Lumos Pharma Inc (LUMO) 2023 Q1 法說會逐字稿

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.

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 Investors page of the company's website. Speaking on today's call will be Rick Hawkins, CEO and Chairman; and Lori Lawley, our CFO. John McKew, our President and Chief Science Officer; and David B. Karpf, our Chief Medical Officer, will join for the question-and-answer section. I will now turn the call over to Rick.

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 in the quarter in recent weeks before turning it over to Lori for a review of our financial results and John McKew and David Karpf 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, LUM-201, in idiopathic pediatric growth hormone deficiency, led by the completion of patient enrollment in both our Phase II OraGrowtH210 and OraGrowtH212 trials. And we can confirm our expectation to report primary outcome data on up to 82 subjects in the dose range finding OraGrowtH210 trial and up to 22 subjects in the PK/PD OraGrowtH212 trial in the fourth quarter of 2023. Importantly, as predicted, baseline characteristics for OraGrowtH210 subjects converge across the 1.6 mg per kg LUM-201 and the growth hormone cohort 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 conversions of age and other key predictive baseline characteristics across these 2 cohorts at full enrollment, we now have better balance and baseline characteristics and therefore, believe we should see more similar growth rates between these 2 arms and final analysis. During the quarter, we were pleased to see our updated interim data from our trials presented at the 2023 International Meeting of Pediatric Endocrinology or MPA, that was held in Buenos Aires, Argentina in March. The presented data demonstrate that LUM-201 possesses both a natural endogenous mechanism of action with potency to simulate meaningful growth to the moderate idiopathic PGHD patient population as well as a favorable safety profile. This included an oral presentation of OraGrowtH212 data by Dr. Fernando Cassorla that further supported the pulsatile mechanism of action of LUM-201 and highlighted growth stimulated with LUM-201 and PEM positive idiopathic PGHD subjects and a poster presentation by Dr. Alison Lumster, demonstrating that the 1.6 mg per kg LUM-201 dose produced 8.6 centimeters a year annualized height velocity and again, in line with historical growth for moderate idiopathic PGHD patients treated with injectable standard of care growth hormone. 

Again, data demonstrated that LUM-201 possesses a favorable safety and tolerability profile. The presented data further reinforce our prediction from the interim analysis we announced last November that the 1.6 mg per kg LUM-201 dose is on track to meet growth expectations based on historical database averages. Importantly, we believe the Enthimedical meeting was critical for raising awareness and understanding of LUM-201 among key opinion leaders in global pediatric endocrine community. Among the pediatric endocrinologists in attendance at FA, the interest in LUM-201 in its potential as an oral therapeutic to treat PGHD was significant. There are those present who are familiar with Merck's original evaluation of LUM-201 in an all-comers PGHD trial and the lack of success there. Yet the trial yet that trial, I should say, enroll 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 PGHD patients selected by our PEM strategy, grew in line with historical averages. There was an acknowledgment that LUM-201 has the potential to become the first oral therapeutic to address this patient population treated solely by injectable therapies for the last 4 years. And we are pleased that interim data from our both oral growth trials were also accepted for presentation at the upcoming pediatric InnoSociety meeting later this week, including an oral presentation on OraGrowtH210 trial interim data given by Dr. Andrew Dover, Chief of Endocrinology and Children's National Hospital and a poster presentation on OraGrowtH212 trial, interim data by Dr. Cassorla and presented by our own Dr. David Karpf.

We believe that presentations at MPA and PES and other medical meetings will continue to increase awareness of LUM-201 among the pediatric endocrinology community and garner even greater excitement for the potential for our oral therapeutic candidate in pediatric growth hormone deficiency. Now turning to other developments now. We continue to support our clinical collaboration with Dr. Laurel Dickel and Massachusetts General Hospital to explore the potential of LUM-201 in nonalcoholic fatty liver disease or NAFLD. This investigator-initiated pilot study was supported by data presented by Dr. Dickel at the Endo-22 conference -- and at that medical meeting, Dr. Dickel reviewed positive data, evaluating injectable growth hormone in NAFLD, which supported the assessment of oral LUM-201 in the same indication. As NAFLD is a chronic condition, prevalent in approximately 25% of adults worldwide, a daily oral therapeutic, such as LUM-201 could provide a welcome alternative to a lifetime of daily injections of growth hormones in this indication. Enrollment in this pilot study of LUM-201 in NAFLD is continuing. 

As we mentioned on our last earnings call, Lumos Pharma filed a novel formulation path for LUM-201 last year, which could assume IP protection to 2042. Now currently, LUM-201 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 7.5 and 12 years on 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 LUM-201 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 LUM-201 in other indications and geographic regions. As we mentioned on our last earnings call, we have narrowed our focus to idiopathic stress factor, 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.

