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spk06: Good afternoon, and welcome to Lumos Pharma's Q1 2023 Financial Results Conference Call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the call over to Lisa Miller, Senior Director of Investor Relations.
spk01: Thank you, Operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements. Information presented on this call is contained in the press release we issued this afternoon and in our Form 10-Q, which may be accessed from the investor's page of the company's website. Speaking on today's call will be Rick Hawkins, CEO and Chairman, and Lori Lawley, our CFO. John McHugh, our President and Chief Science Officer, and David B. Karp, our Chief Medical Officer, will join for the question and answer section. I will now turn the call over to Rick.
spk13: Thank you, Lisa, and good afternoon, everyone. And after the market closed today, we issued a press release announcing our first quarter 2023 financial results and provided an update on our clinical programs. As is our practice, we'll keep our prepared remarks on today's call brief so we can maximize the time available for Q&A. I'll touch on some of the highlights from the quarter in recent weeks before turning it over to Lori for a review of our financial results. And John McHugh and David Karp will join us to answer your questions. So let's begin. As we reported this afternoon, during our first quarter of 2023, we made significant progress in advancing our oral therapeutic candidate, LUM201, in idiopathic pediatric growth hormone deficiency led by the completion of patient enrollment in both our Phase II Oral Growth 210 and Oral Growth 212 trials. And we can confirm our expectation to report primary outcome battle on up to 82 subjects in the dose range finding Oral Growth 210 trial and up to 22 subjects in the PKPD Oral Growth 212 trial in the fourth quarter of 2023. Importantly, as predicted, Baseline characteristics for OBRA 210 subjects converged across the 1.6 mg per kg LUM201 and the growth hormone cohorts between the interim data we announced in November and full enrollment. You may recall that the control arm for the interim analysis included outliers with greater growth than prior data precedence. With the convergence of age and other key predictive baseline characteristics across these two cohorts at full enrollment, we now have better balance in baseline characteristics and therefore believe we should see more similar growth rates between these two arms at final analysis. During the quarter, we were pleased to see an updated interim data from our trials presented at the 2023 International Meeting of Pediatric Endocrinology, or MPEG, That was held in Buenos Aires, Argentina in March. The presented data demonstrate that LUMSU01 possesses both a natural endogenous mechanism of action with potency to stimulate meaningful growth in a moderate idiopathic PGSD patient population, as well as a favorable safety profile. This included an oral presentation of oral growth 212 data by Dr. Fernando Casorla that further supported the pulsatile mechanism of action of LUM201 and highlighted growth stimulated with LUM201 in PEM-positive idiopathic PGHD subjects and a poster presentation by Dr. Allison Lumsford demonstrating that the 1.6 mgs per kg LUM201 dose produced 8.6 centimeters a year, annualized height velocity, again, in line with historical growth from modern idiopathic PGSD patients treated with injectable standard of care growth hormone. Again, data demonstrated that LUM201 possesses a favorable safety and tolerability profile. The presented data further reinforced our prediction from the interim analysis we announced last November that the 1.6 make per kg LUM201 dose is on track to meet growth expectations based on historical database averages. Importantly, we believe the MPA medical meeting was critical for raising awareness and understanding of LUM201 among key opinion leaders and global pediatric endocrine community. Among the pediatric endocrinologists in attendance at MPA, the interest in LUM201 and its potential as an oral therapeutic to treat PGHD was significant. There are those present who are familiar with Merck's original evaluation of LUM2-01 in an all comers PGHD trial and the lack of success there. Yet the trial, yet that trial I should say enrolled both severe PGHD patients unable to secrete growth hormone as well as more moderate or idiopathic PGHD subjects. Once this audience was shown Lumos Pharma's data demonstrating that moderate idiopathic PTSD