G1 Therapeutics, Inc.

Good day and thank you for standing by. Welcome to the G1 Therapeutics Second Quarter 2022 Financial Results Call. At this time, all participants are in the 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 11 on your telephone. You will then hear an automated message advising that your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker for today, Mr. William Roberts. Please go ahead.

Thank you, Mikey. Good morning, everyone, and welcome to the G1 conference call to discuss our second quarter 22 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 22 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 and toposide-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 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 3rd, 2022. Joining me on the call today are Jack Bailey, our Chief Executive Officer, Andrew Perry, our Chief Commercial Officer, Raj Malik, our Chief Medical Officer, and Jen Moses, our Chief Financial Officer. And with that, I'll turn the call over to Jack.

Thanks, Will, and good morning, everyone. Thanks for joining us on the call. Today's headline is that we have achieved a variety of important foundational milestones that we set for ourselves for the first half of 2022. I'll briefly touch on three of them. First, I'm proud of the decisiveness and strategic execution shown by the G1 team over the past few quarters regarding the commercialization of COSELLA. We identified the issue of needing to better access top target prescribers and accounts, We made the right decisions quickly and executed decisively to correct course, including building our own Costella-focused sales team. And as a result, during the quarter, we saw an inflection in sales. The momentum we experienced in the quarter is evident as our team worked to bring this innovative drug to more patients with small cell lung cancer than ever before. Costella is an important and unique drug. It is proactively administered and covers multiple lineages, enabling oncologists for the first time to reduce or prevent the serious hematologic side effects of chemotherapy preemptively, rather than waiting for treating them reactively with a variety of single lineage interventions, which of course carry their own unintended and potentially dangerous consequences. As you'll hear from Andrew, we experienced good growth during the quarter. including growing vial volume by almost 60% period over period. Second, the team has executed the majority of our clinical programs extremely well during a period of significant headwinds, including COVID-19 and the ongoing crisis in Ukraine, which impacted many clinical trials of different products. Most importantly, we achieved the important milestone in the second quarter of completing enrollment in our Phase III Line Extension Trial of Trilocyclib in 326 participants with metastatic colorectal cancer. We expect the initial results, including those from the primary endpoint, in the first quarter of 2023. And, as you read in this morning's press release, We recently also had key enrollment milestones in both our Phase II bladder and our Phase II trial assessing the mechanism of action for tritocycline. Further, as you will hear from Raj, we expect to provide the initial results from each of our five ongoing Phase II and Phase III clinical trials over the coming 18 months, starting in the fourth quarter of this year. Third, from a corporate perspective, we were recently very pleased to share that the China National Medical Products Administration had conditionally approved the marketing authorization for COSELLA, which was jointly developed for use in Greater China in partnership with Sincere. As a result, G1 will receive a $13 million milestone payment from Sincere, part of a total milestone consideration of up to $156 million. We also expect to receive double-digit royalties on future annual net sales of Procella in China, which Jen will describe later in the call. This morning, I will first ask Anju to cover our recent commercial progress, including an update on our efforts of our new field sales team during the second quarter of 2022. Raj will then provide a snapshot of our clinical momentum, including timelines and data expectations. Finally, Jen will provide the financial results for the quarter, including an update on financial ramifications of the sincere approval and a reminder that our cash runway takes us into 2024. Then I'll be back for some concluding comments. With that, I'll turn the call over to Andrew.