Tarcocimab tedromer

Clinical results of KSI-101 in macular edema secondary to inflammation (MESI) from a tertiary care uveitis practice demonstrate outcomes consistent with results from the U.S. Phase 1b APEX study, supporting continued global development and expansion of the Phase 3 PEAK and PINNACLE program into Asia. Ongoing advancement of bispecific therapies in geographic atrophy and ocular inflammatory disease; preclinical data continue to support a multi-target approach to address limitations of current single-target therapies. The ABCD PlatformTM, an evolution of Kodiak's ABC platform to include conjugation of small molecules and other drugs, continues to advance as a versatile system for targeted, multi-modal drug development in retina and glaucoma optic neuropathy. PALO ALTO, Calif., May 1, 2026 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a precommercial retina-focused biotechnology company committed to researching, developing and commercializing transformative therapeutics, today announced it will present pipeline advances and clinical results of KSI-101 in a cohort of tertiary care MESI patients at the 2026 American Uveitis Society (AUS) Meeting and the 2026 Association for Research in Vision and Ophthalmology (ARVO) Meeting. "Results from a tertiary care uveitis practice were highly consistent with those observed in the U.S. Phase 1b APEX study," said Pablo Velazquez-Martin, M.D., Chief Medical Officer of Kodiak Sciences. "These findings add to the growing body of evidence supporting KSI-101 in MESI and provide early support for its applicability across diverse patient populations globally, irrespective of the underlying cause of the inflammation and the severity of the disease." "Our presentations at the American Uveitis Society and the Association for Research in Vision and Ophthalmology showcase both the clinical progress of KSI-101 and the continued advancement of our pipeline molecules and pipeline science," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sciences. "We look forward to engaging with colleagues at these conferences as we continue to deepen our science and grow our team." Presentations at American Uveitis Society –Saturday, May 2, 2026, in Aurora, Colorado Format: Oral presentation Presentation Title: Bispecific Trap-antibody Inhibiting Interleukin-6 and Vascular Endothelial Growth Factor (KSI-101): Week 24 Results from the Phase 1b APEX Study in Patients with Macular Edema Secondary to Inflammation (MESI) Speaker: Dr. Edmund Tsui, M.D., Associate Professor-in-Residence of Ophthalmology, Stein Eye Institute, David Geffen School of Medicine, University of California, Los Angeles (UCLA), USA Time: 7:45pm MT Presentations at Association for Research in Vision and Ophthalmology – May 3-7, 2026, in Denver, Colorado. Kodiak will have six poster presentations. Presentations are listed below and grouped by topic. These presentations will be made available under Kodiak's "Scientific Presentations" page on kodiak.com. Phase 1b APEX Data of KSI-101 in MESI, Including New Data from a Tertiary Care Cohort KSI-101 is a first-in-class, locally administered, high-strength bispecific protein in clinical development for the treatment of MESI, a heterogeneous group of diseases caused by a common pathophysiology – inflammation and blood-retinal barrier disruption. In the Phase 1b APEX study conducted in the United States, KSI-101 demonstrated rapid and meaningful visual and anatomical gains and was well tolerated. KSI-101 was further evaluated in an Asian clinical cohort. Results from this cohort were consistent with those observed in the U.S., supporting continued global development and expansion into Asia for the Phase 3 MESI program PEAK and PINNACLE. At this year's ARVO meeting, we will present results from both the U.S. study and, for the first time, results from the Asian cohort. 1.Title: Bispecific Trap-Antibody Inhibiting Interleukin-6 and Vascular Endothelial Growth Factor (KSI-101): Clinical PK/PD Cohort in Asian Patients with Macular Edema Secondary to Inflammation (MESI) Poster Session: Clinical features and treatment outcomes in uveitis Date and Time: Monday, May 4, 11:15-1:00pm MT Poster Number: 1568-0229 Speaker: Dr. Yih-Shiou Hwang, M.D., Ph.D., Professor and Head of Ophthalmology, Chang Gung Memorial Hospital, Linkou, Taipei and Taoyuan, Taiwan and Chang Gung University We will present first-time results from a clinical cohort of Asian patients with MESI treated at tertiary uveitis centers in Taiwan. Patients achieved meaningful visual improvements, including a ≥15-letter gain in 58% of patients and a mean BCVA increase of +17.8 letters at Week 24. Central subfield thickness (CST) was reduced to <325 µm after a single injection with sustained retinal dryness during follow-up. Improvements were observed across different underlying etiologies. These findings were consistent with those observed in the Phase 1b U.S. APEX study. 