Karyopharm Therapeutics Inc.

Good afternoon. My name is Jason. I'll be your conference operator today. At this time, I would like to welcome everyone to CarioPharm Therapeutics' third quarter 2022 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, please press star then zero on your telephone keypad. I'd now like to turn the call over to Elhan Webb, Senior Vice President of Investor Relations.

Thank you, Operator, and thank you all for joining us on today's conference call to discuss the Care of Arms third quarter 2022 financial results and recent company progress. Today, I'm joined by Richard Paulson, President and CEO, Sohanya Cheng, Chief Commercial Officer, Dr. Reshma Rangwala, Chief Medical Officer, and Mike Mason, Chief Financial Officer. Today we issued a press release detailing Care of Farms financial results for the third quarter 2022. This release, along with a slide presentation that we will reference during today's call, are available on our website. For today's call, as seen on slide two, Richard will start with some opening remarks, Sohania will provide a commercial update, then Rejma will provide an update on our clinical development programs. Mike will then present an overview of financial highlights from the quarter, and Richard will end with some closing remarks before opening the call up for questions. 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 quarterly report on 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 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 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 day subsequent to today. In addition, we will also be providing on this call outlook for non-GAAP R&D and SG&A expenses for 2022. We are not providing reconciliations of these forward-looking non-GAAP measures because projections of stock compensation expense, which is required for such reconciliations, are not available without unreasonable efforts. I will now turn the call over to Richard. Please turn to slide four.

Thank you, Elhan, and good afternoon to everyone joining us on the call and webcast. Today, I'm excited to provide an update on our plan as we continue to execute on our growth strategy through our focused pipeline targeting life-threatening cancers. Turning to slide five, KaryoPharm was founded in 2008 as an innovation and patient-focused company, developing first-in-class oral selective inhibitors of nuclear export, which target XPO1 that mediates multiple processes integral to cancer cell growth. Fast forward to KaryoPharm today, where we are successfully leveraging that fundamental mechanism of action to build upon our existing multi-myeloma franchise. anchored around our commercial drug Expovio. Expovio's footprint now reaches 40 countries and combined with increasing use in earlier lines of therapy in multiple myeloma, we are currently expecting total revenue of between 155 to 165 million in 2022. We are working to expand indications through advancing our focused clinical pipeline. This pipeline is comprised of mid and late stage clinical development programs that is being purposely built and strategically focused to help patients who suffer from cancers with high unmet need to demonstrate efficacy at lower doses with improved tolerability and where we believe we will have the highest probability of success. Based on compelling data signals, we are pursuing opportunities in endometrial cancer, myelofibrosis, and myelodysplastic syndromes. Collectively, we believe we have the potential to achieve multiple product approvals over the next two to four years. We've also evolved our leadership with a team of dedicated and highly accomplished executives from across the biopharmaceutical industry, specifically with commercialization and mid to late stage clinical development experience to lead us in delivering our targeted mid and late stage clinical pipeline. With a strengthened leadership team in place, we believe we can achieve both scientific and commercial excellence while executing on our key corporate objectives. Let's now turn to the third quarter of 22, which was marked by several meaningful achievements as outlined on slide six. In Q3, we saw US Expovio net product revenues of 32 million, which translated to a 20% year-over-year growth compared to Q3 of 21. despite an increasingly competitive multiple myeloma market. We continue to see increasing use of Expovio in earlier lines with strong growth in the community setting. So Hanya will provide more detail in a moment. Internationally, Expovio received full marketing authorization in July 22 from the European Commission for the treatment of patients with multiple myeloma after at least one prior therapy. This has opened the door for recent commercial launches in Germany and Austria by our partner Menorini, important steps forward for patients in Europe where nearly 51,000 new cases of multiple myeloma are diagnosed each year. With patient access for Cell and XOR starting to expand across the world, we expect revenues in ex-US territories to have an increasing contribution to total Cell and XOR revenues in the future. On the clinical side, we are delivering on our focus pipeline. Given the meaningful improvement in PFS observed with saline XOR in the exploratory TP53 wild-type subgroup in our CIENDO study, we are excited about the initiation of our pivotal phase three study. This study will utilize Foundation Medicine's tissue-based next-generation sequencing test to identify this important group of patients. As highlighted in the ASH abstracts released today, the combination of selanexor and ruxolitinib evaluated in the phase one export MF034 study continues to demonstrate compelling activity. And Reshma will provide more detail on this momentarily. In addition, we were granted EU orphan medicinal product designation for selanexor for the treatment of myelofibrosis in Europe. In myelodysplastic syndromes, after completing enrollment in Q2 for the interim analysis in our relapse and refractory MDS phase 2 study, we are waiting for overall survival data to mature and expect to present data late this year or early next year. Finally, as Mike will provide more detail later in the call, in the third quarter, we continue to execute on our cost reduction initiatives. in line with the evolution of our focused and prioritized pipeline. As we now turn to slide seven, I would like to turn the call over to Sohanya for her review of the commercial performance for the quarter. Sohanya.