G1 Therapeutics, Inc.

Hello, and thank you for standing by. Welcome to the G1 Therapeutics Third Quarter 2022 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, one, one, on your telephone. You will then hear an automated message advising that your hand is raised. I would now like to hand the conference over to your opening speaker, the Vice President of Communications, Will Roberts. Will, please proceed.

Thank you, Sheena. Good morning, everyone, and welcome to the G1 Conference Hall to discuss our third quarter 22 financial results and business updates. The press release on these financial results was issued this morning and can be found in the news section of our corporate website, qntherapeutics.com. On this morning's call, the team will provide a business overview of the third 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 etoposide-containing regimen or a Topotecan-containing regimen for extensive stage small cell lung cancer, or ESSVLC. A Q&A session, as Sheena said, 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 judgment as of today and may involve certain risks 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, November 2nd, 22. Joining me on the call today are Jack Bailey, our Chief Executive Officer, Raj Malek, our Chief Medical Officer, Andrew Perry, our Chief Commercial Officer, and Jen Moses, our Chief Financial Officer. I'll now turn the call over to Jack.

Jack? Good morning, everyone. Thank you for joining us on the call today. During the third quarter, we demonstrated continued execution on our clinical program, but also experienced lower COSELLA sales momentum versus what we achieved in the second quarter. I'll cover both in my opening comments, and then Raj and Andrew will each provide additional color to both topics. First, I'm proud of the progress the clinical team achieved. As Raj will discuss, among the clinical milestones that we've reached during the quarter and since our R&D day in September, we announced this morning that we are seeing encouraging initial safety results from our Phase II ADC trial with Salsituzumab-Govetikin that shows its potential to provide clinically meaningful reductions of over 50% in adverse events related to Salsituzumab such as myelosuppression, diarrhea, and potentially even alopecia, compared to previously published single agent safety profile of this ADC. We also completed enrollment in our phase three metastatic triple negative breast cancer trial, and for our phase two bladder cancer trial. And as we discussed on our last call, the trial cycle mechanism of action trial. Next, our phase two MOA trial results have been accepted for presentation at the San Antonio Breast Cancer Symposium meeting. Two abstracts providing additional non-clinical data on trilocyclin's potential anti-tumor effect have been accepted for presentation at the Society for Immunotherapy of Cancer meeting in November. Finally, and perhaps of most importance, our timelines for initial results remain intact for our pivotal phase three trials in colorectal cancer and in triple negative breast cancer. At the same time, we are cognizant of the fact that we did not deliver the level of sales results that we were expecting. As you'll hear from Andrew, we are working through some market variability due to new patient flow, pressure on organizational staffing, and account additions at different times of the year. Though this was balanced by a 12% increase in reorders from existing accounts. We are putting in place a variety of actions that Andrew will describe that will drive growth over the coming months. We hear every day from healthcare professionals and patients who have experienced the unique benefit that only Cocella provides. It's a paradigm changing drug that enables oncologists for the first time to proactively reduce or prevent the serious multi lineage hematologic side effects of chemotherapy rather than treating them reactively. we remain as confident in the potential of Casella today as ever. And as the initial results from our ADC trial underscore, extensive stage small cell lung cancer is just the start. We are convinced of its potential value in much bigger markets like colorectal cancer. Since this morning marks the first of many new clinical data disclosures over the coming months, I will first ask Raj to provide an overview of our clinical momentum during the quarter and since our R&D day, starting with an overview of the initial ADC safety results. Angie will then cover our recent commercial actions and results, including an update on the efforts of our field sales team during the third quarter of 2022. Finally, Jen will provide the financial results for the quarter. Then I'll be back for some concluding comments. With that, I'll turn the call over to Raj.