2.Title: Bispecific Trap-Antibody Inhibiting Interleukin-6 and Vascular Endothelial Growth Factor (KSI-101): Phase 1b APEX Study in Patients with Macular Edema Secondary to Inflammation (MESI) Poster Session: Translational uveitis research and quality-of-life in uveitis Date and Time: Wednesday, May 6, 2026; 10:15-12:00pm MT Poster Number: 4282-0552 Speaker: Dr. Shawn C. Kavoussi, M.D., Texas Retina Center, Houston, TX In the Phase 1b APEX study over 24 weeks in patients with MESI, KSI-101 demonstrated robust and consistent anatomic and visual improvements. Over half of patients achieved at least ≥15-letter gains, and more than 90% of patients achieved resolution of both IRF and SRF by Week 8. Responses were consistent irrespective of different underlying etiologies. Based on these positive results, the 5 mg and 10 mg dose levels have advanced into the actively recruiting Phase 3 PEAK and PINNACLE studies. Ocular Inflammatory Disease Ocular inflammatory disease is the fourth leading cause of vision loss among working-age adults in the developed world. Approximately one-third of patients with ocular inflammation develop macular edema, the leading cause of vision loss in this population. Steroids remain the mainstay treatment but can cause significant and permanent ocular adverse effects, especially with long-term use or high doses. There are no approved, locally administered biologics. Beyond KSI-101, currently in Phase 3 clinical development, Kodiak is advancing KSI-102 and KSI-103, two novel biologic therapies designed to address the complex cytokine interactions driving chronic inflammatory ocular diseases. 3. Title: Novel Intravitreal Bispecific Anti-Inflammatory Biologics Designed for Retinal Inflammatory Diseases Preserve Endothelial Barrier and Prevent Leukocyte Adhesion in Cell-Based Assays Poster Session: AMD pathology I Date and Time: Sunday, May 3, 2026; 8:00 – 9:45am MT Poster Number: 76-0106 Elevated levels of pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) play distinct yet complementary roles in driving inflammation and vascular permeability in retinal inflammatory diseases. Therapies targeting these cytokines individually may not fully address both disease drivers. We present cell-based data demonstrating the biological activity of KSI-102, a novel bispecific antibody that potently inhibits both TNF-α and IL-6 simultaneously. These findings support further development of intravitreal bispecific therapies, including KSI-102 and the broader anti-inflammatory bispecific franchise such as KSI-103 (an IL-1 trap and anti-IL-6 antibody fusion), with the potential to enhance therapeutic outcomes in inflammatory ocular diseases. Geographic Atrophy Geographic atrophy (GA), the advanced form of dry age-related macular degeneration, affects approximately one million patients in the U.S. and is characterized by progressive retinal atrophy that can extend to the macula and fovea, leading to irreversible vision loss. While two anti-complement therapies are currently approved, they provide modest benefit, require frequent intravitreal injections, and have been associated with an increased risk of conversion to choroidal neovascularization in some patients. GA is driven by multiple inflammatory pathways, and we are advancing both our ABCD platform-based "duet" and bispecific therapies designed to address this complexity. 4.Title: IL-6/Complement and VEGF/Complement Dual Inhibitors for Geographic Atrophy Poster Session: AMD: New drugs, delivery systems, and mechanisms of action II (section: Physiology/Pharmacology) Date and Time: Sunday, May 3, 2026; 1:00-2:45pm MT Poster Number: 447-0184 We engineered bispecific molecules by fusing complement inhibitors targeting C3b/C4b with anti-VEGF or anti-IL-6, creating multimodal candidates that demonstrate potent, broad complement inhibition while simultaneously blocking VEGF or IL-6 signaling. These results support a multi-target approach to addressing the underlying drivers of GA pathology and highlight the potential to improve outcomes beyond single-target therapies. Enhancing Therapeutic Efficacy with the ABCD Platform Antibody Drug Conjugates (ADCs) and Antibody Oligonucleotide Conjugates (AOCs) are promising platforms for targeted drug delivery but have a limited drug antibody ratio (DAR), which poses significant challenges in optimizing therapeutic efficacy. Kodiak's Antibody Biopolymer Conjugate Drug (ABCD) platform addresses this limitation by utilizing a customizable biopolymer to enable the design and development of multifunctional, high DAR therapeutics with the potential of a quarterly dosed intravitreal therapy for ophthalmic and systemic applications. 