G1 Therapeutics Provides Fourth Quarter and Full Year 2021 Financial Results and Operational Highlights
- Completed Hiring, Training, and Deployment of G1’s COSELA Sales Team -
- Announced That Initial Results from Phase 3 Trial of Trilaciclib in Colorectal Cancer (PRESERVE 1) Are Now Expected Early in the First Quarter of 2023 -
- Initiated Two New Phase 2 Trials to Confirm the Immune-Based Mechanism of Action (MOA) of Trilaciclib and to Help Clarify the Potential Synergistic Effects of Trilaciclib and an Antibody-Drug Conjugate (ADC) -
- Management to Host Webcast and Conference Call today at
“2021 was an important foundational year for G1; but I expect 2022 to be a year of strong execution across the Company and value creation for our shareholders and the people living with cancer we seek to serve,” said
Fourth Quarter 2021 and Recent Highlights
- Achieved Total Revenue of
$5.8Million: G1 recognized total revenues of $5.8 millionin the fourth quarter of 2021, including $4.4 millionin net product revenue from sales of COSELA.
- Ended the Fourth Quarter 2021 with Cash and Cash Equivalents of
$221.2million: The Company’s current financial position is expected to be sufficient to fund G1’s operations and capital expenditures into 2024.
- Completed Hiring, Training, and Deployment of G1’s COSELA Sales Team: G1 and
Boehringer Ingelheimterminated the co-promotion agreement for COSELA, effective March 2, 2022. G1 has hired and fully deployed its sales team, including the Vice President of Sales, four Regional Sales Directors, and a total of 34 Oncology Sales Account Managers (OSAMs). The G1 sales team is targeting all U.S.accounts to accelerate sales activities and help maximize the adoption of COSELA. (Press release here)
- Received Permanent J-code for COSELA Effective
October 1, 2021: The permanent J-code that was issued in July 2021by the Centers for Medicare & Medicaid Services(CMS) is effective as of October 1, 2021, for provider billing for all sites of care. (Press release here)
- Announced that Initial Data from Pivotal Phase 3 Trial of Trilaciclib in Colorectal Cancer (CRC) (PRESERVE 1) Are Now Expected Early in the First Quarter of 2023: This Phase 3 multi-center, randomized, placebo-controlled trial is designed to confirm the benefit of trilaciclib in combination with 5-FU-based regimens. PRESERVE 1 is being conducted in approximately 300 mCRC patients being treated with first line FOLFOXIRI, a highly efficacious but highly myelosuppressive chemotherapy frequently used in this setting. The primary endpoint of this trial is myeloprotection, with survival measures including progression free survival (PFS) and overall survival (OS) also being assessed as secondary endpoints. G1 expects to announce the initial results from this Phase 3 trial including myeloprotection and objective response rate (ORR) endpoints early in the first quarter of 2023, earlier than previously stated.
- Initiated New Phase 2 Trial of Trilaciclib in Combination with an Antibody-Drug Conjugate (ADC) in Triple-Negative Breast Cancer: The Company initiated a Phase 2, single arm, open-label trial of trilaciclib to study the potential synergistic effects of trilaciclib and the antibody-drug conjugate (ADC) Trodelvy® (sacituzumab govitecan-hziy) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). The primary objective is to evaluate the anti-tumor efficacy of trilaciclib when administered prior to sacituzumab govitecan-hziy as measured by PFS. Data from this trial will help determine future ADC combinations. Initial results including ORR and myeloprotection endpoints are expected in the fourth quarter of 2022. (Press release here)
- Initiated New Phase 2 Trial of Trilaciclib to Support its Immune-based Mechanism of Action: G1 initiated a Phase 2, single arm, open-label trial of trilaciclib in patients with early-stage TNBC designed to confirm the mechanism of action of trilaciclib in modulating the anti-tumor immune response with and without a checkpoint inhibitor. This trial is replacing I-SPY2 neoadjuvant breast trial in G1’s pipeline given the landscape shift from chemotherapy only to chemotherapy + I/O. The primary endpoint is to evaluate the immune-based mechanism of action of trilaciclib after a single-dose as measured by the change in the ratio of effector CD8+ tumor-infiltrating lymphocytes (TILs) to suppressor regulatory T cell (Tregs) in the tumor microenvironment. Data from this trial will inform design of future pivotal studies across multiple tumor types and treatment combinations. Initial results including immune endpoints (e.g., CD8+ TIL / Treg ratio) are expected in the fourth quarter of 2022. (Press release here)
- Reiterated Expectation of Initial Data in the Second Half of 2023 from Pivotal Phase 3 Trial of Trilaciclib in 1L TNBC (PRESERVE 2); Changes in Market Landscape Drive Strategic Decision to Discontinue 2L Arm: The treatment landscape is shifting rapidly in 2L TNBC given the expanded indication and rapid uptake of Trodelvy® (sacituzumab govitecan-hziy) in 2L/3L TNBC, creating significant barriers to enrollment in this cohort and dramatically reducing the future market opportunity in 2L. As such, the Company has made the strategic decision to discontinue the 2L arm of the trial and will continue to enroll and focus on 1L mTNBC, an area of high unmet medical need. G1 has also modified the protocol to include post-checkpoint patients in the 1L arm to develop clinical experience in this setting. The Company has confirmed that it expects initial results from this pivotal trial, including interim overall survival, in the second half of 2023.
