On May 1, 2024 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported a corporate and financial update for the first quarter ended March 31, 2024 (Press release, G1 Therapeutics, MAY 1, 2024, View Source [SID1234642515]).
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"Our focus for 2024 is on developing trilaciclib toward potential category leadership in triple negative breast cancer and maximizing the uptake of COSELA in its first indication in extensive stage small cell lung cancer; we’ve made progress on both in the first four months of the year," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "Regarding our clinical progress, we have two important readouts later this year, the first of which is an ASCO (Free ASCO Whitepaper) poster presentation in early June on the mature results from our Phase 2 trial of trilaciclib in combination with a TROP2 ADC. This will be followed by the readout of our Phase 3 PRESERVE 2 1L mTNBC trial late in the second quarter of this year. Regarding COSELA for extensive stage small cell lung cancer, we remain confident in our annual net sales guidance of $60 to $70 million."
First Quarter 2024 and Recent Highlights
Financial
Recognized $14.1 Million in Net COSELA Revenue: Vial volume grew four percent in the first quarter of 2024 over the prior quarter.
Cash Runway Extends into the Third Quarter of 2025: G1 ended the first quarter of 2024 with cash, cash equivalents, and marketable securities of $65.2 million.
Clinical
Updated Efficacy Results from Phase 2 Trial of Trilaciclib in Combination with an ADC Accepted for Poster Presentation at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting: In January 2024, the Company provided preliminary data from this Phase 2 trial in combination with the TROP2 ADC sacituzumab govitecan (SG) in patients with mTNBC suggesting clinically meaningful improvements in overall survival among patients receiving trilaciclib with SG compared to SG alone using historical data from the ASCENT study. Updated efficacy results will be presented in a poster at the 2024 ASCO (Free ASCO Whitepaper) Meeting, which is being held from May 31 to June 4, 2024.
Final Analysis of the Phase 3 PRESERVE 2 Trial in 1L mTNBC is Estimated to Occur in Late Second Quarter 2024: The final analysis will be conducted on the intent-to-treat (ITT) population, which includes the survival events from patients enrolled in the Ukraine. Based on recent interactions with the U.S. Food and Drug Administration regarding the inclusion of these events, the final analysis is now expected late in the second quarter of 2024. If the pivotal results are positive, the Company will engage the U.S. Food and Drug Administration ahead of a supplemental New Drug Application (sNDA) filing for this indication.
Corporate
Announced License Agreement for Lerociclib with Pepper Bio, Inc. ("Pepper Bio"): Pepper Bio will gain exclusive rights to develop, manufacture, and commercialize lerociclib for all indications except for certain radioprotectant uses in the US, Europe, Japan, and all other global markets, excluding the Asia-Pacific region. Under the terms of the agreement, G1 is expected to receive upfront payments totaling mid-single digit millions within 12 months and is eligible to receive a maximum of $135M upon achievement of development and commercial milestones in up to three indications. In addition, Pepper Bio will pay G1 a double-digit royalty on aggregate annual net sales of lerociclib. (See May 1, 2024 press release here)
First Quarter 2024 Financial Results
As of March 31, 2024, cash, cash equivalents and marketable securities totaled $65.2 million, compared to $82.2 million as of December 31, 2023. The Company believes that its current cash runway is sufficient to fund its operations into the third quarter of 2025.
Total revenues for the first quarter of 2024 were $14.5 million, including $14.1 million in net product sales of COSELA and license revenue of $0.4 million, related to patent and clinical trial costs reimbursed by EQRx, Simcere, and Genor, compared to $12.9 million in total revenues in the first quarter of 2023.
Operating expenses for the first quarter of 2024 were $23.5 million, compared to $38.7 million for the first quarter of 2023. GAAP operating expenses include stock-based compensation expense of $2.5 million for the first quarter of 2024, compared to $3.8 million for the first quarter of 2023.
Cost of goods sold expense for the first quarter of 2024 was $1.1 million, compared to $1.5 million for the first quarter of 2023, the decrease was primarily due to a cancellation fee recognized during the quarter ended March 31, 2023.
Research and development (R&D) expenses for the first quarter of 2024 were $7.3 million, compared to $15.5 million for the first quarter of 2023. 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 first quarter of 2024 were $15.1 million, compared to $21.8 million for the first quarter of 2023. The decrease in SG&A expenses was primarily due to decreases in personnel costs, commercialization activities, and medical affairs.
The net loss for the first quarter of 2024 was $10.2 million, compared to $27.6 million for the first quarter of 2023. The basic and diluted net loss per share for the first quarter of 2024 was $(0.20), compared to $(0.53) for the first quarter of 2023.
2024 Financial Guidance
G1 today reaffirmed its full year 2024 financial guidance. The Company expects to generate between $60 million and $70 million in COSELA net revenue in 2024. G1’s product revenue guidance is based on expectations for continued acceleration of sales performance of COSELA in the U.S. Additionally, the Company believes that its current cash runway is sufficient to fund its operations into the third quarter of 2025.
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 ended March 31, 2024.
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. View Source
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.