KOD

PALO ALTO, Calif., Aug. 13, 2026 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), today reported recent business highlights and financial results for the second quarter ended June 30, 2026. "Kodiak continues to execute broadly across our late-stage clinical portfolio as we approach three Phase 3 readouts between now and the end of this year," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sciences. "We remain on track for September 2026 DAYBREAK Phase 3 topline results evaluating both Zenkuda and KSI-501 in treatment-naïve wet AMD, followed by December 2026 PEAK Phase 3 Pivotal Analysis 1 topline results evaluating KSI-101 in Macular Edema Secondary to Inflammation. We completed enrollment of the first 300-patient cohort supporting Pivotal Analysis 1 of the Phase 3 PEAK study, initiated patient enrollment in the Phase 3 ALTO study of KSI-501 in Diabetic Macular Edema, and we continue BLA preparation activities for Zenkuda. Together, these efforts reflect our continued focus on disciplined execution as we advance our late-stage portfolio toward important clinical and regulatory milestones." Recent Business Highlights Phase 3 DAYBREAK Study — Topline Data Expected September 2026 Kodiak continues execution of the Phase 3 DAYBREAK study evaluating both Zenkuda and KSI-501 in patients with treatment-naïve wet age-related macular degermation (wet AMD). Topline data for the one-year primary endpoint (Zenkuda and KSI-501) are expected in September 2026. Phase 3 PEAK Study – Pivotal Analysis 1 Topline Data Expected December 2026 Enrollment of the first 300-patient cohort supporting Pivotal Analysis 1 of the Phase 3 PEAK study evaluating KSI-101 in patients with Macular Edema Secondary to Inflammation (MESI) was completed during the second quarter. Topline data from Pivotal Analysis 1 are expected in December 2026. Completion of enrollment in the second pivotal cohort evaluating 600 subjects across PEAK and PINNACLE supporting Pivotal Analysis 2 is expected in the fourth quarter of 2026, with topline data anticipated in the second quarter of 2027. Zenkuda (tarcocimab tedromer) — Advancing Toward Biologics License Application (BLA) Submission Kodiak remains focused on regulatory, manufacturing and other BLA preparation activities supporting the planned development path for Zenkuda. KSI-501 — Phase 3 ALTO Study in Diabetic Macular Edema (DME) The first patients have been enrolled in the global Phase 3 ALTO study evaluating KSI-501 versus aflibercept in patients with DME. The approximately 910-patient study is designed to demonstrate superiority of KSI-501 versus aflibercept and represents the second registrational Phase 3 study of KSI-501, following DAYBREAK in wet AMD. Second Quarter 2026 Financial Results Cash Position Kodiak ended the second quarter of 2026 with $125.9 million of cash and cash equivalents. We expect that our current cash and cash equivalents will support our current and planned operations into 2027. Net Loss Net loss for the second quarter of 2026 was $65.6 million, or $1.05 per share on a basic and diluted basis, as compared to a net loss of $54.3 million, or $1.03 per share on a basic and diluted basis, for the second quarter of 2025. Net loss for the second quarter of 2026 included non-cash stock-based compensation expense of $11.6 million, as compared to $15.6 million for the second quarter of 2025. R&D Expenses Research and development (R&D) expenses were $56.1 million for the second quarter of 2026, as compared to $42.8 million for the second quarter of 2025. R&D expenses for the second quarter of 2026 included non-cash stock-based compensation expense of $5.8 million, as compared to $7.7 million for the second quarter of 2025. The increase in R&D expenses in the second quarter of 2026 was primarily driven by increased clinical activities related to our active PEAK/PINNACLE studies and increased manufacturing activities across our Phase 3 programs. G&A Expenses General and administrative (G&A) expenses were $10.8 million for the second quarter of 2026, as compared to $12.8 million for the second quarter of 2025. G&A expenses for the second quarter of 2026 included non-cash stock-based compensation expense of $5.8 million, as compared to $7.9 million for the second quarter of 2025. 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 September 2026. 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. Specific objectives for Zenkuda in DAYBREAK are (1) to assess safety, (2) to meet the primary endpoint of non-inferiority of best corrected visual acuity, (3) to explore the strength of fluid control through the loading phase, and (4) to demonstrate a differentiated durability profile. General objectives for Zenkuda in DAYBREAK are to 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 September 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. Kodiak has advanced KSI-501 into the registrational Phase 3 study DAYBREAK to evaluate its efficacy and safety in wet AMD. DAYBREAK uses KSI-501's enhanced 50 mg/mL formulation containing both conjugated and unconjugated antibody that is intended to balance immediacy and durability. DAYBREAK has completed enrollment. Topline data for the one-year primary endpoint in DAYBREAK are expected in September 2026. Kodiak has also advanced KSI-501 into the registrational Phase 3 ALTO study designed to demonstrate the superiority of bispecific KSI-501 (anti-VEGF, anti-IL-6) versus monospecific aflibercept (anti-VEGF) in patients with diabetic macular edema. The ALTO study is now enrolling patients. 