G1 Therapeutics Q1 2024 Financial Results and Operational Highlights

G1 Therapeutics, Inc., an oncology company based in Research Triangle Park, N.C., has reported significant milestones and financial updates for the first quarter of 2024. CEO Jack Bailey emphasized the company's progress in the development of trilaciclib, particularly for triple-negative breast cancer (mTNBC) and its initial indication for extensive stage small cell lung cancer (SCLC). The company reaffirmed its net revenue guidance for COSELA, expecting it to reach between $60 and $70 million for 2024.

In the first quarter of 2024, G1 Therapeutics achieved $14.1 million in net revenue from COSELA sales, a four percent increase over the previous quarter. The company ended the quarter with $65.2 million in cash, which is anticipated to support operations until the third quarter of 2025.

Clinical progress includes notable updates. The Phase 2 trial of trilaciclib combined with a TROP2 antibody-drug conjugate (ADC) has shown promising preliminary results, suggesting enhanced overall survival for patients with mTNBC when trilaciclib is used alongside sacituzumab govitecan (SG), compared to historical data from the ASCENT study. These findings will be detailed in a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 to June 4, 2024. Additionally, the final analysis of the Phase 3 PRESERVE 2 trial, which evaluates overall survival in 1L mTNBC, is anticipated by late second quarter of 2024. This analysis will include survival events from patients enrolled in Ukraine, following recent consultations with the U.S. Food and Drug Administration (FDA). Positive outcomes could lead to a supplemental New Drug Application (sNDA) filing.

Corporate developments include a licensing agreement with Pepper Bio, Inc., granting them exclusive rights to develop, manufacture, and commercialize lerociclib for all indications except certain radioprotective uses across various regions, excluding the Asia-Pacific. G1 Therapeutics is set to receive upfront payments in the mid-single digit millions within 12 months and could earn up to $135 million upon achieving development and commercial milestones. Additionally, Pepper Bio will pay G1 a double-digit royalty on annual net sales of lerociclib.

Financially, G1 Therapeutics recognized total revenues of $14.5 million for the first quarter, including $14.1 million from COSELA product sales and $0.4 million from license revenue related to patent and clinical trial cost reimbursements. This compares to $12.9 million in total revenues for the same quarter in the previous year. Operating expenses decreased significantly to $23.5 million from $38.7 million in the first quarter of 2023, driven by reductions in research and development (R&D) and selling, general, and administrative (SG&A) expenses. Notably, R&D expenses fell to $7.3 million from $15.5 million, and SG&A expenses dropped to $15.1 million from $21.8 million. These decreases were primarily due to lower personnel costs, reduced commercialization activities, and decreased clinical program costs. The net loss for the quarter was $10.2 million, a substantial improvement from the $27.6 million net loss in the first quarter of 2023.

G1 Therapeutics reaffirmed its financial guidance for the full year 2024, expecting COSELA net revenue to be between $60 million and $70 million. The company believes its current cash reserves will sustain operations through the third quarter of 2025.

The company will host a webcast and conference call to discuss these updates. Participants are encouraged to register online to receive an access number and unique PIN for the live conference call. An archived webcast will be available on the company's website for 90 days following the event.