Moleculin Biotech, Inc.

Good morning. Welcome to the Molecular and Biotech First Quarter 2025 Update Conference Call and Webcast. The 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, Janine Thomas, Investor Relations. Please go ahead, Janine.

Thank you, Rob, and good morning, everyone. 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 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 investor 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 and 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 of, or that any independent source verified any of the information obtained from a third party source. Any data discussed regarding clinical trials and progress are considered preliminary and subject to change. So joining us on today's call from Moleculin's leadership team are Walter Klint, Chairman and Chief Executive Officer, Dr. John Paul Wamek, 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 Clem. Wally, please proceed.

Thanks, Janine. 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 anamycin for the treatment of relapsed and refractory 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 anamycin, which may now be referred to in literature as naxorubicin. This was an important first step in actually launching anamycin once it receives new drug approvals. And, you know, compared with some of the unpronounceable crazy drug names out there, we're really pleased with Maxtorubicin, especially since it sounds a lot like the next Rubicin, which really plays into the next generation positioning of animicin. 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 anamycin. 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 MD107 clinical trial using anamycin 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 anamycin 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 WP-1066, 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, our Senior Chief Medical Officer, to give you a few more insights into our clinical activity. Paul?