5.Title: Mechanistic Support for Ocular Intracellular Drug Delivery: Receptor-Mediated Uptake and Trafficking of Antibody-Biopolymer Conjugates (ABC) in Primary Endothelial Cells Poster Session: AMD: New drugs, delivery systems, and mechanisms of action II (Section Physiology/Pharmacology) Date and Time: Sunday, May 3, 2026; 1:00-2:45pm MT Poster Number: 451-0188 We evaluated the intracellular behavior of antibody biopolymer conjugates (ABC) in primary endothelial cells using an anti-VEGFR2 model system. ABCs internalized efficiently as intact conjugates and trafficked through endosomal pathways with sustained intracellular persistence. These findings expand the mechanistic evidence supporting the ABCD platform as a versatile system for high DAR, targeted intracellular delivery, highlighting its potential to enable delivery of a broad range of therapeutic payloads for retinal diseases. 6.Title: Biopolymer Platform for Controlled Loading, Release, and Extended Durability of Intraocular Therapeutics with Multiple Mechanisms of Action Poster Session: AMD: New drugs, delivery systems, and mechanisms of action II (Section Physiology/Pharmacology) Date and Time: Sunday, May 03, 2026; 1:00-2:45pm MT Poster Number: 444-0181 Here we present a glaucoma "duet" leveraging the ABCDTM platform and incorporating two small molecules –an inhibitor for the NLRP3 inflammasome for neuroprotection and an intraocular pressure (IOP)-lowering agent– at high DAR. Both drugs were loaded in equal proportion (DAR 125 each), confirming independent, sequential conjugation on the same polymer. Payload release characterization demonstrates successful drug unloading from ABCD molecules using pH-labile linkers. These data continue to support the dual-action approach to address the multifactorial nature of glaucoma optic neuropathy and highlight the versatility of the ABCD platform across ophthalmic indications. About Kodiak Sciences Inc. Kodiak Sciences (Nasdaq: KOD) is a precommercial retina-focused biotechnology company committed to researching, developing and commercializing transformative therapeutics. We are focused on bringing new science to the design and manufacture of next-generation retinal medicines to prevent and treat the leading causes of blindness globally. We are developing a portfolio of three late-stage clinical programs. Zenkuda™ (tarcocimab tedromer) has a BLA-ready profile in diabetic retinopathy, retinal vein occlusion and wet AMD, and, together with KSI-501, is being explored in the BLA-facing Phase 3 DAYBREAK wet AMD study, with topline data expected in 3Q 2026. Zenkuda and KSI-501 target the $15 billion anti-VEGF market across retinal vascular diseases. KSI-101 is a bispecific protein being explored in two BLA-facing Phase 3 studies in Macular Edema Secondary to Inflammation (MESI), with topline data readouts expected to begin in 4Q 2026. Forward-Looking Statements: This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include, but are not limited to, statements regarding: the sufficiency of clinical results from the Asian cohort to support continued global development and expansion of the Phase 3 PEAK and PINNACLE program into Asia; the applicability of KSI-101 across diverse patient populations globally; Kodiak's advancement of KSI-102 and KSI-103 as novel biologic therapies designed to address the complex cytokine interactions driving chronic inflammatory ocular diseases, and the potential of such therapies to enhance therapeutic outcomes in inflammatory ocular diseases beyond current single-target therapies; the potential of IL-6/Complement and VEGF/Complement bispecific molecules to improve outcomes in geographic atrophy beyond current single-target, anti-complement therapies; the potential of the ABCD Platform™; the potential of the glaucoma "duet" leveraging the ABCD Platform™ to address the multifactorial nature of glaucoma optic neuropathy through a dual-action approach; expectations regarding the timing of topline data readouts from the DAYBREAK Phase 3 study for both Zenkuda and KSI-501; and expectations regarding the timing of topline data readouts from the Phase 3 PEAK and PINNACLE studies for KSI-101. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "could," "expect," "plan," "believe," "intend," "pursue," "anticipate," "look forward," and other similar expressions, among others. