Workflow
G1 Therapeutics(GTHX)
icon
Search documents
G1 Therapeutics (GTHX) Investor Presentation - Slideshow
2020-09-18 17:41
Trilaciclib: Myelopreservation Therapy - Trilaciclib is a first-in-class myelopreservation therapy designed to protect bone marrow and immune system function from damage caused by chemotherapy[4, 14, 37] - The company is preparing for Trilaciclib launch in Q1 2021, co-promoting with Boehringer Ingelheim[5] - In a Phase 2 trial for metastatic triple-negative breast cancer (mTNBC), trilaciclib showed a statistically significant improvement in overall survival (OS) with a hazard ratio (HR) of 0.36 (p-value = 0.0015) compared to the control group[28] - In SCLC trials, patients receiving trilaciclib experienced a significant reduction in the mean duration of severe neutropenia in cycle 1, from 4 days (placebo + chemo) to 0 days (trilaciclib + chemo) [22] - In SCLC trials, the occurrence of severe neutropenia was reduced from 52.9% (placebo + chemo) to 11.4% (trilaciclib + chemo)[22] - In SCLC trials, the occurrence of G-CSF administration was reduced from 56.3% (placebo + chemo) to 28.5% (trilaciclib + chemo)[22] - In SCLC trials, the occurrence of RBC transfusions on/after 5 weeks was reduced from 26.1% (placebo + chemo) to 14.6% (trilaciclib + chemo)[22] - In SCLC trials, the occurrence of Grade 3/4 thrombocytopenia was reduced from 36.1% (placebo + chemo) to 19.5% (trilaciclib + chemo)[22] Rintodestrant: Oral SERD - Rintodestrant is a potential best-in-class oral SERD (selective estrogen receptor degrader) for ER+ breast cancer treatment[4, 37] - Phase 1 data showed ER occupancy ≥ 80% in doses ≥ 600 mg, with preliminary evidence of anti-tumor activity[41]
G1 Therapeutics (GTHX) Investor Presentation - Slideshow
2020-08-13 22:10
NASDAQ: GTHX NASDAQ: GTHX | 1 Next Generation Cancer Therapies August 2020 Forward-looking statements This presentation 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 forwardlooking statements. Forward-looking statements ...
G1 Therapeutics(GTHX) - 2020 Q2 - Earnings Call Transcript
2020-08-06 03:42
Financial Data and Key Metrics Changes - As of June 30, 2020, the company had $234.3 million in cash and cash equivalents, down from $269.2 million as of December 31, 2019, which includes $20 million from Hercules financing but not the upfront proceeds from agreements with Simcere, EQRx, and Genor [39] - The company increased its 2020 cash guidance to finish the year with $185 million to $200 million, up from previous guidance of $110 million to $130 million [40][41] Business Line Data and Key Metrics Changes - The company completed the new drug application (NDA) filing for trilaciclib and initiated the rintodestrant/palbociclib combination trial as scheduled [9] - The co-promotion agreement with Boehringer Ingelheim is expected to enhance the launch strategy for trilaciclib, providing a capital-efficient approach compared to building an internal sales force [12][22] Market Data and Key Metrics Changes - The company is collaborating with Simcere Pharmaceuticals Group in China to evaluate trilaciclib in additional tumor types, leveraging Simcere's expertise in executing clinical trials in China [15] - The company anticipates that trilaciclib will be included in the NCCN guidelines after approval, which would enhance its market positioning [30] Company Strategy and Development Direction - The primary focus is on maximizing the potential of trilaciclib across multiple indications while continuing to advance rintodestrant [8][42] - The company aims to establish a commercial infrastructure to support the trilaciclib launch strategy and is exploring additional partnerships for rintodestrant [10][43] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the COVID-19 pandemic without significant interruptions to business operations [16] - The company expects to receive a response from the FDA regarding the NDA submission for trilaciclib later in August 2020, with a potential approval in the first quarter of 2021 [11] Other Important Information - The company has secured $40 million in upfront payments from strategic partnerships, with potential milestone payments of up to $486 million [9] - The company has a flexible credit facility of $100 