11/2/2023

speaker
Drew
Conference Operator

Good morning. My name is Drew, and I will be your conference operator today. At this time, I would like to welcome everyone to the CarioPharm Therapeutics Third Quarter 2023 Financial Results Conference Call. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company's request. If you require operator assistance, press star then zero. I would now like to turn the call over to Ilhan Webb, Senior Vice President, Investor Relations.

speaker
Ilhan Webb
Senior Vice President, Investor Relations

Thank you, and thank you all for joining us on today's conference call to discuss Kara Farms' third quarter 2023 financial results and recent company progress. We issued a press release this morning detailing our financial results for the third quarter 2023. This release, along with a slide presentation that we will reference during our call today, are available on our website. For today's call, as seen on slide 2, I'm joined by Richard, Rejma, Sohani, and Mike, who will provide an update on our results for the third quarter and recent clinical developments. Before we begin our formal comments, I'll remind you that various remarks we'll make today constitute forward-looking statements, FLS, for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995, as outlined on slide 3. Actual results may differ materially from those indicated by these epaules as a result of various important factors, including those discussed in the Risk Factors section of our most recent Form 10-Q, which is on file with the SEC, and in other filings that we may make with the SEC in the future. Any FLS represent our views as of today only. While we may elect to update these FLS at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these FLS as representing our views as of any later date. I will now turn this slide over to Richard. Please turn to slide four.

speaker
Richard Paulson
President and Chief Executive Officer

Thank you, Elhan. Good morning, everyone, and thank you for joining CarioFarm's Q3 2023 earnings call. Turning to slide five, we are strongly positioned for our next stage of growth, driven by our focused and rapidly advancing mid and late stage pipeline of innovative, first in class, oral, selective inhibitors of nuclear export that target XPO1, as well as a strong commercial organization that continues to positively impact the lives of multiple myeloma patients every day. Our U.S. and global commercial presence is on track to deliver 145 to 160 million of annual total revenues in 2023 and provides us with the capabilities needed to launch in new indications, if approved, following the outcome of our three pivotal Phase III clinical trials. We have the opportunity to significantly improve standard of care for patients across these indications, and we continue to generate compelling data, including impressive durability data observed with Selenexor 60 mg in combination with Ruxolitinib in patients with myelofibrosis, as well as substantial progression-free survival observed in patients with TP53 wild-type endometrial cancer, which Reshma will expand upon shortly. We are committed to deliver on the opportunities ahead of us and believe Selinexor could generate approximately $2 billion of peak annual revenues in the U.S. alone. With a cash runway through late 2025, we have the financial strength to deliver on key data readouts from our three phase three studies. We will continue to be disciplined about our expense management, focusing our resources on our prioritized late stage pipeline. As we move to slide six, presented here is an overview of the timing of the upcoming key data readouts, which we expect in 2024 and 2025. Each of our ongoing Phase III clinical trials, if successful, represents an incredibly meaningful growth opportunity for our organization with the potential to deliver roughly $2 billion in annual peak revenues. Our proven and established commercialization and late-stage development capabilities are focused on executing with our current label and rapidly progressing these pivotal Phase III programs. An approval in just one of these three indications is a transformational opportunity for CarioPharm, and the clinical data that Raishma will review today continues to strengthen our confidence in each of these programs. With the potential for pivotal catalysts over the next two years, and with the cash runway to deliver on each of these top line readouts, we are well positioned for our next stage of growth. Moving to slide seven, I would now like to turn the call over to Reshma to expand further on our clinical pipeline progress. Reshma?

Disclaimer

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