G1 Therapeutics Provides Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights
- Achieved significant revenue growth in 2023 with $46.3 million in net COSELA sales.
- Provided strong revenue guidance of $60 to $70 million for 2024.
- Final analysis of Phase 3 PRESERVE 2 trial expected in Q3 2024.
- Positive results from Phase 2 trial in combination with TROP2 ADC for metastatic triple negative breast cancer.
- Cash runway extended into 2025, ensuring financial stability.
- New analyses showed improved overall survival with subsequent anticancer therapies for trilaciclib patients.
- None.
Insights
The reported net revenue from sales of COSELA for the full year 2023, marking a 48% growth over the previous year, is a significant indicator of the company's commercial success and scalability of its oncology product. The provided guidance for 2024 projects a continuation of this growth trajectory, suggesting a positive outlook for the company's financial health. This growth is particularly notable given the broader context of the pharmaceutical industry where drug sales can be volatile and subject to regulatory and market pressures. The extension of the cash runway into 2025 implies a stable financial position that could reassure investors about the company's ability to sustain operations and invest in further clinical development without immediate need for additional financing.
The announcement of the final analysis of the Phase 3 PRESERVE 2 trial evaluating overall survival in metastatic Triple Negative Breast Cancer (mTNBC) for the third quarter of 2024 is a critical milestone for the company. The potential label expansion for trilaciclib, if the trial is successful, could significantly impact treatment protocols for mTNBC, a cancer subtype with limited treatment options and generally poor prognosis. The preliminary data suggesting improved overall survival when trilaciclib is used in combination with a TROP2 antibody-drug conjugate further underscores the therapeutic potential and versatility of the drug, potentially enhancing its value proposition and marketability.
The inclusion of COSELA as a myeloid supportive agent in the updated ASCO SCLC guidelines could potentially boost the drug's adoption rate among oncologists, leading to increased market penetration. This endorsement by a reputable authority in oncology care standards may influence prescribing behaviors and can be leveraged in marketing strategies to enhance brand credibility. Furthermore, the reported decrease in hospitalization and cytopenia events in patients with extensive-stage small cell lung cancer (ES-SCLC) aligns with the current healthcare trend towards value-based care, where reducing hospital admissions and improving patient outcomes are key metrics for success.
- Achieved
- Net COSELA Revenue Grew
- Announced That Final Analysis of Phase 3 PRESERVE 2 Trial Evaluating Overall Survival in Metastatic Triple Negative Breast Cancer is Estimated to Occur in the Third Quarter of 2024 -
- Presented New Analyses Indicating that Patients Who Previously Received Trilaciclib in a Clinical Trial Setting Experienced Improved Overall Survival with Subsequent Anticancer Therapies -
- Provided Initial Results from Phase 2 Trial in Combination with a TROP2 Antibody-Drug Conjugate Indicating Improvements in Overall Survival for Patients Receiving Trilaciclib -
- Management to Host Webcast and Conference Call today at 8:30 AM ET -
RESEARCH TRIANGLE PARK, N.C., Feb. 28, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today provided a corporate and financial update for the fourth quarter and full year ended December 31, 2023.
“The strong fourth quarter 2023 vial volume growth of COSELA, which has continued through the beginning of 2024, highlights not only the importance of this unique drug to oncologists treating people living with extensive-stage small cell lung cancer, but also the significant addressable market still available to us as we drive continued penetration and growth,” said Jack Bailey, Chief Executive Officer of G1 Therapeutics. “Looking ahead, our primary clinical focus is on completing our ongoing trials of trilaciclib in metastatic triple negative breast cancer, including our pivotal PRESERVE 2 trial. We remain confident in the potential of trilaciclib in this trial given the robust long term survival benefit observed in prior trials and the increased statistical power for the final analysis. If successful, we would work closely with the U.S. Food and Drug Administration to expeditiously file for label expansion and bring this therapy to patients as quickly as possible."
