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This Day That Year: G1 Therapeutics

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Shares of G1 Therapeutics Inc. (GTHX) have returned a whopping 230% over the last 1 year while the iShares NASDAQ Biotechnology Index (ETF) has gained a mere 11% during the same period.

It was on this day last year, i.e. on May 17, 2017, that G1 Therapeutics debuted on the Nasdaq by setting a public offering at $15.00 per share.

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.

Anticipated Upcoming Milestones:

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.

Patient enrollment in the phase IIa trial of Trilaciclib plus Topotecan in second-/third-line small cell lung cancer is expected to be completed in the second quarter.

Patient enrollment in the phase II trial of Trilaciclib plus Gemcitabine/Carboplatin in triple-negative breast cancer is also expected to be completed in the second quarter.

Preliminary data from the above two trials are 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 to be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2018.

A phase Ib/II trial of G1T38 in combination with AstraZeneca's (AZN) Tagrisso for the treatment of patients with EGFR mutation-positive non-small cell lung cancer was initiated last month. The trial is expected to enroll approximately 145 participants.

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.

Key Numbers: (As of March 31, 2018)

Accumulated deficit: $149.5 million
Revenue: Nil
Cash on hand: $194.4 million
Shares Outstanding: 32.7 million

GTHX has traded in a range of $12.04 to $52.44 over the last 1 year. The stock closed Wednesday's (May 16) trading at $49.13, up 4.73%.

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