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that results from the Asian cohort or the U.S. Phase 1b APEX study may not be predictive of or replicated in the Phase 3 PEAK or PINNACLE studies; the risk that the Phase 3 PEAK and PINNACLE studies for KSI-101 may not achieve their primary endpoints or may not do so on the anticipated timeline; the risk that the DAYBREAK Phase 3 study for Zenkuda or KSI-501 may not achieve its primary endpoint or may not do so on the anticipated timeline; the risk that a BLA for Zenkuda (tarcocimab tedromer) or any other product candidate may not be accepted by, or receive approval from, the FDA or foreign regulatory agencies when expected, or at all; the risk that cessation, modification, or delay of any ongoing clinical studies and Kodiak's development of KSI-101, KSI-102, KSI-103, Zenkuda, KSI-501, or any other product candidate may occur; the risk that safety, efficacy, and durability data observed in Kodiak's product candidates in current or prior studies may not continue or persist; the risk that preclinical data for KSI-102, KSI-103, the geographic atrophy bispecific molecules, or the ABCD Platform™ may not translate to clinical outcomes; the risk that the ABCD Platform™ may not achieve the anticipated drug-to-antibody ratios, dosing intervals, or therapeutic payloads in clinical development; the risk that any one or more of Kodiak's product candidates or platform technologies may not be successfully developed, approved, or commercialized; the risk that Kodiak's research and development efforts and ability to advance product candidates into later stages of development may fail; adverse conditions in the general domestic and global economic markets, which may significantly impact Kodiak's business and operations, including its clinical trial sites, as well as the business or operations of its manufacturers, contract research organizations, or other third parties with whom Kodiak conducts business; as well as the other risks identified in the section entitled "Risk Factors" in Kodiak's most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Kodiak's subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Kodiak undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Readers are cautioned not to place undue reliance on such forward-looking statements. SOURCE Kodiak Sciences Inc. 21% more press release views with Request a Demo

PALO ALTO, Calif., March 31, 2026 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), today reported recent business highlights and financial results for the fourth quarter and full year ended December 31, 2025. "Kodiak's momentum has continued to build, highlighted by positive Phase 3 topline results from the GLOW2 study and multiple advancing late-stage and pipeline programs that together reinforce the company's differentiated molecules, platform and long term growth strategy," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sciences. "The GLOW2 Phase 3 study delivered strong topline results showing meaningful efficacy, safety and durability of Zenkuda (tarcocimab tedromer) in diabetic retinopathy. These results represent a significant validation of the company's ABC platform, and we intend to move on an accelerated timeline toward a multi-indication Biologics License Application (BLA) submission for Zenkuda." We have also completed enrollment in the Phase 3 DAYBREAK study of both Zenkuda and KSI-501 in patients with neovascular age-related macular degeneration (wet AMD), with approximately 690 subjects enrolled. Topline data is expected in September 2026. We are also rapidly advancing KSI-101 with enrollment progressing well in the Phase 3 PEAK and PINNACLE studies. Topline results from PEAK are expected in 4Q 2026 and for PINNACLE in 2Q 2027. KSI-101 demonstrated compelling data in the Phase 1b APEX study in patients with macular edema secondary to inflammation (MESI). Final Phase 1b APEX data showed rapid and robust improvements in both vision and retinal anatomy, including high rates of ≥15-letter BCVA gains, early and sustained retinal drying, and encouraging durability. These findings support continued development and highlight the breadth of Kodiak's platform beyond anti-VEGF therapies into inflammatory retinal diseases. Beyond our lead programs, we continue to expand a diversified pipeline of bispecific antibody candidates, including KSI-102 and KSI-103, targeting key inflammatory pathways, as well as retina duet programs in glaucoma and geographic atrophy. Our duet programs, built on the ABC platform, reflect a strategy to address a broad range of high prevalence retinal diseases with differentiated, multi-targeted approaches. In parallel, we have made tremendous progress with our digital health and artificial intelligence capabilities through the VETi (Visual Engagement Technology and Imager) platform. Progress across hardware, software and machine learning is enabling the development of an AI-powered wearable headset with applications in retina care, alongside broader opportunities in identity security and cognitive science. This progress is reflective of Kodiak's long term planning and execution towards an enhanced identity as a vision sciences company, integrating proprietary therapeutics and next-generation vision technologies. Recent Business Highlights Zenkuda (tarcocimab tedromer) On March 26, 2026, Kodiak announced positive topline results in GLOW2, the second Phase 3 study in diabetic retinopathy, demonstrating superiority