million to support its operations and development plans [9][38] Q&A Session Summary Question: NCCN Guidelines for G-CSF Utilization - Management discussed the current guidelines for G-CSF utilization and how trilaciclib could fit within those guidelines, particularly for small cell lung cancer and myeloid growth factors [48][49] Question: Additional Trial Opportunities - Management confirmed plans for a registrational trial in triple-negative breast cancer (TNBC) in 2021, with primary endpoints focused on survival measures [51] - The colorectal trial will involve approximately 300 patients and will evaluate the occurrence and duration of severe neutropenia [52][53] Question: Provider Awareness of Trilaciclib - Management indicated that awareness of trilaciclib is growing among academic professionals, with ongoing efforts to engage community practitioners [55] Question: Business Development Priorities - Management stated that they are not rushing into further deals and are focused on executing existing agreements to deliver shareholder value [59] Question: Payer Discussions - Management is engaged in discussions with payers and anticipates that trilaciclib will be priced at a premium to Neulasta, reflecting its multi-lineage benefits [62][63]
G1 Therapeutics(GTHX) - 2020 Q1 - Earnings Call Transcript
2020-05-10 14:39
G1 Therapeutics, Inc. (NASDAQ:GTHX) Q1 2020 Earnings Conference Call May 6, 2020 4:30 PM ET Company Participants Jeff Macdonald - Senior Director, IR & Corporate Communications Mark Velleca - CEO, President & Director Rajesh Malik - Chief Medical Officer, SVP, R&D Jennifer Moses - CFO Conference Call Participants Dane Leone - Raymond James & Associates Christopher John - Cowen and Company David Nierengarten - Wedbush Securities Edward White - H.C. Wainwright & Co. Operator Good afternoon, ladies and gentlem ...
G1 Therapeutics(GTHX) - 2020 Q1 - Earnings Call Presentation
2020-05-08 17:01
NASDAQ: GTHX NASDAQ: GTHX | 1 Next Generation Cancer Therapies May 2020 Forward-looking statements This presentation 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 forwardlooking statements. Forward-looking statements in ...
G1 Therapeutics (GTHX) Investor Presentation - Slideshow
2020-04-15 19:57
NASDAQ: GTHX NASDAQ: GTHX | 1 Next Generation Cancer Therapies April 2020 Forward-looking statements This presentation 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 forwardlooking statements. Forward-looking statements i ...
G1 Therapeutics (GTHX) Investor Presentation - Slideshow
2020-03-02 20:37
Trilaciclib - Trilaciclib is a first-in-class myelopreservation therapy designed to preserve bone marrow and immune system function from damage caused by chemotherapy[4, 14] - In Small Cell Lung Cancer (SCLC) trials, trilaciclib reduced chemotherapy-related toxicity and the need for rescue interventions, leading to significant improvements in patient experience, less neutropenia and anemia, and reduced G-CSF usage and transfusions[15] - In a patient survey, 88% of SCLC respondents reported that myelosuppression had a moderate to major impact on their life, with 63% noting fatigue as their biggest myelosuppressive issue[16] - Data from pooled SCLC trials showed that patients receiving trilaciclib experienced a significant reduction in the mean duration of severe neutropenia in cycle 1, from 4 days in the placebo group to 0 days in the trilaciclib group[19] - In metastatic triple-negative breast cancer (mTNBC), preliminary data showed that the median overall survival (OS) was 20.1 months for patients treated with trilaciclib plus gemcitabine/carboplatin (GC), compared to 12.6 months for those treated with GC alone[27] Rintodestrant - Rintodestrant (G1T48) is a potential best-in-class oral Selective Estrogen Receptor Degrader (SERD) for ER+, HER2- breast cancer[4, 37] - Phase 1 data showed that rintodestrant was well-tolerated, with ER occupancy ≥ 80% in doses ≥ 600 mg, and preliminary evidence of anti-tumor activity in a heavily pre-treated population[38] - The company is assessing the potential of rintodestrant in a Phase 1/2a program with approximately 100 patients enrolled by year-end 2020, with additional data expected in 4Q20[40] Lerociclib - Lerociclib is a differentiated oral CDK4/6 