5/5/2021

speaker
Operator
Conference Call Operator

Ladies and gentlemen, thank you for standing by and welcome to the G1 Therapeutics 2021 First Quarter 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 1 on your telephone keypad. If you require any further assistance, please press star 0. I would now like to hand the conference over to our speaker today, Mr. Will Roberts. Please go ahead.

speaker
Will Roberts
Call Host/Corporate Communications

Thank you, Jillian. Good afternoon, everyone, and welcome to the G1 conference call to discuss our first quarter 2021 financial results and business update. The press release on these financial results was issued after market closed this afternoon and can be found in the news section of our corporate website, g1therapeutics.com. On this afternoon's call, the team will provide a business overview of the first quarter including an update on our launch progress with COSELLA, which was approved by the U.S. Food and Drug Administration on February 12, 2021, 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 ES-SCLC. And it became available in the channel in early March. A question and answer session will follow the prepared comments. 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 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 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, March 5, 2021. Joining me on the call today are Jack Bailey, our Chief Executive Officer, Soma Gupta, our Chief Commercial Officer, Jen Moses, our Chief Financial Officer, and Raj Malek, our Chief Medical Officer. And with that, I'll turn the call over to Jack. Jack?

speaker
Jack Bailey
Chief Executive Officer

Thanks, Will. Good afternoon, everyone, and thank you for joining us on the call today. We certainly hope that you and your families are healthy and well. Today's headline is one of progress toward our mission via continued execution by the G1 team on both our launch efforts for COSELLA in extensive stage small cell lung cancer and in our clinical efforts as we execute on our robust development plan. As many of you know, G1 was founded in 2008 by Dr. Norman Ned Sharpless, the current director of the National Cancer Institute, to discover novel therapeutics that target protein kinases that help mediate cell division. His mission even then was to improve the experience of chemotherapy and to improve and extend the lives of people living with cancer. And I'm happy to say that our mission has not changed as the company has evolved. The development, approval, and launch of COSELLA in extensive stage small cell lung cancer is one example of how we are actively advancing that mission. Another is our tumor agnostic clinical program with late stage clinical trials ongoing or soon to be initiated in multiple tumor types. SOMA will share that the early indicators are suggestive of a drug that is being well received by oncologists and oncology nurses, and is well covered by payers. COSELLA is already being administered to patients. It fits well into the oncologist's workflow. Oncology nurses are being actively educated on its benefits. It's reasonably priced and supported by strong budget impact data. It was quickly added to two NCCN guidelines, and it represents the start of a true paradigm shift in chemotherapy patient support from reactive single lineage treatment with multiple drugs depending on the side effect to that of proactive multi-lineage myeloprotection. Equally good progress has been made in our clinical efforts with Cocella. Since the beginning of the first quarter, we started dosing patients in our pivotal colorectal cancer trial We've initiated our pivotal TMBC trial. We also opened an investigator-initiated trial portal, which is generating a number of interesting potential opportunities. And we expect to initiate two more Phase II trials later this quarter in non-small cell lung cancer and bladder cancer. So by the end of the current quarter, we expect to have two Phase III registrational trials and three Phase II trials underway. Now, today's call will cover an important amount of information. I'll ask Soma to discuss our commercial efforts through the end of March, our first four weeks of being a commercial organization, and provide some leading and lagging indicators of COSELLA's access and uptake. Raj will then provide an update on our medical efforts and also our recent clinical milestones in the first quarter. Finally, Jen will provide the financial update for the first quarter of 2021. Then I'll be back for some concluding comments. I'll now turn the call over to Soma for her update on our commercial efforts and results over the first four weeks of sales. Soma?

Disclaimer

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