Company Description
Kodiak Sciences Inc. (NASDAQ: KOD) is a precommercial, retina-focused biotechnology company that is researching, developing and aiming to commercialize therapeutics for serious eye diseases. According to the company’s public statements, Kodiak Sciences is focused on bringing new science to the design and manufacture of next generation retinal medicines to help prevent and treat leading causes of blindness globally. Its work sits within the biological product manufacturing space, with an emphasis on biologic drug candidates for retinal vascular and inflammatory eye conditions.
Retina-focused biotechnology model
Kodiak Sciences describes itself as a precommercial company, meaning it is focused on clinical development rather than marketed products. The company’s strategy centers on building a portfolio of late-stage clinical programs in retinal disease. It is developing drug candidates that target pathways such as vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6), which are implicated in retinal vascular diseases and macular edema secondary to inflammation (MESI). The company highlights that it is working on next generation retinal medicines intended to address high-prevalence conditions that can lead to vision loss and blindness.
ABC Platform and molecular engineering
Kodiak Sciences reports that its discovery and development engine is built on its proprietary ABC® Platform (Antibody Biopolymer Conjugate platform). The company states that this platform uses molecular engineering to merge the fields of protein-based and chemistry-based therapies. The ABC Platform has been described as central to Kodiak’s approach to designing investigational therapies with attributes such as high potency and extended durability in ocular tissues. The platform underpins multiple clinical candidates in the company’s pipeline and is referenced as a key technology in its public communications.
Late-stage clinical pipeline
According to recent company disclosures, Kodiak Sciences is developing a portfolio of three late-stage clinical programs in retinal disease:
- Tarcocimab – an investigational anti-VEGF therapy built on the ABC Platform. It is designed to maintain potent and effective drug levels in ocular tissues for longer than existing available agents. Tarcocimab is being developed as an intravitreal biologic monotherapy for VEGF-driven retinal vascular diseases. The company reports that tarcocimab has completed three Phase 3 pivotal clinical studies: GLOW1 in diabetic retinopathy (DR), BEACON in retinal vein occlusion (RVO) and DAYLIGHT in neovascular age-related macular degeneration (wet AMD). Tarcocimab is currently being studied in Phase 3 trials GLOW2 (diabetic retinopathy) and DAYBREAK (wet AMD), both of which have completed enrollment.
- KSI-501 – an investigational anti-IL-6, VEGF-trap bispecific therapy built on the ABC Platform. Kodiak Sciences states that KSI-501 is being developed for high-prevalence retinal vascular diseases to address needs such as extended durability and targeting disease biology beyond VEGF alone. In preclinical models described by the company, KSI-501 was shown to inhibit both VEGF and IL-6 and to normalize the blood retinal barrier. A completed Phase 1 multiple ascending dose study in diabetic macular edema demonstrated clinically meaningful and sustained improvements in visual acuity and fluid reduction. KSI-501 has been advanced into the Phase 3 DAYBREAK study in wet AMD, which has completed enrollment.
- KSI-101 – a novel, potent and high-strength (100 mg/mL) bispecific protein targeting IL-6 and VEGF. Kodiak Sciences is developing KSI-101 for patients with macular edema secondary to inflammation (MESI), a heterogeneous group of serious retinal diseases characterized by macular edema and visual impairment. The company notes that there are currently no available intravitreal biologic therapies addressing the full spectrum of MESI diseases and views MESI as a distinct market segment separate from the established anti-VEGF market. KSI-101 has been evaluated in the Phase 1b APEX study in both diabetic macular edema (DME) and MESI, where the company reports meaningful visual and anatomical gains and a favorable tolerability profile. Based on APEX, the top two dose levels (5 mg and 10 mg) were advanced into two Phase 3 superiority studies, PEAK and PINNACLE, which are actively enrolling MESI patients.
Clinical programs and disease focus
Kodiak Sciences’ programs are concentrated on retinal vascular diseases and inflammatory retinal conditions. In diabetic retinopathy, the GLOW1 Phase 3 study of tarcocimab demonstrated that extended 6‑month dosing in every patient could achieve strong efficacy in treating existing disease and preventing progression, including reductions in sight‑threatening complications such as diabetic macular edema and proliferative diabetic retinopathy. The ongoing GLOW2 study mirrors GLOW1’s design, with intravitreal tarcocimab injections at specified weeks and a primary endpoint based on improvement on the Diabetic Retinopathy Severity Scale.
In wet AMD and retinal vein occlusion, Kodiak Sciences reports that tarcocimab has been evaluated in Phase 3 trials including BEACON and DAYLIGHT. The BEACON study compared extended every‑8‑week dosing of tarcocimab with every‑4‑week dosing of aflibercept over the first 6 months, and described similar vision and anatomical outcomes at one year despite fewer injections in the tarcocimab arm. In DAYLIGHT, tarcocimab was tested on a once‑monthly dosing interval and demonstrated non‑inferior efficacy results with safety and tolerability consistent with expectations described by the company.
The DAYBREAK Phase 3 study is a non‑inferiority trial evaluating parallel investigational arms of tarcocimab and KSI‑501 against aflibercept in treatment‑naïve wet AMD. Kodiak Sciences explains that DAYBREAK incorporates learnings from prior pivotal trials and uses a treat‑to‑dryness approach based on retinal fluid as a marker of disease activity. For tarcocimab, individualized dosing every 4 to 24 weeks follows four monthly loading doses, while KSI‑501 uses fixed every‑8‑week dosing with additional individualized dosing as needed. The study is designed to assess durability, explore efficacy of bispecific IL‑6 and VEGF inhibition, and support potential regulatory applications.