patients selected by our PEM strategy grew in line with historical averages, there was an acknowledgement that LUM201 had the potential to become the first oral therapeutic to address this patient population treated solely by injectable therapies for the last 40 years. And we are pleased that interim data from our both oral growth trials were also accepted for presentation at the upcoming Pediatric Endocrine Society meeting later this week, including an oral presentation on oral growth 210 trial interim data given by Dr. Andrew Dauber, Chief of Endocrinology at Children's National Hospital, and a poster presentation on oral growth 212 trial interim data by Dr. Casorla and presented by our own Dr. David Karpf. We believe that presentations at MPEG and PES and other medical meetings will continue to increase awareness of Blum201 among the pediatric endocrinologist community and garner even greater excitement for the potential for our oral therapeutic candidate in pediatric growth hormone deficiency. And turning to other developments now, we continue to support our clinical collaboration with Dr. Laurel Dichtel and Massachusetts General Hospital to explore the potential of LUM201 in non-alcoholic fatty liver disease or NAFLD. This investigator-initiated pilot study was supported by data presented by Dr. Dichtel at the Endo22 conference. And at that medical meeting, Dr. Dichtel reviewed positive data evaluating injectable growth hormone in NAFLD, which supported the assessment of oral LUM201 in the same indications. As NAFLD is a chronic condition prevalent in approximately 25% of adults worldwide, a daily oral therapeutic such as LUM201 could provide a welcome alternative to a lifetime of daily injections of growth hormone in this indication. Enrollment in this pilot study of LUM201 in NAFLD is continuing. And as we mentioned on our last earnings call, LUMOS Pharma filed a novel formulation patent for LUM201 last year, which could extend IP protection to 2042. Now, currently, LUM201 has patent protection through 2036 for the detection and treatment of growth hormone deficiency, as well as orphan drug designation, which offers extended protection of up to seven and a half and 12 years from the date of drug approval in the U.S. and Europe, respectively. We expect to hear from the U.S. Patent Office later this year. As previously mentioned, we believe that LUM201 has the potential to address up to 10 other indications currently treated by injectable growth hormone. We've done a lot of work internally to assess the potential of LUM201 and other indications and geographic regions. As we mentioned on our last earnings call, we have narrowed our focus to idiopathic short stature or ISS and Prader-Willi syndrome where we see a sizable opportunity both in the U.S. and internationally. While we assess these opportunities, we remain committed to the prudent use of our cash and ensuring our capital allocation is focused on advancing our core program. With that, I'm going to turn it over to Lori for a review of our financial results.
spk09: Thank you, Rick. Leumont Pharma ended the quarter on March 31st, 2023 with cash, cash equivalents, and short-term investments totaling $58 million compared to $67.4 million on December 31st, 2022. We reiterate our expectation for average cash use of approximately $9.5 to $10.5 million per quarter through 2023. Cash, cash equivalents, and short-term investments as of March 31st, 2023 are expected to support operations into the third quarter of 2024, well beyond our announcement of top-line phase two trial results in the fourth quarter of 2023. Research and development expenses were $4.4 million for the quarter ended March 31, 2023, an increase of approximately $0.1 million compared to the prior year period. The increase was primarily due to an increase of $0.5 million in clinical trial expense and $0.1 million in legal and consulting expenses offset by a decrease of $0.5 million in contract manufacturing expenses. General and administrative expenses for the quarter were $4.4 million, an increase of approximately $0.7 million compared to the prior year period. The increase was primarily due to increases of $0.4 million in licensing expenses, $0.2 million in personnel-related expenses, and $0.2 million in travel expenses. The net loss for the quarter ended March 31, 2023 with $7.3 million compared to a net loss of $7.7 million for the same period in 2022. We end at Q1 2023 with 8,183,296 shares outstanding. With that, I will turn the call back to Rick to conclude for us.
