On November 2, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that a corporate and financial update for the third quarter ended September 30, 2022 (Press release, G1 Therapeutics, NOV 2, 2022, View Source [SID1234622767]).

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"During the third quarter of 2022, we demonstrated continued execution on our clinical programs, but also experienced lower COSELA sales momentum versus what we achieved in the second quarter," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "Regarding the former, today we provided encouraging initial safety data from our ongoing Phase 2 trial of trilaciclib in combination with an ADC showing its potential to reduce the rates of adverse events associated with the ADC sacituzumab govitecan-hziy, including myelosuppression, diarrhea, and potentially alopecia. We also completed enrollment in our pivotal Phase 3 mTNBC trial and in our Phase 2 bladder cancer and mechanism of action trials. Regarding the latter, we are actively working through variability in the ES-SCLC market at certain times of the year due to patient flow and account staffing, and have recently put in place a variety of actions that we believe will enable us to drive growth over the coming months. G1’s mission is to improve the lives of those affected by cancer by effectively developing trilaciclib and by ensuing broad access to COSELA, and we remain dedicated to excellence in both areas."

Third Quarter 2022 and Recent Highlights

Financial

Achieved $8.3 million in Net COSELA Revenue: G1 recognized total revenues of $23.6 million in the third quarter of 2022, including $8.3 million in net product revenue from sales of COSELA.

Ended the Third Quarter 2022 with Cash, Cash Equivalents, and Marketable Securities of $123.0 million.
Clinical

Announced Initial Safety Data from Phase 2 Trial of Trilaciclib in Combination with an Antibody-Drug Conjugate; Additional Results Including Initial Efficacy Expected in 1H23: Initial Phase 2 safety data suggest on-target effect of trilaciclib to reduce (>50%) the rates of adverse events associated with the ADC sacituzumab govitecan-hziy, including myelosuppression, diarrhea and potentially alopecia due to the presence of CDK4/6-expressing cells in the intestinal crypt and hair follicles, relative to the previously published sacituzumab govitecan-hziy single agent safety profile. The Company anticipates disclosure of a more comprehensive data set including safety and initial efficacy results at a medical meeting in the second quarter 2023.

Completed Enrollment in Pivotal Phase 3 Clinical Trial of Trilaciclib in Patients with mTNBC: Enrollment in PRESERVE 2 is complete at 187 patients receiving first line trilaciclib or placebo prior to gemcitabine and carboplatin (GC). The primary endpoint is to evaluate the effect of trilaciclib on overall survival (OS) compared with placebo in patients receiving first-line GC. Key secondary endpoints include assessment of the effect of trilaciclib on patients’ quality of life compared with placebo, myeloprotection measures, progression free survival (PFS), and overall rate of response (ORR). G1 expects the interim OS analysis to be conducted by its data monitoring committee at 70% of events in the second half of 2023. If the trial meets the interim analysis stopping rule, it will terminate, and G1 will report the topline results. If it does not, the trial will continue to the final analysis. (Press release here)

Completed Enrollment in Phase 2 Clinical Trial of Trilaciclib in Combination with Chemotherapy and the Checkpoint Inhibitor Avelumab in Patients with Bladder Cancer (mUC): Enrollment is complete at 92 patients in PRESERVE 3. The primary endpoint is PFS. Key secondary endpoints include overall survival, overall response rate, duration of response, and myeloprotection. Initial safety and response data are expected in the fourth quarter of 2022 followed by data on the primary endpoint of progression free survival in 2023.

