Spectrum Pharmaceuticals, Inc.

Good day and thank you for standing by. Welcome to the Spectrum Pharmaceutical second quarter 2021 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone keypad. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Mr. Kirk Gustafson, Chief Financial Officer. Please go ahead.

Thank you, Operator, and good afternoon to everyone. Thank you for joining us today for Spectrum Pharmaceutical's second quarter 2021 financial results conference call. Our second quarter financial results press release was sent out earlier this afternoon and is available on our website at www.stpirx.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, everyone, and thank you for joining us, and thank you for your interest in Spectrum. As most of you are aware, Spectrum received a complete response letter from the FDA last week regarding the BLA for Rolantis, seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. The entire company is greatly disappointed by the CRL. However, I can assure you that our team is already working closely with our partners to resolve the CRL. The CRL cited deficiencies related to manufacturing at the bulk manufacturing facility in which will need to be remediated and indicated that re-inspection will be necessary. The CRL also cited deficiencies at the fill and finish facility, which will need to be remediated. We are in communication with our CMOs, and the remediation work is already underway. The company is seeking further clarification from the FDA regarding the remediation timelines and the plans to meet with the agency as soon as possible. The CRL did not cite any need for a new clinical trial. We look forward to providing an update following this engagement with the FDA. Now let me shift to Poseyotinib, our other late-stage pipeline asset. Spectra's Poseyotinib program has continued to make great progress in 2021, and we are advancing to a very important milestone, the submission of the MDA. The MDA for Poseyotinib will be based on the positive data from Cohort 2 of the Zena 20 study. The cohort evaluated previously treated patients with non-small cell lung cancer with HER2 exon 20 insertion mutations and met the pre-specified primary endpoint in these patients. Poseyatinib has fast-track designation, an indicator of the medical need that this drug may be able to alleviate for patients with this terrible disease for which there is no approved therapy. An additional advantage of fast-track designations is the ability to have more frequent interactions with the agency. During the second quarter, we took advantage of this designation to meet with the agency, and Dr. Francois will update you further. We remain on track to submit the POSI-NDA later this year. Our recent data presentations at ESMOTAT, AACR, and ASCO shows that twice-daily dosing data appears to provide a significant improvement in both efficacy and tolerability. And with that, I'm going to turn the call over to Dr. Francois Labelle, our CMO, for an update on our clinical development progress for posiatinib. Dr. Labelle.