Good afternoon, and welcome to Lumos Pharma's Q1 2023 Financial Results Conference Call. [Operator Instructions]. As a reminder, this conference call is being recorded. I'll 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 Scientific Officer; and David Karpf, our Chief Medical Officer, will join for question-and-answer session. 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 providing 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 McKew and David Karpf will join us to answer your questions. So, let's begin.

As we reported this afternoon, during the first quarter of 2023, we made significant progress and advancing our oral therapeutic candidate LUM-201 in Idiopathic Pediatric Growth Hormone Deficiency, led by the completion of patient enrollment, and both our phase II OraGrowtH210 and OraGrowtH212 trials.

And we can confirm our expectation to report primary outcome battle on the 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 a 1.6 mg per kg LUM-201 and the OraGrowtH210 cohort. Between the interim data we announced in November and for enrollment. You may recall that the control arm for the interim analysis included outliers with greater growth than prior data presents.

With a convergence of age and other key predictive baseline characteristics across these two cohorts at full enrollment. We now have better balanced and 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 updated interim data from our trials presented at the 2023 international meeting, a pediatric endocrinology or MPEG that was held in one side of Argentina in March.

To present data demonstrate the LUM-201 possesses both a natural endogenous mechanism of action with potency to stimulate meaningful growth in a modern 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 gross stimulated with LUM-201 and PEM-positive idiopathic PGHD subjects and a poster presentation by Dr.

Alison Lunsford, demonstrating that the 1.6 mg per kg LUM-201 dose produced eight six centimeters a year annualized site's velocity, again, in line with historical growth for modern idiopathic PGHD patients treated with injectable standard of care growth hormone.

Again, data demonstrated that LUM-201 possesses a favorable safety and tolerability profile that presented data further reinforce our prediction from the interim analysis we announced last November, that's a 1.6 mg per kg LUM-201 dose is on track to meet growth expectations based on historical database averages.

Importantly, we believe the infant medical meeting was critical for raising awareness and understanding of LUM-201 among key opinion leaders and global pediatric intercom community. Among the pediatric endocrinologist in attendance and FA they interest in LUM-201 is 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 and all comers PGHD trial and the lack of success there. 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 Pediatric PGHD patients selected by our PEM strategy grew in line with historical averages.

There was an acknowledgment that LUM-201 had the potential to become the first oral therapeutic to address this patient population treated solely by injectable therapies for the last four years.

And we are pleased that interim data from our books or growth trials were also accepted for presentation at the upcoming Pediatric Endocrine Society Meeting later this week, including an oral presentation on OraGrowtH210 trial interim data given by Dr.

Andrew Dauber, Chief of Endocrinology at Children's National Hospital and a poster presentation on OraGrowtH212 trial interim data by Dr. Kasora, and presented by our own Dr. David Karpf.

We believe that presentations at IMPE and PES and other medical meetings will continue to increase awareness of LUM-201 among the pediatric endocrinologist’s 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. Laura Dichtel in Massachusetts General Hospital to explore the potential of LUM-201 in non-alcoholic fatty liver disease or NAFLD. This investigator initiated pilot study was supported by data presented by Dr. Dichtel at the end of 2022 conference. And at that medical meeting, Dr.

Dichtel reviewed positive data, evaluating injectable growth hormone in NAFLD with supporting 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 gross hormone 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 patent for LUM-201 last year, which could have sent 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 years 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 LUM-201 has the potential to address up to 10 other indications currently treated by injectable growth hormone. We have done a lot of work internally to assess the potential of LUM-201 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. I'm going to turn it over to Lori for review or 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 in the first quarter of 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 $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 $0.4 million and licensing expenses, $0.2 million and 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 $7.7 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 trials from 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 inner data announcement last November and full enrollment, age and other baseline characteristics for over 210 subjects converge, or converge across 1.6 mg per kg of 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 IMPE 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, but potency to stimulate meaningful growth in this idiopathic PGHD patient population.

We continue to support the exploration of LUM-201 for the treatment of natural through a pilot investigator-initiated trial, we have narrowed our focus for future indications for LUM-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 from LUM-201, which if approved, extended IP protection for the commercialized version of LUM-201 through November of 2022.

So, 2023 is off to a good start to Lumos Pharma. We believe we're poised to demonstrate that LUM-201 has the potential to disrupt the worldwide growth hormone market has been dominated for almost 40 years by injectable products.

We're excited to continue to advance our programs and look forward to disclosing the top-line data in the fourth quarter of 2023. Thank you very much and operator we're ready to take questions..

[Operator Instructions] Our first question comes from the line of Catherine Novack Novak of Jones Research. Your line is now open..

Hi, good afternoon, congrats on the quarter. Thank you, so much for taking my question. I'm just curious, as you're attending these medical meetings speaking with KOLs, how significant are six months AHV data for KOL in this space? 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 II b 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..

