Viking Therapeutics(VKTX) - 2020 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Research and development expenses for Q3 2020 were $7.1 million, up from $5.3 million in Q3 2019, primarily due to increased clinical study expenses, salaries, and stock-based compensation [12] - General and administrative expenses for Q3 2020 were $2.7 million, compared to $2.2 million in Q3 2019, driven by higher stock-based compensation and insurance expenses [13] - Net loss for Q3 2020 was $9.3 million or $0.13 per share, compared to a net loss of $5.7 million or $0.08 per share in Q3 2019 [13] - For the first nine months of 2020, research and development expenses totaled $22.9 million, up from $17.1 million in the same period in 2019 [14] - The net loss for the first nine months of 2020 was $28.5 million or $0.39 per share, compared to a net loss of $18.3 million or $0.25 per share in the same period in 2019 [15] - Cash, cash equivalents, and short-term investments totaled $255.3 million as of September 30, 2020, down from $275.6 million at the end of 2019 [16] Business Line Data and Key Metrics Changes - The lead program VK2809 continued patient enrollment in the Phase 2b VOYAGE study for nonalcoholic steatohepatitis (NASH) and fibrosis, with expectations to complete enrollment in the first half of 2021 [7][22] - VK0214 advanced into clinical development with the initiation of a Phase 1 trial in healthy subjects, with plans for a Phase 1b study in patients with X-linked adrenoleukodystrophy (X-ALD) [9][24] Market Data and Key Metrics Changes - The majority of U.S. clinical sites for VK2809 were open for patient enrollment despite COVID-19 disruptions, with plans to expand internationally [7][22] - The VOYAGE study is targeting approximately 340 patients across five treatment arms, focusing on patients with F2 and F3 fibrosis [21] Company Strategy and Development Direction - The company is focused on executing its two clinical programs, VK2809 for NASH and VK0214 for X-ALD, while managing cash resources carefully to support ongoing trials [25][26] - The strategy includes exploring the potential for intermittent dosing based on the durability of liver fat reduction observed in VK2809 trials [30] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges in patient enrollment due to COVID-19 but remains optimistic about completing enrollment in the first half of 2021 [35] - The regulatory pathway for VK0214 is expected to involve discussions with the FDA regarding endpoints and registration, with potential data from the Phase 1b study by late 2021 [35][71] Other Important Information - The company plans to open additional clinical sites in Europe imminently, with some delays attributed to administrative issues [45] - Management is preparing a manuscript for the 12-week study results, with intentions to submit it to a journal soon [39] Q&A Session Summary Question: Comments on the additional data presented at EASL regarding liver fat reduction - Management confirmed that the subgroup analysis did not change the powering assumptions for the VOYAGE study, focusing on overall assessments [29] Question: Challenges with enrollment and COVID-19 impact - Management acknowledged the difficulties but remains confident in completing enrollment as planned, despite the ongoing pandemic [35] Question: Timeline for presenting additional data from the Phase 2a study - Management indicated that there are no plans for additional data presentations this year, but a manuscript is in preparation [39] Question: Regulatory pathway for X-ALD and potential data timeline - Management expects to initiate a registration study for X-ALD in 2022, pending successful Phase 1 results [71] Question: Expectations for lower dose efficacy in VOYAGE study - Management explained that lower doses were included to better understand the dose-response relationship, with expectations for efficacy at higher doses [64] Question: Treatment protocols for patients testing positive for COVID during the trial - Management stated that COVID-19 would be treated like any other illness that could lead to withdrawal from the study [52] Question: Plans for targeting patients with cerebral involvement in X-ALD - Management confirmed that the current focus is on adult males with AMN, excluding those with cerebral involvement for the time being [92]