of Zenkuda (tarcocimab tedromer) over sham. Building on the success of GLOW1 and with all patients on a 6-month dosing interval, Zenkuda demonstrated superiority to sham with 62.5% of Zenkuda-treated patients achieving a ≥2-step improvement in diabetic retinopathy severity score (DRSS) compared to 3.3% of sham-treated patients (p<0.0001). Zenkuda also demonstrated superiority to sham with an 85% risk reduction in the key secondary endpoint of development of sight threatening complications (2.4% with Zenkuda vs 15.8% with sham, p=0.0001) and with a ≥3-step improvement in DRSS (13.7% with Zenkuda vs 0% with sham, p<0.0001). Zenkuda also demonstrated strong efficacy independent of concomitant GLP-1 receptor agonist use. In Zenkuda-treated patients, the proportion achieving a ≥2-step improvement in DRSS was 60.0% among those using GLP-1 medications versus 64.3% among those not using GLP-1 medications, supporting Zenkuda's efficacy profile in a real-world diabetic population. Zenkuda was well tolerated with no reported instances of intraocular inflammation, retinal vasculitis or occlusive retinal vasculitis and a low cataract adverse event rate of 2.3% versus 1.6% with sham. The safety data support Zenkuda's enhanced commercial formulation and elevate the established safety profile of Kodiak's biologics-based ABC Platform. Based on the strong efficacy, safety and durability data demonstrated in the GLOW2 study, Zenkuda now has a multi-indication BLA-ready profile, and Kodiak intends to accelerate the BLA submission timeline. KSI-101: Strong Clinical Results and Advancing Phase 3 Program On February 7, 2026, Kodiak presented final Phase 1b APEX clinical results for KSI-101 in MESI at the Angiogenesis, Exudation and Degeneration annual meeting. Demonstrated robust anatomical and visual responses across MESI patients. More than half of patients achieved ≥15-letter gains in best corrected visual acuity (BCVA), with additional benefit at higher dose levels. Rapid vision improvements and anatomical response observed with 10-letter gains by Week 4 in top dose groups and OCT CST <325 microns achieved as early as Week 1 in top dose groups. Continued anatomical improvement over time with >90% resolution of intraretinal (IRF) and subretinal fluid (SRF) by Week 8 and 20/25 Snellen visual acuity by Week 20. In top dose groups, ≥90% achieved complete absence of IRF and SRF, indicating retinal dryness and normalization of retinal architecture. Completion of Follow-on Equity Offering In December 2025, we completed an equity offering in which we issued and sold 8 million shares of common stock at a public offering price of $23.00 per share. Net proceeds were $173.0 million after the underwriting discount. We believe that our current cash and cash equivalents will support our current and planned operations into 2027. Fourth Quarter and Full Year 2025 Financial Results Cash Position Kodiak ended 2025 with $209.9 million of cash and cash equivalents. Net Loss Net loss for the fourth quarter of 2025 was $56.7 million, or $1.04 per share on both a basic and diluted basis, as compared to a net loss of $44.1 million, or $0.84 per share on both a basic and diluted basis, for the fourth quarter of 2024. Net loss for the quarter ended December 31, 2025 included non-cash stock-based compensation of $13.3 million, as compared to $8.6 million for the quarter ended December 31, 2024. R&D Expenses Research and development ("R&D") expenses were $45.5 million for the quarter ended December 31, 2025, as compared to $31.8 million for the quarter ended December 31, 2024. R&D expenses for the fourth quarter of 2025 included non-cash stock-based compensation of $6.8 million, as compared to $0.2 million for the fourth quarter of 2024. The increase in R&D expenses in the fourth quarter of 2025 was primarily driven by increased clinical activities related to our active DAYBREAK and PEAK/PINNACLE studies and higher stock-based compensation relative to a year ago due to forfeitures of equity awards in the fourth quarter of 2024. R&D expenses were $182.4 million for the year ended December 31, 2025, as compared to $126.1 million for the year ended December 31, 2024. R&D expenses for the full year of 2025 included non-cash stock-based compensation of $29.5 million, as compared to $24.2 million for the full year of 2024. The increase in R&D expenses for the full year of 2025 was primarily driven by increased clinical activities related to our active DAYBREAK and PEAK/PINNACLE studies. G&A Expenses General and administrative ("G&A") expenses were $12.0 million for the quarter ended December 31, 2025, as compared to $14.4 million for the quarter ended December 31, 2024. G&A expenses for the fourth quarter of 2025 included non-cash stock-based compensation of $6.5 million, as compared to $8.4 million for the fourth quarter of 2024. Additionally, sublease