Moleculin Biotech, Inc.

Hello, and welcome to the Molecule and Biotech Q1 2023 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. Good morning and welcome, 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 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 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 source. Any data discussed regarding clinical trials in progress are considered preliminary and subject to change. Joining us on today's call from Moleculin's leadership team are Walter Klent, Chairman and Chief Executive Officer, Dr. John Paul Wamek, Senior Chief Medical Officer, and Jonathan Foster, Executive Vice President and Chief Financial Officer. I would now like to turn the call over to Walter Klent, Chairman and CEO, Wally, please proceed.

Thanks, Janine. We're going to keep this call relatively brief and highly focused on clinical results. First, though, I'd like to add some context here. We think there's a serious disconnect between today's share price and what is actually happening with our clinical data. So I'd like for us to take a deeper dive into both AML and soft tissue sarcoma. In yesterday's press release on clinical activity, we provided a very important detail about the final cohort in our MB105 clinical trial. That's the single agent trial in AML, and the final cohort had five patients treated at 240 milligrams per square meter. The official clinical study report, or what we call the CSR, listed one CR, that's a complete response, and three PRs or partial responses. But as we point out in the release, two of those subjects listed as PRs actually cleared their bone marrow blasts below 5%, which per the protocol and per industry standards constitutes a complete response, not a partial response. By the time the CSR was audited for publication, the clinician who had labeled those subjects as PRs instead of PRs had already left for another institution and position. But based on the analysis of our CMOs, we believe that these were both truly complete responses. So why am I focused on this detail? It's because in accordance with our protocol and with the industry norm for AML, we believe we didn't just have five of the last eight patients treated respond. Four of them were complete responses. And to have a 50% complete response rate in mostly elderly and heavily pretreated fourth and fifth line AML patients, well, we think that is remarkable. and we want you to understand why the entire molecular team is so excited about the progress we're making. Another important nuance in our data is playing out in soft tissue sarcoma. With nearly half of our MB107 trial enrolled, we're seeing a preliminary median progression-free survival, or PFS, approaching three months. While that is a significant improvement over historical norms for untreated patients in other clinical trials, we believe it's actually much better than it appears. And that's because most prior clinical trials of quote-unquote advanced soft tissue sarcoma patients include a spectrum of patients from those who are simply no longer resectable, those are patients whose PFS is expected to be much better than average, to those who have lung metastases, and those are the folks with PFS that is expected to be much, much worse. In MB107, we are only enrolling the latter, and that's to say only patients with lung metastases and with the worst possible prognosis. So for us to be nearly doubling the historical median PFS expected in untreated advanced STS patients, But to do so while treating only lung MET patients, well, we think, again, we think that is remarkable. And yes, these data are preliminary, and we have more patients to recruit. But thus far, we are performing above expectations in arguably the worst possible patients. And we're doing this without the cardiotoxicity expected from currently prescribed anthracyclines. If you're an investor in Moleculin or considering an investment, we think this is where you should be focused. This is where the most immediate opportunity for success can be envisioned. And it's why I'm eager to have our senior chief medical officer, Dr. Paul Wamek, expand further on our clinical progress. Paul?