Kodiak Sciences Announces Recent Business Highlights and Fourth Quarter and Full Year 2025 Financial Results
Rhea-AI Summary
Kodiak Sciences (Nasdaq: KOD) reported Q4 and full-year 2025 results and program updates on March 31, 2026. Key highlights: positive Phase 3 GLOW2 topline for Zenkuda with 62.5% vs 3.3% ≥2-step DRSS improvement and 85% risk reduction for sight-threatening complications, intent to accelerate a multi-indication BLA, KSI-101 strong Phase 1b APEX data, DAYBREAK enrollment ~690 with topline in Sept 2026, cash $209.9M and $173.0M net proceeds from an 8.0M-share offering supporting operations into 2027.
Positive
- GLOW2 efficacy: 62.5% ≥2-step DRSS vs 3.3% with sham
- Major secondary outcome: 85% risk reduction in sight-threatening complications (2.4% vs 15.8%)
- Raised $173.0M net proceeds from 8.0M-share offering; cash $209.9M supports operations into 2027
- KSI-101 APEX: >50% achieved ≥15-letter BCVA gains; rapid anatomical drying in top dose groups
Negative
- Q4 net loss widened to $56.7M from $44.1M year-ago (≈+28.6%)
- R&D spending rose to $182.4M in 2025 from $126.1M in 2024 (≈+44.6%)
- Equity dilution: issued 8.0M shares in December 2025, creating shareholder dilution risk
Key Figures
Market Reality Check
Peers on Argus
KOD fell 9.03% on elevated volume while close peers showed mixed moves (e.g., ATYR +4.7%, OLMA +7.73%, OPT -2.01%). This points to stock-specific reaction rather than a broad biotech move.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 13 | Q3 2025 earnings | Positive | +3.4% | Reported Q3 loss but strong APEX data and Phase 3 enrollment progress. |
| Aug 13 | Q2 2025 earnings | Positive | +16.5% | Highlighted late-stage pipeline progress and promising KSI-101 Phase 1b data. |
| May 14 | Q1 2025 earnings | Negative | -15.5% | Wider quarterly loss with higher R&D spend despite solid cash runway. |
| Mar 27 | FY 2024 earnings | Positive | -4.9% | Improved loss and solid cash but shares slipped despite pipeline progress. |
| Nov 14 | Q3 2024 earnings | Neutral | +4.3% | Ongoing losses offset by strong tarcocimab data and adequate cash levels. |
Earnings releases have produced mixed but mostly aligned reactions, with both strong rallies and sharp selloffs; the average same-tag move is modest at 0.76%.
Recent earnings updates for Kodiak have consistently paired sizeable net losses with advancing late-stage retina programs. Cash balances moved from $197.9M in Q3 2024 to $168.1M at 2024 year-end and then fluctuated through 2025 as R&D spend rose for three Phase 3 assets. Price reactions ranged from a +16.47% spike to a -15.48% drop, indicating that earnings days can be volatile. Today’s full-year 2025 report continues the pattern of heavy R&D investment alongside pipeline progress.
Historical Comparison
In the past five earnings updates, KOD’s average move was 0.76%, with swings from -15.48% to +16.47%. Today’s -9.03% decline fits within this historically wide earnings-day range.
Across successive earnings reports, Kodiak has maintained a loss-making profile while steadily advancing three Phase 3 retina assets toward multiple topline readouts and an eventual BLA strategy.
Market Pulse Summary
This announcement combines robust GLOW2 Phase 3 data for Zenkuda with detailed 2025 financials, including a year-end cash balance of $209.9M after a December equity raise. The company continues to post substantial net losses as it funds multiple Phase 3 programs and digital vision technologies. Investors monitoring this story often focus on upcoming topline readouts, execution on accelerated BLA plans, and the pace of R&D spending relative to available cash.
Key Terms
biologics license application (bla) regulatory
phase 3 medical
diabetic retinopathy severity score (drss) medical
glp-1 receptor agonist medical
best corrected visual acuity (bcva) medical
intraretinal (irf) and subretinal fluid (srf) medical
macular edema medical
AI-generated analysis. Not financial advice.
"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 to3.3% 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 vs15.8% with sham, p=0.0001) and with a ≥3-step improvement in DRSS (13.7% with Zenkuda vs0% 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 versus64.3% 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% versus1.6% 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
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
Net Loss
Net loss for the fourth quarter of 2025 was
R&D Expenses
Research and development ("R&D") expenses were
R&D expenses were
G&A Expenses
General and administrative ("G&A") expenses were
G&A expenses were
About Diabetic Retinopathy
Approximately 9.7 million people in the
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
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 www.clinicaltrials.gov under Trial Identifier NCT05066230 (https://clinicaltrials.gov/study/NCT05066230) and NCT06270836 (https://clinicaltrials.gov/show/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
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
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 www.clinicaltrials.gov under Trial Identifier NCT06556368 (https://clinicaltrials.gov/study/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
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.
Kodiak Sciences Inc. | ||||||||||||||||
Three Months Ended | Year Ended | |||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
Operating expenses | ||||||||||||||||
Research and development | $ | 45,493 | $ | 31,772 | $ | 182,373 | $ | 126,095 | ||||||||
General and administrative | 11,960 | 14,407 | 52,015 | 60,754 | ||||||||||||
Total operating expenses | 57,453 | 46,179 | 234,388 | 186,849 | ||||||||||||
Loss from operations | (57,453) | (46,179) | (234,388) | (186,849) | ||||||||||||
Interest income | 757 | 2,130 | 4,517 | 11,148 | ||||||||||||
Other expense, net | (40) | (56) | (96) | (506) | ||||||||||||
Net loss | $ | (56,736) | $ | (44,105) | $ | (229,967) | $ | (176,207) | ||||||||
Net loss per share, basic and diluted | $ | (1.04) | $ | (0.84) | $ | (4.32) | $ | (3.35) | ||||||||
Weighted-average shares outstanding, basic and | 54,433,267 | 52,650,631 | 53,208,311 | 52,583,148 | ||||||||||||
Kodiak Sciences Inc. | ||||||||
December 31, | December 31, | |||||||
Cash and cash equivalents | $ | 209,862 | $ | 168,074 | ||||
Working capital | 169,283 | 146,363 | ||||||
Total assets | 351,533 | 335,578 | ||||||
Accumulated deficit | (1,558,705) | (1,328,738) | ||||||
Total stockholders' equity | 157,383 | 150,288 | ||||||
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SOURCE Kodiak Sciences Inc.
FAQ
What did Kodiak (KOD) announce about Zenkuda in the March 31, 2026 release?
How much cash did Kodiak (KOD) report at year-end and how long will it last?
What are Kodiak's near-term clinical data milestones for KSI-101 and DAYBREAK in 2026–2027?
How did Kodiak's R&D and net loss change in 2025 versus 2024?
What did Kodiak (KOD) say about safety results for Zenkuda in GLOW2?
