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Good morning. Welcome to the Moleculin Biotech First Quarter 2025 Update Conference Call and Webcast. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to turn the call over to your host Jenene Thomas, Investor Relations. Please go ahead, Jenene.

Thank you, Rod, and good morning, everyone. At this time, I'd 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 that 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 Moleculin’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 Moleculin 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, fairness, accuracy, or completeness or that any independent source has 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 Moleculin’s leadership team are Walter Klemp, Chairman and Chief Executive Officer; Dr. John Paul Waymack, 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 Klemp. Wally, please proceed.

Thanks, Jenene. Hello, and welcome to our first quarter earnings conference call. For most of our investors, the focus is on the Phase 3 MIRACLE trial, studying Annamycin for the treatment of relapsed and refractory acute R/R Acute Myeloid Leukemia. And with good reason. This trial has now officially started with the first patient already treated and more on the way. In total, we now have 38 sites selected worldwide between the US, Europe, Middle East and North Africa. We just announced this week that we also received complete sign off from the European Medicines Agency for all nine countries that we wanted to open in the EU. That was one of the longest lead time items for getting the EU up and running. So it was a major milestone and a real show of support from the EMA for our trial design and our objectives. Also, the World Health Organization has officially recognized a new generic drug name for Annamycin, which may now be referred to in literature as naxtarubicin. This was an important first step in actually launching Annamycin once it receives new drug approval. And compared with some of the unpronounceable crazy drug names out there, we're really pleased with naxtarubicin, especially since it sounds a lot like the next Rubicin, which really plays into the next generation positioning of Annamycin. You should expect to see us using both names together until such time as we establish an FDA approved brand name, which is the next step in positioning the drug for launch. And we also announced some additional patent protection for Annamycin. Even though we already had composition of matter protection extending into at least 2040, these additional patents just continue to build a wider fence of protection around our core asset. We should also be announcing a date for the presentation of the final data from our MB-107 clinical trial using Annamycin to treat advanced soft tissue sarcoma. Although the preliminary numbers were impressive, we think the final data are really going to turn some heads. So we look for an announcement on that. So please look for an announcement on this in the coming weeks. Now, this graphic gives you a better perspective on the status of our site selection and approval process for the MIRACLE trial. Compared with the version from our last earnings call, we now have the great majority of countries and sites approved from a regulatory standpoint. And now we're just wrapping up hospital contracts and local ethics approvals. Just to be clear though, the most important milestone for us coming up will be the unblinding of the first 45 patients. A lot of eyes will be on us for this data point, as it should tell the world definitively that we are likely headed for new drug approval. With that said, what you see here is what gives us so much confidence that we expect to have those first 45 patients treated before the end of this year. To drive this home, just averaging one patient per site for the remainder of the year gets us there. And given the enthusiasm that we've seen from these sites, we think we're going to outpace that rate. Now look, we know a lot of investors think that Annamycin is the entire ballgame for us. And to be sure, it's where most of the attention should be focused because it's so close to NDA submission. But we do have two other very exciting technologies. And one of them is WP1066, our lead STAT3 inhibitor. Don't forget that WP1066 has already shown activity in the treatment of brain tumors. And that was with a very inefficient form of drug delivery. Well, now WP1066 is in another investigator-sponsored clinical trial, this time in combination with radiation at Northwestern University. And since we announced this trial in September of last year, we've already recruited seven patients. That's nearly a patient per month for just one site. So this is moving quickly. Now, this is still with the existing oral delivery, which we know isn't optimal. And we're collaborating with Emory University on the development of an IV delivery for 1066, which we think could significantly improve its activity. So we'll keep you updated as more developments occur here. Well, that gives you a high-level overview of recent events, so now let me hand things over to Dr. Paul Waymack, Senior Chief Medical Officer, to give you a few more insights into our clinical activity. Paul?