Thank you, Rick. Lumos Pharma ended the quarter on March 31, 2023, with cash, cash equivalents and short-term investments totaling $58 million compared to $67.4 million on December 31, 2022. We reiterate our expectation for average cash use of approximately $9.5 million to $10.5 million per quarter through 2023. Cash, cash equivalents and short-term investments as of March 31, 2023, are expected to support operations into the third quarter of 2024, well beyond our announcement of top line Phase II 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 $1.1 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, was $7.3 million compared to a net loss of $7.9 million for the same period in 2022. We ended Q1 2023 with 8,183,296 shares outstanding. With that, I will turn the call back to Rick to conclude for us.

Thank you, Lori. To recap, our Phase II clinical trial for LUM-201 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 interdata announcement last November in full enrollment, age and other baseline characteristics for OraGrowtH210 subjects converge or converged across 1.6 mg per kg, LUM-201 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 MPA in March, and our data to be presented at PES later this week. We believe that presented data for the demonstrate that LUM-201 possesses both a favorable safety profile and a natural endogenous mechanism of action with potency to stimulate meaningful growth in this idiopathic PGHD patient population. We continue to support the exploration of LUM-201 for the treatment of NAFLD through a pilot investigator-initiated trial, we have narrowed our focus for future indications for LUM-201 to 2 compelling opportunities in 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 LUM-201, which has approved extended IP protection for the commercialized version of LUM-201 through November of 2022. So 2023 is off to a good start for Lumos Pharma. We believe we're poised to demonstrate that LUM-201 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.

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. (Operator Instructions) Please stand by while we compile the Q&A roster. Our first question comes from the line of Catherine Novack of Jones Research.

Hi, good afternoon. Congrats on the quarter. I'm just curious as you're attending these medical meetings speaking with KOLs, how significant our 6-month AHV data Berkespace? 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 the Phase IIb as well? And can you give us a sense of how much follow-up you'll have for some patients beyond the initial 6 months?

Thanks for the question, Catherine. I'll let our Chief Medical Officer, David Karpf, begin to answer that question. I think that John McKew may have something to add. So go ahead, David.

Sure. Thank you very much for the question. It's important to point out that the Phase II studies for all of the management are 6 months in duration. So a 6-month AHV is, to some extent, protected the 12-month. But as you point out, the 12 months is the endpoint in the pivotal Phase III trials. And we were very encouraged that the 12-month data looked actually even better for us than the 6-month aged in the interim analysis -- let's see -- we are committed -- as you know, we have fully enrolled all 82 subjects in each group in the 212 trial, and we'll have the 6-month high velocity on all of those subjects in the 4Q presentation, so we also showed some 9 and 12-month data in this kind of the data will 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 I add anything?

No. I mean I think I'll just stress a little bit, Catherine that. We'll have data beyond 12 months as well. So the durability of effect can be there, and we can really understand what the slow pace of an individual patient's growth is.

Got it. And then I'm wondering if you can give me a sense of next steps, potential next steps following the Phase IIb readout. Can we anticipate initiation of registration directed Phase III program? How confident are you in taking the 1.6 mg/kg dose forward into pivotal studies? And are there any modifications you might make to enrollment or trial design for a pivotal study?

Thanks, Catherine. I can tell you, we are fully committed to the whole team and doing everything it's going to take to start this Phase III 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 II study. But in addition to that, we're adding some other territories around the world that have been traditionally high rollers in countries like China, extremely high rollers in fact. But also, I think we're pretty confident going forward given the fact that when all the long-acting growth hormone studies were being conducted, especially the later stage, there was a great deal of competition between 3 separate companies who are 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 is as far as we know, doing trials in PGHD out there at this time or by the time we start our Phase III. John, do you want to add in terms of the other part of that question?

Sure. So I heard 3 questions, Catherine. So I'll start with the first one, which is kind of timing of moving from Phase II. 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 will also dig very deeply to this data and prepare our request for an end of Phase II meeting with the FDA, right? And that will be a very important step towards moving to our pivotal. We'll negotiate kind of the outlines of the Phase III trial, the noninferiority 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 Phase III commercial products. So I think that will be a very important next step. And as Rick said, we'll be working very, very closely 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 authority is okay, that we'll be ready to really quickly move into enrolling subjects. So you also asked about the 1.6 being the dose to move forward. And I think that's -- 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 of 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 III. And I think the way I would answer that is that there's -- we learned an enormous amount about the kind of patients who respond to our LUM-201 from our Phase II study, right? So we've not only figured out what those patients are like. We've applied this pen 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 treated population. So I think we have a lot of knowledge to apply to the Phase III kind of final design to help us very quickly isolate the right population to move forward. So I think I've checked off all 3 of the questions.