income from one of our corporate office buildings helped offset G&A expenses in the fourth quarter of 2025. G&A expenses were $52.0 million for the year ended December 31, 2025, as compared to $60.8 million for the year ended December 31, 2024. G&A expenses for the full year of 2025 included non-cash stock-based compensation of $29.4 million, as compared to $36.1 million for the full year of 2024. Additionally, sublease income from one of our corporate office buildings helped offset G&A expenses in 2025. About Diabetic Retinopathy Approximately 9.7 million people in the U.S. have diabetic retinopathy (DR), a progressive disease that occurs when damaged blood vessels leak blood and fluid into the retina. DR can progress quickly into vision-threatening complications including proliferative diabetic retinopathy (PDR) or diabetic macular edema (DME). More than 50% of patients with moderate or severe non-proliferative DR develop DME by Year 4. Current treatment guidelines for DR are largely reactive, with intervention typically initiated only after the development of PDR or center-involved DME, when retinal damage may be irreversible and associated with permanent vision loss. Although anti-VEGF therapy has been shown to reduce the risk of DME by approximately 50% compared to laser or no treatment, utilization remains limited. This underutilization is primarily driven by the asymptomatic nature of the disease and the substantial treatment burden of current intravitreal injection therapies. The growing use of GLP-1–based therapies in patients with diabetes represents an important factor to consider in the management and treatment of DR. About Zenkuda™ (tarcocimab tedromer) Zenkuda is an investigational anti-VEGF therapy built on Kodiak's proprietary Antibody Biopolymer Conjugate (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 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 through 6-month label for all patients with retinal vascular disease (treatment-naïve, treatment-experienced, mild patients, and severe patients). 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 patients and prevented disease progression with 100% of patients on extended 6-month dosing at Year 1. In the BEACON study, during the first 6 months, Zenkuda-treated patients were dosed at 8-week intervals (as opposed to 4-week intervals for aflibercept). In the second 6 months, identical retreatment criteria were used for the Zenkuda and aflibercept arms, and nearly half of Zenkuda patients did not require any treatment while achieving similar vision and anatomical outcomes as the aflibercept group at one year. In the DAYLIGHT study, Zenkuda demonstrated non-inferior efficacy results and compelling safety and tolerability at a once-monthly dosing interval. Zenkuda is currently being studied in the Phase 3 DAYBREAK study in wet AMD, the final anticipated Phase 3 study in the program. In DAYBREAK, patients are treated on an every 1-month through every 6-month treatment interval, depending on an AI-driven assessment of disease activity. Topline results for the DAYBREAK one-year primary endpoint are expected in 3Q 2026. About GLOW1 and GLOW2 GLOW1 and GLOW2 were prospective, randomized, double-masked, sham-controlled, multicenter Phase 3 studies evaluating Zenkuda 5mg in participants with diabetic retinopathy. Both studies employed extended-interval dosing regimens with an ultimate treatment interval of every six months. The primary endpoint was the proportion of eyes improving by ≥2 steps on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 48. Additional outcome measures include the proportion of eyes developing a sight-threatening complication of diabetic retinopathy and the proportion of eyes improving ≥3 steps on DRSS from baseline at Week 48. Additional information about GLOW1 and GLOW2 can be found on under Trial Identifier NCT05066230 () and NCT06270836 (). In the GLOW1 study, patients were randomized 1:1 to receive either sham injections or Zenkuda via intravitreal injection at baseline, Week 8, Week 20 and Week 44, for a planned four injections in year one. The Phase 3 GLOW1 study demonstrated that, with extended 6-month dosing in every patient, Zenkuda can achieve strong efficacy both in treating existing disease (primary endpoint) and preventing vision threatening complications and disease progression (key secondary endpoint). In GLOW1, Zenkuda met its primary endpoint of the proportion of patients with at least a 2-step improvement on the DRSS score with 41.1% of Zenkuda-treated patients demonstrating at least a 2-step improvement versus 1.4% of patients in the sham group, a 29-fold increased response rate ratio (p-value less than 0.0001). Zenkuda also met all key secondary endpoints, including greater reductions in the proportion of patients developing sight-threatening complications (such as diabetic macular