Financial Data and Key Metrics Changes - As of March 31, 2022, the company had approximately $217 million in cash and marketable securities, providing a cash runway expected to last through 2025 [23][24] - R&D expenses were approximately $6 million in Q1 2022, an increase compared to the prior year due to heightened activity in the INTERCEPT-AD trial [25] - G&A expenses were $3.2 million in the quarter, reflecting increased headcount and costs associated with being a public company [26] - The loss from operations for the quarter was $9.2 million, with a comprehensive loss of $9.7 million, significantly lower than the $27 million loss in the prior year period [26][28] Business Line Data and Key Metrics Changes - The INTERCEPT-AD clinical trial is ongoing, with enrollment now at 11 active sites, an increase from eight sites previously [9][10] - The company is preparing for a future Phase 2/3 trial of ACU193, with significant progress in drug substance production and formulation [11] Market Data and Key Metrics Changes - The company anticipates growing interest in upcoming clinical and regulatory developments for other Alzheimer's disease programs, which could positively impact enthusiasm for ACU193 [13] Company Strategy and Development Direction - The company is focused on advancing ACU193 through multiple critical milestones, with a strong emphasis on the ongoing INTERCEPT-AD trial [8] - The strategy includes preparing for a Phase 2/3 trial rapidly after demonstrating proof-of-mechanism in the ongoing trial [11] - The company aims to operate efficiently to maintain its cash runway through 2025 [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of ACU193 and the broader Alzheimer's treatment landscape, despite recent setbacks in the industry [35] - The company is committed to developing ACU193 for patients and is closely monitoring the outcomes of other late-stage products [36] Other Important Information - A publication in Frontiers in Neuroscience supports the rationale for targeting soluble A oligomers in early Alzheimer's disease, highlighting ACU193's unique selectivity [14][15] - The trial design includes a focus on demonstrating target engagement and proof-of-mechanism, with safety and tolerability being key objectives [21] Q&A Session Summary Question: Can you remind us about the Phase 1 data readout and how you will assess percent change in oligomer levels? - Management clarified that the focus will be on measuring the concentration of ACU193 bound to oligomers, with a goal to demonstrate binding in spinal fluid after dosing [30][31] Question: Thoughts on recent moves for lecanemab and gantenerumab? - Management acknowledged the frustration in the Alzheimer's space regarding recent decisions but remains optimistic about the potential of ACU193 [35] Question: How does the plasma half-life of ACU193 compare to other anti-amyloid antibodies? - Management indicated that data on plasma half-life is still being gathered, and they do not anticipate a safety titration for ACU193 due to its selectivity for oligomers [36][37]
Acumen Pharmaceuticals(ABOS) - 2022 Q1 - Earnings Call Transcript