Denaili Therapeutics’’ IPO has raised $250 million, the largest biotech listing this year, which brings Denali into position to push its candidates against Alzheimer’s and Parkinson’s diseases through early clinical trials. The California-based biotech reached the $250 million point by placing its stock price at the midpoint of the range, at $18 per share. This resulted in an initial public offering larger than Ablyn in terms of both amounts raised as well as a market cap.
Denaili reserved up to $35 million to advance its Alzheimer’s disease candidate DNL747, which is currently in preclinical trials and is anticipated to advance to phase 2a, driven by the funds from the IPO. The candidate, a small molecule inhibitor of RIPK1, will also be examined in patients with ALS. Denaili has reserved another $20 to $25 million for the development of small molecule inhibitors of LRRK2 in Parkinson’s disease.
Presently, Denali is observing two candidates. The biotech intends to have both candidates complete phase 1 studies prior to choosing one to move into phase 1b in Parkinson’s patients with LRRK2 mutations.
Although, DNL201 is more advanced the FDA put a hold in place after reviewing preclinical toxicity data. If the hold is sustained, Denaili believes that LRRK2 kinase inhibition could be limited to about 50%, theoretically restricting the drug’s efficacy. Denaili has suggested a temporary exposure cap the biotech’s additional LRRK2 candidate, DNL151. Denaili could wind up with an exposure cap for its phase 1 Alzheimer’s trial as well if mandated by the FDA, as high doses of the drug resulted in toxicity in a 28-day safety study in monkeys.
Denaili’s IPO reveal that investors’ sediment of the programs will not be affected by the issues. With the increased need for drugs that show effectiveness in the treatment of Alzheimer’s, as well as the proficiency of Denaili’s team, one would believe that the safety issues can be figured out if the drugs show to have success.