Denali(US:DNLI)2025-05-06 20:03Financial Performance - Denali Therapeutics reported a net loss of $133.0 million for Q1 2025, compared to a net loss of $101.8 million in Q1 2024, reflecting an increase of approximately 30.5% year-over-year[13] - Total research and development expenses for Q1 2025 were $116.2 million, up from $107.0 million in Q1 2024, marking an increase of about 8.6%[14] - General and administrative expenses rose to $29.4 million in Q1 2025, compared to $25.2 million in Q1 2024, an increase of approximately 16.5%[15] - Denali's total operating expenses for Q1 2025 were $145.6 million, compared to $132.3 million in Q1 2024, reflecting an increase of approximately 10%[21] Cash and Assets - Cash, cash equivalents, and marketable securities totaled approximately $1.05 billion as of March 31, 2025[16] Regulatory Developments - Denali completed the Biologics License Application (BLA) submission for tividenofusp alfa for Hunter syndrome, initiating the FDA's 60-day filing review process[3] - The FDA granted Breakthrough Therapy Designation for tividenofusp alfa in January 2025, which is also designated as Fast Track, Orphan Drug, and Rare Pediatric Disease[3] - Denali is conducting the ongoing global Phase 2/3 COMPASS study to support global regulatory approvals for tividenofusp alfa[3] - The company is collaborating with the FDA under the START program for accelerated development of DNL126 for Sanfilippo syndrome Type A[4] Operational Developments - Denali's clinical biomanufacturing facility in Salt Lake City commenced operations, enhancing U.S. manufacturing capabilities and supply chain control[9] Contact Information - Investor Relations contact is Laura Hansen, Ph.D., Vice President, reachable at hansen@dnli.com[23] - Media contact is Rich Allan from FGS Global, reachable at Rich.Allan@fgsglobal.com[23]