Kura Oncology(US:KURA)2021-11-07 04:57Financial Data and Key Metrics Changes - Research and development expenses for Q3 2021 were $22.4 million, up from $16.6 million in Q3 2020, primarily due to increased clinical trial costs and personnel expenses [30] - General and administrative expenses for Q3 2021 were $11.3 million, compared to $7.6 million in Q3 2020, driven by higher personnel costs and professional fees [31] - Net loss for Q3 2021 was $33.4 million or $0.50 per share, compared to a net loss of $23.8 million or $0.42 per share in Q3 2020 [31] - As of September 30, 2021, cash, cash equivalents, and short-term investments totaled $543.4 million, down from $633.3 million as of December 31, 2020 [32] Business Line Data and Key Metrics Changes - KO-539 showed encouraging single-agent activity in relapsed and/or refractory AML, with a favorable safety profile and no evidence of QTC prolongation [9][10] - The Phase 1b study of KO-539 is currently enrolling two expansion cohorts, with preliminary results indicating activity at both doses [12][13] - Tipifarnib has been awarded breakthrough therapy designation from the FDA for HRAS mutant HNSCC, based on data from the Phase 2 RUN-HN trial [20][21] Market Data and Key Metrics Changes - The overall response rate for tipifarnib in patients with angioimmunoblastic T-cell lymphoma was reported at 56.3%, with a median overall survival of 32.8 months [20] - The company is preparing for a Phase 1/2 study of tipifarnib in combination with alpelisib in HNSCC, with the first clinical site activated [24][25] Company Strategy and Development Direction - The company remains focused on three main programs: KO-539 in acute leukemia, tipifarnib in head and neck squamous cell carcinoma, and KO-2806 in solid tumors [8] - The development strategy for KO-539 aims to register it as a monotherapy while exploring combination therapies to expand treatment options [16][75] - The company is actively preparing for combination trials and is exploring partnerships to enhance development opportunities [63][75] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of clinical trials and the potential of their drug candidates to create significant value for patients and shareholders [8][16] - The company anticipates sufficient cash reserves to fund operations into 2024, despite the increase in operating expenses [32][33] - Management remains optimistic about the clinical activity of KO-539 and the potential for registration in both NPM1 and KMT2A populations [46] Other Important Information - The company plans to provide updates on the Phase 1 study results at future medical meetings, pending the determination of the recommended Phase 2 dose [15] - The company has identified opportunities for farnesyl transferase inhibitors in combination with other targeted therapies in large solid tumor indications [27] Q&A Session Summary Question: Can you provide more details on the evidence of activity and safety profile? - Management indicated that they are encouraged by the clinical activity observed in both dose cohorts but could not provide more granular details at this stage due to the nature of the Phase 1b study [38][39] Question: What is the latest thinking on KO-539's activity in different genetic subtypes? - Management stated that they have not observed any significant differences in activity between NPM1 and KMT2A populations and expect the recommended Phase 2 dose to support efficacy in both [41][43] Question: How do you interpret competitor data in the context of the relapsed/refractory patient population? - Management noted that while competitor data showed lower response rates, it is early in the study, and they remain optimistic about their own data and the potential for longer duration of response [52][54] Question: What are the go/no-go criteria for moving forward with KO-539? - Management confirmed that they have established go/no-go criteria based on achieving a sufficient level of CR/CRH to support confidence in a properly powered trial [70] Question: How will the company approach combination trials once the recommended Phase 2 dose is established? - Management indicated a desire to maintain control over trial design and execution while exploring opportunities for investigator-sponsored trials (ISTs) [64][75] Question: Have global supply chain issues impacted the company's activities? - Management reported no significant impact from supply chain issues, attributing their resilience to the nature of their drug candidates being small molecules that can be administered on an outpatient basis [85] Question: How is duration of response measured in trials, particularly regarding transplant? - Management clarified that duration of response is tracked until the point of transplant, at which data are censored to avoid confounding results [91]