Thanks for the question Catherine and 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 the question. It's important to point out that the phase II studies for all of the other ones are six months in duration. So, six months AHV is some particular club of AHV. But as you point out, the 12 months AHV is the endpoint in the pivotal phase III trials.

And we were bringing her to the 12-month data look to actually even better for us than the six-month agent did any interim analysis. Let's see. We are committed, as you know, we have fully enrolled all 82 subjects, introducing the content while loving subjects in each group in the tutorials trial.

And we'll have to six-months my philosophy on all of those subjects in the 4Q presentation. We also showed some nine to 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 print to present.

John, do you want to 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 effect can be there. And we can really understand what the slope is an injury visual patients’ group is..

Got it. And then I'm wondering if you can give me a sense of next steps, potential next steps following the phase II b read out.

Can we anticipate initiation of registration and directed phase III program? How confident are you in taking the 1.6 mg per kg goes forward into pivotal studies and are there any modifications you might make to enrollment or child design for 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 are adding some other territories around the world that have been traditionally high enrollers in countries like China, extremely hiring enrollers in fact.

But also, I think we are 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 three 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, the competition has been diminished. There is no one else as far as we know doing trials in PGHD out there at this time or by the time we started our Phase III.

John, do you want to add in terms of the other part of that question?.

Sure. So, I heard three 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 on how we are approaching this and thinking through this large data package that we're going to get.

Obviously, we will analyze it quickly and get it out in top-line form to investors in the public.

We'll also dig very deeply into 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 will negotiate kind of the outline for the Phase III trial, the non-inferiority margin, all the pieces that are going to be required for us to move forward.

We will also have 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 will 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 authorities okay that we will 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 is, we have learned an enormous amount about the kind of patients who respond to our LUM-201 from our Phase II study, right? So, we not only figured out what those patients are like, we have 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 for finding these patients among their treating population. So, I think we have a lot of knowledge to apply to the Phase III kind of final designs to help us very quickly to isolate the right population and move forward.

So, I think I've checked up all three of the questions..

Cath, I might add, with meetings like FDA and other connections with the investigator community, I think as we share the results with these investigators and KOLs, I think there is almost a palpable excitement in the community, because this is the first time that they have been able to work with an oral therapeutic in this space.

So, I think that those walls were in getting enrollment and going well for this Phase III trial..

Could I add a little bit?.

Sure. Go ahead, David..

Okay. You will 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 homogeneity of the patient population, and having good balance between the groups.

I'd like to point out that you see the impact of heterogeneity, if you look at the Phase III, essentials height trial, versus the Phase III, real for sick right at trial. Both of those trials are inherently more heterogeneous in our trials, because they ruled the full spectrum of disease, severe, organic to moderate, less severe idiopathic.

But the real for the severe trial had a higher percentage of severe patients then did the high trial. As a result, the growth hormone response and the control group of that product 11.7 centimeters per year to 12 months. In contrast, in the high trial with severe, but not as many as the real.

The response was 10.3 centimeters, 1.4 centimeters lower, because our Phase III will be a much more homogeneous trial, because we're only selecting the less severe idiopathic who are further up also to come chosen. It'll be inherently more homogeneous than either of those two trials.

And because it's less severe, we would expect to see a high velocity similar to that in the U.S. population in the high trial, which is in concordance with the databases, around 8.3 centimeters to 8.6 centimeters per year.

And then there are three factors, which will predict the Phase III trial will be even more homogeneous, certainly than our Phase II trial. Most importantly, and have a sort of balance, important 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 LUM-201 and 120 subjects to 140 subjects, versus 60 subjects to 70 subjects on growth hormone. The much larger trial inherently will get much more, a better balance than either our 10 subjects to improve interim analysis, or even the 20 subjects were reporting in the fourth quarter.

The greater side of the trial also allows us to try to find by three factors to two 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 to inclusion criteria, which will make it important, very similar to that in the high trial, which further improve the homogeneity of the trial.

Does that answer your question about the Phase III design?.

Next question comes from Charles Duncan of Cantor Fitzgerald. Your line is now open. .

Good afternoon, Rick and team. Thanks for taking our question. And congrats on your progress in the quarter. I had a couple of questions. First about the IMPE meeting. It sounds like well as you characterize it 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 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 it with your answer..

Sure, thanks, Charles, appreciate that question. So, I think, we had, as Rick mentioned, a presentation and a poster in IMPE and a booth as well. And so, we got lots of interactions with I think, some of the key European, South American and U.S. pediatric endocrinologist.

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 pretenders 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, mentioned 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 deficient or are going to take the shots, or take the treatment, however, comes and I think that there is an opportunity there for this group of kids who is more moderate than maybe a little needle of bursts.

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 modern population..

I will just add to that, even in the current time, PGHD ecologists are dividing their population into idiopathic versus severe organic, and they're really seeing a lot more idiopathic PGHD and, right now, they just can often when 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 empathic population in their current kids.

