Kodiak Sciences to Present Pipeline Advances and KSI-101 Clinical Data, Including Results from a MESI Cohort in a Tertiary Care Uveitis Practice, at Upcoming Scientific Conferences
- 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.
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