G1 Therapeutics Provides First Quarter 2022 Financial Results and Operational Highlights
- Fully Deployed G1’s COSELA Sales Team as of
- Confirmed Expected Timelines for Initial Results of Ongoing Phase 2 and Pivotal Phase 3 Clinical Trials of Trilaciclib -
- Presented Real-World Data Showing Impact of Trilaciclib on Hospitalizations and Burden of Myelosuppression in Patients with Extensive-Stage Small Cell
- Management to Host Webcast and Conference Call today at
“The first quarter of 2022 was a period of transition and execution across the G1 business,” said
First Quarter 2022 and Recent Highlights
- Achieved Total Revenue of
$6.9Million: G1 recognized total revenues of $6.9 millionin the first quarter of 2022, including $5.5 millionin net product revenue from sales of COSELA.
- Ended the First Quarter 2022 with Cash and Cash Equivalents of
$183.0Million: The Company’s current financial position is expected to be sufficient to fund G1’s operations and capital expenditures into 2024.
- Fully Deployed COSELA Sales Team: On
March 2, 2022, the co-promotion agreement for COSELA between G1 and Boehringer Ingelheimwas terminated. As of February 15, 2022, G1 had fully deployed its sales team into regions across the U.S.to accelerate sales activities and help maximize the adoption of COSELA.
- Reiterated Expectation of Initial Data in the Fourth Quarter of 2022 from Three Phase 2 Trials of Trilaciclib: G1 has reiterated that it expects to release initial data from multiple ongoing Phase 2 clinical trials of trilaciclib in the fourth quarter of 2022. These trials include a Phase 2 trial of trilaciclib in combination with avelumab in bladder cancer; a Phase 2 trial in combination with the antibody-drug conjugate (ADC) Trodelvy® (sacituzumab govitecan-hziy) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC); and a Phase 2 trial designed to confirm the mechanism of action of trilaciclib in modulating the anti-tumor immune response with and without a checkpoint inhibitor in early stage TNBC.
- Reiterated Expectation of Initial Data in 2023 from Two Phase 3 Trials of Trilaciclib: G1 expects to release data from two ongoing pivotal Phase 3 clinical trials of trilaciclib in 2023. Initial results including myeloprotection and Objective Response Rate (ORR) endpoints from PRESERVE 1, our ongoing line extension trial of trilaciclib in patients with colorectal cancer (CRC) receiving first line trilaciclib or placebo administered prior to FOLFOXIRI and bevacizumab, are expected in the first quarter of 2023. Initial results including interim results for Overall Survival (OS) from PRESERVE 2, our ongoing line extension trial of trilaciclib in PD-L1 positive and negative patients with TNBC receiving first line gemcitabine and carboplatin, are expected in the second half of 2023.
- Presented New Real-World Data at the Annual Conference of the National Comprehensive Cancer Network (NCCN) Showing the Impact of Trilaciclib on Hospitalizations and the Burden of Myelosuppression in Patients with ES-SCLC Treated with Chemotherapy: Results showed that the use of trilaciclib prior to chemotherapy was associated with a 50% reduction in the percent of patients with grade ≥ 3 myelosuppressive hematologic adverse events in at least one blood cell lineage and a 74% reduction in the percent of all-cause hospitalizations (days 1 to 21 after treatment), compared to patients who received chemotherapy alone. The analyses were derived using structured, real-world, de-identified clinical patient level data from the
Integra Connectoncology warehouse. (Press release here)
- Published Data in Cancer Treatment and
Research CommunicationsShowing Treatment Patterns and the Burden of Myelosuppression for Patients with Small Cell Lung Cancer(SCLC): Results of this retrospective study showed that 42 percent of small-cell lung cancer patients failed to complete the recommended number of chemotherapy cycles, and 74 percent of patients were admitted to the hospital due to a myelosuppressive event, thus underscoring the burden of myelosuppression. Additionally, health care resource utilization associated with myelosuppression was prominent, suggesting a substantial burden on older patients with SCLC. These data were derived from a descriptive, retrospective study of patients with SCLC aged ≥65 years, identified from linked Surveillance, Epidemiology, and End Results (SEER)-Medicare data. (Publication available here)
- Strategic Decision Made to Discontinue the Rintodestrant Program: After completing our evaluation of the rintodestrant partnering options and recent data in the highly competitive oral SERD space, G1 has made the strategic decision to discontinue the program, including all clinical and partnering efforts. G1 will responsibly wind down all remaining clinical efforts for rintodestrant by the end of this year and revert the rights back to the originator (
University of Illinois Chicago); there are no additional financial obligations due to the originator resulting from the reversion.
First Quarter 2022 Financial Results
Total revenues for the first quarter of 2022 were
Operating expenses for the first quarter of 2022 were
Cost of goods sold expense for the first quarter of 2022 were
Research and development (R&D) expenses for the first quarter of 2022 were
Selling, general, and administrative (SG&A) expenses for the first quarter of 2022 were
The net loss for the first quarter of 2022 was
G1 expects its current cash position of
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||$||183,020||$||221,186|
|Total stockholders' equity||$||100,132||$||143,541|
|Condensed Statements of Operations|
|(in thousands, except per share data)|
|Three months ended
|Product sales, net||$||5,480||$||609|
|Cost of goods sold||669||243|
|Research and development||26,305||16,540|
|Selling, general and administrative||26,709||22,970|
|Total operating expenses||53,683||39,753|
|Loss from operations||(46,781||)||(25,535||)|
|Other income (expense):|
|Other income (expense)||(155||)||(40||)|
|Total other income (expense), net||(2,411||)||(769||)|
|Loss before income taxes||(49,192||)||(26,304||)|
|Income tax expense||-||138|
|Net loss per share, basic and diluted||$||(1.15||)||$||(0.65||)|
|Weighted average common shares outstanding, basic and diluted||42,687,201||40,700,827|
Source: G1 Therapeutics