G1 Therapeutics, Inc.

Good day and thank you for standing by. Welcome to the G1 second quarter financial results conference 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 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to the speaker today, Will Roberts, please go ahead.

Thanks, Jada. Good morning, everyone, and welcome to the G1 conference call to discuss our second 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 corporate website, g1therapeutics.com. On this morning's call, the team will provide a business overview of the second 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 myelosuppression in adult patients when administered prior to a platinum atoposide-containing regimen or atopotecan-containing regimen for extensive stage small cell lung cancer, or ESSCLC. A question and answer session will follow the prepared remarks. 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 such risk 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, August 2, 2023. Joining on the call today are Jack Bailey, our Chief Executive Officer, Andrew Perry, our Chief Commercial Officer, Raj Malek, our Chief Medical Officer, and John Umstead, our Chief Financial Officer. With that, I'll turn the call over to Jack Bailey.

Thanks, Will. Good morning, everyone, and thank you for joining us on the call today. As of mid-year, our goals for 2023 remain unchanged. First, to drive depth of COSELLA usage and adoption especially amongst the top 100 organizations who treat half of all extensive-stage small cell lung cancer patients in the country, second, to prepare for important clinical readouts early next year, and finally, to efficiently manage our cash runway. Regarding the first goal, our objective was to continue to drive quarter-over-quarter COSELLA volume growth by broadening the number of deeply adopting customer organizations and driving depth. particularly amongst our top 100. As you'll hear from Andrew, we did this successfully in the most recent quarter while seeking to navigate a national platinum-based chemotherapy shortage. Despite that headwind, net sales grew 6 percent quarter-over-quarter to 11.1 million, enabling us to reiterate our guidance of 50 to 60 million in CoSALA net sales in 2023. though as a result of the platinum shortage, we will potentially be toward the lower end of that range. It's worth reminding our investors that assuming we continue to hit our internal forecasts, we expect Cosella to drive us to cash flow positivity and profitability in the next few years. Regarding the second goal, this is a particularly exciting time for G1. We presented important new data throughout the quarter from our phase two trials, including that trilocycline can improve the tolerability of an ADC. Importantly, we expect the survival results from our pivotal phase three triple negative breast cancer trial, as well as from two phase two trials in the first quarter of 2024. If the interim phase three TMBC results are positive, we expect to meet with the FDA to discuss filing a potential supplemental NDA shortly after that. Finally, we make good progress during the quarter in strategically managing our finances. First, by obtaining payment from Sincere for relief of future royalty payments on the sales of Cosella in mainland China, and then by amending our debt agreement with Hercules and paying down a portion of our debt to provide additional financial flexibility. Now, we will discuss each of these topics in order. Andrew will cover our recent commercial efforts and results. Raj will then provide an update on our clinical pipeline. And John will provide financial results for the quarter. Finally, I'll be back for some concluding comments. With that, I'll now turn the call over to Andrew. Thank you, Jack.