Moleculin Biotech - Earnings Call - Q4 2024

Executive Summary

• Q4 2024 results were typical of a pre-revenue biotech: no revenue, markedly lower quarterly net loss vs Q3 as warrant fair-value changes and lower OpEx benefited EPS; cash fell to $4.3M at year-end, with February financings adding $9.3M gross and extending runway into Q3 2025.
• Clinical execution advanced: first country approval in Europe, positive FDA guidance enabling ~10% reduction in Part B size, and an amended protocol to unblind primary efficacy at 45 subjects in H2 2025.
• Management reiterated MIRACLE Phase 3 startup timing (first subject targeted in Q1 2025) and highlighted multiple interim unblindings that could be catalysts in H2 2025 and H1 2026.
• Consensus for Q4 EPS was -$1.28; actual diluted EPS was approximately -$0.37, a significant beat driven by non-operating items and lower OpEx; revenue remained $0 as expected for development-stage biotech (Values retrieved from S&P Global)* [Q4 EPS est: GetEstimates].
• Near-term stock drivers: site activation pace, first patient dosing, H2’25 unblinding (n=45) and STS MB-107 readout by end of April 2025.

What Went Well and What Went Wrong

What Went Well

• Positive FDA guidance on the IND amendment allowed a ~10% reduction in Part B size, accelerating timelines and modestly lowering trial scope.
• First country approval (Ukraine) to begin recruiting for MIRACLE; multiple subjects being screened and additional ethics approvals (Georgia, Egypt) in progress.
• Financing momentum: $5.8M warrant exercises and $3.5M registered direct, plus management’s 8-K disclosure of $9.3M gross proceeds in February, extending runway into Q3 2025.
• Quote: “Unlike most pivotal Phase 3 trials, we will have multiple unblinding of data… roughly thirty days after the forty fifth subject is treated, we will be able to see how the drug is performing” — Walter Klemp.

What Went Wrong

• Cash balance declined to $4.3M at year-end, reflecting sustained OpEx; company still requires significant additional financing to fully conduct trials as described.
• Management disclosed MIRACLE cost could reach $60–70M if fully executed; burn expected to rise from ~$5M/qtr in 2025 to $7–8M/qtr in 2026 as CMC ramps for NDA.
• U.S. enrollment likely to lag other geographies given longer IRB/contracting cycles, potentially front-loading recruitment to Ukraine/Middle East/EU before U.S. sites are active.

Transcript

Operator (participant)

Hello, and welcome to the Molecular Biotech Fourth Quarter and Full Year twenty twenty four Update Conference Call and Webcast. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. At this time, I would like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs, expectations or future projections. These are forward looking statements and involve risks and uncertainties.

Forward looking statements on this call are made pursuant to the Safe Harbor provisions of the federal securities laws and are based on Molecular Land's current expectations and actual results could differ materially. As a result, you should not place undue reliance on any forward looking statements. Some of the factors that could cause actual results to differ materially from these contemplated by such forward looking statements are discussed in the periodic reports Molecular and Files with the Securities and Exchange Commission. These documents are available in the Investors section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully.

Additionally, certain information contained in this webcast relates to or is based on studies, publications, surveys and other data obtained from third party sources in the company's own estimates and research. While the company believes these third party sources to be reliable as of the date of this presentation, it does not independently verify and makes no representation as to the adequacy of fairness, accuracy or completeness or that any independent source have verified any information obtained from third party source. Any data discussed regarding clinical trials and progress are considered preliminary and subject to change. Joining us on today's call from Elektrauma's leadership team are Walter Klimp, Chairman and Chief Executive Officer Doctor. John Paul Weimach, Senior Chief Medical Officer and Jonathan Foster, Executive Vice President and Chief Financial Officer.

I'd now like to turn the call over to Walter Klimp, Chairman and CEO. Wally, please proceed.

Walter Klemp (Founder, Chairman, President & CEO)

Thank you, operator. Good morning, everyone, and thanks for joining us today. I'd like to kick things off with a brief overview of where we are. The entire molecular team has been laser focused on the launch of the MIRACLE Phase three pivotal trial for Ranamycin. Now, this is a study designed to win approval for Ranamycin in combination with Cicerabine for the second line treatment of relapsed and refractory AML patients.

