated therapeutic outcome that is in line or better than published results of existing therapies.
Roger: And it should be noted that this data is especially compelling when compared to published data from 10 days at TPI.
Roger: Like sample of treatment naive ph ILD patients at the National Jewish Health Center that we have discussed previously.
Roger: 69% of patients discontinued therapy. After a median time of only 40 days.
Roger: With drug related Aes, especially cough and clinical worsening listed as the primary reasons for discontinuation of divergent DPI.
Mac: We look forward to highlighting more robust dataset from the assent trial at the Ats International Conference in San Francisco This is Mac.
Mac: With regard to our third share of its imperative to build upon our commercial and medical prowess. We have built a commercial enterprise. We feel is best in class. Our team has been in place for every year and a half and continues to support the use of Nebraska injection, while also reinforcing our relationships with our health care providers and our understanding of the unmet needs of ph in ph ILD patients.
Mac: Throughout the country.
Mac: We are prepared to provide a seamless service to patients and providers. Upon launch if you strip out and look forward to educating the ph pitch in ph ILD gets deep communities on the favorable potentially game changing product atrophy, which attribute future.
Mac: Okay.
Mac: Lastly, as we look at our fourth imperative to innovate and develop better therapeutic options. We continue to advance <unk> 606, our sustained release formulation of personnel that provides for consistent 24 hour drug exposure and 212 hour dosing segments, including during sleeping hours.
Mac: We know that continuous infusion has shown the best efficacy with prostacyclin analogue and will and we believe that the PK profile of their success.
Mac: The next closest noninvasive approach to maximizing the benefits from the more targeted inhaled route of administration.
Mac: It is for all those reasons and with an eye towards our pending launch would be trapped in the coming months that we decided to further strengthen our balance sheet as announced yesterday with an extension of our valued partnership with healthcare royalty partners that Mike will speak about now along with an overview of our 2020 for financials Mike.
Mike: Thank you Roger and good morning, everyone before I review, our full year 2024 financial results I'm happy to highlight yesterday's announcement regarding expansion of our financing agreement with healthcare royalty partners.
Mike: Which will provide liquidity up to an additional $100 million of financing in three tranches, including the $25 million tranche funded at closing.
Mike: We are grateful for the trust commitment and confidence that healthcare royalty partners has demonstrated over the years and we are optimistic that these proceeds in a successful launch of <unk>. Following the exploration of exclusivity. This may could lead to our reaching profitability without the need for additional capital.
Mike: Turning to our full year 2024 financial results, which can be found in the press release, you will see that.
Mike: Revenue was $14 million for the year ended December 31, 2024, compared with $17 $5 million for the year ended December 31 2023.
Mike: Revenue related primarily to the promotion agreement with.
Mike: The decrease of $3 $5 million was primarily due to lower sales quantities driven by limitations on the availability of pumps used to administer to postal injection subcutaneously sales quantities will continue to be impacted or at risk until alternative pumps are available.
Mike: Cost of revenue was $5 9 million for the year ended December 31, 2024, compared with $2 9 million for the year ended December 31 2023.
Mike: Cost of cost of revenue related to the promotion agreement as noted above the increase from the prior year was primarily due to our sales force expansion during the fourth quarter of 2023.
Mike: Research and development expenses were $47 8 million for the year ended December 31, 2024, compared with $43 $2 million for the year ended December 31, 2023, the increase of $4 6 million or 11% was primarily due to.
Mike: One a $6 $1 million increase in expenses related to our <unk> hundred six program to a $5 $3 million increase in expenses related to <unk> research and development activities, including the ascend trial.
Mike: Three of $5 $1 million increase in personnel expenses, including stock based compensation related to increased head count.
Mike: And for a $3 5 million upfront license fee due to farmers. So for the exclusive license in Europe to develop and commercialize <unk> recorded during the year ended December 31 2024.
Mike: Offset by one $5 1 million and lower commercial manufacturing expenses, reflecting the impact of expensing you true up your inventory cost in the prior year.
Mike: And two a $10 million upfront license fee due to <unk> for the exclusive license in North America to develop and commercialize <unk>. During the year ended December 31 2023.
