
Financial Performance - The net loss for the three months ended March 31, 2025, was $15.0 million, representing a 35% increase from a net loss of $11.1 million in the same period in 2024[142]. - Total operating expenses for the three months ended March 31, 2025, were $14.9 million, a 32% increase from $11.2 million in the same period in 2024[142]. - Cash used in operating activities for Q1 2025 was $9.6 million, primarily due to a net loss of $15.0 million[167]. - Interest income decreased by 54% to $406,000 for the three months ended March 31, 2025, compared to $887,000 for the same period in 2024[150]. - As of March 31, 2025, the company had an accumulated deficit of $391.5 million[154]. Research and Development - Research and development expenses increased by 120% to $8.1 million for the three months ended March 31, 2025, compared to $3.7 million for the same period in 2024[142]. - The development costs for eDSP rose by $3.4 million, primarily due to clinical trial costs of $6.2 million[144]. - The company anticipates needing to raise substantial additional capital for drug development and operations, influenced by various factors including trial progress and regulatory approvals[159]. - Enrollment for the Phase 3 NEAT clinical trial may conclude early by the end of June 2025, with a target of 86 patients in the primary analysis population[130]. Cash and Investments - Cash, cash equivalents, and short-term investments totaled $31.6 million as of March 31, 2025, which is insufficient to fund operations for the next twelve months[155]. - The company expects existing cash, cash equivalents, and investments to fund operations through early 2026, pending additional program costs[157]. - Cash provided by investing activities was $10.9 million for Q1 2025, mainly from short-term investment maturities[169]. - The company entered into a Controlled Equity Offering Sales Agreement to sell up to $21.9 million of common stock, with $2.9 million raised through its ATM program[161]. Debt and Commitments - As of March 31, 2025, the company had outstanding principal of €10.0 million ($10.8 million) on the EIB Loan, recorded as long-term debt[162]. - The EIB Loan includes four tranches, with maximum borrowings of €30.0 million, and only tranches A and B have been drawn as of March 31, 2025[162]. - The company has approximately $22.8 million in cancellable future operating expense commitments based on existing contracts as of March 31, 2025[172]. - The company recorded accrued expenses of approximately $5.3 million for vendor expenditures as of March 31, 2025[172]. Market Opportunities - The global market for A-T is estimated to represent a peak commercial opportunity of over $1 billion[128]. - The company plans to submit applications for approval in the U.S. and Europe in the second half of 2026, assuming positive results from the NEAT study[130].