- Announced Publication of Data Showing That Proactive Use of Trilaciclib Prior To Chemotherapy in Certain Patients Significantly Reduced the Use of Reactive Supportive Care Therapies After Chemotherapy: Results from a retrospective analysis of the pooled results of three randomized trilaciclib studies were published in Cancer Medicine, demonstrating that patients with extensive-stage small-cell lung cancer (ES-SCLC) who received trilaciclib prior to each chemotherapy treatment had significantly lower use of supportive care therapies—including G-CSFs, ESAs, and RBC transfusions— for chemotherapy-induced myelosuppression than patients who received placebo. (Press release here)
- Presented Data at the 36th Annual Meeting of
The Society for Immunotherapy of Cancer (SITC) Demonstratingthat Trilaciclib Enhanced Patients’ T Cell Immune Function: Results from an immunologic analysis of Phase 2 study data showed that trilaciclib enhanced both CD4 and CD8 T cell function in certain patients with metastatic TNBC when administered prior to chemotherapy. Patients who received trilaciclib prior to gemcitabine/carboplatin (GCb) had fewer immune suppressing cells (myeloid derived suppressor cells; MDSCs) than patients who received GCb alone, whether they were responders or non-responders to treatment, and showed increased T cell function. (Press release here)
- Published Data in the Journal of Medical Economics Showing Cost Savings Associated with Trilaciclib Use Prior To Chemotherapy in Patients with Extensive-Stage Small Cell
Lung Cancer: Data show that the use of trilaciclib prior to first-line chemotherapy resulted in cost savings due to fewer myelosuppressive adverse events and their associated treatment costs in patients with ES-SCLC suggesting that trilaciclib could provide both clinical and economic benefits for the treatment of these patients.
Fourth Quarter and Full Year 2021 Financial Results
Total revenues for the fourth quarter of 2021 were
Operating expenses for the fourth quarter of 2021 were
Cost of goods sold expense for the fourth quarter of 2021 were
Research and development (R&D) expenses for the fourth quarter of 2021 were
Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2021 were
The net loss for the fourth quarter of 2021 was
G1 also expects its current financial position to be sufficient to fund its operations and capital expenditures into 2024.
Webcast and Conference Call
G1 will host a webcast and conference call at
About COSELA™ (trilaciclib) for Injection
COSELA (trilaciclib) was approved by the
COSELA™ (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.
Important Safety Information
COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.
Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.
The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.
This information is not comprehensive. Please click here for full Prescribing Information. https://www.g1therapeutics.com/cosela/pi/
To report suspected adverse reactions, contact
G1 Therapeutics™ and the
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, those relating to expectations for the commercial launch of COSELA (trilaciclib), the therapeutic potential of COSELA (trilaciclib), our ability to generate data to maximize trilaciclib’s applicability to future treatment paradigms, and our reliance on partners to develop licensed products. In addition, COSELA (trilaciclib) may fail to achieve the degree of market acceptance for commercial success, and the impact of pandemics such as COVID-19 (coronavirus), are based on the company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the
G1 Therapeutics Contacts:
Chief Financial Officer
Vice President, Investor Relations & Corporate Communications
Director, Corporate Communications and Public Relations
Balance Sheet Data
|Cash and cash equivalents||$||221,186||$||207,306|
|Total stockholders' equity||$||143,541||$||177,351|
Condensed Statements of Operations
(in thousands, except per share data)
|Three months ended
||Twelve months ended
|Product sales, net||$||4,403||$||-||$||11,120||$||-|
|Cost of goods sold||374||-||2,016||-|
|Research and development||19,790||16,374||76,225||73,271|
|Selling, general and administrative||23,218||24,260||95,692||68,490|
|Total operating expenses||43,382||40,634||173,933||141,761|
|Loss from operations||(37,586||)||(24,088||)||(142,457||)||(96,476||)|
|Other income (expense):|
|Other income (expense)||(138||)||(54||)||(346||)||(542||)|
|Total other income (expense), net||(2,188||)||(780||)||(4,970||)||(1,368||)|
|Loss before income taxes||(39,774||)||(24,868||)||(147,427||)||(97,844||)|
|Income tax expense||246||479||925||1,410|
|Net loss per share, basic and diluted||$||(0.94||)||$||(0.67||)||$||(3.54||)||$||(2.62||)|
|Weighted average common shares outstanding, basic and diluted||42,544,321||38,053,609||41,943,417||37,878,026|
Source: G1 Therapeutics