05/04/2022 | Press release | Distributed by Public on 05/04/2022 04:32
- Achieved $6.9 Million in Total Revenue in the First Quarter of 2022, Including $5.5 Million in Net Revenue from Sales of COSELA™ (trilaciclib) -
- Fully Deployed G1's COSELA Sales Team as of Mid-February 2022 -
- 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 Lung Cancer (ES-SCLC) Undergoing Chemotherapy -
- Management to Host Webcast and Conference Call today at 8:30 AM ET -
RESEARCH TRIANGLE PARK, N.C., May 04, 2022 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today provided a corporate and financial update for the first quarter ended March 31, 2022.
"The first quarter of 2022 was a period of transition and execution across the G1 business," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "In March of this year, we entered a new phase for COSELA promotion as we transitioned fully away from our commercial launch partner Boehringer Ingelheim and put the promotion of COSELA into the hands of our newly deployed G1 sales team; the strong month over month sales performance in March adds to the evidence of good early access to key accounts by our team. Our sales and commercial teams are now fully engaged in driving depth in key top organizations. Regarding our clinical programs, we are approaching a data-rich period, as we currently expect initial results from each of our ongoing Phase 2 and Phase 3 trials over the coming 18 months, starting with data from our three Phase 2 trials in the fourth quarter of this year."
First quarter 2022 and Recent Highlights
Financial
Commercial
Clinical
Medical
Corporate
First Quarter 2022 Financial Results
As of March 31, 2022, cash and cash equivalents totaled $183.0 million, compared to $221.2 million as of December 31, 2021.
Total revenues for the first quarter of 2022 were $6.9 million, including $5.5 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.
Operating expenses for the first quarter of 2022 were $53.7 million, compared to $39.8 million for the first quarter of 2021. GAAP operating expenses include stock-based compensation expense of $5.8 million for the first quarter of 2022, compared to $5.9 million for the first quarter of 2021.
Cost of goods sold expense for the first quarter of 2022 were $0.7 million compared to $0.2 for the first quarter of 2021. 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.
Research and development (R&D) expenses for the first quarter of 2022 were $26.3 million, compared to $16.5 million for the first quarter of 2021. The increase in R&D expenses was driven by an increase in clinical trial spend related to increased activity in all of our clinical trials including an acceleration of enrollment in our Phase 3 CRC trial, which is partially offset by a decrease in costs associated with the manufacturing of active pharmaceutical ingredients and drug product to support clinical trials.
Selling, general, and administrative (SG&A) expenses for the first quarter of 2022 were $26.7 million, compared to $23.0 million for the first quarter of 2021. The increase in SG&A expenses was largely due to an increase in personnel costs due to increased headcount, and an increase in professional services, insurance and other administrative costs.
The net loss for the first quarter of 2022 was $49.2 million, compared to $26.4 million for the first quarter of 2021. The basic and diluted net loss per share for the first quarter of 2022 was $(1.15) compared to $(0.65) for the first quarter of 2021.
Financial Guidance
G1 expects its current cash position of $183.0 million 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 first quarter 2022 ended March 31, 2022. The live call may be accessed by dialing (866) 763-6020 (domestic) or (409) 216-0626 (international) and entering the conference code: 2229795. 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. 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 tumor-agnostic development plan evaluating trilaciclib in a variety of solid tumors, including colorectal, 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 Twitter @G1Therapeutics.
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," "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 U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the company's ability to complete a successful commercial launch for COSELA (trilaciclib); the company's ability to complete clinical trials for, obtain approvals for and commercialize additional indications of COSELA and any of its product candidates other than COSELA (trilaciclib); 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; and market conditions. 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:
Jen Moses
Chief Financial Officer
919-930-8506
[email protected]
Will Roberts
Vice President, Investor Relations & Corporate Communications
919-907-1944
[email protected]
Rebecca Levine
Director, Corporate Communications and Public Relations
(919) 667-8711
[email protected]
G1 Therapeutics, Inc. | |||||||
Balance Sheet Data | |||||||
(in thousands) | |||||||
March 31, | December 31, | ||||||
2022 | 2021 | ||||||
Cash and cash equivalents | $ | 183,020 | $ | 221,186 | |||
Working Capital | $ | 173,353 | $ | 215,952 | |||
Total Assets | $ | 218,239 | $ | 254,094 | |||
Accumulated deficit | $ | (633,651 | ) | $ | (584,459 | ) | |
Total stockholders' equity | $ | 100,132 | $ | 143,541 | |||
G1 Therapeutics, Inc. | |||||||||||||
Condensed Statements of Operations | |||||||||||||
(in thousands, except per share data) | |||||||||||||
Three months ended March 31, | |||||||||||||
2022 | 2021 | ||||||||||||
Revenues: | |||||||||||||
Product sales, net | $ | 5,480 | $ | 609 | |||||||||
License revenue | 1,422 | 13,609 | |||||||||||
Total revenues | 6,902 | 14,218 | |||||||||||
Operating expenses: | |||||||||||||
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): | |||||||||||||
Interest Income | 9 | 19 | |||||||||||
Interest Expense | (2,265 | ) | (748 | ) | |||||||||
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 | $ | (49,192 | ) | $ | (26,442 | ) | |||||||
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