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 September 2026. Additional information about DAYBREAK can be found on www.clinicaltrials.gov under Trial Identifier NCT06556368 (https://clinicaltrials.gov/study/NCT06556368). About ALTO The ALTO Study is a global, multicenter, randomized, double-masked, active comparator-controlled Phase 3 study evaluating the efficacy and safety of intravitreal KSI-501 5 mg compared with intravitreal aflibercept 2 mg in patients with visual impairment secondary to center-involved DME. Approximately 910 patients, treatment-naïve or previously treated, will be randomized 5:3:5 to one of three arms: (A) KSI-501 5 mg every 8 weeks, with monthly assessment for additional individualized dosing, following six monthly loading doses; (B) KSI-501 5 mg on an individualized regimen of every 4 to 24 weeks, following six monthly loading doses; and (C) aflibercept 2 mg every 8 weeks, following five monthly loading doses. The primary endpoint is the mean change in best-corrected visual acuity (BCVA) from baseline to the average of Week 48 and Week 52. The key secondary endpoint is the proportion of patients improving two or more steps on the DRSS from baseline at Week 48. Additional secondary and exploratory endpoints evaluate visual function, retinal anatomy, treatment burden and durability, and safety. Participants will be treated and followed for approximately 96 weeks. About KSI-101 KSI-101 is a novel, potent and high strength (100 mg/mL) bispecific protein targeting IL-6 and VEGF for the treatment of MESI. Data from our dose-finding Phase 1b APEX study demonstrated robust anatomical and visual responses across MESI patients. More than half of patients achieved ≥15-letter gains in best corrected visual acuity, with additional benefit at higher dose levels. Rapid vision improvements and anatomical response were observed with 10-letter gains by Week 4 in top dose groups and OCT CST 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. KSI-101 also continued to be well tolerated with a favorable safety profile. The top two dose levels in APEX have been advanced into the Phase 3 pivotal studies, PEAK and PINNACLE. The PEAK and PINNACLE studies are actively enrolling. About PEAK and PINNACLE The PEAK and PINNACLE studies are superiority studies evaluating two dose levels of KSI-101 (5 mg and 10 mg) compared to sham treatment in patients with MESI. PEAK and PINNACLE are identical in study design with key differences in patient population. PEAK includes patients with more severe disease (moderate to severe macular edema and vision impairment) and PINNACLE includes patients with milder disease (mild macular edema and any vision impairment), as well as patients with moderate to severe macular edema with good vision. Together, PEAK and PINNACLE are designed to enroll complementary patient populations and to cover a wide spectrum of MESI patients. Patients randomized to the KSI-101 treatment arms will receive fixed monthly dosing for 6 doses (from Day 1 to Week 20), with subsequent individualized dosing (up to monthly dosing) for 6 additional visits (Week 24 to Week 44). Patients in the sham arm will receive monthly sham dosing for 6 doses followed by sham PRN. The primary and key secondary endpoints will be evaluated at Week 24. PEAK and PINNACLE are now actively enrolling patients. Topline data readouts for Pivotal Analysis 1 (PEAK patients 1 – 300) and Pivotal Analysis 2 (PEAK patients 301 – 600 and PINNACLE patients 1 – 300) are expected in December 2026 and 2Q 2027, respectively. About Kodiak Sciences Inc. Kodiak Sciences (Nasdaq: KOD) is a pre-commercial 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 September 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). Topline data for Pivotal Analysis 1 (PEAK) are expected in December 2026 and Pivotal Analysis 2 (PEAK+PINNACLE) in 2Q 2027. 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 planned 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; the status of enrollment in, and expectations regarding the timing of topline data readouts from, the PEAK and PINNACLE Phase 3 studies; and the status of enrollment in, and expectations regarding the ALTO study. 