Spectrum Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Spectrum Pharmaceuticals' first quarter 2021 earnings conference call. At this time, all participants are in the listen-only mode. Later, we'll conduct a question-and-answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touchstone telephone. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. Kurt Gustafson, Chief Financial Officer.

Thank you, Operator, and good afternoon to everyone. Thank you for joining us today for Spectrum Pharmaceuticals' first quarter 2021 financial results conference call. Our first quarter financial results press release was sent out earlier this afternoon and is available on our website at www.sppirx.com. Joining me on the call today from Spectrum Pharmaceuticals will be Joe Turgeon, President and CEO, and Dr. Francois Lebel, Chief Medical Officer. Before we get started, I would like to reference the notice regarding forward-looking statements included in today's press release. This notice emphasizes the major uncertainties and risks inherent in the forward-looking statements that we will make this afternoon. These statements are not guarantees of future performance. and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. With that, let me hand the call over to Joe Turgeon, CEO of Spectrum.

Thank you, Kurt. Good afternoon, and thank you for joining us today in the call. In 2020, we laid the groundwork that I believe will allow us to achieve a number of important milestones in 2021 and beyond. During the fourth quarter of 2020, we had a call with the FDA to review the filing strategy for the submission of an NDA for posiatinib based on the positive data from cohort two of the Zena 20 study. The cohort evaluated previously treated patients with non-small cell lung cancer with HER2 exon 20 insertion mutations, and it met the pre-specified primary endpoint in these patients. Based on our discussions and agreement with the agency, we're proceeding with the submission of a new drug application for posiatinib. That work is well underway, and we're planning to submit the NDA later this year. In addition, the FDA granted fast-track designation, which is an indicator of the importance of this drug for patients with this terrible disease. We presented additional data for posyatinib at the ESMO TAT meeting in March and at the AACR annual meeting in early April. Our aspiration for posy extends well beyond the initial NDA filing. We believe this product can be a targeted therapy in oncology across multiple indications. The recent data from the ESMO TAT and AACR was an important step in realizing this promise. The twice-daily dosing has demonstrated a significant improvement in both efficacy and tolerability, which will be important for the program as we advance our development efforts. Now regarding Rolantis, the FDA scheduled the pre-approval inspection of our manufacturing facility for later this month. We believe this inspection marks the final step in the approval process and that Hanmi's world-class facility is ready for this inspection. We are making real progress on our two lead clinical programs with major catalysts expected in the coming months, including a launch and an NDA filing. And with that, I'd like to turn it over to Dr. Francois LaBelle, our CMO, for an update on our clinical development progress. Dr. Francois.