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RESEARCH TRIANGLE PARK, N.C., Aug. 08, 2018 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq:GTHX), a clinical-stage oncology company, today provided an update on its corporate activities, product pipeline and financials for the second quarter ended June 30, 2018.
“We have made impressive clinical progress on trilaciclib in the first half of 2018 and are approaching several important clinical milestones later this year. Additional data from the randomized Phase 2 trilaciclib/chemotherapy trial in first-line small cell lung cancer have been accepted for presentation at the European Society for Medical Oncology Congress in October. We will also be reporting preliminary data from our randomized Phase 2 trials of trilaciclib in second-/third-line SCLC and triple-negative breast cancer in the fourth quarter,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “We have been engaged in productive discussions with U.S. and European regulatory authorities regarding the trilaciclib development program and expect that dialogue to continue.”
Dr. Velleca added: “We presented the first clinical data on lerociclib in patients with ER+, HER2- breast cancer in June at the 2018 American Society of Clinical Oncology Annual Meeting, which showed promising safety, tolerability and anti-tumor activity. We are currently enrolling the Phase 2a dose-expansion portion of that trial, with patients receiving 500 mg once daily without a dosing holiday. In addition, we have initiated the first clinical trial for G1T48, our oral SERD, in ER+, HER2- breast cancer and expect preliminary data next year.”
Anticipated Upcoming Milestones
Second Quarter 2018 Financial Highlights
Webcast and Conference Call
The G1 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 second 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: 3088562. 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. (G1) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for the treatment of cancer. Two of the company’s pipeline assets, trilaciclib and lerociclib, are CDK4/6 inhibitors, a validated and promising class of oncology therapeutics. Trilaciclib and lerociclib have broad therapeutic potential in many forms of cancer and may serve as backbone therapy of multiple combination regimens. Trilaciclib is a short-acting IV CDK4/6 inhibitor designed to preserve hematopoietic stem cell and immune system function (myelopreservation) during chemotherapy. Lerociclib is a potential best-in-class oral CDK4/6 inhibitor for use in combination with other targeted therapies. G1 is also advancing G1T48, a potential best-in-class oral selective estrogen receptor degrader, or SERD, which is targeted for the treatment of ER+ breast cancer.
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 press release include, but are not limited to the following: the therapeutic potential of trilaciclib, lerociclib and G1T48; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; our ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; our ability to recruit and enroll patients in its studies; competition in the industry in which we operate; and market conditions. Each of these forward-looking statements involves risks and uncertainties and are based on our expectations and assumptions as of the date of this press release. Factors that may cause our actual results to differ from those expressed or implied in the forward-looking statements in this press release are further discussed in our filings with the U.S. Securities and Exchange Commission (SEC), including the "Risk Factors" section in our annual report on Form 10-K for the fiscal year ended December 31, 2017 filed with the SEC. Such factors may be amended or updated from time to time in our subsequent periodic and other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. We assume no obligation to update any forward-looking statement after the date of this press release to reflect any change in expectations or future developments, even as new information becomes available.
Head of Investor and Public Relations
|G1 Therapeutics, Inc.|
|Balance Sheet Data|
|June 30,||December 31,|
|Cash and cash equivalents||$||188,227||$||103,812|
|Total stockholders’ equity||$||176,524||$||93,388|
|G1 Therapeutics, Inc.|
|Condensed Statements of Operations|
|(in thousands, except per share data)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||18,385||13,667||35,732||24,752|
|General and administrative||3,268||1,712||6,646||3,006|
|Total operating expenses||21,653||15,379||42,378||27,758|
|Other income (expense)|
|Change in fair value in warrant liability and other liabilities||—||—||—||(41||)|
|Total other income, net||785||185||1,099||219|
|Accretion of redeemable convertible preferred stock||—||(289||)||—||(4,757||)|
|Net loss attributable to common stockholders||$||(20,868||)||$||(15,483||)||$||(41,279||)||$||(32,296||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.64||)||$||(1.09||)||$||(1.33||)||$||(4.09||)|
|Weighted average common shares outstanding, basic and diluted||32,781,921||14,208,115||31,080,650||7,887,341|