On February 23, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported a corporate and financial update for the fourth quarter and full year ended December 31, 2021 (Press release, G1 Therapeutics, FEB 23, 2022, View Source [SID1234608894]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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 Jack Bailey, Chief Executive Officer of G1 Therapeutics. "I’m very excited with the quality and experience of the members of our new COSELA sales team, who are already hired and fully deployed across the U.S., leveraging our exceptional reimbursement coverage, working to convert high intention-to-use into actual usage and uptake by promoting COSELA with prescribing oncologists and fostering clinical advocacy – all with the goal of rapidly improving COSELA usage and adoption in 2022. Further, we expect to provide initial results from three clinical trials in the second half of this year, including the ADC combination, MOA, and bladder cancer Phase 2 trials, with pivotal colorectal cancer trial data expected soon thereafter, early in the first quarter of 2023. We remain confident in the potential for COSELA in its first indication and, as our pipeline evolves, look forward to delivering on our goal of improving the lives of as many people living with cancer as possible."
Fourth Quarter 2021 and Recent Highlights
Financial
Achieved Total Revenue of $5.8 Million: G1 recognized total revenues of $5.8 million in the fourth quarter of 2021, including $4.4 million in net product revenue from sales of COSELA.
Ended the Fourth Quarter 2021 with Cash and Cash Equivalents of $221.2 million: The Company’s current financial position is expected to be sufficient to fund G1’s operations and capital expenditures into 2024.
Commercial
Completed Hiring, Training, and Deployment of G1’s COSELA Sales Team: G1 and Boehringer Ingelheim terminated 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 2021 by 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)
Clinical
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.
Medical
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) (Free SITC Whitepaper) Demonstrating that 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
As of December 31, 2021, cash and cash equivalents totaled $221.2 million, compared to $207.3 million as of December 31, 2020. On November 1, 2021, G1 and Hercules Capital amended Hercules’ loan terms to provide total commitments of $150.0 million, of which $100.0 million was fully available as of amendment closing. To date, G1 has drawn $75.0 million on this facility. An additional $25.0 million of debt facility is currently available but not yet drawn.
Total revenues for the fourth quarter of 2021 were $5.8 million, including $4.4 million in net product sales of COSELA and license revenue of $1.4 million. This license revenue is primarily related to clinical trial reimbursements from EQRx and Simcere. Total revenues for the full-year 2021 were $31.5 million, consisting of license revenue of $20.4 million and net product revenue of $11.1 million from sales of COSELA.
Operating expenses for the fourth quarter of 2021 were $43.4 million, compared to $40.6 million for the fourth quarter of 2020. GAAP operating expenses include stock-based compensation expense of $5.2 million for the fourth quarter of 2021, compared to $4.8 million for the fourth quarter of 2020. Operating expenses for the full-year 2021 were $173.9 million, compared to $141.8 million for the prior year. Stock-based compensation expense for the full-year 2021 was $22.3 million, compared to $18.8 million for the prior year.
Cost of goods sold expense for the fourth quarter of 2021 were $0.4 million compared to $0 for the fourth quarter of 2020. The increase is related to the Company’s period costs for the sales of COSELA, including third-party logistics costs for the sales of COSELA, inventory overhead costs, and personnel costs. Cost of goods sold expense for the full-year 2021 were $2.0 million.
Research and development (R&D) expenses for the fourth quarter of 2021 were $19.8 million, compared to $16.4 million for the fourth quarter of 2020. The increase in R&D expenses was primarily due to an increase in clinical trial spend, which is partially offset by a decrease in costs associated with the manufacturing of active pharmaceutical ingredients and drug product to support clinical trials. R&D expenses for the full-year 2021 were $76.2 million, compared to $73.3 million for the prior year.
Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2021 were $23.2 million, compared to $24.3 million for the fourth quarter of 2020. The decrease in SG&A expenses was largely due to a decrease in spend on commercialization activities and medical affairs, partially offset by an increase in personnel costs due to increases in headcount. SG&A expenses for the full-year 2021 were $95.7 million, compared to $68.5 million for the prior year.
The net loss for the fourth quarter of 2021 was $40.0 million, compared to $25.3 million for the fourth quarter of 2020. Net loss for the full-year 2021 was $148.4 million, compared to a net loss of $99.3 million for the prior year. The basic and diluted net loss per share for the fourth quarter of 2021 was $(0.94) compared to $(0.67) for the fourth quarter of 2020. The basic and diluted net loss per share for the full-year 2021 was $(3.54) compared to $(2.62) for the full-year 2020.
Financial Guidance
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 8:30 a.m. ET today to provide a corporate and financial update for the fourth quarter and full year 2021 ended December 31, 2021. The live call may be accessed by dialing (866) 763-6020 (domestic) or (409) 216-0626 (international) and entering the conference code: 5256086. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.
About COSELA (trilaciclib) for Injection
COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.
Indication
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. View Source
To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.