Kodiak Sciences Inc. ( KOD Quick Quote KOD - Free Report) reported third-quarter 2021 loss per share of $1.30, wider than the Zacks Consensus Estimate of a loss of $1.16 and the year-ago quarter’s loss of 80 cents.
Kodiak Sciences currently does not have any approved product in its portfolio. As a result, the company is yet to generate revenues.
Shares of the cmpany have plunged 19.9% year to date compared with the
industry’s decline of 12.2%. Image Source: Zacks Investment Research Quarter in Detail
Research and development (R&D) expenses were $56 million in the quarter, up 91.1% from $29.3 million reported in the year-ago period. The increase was driven by higher clinical activities related to KSI-301.
General and administrative (G&A) expenses were $11.5 million, up 55.4% on a year-over-year basis, driven by higher headcount and stock-based compensation expenses.
As of Sep 30, 2021, Kodiak Sciences had cash worth $799.2 million compared with $880.9 million as of Jun 30, 2021.
In the absence of an approved product in Kodiak Sciences’ portfolio, its pipeline development remains in key focus, especially its lead eye disease candidate, KSI-301, which is being developed for treating various retinal vascular diseases.
The company is conducting a pivotal phase phase IIb/III DAZZLE study on KSI-301 for treating wet-age-related macular degeneration (wet AMD). Enrollment for the study is complete, with top-line data from the same is expected in the first quarter of 2022.
In June 2021, the company started enrollment in a phase III study — DAYLIGHT — a short-interval study that will evaluate the safety and efficacy of high-frequency KSI-301 in patients with treatment-naïve wet AMD. Enrollment in the study is expected to be completed in the first half of 2022.
The phase III BEACON study is evaluating KSI-301 for addressing macular edema due to retinal vein occlusion (“RVO”). Top-line data from the same is expected in mid-2022. Also, two pivotal phase III studies, namely GLEAM and GLIMMER, are evaluating KSI-301 in patients with treatment-naïve diabetic macular edema (“DME”). Enrollment in the study is expected to be completed in the first quarter of 2022.
Kodiak Sciences remains on course to file a single biologics license application (“BLA”) for KSI-301 to treat wet AMD, DME and RVO.
The company is also evaluating KSI-301 in the pivotal phase III GLOW study for treating patients with non-proliferative diabetic retinopathy without DME. The company does not intend to include this study data and indication in its initial BLA filing mentioned above.
Zacks Rank and Stocks to Consider
Kodiak Sciences currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the biotech sector include
Amicus Therapeutics, Inc. ( FOLD Quick Quote FOLD - Free Report) Atara Biotherapeutics, Inc. ( ATRA Quick Quote ATRA - Free Report) and Galera Therapeutics, Inc. ( GRTX Quick Quote GRTX - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Amicus Therapeutics’ loss per share estimates have narrowed 1.3% for 2021 and 37.5% for 2022 over the past 60 days.
Atara Biotherapeutics’ loss per share estimates have narrowed 7.1% for 2021 and 6.2% for 2022 over the past 60 days.
Galera Therapeutics’ loss per share estimates have narrowed 19.5% for 2021 and 32.3% for 2022 over the past 60 days.