Confirmed that Initial Data from Pivotal Phase 3 Trial of Trilaciclib in Patients with Metastatic Colorectal Cancer (mCRC) (PRESERVE 1) Are Expected in the First Quarter of 2023: G1 has reiterated that it expects to release initial data, including results from the primary endpoint, in the first quarter of 2023. The primary endpoint is myeloprotection as measured by duration of severe neutropenia (DSN) in cycles 1-4 and the occurrence of severe neutropenia (SN) during induction. Key secondary endpoints include the effects of trilaciclib on PFS, OS, and patients’ quality of life compared with placebo. If the data from the primary endpoint are positive, G1 will work closely with the FDA to expedite our filing for regulatory approval in this indication. (Press release here)

Announced Acceptance of Abstract for Poster Presentation of Initial Results from Phase 2 Trial Confirming the MOA of Trilaciclib: This 24 patient Phase 2 trial in early stage TNBC is designed to confirm the MOA of trilaciclib in modulating the anti-tumor immune response. The primary endpoints will assess the immune-based MOA, including the impact of trilaciclib on CD8+ T cells and regulatory T cells, or Tregs, in the tumor microenvironment. Secondary endpoints include pathological complete response (pCR), immune response, and profiling measures. Initial results from the primary endpoint will be presented as a poster presentation during the 2022 SABCS.

Announced Acceptance of Two Abstracts for Poster Presentation during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2022 Annual Meeting: G1 will present two posters during the SITC (Free SITC Whitepaper) meeting: "Transient inhibition of cyclin-dependent kinase 4/6 with trilaciclib enhances inhibitory receptor immunotherapy to improve antitumor efficacy" (abstract #471) and "Trilaciclib, an intravenous cyclin-dependent kinase 4/6 inhibitor, enhances antitumor responses by modulating T cells" (abstract #1314).
Medical

Presented Data at the 2022 Precision Oncology Summit Demonstrating that Trilaciclib Reduces Severe Hematologic Adverse Events and Supportive Care Needs in Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC) When Administered Prior to Chemotherapy: In real- world practice, trilaciclib is used in a heterogeneous population of ES-SCLC patients with variability in timing of trilaciclib initiation, chemotherapeutic backbone, and presence of hematological toxicity before trilaciclib initiation. Despite this heterogeneity, trilaciclib showed consistent potential to reduce occurrence of myelosuppression, supportive care utilization, chemotherapy dose decrease, and treatment delay. (Poster here)
Corporate

Conducted Virtual R&D Day, "Innovations in Oncology: The Science of Trilaciclib": On September 15, 2022, G1 conducted an R&D Day to review the development and expansion strategy for trilaciclib. Included in the agenda was a presentation of new preclinical data supporting potential of trilaciclib to work synergistically with other anti-cancer therapies, including by enhancing the cancer immunity cycle by enhancing T-cell activation, favorably altering the tumor microenvironment, and improving long term immune surveillance. (Webcast of event here)
Third Quarter 2022 Financial Results

As of September 30, 2022, cash and cash equivalents and marketable securities totaled $123.0 million, compared to $221.2 million as of December 31, 2021.

Total revenues for the third quarter of 2022 were $23.6 million, including $8.3 million in net product sales of COSELA and license revenue of $15.3 million, compared to total $4.9 million of total revenue in the third quarter of 2021. This license revenue in the current quarter is primarily related to revenue recognized from two development milestones in the Simcere license agreement, including a $13 million milestone related to the approval of COSELA in China.

Operating expenses for the third quarter of 2022 were $45.1 million, compared to $46.0 million for the third quarter of 2021. GAAP operating expenses include stock-based compensation expense of $4.8 million for the third quarter of 2022, compared to $5.5 million for the third quarter of 2021.

Cost of goods sold expense for the third quarter of 2022 was $1.1 million compared to $0.6 million for the third quarter of 2021, primarily due to an increase in product sales.

Research and development (R&D) expenses for the third quarter of 2022 were $19.6 million, compared to $21.1 million for the third quarter of 2021. The decrease in R&D expenses was primarily due to 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 third quarter of 2022 were $24.4 million, compared to $24.3 million for the third quarter of 2021. The increase in SG&A expenses was due to increases in personnel costs due to increased headcount and administrative costs. The increase is offset by a decrease in medical affairs costs, commercialization costs, and professional and technology costs.

The net loss for the third quarter of 2022 was $25.3 million, compared to $42.5 million for the third quarter of 2021. The basic and diluted net loss per share for the third quarter of 2022 was $(0.59) compared to $(1.00) for the third quarter of 2021.

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, 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.