Thanks, Wally. Before I speak about the MIRACLE trial, let's catch up on our MB-106 Phase 2 trial, which had essentially the same inclusion and exclusion criteria, plus the same treatment regimen for patients as MIRACLE, except we treated some first-line, plus some third-line and beyond subjects in MB-106. Our first patient, who did not receive a bone marrow transplant, but did achieve a complete remission, finally relapsed after over 600 days. While we are disappointed for this subject, it must be said that achieving an almost two-year complete remission for a 78-year-old following 17 cycles of a venetoclax regimen, it's remarkable given the recent literature, which documents the dismal median overall survival for venetoclax regimen failures, which have a median overall survival of less than three months, regardless of further treatments. Our durability for MB-106 is still developing as the final three subjects are maintaining their complete remission. You can see on this chart that receiving a bone marrow transplant definitely correlates with better durability. And if these three keep moving to the right, the median durability for the trial should eventually be even with subject two's durability. That is roughly 400 days. Now, moving on to the MIRACLES trial. We will only treat initial refractory relapsed AML subjects. That is, this is a second-line therapy study, where Annamycin in combination with cytarabine will be delivered on a five-plus-three-days basis, compared to just cytarabine plus placebo. As Wally mentioned, recruitment and treatment of subjects is already underway in Ukraine, and we expect the initial readout of safety and efficacy data on the first 45 subjects around the end of 2025. On May 12th, we announced that the European Medicines Agency, that is, the EMA, they approved our clinical trial application to conduct our MIRACLES trial in all nine countries we submitted to in the EU. We received final reports of acceptable for Belgium, Czechia, France, Germany, Italy, Lithuania, Poland, Romania, and Spain. These approvals were under the condition that we submit results of appropriate non-clinical GLP studies before initiating the Phase 3 portion, that is, part B of the MIRACLES study. Combined with individual country committees and ethics approval for these nine countries in the EU allows us to proceed enrolling subjects in these countries. Also, in November 2024, we amended our existing US IND by submitting the MIRACLES trial protocol, which allows for dosing of US AML patients above the lifetime maximum allowable dose for currently prescribed anthracycline. Since then, we received FDA feedback and guidance on that amendment. This feedback allowed a reduction in the number of subjects to be enrolled in part B of the Phase 3 pivotal protocol to 222 patients. And obviously, any reduction in recruitment numbers helps to shorten the time to completion of the trial. FDA made a number of other requests related to our protocol. These requested changes focused mainly on safety and subject monitoring, clinical pharmacology, and inclusion exclusion criteria. None of the requests resulted in significant alterations in the overall trial design or the dosing of Annamycin. Our last response to FDA was submitted on April 18, 2025, and we have not yet received follow-up communication since that time. We are therefore now proceeding with this amended miracle trial protocol in the U.S. As is typical with large, pivotal Phase 3 global clinical trials at their onset, there are minor differences between the U.S. and EU protocols due to FDA and EMA requests. However, we do not view these as a barrier to successfully completing the study, and we are now working to harmonize the protocols into a single global version. Regarding our newly initiated Phase 3 study, it was designed after an end of Phase 1/2 meeting with FDA. It is to be a randomized study comparing the dosing regimen with which we had great success in our MD-106 study, that is, Annamycin plus high-dose cytarabine, with a 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 Mirros and Classic 1 clinical trials, used it and both achieved approximately a 17.5% complete remission rate among patients randomized to receive high-dose cytarabine plus placebo. To that end, we can expect we will need for our Annamycin plus high-dose cytarabine treatment arm to beat a 17.5% complete response rate to a statistically significant degree for our drug to be approved by FDA for market. But as a reminder, in our MD-106 study, this combination of Annamycin plus high-dose cytarabine achieved a 50% complete remission rate. The primary efficacy endpoint for this study will be the rate of complete remission of the leukemia at approximately day 35. During Part A of our study, we will have two different Annamycin treatment arms, a 190 milligram per meter square treatment arm and a 230 milligram per meter square treatment arm. There will be an unblinding of the data in Part A after the first 45 patients have completed their efficacy analyses and a second unblinding after between 75 and 90 patients have completed their efficacy analyses. These interim looks at the data are in part to determine which of the two Annamycin dosing regimens will be taken to completion of the study. In Part B of the study, we will continue enrolling patients, but we will then randomize in a one-to-one ratio the placebo plus Annamycin plus cytarabine treatment arm against whichever of the two dosing regimens of Annamycin was found to be superior plus the cytarabine treatment arm. Finally, as Wally mentioned, we intend to release the final data readout on MD-107 where we treated advanced soft tissue sarcomas, which had metastasized to the lung with Annamycin as monotherapy. Most subjects were treated well above the lifetime maximum anthracycline dose, and yet after reviewing all the cardiac safety data, our expert noted that he saw no signs of study-related drug-induced cardiotoxicity. We are excited about the results of these trials, obviously. Now I'll turn it over to Jon Foster, our Executive Vice President and CFO. Jon?