This is a global study with sites planned for The U. S, Europe and The Middle East. 20 5 sites have been selected to date and we've already announced regulatory and ethics approval in our first European country and we expect several more in second quarter. Patient screening has already begun and we still expect our first patient to be treated yet this quarter. Now, in terms of managing expectations, I should point out that The U.

S. Will likely be one of the last countries to begin enrolling in this trial. Now that's not unique to our trial, but rather it's a function of the fact that the approval process between institutional review boards, ethics committees and hospital contract negotiations just take longer than in most other countries. We do already have our first IRB approval in The U. S.

But in terms of overall timelines, you should expect the non EU and Middle Eastern countries like Ukraine, Egypt and Georgia to start first, followed by the more traditional EU member states and then finally The U. S. One of the most important and exciting aspects of the MIRACLE trial is the amount and timing of visibility that molecular stakeholders will have. Unlike most pivotal Phase three trials, we will have multiple unblinding of data so that there is line of sight to exactly how we're tracking. The first of these will be when we reach 45 subjects and we expect to achieve that before the end of this year.

Then there will be a second unblinding at the end of Part A of the trial at between seventy five and ninety subjects. That should be in the first half of twenty twenty six. Part of the reason we expect this to happen so quickly is that the primary endpoint is complete remission after just one cycle which is approximately one month. So, roughly thirty days after the forty fifth subject is treated, we will be able to see how the drug is performing. The other really exciting part of this is how much we already know about anamycin in second line AML patients.

As Paul will discuss in his segment, our Phase II data just keep getting better. Overall survival keeps climbing at eleven months and durability has reached nine months and is still climbing. As a reminder, the performance of Anamycin in our latest Phase II trial was better than any drug ever approved for second line AML patients. Also as we discussed disclosed recently, our latest analysis shows that anamycin overcomes resistance to venetoclax in AML and is delivering durable complete remission in patients where venetoclax has failed. And through all of this, we continue to see a complete absence of drug related cardiotoxicity.

As I mentioned at a recent conference, the latest Anamycin results were frankly so good that a lot of industry players simply didn't believe them. But I can say with confidence that that is beginning to change. A number of key opinion leaders in The U. S. And Europe have now reviewed the data in detail and have even discussed the results with the investigators in the trial who by the way spans seven sites in two different countries.

These experts are now recognizing the significance of the data and the potential importance of anamycin for AML patients and they are now speaking out about the game changing implications of what if approved will be the first ever non cardiotoxic anthracycline. Let me now hand the call over to our Senior Chief Medical Officer, Doctor. Paul Womack, to discuss our clinical activity in more detail. Paul?

John Paul Waymack (Senior CMO)

Thank you, Wally. Well, as we have noted during prior updates, there is an incredible unmet need in AML. And especially for those patients who either don't respond to initial therapy, that is they are refractory to current therapies or quickly relapse after first line induction therapy. And you can see from our Phase II data obtained in our MB-one hundred and six clinical trial, this is where anamycin excels. As we have previously reported, we achieved a fifty percent complete remission rate in these second line patients.

We treated with anamycin plus high dose cyotirabine, which is more than double the performance you would expect from existing therapies. And the durability of our responses continues to improve. As Wally mentioned, our median progression free survival has now increased to nine months with our overall survival among second line therapy patients at eleven months. And as we previously reported, seventy eight percent of them were recorded as negative in terms of measurable residual disease. So, for second line therapy patients, we believe that our durability is shaping up as truly a game changer.

This fifty percent CR rate in second line therapy with anamycin plus high dose cytarabine compares very favorably to a seventeen percent to eighteen percent CR rate reported in two large recent clinical studies in patients with refractory and relapsed AML. And I should note that in both of these studies, the control arm used high dose cytarabine, the exact same control arm we intend to use in our Phase III study. Moving on to our new Phase III study, the MIRACLE trial, it was designed after an end of Phase onetwo meeting with FDA. It is to be a randomized study comparing the dosing regimen with which we had great success in our MB-one hundred and six study that is anamycin plus high dose cytarabine with the control arm of placebo plus high dose cytarabine. We chose this design because FDA encouraged it and because two recent large randomized clinical trials in refractory and relapsed AML patients that is the MIROS and CLASSIC one clinical trials, which are the ones we mentioned in the prior trial, used it and both achieved approximately a seventeen point five percent CR rate among patients randomized to receive high dose cytarabine plus placebo.

