G1 Therapeutics, Inc.

Good day, and thank you for standing by. Welcome to the G1 Therapeutics third quarter 2023 financial results call. At this time, all participants are in 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 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Will Roberts, Vice President of Communications. Please go ahead.

Will Roberts Thank you, Theresa. Good morning, everyone, and welcome to the G1 conference call to discuss our third quarter 2023 financial results and business update. The press release on these financial results was issued this morning and can be found in the news section of our website. g1therapeutics.com. On this morning's call, the team will discuss a business overview on the third quarter of 2023, including an update on our clinical programs and our commercial progress in that period with COSELLA, which is approved and commercially available to decrease the incidence of chemotherapy-induced myelob suppression in patients, adult patients, when administered prior to a platinum atoposide-containing regimen or atopotecan-containing regimen for extensive-state small-cell lung cancer. A Q&A session will follow the prepared comments. Before we begin, I want to remind you that today's webcast contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements represent management's judgment as of today and may involve risk and uncertainties that could cause actual results to differ materially from those expressed in or implied by these statements. For more information on these 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, November 1, 2023. Joining me on the call are Jack Bailey, our Chief Executive Officer, Andrew Perry, our Chief Commercial Officer, Raj Malik, our Chief Medical Officer, and John Umstead, our Chief Financial Officer. With that, I'll turn the call over to Jack.

Thanks, Will. Good morning, everyone, and thank you for joining us on the call today. I'm glad to have the opportunity to discuss our project progress during the third quarter. We've experienced two quarters of selling into a strong headwind of a national platinum-based chemotherapy shortage. The shortage has been significant and prolonged, as you've likely read. The good news is that it appears to be waning, and the FDA reports suggest resolution by the end of this year. Yet despite the chemotherapy shortages, Coachella has grown quarter over quarter on a volume basis, Although due to wholesaler purchasing patterns, ex-factory sales were slightly down in the third quarter. As you saw in this morning's press release, because of the ongoing platinum shortage, we have decreased our COSELLA net sales guidance for 2023 to $44 to $47 million. While we are disappointed in the impact of the shortage, we remain confident in the opportunity for significant growth as reflected by a record month of sales in October. Andrew will provide additional color on our commercial results momentarily. Beyond that, continued therapeutic innovation for people diagnosed with triple negative breast cancer is paramount. And as we approach the overall survival readouts from our ongoing trials in TMDC, there is palpable excitement among clinicians regarding the potential for Trilocyclic to improve survival and a significant opportunity for G1. Most importantly, all eyes are on the interim overall survival analysis for PRESERVE-2, our pivotal trial of trilocyclic in TMBC. If the results of the interim analysis in the first quarter of next year are positive, we will work closely with the FDA to expand the indication of COSELLA. We look forward to these results and the opportunity for G1 to further establish our position as an innovation leader in this setting. We will discuss each of these topics in order. Andrew will cover our recent commercial results. Raj will provide an update on our clinical pipeline, including an update on the TMBC Phase III trial. John will then provide the financial results for the quarter and remind you of our revenue, expense, and cash expectations. Finally, I'll be back for some concluding comments. With that, I'll turn the call over to Andrew.