G1 Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to G1 Therapeutics Fourth Quarter 2020 Financial Results Conference Call. At this time, all participants are on listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press the star, then the one key on your touch-tone telephone. Please be advised that today's conference may be recorded. If you recall our persistence, please press star, then zero. I would now like to hand the conference over to your speaker host today, Will Roberts, Head of Investor Relations at G1 Therapeutics. Please go ahead.

Thank you, Livia. Good afternoon, everybody, and welcome to the G1 conference call to discuss our fourth quarter and full year 2020 financial results and business update. The press release on these financial results was issued after market closed this afternoon and can be found in our news section of our corporate website, g1therapeutics.com. On this afternoon's call, the team will provide an overview of the fourth quarter and full year 2020, including an update on our launch progress with COSELLA, which was approved by the U.S. Food and Drug Administration on February 12, 2021, to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum etoposide-containing regimen or topotecan-containing regimen for extensive stage small cell lung cancer, or ES SCLC. A question and answer session will follow the prepared remarks. Before we begin, I'd like to remind you that today's webcast contains forward-looking statements within the meaning of the Private Security Litigation Reform Act of 1995. Such statements represent management's judgment as of today and may involve certain risks and uncertainty that could cause actual results to differ materially from those expressed in or implied by these statements. For more information on such risks and uncertainties, please refer to our filings with the Securities and Exchange Commission, which are available from the SEC or on our corporate website. Any forward-looking statements represent our views as of today, February 24, 2021. Joining me on the call today are Jack Bailey, our Chief Executive Officer, Raj Malek, our Chief Medical Officer, Soma Gupta, our Chief Commercial Officer, and Jen Moses, our Chief Financial Officer. I'll now turn the call over to Jack Bailey, our CEO.

Jack? Thanks, Will. Good afternoon, everyone, and thank you for joining us on the call today. We hope that you and your families are well. Today's headline is that G1 is a very different company than it was a year ago or even last quarter. Only eight days ago, we were on a call with you to announce the FDA approval of COSELLA, the first and only FDA-approved therapy that is administered proactively to deliver multi-lineage myeloprotective benefits to patients with extensive stage small cell lung cancer. The entire G1 team is energized to be making this important therapy available to cancer patients. But of equal importance is our rapidly evolving clinical pipeline, intelligently designed to help address the unmet needs of people with a variety of different cancers who require a range of chemotherapy. we are initiating and conducting clinical trials evaluating COSELLA across an array of cancers and chemotherapy regimens. Within the first half of 2021, we expect to have two registrational trials underway, one in colorectal cancer, in which we began dosing patients last month, and another in metastatic triple negative breast cancer, which we'll initiate in the first half of this year. we will also have three Phase II studies underway. These include our I-SPI-2 neoadjuvant breast cancer trial, which was initiated last year. And as we announced in January at the J.P. Morgan Conference, we expect to initiate Phase II trials in both non-small cell lung cancer and bladder cancer in the first half of 2021, with each study having anti-tumor efficacy as the primary endpoint. Regarding the bladder cancer trial, we announced an important supply agreement with Merck KGA of Darmstadt, Germany, and Pfizer in our press release this afternoon, which Roz will describe in more detail. G1 was founded with the sole purpose of making a difference in the lives of people living with cancer. The launch of COSELLIT is the first step. We believe that COSELLIT will be an important therapy in the arsenal for improving the lives of patients with a variety of cancer diagnoses as we work toward the goal of developing it as a tumor agnostic solution for patients with cancer. And it also represents an excellent opportunity to bring strong value to our shareholders. This is a transitional call for us, given that we are only a few days past turning the corner to becoming a commercial organization, and just a few days past our last call with you all on the commercial launch readiness. So while Jen will cover our financial results for the fourth quarter and full year 2020 toward the back end of the call, the rest of the call will largely be forward-looking. I will ask Raj to cover our clinical focus with COSELLA, including a reminder of its mechanism of action, which we believe will be broadly applicable. SOMA will then briefly provide an update on some of our launch efforts over the past eight days, including the ongoing launch meeting being held this week. then I'll be back for some concluding comments. I'll now turn the call over to Raj for an update on COSELLA in the clinic. Raj?