Fourth Quarter 2023 and Recent Highlights
Financial
- Recognized
$13.9 Million and$46.3 Million in Net COSELA Revenue for the Fourth Quarter and Full Year 2023: Net COSELA revenue and vial volume grew29% and19% , respectively, during the fourth quarter over the third quarter of 2023 despite the impact of a platinum-based chemotherapy shortage. G1 recognized total revenues of$14.9 million and$82.5 million for the fourth quarter and full year of 2023, respectively.
- Cash Runway Extends into 2025: G1 ended 2023 with cash, cash equivalents, and marketable securities of
$82.2 million .
Clinical
- Final Analysis of the Phase 3 PRESERVE 2 Trial in Metastatic Triple Negative Breast Cancer (mTNBC) is Estimated to Occur in the Third Quarter of 2024: G1 announced that the Independent Data Monitoring Committee (DMC) recommended continuation of the Phase 3 PRESERVE 2 trial, evaluating trilaciclib in combination with gemcitabine and carboplatin for 1L treatment of mTNBC, to the final analysis. The DMC did not express any concerns or recommend any other changes to the study. The final analysis will be conducted on the intent-to-treat (ITT) population. G1 remains blinded to all data. (See February 12, 2024 press release here)
- Initial Efficacy Results from Ongoing Phase 2 Antibody-Drug Conjugate (ADC) Trial Suggest Improved Overall Survival (OS) Among Patients Receiving Trilaciclib in Combination with a TROP2 ADC: The preliminary data provided in January 2024 from the ongoing Phase 2 trial of trilaciclib in combination with the ADC sacituzumab govitecan (SG) in patients with mTNBC patients suggested clinically meaningful improvements in OS among patients receiving trilaciclib in combination with SG compared to SG alone (using historical data from the ASCENT study), including (1) median OS of 17.9 months with trilaciclib versus 12.1 months for SG alone and (2) estimated 12-month survival of
59% of patients receiving trilaciclib in combination with SG, representing a ~20% improvement over SG alone. The Company expects to provide updated OS results from this study mid-2024. (See January 8, 2024 J.P. Morgan update press release here)
Medical
- Presented New Post Hoc Analyses Indicating that Patients Who Previously Received Trilaciclib Experienced Improved OS with Subsequent Anticancer Therapies (SACT): G1 presented new data at the 2023 San Antonio Breast Cancer Symposium (SABCS) from patients with mTNBC who participated in G1’s Phase 2 trial. These data indicate that patients who received trilaciclib with their cytotoxic chemotherapy during the trial and then received SACT after trilaciclib discontinuation exhibit statistically significant and clinically meaningful improvements in median OS (32.7 months versus 12.8 months; p=0.001). Additionally, median OS for patients who received prior trilaciclib was improved from the time they started their first SACT compared to patients who did not receive prior trilaciclib (14.0 months versus 5.8 months; p=0.001). (See December 5, 2023 SABCS press release here)
- Presented Four Posters During the 2023 ASCO Quality Care Symposium: These provide new real-world evidence indicating that trilaciclib administered prior to chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC) lowers the rate of hospitalization and cytopenia events and may improve survival. (See October 27, 2023 ASCO Quality Care Symposium press release here)
- COSELA Recommended as a Myeloid Supportive Agent in the Updated ASCO SCLC Guidelines: The SCLC guidelines provide evidence-based recommendations to practicing clinicians on the management of patients with SCLC. (See October 18, 2023 ASCO Guidelines press release here)
Fourth Quarter and Full Year 2023 Financial Results
As of December 31, 2023, cash, cash equivalents and marketable securities totaled
Total revenues for the fourth quarter of 2023 were
Operating expenses for the fourth quarter of 2023 were
Cost of goods sold expense for the fourth quarter of 2023 was
Research and development (R&D) expenses for the fourth quarter of 2023 were
Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2023 were
The net loss for the fourth quarter of 2023 was
2024 Financial Guidance
G1 today provided full year 2024 financial guidance. The Company expects to generate between
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 ended December 31, 2023.
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 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 (>
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 at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
About G1 Therapeutics
G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA® (trilaciclib). G1 has a deep clinical pipeline and is executing a development plan evaluating trilaciclib in a variety of solid tumors, including breast, lung, and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on X (formerly known as Twitter) @G1Therapeutics and LinkedIn.