Catherine, I might add with meetings like MPA and other connections with the investigator community. I think these 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 that was in getting enrollment and going well for the Phase III trial.

Rick, can I add a little bit? Sure, sure. Go ahead, David. Okay. You also seem to ask about the design of the Phase III. And there, what I'd like to do is say that the key factors really for successful Phase III is having a good how much entity of the patient population and having good balance between the groups? I'd like to point out that the -- you can see the impact of heterogeneity, if you look at the Phase III Ascendis heiGHt trial versus the Phase III REAL4segriTeD trial. Both of those trials are inherently more heterogeneous in our trials because they roll the full spectrum of disease, severe organic to moderate, less severe idiopathic. But the REAL4segriTeD trial had a higher percentage of severe patients than did the heiGHt trial. As a result, the growth hormone response in the control group of that probe is 11.7 centimeters per year in 12 months. In contrast, in the heiGHt trial with severe but not as many as Real, the response was 10.3, 1.4 centimeters lower. Because our Phase III will be a much more homogeneous trial because we're only selecting the lesser idiopathic who are further also Petrosen. It will be inherently more homogeneous in either of those 2 trials. And because it's less severe, we'd expect to see a high velocity similar to that in the EPA population in the heiGHt Trial, which is concordant with the data basis around 8.3 to 8.6 nanometers per year. 

And then there are 3 factors which will predict the Phase III trial will be even more homogeneous, certainly than our Phase III drug. Most importantly, inhibitor balance is importantly in a Phase III 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 LUM-201 in 120 to 140 subjects versus 60 to 70 subjects on growth hormone. The much larger trial inherently would get much more better -- much better balance than either a 10 subject per group interim analysis or even the 20 subjects were reporting in fourth quarter. The greater start of the trial also allows us to stratify by 3 factors there are 2 factors, which will also improve the balance. And then what really speaks to the homogeneity is that based upon our learnings from Phase II, we're actually adding 2 inclusion criteria, which will make a concordant very similar to that in the heiGHt trial, which has further improved the homogeneity of the trial. Does that answer your question about the Phase III design?

That does answer the question. Thanks so much . Looking forward to data coming up at the end of this year. Thank you very much.

One moment for our next question. Our next question comes from Charles Duncan of Cantor Fitzgerald.

Rick and team, thanks for taking our questions, and congrats on progress in the quarter. I had a couple of questions. First about the in-pay meeting. It sounds like -- well, as you characterized it, was enthusiasm was helpable. 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 there? And then in terms of the implications for the Phase III 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?

Thanks for the question, Charles. And John, I'm going to let you start with your answer.

Sure. Thanks Charles. We appreciate the question. So I think we had, as Rick mentioned in the presentation and a poster in pay 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 they really got an understanding of a broad understanding of the mechanism 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 ped endos that we chat with, and they really do see the impact this molecule could have in that population, right, the more moderate PGHD population. And I'll just mention broadly in this population that there are kids who are needle-phobic. And the kids who are probably most needle-phobic tend to be in that moderate PGHD population, right? Because they're really severely growth hormone 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 is more moderate than maybe a little needle of burst. 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 those clinical data that we've been releasing among the pediatric endocrinology community about the advantages that this molecule offers to the moderate population.

I'll just add that even at the current time, pediatric endocrinologists are dividing their population into idiopathic versus severe organic. And they're really seeing a lot more idiopathic in sub-- right now, they just can offer them on therapy, but I think that this will play into the enrollment in our trial because they're already making the separation between the organic and the idiopathic population in their current kids. I think also that the -- so just having hepatic GHD is pretty predictive for response to Q1, and that's really augmented by also being positive I will also point out that the pen test based upon the Phase II data will be much simpler in Phase III and at launch with simply the single dose of LUM-201 and a single blood test an hour later, which I think will be very, very acceptable because it's far less burdensome than the 2 times kids undergo with all of our pediatric endocrinologists.

Helpful, John and David. I appreciate that added color. I had a question about the commercial form. I'm not sure if I misheard or misheard this, but do you have a commercial form to be able to move into Phase III? Or is that something you're still developing? And would you start a Phase III without a commercial form if it is the case that you're still developing?

No. Good question, Charles, and I'm going to let John answer that.

Yes. I mean, obviously, we want to interact with the FDA and 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 fully explore that product in Phase III. And I think we've talked about the patent we recently submitted, which is tied into formulation and aspects of the molecules that new opportunities in formulation. 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 our plan is to move forward and get agreement with the FDA, as I mentioned, as we move towards a Phase III study.