I think also that the, so just having idiopathic PGHD is pretty predictive response to include one and that's really augmented by also being compositive.

I will also point out that the PEM test based upon the phase two data will be much simpler in phase III and watch with simply a single dose of aluminum into alignment and a single blood test an hour later, which I think will be very, very acceptable.

Because it's far less burdensome than that to some tests these kids undergo without with all of our pediatric endocrinologist..

Helpful John and David. 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 are still developing? And would you start a Phase III without a commercial form if it is the case that you are 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 are going to move forward with the commercial product. And the best possible way to do that is to fully explore that product in Phase III.

And I think we have talked about the patent we have recently submitted, which is tied into formulation and aspects of the molecule that led new opportunities in formulation. So, I think we are 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 the Phase III study..

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

Okay. That clarifies it. Then last question is more strategic John or Rick, excuse me. We have 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 think there is any question that, when a company gets at this stage in development of their product, there is typically what happens is a number of players show up. And as, this is a mature space. There are major players.

And there is no question that, we will be fully engaged in choosing the right partners at the right time, the right territories is a nice problem to have. And our business development is led by almost a 30-year veteran Aaron Schuchart. And Aaron is a busy man these days. Let's put it that way..

Okay. Thanks for taking my questions..

[Operator Instructions]. Our next question comes from Leland Gershell of Oppenheimer. Your line is now open..

Thanks for the update and for taking my questions. Rick wanted to know, in addition to the baseline characteristics update for the 1.6 mg, 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 are looking at in the study? Thanks..

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

We just 1.6 mg cohorts those are kind of the two most important cohort doses are the two important cohorts that compare based on our interim analysis. But we obviously have a fine 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..

Okay. Thank you. And I also want to ask with respect to starting the Phase III.

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 bioequivalence type study to get into the Phase III or any other clinical work that you have to do? Thanks..

Go ahead, John..

Yes. I mean, in general, when you introduce new formulation, you have to do bridging study to compare it back to the data that you have in Phase II. 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 then starting the next the pivotal study?.

John?.

I mean, we were obviously keen to keep that up as soon as possible. As soon as we can, because I think it is the, it would be key to moving forward. So yes, it is definitely to-do list..

As much of any work that we can do [indiscernible] 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..

Okay.

So, Rick, so it sounds like you may be generating those data in parallel with completing the two tendency, 12 studies, or the starting two, and then we could be a bit accelerated as we get into starting the Phase III?.

There's a lot of work to be done between the completion of the trial, the reporting of the data, everything 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..

Got it. Very good. Okay, thanks for taking my questions..

Our next question comes from Ed White of H.C. Wainwright. Your line is now open..

Good afternoon. Thanks for taking my question. Actually, I just have one, you had mentioned that you've 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?.

Obviously, company at this stage of 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 the studies.

We're going to focus on 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 spent a lot of time with the KOL community and ISS and PWS.

Know that they're there, it'd be excellent directions for the for us to take. And we'll both start those studies as quickly as we're able to given any kind of financial restrictions we may or may not have. .

Our next question comes from Yasmeen Rahimi of Piper Sandler. Your line is now open..

Hi, team, thanks so much for taking the questions, 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 run. 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 up to 52 weeks treatment duration? Like, assuming you started your phase III in early 2024? Like, how soon could you be able to bring into 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 are the various data scenarios that you are expecting to see and what action would you take, as we're heading into the top-line data from 210 and 211? And I'll jump back into the queue. Thank you..

Okay, thanks. Yes. And good to hear from you appreciate the question. I think there's a great deal of precedence. And in terms of how long it's taken most companies to enter about a study of about the size. I want to go back to, I think my discussion will be earlier, and the fact is that there was a great deal of competition between three companies.

Concurrently conducting a three large phase III studies globally. That doesn't exist for us. That's one positive thing.

And also, like John said earlier, in effect, is that we I think we've taught the K Well 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, obviously derisking all the trials by using our PDM strategy.

In terms of time to enroll, I think, once again, I think the ascendance trial, 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 have 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, and we're expecting to see, John would you comment please..

Sure. Maybe I'll just comment a little bit first on the timing. 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 and non-inferiority margin.

And then after that meeting, we submit the protocol and then we get the POK from the FDA. We have to reach out to all of the other regulatory agencies, ex-U.S. to get thereby, and then we can potentially start the Phase III.

We'll do as much upfront work as we can, as we talk about in terms of lining CISO [ph] getting everything ready as quickly as we can while we wait for all those regulatory approvals. So, I just wanted to check through the timeline of starting Phase III.

And then, what was the other piece you want to move on?.

The last one 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. And 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 those specifics of the cost available, we will definitely put out that guidance..

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 also improved by the time I get this readout..

Great. Thank you so much, team..

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