Mike: General and administrative expenses were $81 6 million for the year ended December 31, 2024, compared with $44 7 million.
For the year ended December 31, 2023, the increase of $36 9 million or <unk>, 82% was primarily due to one.
Mike: $19 $7 million increase in personnel expenses, including stock based compensation driven by higher head count and expansion of our sales force in the fourth quarter of 2023.
Mike: Two a $7 $9 million increase in legal fees related to our ongoing <unk> related litigation and three a $6 $8 million increase in commercial expenses in preparation for the potential commercialization of <unk>.
Mike: In summary, we incurred a net loss for the 12 months ended December 31, 2024 of $134 million or $1.66 per basic and diluted share compared to a net loss of $78 5 million or $1 21 per basic and diluted share for the 12 months ended.
Speaker Change: For 31, 2023 with that I would now like to turn the call back over to Roger.
Roger: Thank you Mike as you can see we are well positioned clinically commercially and financially for them.
Roger: Potential launch of our first product based on our proprietary print technology, which will serve as the growth engine for our continued evolution in inflection.
Roger: Now I'd like to open the call for questions. Operator first question. Please.
Roger: Thank you as a reminder to ask a question. Please press star one of your telephone and wait for your name to be announced to withdraw your question. Please press star one again.
Operator: Our first question comes from the line of Julian Harrison with <unk>. Your line is now open.
Julian Harrison: Hi, Good morning. Thank you for taking my questions. Roger you touched on this a little in your prepared remarks, but just wondering if you could talk more about the administrative sequence and timeline to convert your triplet tentative approvals.
Operator: <unk> to full approvals.
Roger: Yes, so as we sit in.
Julian Harrison: Julian and great to talk to you. So as we said in the opening.
Julian Harrison: We plan to request final approval in the coming weeks.
Julian Harrison: In the tentative approval label that we received in August It was recommended and suggested that we apply for final approval either two or six months ahead of us.
Julian Harrison: The action date, which would be May 23.
Julian Harrison: Given we view this as a class one resubmission because no new data will be required for approval.
Julian Harrison: Approval.
Julian Harrison: We have been in concert with agency working to deliver that letter.
Julian Harrison: Around the March 2020 timeframe. So that we can be granted final approval around like 20 <unk>.
Julian Harrison: I don't know that specifically addresses what you're seeking yes.
Julian Harrison: Absolutely that's very helpful. Thank you and then a follow up if I may on <unk> 606, I am curious what the physician feedback has been so far for our lower <unk> broader AUC longer half life alternative to Nebulize titles. So.
Julian Harrison: And then sorry, if I missed it I'm wondering also when specific when specifically you plan to initiate the phase three respire trial.
Rajiv Soccer: Yeah, Great and we were fortunate to have Dr. Rajiv soccer on the call today, So rajeev if you wouldn't mind.
Rajiv: Yeah, Thanks, Julien for the question.
Rajiv Soccer: So first of all I think the current open label studies.
Rajiv Soccer: <unk> continues to gain very well we had we have long term safety data that is accrued since the inception of the study.
Rajiv Soccer: The what we're clear feedback is as twice a day dosing is an absolute game changer for.
Rajiv Soccer: For these patients when you inhaled <unk> approximately I think thats first and foremost.
Rajiv Soccer: Second of all I think that.
Rajiv Soccer: The use of the life of some itself has showcased some what we believe is some highlight some impressive safety advantages.
Rajiv Soccer: And finally further reducing the C Max with Detroit today dosing profile and the sustained release formulation of the liposome itself does we have noted that systemic side effects continue also to be further abated.
Rajiv Soccer: Even beyond what we initially.
Rajiv Soccer: So I think the combination of both of those are going to be highly encouraging.
Rajiv Soccer: Four four as we advance towards the inspire study.
Rajiv Soccer: Lars to initiating the <unk> study, we're working full steam ahead to prepare to initiate the study by by year's end.
Rajiv Soccer: We're it's around March right now and so we look forward to providing further information as we get closer to that timeframe at the end of the year.