To that end, we can expect we will need for our animism plus high dose cytarabine treatment arm to beat a seventeen point five percent CR rate to a statistically significant degree for our drug to be approved by FDA for marketing. And again, in our MB-one hundred and six study, this combination of high dose cytarabine plus anamycin achieved a fifty percent CR rate. For our Phase three study, as I noted, we will be comparing anamycin plus high dose cytarabine against placebo plus high dose cytarabine. During Part A of the study, we will have two different anamycin treatment arms, a one hundred and ninety milligram per meter square treatment arm and a two thirty milligram per meter square treatment arm. There will be unblinding of the data in Part A after the first forty five patients have completed their efficacy analyses and the second unblinding after between seventy five percent and ninety percent of patients have completed their efficacy analyses.

These interim looks at the data are in part to determine which of the two animosin dosing regimens will be taken to completion of the study and the primary efficacy endpoint is the rate of complete remission of leukemia at approximately day thirty five. All patients will be eligible for standard treatments after completion of their experimental therapy. We have already had one site that has been activated and believe that we may begin treating our first patient before this quarter is over. As I previously noted, Part A of the study will determine which of the two animizing dosing regimens to take all the way through to completion of Part B. Part B will randomize two twenty two patients to receive placebo plus high dose cytarabine or anamycin plus high dose cytarabine using whichever animizing dosing regimen Part A found to be superior.

The next slide documents our timelines. I should note as shown on this slide that there is a small possibility that the results from our analyses at the end of Part A could be so definitive so as to confirm the efficacy of anamycin plus high dose cytarabine. If this were to happen, then we might be able, for ethical reasons, to complete Part B as a single arm study. Finally, let me note that although we have had no major clinical updates since our MD-one hundred and six study completed enrollment last year, we have been quite busy clinically designing our Phase three study, obtaining regulatory approval for conducting the study on multiple continents and signing up various hospitals and investigators to participate. As of today, we have approximately 25 sites selected to participate in the study and another approximately 45 who are in the process of completing the selection process, and we still believe that we can begin treating the initial patient in our MB108 study in this quarter.

John, let me pass the baton off to you now.

Jonathan Foster (EVP & CFO)

Thanks, Paul. Well, as we've moved forward with the MIRACLE trial, as Paul just mentioned, so have we with our market cap and our capital raises. With our cash on hand at the end of the year, plus the roughly $9,000,000 that we raised in February of this year twenty twenty five. That combined cash balance of approximately $13,000,000 takes us into the third quarter of twenty twenty five. Our focus in 2024 and into 2025 was and remains on the development of Anamycin, while relying on externally funded programs on WP1066 and WP1122.

Overall, we reduced our operating expenses in 2024 over 2023 by about $3,000,000 Our current market cap is $16,200,000 with 14,000,000 shares outstanding. This is up from year end due to issuance of equity in February of twenty twenty five and our trailing one year trading volume is 1,400,000.0 shares per day. We remain focused on operational execution and meeting our milestones, been very important to us. We've delivered on successfully contracting CROs and sites and early country approvals as we had planned for the MIRACLE trial And we're looking forward to the next upcoming milestones. In first quarter to the third quarter of this year, we'll be updating you on MIRACLE trial site selection and approvals by countries.

In the first quarter of this year, as Wally and Paul discussed, first subject enrolled and treated in our MIRACLE trial. We'll also be doing the data readout and unblinding of efficacy and safety data by the end of this year. And then in the first half of twenty twenty six, we'll have the remaining patients given us a total as Paul mentioned between seventy five and ninety subjects data, we'll unblind that, we'll share that safety and efficacy data with you and we'll also set the optimum dose for Part B of the MIRACLE trial. And then the milestones that follow these readouts and almost just within a year from today, this speed of milestones we believe is exceptional for Phase three trial. Additionally, we expect to publicly release the data readout from MB107, which is our clinical trial with anamycin and monotherapy treating advanced soft tissue sarcoma metastasized to the lungs in April.

And we hope to use that data to develop a pivotal investigator initiated trial in Europe later in 2025. So as one can see, we expect to be extremely busy in 2025. Wally?

Walter Klemp (Founder, Chairman, President & CEO)

Thanks, John. Again, we want to thank everyone for your support throughout 2024. Now it all comes down to this truly pivotal year in 2025. Look, Anamycin isn't just disruptive.