Thanks Paul. We ended the quarter with about $8 million with cash on hand. This should run our operations into the third quarter of this year. To get us well into the first quarter of 2026, we will need to raise approximately $15 million. Now we expect this amount will get us beyond the initial 45-subject data readout, supporting our efficacy rates with 30 additional subjects receiving Annamycin or naxtarubicin. Also, by then we should have a total of 75-90 subjects recruited, moving us closer to the second data readout and the first half of 2026. Our market cap is up to over $14 million with 14.1 million shares outstanding. Our trading volume is healthy with a three-month trading volume of almost 6 million shares per day. It is spiky. We had a healthy volume of about 2.4 million shares traded this past Monday with the EU news that Wally and Paul just mentioned. Now, we've been busy by looking at this chart. We've delivered on contracting sites, site selections, presenting presentations, medical posters on MD-106, and also on our sponsored research at MD Anderson. Most importantly is what we announced Monday, the approval of the EU member countries. Obtaining all of these approvals with just 17 employees supported by a great team of consultants on the timeline which we expected and we told the public is something of which we're very, very proud. This sets the stage for announcing outside of the EU and the U.S. additional country regulatory approvals along with first by country hospital site initiation visits which sets them up to be open to recruitment. We'll update you on recruitment on our path to get to the initial 45 subjects, 15 of the control arm, and 30 with the two different doses of Annamycin. Now, this safety and efficacy readout in addition to the MD-106 data should provide the market enough data to support a substantial increase in our market cap. Wally?

Thanks, Jon. From a big picture perspective, we are all intensely focused on pushing Moleculin’s market cap into the range that it truly deserves, and we think the building blocks for that market cap breakout are well placed. Annamycin is a truly disruptive technology in a space where exit valuations are often measured in the billions. The fact is we are positioned to possibly become the first ever non-cardiotoxic anthracycline. And don't forget, anthracyclines are used to treat not just AML but nearly half of all cancers and 60% of all childhood cancers. And Moleculin doesn't just avoid cross-resistance with other anthracyclines and chemotherapies like venetoclax. It actually outperforms current anthracyclines in most preclinical tumor models. It's not just that we believe we have a better drug here. It's far more clinically advanced than we think the market is giving us credit for. Our Phase 2 efficacy data is better than any drug ever approved for second-line AML therapy, and we should have Phase 3 data to share publicly by the second half of this year. All of this is supported by a diverse pipeline of follow-on technologies and is managed by a truly veteran drug development team with multiple FDA approvals and big pharma exits to our names. The key milestones are coming quickly this year, so stay tuned for a wild ride at Moleculin. Operator, we're now ready to open up for Q&A.

[Operator Instructions] The first question is from the line of Jonathan Aschoff with ROTH Capital.

Thanks. Good morning, and congrats on getting MIRACLE enrolling. I was curious, the statement about the results will be submitted as a substantial modification to the EMA, does that have any negative implications for the timeline of EU approval versus U.S.?

Well, we don't think so. As the issue here is EMA requested some additional GLP preclinical data that we know we can produce. It's just a matter of timing and budgeting. So the issue here will be how quickly we can complete that GLP testing before the EU countries are allowed to move on to Part B. That said, Jonathan, the timelines that we've built, we would continue to be recruiting in the U.S. sites and the non-EU sites even during that interim period, in theory. So the trial really doesn't have to slow down, and we believe we will get to the requisite number of EU patients to satisfy EU approval requirements. So the answer is, in theory, it shouldn't change the timeline for approval for EMA, but we have to acknowledge that depending on the time it takes to get those GLP studies done, that it could, but that's not our expectation.

Okay. How close is Emory, you think, to getting an optimal formulation? Like in the bag by the end of this year, or is it something that could drag out a little?

The thing every time you ask a scientist to give you a timeline for discovering something new, they'll give you a lecture on what it takes to discover something new, right? We think we're beyond having to discover something new stage and that where we are now is actually implementing a strategy for a new formulation that satisfies the needs for IV delivery. So we feel like we're now in blocking and tackling and just getting the preclinical work done so that we can move this into clinic. And I feel like your sort of estimate there for by the end of the year is a decent target, but I do have to acknowledge things can always -- you can always get speed bumps when you're developing a new formulation. So we don't want to overpromise there, but I think you should expect to hear something from us before the end of the year.

Okay, that's very fair. One for Jon, please. Is that $3.5 million sort of a fair run rate for R&D for the rest of the year's quarters, or is that, I mean, that should go up, shouldn't it?

