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CENTOGENE to conduct a targeted global identification and recruitment campaign to support Denali麓s LRRK2 inhibitor program

ROSTOCK, Germany & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Oct. 3, 2018-- and (NASDAQ: DNLI) today announced a strategic collaboration for the global identification and recruitment of LRRK2 mutation carrier Parkinson鈥檚 disease (鈥淧D鈥�) patients.

CENTOGENE will conduct a targeted global recruitment campaign focused on the early identification and characterization of LRRK2 PD patients and sequence the LRRK2 gene in these patients. Under the terms of the agreement, CENTOGENE will utilize 庐, its proprietary, validated, dried blood spot collection kit, to identify PD patients with a mutation in the LRRK2 gene for recruitment into Denali鈥檚 clinical trials.

Mutations in the LRRK2 gene are one of the most commonly known genetic causes of Parkinson鈥檚 disease and a driver of lysosomal dysfunction, which contributes to the formation of Lewy body protein aggregates and neurodegeneration.

鈥淥ur exclusive collaboration underscores CENTOGENE鈥檚 strong capability to accelerate the early identification of patients with rare genetic diseases worldwide. As a leader in providing genetic insights in rare diseases, we believe we can contribute to Denali鈥檚 development of disease modifying medicines for patients with Parkinson鈥檚 disease. CENTOGENE will help Denali speed up the enrollment of patients in clinical studies for its LRRK2 program,鈥� said Dr. Arndt Rolfs, CEO and founder of CENTOGENE.

鈥淒enali is the first company to conduct clinical trials with LRRK2 inhibitors for the treatment of Parkinson鈥檚 disease. This partnership with CENTOGENE is a central part of our global efforts to identify and recruit PD patients with a mutation in the LRRK2 gene into our planned clinical studies,鈥� said Carole Ho, M.D., Chief Medical Officer and Head of Development at Denali. 鈥淲e are impressed with CENTOGENE鈥檚 approach and technology and believe that our joint efforts will accelerate the enrollment of PD patients and the completion of our clinical trials.鈥�

About CENTOGENE

CENTOGENE unlocks the power of genetic insights to improve the quality of life of patients with genetic diseases. CENTOGENE achieves this through knowledge created by its worldwide diagnostic testing services incorporating global diversity, the world鈥檚 leading proprietary human genetic interpretation database, CentoMD庐 and solutions for pharmaceutical companies developing life-changing orphan drugs. As one of the largest genetic testing companies worldwide, CENTOGENE is dedicated to transforming the science of genetic information into solutions and hope for patients with rare diseases and their families. ;

About Denali Therapeutics

Denali is a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the blood-brain barrier and guiding development with biomarker monitoring to demonstrate target engagement and select patients. Denali is based in South San Francisco. For additional information, please visit

Cautionary Note Regarding Forward Looking Statements

This 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, plans for CENTOGENE to conduct a targeted global recruitment campaign focused on the early identification and characterization of LRRK2 Parkinson鈥檚 disease patients, the results of utilizing 庐 to collect patient samples to identify patients with a mutation in the LRRK2 gene for recruitment into Denali clinical trials, CENTOGENE鈥檚 ability to enable Denali to speed up the enrollment of patients in clinical studies for its LRRK2 program, statements made by CENTOGENE鈥檚 CEO and founder, and statements made by Denali鈥檚 Chief Medical Officer and Head of Development.

Actual results are subject to risks and uncertainties and may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to, risks related to: the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of the agreement; Denali鈥檚 early stage of clinical drug development; Denali鈥檚 ability to conduct or complete clinical trials on expected timelines; Denali鈥檚 ability to enroll patients into its clinical trials; and other risks, including those described in Denali鈥檚 Annual Report on Form 10-K filed with the SEC on March 19, 2018, Denali鈥檚 Quarterly Report on Form 10-Q filed with the SEC on August 9, 2018and Denali鈥檚 future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Denali as of the date hereof. Denali disclaims any obligation to update any forward-looking statements, except as required by law.

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