spk13: Thank you, Lori. To recap, our Phase II clinical trials for LUM201 are now fully enrolled, and we're in a position to report top-line data from both studies in the fourth quarter of 2023. Additionally, between our interim data announcement last November and full enrollment, Age and other baseline characteristics for oral growth 210 subjects converged across 1.6 mgs per kg LUM201 and growth hormone cohorts as predicted, given the stratification of the trial by age and the balancing effect of the additional subjects included at full enrollment. Our confidence in these trials is reinforced by additional data presented at MPAE in March and our data to be presented at PES later this week. We believe the presented data further demonstrate that Loom 201 possesses both a favorable safety profile and a natural endogenous mechanism of action with potency to stimulate meaningful growth in this idiopathic PGSD patient population. We continue to support the exploration of Loom 201, the treatment of NAFLD through a pilot investigator-initiated trial, we have narrowed our focus for future indications for Loom 201 to two compelling opportunities and attractive markets. In addition, by prioritizing our PGHD program and being conservative with our cash usage, we expect our current capital to support operations into the third quarter of 2024. We also submitted a patent application for LUM201, which has approved extended IP protection for the commercialized version of LUM201 through November of 2042. So, 2023 is off to a good start for Lumos Pharma. We believe we're poised to demonstrate that LUM201 has the potential to disrupt the worldwide growth hormone market that's been dominated for almost 40 years by injectable products. We're excited to continue to advance our programs and look forward to disclosing top line data in the fourth quarter of 2023. Thank you very much. And operator, we're ready to take questions.
spk06: Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Catherine Novak of Jones Research. Your line is now open.
spk11: Hi, good afternoon. Congrats on the quarter. Thanks so much for taking my questions. I'm just curious, as you're attending these medical meetings, speaking with KOLs, how significant are six-month AHV data for KOLs in this space? You know, we know that the important endpoint is going to be 12 months, and that's where you also start to see the attenuation of injectable growth hormone AHV. So how important is it going to be to show 12-month data in this phase to be as well? And can you give us a sense of you know, how much follow-up you'll have for some patients beyond the initial six months.
spk13: Thanks for the question, Catherine. I'm going to let our chief medical officer, David Karp, begin to answer that question. I think that John McHugh may have something to add. So go ahead, David.
spk05: Sure. Thank you very much for the question. It's important to point out that the phase two studies for all of the are six months in duration. So six-month AHV is to some extent predictive of 12-month AHV. But as you point out, the 12-month is the endpoint in the pivotal phase three trials. And we were very encouraged that the 12-month data looked actually even better for us than the six-month data did in the intra-analysis. Let's see. We are committed, as you know, we are fully enrolled, all 82 subjects, well, each subject in the 210 trial, 11 subjects in each group in the 212 trial, and we'll have the six-month height velocity on all of those subjects in the fourth Q presentation. So we also showed some 9- and 12-month data. In this cut of the data, we'll have even a greater sample size at 9, 12, and later time points as well. So we should have a reasonable amount of 12-month data in the fourth quarter to present. John, do you want to add anything?
spk04: No, I mean, I think I'll just stress a little bit, Katherine, that we'll have data beyond 12 months as well, so the durability of the fact can be there and we can really understand what the, you know, the slope is of an individual patient's growth is.
spk11: Got it. And then I'm wondering if you can give me a sense of next steps, you know, potential next steps following the Phase 2b readout. Can we anticipate initiation of registration and directed Phase 3 program? How confident are you in taking the 1.6 mg per kg dose forward into pivotal studies? And are there any modifications you might make to enrollment or trial design for a pivotal study?
spk13: Thanks, Catherine. I can tell you, you know, we are fully committed to the whole team and doing everything it's going to take to start this phase three study as quickly as possible, including the recruitment of the study sites around the world. First, we know who the high responders have been in the phase two study. But in addition to that, we're adding some other territories around the world that have been traditionally high in rollers in countries like China, extremely high rollers, in fact. But also, I think we're pretty confident going forward, given the fact that that when all the long-acting growth hormone studies were being conducted, especially the later stage, there was a great deal of competition between three separate companies who were competing for the same patient population. I think we have a sort of a clean slate, and we don't have this as much of a, let's say that the competition has been diminished. No one else, as far as we know, doing trials in PTSD out there at this time or by the time we start our phase three. John, do you want to add in terms of the other part of that question? Sure.
