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RESEARCH TRIANGLE PARK, N.C., Feb. 28, 2019 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today reported financial results for the fourth quarter and full-year ended December 31, 2018. The company also highlighted 2018 operational results and upcoming 2019 milestones.
“Data from four randomized Phase 2 trials showed the 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 have scheduled meetings with U.S. and European regulatory authorities in the first half of 2019 to discuss the totality of data and next steps for the development of trilaciclib. We will provide an update on these meetings in the second quarter.”
“We made substantial progress across our three clinical-stage product candidates in 2018. We reported positive results from all four Phase 2 trilaciclib trials, presented proof-of-concept data on lerociclib in breast cancer, initiated a trial of lerociclib in non-small cell lung cancer, and brought our oral selective estrogen receptor degrader G1T48 into the clinic,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “These accomplishments will drive a number of important clinical and regulatory milestones in 2019 in the advancement of our pipeline.”
Anticipated Milestones for 2019
Fourth Quarter and Full-Year 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 financial update for the fourth quarter and full-year of 2018. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 2698949. 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.
Clinical program updates will be provided at the Investor Day 2019 meeting on March 6.
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 also has an active discovery program focused on cyclin-dependent kinases 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 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
|December 31,||December 31,|
|Cash and cash equivalents||$||369,290||$||103,812|
|Total stockholders’ equity||$||358,820||$||93,388|
G1 Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except per share data)
|Three Months Ended December 31,||Year Ended December 31,|
|Research and development||19,077||15,076||70,683||53,881|
|General and administrative||7,009||2,206||18,603||7,087|
|Total operating expenses||26,086||17,282||89,286||60,968|
|Other income (expense)|
|Change in fair value in warrant liability and other liabilities||—||—||—||(41||)|
|Total other income, net||1,994||301||3,998||847|
|Accretion of redeemable convertible preferred stock||—||—||—||(4,757||)|
|Net loss attributable to common stockholders||$||(24,092||)||$||(16,981||)||$||(85,288||)||$||(64,878||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.65||)||$||(0.60||)||$||(2.56||)||$||(3.57||)|
|Weighted average common shares outstanding, basic and diluted||37,203,233||28,362,323||33,316,719||18,197,970|