Moleculin Biotech, Inc.

Hello and welcome to the Moleculin Biotech Fiscal Year 2022 Quarterly Update Conference Call and Webcast. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to your host, Janine Thomas, Investor Relations. Please go ahead, Janine.

Thank you, Kevin. Hello and welcome to the Moleculin Biotech Quarterly Update Conference Call and Webcast. Following the presentation, there will be a question and answer session, and note that this webcast is being recorded at the company's request, and a replay will be made available on the company's website following the end of the event. 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 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 has not independently verified and makes no representation as to the adequacy, fairness, accuracy, or completeness of, or that any independent source has verified any information obtained from a third-party sources. So joining us on the call today is Moleculin's leadership team. We have Walter Klimt, Chairman and Chief Executive Officer, Dr. John Paul Wamek, Senior Chief Medical Officer, and Jonathan Foster, Executive Vice President and Chief Financial Officer. It is now my pleasure to turn the call over to Wally Klump, Chairman and CEO. Wally, please proceed.

Thanks, Janine. Hello, everyone, and again, welcome to today's Moleculin Biotech Earnings Call. As you would expect, we'll be updating you on financial aspects of the company, but the most important aspect of today's call will be an update on our key clinical programs. And in that regard, from this point forward our plan is to provide these clinical updates with each subsequent quarterly and year-end call and furthermore given the fact that our current clinical trials are open label we'll be free to provide substantive updates on preliminary readouts for safety and efficacy with with each one of these updates we're also really excited for Moleculent to finally be entering phase two activity. When we went public in 2016, we had zero clinical activity and really nothing more than a promising pipeline of preclinical technologies. But as of today, we've either concluded or conducting or cleared to begin 11 clinical trials involving three different technologies in a range of indications. What's more, we've successfully established safety and also witnessed clinical activity in three of these indications. Importantly, this is just in the phase one stages of our clinical programs. Now, without a doubt, the most immediate opportunity for a clinical breakthrough is with anamycin, largely because it's the farthest along in its clinical development. So with this in mind, we'll spend the bulk of this call talking about where we are and where we expect to be with Anamycin in the near future. But it is worth reminding investors that we have two more distinctly different technologies in addition to Anamycin, and those programs continue to progress and provide valuable diversification to your investment and multiple ways for Moleculin to succeed. Now, everything we've done up to and including in 2022 has essentially set the stage for a year of phase two clinical data in 2023. All this preparation is now finally culminating in phase two activity. In fact, we have three phase 1B2 clinical trials underway with anamycin. And one of our STS trials has already reached the 50% mark for recruitment of the phase two portion of that trial. And our AML clinical trial of anamycin in combination with cytarabine, well, that's building off of an 80% response rate in the single agent trial completed last year. Now, In just a little bit, our Senior Chief Medical Officer, Dr. Paul Weymack, will give you some more insights into these trials and more. But before he does, I'd just like to review what makes the anamycin so important and why it is truly a next-generation anthracycline. Anamycin was created at MD Anderson Cancer Center to overcome the well-known problems of currently prescribed anthracycline. Anthracyclines like doxorubicin and donorubicin have been and continue to be cornerstone chemotherapies for a wide range of indications. For example, they are for the vast majority of patients the first line treatments for advanced soft tissue sarcoma and for acute myelogenous leukemia. But these heavily used anthracyclines can fall prey to multidrug resistance. They're limited in their use by their significant cardiotoxicity, and their efficacy is further limited in certain organs because of limitations in their pharmacokinetics, which essentially means they have trouble getting to certain locations in the body in therapeutic quantities. Well, anamycin was specifically designed to overcome these limitations. Perhaps most significantly, anamycin has little to no cardiotoxicity. In fact, in the first 42 patients we've treated that have been reviewed by an independent cardiology expert, there has been no evidence of cardiotoxicity, even though 32 of those patients have been taken above the lifetime maximum allowable anthracycline dose level set by the FDA. And some have been taken to well over double that limit. The bottom line is we fully believe the absence of cardiotoxicity coupled with the fact that anamycin typically outperforms doxorubicin in most animal tumor models means that anamycin has the potential to displace doxorubicin in a range of indications and keep in mind the doxorubicin has been a billion dollar revenue generally and if that's not enough anamycin also has the potential to go where current anthracyclines can't at least not in therapeutic quantities what we call the unique organotropic nature of animicin allows it to accumulate in the lungs in animals, in animal models, at up to 30 times the level of doxorubicin. And we just announced a presentation at the upcoming AACR meeting that will show a similar affinity for the liver. And we also have data showing this potential in the pancreas. All this really does point to promising therapeutic potential. But what really matters is phase two clinical data. And here to talk more about that is our senior chief medical officer, Dr. Paul Weymack. Paul?