Yes, it'll go up, especially as we head into 2026 when we bring on the GLP and some manufacturing expenses. Right now we have enough drug for Part A, we'll have to start manufacturing drug for Part B.

The next question is in the line of Jason McCarthy with Maxim Group.

Hey, guys, thank you for taking the questions. Good morning. You mentioned the primary is the 35-day CR rate call it one month just for simplicity. Do you need any durability data for potential approval, or is one month enough? And what are really the expectations for cytarabine alone? And if CRs are achieved with cytarabine, how long do they typically last? I'm trying to get a sense of what the bar is going to be here when you get to that unblinded interim data and say, like this looks like this should carry through all the way to the end for an approvable drug.

Well, I'm going to ask Paul to sort of give you a more thorough answer, Jason, but the good news, just to be really clear, the good news is durability is not a primary endpoint for approval here. It's a secondary objective. So, our approval doesn't depend on that. But it's still an interesting topic, and I think it's important to talk about. So, Paul, do you want to maybe give a more thorough response to Jason here?

That's a good question. As Wally said, FDA has said that's their primary endpoint. And these studies I quoted that had the 17% to 18% CR rate with high-dose cytarabine, these were not small studies. These were studies where the control arm of cytarabine plus placebo had hundreds of patients. So, we are, therefore, quite confident that in our trial, the CR rate with cytarabine is going to be in the teens. It will, as far as durability, it will last for a few months. But that's a secondary endpoint. Of course, the ultimate arbitrator is FDA. But at our end of Phase 1, two meeting, they said that's our endpoint, and they understand that we are not powered to show statistical significance for, we're not reasonably powered to show statistical significance for these other ones. There should be a strong trend. This is because that's what the FDA asked for. And when you look at the recent approvals for AML drugs, CR rate was the primary endpoint. The secondaries were overall survival durability. Those were trends. They never reached statistical significance for these drugs. So, we think we're in good shape there. And certainly, if we are anywhere near the 50% CR rate, we're in great shape.

There's a nuance here, too, Jason, that I think is important to feed in. And that is the prior studies that Paul mentioned, two specifically, the Mirros trial and the Classic 1 trial. Both of those studies allowed multiple cycles of cytarabine before measuring for CR. So, that's a difference between their trial designs and ours. In our trial, you only get one cycle. You only get that roughly 35 days. And that's when we measure. So, if the patient can't get a CR off of a single cycle of cytarabine plus placebo, then that counts as not a CR. So, partly why Paul said we expect it to be in the teens, what he didn't say was our instincts say it's probably going to be lower than that 17.5% because those patients were allowed more than one cycle of cytarabine. In ours, they won't get more than one cycle. So, logic says we should expect that number to be lower. Now, we're not statistically planning on that, but it's what we expect.

And I'd imagine that some of your results or could they be impacted by underlying factors like age and mutational genomic alterations, are those things that will be considered when you announce the data?

Well, for sure, we will stratify by age and by genetic mutations, but our primary endpoint isn't dependent upon it. And interestingly, when you look at the Phase 2 data that we've talked about, that Paul's talked about, we're pretty agnostic to what genetic mutations are and to what prior therapies were. So, but our view is we're glad for all comers. It's a funny, just an anecdotal story. When Paul and I presented this protocol to a number of practitioners, a common theme from the practitioner was, well, we assume you're going to exclude venetoclax failures because they're so difficult to treat. And our answer is no, absolutely not. Bring them on. We are not excluding venetoclax failures. In fact, we're hoping for them because the results are so dismal for those patients. And our Phase 2 data say we deliver essentially the same CR rate for venetoclax failures as we do for anybody else. So, we are not sensitive to those differentiations in terms of, because obviously fitness for intensive chemotherapy is largely determined by age. So, there's also the assumption that we are adverse to elderly patients and that's just not the case. Our median age in the Phase 2 data set was in the 60s. And so, we're happy to have elderly patients and we're happy to have mutational abnormalities and venetoclax failures.

This will conclude today's question-and-answer session and also conclude today's call. Thank you for your participation. You may now disconnect your lines at this time. Have a wonderful day.

Hello, and welcome to the Moleculin Biotech Fourth Quarter and Full Year 2024 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'd 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 that 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 Moleculin’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 different materially from these contemplated by such forward-looking statements are discussed in the periodic reports Moleculin 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, 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 Moleculin’s leadership team are Walter Klemp, Chairman and Chief Executive Officer; Dr. John Paul Waymack, 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 Klemp, Chairman and CEO. Wally, please proceed.

