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Phase Two Studies Start for Therapy for Chemo-Treated Breast Cancer Patients
Research Report

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New clinical trials for G1 Therapeutics’ Cosela are “central to our investment thesis,” H.C. Wainright & Co. noted in a new research report.

G1 Therapeutics Inc. (GTHX:NASDAQ) began two Phase Two clinical trials of Cosela (trilaciclib) in patients with early-stage triple negative breast cancer (TNBC), H.C. Wainwright & Co. analyst Edward White reported in a Dec. 1 research note.

"Expanding the Cosela label is central to our investment thesis, and we view the initiation of the new TNBC studies positively," White wrote.

Cosela is a CDK4/6 inhibitor designed to lessen chemotherapy-induced damage to bone marrow and improve patient outcomes. The U.S. Food and Drug Administration approved Cosela in February in adult patients with late-stage small cell lung cancer, White indicated. In that population, Cosela is given before certain chemotherapies and used to decrease the incidence of chemotherapy-caused myelosuppression.

Also of note, H.C. Wainwright has a $71 per share price target on G1 Therapeutics, which represents a potential 450% return from where the stock is currently trading, around $12.90 per share.

The Phase 2 study U.S.-based G1 Therapeutics most recently launched aims to evaluate the immune-based mechanism of action of Cosela in TNBC patients after one dose, White noted. Therefore, the primary endpoint is change in the ratio of CD8+ tumor-infiltrating lymphocytes to regulatory T cells within the tumor.

The analyst described how the study will work. Before receiving Cosela, three tumor tissue samples will be obtained and assessed as a baseline. Patients then will receive one Cosela dose and one week afterward, have a biopsy.

The treatment cycle then will begin. Patients will receive Cosela on the first day of each cycle of anthracycline/cyclophosphamide, for four cycles. Next, patients will receive Cosela on the first day of each cycle of taxanes, for 12 cycles.

Three to five weeks after the last chemotherapy dose, if patients have residual disease, they are to undergo another biopsy. Treatment will continue until it is finished or stopped.

"This Phase 2 study," White wrote, "is expected to help guide the company's future development decisions across additional tumor types and new treatment combinations."

The second Phase 2 trial G1 Therapeutics initiated this week also will assess Cosela but in a different set of TNBC patients. These participants have a tumor that has either metastasized or is locally advanced and unresectable. In this study, Cosela will be given prior to Trodelvy being administered, and the drug's anti-tumor efficacy and myeloprotection will be evaluated. 

H.C. Wainwright & Co. has a Buy rating on G1 Therapeutics.


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Important Disclaimers for H.C. Wainwright & Co., G1 Therapeutics Inc., Dec. 1, 2021

This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. 
H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.
Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.
I, Edward White , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of G1 Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of November 30, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of G1 Therapeutics, Inc.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report. The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from G1 Therapeutics, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from G1 Therapeutics, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in G1 Therapeutics, Inc. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request.
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