edema and proliferative diabetic retinopathy) versus sham, demonstrating an 89% decreased risk (2.3% with Zenkuda versus 21.0% with sham, p-value < 0.0001). The Phase 3 GLOW2 study was designed as a confirmatory study to the Phase 3 GLOW1 study. Patients were randomized 1:1 to receive either sham injections or Zenkuda via intravitreal injection at baseline, Week 4, Week 8, Week 20 and Week 44, for a planned five injections in year one. The Phase 3 GLOW2 study confirmed findings from GLOW1 that, with extended 6-month dosing in all Zenkuda-treated patients, Zenkuda can achieve strong efficacy both in treating existing disease (primary endpoint) and preventing vision threatening complications and disease progression (key secondary endpoint). In GLOW2, Zenkuda met its primary endpoint of the proportion of patients with at least a 2-step improvement on the DRSS, with 62.5% of Zenkuda-treated patients demonstrating at least a 2-step improvement versus 3.3% of patients in the sham group, a 19-fold increased response rate ratio (p-value < 0.0001). Zenkuda also met all key secondary endpoints, including greater reductions in the proportion of patients developing sight-threatening complications (such as diabetic macular edema and proliferative diabetic retinopathy), versus sham, demonstrating an 85% decreased risk (2.4% with Zenkuda versus 15.8% with sham, p-value ≤ 0.0001). About DAYBREAK (and Zenkuda) The Phase 3 DAYBREAK study is a non-inferiority study evaluating parallel investigational arms of Zenkuda and KSI-501 against active comparator aflibercept. The DAYBREAK study incorporates learnings from prior pivotal trials of Zenkuda and was designed to maximize the probability of meeting the primary endpoint of non-inferiority in visual acuity gains. Patients randomized to Zenkuda will receive individualized dosing every 4 to 24 weeks on an as needed basis following four monthly loading doses. Patients randomized to aflibercept will be dosed per label. The individualized dosing of Zenkuda is determined by a treat-to-dryness proactive approach using the presence of retinal fluid as a disease activity marker, which resembles retina specialists' practice and optimizes each patient's treatment, instead of using a combination of central subfield thickness and vision loss. The objectives for Zenkuda in DAYBREAK are to assess its durability potential, strengthen its competitive position in wet AMD and bolster the possible regulatory application package for the program. DAYBREAK was designed to showcase the potential for Zenkuda to be a mainstay biologic for VEGF-driven retinal vascular diseases with both a strong efficacy/immediacy (driven by its enhanced formulation) and a strong durability (driven by its ABC®design and science of durability). Topline data for the one-year primary endpoint in DAYBREAK are expected in 3Q 2026. About KSI-501 KSI-501 is an investigational anti-IL-6, VEGF-trap bispecific therapy built on the ABC platform and is being developed for high prevalence retinal vascular diseases to address the leading unmet needs of extended durability and targeting disease biology beyond VEGF for differentiated efficacy. KSI-501 is designed to provide high immediacy/efficacy, driven by the enhanced formulation, and high durability, driven by the ABC® platform and our science of durability. In preclinical models, KSI-501 was shown to be a potent inhibitor of VEGF and IL-6 and, further, was shown to normalize the blood retinal barrier, opening up the possibility that KSI-501 may be a disease-modifying therapy for retinal vascular diseases. Furthermore, higher intraocular levels of IL-6 correlated with poorer BCVA outcomes over time in wet AMD patients treated with anti-VEGF monotherapy, which suggests that IL-6 inhibition in combination with anti-VEGF therapy could lead to improved outcomes. Kodiak has advanced KSI-501 into the Phase 3 study DAYBREAK to evaluate its efficacy and safety in wet AMD. DAYBREAK has completed enrollment. DAYBREAK uses KSI-501's enhanced 50 mg/mL formulation containing both conjugated and unconjugated antibody that is intended to balance immediacy and durability. Topline data for the one-year primary endpoint in DAYBREAK are expected in 3Q 2026. About DAYBREAK (and KSI-501) The DAYBREAK study is a non-inferiority study evaluating parallel investigational arms of KSI-501 and Zenkuda against active comparator aflibercept. Patients randomized to KSI-501 will receive fixed every 8-week dosing with additional individualized dosing (up to monthly dosing) on an as needed basis after four monthly loading doses. Patients randomized to aflibercept will be dosed per label. Using the same treat-to-dryness approach as Zenkuda, coupled with fixed intensive proactive dosing, our goal is to maximize both the probability of meeting the primary endpoint as well as the probability of demonstrating