KOD — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-07

• Our lead investigational medicine, Zenkuda (tarcocimab), is an anti-VEGF antibody biopolymer conjugate under development for the treatment of high prevalence retinal vascular diseases. Zenkuda is being developed as a mainstay intravitreal biologic monotherapy that provides high immediacy, driven by …

• KSI-101, our third investigational medicine, is a high strength (100 mg/mL) antibody-based therapy with a bispecific mechanism of action targeting both interleukin-6 (IL-6) and VEGF. We are developing KSI-101 for patients with macular edema (retinal fluid) secondary to inflammation (“MESI”). Data fr…

• Our VETi (Visual Engagement Technology and imager) program has achieved significant advancements in hardware, software and algorithms development. VETi is our AI- and machine-learning-enabled wearable headset with applications in retina care alongside broader opportunities in identity security and c…

• Zenkuda is an investigational anti-VEGF therapy built on our proprietary ABC platform. Zenkuda has a mean ocular half-life in humans of 20 days, approximately three times longer than approved anti-VEGF therapies, and is designed to maintain effective drug levels in ocular tissues for longer. Zenkuda…

• Zenkuda has completed four successful Phase 3 pivotal studies: the Phase 3 GLOW1 and GLOW2 studies in diabetic retinopathy ("DR"), the Phase 3 BEACON study in retinal vein occlusion ("RVO") and the Phase 3 DAYLIGHT study in wet AMD. In the GLOW1 and GLOW2 studies, Zenkuda successfully treated DR pat…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• Kodiak's lead investigational medicine, tarcocimab, is a novel anti-VEGF antibody biopolymer conjugate under development for the treatment of high prevalence retinal vascular diseases. Tarcocimab is being developed as a mainstay intravitreal biologic that provides high immediacy/efficacy and high du…

• KSI-101, our third investigational medicine, is a novel, potent and high strength (100 mg/mL) antibody-based therapy with a bispecific mechanism of action targeting both interleukin-6 (IL-6) and VEGF. We are developing KSI-101 for patients with macular edema (retinal fluid) secondary to inflammation…

• Our VETi™ (Visual Engagement Technology and imager) program has achieved significant advancements in hardware, software and algorithms development. VETi is our AI- and machine-learning-enabled wearable headset with the potential to be used in a variety of ways to bolster our commercial retina franch…

• Tarcocimab is an investigational anti-VEGF therapy built on Kodiak's proprietary Antibody Biopolymer Conjugate (“ABC”) Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing available agents.

• Tarcocimab is being developed as a mainstay intravitreal biologic monotherapy 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 …

Text added vs the prior filing · source: 10-Q · 2026-05-07

• We may in the future develop other product candidates, advance additional product candidates into clinical trials and terminate such trials prior to their completion. It will take additional investment and time for such programs to reach the same stage of development as tarcocimab, KSI-501 and KSI-1…

• Preliminary, interim and ongoing data from our preclinical studies and clinical trials is subject to a number of risks and uncertainties and may change as more patient data become available.

• We may from time to time have access to certain data from our preclinical studies and clinical trials on a preliminary, interim or ongoing basis. Such data is typically incomplete and is subject to a number of risks and uncertainties. In particular, any analysis of preliminary, interim or ongoing da…

• From time to time, we may also disclose any such preliminary, interim or ongoing data from our preclinical studies and clinical trials. Any such preliminary, interim or ongoing data are subject to the risks and uncertainties described above, and accordingly investors should not place undue reliance …

• may not reflect all of the data we have received. It is possible that investors and others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure. If any preliminary, interim or ongoing data, or any related findings or conclusion, that we c…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• We have conducted a Phase 1 study of KSI-501 to evaluate the safety, tolerability and bioactivity of KSI-501 in DME. Although we have completed enrollment in the Phase 3 DAYBREAK study for patients with wet AMD, it could take years before a registrational-type trial is completed, if at all. In addit…

• During the conduct of clinical trials, patients report changes in their health, including illnesses, injuries, and discomforts, to their study doctor. Often, it is not possible to determine whether or not the product candidate being studied caused these conditions. It is possible that as we test our…

• Drug-related side effects could affect patient recruitment, the ability of enrolled patients to complete the study and/or result in potential product liability claims. We may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to …

• any products we may develop may also face competition from other types of therapies, such as gene-editing therapies and drug delivery devices.

• Roche’s product, Vabysmo (faricimab) received FDA approval for the treatment of wet AMD and DME in January 2022 and received FDA approval for RVO in October 2023. Vabysmo has gained rapid adoption since launch and garnered significant market share. Regeneron’s product, Eylea HD (high dose aflibercep…