Speaker Change: Okay, great. Thank you again and congrats on all the progress.
Julien: Thank you Julien.
Our next question comes from the line of Jason <unk> with Bank of America. Your line is now open.
Bob Patel: Hey, Good morning, This is Bob Patel on for Jason.
Bob Patel: Two questions from us the first is given a green space in ph ILD, what's liquidity a strategy to drive early market penetration for Ya <unk>.
Bob Patel: Can you share the market marketing differentiation that you plan to promote to doctors and then given the 500 <unk> pathway should we expect any differences in the label for <unk> versus <unk>, So DPI I know.
Bob Patel: In the past you've mentioned.
Bob Patel: Demonstrating penetration to three times higher doses compared to previous a DPI.
Bob Patel: Yes, So I'll answer the second question first and then I'll add.
Scott: As Scott <unk>, our Chief commercial officer, if he would address.
Scott: Launch dynamics around ph, ILD and differentiation that we intend to emphasize.
Speaker Change: So youre exactly correct patent I think the label it as a 500 <unk> we share obviously, the indication claims and things like that but where we differ from the label is in the.
Scott: Dose titration table.
Scott: Because in our.
Scott: Study that we use to bridge.
Scott: So that we could escalate to doses as you mentioned that the three times higher than the target therapeutic dose of the brand.
Scott: That will be in the label and I think it's an important point of differentiation because it is what it is.
Scott: Enabled using our proprietary print technology to drive the particles to lower airway preferentially and avoid the toxicities associated with that upper airway deposition.
Scott: It's going to help us drive the maximal outcome for these patients as they continued to progress and therefore help us keep those patients on therapy longer as our presumption. So.
Scott: We think these are important and critical aspects. If you look across any route of administration of prostacyclin does matters.
Scott: And the ability to try it does usually predicts the sort of therapeutic utility of that therapy, and that's why I think.
Scott: So as labeled has had limitations in dosing and it's also my other drugs like <unk>, an oral formulation.
Scott: Which is does limited and does ceiling also has limitations over the long and chronic treatment course of these patients so lots of opportunity there from us from a labeling and dosing standpoint so.
Scott: So Scott if you could talk a little bit about kind of how we are going to approach this market without giving away the shop too much.
Scott: Sure.
Speaker Change: Good morning, so so if.
Speaker Change: If you think about it we have the usual designation between centers and communities.
Speaker Change: We're going we are approaching and we will continue to approach both especially after launch.
Speaker Change: The situation in the centers is that the patients are really flowing in.
Speaker Change: The increasing number of patients flowing in as the awareness of ph ILD.
Speaker Change: Increases in we will obviously only add fuel to that fire. So we're in the centers and we're going to make sure that we.
Speaker Change: Ensure that <unk> is the first choice.
Speaker Change: Cyclin for those patients that have ph ILD for a lot of the reasons that Roger just outlined and you've heard us talk about before so we're going to harvest those patients immediately.
Speaker Change: Doing as in the community and there is many many patients out there that doctors don't even know exist they have ILD.
Speaker Change: Doctors aren't looking for ph to help increase awareness, we need to help increase diagnosis and then either get that doctor to prescribe or to refer that patient into one of the centers and we've actually been doing that over the last six months or a year.
Speaker Change: Going deeper and deeper into the community educating on ph ILD, even before we get on the market because we know that that's only going to behoove us once we do get out in the market because we do believe we have.
Speaker Change: The superior product.
Speaker Change: Great. Thank you Scott so much.
Our next question comes from the line of Serge Belanger with Needham. Your line is now open.
Serge Belanger: Hi, good morning.
Speaker Change: A couple of commercially related terrific questions probably for Scott.
Speaker Change: Can you remind us the breakdown between commercial and Medicare coverage for both ph in ph ILD.
Speaker Change: And then assuming we're going to get approval here in a couple of months.
Speaker Change: Can you talk about what you expect in terms of the ramp up in coverage across boats.
Speaker Change: Commercial and Medicare.
Speaker Change: I guess over the next 12 months or so.
Speaker Change: Yes, Great question, Great question, sorry, Scott.
Serge Belanger: Yes, good morning Serge.