It has the opportunity to change history becoming the first ever non cardiotoxic anthracycline and its unique patented structure is designed to be not just safer and more tolerable, but its lack of cross resistance with traditional cancer therapies means it truly has the opportunity to fill a huge unmet need not only in AML but in a wide range of cancers. The clinical advancement of Anamycin is now in extremely rare territory. You just don't find small biotechs that go into a pivotal Phase three trial with data better than any drug ever approved in the space and then have the opportunity for an early look at approval data. And in our case, the approval bar is extremely low and we expect everyone will have a chance to confirm that before this year is out. Moleculin has a diverse exciting pipeline and is guided by one of the most experienced development teams in biotech.

Twenty twenty five is our year to bring this all together. You won't want to miss what's about to unfold. So thanks again everyone and have a great day. Now open for questions.

Operator (participant)

Thank you. We'll now be conducting a question and answer session. Our first question today is coming from Jonathan Ashcroft from Roth Capital Partners. Your line is now live.

Jonathan Aschoff (Managing Director, Senior Research Analyst)

Thank you. Good morning, guys. I was curious what efficacy is required to pick one anamycin dose at forty five patients rather than waiting till ninety if it doesn't happen at forty five?

Walter Klemp (Founder, Chairman, President & CEO)

Well, it's that's a multi variable equation that we would be ill advised to speculate in too much detail. But generally speaking, let me start by saying this and I'm going to invite Paul to maybe give some additional thoughts.

If we do as well in Part A, if Anamycin does as well as it did in the Phase two clinical trial and HYDAC simply performs as prior clinical trials have indicated, then we probably hit that number, that statistical significance that's required to frankly shorten the trial and accelerate approval even faster. That said, I mean, one, we don't have to be that good to win approval, but I know you're asking what could excel, what would it take to accelerate. And but there's another possibility here and we would argue a probability and that is that the HYDAC numbers are not are likely not to be as good as the historical numbers. And the reason is because those historical numbers were allowed multiple cycles of the drug to get their seventeen percent to 18% CR rate, whereas our CR rate of fifty percent came with just one cycle and that's all that HYDAC is allowed in this trial as well. So we expect HYDAC will probably underperform published statistics because they're going to be limited it's going to be limited to one cycle.

So there are multiple ways to get to the point you're looking for, Jonathan. And obviously, we can't speculate too much about which of those outcomes. That's why we got to run the trial. But Paul, do you have additional thoughts there?

John Paul Waymack (Senior CMO)

Yes. As Wally said, this is a multi variable equation with not only what is the efficacy, what is the safety, what is the pharmacokinetic data. There will be also the secondary endpoint. It is very difficult to predict. As I said, I think the odds are against us ending early, but it is a possibility. It is a definite possibility.

Jonathan Aschoff (Managing Director, Senior Research Analyst)

All right. Thanks for that. Towards the end of the trial, what was the thinking that went into cutting off about ten percent of patients from Part D? Was there much thinking behind that or not really that much?

Walter Klemp (Founder, Chairman, President & CEO)

Well, that really came as a result of FDA when they review protocols will often comment and make suggestions.

In this particular case, they specifically requested or suggested that we follow a slightly different biostatistical scheme than originally planned. And that recommendation essentially allowed us to reduce the number of patients.

Jonathan Aschoff (Managing Director, Senior Research Analyst)

Okay. That's straightforward enough. On the other program, what is the STS long net efficacy bogey you need to hit to proceed to even if it's just an investigator sponsored pivotal trial?

Walter Klemp (Founder, Chairman, President & CEO)

Well, I mean, we've frankly already hit that in really broad strokes. The STS patients we've treated turned out to be much more, if you will, challenged than we originally expected. The early part of the trial was focused on third and fourth line patients, but as the trial progressed and we got through the Phase two part of the trial, that got even worse. So, now we haven't published the officially published the results yet, but we're about to. But what you'll see is we were really treating the bottom of the barrel and we were getting we're seeing OS numbers that are what you would normally expect in first line patients who were treated with docs, for example.

Well, to get that kind of performance in third, fourth and beyond line, it has already gotten the attention of sarcoma experts. One of the most prestigious sarcoma institutes in Europe has looked at the they've looked at the data and said, we'd really like to we think this thing is ready for a pivotal approval trial and we'd like to be leading that if possible. So we still need to get the clinical study report done and published. Like I said, that's coming, but the data are very strong.