spk04: So, I heard three questions. Catherine. So I'll start with the first one, which is kind of timing of moving from phase two. So we are incredibly methodical in how we're approaching this and thinking through this large data package that we're going to get. Obviously, we'll analyze it quickly and get it out in top line form to investors and the public. We'll also dig very deeply into this data and prepare our request for an end of phase two meeting with the FDA, right? And that'll be a very important step towards moving to our pivotal. We'll negotiate kind of the outlines of the phase three trial, the non-inferiority margin, all the pieces that are going to be required for us to move forward. We'll also have a discussion with the FDA about our, you know, phase three commercial products. So I think that'll be a very important next step. And as Rick said, you know, we'll be working very, very closely, you know, with our CRO to do as much upfront work as we can in the U.S. and globally, right? And so when we get both the U.S. and ex-U.S. regulatory authorities okay, that we'll be ready to really quickly move into enrolling subjects. You also asked about the 1.6 being the dose to move forward, and I think that's, you know, right now that's what we feel comfortable with after the interim analysis, but obviously we're going to wait until we have the full data set at Q4 to make a final decision there. But the data right now points to 1.6 as being optimal. And the third part of your question was about patient selection in phase three. And I think the way I would answer that is that there's, we've learned an enormous amount about the kind of patients who respond to our LUM201 from our phase two study, right? So we've not only figured out what those patients are like, we've applied this end strategy to those subjects to really isolate them prospectively and bring them into the trial. We understand in terms of enrollment, we found a number of KOLs who are really good at finding these patients among their treating population. we have a lot of knowledge to apply to the phase three kind of final design to help us very quickly isolate the right population and move forward. So I think I've checked off all three of the questions.
spk13: You know, Katherine, I might add, you know, with meetings like MPA and other connections with the investigator community, I think as we share the results with these investigators and KOLs, I think there's almost a palpable excitement in the community because this is the first time that they've been able to work with an oral therapeutic in this space. So I think that bodes well for us in getting enrollment going and going well for this phase three trial.
spk05: And Rick, could I add a little bit?
spk13: Sure, sure. Go ahead, David.
spk05: Okay. You also seemed to ask about the design of the phase three. And there what I'd like to do is say that the key factors really for successful phase three is having a good homogeneity of the patient population and having good balance between the group. I'd like to point out that you can see the impact of heterogeneity if you look at the Phase III Ascended Height Trial versus the Phase III Real IV Segraia Trial. Both of those trials are inherently more heterogeneous than our trials because they rule the full spectrum of disease, severe organic to moderate, less severe idiopathic. But the Real IV the GRE trial had a higher percentage of severe patients than did the high trial. As a result, the growth hormone response in the control group of that trial was 11.7 centimeters per year for 12 months. In contrast, in the high trial with, you know, severe but not as many as the real, the response was 10.3, 1.4 centimeters lower. Because our phase three will be a much more homogeneous trial because we're only selecting the less severe idiopathic who are further also PEM chosen, it'll be inherently more homogeneous in either of those two trials. And because it's less severe, we'd expect to see a high-velocity similar to that in the idiopathic population in the high trial, which is concordant with the databases, around 8.3 to 8.6 centimeters per year. There are three factors which will predict that the Phase III trial will be even more homogeneous, certainly than our Phase II trial. Most importantly, and have a better balance, importantly, than the Phase II trial. As far as balance, the Phase III will be much, much larger than Phase II. So the Phase III will be one dose of LUM201 in 120 to 140 subjects versus 60 to 70 subjects on growth hormone. The much larger trial inherently will get much better balance than either our 10 subjects per group interim analysis or even the 20 subjects we're reporting in fourth quarter. The greater size of the trial also allows us to stratify by three factors instead of two factors, which will also improve the balance. And then what really speaks to the homogeneity is that based upon our learnings from phase two, we're actually adding two inclusion criteria, which will make the concordant very similar to that in the high trial, which should further improve the homogeneity of the trial. Does that answer your question about the phase redesign?
