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G1 Therapeutics, Inc.
2/23/2022
Good morning, ladies and gentlemen, and welcome to G1 Therapeutics' fourth quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. I would now like to turn the conference over to your host today, Will Roberts, Head of Corporate Communications. Sir, please go ahead.
Thank you, Joanna. Good morning, everyone, and welcome to the G1 conference call to discuss our fourth quarter 2021 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 fourth quarter and full year of 2021, including an update on our clinical programs and our commercial progress in that period with COSELLA, which is approved by the U.S. Food and Drug Administration 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 EFS-CLC. A Q&A 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 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, February 23rd, 2022. 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 Jen Moses, 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's headline is that the fourth quarter of 2021 was an important period of commercial transition and clinical execution for G1. That positions us well for a very important year for our shareholders, healthcare professionals, and most importantly, the patients we seek to treat. Regarding our commercial organization, Cosella is a one-of-a-kind drug. we are beginning to shift the paradigm from having to treat the dangerous consequences of myelosuppression resulting from chemotherapy to proactively providing multilineage myeloprotection, all with a single drug. There is no other drug on the market that provides that kind of protection. And I'm happy to say that we are almost fully transitioned away from our former co-promotion partner, BI, our commercial plan, and bringing this important drug to oncologists and oncology nurses across the nation. As you will hear from Andrew, we are now actively commercializing COSELLA through our own G1 sales team, who are now fully trained and recently deployed in their regions to drive access and uptake. I couldn't be more pleased with the talent and the drive of this team, and I'm very proud to have them as part of the G1 organization. We have seen early encouraging signs of execution, including adding 10 top 100 accounts in the first 10 weeks by the initial seven oncology sales account managers, or OSAMs, deployed in their region. And as of the beginning of this month, we have achieved our 2021 year-end goal of trial of COSELLA in 50 of the top 100 accounts. We will continue to drive breath but have already begun to pivot toward driving organizational depth of use of Costella, something that our new sales team is uniquely prepared to do thanks to their strong relationships and access to these key accounts. Our goal for the current quarter is to complete the sales team onboarding nationwide and the transition away from BI so that sales growth is reestablished as quickly as possible. Turning to our clinical operations, We made excellent progress in 2021 and expect 2022 to be an exciting year for G1. Thanks to strong execution by our clinical team, I'm happy to announce that we are on track to share the initial data from our pivotal phase three trial of trilocyclic and colorectal cancer earlier than expected, certainly no later than the first quarter, early in the first quarter of 2023. We also anticipate presenting the initial results from three phase two trials later this year. One in combination with an ADC, one to confirm the mechanism of action of Trialacyclib in modulating anti-tumor response, and one in bladder cancer with the immune checkpoint inhibitor Avalumab. Needless to say, we have a lot on which to update you on this call. I will first ask Andrew to cover our recent commercial efforts, including the status of the sales organization, and some early lead measures of success from our new OSAMs. Raj will then provide an update on some of our medical and clinical momentum, including commenting on the rationale of the two new Phase II trials that we initiated in the fourth quarter and a reminder of our expectations for timing of results. Finally, Jen will provide the financial results for the quarter, including that our cash runway takes us into 2024. Then I'll be back for some concluding comments. With that, I will turn the call over to Andrew. Thank you, Jack.
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