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 DR, RVO, or wet AMD; 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; 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; safety, efficacy, and durability data observed in Kodiak's product candidates in current or prior studies may not continue or persist; 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 DAYBREAK Phase 3 study for Zenkuda or KSI-501 and/or the PEAK Phase 3 study for KSI-101 may not achieve its primary endpoint or may not do so on the anticipated timeline; any one or more of Kodiak's product candidates may not be successfully developed, approved, or commercialized; sufficient capital may not be available as expected, or at all, to complete the development of any products; adverse conditions in the U.S. and global economic markets 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. View original content:https://www.prnewswire.com/news-releases/kodiak-sciences-announces-recent-business-highlights-and-second-quarter-2026-financial-results-302851311.html

Find your next quality investment with Simply Wall St's easy and powerful screener, trusted by over 7 million individual investors worldwide. Kodiak Sciences (KOD) is back in focus after reporting positive topline Phase 3 GLOW2 results for Zenkuda in diabetic retinopathy, supporting a potential multi indication filing and sharpening attention on its late stage pipeline. See our latest analysis for Kodiak Sciences. The latest share price of US$43.68 comes after a 90 day share price return of 89.58% and a very large 1 year total shareholder return, as fresh Phase 3 data and recent conference presentations keep momentum building despite ongoing quarterly losses. If this kind of clinical news has your attention, it can be helpful to see what else is moving in the sector with the 35 healthcare AI stocks With shares up sharply over the past year, Kodiak now trades at US$43.68, below an average analyst price target of about US$56. So is the market still underestimating the late stage pipeline, or already pricing in future growth? Kodiak trades on a P/B of 17.2x, well above both its direct peers at 3.9x and the broader US Biotechs industry at 2.5x. P/B compares a company’s market value with its book value. A higher multiple often reflects strong expectations for future assets and returns that are not yet visible in current financials. For Kodiak, this is sitting alongside minimal reported revenue, ongoing losses of $229.967m and a clinical stage pipeline that is still moving through trials. With forecasts pointing to no revenue next year and continued losses over the next 3 years, the market is clearly paying up relative to book value, even as Kodiak is flagged as trading 87.2% below the SWS DCF estimate of future cash flow value at $342.57. Compared with both peer and industry P/B levels, the current 17.2x looks materially richer, which places more weight on how investors view the late stage retinal portfolio than on present balance sheet metrics. See what the numbers say about this price — find out in our valuation breakdown. Result: Price-to-book of 17.2x (OVERVALUED) However, there are clear pressure points, including continued quarterly losses of $229.967m and a complete lack of reported revenue, which could challenge sentiment. Find out about the key risks to this Kodiak Sciences narrative. The P/B of 17.2x paints Kodiak as expensive relative to peers, yet our DCF model points in the opposite direction, with the stock trading 87.2% below an estimated future cash flow value of $342.57. When one method flags rich and another signals cheap, which signal should carry more weight? Before placing too much emphasis on either view, it can help to understand how the cash flow assumptions align with Kodiak’s clinical profile and funding needs, and how sensitive that $342.57 figure is to changes in timing or probability of success for the pipeline. Look into how the SWS DCF model arrives at its fair value. Simply Wall St performs a discounted cash flow (DCF) on every stock in the world every day (check out Kodiak Sciences for example). We show the entire calculation in full. You can track the result in your watchlist or portfolio and be alerted when this changes, or use our stock screener to discover 51 high quality undervalued stocks. If you save a screener we even alert you when new companies match - so you never miss a potential opportunity. With mixed signals from valuation and the clinical story, are you leaning bullish or cautious here, and how quickly do you want to firm up that view? Take a closer look at the 1 key reward and 5 important warning signs If Kodiak has sharpened your appetite for opportunities, do not stop here, cast a wider net with focused stock ideas that match your style and risk tolerance. Target potential mispricings by scanning for companies that look high quality yet priced for value with the 51 high quality undervalued stocks Prioritise resilience by checking out companies screened for lower risk profiles and sturdier fundamentals using the 71 resilient stocks with low risk scores Hunt for underfollowed opportunities by reviewing the screener containing 23 high quality undiscovered gems that combine solid data with limited market attention This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include KOD. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

