ADDED
As of March 19, 2026, the registrant had 61,847,870 shares of common stock, $0.0001 par value per share, outstanding.
We have based these forward-looking statements largely on our current expectations about future events.
Forward-looking statements are not guarantees of future performance or results.
Forward-looking statements are based on information available at the time those statements are made and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those in the forward-looking statements.
These statements reflect our current views and are based on assumptions and subject to risks and uncertainties, including those set forth in Part I, Item 1A Risk Factors.
iii SELECTED R ISKS AFFECTING OUR BUSINESS Investing in our common stock involves numerous risks, including the risks described in Part I, Item 1A Risk Factors of this Annual Report on Form 10-K, any one of which could materially adversely affect our business, financial condition, results of operations and prospects.
Our prospects are heavily dependent on our ability to successfully develop, obtain regulatory approval for and successfully commercialize tarcocimab, KSI-501 and KSI-101, our product candidates, which are currently in clinical development for multiple indications.
The regulatory approval processes of the FDA, European Medicines Agency, or EMA, and comparable foreign regulatory authorities are lengthy, time consuming, expensive and inherently unpredictable.
The lead investigational medicine, tarcocimab tedromer ( Zenkuda or KSI-301 or tarcocimab ), is an anti-VEGF therapy built on Kodiak's proprietary ABC platform.
Zenkuda has a mean ocular half-life in humans of 20 days, approximately three times longer than approved anti-vascular endothelial growth factor ("VEGF") therapies, and is designed to maintain effective drug levels in ocular tissues for longer.
REMOVED
As of February 28, 2025, the registrant had 52,748,343 shares of common stock, $0.0001 par value per share, outstanding.
Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2024 Page Special Note Regarding Forward-Looking Statements ii Risk Factor Summary iv PART I.
We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business.
Forward-looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved.
These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties, including those set forth under the section of this Annual Report on Form 10-K titled Part I, Item 1A Risk Factors and elsewhere in this Annual Report.
iii R ISK FACTOR SUMMARY Investing in our common stock involves numerous risks, including the risks described in Part I, Item 1A Risk Factors of this Annual Report on Form 10-K, any one of which could materially adversely affect our business, financial condition, results of operations, and prospects.
Our prospects are heavily dependent on our tarcocimab, KSI-501 and KSI-101 product candidates, which are currently in clinical development for multiple indications.
The regulatory approval processes of the FDA, EMA and comparable foreign regulatory authorities are lengthy, time consuming, and inherently unpredictable.
The lead investigational medicine, tarcocimab tedromer ( KSI-301 or tarcocimab ), is built from Kodiak s ABC Platform and to date, has completed three successful Phase 3 pivotal clinical studies across three high prevalence retinal vascular diseases.
Tarcocimab is intended to be a mainstay intravitreal biologic that provides high immediacy, driven by the enhanced formulation, and high durability, driven by the ABC Platform and our science of durability, with the ultimate objective of providing, once approved, a flexible 1-month through 6-month label for all patients who may benefit from anti-vascular endothelial growth factor ( anti-VEGF ) therapy.