And to answer your question, Charles, of course, that product will be used in our Phase III trial.

Okay. That clarifies it. And then last question is more strategic. John or Rick, excuse me, we've talked in the past about potential for other geographies in which PGHD 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 the collaborator or not in other geographies?

Yes. I don't -- there think there's any question that when a company gets at this stage in the development of their product, there's typically what happens is the number of players show up. And as you know, in this -- this is a mature space. There are major players. And there's no question that will be fully engaged, and choosing the right partners at the right time to write territories is a nice problem to have. And our business development is led by almost a 30-year veteran in Aaron Schuchart. And Aaron is a busy man these days. Let's put it that way.

One moment for the next question. Our next question comes from Leland Gershell of Oppenheimer.

Rick, I 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 2 doses that you're looking at in the study?

Yes. John, I'm going to let you answer that question, but thanks for the question, Leland.

Yes. We just took on 1.6% growth mark because those are kind of the 2 most important cohort doses or the 2 or cohorts that compare based on our interim analysis, but we obviously have a refined 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 in generally in the same direction.

Okay. And I also wanted to ask with respect to starting the Phase III. This may have been asked earlier, but with respect to the new oral formulation, assuming that the USPTO granted those claims, would you -- would it simply be a matter of a bridging study bioequivalence type study to get into the Phase III or any other clinical work that you have to do?

Yes. I mean, in general, when you introduce a new formulation, you have to do a bridging study, right, to compare back to the data that you have in Phase II. So that is correct.

And presumably, that would -- that could be done inside of 2024. How should we think about the timing of that with respect to them starting the next -- the pivotal study?

Yes. 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.

Yes. Okay. It's 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 III study as quickly as we possibly can.

Right. Okay. So Rick, so it sounds like you may be generating those data in parallel with completing the 210 and 212 studies? Or are they starting to and then we -- you could be a bit accelerated as we get into starting the Phase III?

Yes, 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 II meeting with the FDA. So yes, so in that time period, obviously, there's a lot of parallel work that's going to be done.

One moment for our next question. Our next question comes from Ed White of H.C. Wainwright

Actually, I just have one. You had mentioned that you narrowed the indication targets to ISS and PWS. 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. Can you run that study alongside of the Phase III that you're planning?

Good question. And obviously, as a company at this stage in development and the market conditions as 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 PGHD 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, these are -- we spend a lot of time with the KOL community in ISS and PWS know that there are be excellent direction for us to take. And we'll try to start those studies as quickly as we're able to give any kind of financial restrictions we may or may not have.

Our next question comes from Yasmeen Rahimi of Piper Sandler.

Two for you. Maybe if you could just allude to what the cost of the Phase III would be based on some of the analysis that you have launched. if you could provide some color there? And then also maybe some color around when you do the math in terms of like enrollment timeline and 12, 32 weeks treatment duration, like assuming you start your Phase III in early 2024, like how soon could you be able to bring it to the finish line? If you could just provide some timing around that would be helpful. And then the third component of my question is like what is -- 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.

Okay. Thanks and good to hear from you. I appreciate the question. I think there's a great deal of precedence in terms of how one has taken most companies to enter a study of about this size. I want 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 3 companies concurrently conducting 3 large Phase III 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 caught the KOL community quite well in terms of the type of the patient we'd be looking for in this clinical trial in addition to the fact that, obviously, derisking all the trials by using our PEM strategy. In terms of time to enroll, I think, once again, I think the Ascend is trial in the Phase III took about 18 months. I think the trial was perhaps a little bit larger than we're thinking of or 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 a geographic area like China that has super enrollers. I think we're going to do everything we can to even beat that strategy. And of course, all patients will be treated for a year. In terms of the data scenarios I was expecting to see, John, would you comment, please?

Sure. Maybe I'll just comment a little bit first on the timing. 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 II with the agency. And from there, we have to agree on our Phase III protocol, the noninferiority merchant. And then after that meeting, we submit the protocol and then we get the OK from the FDA. We also have to reach out to all of the other regulatory agencies ex U.S. get their buy-in and then we can officially start the Phase III. We'll do as much upfront work as we can, as we talked about in terms of linings, 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 III. And then what was the other piece you want to make...

The lesson was the cost of the Phase III. And I'm going to let Lori jump in and answer that question.

Sure. Yes. I think at this point in time, we are not giving any guidance around the cost of the Phase III. 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 III. And so at the point in time that we have the specifics of the cost available, we will definitely put out that guidance.

Yes. 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 improve by the time we get this readout.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.