PALO ALTO, Calif., May 7, 2026 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), today reported recent business highlights and financial results for the third quarter ended March 31, 2026. "Kodiak has entered 2026 with continued momentum and increasing clarity as we advance toward key clinical readouts and our first planned regulatory submission," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sciences. "The recent positive Phase 3 GLOW2 results for Zenkuda reinforce the strength of our ABC Platform and position us to move forward on our first multi-indication BLA submission. At the same time, we are making meaningful progress across our late-stage portfolio, including continued advancement of KSI-101 and KSI-501, and we eagerly anticipate the September readout for DAYBREAK Phase 3 in wet AMD and the December readout for PEAK Phase 3 in MESI. This year is a defining period for Kodiak, with important opportunities for further clinical validation, regulatory progress and continued evolution of our identity as a vision sciences company," continued Dr. Perlroth. Recent Business Highlights Zenkuda (tarcocimab tedromer) — Accelerating Toward BLA Submission On March 26, 2026, Kodiak announced positive topline results in GLOW2, the second Phase 3 study of Zenkuda (tarcocimab tedromer) in diabetic retinopathy (DR), demonstrating superiority over sham. 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 showed strong efficacy independent of GLP-1 receptor agonist use, supporting its profile in a real-world diabetic population. Zenkuda was well tolerated with no instances of intraocular inflammation, retinal vasculitis or occlusive retinal vasculitis, and a low cataract adverse event rate (2% per arm). Combined with the previously reported Phase 3 study readouts (GLOW1, BEACON and DAYLIGHT), Zenkuda now has a multi-indication BLA-ready profile. Phase 3 DAYBREAK Study — Topline Data Expected September 2026 Enrollment in the DAYBREAK Phase 3 study of both Zenkuda and KSI-501 in patients with treatment-naive neovascular age-related macular degeneration (wet AMD) was completed with approximately 690 subjects enrolled. Topline data from the one-year primary endpoint for DAYBREAK are expected in September 2026, evaluating both Zenkuda and KSI-501. KSI-101 — Phase 3 Programs Advancing Enrollment is progressing well in the Phase 3 PEAK and PINNACLE studies of KSI-101 in patients with macular edema secondary to inflammation (MESI), evaluating the 5 mg and 10 mg dose levels. Topline results from PEAK are expected in 4Q 2026. Topline results from PINNACLE are expected in 2Q 2027. On February 7, 2026, Kodiak presented final Phase 1b APEX data at the Angiogenesis, Exudation and Degeneration annual meeting: 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 with 10-letter gains by Week 4 and OCT CST <325 microns achieved as early as Week 1 in top dose groups. In top dose groups, ≥90% achieved complete absence of intraretinal fluid (IRF) and subretinal fluid (SRF), indicating retinal dryness and normalization of retinal architecture. First Quarter 2026 Financial Results Cash Position Kodiak ended the first quarter of 2026 with $169.5 of million cash and cash equivalents. We believe that our current cash and cash equivalents will support our current and planned operations into 2027. Net Loss Net loss for the first quarter of 2026 was $58.2 million, or $0.94 per share on a basic and diluted basis, as compared to a net loss of $57.5 million, or $1.09 per share on a basic and diluted basis, for the first quarter of 2025. Net loss for the first quarter of 2026 included non-cash stock-based compensation expense of $12.2 million, as compared to $15.9 million for the first quarter of 2025. R&D Expenses Research and development ("R&D") expenses were $48.5 million for the first quarter of 2026, as compared to $43.6 million for the first quarter of 2025. R&D expenses for the first quarter of 2026 included non-cash stock-based compensation expense of $6.2 million, as compared to $7.9 million for the first quarter of 2025. The increase in R&D expenses in the first quarter of 2026 was primarily driven by increased clinical activities related to our active PEAK/PINNACLE and DAYBREAK studies. G&A Expenses General and administrative ("G&A") expenses were $11.2 million for the first quarter of 2026, as compared to $15.4 million for the first quarter of 2025. G&A expenses for the first quarter of 2026 included non-cash stock-based compensation expense of $6.0 million, as compared to $8.0 million for the first quarter of 2025. Additionally, sublease income from one of our corporate office buildings helped offset G&A expenses in the first quarter of 2026. 