G1 Therapeutics Provides Third Quarter 2023 Financial Results and Operational Highlights
- Recognized Total Revenue of
Vial Volume Grew 3% Over Prior Quarter -
- Confirmed Expectation of Interim Overall Survival (OS) Analysis for Pivotal Phase 3 PRESERVE 2 Trial in Metastatic Triple Negative Breast Cancer (TNBC) in the First Quarter of 2024 -
- Reiterated Expectation of Initial OS Results from Phase 2 Trial of Trilaciclib in Combination with an Antibody-Drug Conjugate (ADC) in the First Quarter of 2024 -
- COSELA Recommended in Updated American Society of Clinical Oncology (ASCO) Small Cell
- Management to Host Webcast and Conference Call today at
“Despite the impact of the ongoing platinum-based chemotherapy shortage, we continue to be encouraged by the mounting real-world evidence confirming the benefit of COSELA and the support of organizations like ASCO through their recent SCLC guideline update recommending its use; we believe these are indicative of the potential of COSELA,” said
Third Quarter 2023 and Recent Highlights
$10.8 Millionin Net COSELA Revenue: G1 recognized total revenues of $12.3 millionfor the third quarter of 2023. Vial volume grew 3% over the second quarter of 2023 despite the impact of an ongoing platinum-based chemotherapy shortage.
- Ended the Third Quarter of 2023 with Cash, Cash Equivalents, and
Marketable Securitiesof $94.4 Million. The Company’s current financial position is now expected to be sufficient to fund G1’s operations and capital expenditures beyond the third quarter of 2024.
- Confirmed Expectation of Interim OS Analysis of Pivotal Phase 3 Clinical Trial (PRESERVE 2) in Patients with mTNBC in the First Quarter of 2024: G1 expects the interim OS analysis to be conducted by its data monitoring committee in the first quarter of 2024. If the trial meets the interim analysis stopping rule, it will be unblinded and G1 will report the top line results. If it does not, the trial will continue to the final analysis, expected later in 2024. If the results of the interim OS analysis are positive, the Company intends to meet with the
U.S. Food and Drug Administrationto discuss filing a supplemental new drug application (sNDA) as soon as possible in 2024.
- Reiterated Expectation of Timing for Initial OS Results from Phase 2 Trial of Trilaciclib in Combination with the ADC Sacituzumab Govitecan-Hziy: The Company expects to report these results in the first quarter of 2024.
- Phase 2 Bladder Cancer Trial (PRESERVE 3) To Be Concluded in the Fourth Quarter of 2023; OS Trend Favoring Trilaciclib Observed in Maintenance Phase: G1 intends to conclude the trial this quarter following the next protocol defined analyses of survival and report the results at a future medical meeting. PRESERVE 3 is a signal finding study designed to assess the potential additive contribution of trilaciclib to anti-cancer therapy, including in combination with the immune checkpoint inhibitor avelumab alone without chemotherapy during the maintenance part of the study. To date, an overall survival trend in favor of the trilaciclib plus avelumab arm in the maintenance phase was observed, suggesting a potential additive benefit when used in combination with a checkpoint inhibitor, which will inform future studies in G1's core areas of focus.
- COSELA Recommended as a Myeloid Supportive Agent in the Updated ASCO SCLC Guidelines: Multidisciplinary panels of experts, including patient advocates, develop ASCO’s clinical practice guidelines. The SCLC guidelines provide evidence-based recommendations to practicing clinicians on the management of patients with SCLC. (press release here)
- Presented Four Posters During the 2023 ASCO Quality Care Symposium: These posters provide new real-world evidence indicating that trilaciclib administered prior to chemotherapy in patients with ES-SCLC lowers the rate of hospitalization and cytopenia events and may improve survival. In addition, multiple analyses indicate the consistent impact of chemotherapy-induced myelosuppressive events, including severe neutropenia, thrombocytopenia, and anemia, on patients with ES-SCLC being treated with chemotherapy as well as the resulting impact on healthcare resource utilization. The posters are available on the
G1 Therapeuticswebsite. (press release here)
- Announced New Publication Highlighting the Real-World Impact of Trilaciclib on Myelosuppressive Events in Patient with ES-SCLC: Real-world outcomes data from published and new unpublished studies indicate the potential of trilaciclib to reduce single and multilineage myelosuppressive events associated with chemotherapy, cytopenia-related healthcare utilization, and hospitalizations. This review of real-world experience with trilaciclib was published in Advanced Therapy. (press release here)
Third Quarter 2023 Financial Results
Total revenues for the third quarter of 2023 were
Operating expenses for the third quarter of 2023 were
Cost of goods sold expense for the third quarter of 2023 was
Research and development (R&D) expenses for the third quarter of 2023 were
Selling, general, and administrative (SG&A) expenses for the third quarter of 2023 were
The net loss for the third quarter of 2023 was
2023 Financial Guidance
As a result of the ongoing shortage of platinum-based chemotherapy, G1 today lowered its full year 2023 net revenue guidance. The Company expects to generate between
Webcast and Conference Call
G1 will host a webcast and conference call at
Please note the following process to access the call via telephone: To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended to join 10 minutes prior to the start of the event. 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
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
www.g1therapeutics.com and follow us on X (formerly known as Twitter) @G1Therapeutics and LinkedIn.
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 sales of COSELA (trilaciclib), the therapeutic potential of COSELA (trilaciclib), our full year 2023 financial guidance, our ability to generate data to maximize trilaciclib’s applicability to future treatment paradigms, our ability to drive growth of COSELA among our top accounts, our ability to obtain approvals for and commercialize additional indications of COSELA (trilaciclib), our ability to complete our ongoing clinical trials on time, our ability to minimize the impact of a national platinum-based chemotherapy shortage, and our reliance on partners to develop licensed products. If we are not in compliance with the minimum cash covenant with our debt facility, we may be subject to the acceleration clauses in our loan agreement, and the lender may call the debt, resulting in our immediate need for additional funds. In addition, COSELA (trilaciclib) may fail to achieve the degree of market acceptance for commercial success. Each of these forward-looking statements is based on the company’s expectations and assumptions as of the date of this press release and 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
Condensed Balance Sheet Data (unaudited)
|Cash and cash equivalents and Marketable securities|
|Total stockholders' equity|
Condensed Statements of Operations (unaudited)
(in thousands, except per share data)
|Three Months Ended
||Nine Months Ended
|Product sales, net||$||10,839||$||8,269||$||32,422||$||22,467|
|Cost of goods sold||3,076||1,111||5,939||2,756|
|Research and development||8,811||19,581||36,331||66,729|
|Selling, general and administrative||16,781||24,432||55,966||76,857|
|Total operating expenses||28,668||45,124||98,236||146,342|
|Loss from operations||(16,368||)||(21,548||)||(30,598||)||(105,291||)|
|Other income (expense)|
|Other income (expense)||599||48||1,692||(234||)|
|Total other income (expense), net||(931||)||(2,505||)||(4,278||)||(7,400||)|
|Loss before income taxes||(17,299||)||(24,053||)||(34,876||)||(112,691||)|
|Income tax expense||905||1,219||2,213||1,219|
|Net loss per share, basic and diluted||$||(0.35||)||$||(0.59||)||$||(0.72||)||$||(2.67||)|
|Weighted average common shares outstanding, basic and diluted||51,777,731||42,799,342||51,697,989||42,731,826|
Source: G1 Therapeutics