G1 Therapeutics, Inc.

Good day and thank you for standing by. Welcome to the G1 Therapeutics first quarter 2023 financial results conference call. At this time, all participants are in listen-only mode. After the presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message confirming that 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 over the conference to your speaker today, Will Roberts in Communications. Will, please go ahead.

Thank you, Mark. Good morning, everyone, and welcome to the G1 conference call to discuss our first quarter 2023 financial results and business update. The press release on these financial results was issued this morning. and can be found in a new section of our corporate website, g1350.com. On this morning call, the team will provide a business overview of the first quarter of 2023, including an update on our clinical programs and our commercial progress in that period with Costella, which is approved and commercially available to decrease the incidence of chemotherapy-induced myelosuppression in patients when administered prior to a platinum toposide-containing regimen or topotecan-containing regimen for extensive stage small cell lung cancer. As Mark mentioned, a Q&A 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 uncertainty 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, May 3, 2023. Joining me 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. And with that, I'll turn the call over to Jack. Jack?

Thanks, Will. Good morning, everyone, and thank you for joining us on the call today. As you will hear from Andrew momentarily, our goal in the first quarter was to accelerate the Cosella volume growth we saw in the fourth quarter of 2022 by building the platform of deeply adopting customer organizations, and we executed on that goal. The team grew file volume by 21% over the prior quarter. Sales accelerated as well, growing 18% over the prior quarter, which is a meaningfully higher growth rate than we saw in Q4 of 2022. March was our highest volume month to date, and April was also one of our highest months. We have continued to learn and evolve our sales efforts. We are identifying the right combination of activities directed to the right accounts, primarily in community settings. In the first quarter of 2023, successful execution of these commercial initiatives and positive experiences with the drug led to increased penetration and improved results. reinforcing our confidence in achieving our sales guidance of 50 to 60 million in net sales in 2023, which we are reiterating today. Now, regarding the clinical pipeline, as Raj will discuss, we are executing on our ongoing clinical trials with near-term data readouts, in particular, our two Phase II studies and our Phase III in triple negative breast cancer. Updated data are being presented from those two Phase IIs later this quarter, and the interim OS analysis for the TMBC Phase III is now expected to occur in the first quarter of 2024. And as mentioned on our last call, we are conducting our business in a manner that is mindful of our cash and expenses, with the goal of extending our cash runway through all of our clinical readouts. To that end, we announced this morning that we have proactively strengthened our balance sheet even further in a manner that is non-equity diluted to our shareholders by monetizing all future royalties and milestones from CIMCIR. This brings us $30 million now and up to $48 million in total. This transaction has allowed us to extend our cash runway further into 2024 and beyond each of these data readouts. As a reminder, we retain the rights to try the cyclips throughout the rest of the world. Now we'll take these in order Andrew will first cover our recent commercial efforts since the start of the first quarter of 2023. Raj will reiterate the timing of upcoming data readouts. And finally, John will provide the financial results for the quarter and remind you of our revenue, expense, and cash guidance and discuss the addition to our cash reserves. Then I'll be back for some concluding comments. With that, I will now turn the call over to Andrew.