Karyopharm Therapeutics Inc.

Good morning. My name is Joelle and I will be your conference operator today. At this time, I would like to welcome everyone to the CarioPharm Therapeutics fourth quarter and full year 2024 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 now like to turn the call over to Sharon Strong, Senior Vice Director, Thank you, Joelle.

And thank you all for joining us on today's conference call to discuss Carrier Farms' fourth quarter and full year 2024 financial results and recent company progress. We issued a press release this morning detailing our financial results for the fourth quarter and full year 2024. 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 two, I'm joined by Richard, Reshma, Sohania, and Lori, who will provide an update on our results for the fourth quarter, 2024, and recent clinical developments. 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 factors section of our most recent Form 10-Q or 10-K on file with the SEC and in other filings that we will 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.

Good morning. Thank you, Brendan, and thank you all for joining us today for CarioFarm's Q4 2024 earnings call. In 2024, we delivered solid financial results, delivering on our range of guidance, with a profitable U.S. commercial organization and growing global demand in multiple myeloma. We continue to execute well on our cost reduction initiatives, reduce total expenses, particularly SG&A, while focusing resources on our phase three clinical trials. Turning to slide five, in 2025, we expect to grow Expovio net product revenue, further reduce expenses, and advance our transformative programs in myofibrosis and endometrial cancer, unlocking our innovation and growth strategy. Importantly, for 2025, we remain on track to complete enrollment in our Phase 3 Sentry Trial in the first half of this year and announce top-line data in the second half of this year. Today, we are announcing modifications to our Phase 3 Trial in endometrial cancer Following discussions with the FDA in recent months, our endometrial cancer data could become a key catalyst for us in 2026. First, let's focus on the transformational opportunity in 2025 to redefine the standard of care in myelofibrosis. As we think about our potential in myelofibrosis, it is worth remembering how we got here, which is outlined on slide 6. We've been taking deliberate steps over many years to put us in the position we are in today. This started with preclinical activity of myelofibrosis, followed by demonstrating a clear monotherapy signal in the essential investigator-sponsored trial that was presented at ASH in 2021. Following this, we initiated a Phase I study of salinexor in combination with ruxolitinib in JAK inhibitor-naive patients. We presented data from this trial at ASH in both 2022 and 2023. This data demonstrated a strong signal of benefit for the combination of salinexor and ruxolitinib. Based on this signal, we received both fast-track designation and orphan drug designation from the FDA and rapidly initiated our Phase III sensory trial. We also watched and learned as other clinical trials evolved and aligned with the FDA last year on a change in our co-primary endpoint to absolute TSS. This was a very favorable change that we believe increases the probability of success of our Phase III sentry trial and a change that is strongly supported by leading KOLs and patient advocacy organizations. We continue to progress our Phase III sentry trial faster than historical benchmarks will remain incredibly focused on high-quality clinical trial execution. As I noted earlier, we remain on track to complete enrollment in the first half of this year with top-line data expected in the second half of 2025. As outlined on slide 7, leading KOLs 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 myelofibrosis and are encouraged by the strength of our data. Finally, I cannot overstate how transformational this opportunity could be for our organization. As shown on slide 8, we believe the peak revenue potential for Selinexor in myelofibrosis, if approved, is approximately $1 billion in the U.S. alone. We are eager to see the outcome of our Phase 3 trial and the potential opportunity ahead. Now, I'd like to turn the call over to Reshma to discuss our programs in myelofibrosis, endometrial cancer, and multiple myeloma. Reshma?