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Preliminary data from three additional randomized Phase 2 clinical trials of trilaciclib expected by end of 2018
Management to host webcast and conference call today at 4:30 p.m. ET
RESEARCH TRIANGLE PARK, N.C., Nov. 07, 2018 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today reported financial results and provided an update on its corporate activities and product pipeline for the third quarter ended September 30, 2018.
“Data from our randomized Phase 2 clinical trial of trilaciclib and chemotherapy in first-line small cell lung cancer showed robust myelopreservation benefits. By the end of the year, we will report data from three additional randomized Phase 2 trials in a variety of indications. Collectively these trials will provide preliminary data on the potential anti-tumor efficacy and myelopreservation benefits of trilaciclib across different indications, lines of therapy, and chemotherapy regimens,” said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. “We plan to request meetings with U.S. and European regulatory authorities in early 2019 to discuss data from more than three hundred participants who received trilaciclib across multiple clinical trials.”
“Enrollment remains on track for our lerociclib clinical trials in ER+, HER2- breast cancer and EGFRm non-small cell lung cancer, as well as our G1T48 trial in ER+, HER2- breast cancer, and we plan to report data on each of these programs in 2019,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “Our strong balance sheet enables us to advance our three product candidates and begin investment in pre-commercialization activities for trilaciclib.”
Anticipated Milestones for Fourth Quarter 2018
Third Quarter 2018 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 of 2018. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 6188644. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com.
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, lerociclib and G1T48, that are designed to enable more effective combination treatment strategies and improve patient outcomes across multiple oncology indications.
G1 is based in Research Triangle Park, NC. 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 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.
Head of Investor and Public Relations
|G1 Therapeutics, Inc.|
|Balance Sheet Data|
|September 30,||December 31,|
|Cash and cash equivalents||$||390,524||$||103,812|
|Total stockholders’ equity||$||379,255||$||93,388|
|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||15,873||14,054||51,605||38,806|
|General and administrative||4,949||1,875||11,595||4,881|
|Total operating expenses||20,822||15,929||63,200||43,687|
|Other income (expense)|
|Change in fair value in warrant liability and other liabilities||—||—||-||(41||)|
|Total other income, net||904||328||2,003||547|
|Accretion of redeemable convertible preferred stock||—||—||-||(4,757||)|
|Net loss attributable to common stockholders||$||(19,918||)||$||(15,601||)||$||(61,197||)||$||(47,897||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.59||)||$||(0.55||)||$||(1.91||)||$||(3.24||)|
|Weighted average common shares outstanding, basic and diluted||33,829,437||28,318,656||32,006,978||14,772,621|
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Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g...