RESEARCH TRIANGLE PARK, N.C., Nov. 01, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today provided a corporate and financial update for the third quarter ended September 30, 2023.
“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 Jack Bailey, Chief Executive Officer of G1 Therapeutics. “Beyond that, our focus remains on establishing our leadership position in TNBC. As we approach OS readouts from our ongoing trials, including most importantly the interim OS analysis of our pivotal Phase 3 TNBC trial, there is palpable excitement among clinicians regarding the potential for trilaciclib to improve survival. If successful in the interim analysis, we look forward to working closely with the U.S. Food and Drug Administration to expand the indication of this important drug."
Third Quarter 2023 and Recent Highlights
Financial
Clinical
Medical
Third Quarter 2023 Financial Results
As of September 30, 2023, cash and cash equivalents and marketable securities totaled $94.4 million, compared to $145.1 million as of December 31, 2022.
Total revenues for the third quarter of 2023 were $12.3 million, including $10.8 million in net product sales of COSELA and license revenue of $1.5 million, primarily related to supply and manufacturing services from Simcere and patent and clinical trial costs reimbursed primarily by EQRx and Simcere, compared to $23.6 million in total revenues in the third quarter of 2022.
On August 1, 2023, the Company received formal notice from EQRx of their intent to terminate the lerociclib license agreement as part of their proposed acquisition by Revolution Medicines, Inc. G1 received a payment of $1.6 million during the quarter ended September 30, 2023 for the remainder of the costs to wind down the lerociclib study. No milestones have been achieved through September 30, 2023, and as a result of the termination, the Company will not receive any further milestone payments or future royalties from EQRx.
Operating expenses for the third quarter of 2023 were $28.7 million, compared to $45.1 million for the third quarter of 2022. GAAP operating expenses include stock-based compensation expense of $3.7 million for the third quarter of 2023, compared to $4.8 million for the third quarter of 2022.
Cost of goods sold expense for the third quarter of 2023 was $3.1 million, compared to $1.1 million for the third quarter of 2022, primarily due to an increase in sales volume and a one-time inventory reserve for potential product obsolescence.
Research and development (R&D) expenses for the third quarter of 2023 were $8.8 million, compared to $19.6 million for the third quarter of 2022. The decrease in R&D expenses was primarily due to a decrease in the Company's clinical program costs.
Selling, general, and administrative (SG&A) expenses for the third quarter of 2023 were $16.8 million, compared to $24.4 million for the third quarter of 2022. The decrease in SG&A expenses was primarily due to decreases in commercialization activities, personnel costs, and medical affairs.
The net loss for the third quarter of 2023 was $18.2 million, compared to $25.3 million for the third quarter of 2022. The basic and diluted net loss per share for the third quarter of 2023 was $(0.35), compared to $(0.59) for the third quarter of 2022.
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 $44 million and $47 million in COSELA net revenue in 2023. G1's product revenue guidance is based on expectations for continued acceleration of sales performance of COSELA in the U.S.
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 third quarter ended September 30, 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 (>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 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," "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 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 successfully commercialize COSELA (trilaciclib); the company’s ability to complete clinical trials for, obtain approvals for and commercialize additional indications of 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:
John W. Umstead V
Chief Financial Officer
919-747-8419
This email address is being protected from spambots. You need JavaScript enabled to view it.
Will Roberts
Communications Officer
Vice President, Investor Relations & Corporate Communications
919-907-1944
This email address is being protected from spambots. You need JavaScript enabled to view it.
G1 Therapeutics, Inc. Condensed Balance Sheet Data (unaudited) (in thousands) | |||||
September 30, 2023 | December 31, 2022 | ||||
Cash and cash equivalents and Marketable securities | $94,352 | $145,070 | |||
Working Capital | $92,450 | $143,912 | |||
Total Assets | $133,097 | $187,965 | |||
Accumulated deficit | $(769,107) | $(732,018) | |||
Total stockholders' equity | $43,022 | $68,747 |
G1 Therapeutics, Inc. Condensed Statements of Operations (unaudited) (in thousands, except per share data) | |||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Revenues | |||||||||||||||
Product sales, net | $ | 10,839 | $ | 8,269 | $ | 32,422 | $ | 22,467 | |||||||
License revenue | 1,461 | 15,307 | 35,216 | 18,584 | |||||||||||
Total revenues | 12,300 | 23,576 | 67,638 | 41,051 | |||||||||||
Operating expenses | |||||||||||||||
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) | |||||||||||||||
Interest income | 585 | 211 | 1,944 | 270 | |||||||||||
Interest expense | (2,115 | ) | (2,764 | ) | (7,914 | ) | (7,436 | ) | |||||||
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 | $ | (18,204 | ) | $ | (25,272 | ) | $ | (37,089 | ) | $ | (113,910 | ) | |||
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 |
Last Trade: | US$7.15 |
Daily Volume: | 0 |
Market Cap: | US$377.230M |
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