additional efficacy benefits. The primary endpoint is non-inferiority in change in visual acuity from baseline to the average of Week 40, 44 and 48. The objective for KSI-501 in DAYBREAK is to explore the efficacy potential of bispecific IL-6 and VEGF inhibition in a broad treatment-naïve wet AMD population. DAYBREAK has completed enrollment. Topline data for the one-year primary endpoint in DAYBREAK are expected in 3Q 2026. Additional information about DAYBREAK can be found on under Trial Identifier NCT06556368 (). About Kodiak Sciences Inc. Kodiak Sciences (Nasdaq: KOD) is a precommercial retina-focused biotechnology company committed to researching, developing and commercializing transformative therapeutics. We are focused on bringing new science to the design and manufacture of next-generation retinal medicines to prevent and treat the leading causes of blindness globally. We are developing a portfolio of three late-stage clinical programs. Zenkuda™ (tarcocimab tedromer) has a BLA-ready profile in diabetic retinopathy, retinal vein occlusion and wet AMD, and, together with KSI-501, is being explored in the BLA-facing Phase 3 DAYBREAK wet AMD study, with topline data expected in 3Q 2026. Zenkuda and KSI-501 target the $15 billion anti-VEGF market across retinal vascular diseases. KSI-101 is a bispecific protein being explored in two BLA-facing Phase 3 studies in Macular Edema Secondary to Inflammation (MESI), with topline data readouts expected to begin in 4Q 2026. Kodiak®, Kodiak Sciences®, ABC®, ABC Platform™, Zenkuda™, VETi™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions. Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding: Kodiak's intention to move on an accelerated timeline toward a multi-indication BLA submission for Zenkuda; expectations regarding the timing of topline data readouts from the DAYBREAK Phase 3 study for both Zenkuda and KSI-501; expectations regarding the timing of topline data readouts from the PEAK and PINNACLE Phase 3 studies; and the development of an AI-powered wearable headset with applications in retina care, alongside broader opportunities in identity security and cognitive science. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "anticipate," "believe," "could," "expect," "intend," "may," "plan," "pursue," "should," "will," "would," and other similar expressions, among others. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the completed Phase 3 studies for Zenkuda may not be sufficient to support a BLA submission or approval in diabetic retinopathy, retinal vein occlusion, or wet AMD; the risk that a BLA for tarcocimab tedromer or any other product candidate may not be accepted by, or receive approval from, the FDA or foreign regulatory agencies when expected, or at all; the risk that cessation, modification, or delay of any ongoing clinical studies and Kodiak's development of Zenkuda, KSI-501, KSI-101, or any other product candidate may occur; the risk that safety, efficacy, and durability data observed in Kodiak's product candidates in current or prior studies may not continue or persist; the risk that KSI-501 may not inhibit VEGF and IL-6 or have an impact on the treatment of patients as expected, and that preclinical data suggesting the possibility that KSI-501 may be a disease-modifying therapy may not translate to clinical outcomes; the risk that the DAYBREAK Phase 3 study for Zenkuda or KSI-501 may not achieve its primary endpoint or may not do so on the anticipated timeline; the risk that the PEAK Phase 3 study for KSI-101 may not achieve its primary endpoint or may not do so on the anticipated timeline; the risk that any one or more of Kodiak's product candidates may not be successfully developed, approved, or commercialized; the risk that Kodiak's research and development efforts and ability to advance product candidates into later stages of development may fail; the risk that sufficient capital may not be available as expected, or at all, to complete the development of any products; adverse conditions in the general domestic and global economic markets, which may significantly impact Kodiak's business and operations, including its clinical trial sites, as well as the business or operations of its manufacturers, contract research organizations, or other third parties with whom Kodiak conducts business; as well as the other risks identified in the section entitled "Risk Factors" in Kodiak's Annual Report on Form 10-K for the year ended December 31, 2025, as well as discussions of potential risks, uncertainties, and other important factors in Kodiak's subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Kodiak undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Readers are cautioned not to place undue reliance on such forward-looking statements. SOURCE Kodiak Sciences Inc. 21% more press release views with Request a Demo