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 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 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 www.clinicaltrials.gov under Trial Identifier NCT06556368 (https://clinicaltrials.gov/study/NCT06556368). About KSI-101 KSI-101 is a novel, potent and high strength (100 mg/mL) bispecific protein targeting IL-6 and VEGF. We are developing KSI-101 for patients with macular edema (retinal fluid) secondary to inflammation (MESI). MESI is a heterogenous group of diseases that clinically present with macular edema and visual impairment which are caused by a common pathophysiology–inflammation and blood retinal barrier disruption. The clinical presentation of retinal fluid and visual impairment is a mainstay in these patients, irrespective of the location of the inflammation inside of the eye (anterior, intermediate, posterior or all intraocular compartments) or the specific etiology (defined autoimmune associated, idiopathic, post-procedural, or inflammatory choroidal neovascularization). Currently there are no available intravitreal biologic therapies addressing the spectrum of MESI diseases. We believe that MESI represents a new market segment separate from the established anti-VEGF market. Data from our dose-finding Phase 1b APEX study 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 was 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 was observed 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. KSI-101 also continued to be well tolerated with a favorable safety profile. The top two dose levels in APEX have been advanced into the Phase 3 pivotal studies, PEAK and PINNACLE. The PEAK and PINNACLE studies are actively enrolling. About PEAK and PINNACLE The PEAK and PINNACLE studies are superiority studies evaluating two dose levels of KSI-101 (5 mg and 10 mg) compared to sham treatment in patients with MESI. PEAK and PINNACLE are identical in study design with key differences in patient population. PEAK includes patients with more severe disease (moderate to severe macular edema and vision impairment) and PINNACLE includes patients with milder disease (mild macular edema and any vision impairment), as well as patients with moderate to severe macular edema with good vision. Together, PEAK and PINNACLE are designed to enroll complementary patient populations and to cover a wide spectrum of MESI patients. Patients randomized to the KSI-101 treatment arms will receive fixed monthly dosing for 6 doses (from Day 1 to Week 20), with subsequent individualized dosing (up to monthly dosing) for 6 additional visits (Week 24 to Week 44). Patients in the sham arm will receive monthly sham dosing for 6 doses followed by sham PRN. The primary and key secondary endpoints will be evaluated at Week 24. PEAK and PINNACLE are now actively enrolling patients. Topline data readouts for PEAK and PINNACLE are expected in 4Q 2026 and 2Q 2027, respectively. 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 planned 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; and the status of enrollment in, and expectations regarding the timing of topline data readouts from, the PEAK and PINNACLE Phase 3 studies. 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 DR, RVO, or wet AMD; 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; 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; safety, efficacy, and durability data observed in Kodiak's product candidates in current or prior studies may not continue or persist; 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 DAYBREAK Phase 3 study for Zenkuda or KSI-501 and/or the PEAK Phase 3 study for KSI-101 may not achieve its primary endpoint or may not do so on the anticipated timeline; any one or more of Kodiak's product candidates may not be successfully developed, approved, or commercialized; sufficient capital may not be available as expected, or at all, to complete the development of any products; adverse conditions in the U.S. and global economic markets 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. View original content:https://www.prnewswire.com/news-releases/kodiak-sciences-announces-recent-business-highlights-and-first-quarter-2026-financial-results-302766182.html

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. View original content:https://www.prnewswire.com/news-releases/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-302759852.html

A month has gone by since the last earnings report for Kodiak Sciences Inc. (KOD). Shares have added about 2% in that time frame, underperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Kodiak Sciences due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important catalysts. Kodiak Q4 Loss Wider Than Expected, Pipeline Development in Focus Kodiak reported fourth-quarter 2025 loss of $1.04 per share, wider than the Zacks Consensus Estimate of $1.02 per share. The company had incurred a loss of 84 cents per share in the year-ago quarter. The company currently does not have any approved products in its portfolio. As a result, it is yet to generate revenues. KOD's Q4 Results in Detail Research and development expenses were $45.5 million in the reported quarter, up 43.1% year over year. The rise was mainly due to increased clinical