8/11/2023

speaker
Kevin
Conference Call Operator

Hello, and welcome to the Molecular and Biotech 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. You may press star one at any time to be placed into question queue. 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.

speaker
Janine Thomas
Investor Relations

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, molecular 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 of 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 the call today from the Moleculins Management Team are Walter Klint, Chairman and Chief Executive Officer, Dr. John Paul Waymack, Senior Chief Medical Officer, and Jonathan Foster, Executive Vice President and Chief Financial Officer. I would now like to turn the call over to Mr. Klempp, Chairman and CEO. Wally, please proceed.

speaker
Walter Klint
Chairman and Chief Executive Officer

Thanks, Janine. And thanks to everyone on today's call for your interest in molecular. We reiterated our commitment on our last two quarterly calls that 2023 would be our year of data. And now the data from our priority pipeline programs are coming into view. We've now completed the phase 1B portion of our MB106 trial. That's the AML trial in Europe studying the combination of anamycin with cytarabine or ARAC. Importantly, that means we've now established our phase 2 dose and have commenced phase 2 recruitment. In the meantime, the preliminary CR rate or complete response rate for the phase 1B portion of our AML program looks to be 33%. And as our senior CMO, Dr. Paul Weymouth will discuss, that's already well above the benchmark used for approval in the class of patients we're targeting. In our other lead indication of soft tissue sarcoma, we're now seeing 73% of subjects exhibiting stable disease after two cycles of treatment. Again, this is above expectations at this stage of STS long metastases. and indicative of an encouraging efficacy signal. As always, I should stress that these data are preliminary and subject to change, but so far we are very encouraged by what we're seeing. So when we look at the milestones we've set out for this year with anamycin, we've already delivered on the first three and we have more to come. Specifically, we expect to be announcing phase two data for AML and more phase two data for STS, which we intend to do with each quarterly and year-end call. And let's not forget that there's ongoing development work in our other two technologies, and that should be generating news flow yet this year. But we know that the main focus for most investors is on animicin. And here to discuss that in more detail is our senior chief medical officer, Dr. Paul Wemack. Paul?

Disclaimer

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