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DENALI Denali Therapeutics Reports Third Quarter 2021 Financial Results and Business Highlights November 4 , 2021 8:01 PM PDT SOUTH SAN FRANCISCO , Calif . , Nov. 04 , 2021 ( 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 third quarter ended September 30 , 2021 , and provided business highlights . " We continue to advance our broad therapeutic pipeline , strengthen our strategic collaborations , and build out our manufacturing and commercial capabilities , " said Ryan Watts , Ph.D. , Denali's Chief Executive Officer . " In the third quarter , we began a Phase 1b study of our potential first - in - class elF2B activator , DNL343 , in individuals with amyotrophic lateral sclerosis ( ALS ) . Also in ALS , Sanofi has advanced our RIPK1 inhibitor , SAR443820 ( DNL788 ) , into Phase 2 development . In Parkinson's disease ( PD ) , we presented a progress update at Biogen's R & D Day event on our LRRK2 inhibitor collaboration , highlighting data and activities to support late - stage development of BIIB122 ( DNL151 ) . In addition , our Transport Vehicle ( TV ) -enabled portfolio continues to move forward . Our Phase 1/2 study of DNL310 ( ETV : IDS ) for Hunter syndrome is now enrolling Cohort C , which is designed to further explore clinical endpoints in participants younger than four years of age . In parallel , we have begun activities to initiate a pivotal Phase 2/3 study of DNL310 for Hunter syndrome in the first half of 2022. Furthermore , we have started building out a clinical manufacturing facility to support our development plans and expansion of our TV platform programs . " Recent Pipeline Highlights Expanding antisense oligonucleotides ( ASOs ) research collaboration with Secarna : In October 2021 , Denali and Secarna expanded their strategic research collaboration for the discovery and development of ASOs to treat neurodegenerative diseases with the addition of multiple new targets and indications . As part of the research collaboration originally formed in the fall of 2020 , Secarna uses its discovery and development platform , LNA - plus TM to generate ASO candidates and Denali applies its Oligonucleotide Transport Vehicle ( OTV ) technology designed to enhance central nervous system ( CNS ) delivery of ASOS . Following the discovery period , Denali is solely responsible for all development and commercialization activities . Secarna will receive a target - based technology access fee and prepaid R & D fee and is eligible to receive milestone payments and royalties for each program that Denali progresses through development and commercialization . Commenced dosing in Phase 1b study of elF2B activator DNL343 in ALS : In October 2021 , Denali presented results from a Phase 1 healthy volunteer study demonstrating that DNL343 met safety and biomarker goals . The Phase 1 data supported initiation of a Phase 1b study in participants with ALS , which commenced dosing in August 2021 ( study number NCT05006352 ) . The Phase 1b study is a multicenter , randomized , placebo - controlled , double - blind , 28 - day study followed by an 18 - month open - label extension , designed to evaluate the safety , pharmacokinetics , and pharmacodynamics of DNL343 in approximately 30 participants with ALS . Further information on the Phase 1b study can be accessed on the ClinicalTrials.gov website or by clicking here . Advancing CNS - penetrant RIPK1 inhibitor SAR443820 ( DNL788 ) into Phase 2 study in ALS : In October 2021 , Denali announced that its partner Sanofi advanced development of SAR443820 in ALS and that the U.S. FDA granted SAR443820 Fast Track designation for the potential treatment of ALS . Results from a Phase 1 study of SAR443820 in healthy volunteers demonstrated robust target engagement at doses that were generally well tolerated . Sanofi plans to initiate the Phase 2 study , named HIMALAYA , in the first quarter of 2022 . Presented BIIB122 ( DNL151 ) program progress in PD at Biogen's R & D Day : In September , at Biogen's R & D Day event , Denali provided a progress update on its collaboration with Biogen to develop BIIB122 ( DNL151 ) for PD . The companies highlighted data supporting the advancement to late - stage clinical development and ongoing start - up activities for BIIB122 ( DNL151 ) in preparation to commence PD studies . As previously announced , two studies are planned : one in participants with PD who do not carry a LRRK2 mutation and another in PD participants with LRRK2 mutations . Biogen will lead operationalization and conduct of these studies . Published preclinical proof of concept for DNL593 ( PTV : PGRN ) in Cell : In August , Denali announced publication of the company's research in Cell demonstrating preclinical proof of concept for using its Protein Transport Vehicle ( PTV ) to enhance brain uptake of peripherally administered progranulin ( PTV : PGRN ) by multiple cell types in the brain , including neurons and microglia . In addition , PTV : PGRN rescued both neurodegeneration and microglial dysfunction in progranulin - deficient mice . This research supports the potential utility of DNL593 in treating certain types of frontotemporal dementia ( FTD ) , especially FTD - GRN caused by progranulin deficiency . Recent Corporate Highlights Expanding leadership : In September 2021 , Denali announced the appointment of Katie Peng to the newly created role of Chief Commercial Officer . Ms. Peng is a proven commercial leader with broad global experience in building and running commercial