G1 Therapeutics Provides Fourth Quarter and Full Year 2022 Financial Results and Operational Highlights
- Announced Top Line Results from Pivotal Phase 3 Trial of Trilaciclib in Patients Receiving FOLFOXIRI + Bevacizumab for Metastatic Colorectal Cancer (CRC) (PRESERVE 1) -
- Provided Initial Results from Two Phase 2 Trials in Triple Negative Breast Cancer (TNBC) Demonstrating Potential of Trilaciclib to Reduce (>50%) the Rates of Adverse Events Related to an Antibody-Drug Conjugate (ADC) and Favorably Alter the Tumor Microenvironment -
- Announced Executive Succession Plan: Chief Financial Officer
- Management to Host Webcast and Conference Call today at
“Since the start of 2022, the G1 team has achieved the milestones we put forth at the beginning of the year and did so with the resolve expected of a company focused on the needs of the cancer patients we seek to treat,” said
Continued Bailey, “On behalf of the G1 team, I’d also like to express my gratitude to
Fourth Quarter 2022 and Recent Highlights
$8.9 Millionand $31.3 Millionin Net COSELA Revenue for the Fourth Quarter and Full Year 2022: Results represent a 102% increase and a 182% increase over the corresponding periods in 2021. G1 recognized total revenues of $10.3 millionand $51.3 millionfor the fourth quarter and full year of 2022, respectively.
- Completed Public Offering Resulting in
$52.0 Millionin Net Proceeds: In November 2022, G1 closed an underwritten public offering of its common stock at a public offering price of $6.50per share.
- Ended the Fourth Quarter 2022 with Cash, Cash Equivalents, and
Marketable Securitiesof $145.1 Million.
- Announced Top Line Results from Pivotal Phase 3 Trial of Trilaciclib in Patients Receiving FOLFOXIRI + Bevacizumab for Metastatic Colorectal Cancer (CRC) (PRESERVE 1): G1 announced top line results from its pivotal Phase 3 PRESERVE 1 trial showing that the trial achieved its co-primary endpoints related to severe neutropenia with statistical significance (p<0.001). These results further validate the myeloprotection benefit of trilaciclib. Despite the achievement of the co-primary endpoints and other secondary measures of myeloprotection and tolerability, early anti-tumor efficacy data, including overall response rate, favored patients receiving placebo compared to trilaciclib. Given the differential in these anti-tumor efficacy metrics and the low likelihood of achieving the progression-free survival and overall survival (OS) endpoints, G1 has discontinued PRESERVE 1. (Press release here)
- Completed Enrollment in Pivotal Phase 3 Clinical Trial of Trilaciclib in Patients with mTNBC: Enrollment in PRESERVE 2 is complete at 187 patients receiving first line trilaciclib or placebo prior to gemcitabine and carboplatin (GC). The primary endpoint is to evaluate the effect of trilaciclib on OS compared with placebo in patients receiving first-line GC (press release here). The interim OS analysis will be conducted by its data monitoring committee at 70% of events. Based on recent evaluations, the number of actual events appears to be occurring more slowly than predicted. As a result, G1 now expects the interim OS analysis to be conducted in the first half of 2024. If the trial meets the interim analysis stopping rule, it will terminate, and G1 will report the top line results. If it does not, the trial will continue to the final analysis.
