What happened
Shares of Kodiak Sciences (KOD +0.56%) were tumbling 11.1% lower as of 12:07 p.m. EDT on Monday. The decline came after the company provided its first-quarter update.
So what
Kodiak reported a net loss in Q1 of $0.98 per share with no revenue. That bottom-line result was a little worse than the average analysts' estimate of a net loss of $0.97 per share. However, the sell-off of the biotech stock probably stemmed more from another announcement.
The company already has four pivotal late-stage studies in progress for lead candidate KSI-301. Two of those studies target diabetic macular edema (DME), an eye disease that's a complication of diabetes. One targets retinal vein occlusion (RVO). Kodiak also has a phase 3 study under way evaluating KSI-301 in treating wet age-related macular degeneration (AMD). Today, the drugmaker announced that it's adding another late-stage study in the wet AMD indication.
Image source: Getty Images.
Kodiak said that physicians have told it they'd like for KSI-301 to be able to be given at more frequent dosing for patients with wet AMD. As a result, the company is launching a study that will evaluate monthly dosing of KSI-301. It expects to begin enrollment this summer and use data from the study in its regulatory filing.
Investors appear to be concerned that Kodiak's regulatory submission will be later than they initially hoped. However, Kodiak thinks that the addition of the new clinical study will position KSI-301 for the broadest possible label and help make the drug a bigger commercial success if approved.
Now what
Kodiak expects to complete patient recruitment in the fourth quarter for its two DME studies and its RVO study. The company also said it's on track for the last patient visit related to the primary efficacy endpoint in its initial wet AMD late-stage study before year-end.
