Karyopharm Therapeutics Inc.

Good morning. My name is Debbie, and I will be your conference operator today. At this time, I would like to welcome everyone to Karyopharm Therapeutics' second quarter 2020 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 Mr. Ian Karp, Kerrio Farms, Senior Vice President, Investor and Public Relations. Please go ahead.

Thank you, Debbie, and thank you all for joining us on today's conference call to discuss Kerrio Farms' second quarter 2020 financial results and business update. This is Ian Karp, and I'm joined today by Dr. Michael Kaufman, Chief Executive Officer, Dr. Sharon Shacham, President and Chief Scientific Officer, Mr. Mike Mason, Chief Financial Officer, Mr. John Desmarais, Chief Commercial Officer, and Mr. Christopher Firminano, Chief Business Officer and General Counsel. On the call today, Michael and John will provide an overview of key recent corporate developments and an update on our commercial progress. And then Mike Mason will highlight the second quarter 2020 financial results. We will conclude with the Q&A portion of the call. Earlier this morning, we issued a press release detailing Karyopharm's results for the second quarter of 2020. This release, along with a slide presentation that we plan to reference, are available on our website at carrierpharm.com. 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. These include statements about our future expectations, clinical developments, and regulatory matters and timelines, the potential success of our products and product candidates, including our expectations related to the commercialization of Expovia, financial projections, and our plans and prospects. 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 quarterly report on Form 10-Q, which is on file with the SEC, and another filing that we may make with the SEC in the future. Any forward-looking statements represent our views of today only, but 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, we should not rely on these forward-looking statements as we're representing our views as of any date subsequent to today. In addition, please note that any references we make to clinical trial data during today's discussion refer to interim unaudited site data unless otherwise specified. I'll now turn the call over to Dr. Michael Kaufman, Chief Executive Officer.

Thank you, Ian, and good morning, everyone. Before I specifically review Karyopharm's performance in the second quarter, I'd like to put into some context where Karyopharm is on its journey to becoming a leading global oncology-focused pharmaceutical company. When Dr. Sharon Shacham and I founded the company over 12 years ago, we had a vision that one day we would create medicines that improve the lives of patients suffering from cancer and other serious diseases. We spent the first five or so years building the organization and growing the body of scientific and clinical evidence around XPO1 inhibition, leading to the approval of the first-in-class oral compound, Expobio. and in July of last year, we officially transitioned to a commercial company with the initial FDA approval and launch of Expobio and relapsed or refractory multiple myeloma. This year, we achieved an additional important milestone on our journey as Expobio received its second FDA approval at the end of June and became the first branded therapy to be approved in both myeloma and DLBCL. and as we look out towards next year and beyond, we expect to expand our commercial reach and advance a robust clinical development pipeline, including into solid tumor indications, all in support of the patients and families in need of new treatment options for devastating cancers. Please now turn to slide five. In the second quarter, we achieved record quarterly Expovio sales of $18.6 million, the strongest quarter since our July 2019 launch. Total revenue for the quarter reached $33.5 million, which included most of the payment from one of our international partners, Antigene, in the quarter for our expanded territory agreement which we announced earlier this year. The 16% increase in Expovio net sales compared to the first quarter of 2020 was driven by increased demand from both academic and community-based physicians. Importantly, we saw more than 170 new physician accounts prescribe Expovio for the first time in a quarter Thank you. Thank you. We were able to launch immediately by leveraging our existing commercial infrastructure, given the overlap between oncologists treating myeloma and DLBCL, particularly in a community setting. At the annual ASCO meeting in May, we presented the detailed results from the highly successful Phase 3 Boston study in patients with previously treated myeloma. Boston is our randomized trial of once-weekly Selenexer with once-weekly Velcade along with dexamethasone, and Dexamethasone. The trial met its pre-specified primary endpoint, and based on these results, we quickly submitted a Supplemental New Drug Application, or SNDA, to the FDA for Expovio for the treatment of myeloma after at least one prior line of therapy. FDA has filed the application and assigned an action date of March 19, 2021, under the Prescription Drug User Fee Act, or PDUFA. I'm also pleased to announce that we have now completed enrollment in our Phase 3 study of Selenixer in patients with heavily pre-treated, de-differentiated liposarcoma and expect top-line data in the second half of this year. If these data are positive, we believe this will be a very important step towards our goal of bringing Expovio to patients battling solid tumors, in addition to those with hematologic malignancies. We also made important progress in our clinical pipeline outside of cancer, and today we are providing an update on our placebo-controlled, Phase 2 trial of low-dose selenexer for patients with severe COVID-19, that is, patients who are hospitalized, hypoxic, and require supplemental oxygen. This program was prioritized at Keriopharm and rapidly advanced into the clinic in a matter of weeks due to the encouraging antiviral and anti-inflammatory activity of Expobio inhibition with selenexer. Recall that in addition to its roles in cancer, XPO1 may also be an important target in viral infections by facilitating the transport of several key viral proteins from the nucleus of the host cell to the cytoplasm. At the planned interim analysis of the randomized Phase II study with approximately 120 patients, the results indicated that Selenoxir is unlikely to demonstrate a statistically significant efficacy benefit across the entire population. were studied. However, Selinexer does appear to confer clinical benefit in a subpopulation of patients that represents about three-quarters of the whole severe COVID-19 population. Based on these results, we have discontinued the current study and expect that future clinical development of low-dose Selinexa for patients with COVID-19 will focus on a subpopulation where we saw the significant effects. I'll provide some additional details on these specific results later in today's presentation. On the corporate development front, we were excited to announce our entry into a Cooperative Research and Development Agreement, or CRADA, with the National Cancer Institute's Cancer Therapy Evaluation Program for the research of Expobio in various oncology indications, which we hope yields additional opportunities for us and patients in the future. Finally, on the financial front, we ended the quarter with a strong cash position of approximately $348 million that we expect will be sufficient to fund our planned operations into the middle of 2022. Please now turn to slide six, where I'll ask John Demery, our Chief Commercial Officer, to provide some additional details on Expobio sales performance during the second quarter. Thank you, Michael, and good morning, everyone.