Athira Pharma(US:ATHA)2022-03-24 23:03Financial Data and Key Metrics Changes - Research and development expenses increased to $42.8 million for the year ended December 31, 2021, compared to $13.3 million for the previous year, driven by increased clinical trial activities and expanded personnel [25] - General and administrative expenses rose to $21.2 million for the year ended December 31, 2021, up from $6.7 million in 2020, primarily due to increased personnel expenses and infrastructure expansion [26] - The net loss for the year was $54.9 million or $1.49 per share, compared to a net loss of $19.9 million or $1.67 per share in 2020 [26] - Cash, cash equivalents, and investments at the end of 2021 were $319.7 million, up from $268.2 million at the end of 2020, indicating a strong position to support clinical programs [26] Business Line Data and Key Metrics Changes - The company is advancing its clinical development programs, particularly focusing on fosgonimeton (fosgo) for neurodegenerative diseases, with significant progress in clinical trials [6][20] - Enrollment for the Phase 2 ACT-AD study was completed with 77 participants, and top-line data is expected in the second quarter of 2022 [14][17] - The Phase 3 LIFT-AD study is currently enrolling up to 420 subjects in the US, with an anticipated completion of enrollment in the third quarter of 2022 [10][20] Market Data and Key Metrics Changes - There are currently 55 million people suffering from Alzheimer's disease worldwide, projected to grow to 100 million by 2050, highlighting a significant market opportunity [23] - The company noted that only three to four drugs are available for treating mild-to-moderate Alzheimer's disease, indicating a substantial gap in treatment options [24] Company Strategy and Development Direction - The company is pursuing a diverse clinical development pipeline targeting various neurodegenerative diseases, with a focus on the HGF/MET neurotrophic system [10][20] - The strategy includes leveraging insights from the ACT-AD trial to optimize the statistical analysis plan for the LIFT-AD study [15][21] - The management emphasized the importance of providing tangible cognitive improvements to patients, particularly in the mild to moderate Alzheimer's segment, which accounts for nearly 80% of all Alzheimer's patients [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data readouts and the potential for clinical benefits from fosgo, aiming to address the unmet needs in neurodegenerative disease treatment [22][25] - The company is aware of the trust placed by shareholders and is committed to disciplined financial management while advancing its clinical programs [25][26] Other Important Information - The company expanded its Board of Directors with two industry veterans to strengthen its leadership in drug development [7] - The Phase 2 SHAPE study for Parkinson's disease dementia is also underway, with a focus on the same HGF/MET mechanism [18][19] Q&A Session Summary Question: What to expect from the topline release in Q2 for ACT-AD? - Management indicated that the primary endpoint is P300, with hopes for statistically significant data over six months, and trends in secondary endpoints like ADAS-Cog11 [29] Question: Historical performance of approved drugs for mild-moderate Alzheimer's? - Historically, a 2 to 3 point benefit over placebo is expected in a 26-week trial for mild to moderate Alzheimer's [32] Question: Impact of concurrent cholinergic medication on ACT-AD results? - Management believes that having 60% of patients on cholinergic medication could support the efficacy of the treatment rather than hinder it [34] Question: Enrollment pace for the LIFT study? - Management is targeting completion of enrollment by the end of Q3 2022 [44] Question: Any insights from the blinded data of ACT-AD? - Management stated that the trial is still blinded, and no comments could be made on the findings [42] Question: Need for both cognitive and functional endpoints for registration? - Management acknowledged the importance of both endpoints for registration and emphasized the need for a comprehensive analysis of the data [39]