activities associated with ongoing clinical studies and higher stock-based compensation expenses. General and administrative expenses were $12 million, down 17% year over year, primarily due to lower non-cash stock-based compensation expenses and additional sublease income offsetting costs. As of Dec. 31, 2025, Kodiak had cash, cash equivalents and marketable securities worth $209.9 million compared with $72 million as of Sept. 30, 2025. Full-Year 2025 Results For full-year 2025, the company incurred a net loss of $4.32 per share, wider than a loss of $3.35 per share incurred in 2024. In the past month, investors have witnessed a downward trend in estimates revision. The consensus estimate has shifted -7.58% due to these changes. Currently, Kodiak Sciences has a average Growth Score of C, though it is lagging a lot on the Momentum Score front with an F. Charting a somewhat similar path, the stock has a grade of D on the value side, putting it in the bottom 40% for value investors. Overall, the stock has an aggregate VGM Score of D. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Interestingly, Kodiak Sciences has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Kodiak Sciences Inc. (KOD) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

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 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 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 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 $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. View original content:https://www.prnewswire.com/news-releases/kodiak-sciences-announces-recent-business-highlights-and-fourth-quarter-and-full-year-2025-financial-results-302730611.html

PALO ALTO, Calif., Feb. 4, 2026 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a precommercial retina focused biotechnology company committed to researching, developing and commercializing transformative therapeutics, announced today participation at the virtual Angiogenesis (Angiogenesis, Exudation, and Degeneration) annual meeting on February 7, 2026. Dr. Sumit Sharma, retina and uveitis specialist at the Cole Eye Institute, will present first-time end-of-study clinical results, including Week 24 data, from the Phase 1b APEX study in patients with macular edema secondary to inflammation (MESI). Presentation 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) Time: 5:15 PM EST The presentation will be posted at the start of the event on the "Events and Presentations" section of Kodiak's website at http://ir.kodiak.com/. "This year's Angiogenesis meeting marks the first presentation of end-of-study results from the APEX study for KSI-101. These final data continue to demonstrate robust anatomic and visual improvements in patients with MESI, regardless of the underlying etiology or location of inflammation, further supporting the clinical efficacy and safety profile of KSI-101 observed to date. With PEAK and PINNACLE Phase 3 studies actively enrolling, these final results strengthen our confidence in KSI-101's potential to become a safe, first-line unifying therapy for all causes of MESI," said Victor Perlroth, M.D., Chairman and CEO of Kodiak Sciences. About KSI-101 KSI-101 is a novel, potent and high strength (100 mg/mL) bispecific protein targeting IL-6 and VEGF. We are developing KSI-101 for patients with macular edema (retinal fluid) secondary to inflammation (MESI). MESI is a heterogenous group of diseases that clinically present with macular edema and visual impairment which are caused by a common pathophysiology–inflammation and blood retinal barrier disruption. The clinical presentation of retinal fluid and visual impairment is a mainstay in these patients, irrespective of the location of the inflammation inside of the eye (anterior, intermediate, posterior or all intraocular compartments) or the specific etiology (defined autoimmune associated, idiopathic, post-procedural, or inflammatory choroidal neovascularization). Currently there are no available intravitreal biologic therapies addressing the spectrum of MESI diseases. We believe that MESI represents a new market segment separate from the established anti-VEGF market. We have completed enrollment in our dose-finding Phase 1b study APEX. The APEX study evaluates KSI-101 in two cohorts, Cohort 1 in patients with diabetic macular edema (DME) and Cohort 2 in patients with macular edema secondary to inflammation (MESI). APEX demonstrated that KSI-101 provides meaningful visual and anatomical gains in both DME and MESI and that KSI-101 is well tolerated. Meaningful treatment responses were seen in the MESI population, irrespective of the location of inflammation and specific MESI etiology, opening up the potential for KSI-101 to become a unifying treatment for this patient population. Based on APEX, the top two dose levels tested were selected to advance into the Phase 3 program. The PEAK and PINNACLE Phase 3 studies are actively enrolling MESI subjects at the 5 mg and 10 mg dose levels versus sham. 