spk11: That does answer the question. Thanks so much for taking the questions. Looking forward to data coming up at the end of this year. Thank you very much.
spk13: Thank you, Katherine.
spk06: One moment for our next question. Our next question comes from Charles Duncan of Cantor Fitzgerald. Your line is now open.
spk02: Yeah, good afternoon, Rick and team. Thanks for taking our question and congrats on progress in the quarter. I had a couple of questions. First, about the MPAE meeting, it sounds like, well, as you characterized it, it was Enthusiasm was palpable, and I guess I'm wondering, when you talk to KOLs about the severe versus moderate patient population, I guess I'm wondering if that is a paradigm that is going to prove to be a challenge in the commercial setting, or do you think that the use of the PEMS system is really going to help out their And then in terms of the implications for the phase three program, could we almost assume that PEMS, and I guess the enthusiasm or confidence that a patient may respond, is going to enhance enrollment rates perhaps over the past experience in this field?
spk13: Thanks for the question, Charles. And John, I'm going to let you start with your answer.
spk04: Sure. Thanks, Charles. We appreciate the question. So I think, you know, we had, as Rick mentioned, a presentation and a poster at INPEI and the booth as well. And so we got lots of interactions with, I think, some of the key European, South American, and U.S. pediatric endocrinologists. And, you know, they really got an understanding of a broad understanding of the methods of action of our molecule and how it is different than growth hormone. And I think that connection with the type of patient population that is going to be treated is very clear to most of the pedentals that we chat with. And they really do see the impact this molecule could have in that population, the more moderate TGHD population. And I'll just mention broadly in this population that You know, there are kids who are needle phobic, and the kids who are probably most needle phobic tend to be in that moderate TGHD population, right? The kids who are really severely growth deficient are going to take the shots or take the treatment however it comes. And I think that there is an opportunity there for this group of kids who is more moderate and maybe a little needle averse. I think clinicians really like the opportunity to be able to offer them something that's oral. So I think there's a good understanding as we start to present more and more of this clinical data that we've been releasing among the pediatric endocrinology community about the advantages that this molecule offers to the moderate population.
spk03: Very good. David, anything to add there?
spk05: I'll just add that even in the current time, pediatric endocrinologists are dividing their population into idiopathic versus severe organic. And they're really seeing a lot more idiopathic than severe organic. You know, right now they just can offer them one therapy, but I think that this will play into the enrollment in our trial because they're already making the, you know, the separation between the organic and the and the idiopathic population in their current kids. I think also that the, so just having idiopathic GHD is pretty predictive response to LUM201 and that's really augmented by also being PEM positive. I will also point out that the PEM test based upon the phase two data will be much simpler in phase three and at launch with simply the single dose of LUM201 and a single blood test an hour later. which I think will be very, very acceptable because it's far less burdensome than the two STEM tests these kids undergo with all of our pediatric endocrinologists.
spk02: Helpful, John and David. Appreciate that added color. Had a question about the commercial form. I'm not sure if I misheard or misheard this, Do you have a commercial form to be able to move into phase three? Or is that something you're still developing? And would you start a phase three without a commercial form if it is the case that you're still developing?
spk13: No. Good question, Charles. And I'm going to let John answer that.
spk04: Yeah. I mean, obviously, we want to interact with the FDA. get agreement with them about how we're going to move forward with a commercial product. And the best possible way to do that is to, you know, to fully explore that product in phase three. And, you know, I think we've talked about the patent we recently submitted, which is tied into formulation and aspects of the molecule that let new opportunities in formulation happen. So I think we're going to move down that path with agreement with the FDA about the best way to utilize the molecule and make this a really easy molecule to administer. So, you know, our plan is to move forward and get agreement with the FDA, as I mentioned, as we move towards a phase three study.
