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RESEARCH TRIANGLE PARK, N.C., Nov. 05, 2019 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a corporate and financial update for the third quarter ended September 30, 2019.
“Based on written feedback from the FDA following our pre-NDA meeting in September, we will submit a New Drug Application for myelopreservation in small cell lung cancer. We expect to complete the submission in the second quarter of 2020,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “Our vision is for trilaciclib to become a new standard of care to mitigate myelosuppression in patients receiving chemotherapy. We are committed to making trilaciclib available to small cell lung cancer patients as quickly as possible, and are executing on a regulatory and development strategy to evaluate the myelopreservation benefits of trilaciclib in the most commonly used chemotherapy regimens. We expect to initiate a Phase 3 trial in colorectal cancer in the second half of 2020. In addition, we will continue to explore trilaciclib in triple-negative breast cancer, where preliminary data has demonstrated a survival benefit.”
Third Quarter Regulatory and Clinical Highlights
Third Quarter 2019 Financial Highlights
Webcast and Conference Call
The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the third quarter 2019 ended September 30, 2019. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 3374256. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.
About G1 Therapeutics
G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs. Trilaciclib is a first-in-class therapy designed to improve outcomes for patients being treated with chemotherapy. Lerociclib is an oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies. G1T48 is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. G1 also has an active discovery program focused on cyclin-dependent kinase targets.
G1 is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, lerociclib and G1T48 and the timing for next steps with regard to the trilaciclib marketing applications, and are based on the Company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the Company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the Company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; the Company’s development of a CDK4/6 inhibitor to reduce chemotherapy-induced myelosuppression is novel, unproven and rapidly evolving and may never lead to a marketable product; and market conditions. Except as required by law, the Company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Senior Director, Investor Relations & Corporate Communications
G1 Therapeutics, Inc.
Balance Sheet Data
|September 30,||December 31,|
|Cash and cash equivalents||$||299,933||$||369,290|
|Total stockholders’ equity||$||286,119||$||358,820|
G1 Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except per share data)
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||22,941||15,873||64,510||51,605|
|General and administrative||11,083||4,949||27,979||11,595|
|Total operating expenses||34,024||20,822||92,489||63,200|
|Other income (expense)|
Total other income, net
|Net loss per share, basic and diluted||$||(0.86||)||$||(0.59||)||$||(2.32||)||$||(1.91||)|
|Weighted average common shares outstanding,
basic and diluted