Anavex Life Sciences (AVXL) - 2019 Q2 - Earnings Call Transcript

Financial Data and Key Metrics - Cash used to fund operations in Q2 2019 was $4.3 million, with operating expenses at$8.1 million, up from 4.7 million in Q2 2018 [9] - R&D expenses for Q2 2019 were 6.1 million, compared to $3.2 million in Q2 2018, driven by clinical study advancements for ANAVEX2-73 [9] - Net loss for Q2 2019 was$8 million or $0.17 per share, compared to$4.8 million or $0.11 per share in Q2 2018 [10] - Cash resources as of March 31, 2019, were$19.5 million, sufficient to fund objectives for the next 18 months [10] Business Line Data and Key Metrics - Phase 2 ANAVEX2-73 Parkinson's disease dementia study achieved 70% of the total patient enrollment target [6] - Phase 2b/3 ANAVEX2-73 Alzheimer's disease study has enrolled over 20% of patients [6] - Phase 2 ANAVEX2-73 Rett Syndrome study in the U.S. has enrolled 40% of patients, with a Phase 2 AVATAR study in Australia approved and actively enrolling [7][8] Market Data and Key Metrics - The AVATAR study in Australia is supported by the Rett Syndrome Association of Australia, with the government providing a cashback payment of over 40% for every dollar spent [18] - The Australian dollar's favorable exchange rate provides cost advantages for conducting studies in Australia compared to the U.S. [18] Company Strategy and Industry Competition - The company is focused on executing current clinical studies for ANAVEX2-73, with a strategy to expand studies internationally if needed [16][18] - The sigma-1 receptor activation approach is highlighted as a unique strategy, differentiating from traditional amyloid beta-focused treatments in Alzheimer's disease [25][26] Management Commentary on Operating Environment and Future Outlook - Management is pleased with the pace of clinical study advancements and expects to provide further updates as progress continues [11] - The company believes its cash resources and government support will sustain operations and clinical trials for the next 18 months [10] Other Important Information - Non-cash charges for Q2 2019 totaled $1.9 million, compared to$1.2 million in Q2 2018 [10] - The AVATAR study in Australia is double-blind, randomized, and placebo-controlled, with safety and efficacy endpoints [8] Q&A Session Summary Question: Differences between U.S. and Australian Rett Syndrome studies - The U.S. study focuses on safety and PK with 15 patients, while the AVATAR study in Australia focuses on safety and efficacy with 30 patients [14] - The AVATAR study may not need to be repeated in the U.S. if results are positive, but international expansion is possible [16] Question: Cost and enrollment for the AVATAR study - The AVATAR study is expected to fully enroll in Australia, with potential for additional international sites to accelerate enrollment [18] - The Australian government provides a 40% cashback on study expenses, and the favorable exchange rate reduces costs [18] Question: Enrollment updates for ongoing trials - The company will publicly announce once complete enrollment is achieved for any ongoing trial [20] Question: Enrollment of sigma-1 receptor variant carriers - Both U.S. and AVATAR studies will enroll patients with genetic variances, with no need for balancing between arms [22][23] Question: Sigma-1 receptor approach in Alzheimer's disease - The sigma-1 receptor activation strategy addresses multiple pathological factors in Alzheimer's, beyond amyloid beta [25][26] Question: Cash usage discrepancy - The difference between net loss and cash used is attributed to accruals of accounts payable [29] Question: Age limits in Rett Syndrome trials - Both U.S. and AVATAR studies initially enroll patients aged 18 and older, with plans for separate studies in younger populations [30][32]