spk13: And to answer your question further, Charles, of course, that product will be used in our phase three trial.
spk02: Okay, that clarifies it. Then last question is more strategic. John or Rick, excuse me, we've talked in the past about potential for other geographies in which PGE HD is really a big issue. And I think you alluded to China earlier this call. And I guess I'm wondering, do you think that the data that you could present in the fourth quarter could even further enhance opportunities to pursue development either with a collaborator or not in other geographies?
spk13: Yeah, I don't think there's any question that, you know, when a company gets at this stage in the development of their product, there's typically what happens is a number of players show up. And as you know, in this, this is a mature space. There are major players. And, and there's no question that, that, that we'll be fully engaged and, and, choosing the right partners at the right time, the right territories is a nice problem to have. And our business development is led by, you know, almost a 30-year veteran, Aaron Schuert. And Aaron is a busy man these days, let's put it that way.
spk02: Okay. Thanks for taking my questions.
spk13: Thank you, Charles.
spk06: One moment for the next question. Our next question comes from Leland Gerschel of Oppenheimer. Your line is now open.
spk12: Thanks for the update and for taking my questions. Rick, wanted to know, in addition to the baseline characteristics update for the 1.6 milligrams, I know that's the dose of focus for forward study. but wondering if you may give us the opportunity to hear on what may be a narrowing of the baseline differences in the other two doses that you're looking at in the study. Thanks.
spk13: John, I'm going to let you answer that question, but thanks for the question, Leland.
spk04: We just focused on 1.6 and growth mark because those are kind of the two most important cohort doses are the two important cohorts to compare based on our interim analysis, but we obviously have baseline data. And I think the trends are similar across all the cohorts. There's a little moving around here and there among the different cohorts, but they all are moving generally in the same direction.
spk12: Okay. Thank you. And I also wanted to ask with respect to starting the phase three. I just may have been asked earlier, but with respect to the new oral formulation, assuming that the USPTO grants those claims, would it simply be a matter of a bridging study by equivalence type study to get into the Phase III or any other clinical work that you have to do? Thanks.
spk04: Yeah. Go ahead, John. Yeah, I mean, in general, when you introduce new formulation, you have to do a bridging study, right, to compare back to the data that you have in phase two. So that is correct.
spk12: And presumably that could be done inside of 2024. How should we think about the timing of that with respect to then, you know, starting the next, you know, the pivotal study?
spk08: John?
spk04: Yeah, I mean, we're obviously keen to keep that up as soon as possible, right, as soon as we can, because I think it is, it would be key to moving forward. So, yes, it is definitely on our to-do list.
spk13: Yeah, as much, any work that we can do, Leland, on a parallel basis, without too much risk, we're going to do. We want to start this phase three study as quickly as we possibly can.
spk12: Right. Okay. So, Rick, so it sounds like you may be generating those data in parallel with completing the 210 and 212 studies, or at least starting to, and then you could be a bit accelerated as we get into starting the Phase III.
spk13: Yeah. There's a lot of work to be done between the completion of the trial, the reporting of the data, everything that needs to be done leading up to the end of phase two meeting with the FDA. So, yeah. So, in that time period, obviously, there's a lot of parallel work that's going to be done.
spk12: Got it. Very good. Okay. Thanks very much for taking our questions.
spk06: One moment for our next question. Our next question comes from Ed White of HC Wainwright. Your line is now open.
spk03: Good afternoon. Thanks for taking my questions. Actually, I just have one. You had mentioned that you'd narrowed the indication targets to ISS and PWS. I'm just wondering how to think of the timing to the start of the next indication. Do you think that it's possible to decide which target you will go after this year and then initiate the study for the new indication next year? You know, can you run that study alongside of the phase three that you're planning? Yeah.
