Karyopharm Therapeutics Inc.

Good afternoon. My name is Chloe and I will be your conference operator today. At this time, I would like to welcome everyone to the KWO Forum of Therapeutics First Quarter 2025 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. I would like to turn the call over to Brendan Strong, Senior Vice President, Investor Relations and Corporate Communications. Thank you. Please go ahead.

Thank you, Chloe, and thank you all for joining us on today's conference call to discuss CarioFarm's first quarter 2025 financial results and recent company progress. We issued a press release after the market closed, detailing our financial results for the first quarter of 2025. This release, along with a slide presentation that we will reference during today, are available on our website. For today's call, as seen on slide two, I'm joined by Richard, Reshma, Sohania, and Lori, who will provide an update on our results for the first quarter of 2025 and review new data that we are sharing for the first time today in myelofibrosis. Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995, as outlined on slide three. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factor section of our most recent Form 10-Q and 10-K on file with the SEC and in other filings that we may make with the SEC in the future. Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements 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 forward-looking statements as representing our views as of any later date. I'll now turn the call over to Richard. Please turn to slide four.

Thank you, Brandon, and thank you all for joining us today for CarioFarm's Q1 2025 earnings call. As we continue to execute on our innovation and growth strategy, we are pleased that our phase three century trial in patients with JAK-naive myofibrosis has passed its pre-specified futility analysis and continues as planned without modifications. We are very focused on completing enrollment in this trial while also advancing enrollment in our phase three trial in endometrial cancer as outlined on slide five. As we have discussed in the past, we have a profitable commercial organization in multiple myeloma that can be leveraged to drive rapid commercialization if we receive approval in additional disease areas. Turning to slide six, we are excited to share with you today new clinical data which further strengthens our conviction in Selinexor's potential in combination with ruxolitinib in JAK-naive myelofibrosis patients. The data that Reshma will take you through is Selinexor monotherapy data in a heavily pretreated, hard-to-treat population from our randomized phase two export MF035 trial. The data are very encouraging because they continue to show Selenexor may have an impact across each of the four key hallmarks of the disease. When combined with other clinical and preclinical data we have shared previously, this tells a consistent story which supports our belief that the combination of Selinexor plus Ruxolitinib has the potential to meaningfully improve patient outcomes and redefine the standard of care in myelofibrosis. We look forward to sharing data with you from our Phase III Sentry Trial, which is evaluating Selinexor in combination with Ruxolitinib toward the end of this year or in early 2026. We have now enrolled approximately 80% of the 350 patients that we are targeting for this study and expect to complete our targeted enrollment in the June-July timeframe. As we think about our potential in myofibrosis, it is worth remembering how we got here, which is outlined on slide seven. We have been taking deliberate steps over many years to put us in the position we are in today. We continue to progress our phase three sensory trial faster than historical benchmarks, while remaining incredibly focused on high-quality clinical trial execution. As outlined on slide eight, leading key opinion leaders in myofibrosis, including Dr. Ram Paul from Memorial Sloan Kettering and Dr. Mascarenas from Mount Sinai, continue to highlight the need for new treatment options for patients with myofibrosis and are encouraged by the strength of our phase one combination data. Finally, we continue to believe that the commercial opportunity in myelofibrosis is transformational. As shown on slide 9, if approved, we believe the peak revenue potential for Selenexor in myelofibrosis is up to approximately $1 billion in the U.S. alone. Based on our market research, including discussions with leading key opinion leaders on our Phase I data, and the fact that we are looking to combine Selenexor with the existing standard of care, We believe that commercial uptake would be rapid. We are eager to see the outcome of a phase three trial and the potential opportunity ahead. Now I'd like to turn the call over to Reshma.