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 Moleculin team has been laser focused on the launch of the MIRACLE Phase 3 pivotal trial for Annamycin. Now, this is a study designed to win approval for Annamycin in combination with Cytarabine for the second line treatment of relapsed and refractory AML patients. This is a global study with sites planned for the US, Europe, and the Middle East. The 25 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 US 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 takes longer than in most other countries. We do already have our first IRB approval in the US, 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 US. One of the most important and exciting aspects of the MIRACLE Trial is the amount and timing of visibility that Moleculin stakeholders will have. Unlike most pivotal Phase 3 trials, we will have multiple unblindings 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 75 and 90 subjects. That should be in the first half of 2026. 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 30 days after the 45th 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 Annamycin in second-line AML patients. As Paul will discuss in his segment, our Phase 2 data just keep getting better. Overall survival keeps climbing at 11 months and durability has reached nine months and is still climbing. As a reminder, the performance of Annamycin in our latest Phase 2 trial was better than any drug ever approved for second line AML patients. Also, as we discussed -- as disclosed recently, our latest analysis shows that Annamycin 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 Annamycin 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 US 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, spanned seven sites in two different countries. These experts are now recognizing the significance of the data and the potential importance of Annamycin 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, Dr. Paul Waymack, to discuss our clinical activity in more detail. Paul?

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 their refractory to current therapies, or quickly relapse after first-line induction therapy. And you can see from our Phase 2 data obtained in our MB106 clinical trial, this is where Annamycin excels. As we have previously reported, we achieved a 50% complete remission rate in these second-line patients. We treated with Annamycin plus high-dose Cytarabine, 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 amongst second line therapy patients at 11 months. And as we previously reported, 78% 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 50% CR rate in second-line therapy with Annamycin plus high dose Cytarabine compares very favorably to a 17% to 18% 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 3 study. Moving on to our new Phase 3 study, the MIRACLE trial. It was designed after an end of Phase 1/2 meeting with FDA. It is to be a randomized study comparing the dosing regimen with which we had great success in our MB106 study, that is, Annamycin 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 Mirros and Classic I clinical trials, which are the ones we mentioned in the prior trial, used it, and both achieved approximately a 17.5% CR rate among patients randomized to receive high dose Cytarabine plus placebo. To that end, we can expect we will need for our Annamycin plus high dose Cytarabine treatment arm to beat a 17.5% CR rate to a statistically significant degree for our drug to be approved by FDA for marketing. And again, in our MB106 study, this combination of high dose cytarabine plus Annamycin achieved a 50% CR rate. For our Phase 3 study, as I noted, we will be comparing Annamycin plus high dose Cytarabine against placebo plus high dose Cytarabine. During Part A of the study, we will have two different Annamycin treatment arms, a 190 milligram per meter square treatment arm and a 230 milligram per meter square treatment arm. There will be unblinding of the data in Part A after the first 45 patients have completed their efficacy analyses and the second unblinding after between 75% and 90% of patients have completed their efficacy analyses. These interim looks at the data are, in part, to determine which of the two Annamycin 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 35. 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 Annamycin dosing regimens take all the way through to completion of Part B. Part B will randomize 222 patients to receive placebo plus high-dose Cytarabine or Annamycin plus high-dose Cytarabine using whichever Annamycin 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 Annamycin 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 MB106 study completed enrollment last year, we have been quite busy clinically designing our Phase 3 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 order. Jon, let me pass the baton off to you now.

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 million that we raised in February of this year, 2025, that combined cash balance of approximately $13 million takes us into the third quarter of 2025. Our focus in 2024 and into 2025 was and remains on the development of Annamycin, while relying on externally funded programs on WP1066 and WP1122. Overall, we reduced our operating expenses in 2024 over 2023 by about $3 million. Our current market cap is $16.2 million with 14 million shares outstanding. This is up from year-end to the issuance of equity in February of 2025. And our trailing one-year trading volume is 1.4 million shares per day. We remain focused on operational execution and meeting our milestones, it's 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 the first quarter through 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 have 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 2026, we'll have the remaining patients given us a total, as Paul mentioned, between 75 and 90 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 3 trial. Additionally, we expect to publicly release the data readout from MB107, which is our clinical trial of Annamycin and monotherapy treating advanced soft tissue sarcoma metastases 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?

