Spectrum Pharmaceuticals, Inc.

Good afternoon, everyone, and welcome to the Spectrum Pharmaceuticals third quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. And if anyone should require assistance during the conference, you may press star zero. And as a reminder, I would now like to turn the conference over to your host, Mr. Kurt Gustafson, Spectrum Chief Financial Officer.

Thank you, Operator, and good afternoon to everyone. Thank you for joining us today for our third quarter 2021 financial results conference call. Our third 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, our 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 these 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 on the call today. I really appreciate your interest in Spectrum. As we start to close in on the end of the year, we remain focused on our key corporate priorities. First, to submit the posiatinib NDA, and second, to correct the manufacturing issues identified by the FDA in a Rolantis CRL. Let me start with an update on Rolantis, our drug for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. Last month, we had a Type A meeting with the FDA to better understand the issues that were identified in the CRL. The CRL cited issues at the fill-finish facility and the drug substance facility. At that meeting, we gained clarity that the deficiencies at the fill-finish site have been adequately addressed and are no longer a gating item for resubmission. Regarding the drug substance facility, as of today, we believe that Hanmi has addressed all of the deficiencies cited in the CRL with the exception of one, and we expect the remediation to be completed by the end of the year. Pending successful completion, we would expect a refile shortly thereafter. A Type A meeting also clarified that the FDA will be conducting an on-site inspection as part of the resubmission process. We'd expect a six-month review once we submit. While HANMI is diligently working to resolve the issues associated with the CRL, we are continually monitoring the long-term long-acting GCSF market, and we'll be prepared to adjust our business plans as the market evolves. Now let me shift over to Poseyotinib, the other large late-stage asset we have in our pipeline. The submission of the NDA remains our top corporate priority, which we expect to file shortly. In addition, Spectra's Poseyotinib clinical program has continued to make solid progress this quarter, with data presented in treatment-naive lung cancer patients, as well as preclinical data on POSI in combination with KRAS G12C inhibitors. Now, to get a more detailed update on our clinical development progress, I'm going to turn the call over to Dr. Francois Labelle, our CMO. Dr. Francois, take it away.