Denali Therapeutics Inc.

Good day and thank you for standing by. Welcome to the second quarter 2026 financial results and business highlights. At this time all participants are in a listen only mode. After the speaker's presentation there will be a question and answer session. To ask a question during this session you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Laura Hansen. Please go ahead.

Good afternoon, everyone, and thank you for joining us today to discuss Denali Therapeutics second quarter 2026 financial results and business highlights. Earlier today, we issued our earnings press release and filed our quarterly report. The press release, financial tables, and today's presentation are available in the investor relations section of our website. Before we begin, I would like to remind everyone that today's discussion will include forward-looking statements. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. Please refer to our SEC filings and the questionnaire language in today's press release and presentation for discussion of these risks. Sonali undertakes no obligation to update these four listening statements, except as required by law. Joining me today are Ryan Watts, our Chief Executive Officer, Katie Peng, our Chief Commercial Officer, Alexander Schuth, our Chief Operating and Financial Officer, and Peter Chin, our Chief Medical Officer and Head of Development. Ryan will begin with opening remarks. Katie will then provide an update on the U.S. launch of Avalaya. Ryan will return to discuss pipeline highlights, and Alex will review our financial results. Peter will join the team for the question and answer session. Ryan?

Thanks, Laura, and thank you everyone for joining us today. We will begin on slide five. This was a transformative quarter for Denali. We completed the first full quarter of the Avalaya launch, advanced two transport vehicle-enabled Alzheimer's disease programs into clinical development, and further strengthened our financial position. Before I discuss those highlights, I want to begin with why we are here. At Denali, our purpose is to transform life for people living with serious diseases. That includes children and adults with rare genetic diseases such as Hunter syndrome, Sanfilippo syndrome, FTD granulin, and Pompe disease, as well as the millions of people living with common neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease. Across both groups, our mission is the same, to bring the power of biologic medicine to the brain. Slide six, the common challenge across many of these diseases is the blood-brain barrier. For over a decade, we have built the transport vehicle platform to address that challenge by engineering biologic medicines to cross the blood-brain barrier through receptor-mediated transport. Earlier this year, that work reached an important milestone. Slide seven, with FDA approval of Avalaya, Denali became a commercial company and began delivering our first medicine to patients. for the Hunter Syndrome community, Avalaya is the first new FDA approved therapy in nearly 20 years and a new treatment option designed to reach both the body and the brain. Importantly, Avalaya became the first approved medicine developed using our transport vehicle platform and the first FDA approved biologics specifically designed to cross the brain barrier. For Denali, Avalaya is much more than a product. It is the first proof that our platform can progress from scientific concept to an approved medicine for patients. Slide eight. We believe Denali today represents a powerful and differentiated combination to create significant value for patients, the healthcare system, and investors in the near and long term. We have a commercial product in Avalaya and an encouraging early launch. We have a broad clinical pipeline spanning rare genetic diseases and common neurodegenerative diseases, each with substantial market potential. We have a validated and scalable transport vehicle platform and scientific leadership in the field of BBB transport. We have the operational capabilities and financial strength to execute from discovery through development, manufacturing, and commercialization. Together, these attributes position Denali to create near-term growth and sustainable long-term value. Slide nine. Turning to the quarter, Ablea generated 3.6 million in net product revenue in its first full commercial quarter. The positive response from the Hunter Syndrome community and the physicians caring for these individuals reflects years of partnership with patients, families, advocacy organizations, and clinicians. We could not have achieved this milestone without their unwavering commitment to advancing new treatment options. I also want to recognize the outstanding execution by our commercial team in the early stages of this launch. In the pipeline, BNL628 targeting tau and BNL921 targeting abeta both advanced into clinical development for Alzheimer's disease with initial clinical data expected in 2027. And following the sale of our priority review voucher in July, our pro forma cash, cash equivalents and marketable securities exceeded 1.1 billion. Slide 10. A key focus of today's call will be the Avalaya launch. Katie will walk through the early commercial indicators what we are learning and how we are building the foundation for continued growth.