Thanks, Jon. Again, we want to thank everyone for your support throughout 2024. Now, it all comes down to this truly pivotal year in 2025. Look, Annamycin 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 Annamycin is now in extremely rare territory. You just don't find small biotechs that go into a pivotal Phase 3 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. 2025 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 Instructions] Our first question today is coming from Jonathan Aschoff from Roth Capital Partners. Your line is now live.

Thank you. Good morning, guys. I was curious, what efficacy is required to pick one Annamycin dose at 45 patients rather than waiting until 90 if it doesn't happen at 45?

Well, that's a multivariable 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 Annamycin does as well as it did in the Phase 2 clinical trial, and HiDAC 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. But there's another possibility here, and we would argue a probability, and that is that the HiDAC 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 17% to 18% CR rate. Whereas our CR rate of 50% came with just one cycle, and that's all that HiDAC is allowed in this trial as well. So we expect HiDAC 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?

Yes. As Wally said, this is a multivariable equation with not only what is the efficacy, what is the safety, what is the pharmacokinetic data, there will be also the secondary endpoints. 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.

All right. Thanks for that. Towards the end of the trial, what was the thinking that went into cutting off about 10% of patients from Part D? Was there much thinking behind that or not really that much?

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.

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

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 2 part of the trial, that got even worse. So now we haven't published, 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 Dox, 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 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.

A full investigator-sponsored idea for a pivotal trial. That was pretty much entirely inbound interest.

Yes, yes.

Thank you very much, guys.

Thanks, Jonathan.

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

Hey, Jason.

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?

Jon, you want to handle that one?

Yeah, I mean it's a Phase 3 trial, So if you go out to the full patient load, you're talking upwards of $60 million, $70 million. But our cash burn for the next -- rest of 2025 is $5 million a quarter. We've been very public about that. And then that goes up probably to $7 million or $8 million a quarter in 2026 as we begin 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.

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 relapse refractory setting. You guys, just general thoughts there.

Yeah, I'm going to suggest that Paul tackle this question, but in general, we get that question a lot. 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?

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 cardio toxic. 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 7+3, where the three is an anthracycline. So we should have that market plus half of all first-line therapy patients should get 7+3, where the 3 is an anthracycline. So we should have that market plus half of all first-line therapy patients should get 7+3, but they don't because they're unfit, meaning they're over 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 problems. So we agree eventually, first-line is our ultimate objective in AML and we will proceed there once we have shown that we're approvable for an NDA for second-line therapy.

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

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

Hey, Vernon.

Hey, Wally. Thanks for taking my question. And hey, Jonathan and John. Just wanted to follow up on the questions about the MIRACLE doses. Just wondering if you could walk us through the rationale for choosing the 190 dose discussions at the FDA, and then also what dose do you anticipate using for the soft tissue sarcoma trial?

This all relates to the now infamous Project Optimus that FDA has embarked on. But I think Paul's probably in the best position to maybe comment on the rationale and what we expect going forward. Paul?

Yeah. Obviously we chose 230 for this study because 230 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 190 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 230 versus 110, I'd pick 230. But 230 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 300 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 1/2 meeting with FDA to get their blessing on their entire plan.

Okay. Thanks for that. Just one follow-up. Regarding the 190 dose, I guess we could expect if it was 230, you're going to hit and be better than HiDAC CR rates for what was observed in Mirros and Classic I. But in the 190 dose, do you have to be superior to the 17%, 18% that was observed to continue to perhaps apply for early or you still need to go to 230 if…

Yeah. When we look at the interim results, if one dose is clearly superior to the other, let's say 230 has a much better complete response rate and similar safety, then the comparison would be the 230 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, if our data from 106 are anywhere close to resembling what we're going to get in 108, 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 [0.05] (ph) is for the entire trial. And so you save most of it for the end. So 0.05 would not get you approval after Part A. It would have to be a very statistically significant number. The P would have to be less than 0.01. 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 Annamycin plus Cytarabine is significant compared to placebo plus Cytarabine, and the P is less than it's going to be about something like 0.048, we lose a little of that because of the interim look. It's an easy call that we will win. After Part A, it's a very complicated process. It's difficult to do…

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 230 is a better choice than 190. And we could shorten that by saying more effective, but it does have to be -- 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 230 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 230 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 75 and 90 patients. And that's because we're anticipating the possibility that we may have a clear winner at 45 and therefore no need to keep recruiting at the other dosage. Does that make sense?

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

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 MB106, but in MB105 and MB104 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 230. So, we're, I think that's a very unlikely event, but of course if we got down the road and it looked like 230 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.

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

You bet, Vernon.

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

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.