 SOUTH SAN FRANCISCO, Calif., Aug. 07, 2020 GLOBE NEWSWIRE -- Denali Therapeutics Inc. NASDAQ: DNLI, a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier BBB for neurodegenerative diseases, today reported financial results for the second quarter ended June 30, 2020 and provided business highlights. We are thrilled with the strong progress across our pipeline, the continued productivity across the company despite the current situation imposed by the COVID-19 pandemic, and a new collaboration with Biogen on our LRRK2 program for Parkinsons disease patients and certain TV-enabled programs, said Ryan Watts, Ph.D., CEO. I am particularly excited that our first therapeutic candidate leveraging our proprietary blood-brain barrier crossing TV technology platform has entered clinical studies in patients. We believe the TV platform could transform the treatment of neurological disease.Second Quarter 2020 and Recent Business Highlights Entered into a Collaboration Agreement with Biogen on LRRK2 program for Parkinsons disease and certain transport vehicle TV platform-enabled programs for neurodegenerative diseases - In August 2020, Denali entered into a binding agreement with Biogen to co-develop and co-commercialize Denalis small molecule inhibitors of leucine-rich repeat kinase 2 LRRK2 for Parkinsons disease. Biogen will also receive rights to opt into two programs and a right of first negotiation for two additional programs, in each case for neurodegenerative diseases leveraging Denalis TV technology platform to cross the BBB. Under the terms of the agreement, Biogen will make an upfront payment to Denali of 560 million and make a 465 million equity investment in Denali from the purchase of 13.3 million newly issued shares of Denali common stock at approximately 34.94 per share, representing 11.2 percent of Denalis pro-forma outstanding stock. Should the LRRK2 program achieve certain development and commercial milestones, Denali will be eligible to receive up to 1.125 billion in potential milestone payments. In the LRRK2 collaboration, Biogen and Denali will share responsibility and costs for global development 60 percent Biogen; 40 percent Denali, and will share responsibility and costs as well as profits and losses for commercialization in the U.S. 50 percent Biogen; 50 percent Denali and China 60 percent Biogen; 40 percent Denali. Outside the U.S. and China, Biogen will be responsible for commercialization and pay Denali tiered royalties. The transaction is expected to close after satisfaction of requirements under applicable antitrust laws and other customary closing conditions, and with respect to the collaboration, execution of a definitive collaboration agreement. Selected DNL151 to advance into late stage clinical studies in Parkinsons disease patients - In August 2020, Denali announced that DNL151 has been selected to progress into late stage clinical studies in Parkinsons disease patients with a kinase activating mutation in LRRK2 and in sporadic Parkinsons disease patients. Patient enrollment is expected to commence in 2021. Commenced dosing of DNL310 in Hunter syndrome patients - In August 2020, Denali commenced dosing of its ETV:IDS biotherapeutic DNL310 enabled by its TV platform technology in a Phase 12 Hunter syndrome clinical study. DNL310 is an intravenously administered recombinant form of the iduronate 2-sulfatase IDS enzyme engineered to cross the BBB using Denalis TV technology. It is intended to treat overall clinical manifestations of Hunter syndrome, including cognitive and behavioral function, which are not adequately addressed by current standard of care. Publication of two scientific papers describing blood-brain barrier transport vehicle delivery technology - In May 2020, Denali announced the publication of two new papers describing its BBB delivery technology in Science Translational Medicine. The first paper describes the invention of Denalis TV technology and demonstrates its ability to successfully deliver therapeutic antibodies to the brain at levels sufficient for robust effects. The second paper focuses on the application of the TV technology for lysosomal storage disease by delivering enzymes across the BBB resulting in the normalization of biomarkers in a disease model of Hunter syndrome. RIPK1 CNS program update - In June 2020, together with partner Sanofi, Denali announced results from Phase 1b clinical studies with small molecule RIPK1 inhibitor DNL747 in Alzheimers disease and ALS. Denali and Sanofi have paused DNL747 and switched to DNL788, with plans to initiate a clinical study around year-end 2020. RIPK1 peripheral program update - In July 2020, Denali announced that partner Sanofi has commenced dosing of DNL758, a peripherally-restricted small molecule inhibitor of RIPK1, in a Phase 1b clinical study in hospitalized adult patients with severe COVID-19 lung disease. Prior to this, Sanofi successfully completed the Phase 1 healthy volunteer study with DNL758, which appears well tolerated at doses tested. Further clinical studies in multiple indications are being planned by Sanofi. Leadership promotion - In June 2020, Denali appointed Joe Lewcock, Ph.D. as Chief Scientific Officer. Dr. Lewcock had previously served as Senior Vice President of Biology Discovery. COVID-19 response update - To address risks posed by the COVID-19 pandemic, Denali has implemented policies that enable some of its employees to work remotely. For all on-site personnel, Denali has implemented several safety protocols, including regular, mandatory COVID-19 testing procedures and compliance measures for social distancing and use of personal protective equipment. After initial COVID-19 pandemic shutdown restrictions were put in place in March 2020, Denali experienced a pause in patient recruitment in several clinical trials. Recruitment has since resumed for all affected clinical trials.Second Quarter 2020 Financial ResultsFor the three months ended June 30, 2020, Denali reported a net loss of 58.8 million compared with a net loss of 58.3 million for the three months ended June 30, 2019.Collaboration revenue was 5.8 million for the three months ended June 30, 2020, compared to 4.2 million for the three months ended June 30, 2019. The increase of 1.6 million in collaboration revenue was primarily due to a 4.8 million increase in revenue recognized under the Takeda Collaboration Agreement, partially offset by a 3.2 million decrease in revenue recognized under the Sanofi Collaboration Agreement.Total research and development expenses were 53.2 million for the three months ended June 30, 2020, compared to 51.9 million for the three months ended June 30, 2019. The increase of approximately 1.3 million was primarily due to an increase in personnel-related expenses, including stock-based compensation, attributable to an increase in Denalis research and development headcount and new equity award grants. Additionally, there were increases in external expenses related to progression of Denalis portfolio, including the ETV:IDS and EIF2B programs due to the progress of these programs in the clinic. These increases were partially offset by decreases in the LRRK2 platform associated expenses, reflecting completion of the DNL201 clinical activities and slowdown of DNL151 clinical activities in the three months ended June 30, 2020 as a result of COVID-19, and certain other TV platform and other research and development expenses.General and administrative expenses were 14.0 million for the three months ended June 30, 2020 compared to 15.1 million for the three months ended June 30, 2019. The decrease of approximately 1.1 million was primarily attributable to a decrease in personnel-related expenses, including stock-based compensation, primarily driven by lower stock-based compensation expense related to certain performance and market-based awards, partially offset by increases in professional services costs.Cash, cash equivalents, and marketable securities were 556.8 million as of June 30, 2020.About Denali TherapeuticsDenali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for neurodegenerative diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the BBB and guiding development through biomarkers that demonstrate target and pathway engagement. Denali is based in South San Francisco. For additional information, please visit Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding Denalis progress and business plans; expectations regarding the proposed transaction with Biogen, including all financial aspects of the collaboration and equity investment; the potential benefits and results of the proposed transaction with Biogen; the anticipated completion of the Biogen transaction; plans to conduct clinical development activities and commercialize products; LRRK2 inhibitors as modifying therapy for Parkinsons disease; plans, timelines and expectations related to DNL151, DNL310 and Denalis TV technology; plans, timelines and expectations related to DNL747, DNL788 and DNL758 of both Denali and Sanofi; and statements made by Denalis Chief Executive Officer. 