CENTOGENE and Denali Therapeutics Announce Strategic Collaboration to Recruit LRRK2 Patients for Clinical Trials

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

CENTOGENE and Denali Therapeutics (NASDAQ: DNLI) today announced a strategic collaboration for the global identification and recruitment of LRRK2 mutation carrier Parkinson’s disease (“PD”) 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 CentoCard®, its proprietary, validated, dried blood spot collection kit, to identify PD patients with a mutation in the LRRK2 gene for recruitment into Denali’s clinical trials.

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

“Our exclusive collaboration underscores CENTOGENE’s 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’s development of disease modifying medicines for patients with Parkinson’s disease. CENTOGENE will help Denali speed up the enrollment of patients in clinical studies for its LRRK2 program,” said Dr. Arndt Rolfs, CEO and founder of CENTOGENE.

“Denali is the first company to conduct clinical trials with LRRK2 inhibitors for the treatment of Parkinson’s 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,” said Carole Ho, M.D., Chief Medical Officer and Head of Development at Denali. “We are impressed with CENTOGENE’s approach and technology and believe that our joint efforts will accelerate the enrollment of PD patients and the completion of our clinical trials.”

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’s leading proprietary human genetic interpretation database, CentoMD® 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. www.centogene.com; www.centoMD.com

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 www.denalitherapeutics.com

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’s disease patients, the results of utilizing CentoCard® to collect patient samples to identify patients with a mutation in the LRRK2 gene for recruitment into Denali clinical trials, CENTOGENE’s ability to enable Denali to speed up the enrollment of patients in clinical studies for its LRRK2 program, statements made by CENTOGENE’s CEO and founder, and statements made by Denali’s 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’s early stage of clinical drug development; Denali’s ability to conduct or complete clinical trials on expected timelines; Denali’s ability to enroll patients into its clinical trials; and other risks, including those described in Denali’s Annual Report on Form 10-K filed with the SEC on March 19, 2018, Denali’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2018 and Denali’s 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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CENTOGENE:Doreen Niemann, +49 381 [e-mail] Contact:MacDougall Biomedical CommunicationsLauren Arnold, +1 [e-mail] Therapeutics Inc.:Lizzie Hyland, +1 [e-mail] Warners, +1 [e-mail]