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Denali Therapeutics - On The Move

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Shares of Denali Therapeutics Inc. (DNLI) touched an all-time high of $26.93 on Wednesday, which represents a year-to-date gain of 32%.

Denali is a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases.

The Company's most advanced core programs include LRRK2 inhibitor program to address Parkinson's disease and RIPK1 inhibitor program to address Alzheimer's disease, Amyotrophic lateral sclerosis, and Multiple sclerosis.

The LRRK2 inhibitor program includes DNL201 and DNL151 for Parkinson's disease.

DNL201 is under a phase 1b clinical study in patients with Parkinson's disease. This 28-day study is designed to enroll 30 patients with mild to moderate Parkinson's disease, with and without genetic LRRK2 mutations, who are randomized to receive either a low dose of DNL201, a high dose of DNL201, or placebo.

Data readout from the DNL201 study is expected during Q4, 2019.

The second molecule under the LRRK2 inhibitor program is DNL151, which is under a phase I dose escalation study in healthy volunteers in the Netherlands.

The RIPK1 inhibitor program has I drug candidate in clinical testing - DNL747 - for Alzheimer's disease, Amyotrophic lateral sclerosis, and Multiple sclerosis.

In January 2019, Denali initiated a phase Ib clinical study of DNL747 in patients with Amyotrophic lateral sclerosis, and in the following month, i.e., in February initiated a phase Ib clinical study of DNL747 in patients with Alzheimer's disease.

The phase Ib clinical study of DNL747 in amyotrophic lateral sclerosis is designed to enroll up to 26 patients who will be randomized to receive either DNL747 or placebo. Data readout from this study is expected during Q4 2019.

The phase Ib clinical study of DNL747 in Alzheimer's disease is also designed to enroll up to 26 patients who will be randomized to receive either DNL747 or placebo. Data readout from this study is expected during Q4 2019.

There are also a number of compounds like DNL310, ATV:aSyn, LF1, ATV:TREM2, GB1, ATV:Tau, CH1, CH2, CH3, DNL758 and OTI in research or preclinical testing stage.

Partnerships:

In January of 2018, Denali entered into a deal with Takeda Pharmaceutical for three specified therapeutic product candidates, which are based on Denali's ATV platform, for neurodegenerative diseases. The deal has the potential to generate over $1 billion in milestone payments for Denali.

Last November, Denali inked a deal with Sanofi for RIPK1 inhibitors. The deal, worth over $1 billion in milestones for Denali relates to DNL747 and DNL758.

Denali also has strategic collaborations with SIRION Biotech, CENTOGENE, AbCellera Biologics Inc., and F-star.

Financials:

For the fourth quarter of 2018, Denali reported a net income of $77.5 million or $0.79 per share on collaboration revenue of $125.67 million. This compared with a net loss of $22.9 million or $0.74 per share and nil collaboration revenue in the year-ago period.

The Company ended the year 2018 with cash and cash equivalents of $612.2 million.

Stock Quote:

Shares of Denali debuted on the NASDAQ Global Select Market on December 8, 2017, at a price of $18 each. The stock has traded in a range of $12.32 to $26.93 in the last 1 year.

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