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In The Spotlight: G1 Therapeutics

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Shares of G1 Therapeutics Inc. (GTHX) have returned an impressive 103% year-to-date while the iShares NASDAQ Biotechnology Index (ETF)(IBB) is up a paltry 2.8% during the same period.

G1 Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for the treatment of cancer.

The Company has 3 drug candidates in its pipeline namely, Trilaciclib, G1T38 and G1T48.

The most advanced investigational drug is Trilaciclib, an intravenous CDK4/6 inhibitor in development, to reduce *myelosuppression and enhance immune system function during chemotherapy. * Myelosuppression, one of the side effects of chemotherapy, is defined as a decrease in the bone marrow activity resulting in fewer red blood cells, white blood cells, and platelets. (Source: National Cancer Institute).

Trilaciclib is under four phase II clinical trials - three studies in patients with small-cell lung cancer (SCLC), and one study in patients with triple-negative breast cancer.

The Company reported positive top line data from its phase IIa trial of Trilaciclib in patients undergoing chemotherapy for first-line small cell lung cancer (SCLC) on March 5, 2018.

According to the study findings, Trilaciclib reduced clinically relevant consequences of chemotherapy-induced myelosuppression versus placebo. Trilaciclib was well tolerated, with no treatment emergent adverse events.

The other three ongoing clinical trials of Trilaciclib are:

-- A phase II study of Trilaciclib in combination with Genentech's Tecentriq and chemotherapy as a first-line treatment for small cell lung cancer (SCLC) patients.
-- A phase IIa trial of Trilaciclib plus Topotecan in second-/third-line small cell lung cancer.
-- A phase II trial of Trilaciclib plus Gemcitabine/Carboplatin in triple-negative breast cancer.

Near-term Catalysts:

** The phase IIa trial of Trilaciclib plus Topotecan in second-/third-line small cell lung cancer is designed to enroll 90 patients. Enrollment in this study is expected to be completed next quarter, with preliminary data anticipated in the fourth quarter of 2018.

** The phase II study of Trilaciclib in combination with Tecentriq and chemotherapy as a first-line treatment for small cell lung cancer (SCLC) patients completed enrollment in February of this year - 2 quarters ahead of schedule. The top line data from this study is expected in 2019.

** The phase II trial of Trilaciclib plus Gemcitabine/Carboplatin in triple-negative breast cancer is designed to enroll 90 patients. Enrollment in this study is expected to be completed next quarter, with preliminary data anticipated in the fourth quarter of this year.

Next in the pipeline is G1T38, a next generation oral CDK4/6 inhibitor.

A phase Ib/IIa trial of G1T38 plus Faslodex in ER+, HER2- breast cancer is ongoing. Preliminary phase Ib data from this trial are expected next quarter.

G1T38 is also going to be studied in a phase Ib/II trial in combination with AstraZeneca's (AZN) Tagrisso for the treatment of patients with EGFR mutation-positive non-small cell lung cancer. Accordingly, the phase Ib portion of the trial is expected to be initiated this month.

Up next is G1T48, a proprietary, orally available, selective estrogen receptor degrader (SERD).

The Company expects to initiate a phase I/IIa trial of G1T48 in ER+, HER2- breast cancer patients in the second quarter of 2018.

Recent events:

-- On February 21, 2018, the Company reported financial results for the fourth quarter and full year ended December 31, 2017.

The annual net loss attributable to common stockholders in 2017 was $64.88 million or $3.57 per share compared to a net loss attributable to common stockholders of $34.69 million or $23.33 per share in 2016. No revenues have been generated to date.

The Company ended the year 2017 with cash, cash equivalents and short-term investments of $103.8 million.

-- On March 12, 2018, the Company closed an underwritten public offering of 3.91 million shares of its common stock at a public offering price of $29.50, including 510,000 shares sold pursuant to the full exercise of the underwriters' option to purchase additional shares. The net proceeds received by G1 Therapeutics from the offering were $108.4 million.

G1 Therapeutics went public on the Nasdaq Global Select Market on May 17, 2017, offering its shares at a price of $15.00 each.

GTHX touched an all-time high of $40.96 in intra-day trading yesterday (Mar.20), before closing at $40.35, up 7.46%.

by RTTNews Staff Writer

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