- Announced Initial Results from Phase 2 Trial of Trilaciclib in Combination with an Antibody-Drug Conjugate: Initial Phase 2 safety data suggest on-target effect of trilaciclib to reduce (>50%) the rates of adverse events associated with the ADC sacituzumab govitecan-hziy, including myelosuppression and diarrhea, relative to the previously published sacituzumab single agent safety profile. The Company anticipates disclosure of a more comprehensive data set including safety and initial efficacy results at a medical meeting in the second quarter 2023. (Press release here)
- Confirmed that Initial Results Including the Primary Endpoint of Progression Free Survival from Phase 2 Bladder Cancer Trial of Trilaciclib (PRESERVE 3) Are Anticipated Midyear 2023: G1 has reiterated that additional safety and efficacy results, including results from the primary endpoint of Progression Free Survival, are expected from PRESERVE 3 midyear 2023. (Press release here)
- Presented Results from Phase 2 Mechanism of Action Trial at the San Antonio Breast Cancer Symposium (SABCS) Showing That Trilaciclib Favorably Alters the Tumor Microenvironment: G1 provided initial results from a 24 patient Phase 2 mechanism of action (MOA) trial showing favorable alterations in the tumor microenvironment from a single dose of trilaciclib monotherapy as measured by increases in the proportions of CD8+ T cells compared to T regulatory cells (Tregs) in patients with early-stage triple negative breast cancer (TNBC). (Press release here)
- Presented Nonclinical Study Results at the 2022
Society for Immunotherapy of Cancer (SITC) Conference Elucidating Immune Effectsof Trilaciclib: New nonclinical data show that trilaciclib upregulates key processes within the cancer immunity cycle including that trilaciclib enhances the differentiation of CD8+ T cells into effector memory and central memory T cell populations. In addition, trilaciclib can increase antigen presentation on tumor cells by upregulating HMC Class I and II, and promote T cell recruitment to tumor cells. (Press release here)
- Reduced Headcount and Associated Expenses to Extend Cash Runway Beyond Clinical Trial Readouts: G1 completed a reduction in force of approximately 30%, though the COSELA sales team remains intact. As a result of this and other reductions in spend, G1 currently expects its 2023 operating expense to be 20% to 30% lower than that of 2022. With these adjustments to operating expenses, the top line guidance provided, and other assumptions around partner revenue, the Company believes this extends its cash runway through its upcoming readouts from its ongoing clinical trials.
- Announced Executive Succession Plan:
Jen Moses, G1’s Chief Financial Officer, will resign as of March 15, 2023, and will remain a senior advisor to the organization for one year. As of the date of her departure, G1’s Controller John W. Umstead Vwill be appointed to the role of CFO. Mr. Umsteadhas been with the Company since 2018. Prior to joining the Company, Mr. Umsteadworked for PricewaterhouseCoopers LLPserving clients in various industries ranging from small private companies to large publicly traded corporations in a number of roles of increasing responsibility.
Fourth Quarter and Full Year 2022 Financial Results
Total revenues for the fourth quarter of 2022 were
Operating expenses for the fourth quarter of 2022 were
Cost of goods sold expense for the fourth quarter of 2022 was
Research and development (R&D) expenses for the fourth quarter of 2022 were
Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2022 were
The net loss for the fourth quarter of 2022 was
2023 Financial Guidance
G1 today provided full year 2023 financial guidance. The Company expects to generate between
Webcast and Conference Call
G1 will host a webcast and conference call at
Please note that there is a new 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 that you 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
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 obtain approvals for and commercialize additional indications of COSELA (trilaciclib), and our reliance on partners to develop licensed products. If we are not in compliance with our monthly net revenue covenants or 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, and the impact of pandemics such as COVID-19 (coronavirus). 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
Balance Sheet Data
|Cash and cash equivalents and marketable securities|
|Total stockholders' equity|
Condensed Statements of Operations
(in thousands, except per share data)
|Three Months Ended
||Twelve Months Ended
|Product sales, net||$||8,870||$||4,403||$||31,337||$||11,120|
|Cost of goods sold||992||374||3,748||2,016|
|Research and development||16,587||19,790||83,316||76,225|
|Selling, general and administrative||23,558||23,218||100,415||95,692|
|Total operating expenses||41,137||43,382||187,479||173,933|
|Loss from operations||(30,887||)||(37,586||)||(136,178||)||(142,457||)|
|Other income (expense)|
|Other income (expense)||237||(138||)||3||(346||)|
|Total other income (expense), net||(2,281||)||(2,188||)||(9,681||)||(4,970||)|
|Loss before income taxes||(33,168||)||(39,774||)||(145,859||)||(147,427||)|
|Income tax expense||481||246||1,700||925|
|Net loss per share, basic and diluted||$||(0.73||)||$||(0.94||)||$||(3.38||)||$||(3.54||)|
|Weighted average common shares outstanding, basic and diluted||46,279,808||42,544,321||43,626,113||41,943,417|
Source: G1 Therapeutics