G1 Therapeutics Inc. (NASDAQ:GTHX) has announced its Q3 2020 financial results and corporate updates for the period ended September 30, 2020. The company ended the quarter with cash and cash equivalents of $238.3 million. It has revised its guidance for 2020 and now expects to end the year with $200-$205 million in cash and equivalents.
G1 Therapeutics reports the trilaciclib progress in SCLC
Mark Velleca, the G1 Therapeutics’ CEO, said that since he joined the company in 2014, they have made considerable progress in advancing trilaciclib. Trilaciclib received Priority Review for an NDA, and the PDUFA action date is scheduled for February 15, 2021. Velleca said that the company had built exceptional medical and commercial teams in readiness for the possible approval of trilaciclib in Q1 2021. The company has also developed a comprehensive regulatory and clinical strategy to evaluate trilaciclib in other solid tumors. The evaluation includes a registration study in metastatic colorectal cancer due to commence this quarter.
The FDA accepted the NDA for trilaciclib in treating small cell lung during the quarter and assigned Priority Review. G1 supported the application with positive trilaciclib data from its three randomized clinical studies indicating myelopreservation benefits in SCLC patients treated with chemo. The FDA also granted trilaciclib Breakthrough Therapy Designation. The company plans to present more trilaciclib data analyses on SCLC at the North America Conference on Lung Cancer.
Jack Bailey to take over as new CEO
Velleca, who will be handing over the company’s leadership to Jack Bailey as the new CEO, said that he has been privileged to work with the G1 team to achieve several goals. He said that Bailey, who is a board member, has extensive experience in the launch of novel therapeutics and management of product development to optimize value to patients. Bailey said that he is delighted for the opportunity to head G1 into the next Phase as a commercial company. He added that the company’s priorities are successful execution and launch strategy for trilaciclib in SCLC and advancing it in other tumors.