G1 Therapeutics, Inc. - GTHX STOCK NEWS

G1 Therapeutics announced that the FDA accepted its NDA for trilaciclib, targeting small cell lung cancer (SCLC) patients undergoing chemotherapy, with a PDUFA action date set for February 15, 2021. The drug received Priority Review due to favorable data from three clinical trials demonstrating significant myelopreservation benefits. G1 is launching an Expanded Access Program for patients unable to enter trials. If approved, trilaciclib will be the first myelopreservation therapy intended to mitigate chemotherapy-induced toxicities and improve patient outcomes.

G1 Therapeutics, a clinical-stage oncology company, announced an upcoming presentation by CEO Mark Velleca at two investor conferences in August 2020. The presentations are scheduled for:

• BTIG Virtual Biotechnology Conference on August 10, 2020, at 11:30 a.m. ET
• Wedbush PacGrow Healthcare Virtual Conference on August 11, 2020, at 10:55 a.m. ET

Interested parties can access live and archived webcasts on the company’s Events & Presentations page. G1 Therapeutics focuses on innovative cancer therapies, including its FDA-designated Breakthrough Therapy, Trilaciclib.

G1 Therapeutics (GTHX) has announced a webcast and conference call scheduled for August 5, 2020, at 5:00 p.m. ET, to provide a corporate and financial update for Q2 2020. Investors can participate by calling 866-763-6020 (domestic) or 210-874-7713 (international), using conference code 4648036. The event will be accessible via the company's website.

G1 is focused on developing innovative cancer therapies including Trilaciclib, a Breakthrough Therapy, Rintodestrant, an oral SERD, and Lerociclib, a CDK4/6 inhibitor.

G1 Therapeutics has signed a licensing agreement with EQRx for its drug lerociclib, an oral CDK4/6 inhibitor targeted for breast and lung cancer treatment. G1 will receive an upfront payment of $20 million and could earn up to $290 million in milestone payments, along with tiered royalties based on sales. This marks G1's third strategic collaboration in 2020, aimed at enhancing patient access to their therapies. Lerociclib has shown promising results in clinical trials, indicating a differentiated profile compared to existing treatments.

G1 Therapeutics (GTHX) and Boehringer Ingelheim have entered a three-year co-promotion agreement for trilaciclib aimed at small cell lung cancer (SCLC). G1 retains full commercialization rights and will record U.S. and Puerto Rico revenues. The agreement entails initial payments to Boehringer Ingelheim to support launch efforts, with a decreasing promotion fee structure based on sales performance. G1's NDA for trilaciclib was submitted in June 2020, and it has received Breakthrough Therapy Designation from the FDA. This collaboration aims to enhance marketing capabilities for trilaciclib.

G1 Therapeutics has announced a significant partnership with Genor Biopharma for the exclusive licensing of lerociclib, an oral CDK4/6 inhibitor, in the Asia-Pacific region. G1 will receive a $6 million upfront payment and up to $40 million in milestone payments, along with tiered royalties based on sales. This partnership aims to address the unmet medical needs of HR+, HER2- breast cancer patients in Asia. Preliminary data suggest lerociclib offers a better safety profile compared to existing treatments, potentially improving patient experience.

G1 Therapeutics (GTHX) has secured a $100 million debt financing agreement with Hercules Capital to fund the commercialization and development of its therapy, trilaciclib. This financing includes four tranches, with $30 million accessible right away. The company plans to file a New Drug Application for trilaciclib for small cell lung cancer this month. The agreement aims to enhance G1's balance sheet as it prepares for a commercial launch and evaluates trilaciclib for additional indications.

G1 Therapeutics (GTHX) announced promising data for trilaciclib, an investigational therapy for small cell lung cancer (SCLC). In three Phase 2 trials, trilaciclib significantly reduced myelosuppression and the need for supportive interventions when administered before chemotherapy. Notably, only 44.3% of patients receiving trilaciclib experienced severe hematologic adverse events, compared to 77.1% in the control group. The company aims to complete its New Drug Application (NDA) in Q2 2020, and trilaciclib has received Breakthrough Therapy Designation from the FDA.

G1 Therapeutics (GTHX) provided an update on its corporate and financial status for Q1 2020. The company is on track to submit a New Drug Application (NDA) for trilaciclib for small cell lung cancer (SCLC) in 2Q20. Additionally, it plans to initiate a pivotal trial of trilaciclib in colorectal cancer in 4Q20 and the I-SPY 2 trial in breast cancer in 2Q20. Cash and cash equivalents were reported at $242.4 million, with a net loss of $31 million for Q1 2020. Despite COVID-19, operations remain largely unaffected, and management is optimistic about upcoming milestones.