Kodiak Sciences Inc. ( KOD Quick Quote KOD - Free Report) reported first-quarter 2022 loss per share of $1.83, wider than the Zacks Consensus Estimate of a loss of $1.39. The company reported a loss of 98 cents per share in the year-ago quarter.
Kodiak Sciences currently does not have any approved product in its portfolio. As a result, the company is yet to generate revenues.
Shares of Kodiak Sciences have plunged 93.5% so far this year compared with the
industry’s decline of 28%. Image Source: Zacks Investment Research Quarter in Detail
Research and development expenses were $76.2 million in the quarter, up 89.1% year over year. The increase was driven by higher cost for clinical studies related to KSI-301.
General and administrative expenses were $19.6 million, up 92.1% on a year-over-year basis, driven by higher headcount and stock-based compensation expenses.
As of Mar 31, 2022, Kodiak Sciences had cash worth $671.7 million compared with $731.5 million as of Dec 31, 2021.
In the absence of an approved product in Kodiak Sciences’ portfolio, its pipeline development, especially its lead eye disease candidate, KSI-301, which is being developed for treating various retinal vascular diseases, remains the primary focus.
The company is currently evaluating KSI-301 in the phase III study — DAYLIGHT — for treating patients with treatment-naïve wet age-related macular degeneration (wet AMD). Top-line data from the study is expected in mid 2023.
In February 2022, Kodiak Sciences announced top-line data from the phase IIb/III study evaluating the safety, efficacy and durability of KSI-301 for treating wet AMD. The study failed to meet the primary efficacy endpoint of showing non-inferior visual acuity gains in subjects dosed with extended regimens versus Eylea (aflibercept) administered every eight weeks.
Notably, Eylea is an anti-VEGF treatment developed by
Regeneron ( REGN Quick Quote REGN - Free Report) in collaboration with Bayer’s ( BAYRY Quick Quote BAYRY - Free Report) HealthCare unit.
Regeneron/Bayer’s Eylea has been approved by the FDA for multiple retinal indications, including DME, wet AMD and retinal vein occlusion (“RVO”).
While REGN records net product sales of Eylea in the United States, BAYRY records net product sales of Eylea outside the country.
The phase III BEACON study is also evaluating KSI-301 in patients with treatment-naïve RVO. Top-line data from the same is expected in August 2022.
In February 2022, Kodiak Sciences completed the enrolment of more than 900 patients with diabetic macular edema ("DME") in two phase III studies — GLEAM and GLIMMER — on KSI-301.
The GLEAM and GLIMMER studies are designed to evaluate the durability, efficacy and safety of KSI-301 in treatment-naïve patients with DME. Top-line data from the same is expected in mid-2023.
The company remains on course to file an initial single biologics license application for KSI-301 to treat wet AMD, DME and RVO.
Zacks Rank & Stock to Consider
Kodiak Sciences currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is
Fulcrum Therapeutics, Inc. ( FULC Quick Quote FULC - Free Report) , which has a Zacks Rank #2 (Buy) at present. You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Fulcrum Therapeutics’ loss per share estimates have narrowed 2.3% for 2022 and 3.2% for 2023 over the past 60 days.
Earnings of Fulcrum Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. FULC delivered an earnings surprise of 6.95% on average.