Serge Belanger: So in terms of the breakdown generally think of it as Medicare is the biggest so 50% Medicare probably 30% to 40% commercial and then.
Meaning as Medicare other Dod et cetera.
Serge Belanger: In terms of the coverage over the first year.
Serge Belanger: You probably know we're not commenting on our strategies.
Serge Belanger: We'll say that we have been working with the payers closely for quite some time.
Serge Belanger: And we feel like we have great relationships with us they have the desire to make sure that.
Serge Belanger: We maximize access so we share that desire and I think youll see when we launch that.
Serge Belanger: We're very sound on that front.
Speaker Change: Great. Thanks, Scott Operator next question.
Speaker Change: Our next question comes from the line of Brian <unk> with Raymond James Your line is now open.
Brian: Hi, good morning.
Speaker Change: Can you remind us what key readouts, we should be focusing on for the ascent study and specifically.
Speaker Change: Specifically, we can expect in the data coming at ETF when I have a follow up.
Speaker Change: Yes. Thank you Ryan Rajeev, if you wouldn't mind internally.
Speaker Change: Yeah, Thanks, Ryan so.
Speaker Change: As Roger talked about in the prepared remarks today one of the highlights.
Speaker Change: That we spoke about was the.
Speaker Change: The walk effect that was observed in the first 20 patients treated within eight weeks, which was which showed an observed mean improvement of around 26 four meters.
Speaker Change: I think that first and foremost to highlights a few key key processes first.
Speaker Change: That we can get patients to what we believe is in a new therapeutic goal that surpasses the traditional nine to 12 breaths has typically been.
Speaker Change: Sort of a ceiling effect of tavy so since 2009.
Speaker Change: You've highlighted that we're able to achieve doses and the overwhelming majority of patients by week eight that's equivalent to greater than greater than 50, greater or equal to 15 breath by this time. So so we can get patients up to what we believe is a very effective dose and even higher at an earlier time point and then allow further titration to <unk>.
Speaker Change: Further doses to stabilize the patient entitled amount. So I think that's what's going to be quite encouraging.
Speaker Change: We're going to showcase more regarding the datasets regarding how we how we dose the patients we're going to talk a little bit about.
Speaker Change: Our effects in terms of.
Speaker Change: Some quality of life questionnaires as well.
Speaker Change: And in the future our plan is to as we've talked about the assent study will be fully enrolled within the next few weeks here. So we're really excited about that and then we do plan to prepare and submit for the final data set later in the year and present that at a major and respiratory conference in the future.
Speaker Change: Great. Thank you Rajeev.
Speaker Change: That's helpful. Thank you very much.
Speaker Change: We're doing additional hiring for the commercial field team after potential approval in both indications is confirmed.
Speaker Change: What is the status of the current field team with regards to both hiring and training. Thank you.
Scott: Yes, so Scott if you wouldn't mind.
Scott: Yeah sure. So the status I'll start with that one the status of the current sales team is out there.
Scott: They were locked and loaded and ready.
Scott: Had the team onboard for 14 months now and these were experienced.
Scott: Mostly ph all rare disease folks to begin with and so they've been out in the field strengthening relationships they've been training training training they are absolutely ready.
Scott: Ready to go and very very excited.
Scott: On the future front, we actually just went through another exercise over the course of the last few months to take a look at our our Salesforce sizing strategy.
Scott: We think we're well suited to launch as I mentioned earlier, we will take another look at that once we get out and start to understand sort of the.
Scott: The sensitivity factor for the number of reps and then we'll look at potentially.
Scott: Expanding if that makes sense.
Scott: In the future.
Another thing.
Scott: I would add we are adequately sized sport launch in may in both indications.
Scott: And then as Scott said, obviously as we continue to build.
Scott: Presented unique benefits of each ramp yeah.
Scott: I think I want to articulate at even broader so we could upsize, our salesforce probably in that 2006 timeframe if necessary.
Speaker Change: Operator another question.
Greg Harrison: Our next question comes from the line of Greg Harrison with Scotiabank. Your line is now open.