Jonathan Aschoff (Managing Director, Senior Research Analyst)

Full investigator sponsored idea for a pivotal trial that was pretty much entirely inbound interest?

Walter Klemp (Founder, Chairman, President & CEO)

Yes.

Jonathan Aschoff (Managing Director, Senior Research Analyst)

Thank you very much guys.

Walter Klemp (Founder, Chairman, President & CEO)

Thanks Jonathan.

Operator (participant)

Thank you. Next question today is coming from Jason McCarthy from Maxim Group. Your line is now live.

Walter Klemp (Founder, Chairman, President & CEO)

Hey, Jason.

Jason Mccarthy (Senior Managing Director)

Hi, guys. Thanks for taking the questions. So first question, just in terms of the overall cost of the trial, what are you guys thinking there?

Walter Klemp (Founder, Chairman, President & CEO)

John, you want to handle that one?

Jonathan Foster (EVP & CFO)

Yes. I mean, it's a Phase III trial. So if you go out to the full patient load, you're talking upwards of $60,000,000 70 million dollars But our cash burn for the next rest of 2025 is $5,000,000 a quarter. We've been very public about that. And then that goes up probably to $7,000,000 or $8,000,000 a quarter in 2026 as we began filling out some of the CMC requirements for an NDA. And, but what's very important to us is getting this data out, so we can get back to conversations with bid and big pharma that are very, very interested in these midterm data readouts.

Jason Mccarthy (Senior Managing Director)

Okay, great. And then just a more broad question here. I mean, we're seeing this theme emerging more in AML development of moving to frontline once showing activity in the relapsed refractory setting. You guys just general thoughts there?

Walter Klemp (Founder, Chairman, President & CEO)

Yes. I'm going to suggest that Paul tackle this question, but in general, we get that question a lot of once we get approval in second line, is it logical for this drug to be used in first line? But Paul, you want to expand on that?

John Paul Waymack (Senior CMO)

Yes. Once we document that this drug works and have filed our NDA, we're going to be in multiple different areas. Now one of which we have to be doing a pediatric study to comply with the pediatric requirements that are in place. We're going to be doing a third line therapy study, which, FDA requires. But I agree with you.

Ultimately, it's first line therapy, which is the biggest market because you don't get the second or third line unless you were initially a first line therapy patient. And we have clearly shown, I believe, that unlike all other anthracyclines, we are not cardiotoxic. Unlike other anthracyclines, we don't have a problem with the, multi drug resistance. And we do agree, however, that first line therapy patients should get seven plus three where the three is n antrocycline. So we should have that market plus half of all first line therapy patients should get seven plus three, but they don't because they're unfit, meaning they're 65 or they have a heart problem.

Well, that doesn't apply to us. We've treated people who are unfit in our 106 trial and we had no problem. So, we agree eventually, first line is our ultimate objective in AML and we will proceed there once we have shown that we are approvable for an NDA for second line therapy.

Jason Mccarthy (Senior Managing Director)

Okay, great. That's all for me. Thank you.

Operator (participant)

Thank you. Next question today is coming from Brandon Bernardino from H. C. Wainwright. Your line is now live.

Walter Klemp (Founder, Chairman, President & CEO)

Hey, Brandon.

Vernon Bernardino (Managing Director)

Hey, Wally. Thanks for taking my question. And hey, Jonathan and John. Just wanted to follow-up on the questions about the Merkel doses. Just wonder if you could walk us through the rationale for choosing the one hundred and ninety dose, discussions with the FDA?

And then also what dose do you anticipate using for the soft tissue sarcoma trial?

Walter Klemp (Founder, Chairman, President & CEO)

Sure. This all relates to the now infamous project optimist that FDA has embarked on. But I think Paul is probably in the best position to maybe comment on the rationale and what we expect going forward, Paul?

John Paul Waymack (Senior CMO)

Yes. Obviously, we chose two thirty for this study because two thirty got the great results we were seeing in our 106 study. For OPTIMUS, FDA wanted us to go to a lower dose. We went to one hundred and ninety because we had used that also in our 106 study and saw efficacy. And the FDA has not required us to go any lower.

As far as which one I think will work, I actually think both of them will work to a reasonably similar degree. And so, I think it's going to be a very close call. It's not an easy pick. If I did two thirty versus 110, I'd pick two thirty, but two thirty versus 190, I can't make you a prediction right now as far as which one we'll use. We'll see what all the data show because it's going to be a lot of data.

