Denali Therapeutics Raises $275 Million Public Offering

Denali Therapeutics raise $275 million in an underwritten public offering of 10.4 million shares of its common stock at $26.50 per share.

The company also granted the underwriters a 30-day option to purchase up to an additional 1.6 million shares of its common stock. Before deducting the underwriting discounts and commissions and estimated offering expenses, Denali Therapeutics expects to receive total gross proceeds of approximately $275 million, assuming no exercise of the underwriters’ option to purchase additional shares.

Denali’s portfolio of product candidates are engineered to cross the blood-brain barrier (BBB) to target neurodegenerative diseases. The blood-brain barrier is essential in maintaining the brain’s microenvironment and protecting it from harmful substances and pathogens circulating in the bloodstream. But the barrier has also posed a challenge to drug developers seeking to treat diseases of the central nervous system by preventing most drugs from reaching the brain in therapeutically relevant concentrations.

Denali’s transport vehicle (TV) platform is a proprietary technology designed to effectively deliver large therapeutic molecules such as antibodies, enzymes, proteins, and oligonucleotides across the BBB after intravenous administration. In animal models, antibodies and enzymes engineered with the TV technology have demonstrated more than 20-fold greater brain exposure than similar antibodies and enzymes without this technology. Improved exposure and broad distribution in the brain may enable higher, therapeutically relevant concentrations of product candidates, and thus increase therapeutic efficacy. Preclinical studies have shown Denali’s TV technology results in up to a 30-fold increased uptake and superior pharmacological activity compared to standard antibodies, enzymes, and other proteins, the company said.

The company recently reported new positive interim data from a phase 1/2 study of lead candidate DNL310, a recombinant form of the IDS enzyme engineered to cross the blood-brain barrier, for the treatment of MPS II, also known as Hunter Syndrome, which is caused by a deficiency of the iduronate 2-sulfatase (IDS) enzyme and can lead to progressive cognitive impairment and other severe clinical manifestations. Standard enzyme replacement therapy does not result in sufficient brain concentrations to adequately address cognitive impairment.

Author: Rare Daily Staff