spk13: Yeah, good question. And obviously, the company at this stage and development and the market conditions that they are, we're really fortunate to have the cash runway that we have in terms of getting the readout of these studies. We're going to focus all of our resources on the PGHB indication, obviously, but as the market evolves and we're able to access more capital, then we'll make those decisions along the way. But obviously, we spent a lot of time with the KOL community and ISS and PWS, know that there'd be excellent directions for us to take. And we'll try to start those studies as quickly as we're able to, given any kind of financial restrictions we may or may not have.
spk08: Okay, great. Thanks, Rick.
spk07: One moment for the next question.
spk06: Our next question comes from Yasmine Raimi. of Piper Sandler, your line is now open.
spk10: Hi, team. Thank you so much for taking the questions. Two for you. Maybe if you could just allude to what the cost of the phase three would be based on some of the analysis that you have run, so you could provide some color there. And then also maybe some color around, you know, when you do the math in terms of like enrollment timeline and 12 52 week treatment duration like assuming you start your phase three in early 2024 like how soon could you be able be able to bring it to the finish line so you could just provide some timing around that would be helpful and then the third component of my question is you know like um what is what are you what are the various data scenarios that you are expecting to see and what action would you take as we're headed into the top line data from 210 and 211? And I'll jump back into the queue. Thank you.
spk13: Okay. Thanks, Yaz, and good to hear from you. Appreciate the question. You know, I think there's a great deal of precedence in terms of how long it's taken most companies to enter about, you know, a study of about this size. And I wanted to go back to, I think, my discussion a little bit earlier and the fact is that there was a great deal of competition between three companies, you know, concurrently conducting three large phase three studies globally. That doesn't exist for us. That's one positive thing. And also what John said earlier, and the fact is that we, I think we've taught the KOL community quite well in terms of the type of patient we'd be looking for in this clinical trial, in addition to the fact that, you know, obviously de-risking all the trials by using our PEM strategy. In terms of time to enroll, I think, once again, I think the Ascendus trial, the phase three, took about 18 months. I think the trial was perhaps a little bit larger than we're thinking of or, you know, roughly so. But as I said, we don't have the restraints of a great deal of competition from a number of areas. In addition, by adding, you know, a geographic area like China that has, you know, super-enrollers, I think we're going to do everything we can to even, you know, beat that strategy. And, of course, all patients will be treated for a year. In terms of the data scenarios that we're expecting to see, John, would you comment, please?
spk04: Sure. Maybe I'll just comment a little bit first on the timing. you know, yes, I think I'll just reiterate that when our data package does read out in Q4 of this year, we have to put together a package and request a meeting for end of phase two with the agency. And from there, you know, we have to agree on our phase three protocol and the non-accuracy margin. And then after that meeting, we submit the protocol and then we get the okay from the FDA. We also have to reach out to all of the other agencies regulatory agencies, XUS, get their buy-in, and then we can officially start the phase three. We'll do as much upfront work as we can as we talk about in terms of lining FISA, getting everything ready as quickly as we can while we wait for all those regulatory approvals. So I just wanted to chat through the timeline of starting phase three. And then what was the other piece you wanted to comment on?
spk13: The last one was the cost of the phase three and And I'm going to let Lori jump in and answer that question.
spk09: Sure. Yes, I think at this point in time, we are not giving any guidance around the costs of the Phase 3. You know, we continue, as John mentioned, to refine and work on the planning, and there's still quite a bit to be done to be prepared for a Phase 3. And so at the point in time that we have the specifics of the costs available, we will definitely put out that guidance.
spk13: Yeah, and yes, I think that in spite of what the current market conditions are, I think there have been really good examples of several companies or multiple companies who have been successful in raising capital with positive results. And so that's heartening to us. I think there seem to be even more and more examples as time goes on. So, we hope that the market conditions are also improved by the time we get this readout.
spk10: Great. Thank you so much, Tim.
spk07: Sure. Thank you for your participation in today's conference.
spk06: This does conclude the program. You may now disconnect.
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