inhibitor with a potentially improved safety and tolerability profile compared to other marketed CDK4/6 inhibitors[4, 47] - In a Phase 1b/2 trial, lerociclib plus fulvestrant showed a 65.2% clinical benefit rate and a median progression-free survival of 15 months (immature) in 110 patients with HR+/HER2- advanced breast cancer[49] Market Opportunity - Approximately 1 million U S patients receive chemotherapy annually[6] - The company estimates that there are over 350,000 adjuvant breast cancer patients, over 500,000 colorectal cancer patients, and 20,000 metastatic triple-negative breast cancer patients in the U S, EU5, and Japan[31, 56]
G1 Therapeutics(GTHX) - 2019 Q4 - Earnings Call Transcript
2020-02-27 02:50
Financial Data and Key Metrics Changes - The company reported a net loss of $35.4 million for Q4 2019, compared to a net loss of $24.1 million for Q4 2018 [27] - The net loss for the full year 2019 was $122.4 million, up from a net loss of $85.3 million in 2018 [28] - Operating expenses for Q4 2019 were $36.6 million, compared to $26.1 million for Q4 2018 [28] - Cash and cash equivalents as of December 31, 2019, were $269.2 million, down from $369.3 million as of December 31, 2018 [32] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses for Q4 2019 were $24.5 million, compared to $19.1 million for Q4 2018, with full-year R&D expenses at $89 million versus $70.7 million in the prior year [29][30] - General and administrative (G&A) expenses for Q4 2019 were $12.1 million, compared to $7 million for Q4 2018, with full-year G&A expenses at $40 million compared to $18.6 million in the prior year [31] Market Data and Key Metrics Changes - The company is on track to file a New Drug Application (NDA) and a Marketing Authorization Application (MAA) for trilaciclib in small cell lung cancer in 2020 [7][14] - The company plans to initiate a Phase III trial in colorectal cancer in Q4 2020, targeting a significant patient population [18] Company Strategy and Development Direction - The company aims to advance trilaciclib for small cell lung cancer and explore its potential in colorectal and breast cancer [35][37] - Rintodestrant is positioned as a potential best-in-class treatment for ER-positive HER2-negative breast cancer, with ongoing development plans [9][38] - The company is focusing resources on trilaciclib and rintodestrant while exploring partnerships for lerociclib [26][39] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the pending FDA review of trilaciclib and its potential to improve patient care [40] - The company anticipates an increase in cash burn in 2020 due to investments in regulatory filings and preparations for commercial launch [33] Other Important Information - The company expects to end 2020 with $110 million to $130 million in cash and cash equivalents [34] - The company is exploring non-dilutive opportunities to further capitalize the business [40] Q&A Session Summary Question: Clinical supply agreement with Pfizer - The current supply agreement is for the current study involving about 40 patients, with a step-by-step process for future studies [44][45] Question: Partnerships for lerociclib - The company is exploring both traditional CDK4/6 development areas and other potential applications for lerociclib [46] Question: Pre-commercial activities for trilaciclib - The company is focusing on educating providers about the impact of myelosuppression and plans to have a sales force of less than 50 people for the U.S. launch [51][53] Question: Expansion of trilaciclib indications - The company plans to meet with the FDA to discuss protocol and endpoints for colorectal cancer studies [57] Question: Preliminary data for rintodestrant - Preliminary data will focus on dose escalation and expansion cohorts, not including data on the combination with palbociclib [58] Question: I-SPY trial design - The I-SPY trial is an adaptive design that evaluates the efficacy of novel agents in combination with chemotherapy, with a focus on achieving a high probability of success for Phase III studies [62][66] Question: Efficacy bar for oral SERD in combination studies - The efficacy benchmark for the oral SERD in combination studies is expected to be equivalent to fulvestrant [70]