It's going to be efficacy, short term, long term. It's going to be safety. It's going to be PK. It's going to be a wealth of data which we're going to have to go through very quickly. As far as the sarcoma question, it's an entirely different dosing regimen.

We have used monotherapy to get our results, but we've used a much higher dose. We've used just one each cycle is just one dose. We're around three hundred milligrams per meter square. We're getting good efficacy, reasonable safety. So I think we will be around there.

But before we were to finalize a dosing regimen for a pivotal sarcoma study, we would request an end of Phase onetwo meeting with FDA to get their blessing on their entire plan.

Vernon Bernardino (Managing Director)

Okay. Just thanks for that. Just one follow-up regarding the one hundred and ninety dose. I guess we could expect if it was two thirty, you're going to hit and be better than high XER rates for what was observed in Miros and Classic I. But in the one hundred and ninety dose, do you have to be superior to the seventeen percent, eighteen percent that was observed to continue to perhaps apply for early or you still need to go to two thirty if?

John Paul Waymack (Senior CMO)

Yes. When we look at the interim results, if one dose is clearly superior to the other, let's say two thirty has a much better complete response rate and similar safety, then the comparison would be the two thirty dose versus placebo. We're going to have to be better than whatever we get with the placebo plus high dose cytarabine in order for FDA to approve it. If we go through all the way randomized Part B, it's our data from 01/2006 or anywhere close to resembling what we're going to get in 01/2008, it's going to be an easy win. As far as if we document statistical significance just after Part A, it's a little complicated because of the fact that biostatisticians will tell you the alpha of five is for the entire trial.

And so you save most of it for the end. So five would not get you approval after Part A, would have to be a very statistically significant number. The P would have to be less than one. How much less? That again, it depends on the totality of the data, on the safety data, the PK data and the efficacy data.

So it's difficult to predict. It's easier to predict for we go through to Part B, because there unless something really bad happens as long as your improvement with anamycin plus citerabine is significant compared to placebo plus citerabine and the P is less than it's going to be about something like 0.048, we'll lose a little of that because the interim look, it's an easy call that we will win. After Part A, it's a very complicated process that's difficult to do.

Walter Klemp (Founder, Chairman, President & CEO)

Let me add one insight here Vernon that might also kind of tie this together for you. Let's just say that we get to the 45 subject level and it's just obvious that two thirty is a better choice than 190. And we could shorten that by saying more effective, but it does have to be you have to meet all the safety requirements too. So safety and tolerability and have a decent PK profile. So let's just assume that all those boxes are checked and two thirty is clearly a better choice than 190.

At that point, we probably would just drop continuation of treatment at 190. Now there's a timing problem here. It's a good problem, but it's still an issue and that is that once you get 25 sites up and running, the rate of recruitment picks up dramatically. And so by the time we get the 45 patient data scrub it and lock the database and disclose it, we could well be all the way to 90 patients anyway. But in a perfect world, if we saw the results at 45 and let's just assume that two thirty was the winner, then we would stop recruiting the 190 arm because we don't need any more data.

And that's why when you look at our Part A in the timelines and the disclosures that we say somewhere between seventy five and ninety patients. And that's because we're anticipating the possibility that we may have a clear winner at forty five and therefore no need to keep recruiting at the other dosage. Does that make sense?

Vernon Bernardino (Managing Director)

Yes. Will that be able to preserve the 190 though, such that should any safety signals appear?

Walter Klemp (Founder, Chairman, President & CEO)

That's of course, that's always a possibility. And we don't want to sound overly confident here, but we've got enough experience with this drug, not just in MB-one hundred and six, but in MB-one hundred and five and one hundred and four that were the single agent trials in AML as well as the STS trials, we've got a pretty clear picture of the safety profile of this drug even above two thirty. So we're I think that's a very unlikely event, but of course if we got down the road and it looked like two thirty was all of a sudden surprisingly a problem, then we could revert to 190. But I believe we will have enough data certainly by the end of Part A that everyone will have a lot of confidence in that choice.

Vernon Bernardino (Managing Director)

Thank you. This is very helpful insightful. Thanks for taking my questions.

Walter Klemp (Founder, Chairman, President & CEO)

You bet, Varane. So, operator, I think we're done. I appreciate everybody's time and attention. And again, thanks for joining us.

Operator (participant)

Thank you. That does conclude today's teleconference and webcast. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.