Denali Therapeutics Adds $155 Million from Takeda

Denali Therapeutics Inc., located in South San Francisco, California, had a lot of news to share today.

First off, Denali announced that it had dosed its first patient in a Phase I clinical trial of RIPK1 in healthy volunteers. It has also achieved proof of concept in nonhuman primates for its large molecule blood-brain barrier delivery platform. The compound, DNL747, is a potent, selective and brain-penetrant molecule inhibitor being developed for Alzheimer’s disease and ALS. The study is being conducted in the Netherlands.

Secondly, the company is advancing and expanding its LRRK2 inhibitor program. In December 2017, it has shown progress in humans with DNL201, a LRRK2 inhibitor, in a Phase I trial. The U.S. Food and Drug Administration (FDA) had removed a partial clinical hold on the drug, and the trial in healthy volunteers is continuing. It also has started dosing patients in its second LRRK2 inhibitor, DNL151, in a Phase I trial in the Netherlands. These two compounds are being evaluated in Parkinson’s disease.

Third, in January, the company wrapped a 28-day study showing that its Antibody Transport Vehicle (ATV) technology worked. It showed sustained brain activity as measured by decrease of cerebral spinal fluid amyloid beta in cynomolgus monkeys after being dosed with an anti-BACE1 antibody.

Fourth, the company signed an option and collaboration deal with Takeda Pharmaceutical . Takeda has an option on three named Denali programs to jointly develop and commercialize. The deal is based on the ATV blood-brain barrier delivery platform for neurodegenerative disorders. Takeda paid Denali $155 million in cash and acquired 4,214,559 shares of Denali common stock for $110 million.

Fifth, the company appointed Peter Klein, formerly chief financial officer of Microsoft and WME, to its board of directors as an independent director.

Sixth, but not last, Denali raised $294 million in the fourth quarter of 2017 by the sale of convertible preferred stock and a subsequent initial public offering (IPO).

And finally, the company released its fourth-quarter and full-year financial results. It reported a net loss for the quarter of $22.9 million, compared to $19.4 million in the same quarter of 2016. For the full year, it reported a net loss of $88.2 million, compared to a net loss of $86.7 million in 2016. Total operating expenses for the quarter were $23.5 million, and $90.1 million for the full year. The company reported cash, cash equivalents, and marketable securities as of December 31, 2017 of $467 million.

"The recent clinical progress with our RIPK1 inhibitor and LRRK2 inhibitor programs, along with achieving proof of concept for our blood-brain barrier delivery platform for biologics in nonhuman primates, are important milestones towards our goal of developing medicines for patients suffering from neurodegenerative diseases," said Ryan Watts, Denali’s chief executive officer, in a statement. "Furthermore, we are very excited about initiating our collaboration with Takeda, which has allowed us to expand efforts on our blood-brain barrier delivery technology platform."

Overall, investors seem positive about the company. Investing Bizz writes, "Denali Therapeutics Inc. stock price jumped 9.98 percent with the closing value of $21.53 during Friday trading sessions. Denali Therapeutics Inc. traded 2,247,131 shares at hands when compared with its average volume of 308.55K shares."

Analysts’ consensus rating is 2.5 on a scale of 1 to 5. A score of 3 would typically suggest "hold" and a rating of 1 or 2 would be a "buy," with 4 or 5 representing "sell."

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