G1 Therapeutics® and the G1 Therapeutics logo and COSELA® and the COSELA logo are trademarks of G1 Therapeutics, Inc.
Forward-Looking Statements
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," “could”, “believe,” “goal”, “projections,” "estimate," "intend," “indicate,” “potential,” “opportunity,” “suggest,” 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 related to the potential of trilaciclib in the Phase 3 PRESERVE 2 trial for reasons including the robust long term survival benefit observed in prior trials and the increased statistical power for the final analysis, 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 U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the Company’s dependence on the commercial success of COSELA (trilaciclib); the development and commercialization of new drug products is highly competitive; the Company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the Company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a commercial-stage company; chemotherapy shortages and market conditions. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
G1 Therapeutics Contacts:
John W. Umstead V
Chief Financial Officer
919-747-8419
jumstead@g1therapeutics.com
Will Roberts
Communications Officer
Vice President, Investor Relations & Corporate Communications
919-907-1944
wroberts@g1therapeutics.com
| G1 Therapeutics, Inc. Balance Sheet Data (in thousands) | |||||||
| December 31, 2023 | December 31, 2022 | ||||||
| Cash and cash equivalents and Marketable securities | $ | 82,156 | $ | 145,070 | |||
| Working Capital | $ | 85,232 | $ | 143,912 | |||
| Total Assets | $ | 121,540 | $ | 187,965 | |||
| Accumulated deficit | $ | (779,985 | ) | $ | (732,018 | ) | |
| Total stockholders' equity | $ | 35,386 | $ | 68,747 | |||
| G1 Therapeutics, Inc. Condensed Statements of Operations (in thousands, except share and per share amounts) | |||||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Revenues | (unaudited) | ||||||||||||||
| Product sales, net | $ | 13,922 | $ | 8,870 | $ | 46,344 | $ | 31,337 | |||||||
| License revenue | 951 | 1,380 | 36,167 | 19,964 | |||||||||||
| Total revenues | 14,873 | 10,250 | 82,511 | 51,301 | |||||||||||
| Operating expenses | |||||||||||||||
| Cost of goods sold | 1,256 | 992 | 7,195 | 3,748 | |||||||||||
| Research and development | 7,380 | 16,587 | 43,711 | 83,316 | |||||||||||
| Selling, general and administrative | 15,166 | 23,558 | 71,132 | 100,415 | |||||||||||
| Total operating expenses | 23,802 | 41,137 | 122,038 | 187,479 | |||||||||||
| Loss from operations | (8,929 | ) | (30,887 | ) | (39,527 | ) | (136,178 | ) | |||||||
| Other income (expense) | |||||||||||||||
| Interest income | 529 | 478 | 2,473 | 748 | |||||||||||
| Interest expense | (2,124 | ) | (2,996 | ) | (10,038 | ) | (10,432 | ) | |||||||
| Other income (expense) | 548 | 237 | 2,240 | 3 | |||||||||||
| Total other income (expense), net | (1,047 | ) | (2,281 | ) | (5,325 | ) | (9,681 | ) | |||||||
| Loss before income taxes | (9,976 | ) | (33,168 | ) | (44,852 | ) | (145,859 | ) | |||||||
| Income tax expense | 902 | 481 | 3,115 | 1,700 | |||||||||||
| Net loss | $ | (10,878 | ) | $ | (33,649 | ) | $ | (47,967 | ) | $ | (147,559 | ) | |||
| Net loss per share, basic and diluted | $ | (0.21 | ) | $ | (0.73 | ) | $ | (0.93 | ) | $ | (3.38 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 51,838,834 | 46,279,808 | 51,733,487 | 43,626,113 | |||||||||||
FAQ
What was G1 Therapeutics, Inc.'s net revenue from COSELA sales for the full year 2023?
What is G1 Therapeutics, Inc.'s 2024 net COSELA revenue guidance?
When is the final analysis of the Phase 3 PRESERVE 2 trial expected to occur?
What results were presented from the Phase 2 trial in combination with a TROP2 antibody-drug conjugate?
How long does G1 Therapeutics, Inc.'s cash runway extend?
What did the new analyses indicate for patients who previously received trilaciclib?