Macular edema secondary to inflammation (MESI)
KSI‑101 is being developed for MESI, which Kodiak Sciences describes as a heterogeneous group of serious, vision‑threatening retinal diseases that share a common pathophysiology of inflammation and blood retinal barrier disruption. The company notes that MESI presents clinically with macular edema and visual impairment, regardless of the location of inflammation inside the eye or the specific etiology, such as uveitic macular edema, idiopathic macular edema, post‑procedural macular edema or inflammatory choroidal neovascularization.
In the Phase 1b APEX study, Kodiak Sciences reports that KSI‑101 produced rapid and meaningful gains in best‑corrected visual acuity and substantial reductions in retinal fluid in MESI patients, with a high proportion of patients achieving absence of intraretinal and subretinal fluid at follow‑up time points. The company states that KSI‑101 was well tolerated in both MESI and DME cohorts and that responses were observed across the spectrum of MESI etiologies and inflammation locations. These findings supported selection of the 5 mg and 10 mg doses for the Phase 3 PEAK and PINNACLE studies.
PEAK and PINNACLE are described as complementary superiority studies designed to cover a wide spectrum of MESI patients. PEAK includes patients with more severe disease (moderate to severe macular edema and vision impairment), while PINNACLE includes patients with milder disease as well as those with more severe edema but good vision. Patients randomized to KSI‑101 receive fixed monthly dosing for six doses followed by individualized dosing up to monthly, with sham controls receiving sham injections on a similar schedule. Primary and key secondary endpoints are evaluated at Week 24.
Capital markets activity and listing
Kodiak Sciences’ common stock is registered under Section 12(b) of the Securities Exchange Act of 1934 and trades on The Nasdaq Stock Market LLC under the symbol KOD, as noted in its Form 8‑K filing dated December 18, 2025. The company has used public equity offerings to support its clinical and manufacturing activities. For example, in December 2025, Kodiak Sciences completed an underwritten public offering of 8,000,000 shares of common stock, including shares sold pursuant to the underwriters’ option to purchase additional shares, with gross proceeds of approximately $184 million before expenses, as described in its press release and corresponding Form 8‑K.
The company has also reported quarterly financial results and business highlights via Form 8‑K filings, reflecting research and development spending associated with its Phase 3 programs (including DAYBREAK, GLOW2, PEAK and PINNACLE) and general and administrative expenses. These filings emphasize that increased R&D expenses have been driven by clinical activities and manufacturing related to the Phase 3 programs.
Scientific and investor engagement
Kodiak Sciences regularly participates in scientific and investor conferences. The company has highlighted presentations of KSI‑101 APEX data at meetings such as the Retina Society Annual Scientific Meeting and the EURetina Congress, as well as planned presentations at ophthalmology and angiogenesis meetings. It also participates in healthcare investor conferences and large industry gatherings, and provides webcasts of presentations in the “Events and Presentations” section of its investor relations site.
Through these activities, Kodiak Sciences shares updates on its late‑stage clinical assets—tarcocimab, KSI‑501 and KSI‑101—its ABC Platform, and its view of opportunities in retinal vascular diseases and MESI. The company’s disclosures emphasize its focus on late‑stage development, its use of molecular engineering to design retinal biologics, and its goal of advancing transformative therapeutics for retinal disease.
Position within the biotechnology and manufacturing sector
Within the broader manufacturing sector classification, Kodiak Sciences aligns with biological product manufacturing focused on therapeutic biologics. Its programs involve antibody‑based and bispecific protein candidates administered intravitreally for retinal indications. The company’s emphasis on an internal platform (ABC) and multiple late‑stage trials places it among clinical‑stage biopharmaceutical companies concentrating on ophthalmology and retinal disease.
Key concepts and terminology
- Anti‑VEGF therapy: Biologic drugs that inhibit vascular endothelial growth factor, a driver of abnormal blood vessel growth and leakage in retinal vascular diseases.
- IL‑6 inhibition: Targeting interleukin‑6, a cytokine associated with inflammation, which Kodiak Sciences links to disease activity in conditions such as uveitic macular edema and MESI.
- Intravitreal injection: Delivery of a drug directly into the vitreous humor of the eye, a common route for retinal therapeutics.
- Diabetic retinopathy and macular edema: Diabetic retinopathy is a complication of diabetes affecting retinal blood vessels; macular edema involves fluid accumulation in the macula, leading to vision impairment.
- Wet age‑related macular degeneration (wet AMD): A chronic eye disorder involving abnormal blood vessel growth under the retina, leading to leakage and vision loss.
Summary
According to its public disclosures, Kodiak Sciences Inc. is a Nasdaq‑listed, precommercial biotechnology company focused on retina, with a pipeline of late‑stage clinical programs built on its ABC Platform. Its investigational therapies—tarcocimab, KSI‑501 and KSI‑101—are being studied in multiple Phase 3 trials in diabetic retinopathy, wet AMD, retinal vein occlusion and macular edema secondary to inflammation. The company’s activities center on clinical development, manufacturing scale‑up for biologic candidates, and ongoing engagement with scientific and investment communities.