G1 Therapeutics, Inc.

Good day and thank you for standing by. Welcome to the G1 Therapeutics first quarter 2024 financial results. At this time, our participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during a session, you will need to press Start 101 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press Start 101 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Will Roberts. Please go ahead.

Thank you, Victor. Good morning, everyone, and welcome to the G1 conference call to discuss our first quarter 2024 financial results and business update. The press release on these financial results was issued this morning and can be found in our news section of our corporate website, g1therapeutics.com. On this morning's call, the team will provide a business overview of the 2024 first quarter, including an update on our commercial progress and clinical programs in that period with Casella, 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 topotecan-containing regimen for extensive-stage small-cell lung cancer. 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 and replied by these statements. For more information on such risks 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 1st, 2024. Joining me on the call today are Jack Bailey, our Chief Executive Officer, Andrew Perry, our Chief Commercial Officer, Dr. Raj Malik, our Chief Medical Officer, and John Umstead, our Chief Financial Officer. I'll now turn the call over to Jack.

Jack? Thanks, Will. Good morning, everyone, and thank you for joining us on the call today. From a commercial perspective, we continue to identify and execute on growth opportunities for Cosella. you will hear from andrew our bio volume growth in the quarter was four percent over the fourth quarter of 2023 due to some challenges that he will speak to shortly but as a result of the impact of the actions we've taken and the more recent sales trend we remain confident in our 2024 net sales guidance of 60 to 70 million we are committed to expanding usage of casella in its first syndication in extensive stage small cell lung cancer And assuming we continue to achieve our internal forecast, expect to drive G1 to profitability and cash flow positivity later next year. Now, as you'll hear from Raj, we also remain focused on the opportunity for category leadership across the spectrum of triple negative breast cancer. And in that regard, look forward to two important upcoming data readouts over the coming months. First, we've shown promising results thus far in our ongoing phase two trial when Trialacyclib is combined with the ADC, Sossitusum abgovaticum, including meaningful improvements in median overall and 12-month survival. As you saw this morning, we are excited to provide the updated results in a poster at ASCO 2024 in early June. Next, if the final results from our ongoing Phase III, Preserve II trial of Trialociclib are positive, they would be amongst the most significant data generated in the first-line metastatic setting across PD-L1 status, and a compelling dataset for people living with this extremely aggressive disease. As Raj will discuss, based upon recent interactions with the FDA regarding the inclusion of events from patients enrolled in Ukraine, these results are now expected late in the second quarter of this year. Finally, as you saw in a press release earlier today, we've outlicensed the global rights to Liracyclib, excluding the Asia-Pac region, to an early-stage transomics company called PepperBio. Through this transaction, PepperBio gains exclusive rights to develop, manufacture, and commercialize Liracyclib in those areas for all indications except for certain radioprotectant uses. They've identified CDK4-6 as a key pathway for hepatocellular carcinoma through their proprietary data platform. Lirocyclib will now be their lead clinical stage asset to complement their early stage discovery pipeline. On today's call, Andrew will provide an update on our recent commercial efforts Raj will provide the status of our ongoing TMDC trials and remind you of the timing of the data from each. John will then provide the financial results for the quarter, including our revenue, expense, and cash expectations, along with a review of financials associated with the PepperBio transaction. Finally, I'll be back for some concluding comments. With that, I'll turn the call over to Andrew.