Denali(DNLI) - 2025 Q3 - Quarterly Results

Financial Performance - Net loss for Q3 2025 was $126.9 million, compared to a net loss of $107.2 million in Q3 2024, representing an increase of approximately 18%[14] - Total research and development expenses were $102.0 million for Q3 2025, up from $98.2 million in Q3 2024, reflecting a rise of about 2%[15] - General and administrative expenses increased to $35.5 million in Q3 2025 from $24.9 million in Q3 2024, marking a significant increase of approximately 42.5%[16] Cash and Assets - Cash, cash equivalents, and marketable securities totaled approximately $872.9 million as of September 30, 2025[17] - Total current assets decreased to $882,598,000 from $864,436,000, a decline of approximately 2%[22] - Cash and cash equivalents dropped significantly to $90,963,000 from $174,960,000, a decrease of about 48%[22] - Short-term marketable securities increased to $757,241,000 from $657,371,000, reflecting a growth of approximately 15%[22] - Total assets decreased to $1,055,621,000 from $1,374,180,000, a decline of around 23%[22] - Total stockholders' equity decreased to $926,197,000 from $1,229,684,000, a decline of approximately 25%[22] Liabilities and Equity - Total current liabilities decreased to $90,146,000 from $102,208,000, a reduction of about 12%[22] - Accounts payable decreased to $6,745,000 from $11,137,000, a reduction of about 39%[22] - Accrued compensation decreased to $18,358,000 from $24,728,000, a decline of approximately 26%[22] - Operating lease liability, less current portion decreased to $29,686,000 from $36,673,000, a reduction of about 19%[22] - Deferred research funding and development liability, less current portion increased to $4,038,000 from $0, indicating new funding commitments[22] Regulatory and Development Updates - The FDA extended the review timeline for the BLA of tividenofusp alfa from January 5, 2026, to April 5, 2026, due to a Major Amendment submission[4] - Enrollment in the Phase 1/2 study of DNL126 for Sanfilippo syndrome type A was completed, supporting an accelerated approval path[5] - Two new regulatory applications were submitted for DNL628 for Alzheimer's disease and DNL952 for Pompe disease, expanding the TransportVehicle platform[6] - Denali plans to continue expanding its TV-enabled pipeline, aiming to bring forward one to two new programs annually[10] - Denali's Investor Day is scheduled for December 4, 2025, to discuss progress and strategic priorities, including the launch of tividenofusp alfa[12] Share Information - The weighted average number of shares outstanding was 172,421,492 for Q3 2025, compared to 169,456,988 for Q3 2024[21]