Greg Harrison: Hey, good morning, guys. Thanks for taking the questions.
Greg Harrison: Wondering if you can comment on on your updated cash runway. Following your recent financing then and what assumptions go into that estimate that you could reach profitability with your current balance sheet and then if you could also comment on which factors play into your decision on <unk>.
Greg Harrison: Kevin Your view on future Ipos profile relative to the competitor. Thanks.
Speaker Change: Great I think both of those questions would be what language about Mike.
Greg Harrison: Yes, Greg Great to talk to you again as it relates to runway as we said.
Greg Harrison: With this $100 million of additional financing from Heska royalties $25 million.
Greg Harrison: Received we received at closing.
Greg Harrison: $50 million will be received upon first commercial sale of <unk>.
Greg Harrison: And the final $25 million will be at mutual option. Once we reach a cumulative $100 million in net sales of <unk>.
Greg Harrison: I think it's pretty simple we have we're very excited about the launch of <unk>.
Greg Harrison: As Roger said and Scott have said, we are fully ready from a commercial readiness point of view.
Greg Harrison: From a supply point of view, we feel very bullish about our ability to launch this successfully and we feel that if assuming as Roger said, we filed for full approval here coming up we get full approval on or near the expiration of the exclusivity date.
Greg Harrison: We feel confident if we hit our goals and hit our targets that we can be profitable on this current balance sheet and.
Greg Harrison: And like I said fully support the <unk> hundred six program all of our.
Greg Harrison: Phase four studies, we're doing on <unk>, while also the.
Greg Harrison: Ongoing commercial readiness. So we're very excited we're very confident.
Greg Harrison: We're very happy to have a great partner like healthcare royalties.
Greg Harrison: On this journey and we look forward to launch.
Greg Harrison: As to the second question.
Greg Harrison: We're not going to talk about pricing strategy.
Greg Harrison: I think what I would say is as.
Greg Harrison: We've demonstrated continued to demonstrate and what we feel.
Greg Harrison: Our early results understand only reinforced that.
Greg Harrison: But we feel that we have a superior product profile.
Greg Harrison: And based on that.
Greg Harrison: We want to make sure that we are always balancing patient access.
Greg Harrison: While also fulfilling the value proposition that you're trucking it can bring so we're not going to talk specifically about.
Greg Harrison: Pricing strategies in totality, but I think we're very confident as we come to market that we will have the right strategy to make sure that patients have choice as we as we move forward.
Speaker Change: Great. That's helpful. Thanks, so much.
Speaker Change: I had a question Gregg operator next question.
Speaker Change: Our next question comes from the line of Cory Jumonville with lifestyle capital. Your line is now open.
Cory Jumonville: Good morning, Thanks for taking our questions and congrats on this new efficacy data with the science, it's really exciting.
Cory Jumonville: Just kind of following the theme of more drug is better I recognize that the sample size here.
Cory Jumonville: So relatively small but have you had any type of dose response among patients are those who are reaching two to three fold the Thai base of equivalent dose achieving better outcomes than those in the study who might be.
Cory Jumonville: Kind of in the lower range equivalent to the existing standards of care.
Cory Jumonville: And this also might be a naive question, but is it possible to get these efficacy data on label and how would you go about marketing.
Cory Jumonville: Marketing the six minute walk to prescribers post approval.
Yes, I'll take the second question and then Rajiv.
Speaker Change: Say, what he can about that does.
Cory Jumonville: Does persist effect curve.
Cory Jumonville: So it's not the data is would not be available for <unk>.
Cory Jumonville: Indication claims per se because it's an open label safety study I think it would be part of our annual update to the labor once approved where we could update the clinical pharmacology section.
Cory Jumonville: To describe the data both in terms of safety and potentially in terms of efficacy, but again thats a negotiation with the FDA about what we could could that include in the clinical pharmacology section of the label.
Cory Jumonville: Well I'll reserve.
Cory Jumonville: Sort of commitment on that we'll do the best we can indicate it in there, but I think.
We will abstract and then publish the data and I think as we're seeing this tremendous inbound interest.
Cory Jumonville: On the call.
Cory Jumonville: Describing.
