Immunomedics Inc. (NASDAQ:IMMU) Q4 2019 Earnings Conference Call - Final Transcript
Feb 27, 2020 • 05:00 pm ET
Good afternoon, ladies and gentlemen, thank you for standing by. As a reminder, this call is being recorded. Today is Thursday, February 27, 2020. At this time, I would like to turn the conference over to Chau Cheng, Senior Director of Investor Relations of Immunomedics.
Thank you, Sarah. Before we begin, I would like to remind everyone that during this call we will be making forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements may involve significant risks and uncertainties and therefore actual results could differ materially from those expressed or implied on this call. For factors that could cause such differences, please refer to our regulatory filings with the Securities and Exchange Commission. With us on the call today with prepared remarks are Dr. Behzad Aghazadeh, Executive Chairman and Usama Malik, Chief Financial Officer and Chief Business Officer. Also on the call for Q&A is Brendan DeLaney, Chief Commercial Officer. Following the prepared remarks, we will open the call up for questions. Thank you. Behzad?
Thank you, Charles. Good afternoon everyone and thank you for joining us. With the foundation we laid in 2019, 2020 promises to be an exciting year for Immunomedics. Our top priority for 2019 was the resubmit a high quality BLA for sacituzumab govitecan or SG in late-line metastatic triple-negative breast cancer or mTNBC. To that end, we are pleased to have resubmitted BLA in November 30 and received notification from the FDA in December that the BLA was accepted for filing with a PDUFA date assigned of June 2, 2020. Consistent with industry practice, we're not going to provide details of our regulatory interactions as we are now in an ongoing FDA review period, other than to say we are pleased with the progress to-date. Beyond that, we are keenly looking forward to the FDA action on or before the June 2 PDUFA date. It goes without saying that our near-term number one priority and mission is the approval of sacituzumab govitecan. For all the hard work that has enabled us to reach this point and to get us over the finish line, I'm grateful to my colleagues in manufacturing, quality regulatory affairs and safety.
During 2019, we also laid the foundation for a number of upcoming clinical readouts. Let me begin with ASCENT, our confirmatory Phase III study of sacituzumab govitecan versus treatment of choice in third-line mTNBC patients. It took less than 20 months to complete enrollment of more than 500 patients in the US and Europe into this study. We attribute the success of the unmet need and our investigators excitement in the ability of SG to help patients who are in dire need of new viable treatment options. Since the end of enrollment in July 2019, we've been monitoring the number of events that will trigger the unblinding of this study. As of the most recent sweep, topline readout remains on target for mid-2020 readout. Meanwhile, we are witnessing the same level of enthusiasm from