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Stock To Watch: G1 Therapeutics (GTHX)

G1 Therapeutics, Inc. (GTHX) which is trading over 48% below its 52-week high price of $41.80, recorded on September 12, 2019, has a number of catalysts up its sleeve that can make or break the stock price.

G1 Therapeutics is a clinical-stage biopharmaceutical company developing innovative therapies focused on improving the chemo experience for people living with cancer.

The lead drug candidate is Trilaciclib, a first-in-class myelopreservation therapy that has the potential to make chemotherapy safer, improve the patient experience, and in some settings, help patients live longer.

In clinical trials, Trilaciclib has shown to reduce chemotherapy-related toxicity and the need for rescue interventions.

The Company initiated the rolling NDA submission for Trilaciclib in the indication of small cell lung cancer in the fourth quarter of 2019 and expects to complete the submission in the second quarter of this year.

G1 Therapeutics plans to seek approval of Trilaciclib in Europe in the second half of this year.

A phase II trial comparing the efficacy of novel drugs in combination with standard chemotherapy against standard therapy alone, dubbed I-SPY 2, sponsored by QuantumLeap Healthcare, is underway. Last month, QuantumLeap selected Trilaciclib in the I-SPY 2 trial involving patients with high-risk, early-stage breast cancer subtypes (including HR+, HER2+ and triple-negative breast cancer).

The I-SPY2 trial of Trilaciclib in breast cancer is expected to be initiated in the second quarter of 2020.

The Company expects to initiate a phase III trial of Trilaciclib in colorectal cancer in the fourth quarter of 2020.

Next up in the pipeline is Rintodestrant, formerly G1T48, under a phase I/IIa dose-escalation study in patients with estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer.

Data from the phase I portion of the trial showed Rintodestrant was well tolerated and demonstrated evidence of anti-tumor activity in heavily pre-treated patients. The phase IIa monotherapy portion has completed enrollment, and phase II expansion with Palbociclib combination is expected to be initiated in the first half of this year.

Data update from the Rintodestrant trial is anticipated in the second half of 2020.

The third drug candidate in the pipeline is Lerociclib, currently being evaluated in two phase I/II trials - a trial in combination with fulvestrant for patients with ER+, HER2- breast cancer and in epidermal growth factor receptor mutation (EGFRm) non-small cell lung cancer. Preliminary data from the Lerociclib trial in breast cancer were reported last December.

As of September 30, 2019, the Company's cash, cash equivalents, and short-term investments totaled $299.9 million, which is expected to be sufficient to fund its operations into the second half of 2021.

As of this writing, the stock is currently up 1.26% at $21.64.

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