Cory Jumonville: Over 20 doctors doing this current assent study many of them are they are the seminal thought leaders and I think the fact that they are doing the study and we're seeing the results that we're seeing.
Cory Jumonville: He is going to help highlight the data when they lead panel sessions et cetera, because now theyre seeing the true value print as it relates to.
Cory Jumonville: The trip yet.
Cory Jumonville: And then I will just comment on dose response before I turn it over to Rajeev, it's very hard in a small sample of patients to show a dose response, frankly, plus we're allowing patients to individually titrate the dose that we're not sort of pre defining what dose level.
Cory Jumonville: Patients should titrate to and then measuring that versus effect.
Cory Jumonville: So that's a difficult difficult paradigm to show the dose response and that Rajeev I don't know if you have additional comment there.
Cory Jumonville: Yes, sorry, I think I think just I think a few things to highlight first of all the patients that were rolling in a center are quite heterogeneous.
Speaker Change: We purposely designed the study to showcase safety and Tolerability of your trip yet so we not only include patients with mild <unk>.
Cory Jumonville: <unk> limitations with their problem hypertension.
Cory Jumonville: But also patients with severe hemodynamic impairments with various levels of complexity with the interstitial lung disease and the respiratory.
Cory Jumonville: Physiological impairments.
Cory Jumonville: But I think despite that heterogeneity I think what the data is showing despite the small numbers, but even though if the study continues to enroll and continue to highlight a few things number one.
Cory Jumonville: Clearly the low resistance inhaler combined with our print formulation is absolutely, allowing these patients to titrate.
Cory Jumonville: Your trip to again to what I believe are actually new therapeutic levels.
Cory Jumonville: That's very important because it's well known that Proxenoi therapies.
Cory Jumonville: Titratable it is dose related so it tends to affect tend to improve as dose is escalated the problem with current therapies on the market, including oral and systemic parental therapies is that they are just significantly limited by terrible systemic side effects, especially in the oral therapies with the.
Cory Jumonville: <unk> side effects and of course, the potentials within dwelling lines or subcutaneous.
Cory Jumonville: Complications.
I think with the current inhaled therapies on the market today, we know that.
Cory Jumonville: <unk> and the increase study.
Cory Jumonville: What was very interesting relative to the ascent study is by eight weeks only 50% of the patients in the Thai based on liberalized steady increase through PHR D. We're able to reach the 10 to 12 breath levels.
Cory Jumonville: <unk> in the sense steady despite the.
Cory Jumonville: The heterogeneity and.
Cory Jumonville: The patient population, we're able to get patients.
Cory Jumonville: The overwhelming majority of patients up to more than or equal to 15 breath equivalents. So again I think that what <unk>.
Cory Jumonville: That data is going to show in Etfs, and what Kols that are going to see is that <unk>.
Cory Jumonville: <unk> is very well tolerated and titratable and that they can customize to whatever needs of their patients.
Cory Jumonville: We have with both ph in ph ILD in the very near future.
Cory Jumonville: And Corey that's great answer as you're thinking I think one way, we're going to take on this does issue directly.
Cory Jumonville: They're going to do a directed transition study from patients that they sell they sell DPI that are underserved by those therapies.
Cory Jumonville: And probably because it does limitations, we will transition the MTV trivia improve their does and then and if we should therefore, an improved outcome. We've shown not only it does relate it to outcome.
Cory Jumonville: All such differentiated products.
Cory Jumonville: And in a different way and a helpful way for your trip Yeah. So look for that study to start up in the near future as well.
Speaker Change: So operator next question please.
Speaker Change: Thank you and I'm currently showing no further questions at this time I would like to hand, the call back over to Roger Jeffs for closing remarks.
Speaker Change: Thank you very much. So we really appreciate everyone joining us joining us today and we look forward to speaking again soon bye bye.
Speaker Change: This concludes today's conference call. Thank you for your participation you may now disconnect.
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Speaker Change: Yes.
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Speaker Change: Okay.
Speaker Change: Hum.
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Speaker Change: Thanks.
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Speaker Change: Yes.
Speaker Change: Thanks.
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