- Achieved $8.7 Million in Net Revenue from Sales of COSELA® (trilaciclib) in the Second Quarter of 2022 and $10.6 Million in Total Revenue -

- Completed Patient Enrollment in Pivotal Phase 3 Trial of Trilaciclib in Metastatic Colorectal Cancer (mCRC) (PRESERVE 1) -

- Completed Patient Enrollment in Phase 2 Mechanism of Action Trial of Trilaciclib in Neoadjuvant Triple Negative Breast Cancer (TNBC) -

- Achieved Target Enrollment in Phase 2 Trial of Trilaciclib in Bladder Cancer (mUC) (PRESERVE 3) -

- Announced Approval of COSELA (trilaciclib hydrochloride for injection) with Simcere in China -

- Management to Host Webcast and Conference Call today at 8:30 AM ET -

RESEARCH TRIANGLE PARK, N.C., Aug. 03, 2022 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today provided a corporate and financial update for the second quarter ended June 30, 2022.

“The second quarter of 2022 was a period of continued momentum across the G1 organization toward our mission of improving the lives of those impacted with cancer,” said Jack Bailey, Chief Executive Officer of G1 Therapeutics. “For the first time, our sales team was in full control of COSELA, interacting with prescribers and driving usage and uptake. Thanks to the quality of these engagements, we experienced nearly 60 percent vial volume growth quarter over quarter - our highest quarterly growth rate since the initial launch period. In addition, our clinical team continued to execute on each of our ongoing clinical trials, including achieving important enrollment milestones in our Phase 3 trial of trilaciclib in patients with colorectal cancer and in our Phase 2 bladder cancer and mechanism of action trials.”

Second Quarter 2022 and Recent Highlights

Financial

Clinical

Medical

Corporate

Second Quarter 2022 Financial Results

As of June 30, 2022, cash and cash equivalents totaled $144.0 million, compared to $221.2 million as of December 31, 2021.

Total revenues for the second quarter of 2022 were $10.6 million, including $8.7 million in net product sales of COSELA and license revenue of $1.9 million. This license revenue is primarily related to revenue recognized from amounts to be reimbursed by EQRx and Simcere for costs associated with clinical trials.

Operating expenses for the second quarter of 2022 were $47.5 million, compared to $44.8 million for the second quarter of 2021. GAAP operating expenses include stock-based compensation expense of $5.6 million for the second quarter of 2022, compared to $5.7 million for the second quarter of 2021.

Cost of goods sold expense for the second quarter of 2022 was $1.0 million compared to $0.8 million for the second quarter of 2021, primarily due to an increase in product sales.

Research and development (R&D) expenses for the second quarter of 2022 were $20.8 million, compared to $18.8 million for the second quarter of 2021. The increase in R&D expenses was primarily due to an increase in clinical trial costs offset by a decrease in costs for manufacturing of active pharmaceutical ingredients and drug product to support clinical trials.

Selling, general, and administrative (SG&A) expenses for the second quarter of 2022 were $25.7 million, compared to $25.2 million for the second quarter of 2021. The increase in SG&A expenses was due to increased personnel costs related to headcount and an increase in insurance and other administrative costs. The increase is offset by a decrease in medical affairs costs, commercialization activities, professional and legal fees, and IT-related costs.

The net loss for the second quarter of 2022 was $39.4 million, compared to $39.4 million for the second quarter of 2021. The basic and diluted net loss per share for the second quarter of 2022 was $(0.92) compared to $(0.94) for the second quarter of 2021.

Financial Guidance

G1 expects its current cash and cash equivalents of $144.0 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 second quarter 2022 ended June 30, 2022.

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 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 sales of COSELA (trilaciclib), the therapeutic potential of COSELA (trilaciclib), our ability to generate data to maximize trilaciclib’s applicability to future treatment paradigms, our reliance on partners to develop licensed products, and our expectation that we have sufficient cash to fund our operations into 2024. If we are not in compliance with our monthly net revenue covenants or the minimum cash covenant, 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 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; our ability to meet our monthly net revenue covenants or the minimum cash covenants, 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
jmoses@g1therapeutics.com

Will Roberts
Vice President, Investor Relations & Corporate Communications
919-907-1944
wroberts@g1therapeutics.com

Rebecca Levine
Director, Corporate Communications and Public Relations
(919) 667-8711
rlevine@g1therapeutics.com  


G1 Therapeutics, Inc.
Balance Sheet Data
(in thousands)
    
 June 30, December 31,
 2022 2021
    
Cash and cash equivalents$143,957 $221,186 
Working Capital$139,848 $215,952 
Total Assets$186,879 $254,094 
Accumulated deficit$(673,097) $(584,459)
Total stockholders' equity$66,325 $143,541 


G1 Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except per share data) 
              
       Three months ended June 30 Six months ended June 30,
        2022   2021   2022   2021 
Revenues:       
 Product sales, net$8,718  $2,532  $14,198  $3,141 
 License revenue 1,855   4,072   3,277   17,681 
Total revenues 10,573   6,604   17,475   20,822 
Operating expenses:       
 Cost of goods sold 976   808   1,645   1,051 
 Research and development 20,843   18,752   47,148   35,292 
 Selling, general and administrative 25,716   25,236   52,425   48,206 
Total operating expenses 47,535   44,796   101,218   84,549 
Loss from operations (36,962)  (38,192)  (83,743)  (63,727)
Other income (expense):       
 Interest Income 50   9   59   28 
 Interest Expense (2,407)  (927)  (4,672)  (1,675)
 Other income (expense) (127)  (92)  (282)  (132)
Total other income (expense), net (2,484)  (1,010)  (4,895)  (1,779)
Loss before income taxes (39,446)  (39,202)  (88,638)  (65,506)
Income tax expense -   220   -   358 
Net loss  $(39,446) $(39,422) $(88,638) $(65,864)
              
Net loss per share, basic and diluted$(0.92) $(0.94) $(2.08) $(1.59)
Weighted average common shares outstanding, basic and diluted 42,707,703   42,119,850   42,697,508   41,414,254