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. Tarcocimab and KSI-501 are being explored in two BLA-facing Phase 3 studies in the retinal vascular diseases, targeting the $15 billion anti-VEGF marketplace, with topline data readouts expected in 1Q 2026 and 3Q 2026. 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 in 4Q 2026 (PEAK) and 2Q 2027 (PINNACLE). Kodiak®, Kodiak Sciences®, ABC®, ABC Platform™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions. Forward-Looking Statements This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding Kodiak's plans, commitments, aspirations and goals related to Kodiak's drug candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors which are discussed in the section entitled "Risk Factors" in Kodiak's most recent periodic report filed with the U.S. Securities and Exchange Commission ("SEC") as well as discussions of potential risks, uncertainties, and other important factors in Kodiak's subsequent filings with the SEC. All information in this press release is as of the date presented, and Kodiak undertakes no duty to update such information unless required by law. 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PALO ALTO, Calif., Nov. 13, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), today reported recent business highlights and financial results for the third quarter ended September 30, 2025. "Kodiak Sciences has entered a period of strong, sustained momentum driven by compelling clinical data, accelerated execution and growing external enthusiasm...across all three of our late-stage programs," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sciences. "Looking ahead, we expect this momentum to continue building as we enter an action-packed 2026 with all three of our Phase 3 assets on track for Phase 3 topline data readouts as well as our first planned BLA filing. On top of our late-stage programs, Kodiak's early-stage pipeline is also advancing with increasing speed and conviction, positioning Kodiak for sustained scientific and pipeline leadership globally," continued Dr. Perlroth. Recent Business Highlights Announced follow-up data through week 20 from the Phase 1b APEX study of KSI-101 in patients with macular edema secondary to inflammation (MESI) Meaningful vision gains were rapidly achieved as early as week 4 and showed continued improvement in best corrected visual acuity (BCVA) through week 20, with more than half of patients achieving improvement of 3-lines or more on the eye chart (≥15 letter gain). ≥90% of patients in the top two dose levels achieved and sustained real dryness of the retina, as demonstrated by absence of intraretinal fluid (IRF) as well as subretinal fluid (SRF), key markers of disease activity. The Phase 3 PEAK and PINNACLE studies of KSI-101 are enrolling at a faster-than-expected pace, evaluating the top two dose levels (5 mg and 10 mg) in patients with MESI. Validation from the scientific community for the mechanism of action behind KSI-101 At the recent American Academy of Ophthalmology (AAO) meetings, intraocular interleukin-6 inhibition was shown in Phase 3 clinical trials to deliver a meaningful improvement in vision and anatomy in patients with uveitic macular edema, a key component of MESI. Local IL-6 inhibition also appeared to be well tolerated in these trials. Data appear to highlight a significant opportunity for KSI-101, a potent inhibitor of interleukin-6 that layers on potent inhibition of VEGF, to drive a stronger clinical effect. Completed enrollment in the Phase 3 DAYBREAK study of both tarcocimab and KSI-501 in patients with treatment naive neovascular age-related macular degeneration (wet AMD) DAYBREAK enrolled approximately 690 subjects, with last visit for the 48-week primary endpoint expected in August 2026. Hosted an investor R&D Day webcast on July 16, 2025, providing a comprehensive overview of Kodiak's three late-phase clinical assets Presentations by Dr. Charles Wykoff and Dr. Sumit Sharma, leading retina specialists, shared perspectives on Kodiak's clinical assets. Key highlights included KSI-101: Strong 12-week APEX data; initial addressable market of 150,000+ patients. Upcoming Catalysts Tarcocimab Phase 3 GLOW2 diabetic retinopathy study – topline data on track for 1Q 2026 Phase 3 DAYBREAK wet AMD study – topline data expected 3Q 2026 KSI-501 Phase 3 DAYBREAK wet AMD study – topline data expected 3Q 2026 KSI-101 in MESI Phase 1b APEX study – Week 24 data to be presented by Dr. Sumit Sharma on February 7 at the Angiogenesis, Exudation, and Degeneration 2026 Annual Meeting Phase 3 PEAK study – topline data expected 4Q 2026 Phase 3 PINNACLE study – topline data expected 1Q 2027 Third Quarter 2025 Financial Results Cash Position Kodiak ended the third quarter of 2025 with $72.0 million cash and cash equivalents. Net Loss Net loss for the third quarter of 2025 was $61.5 million, or $1.16 per share on a basic and diluted basis, as compared to a net loss of $43.9 million, or $0.84 per share on a basic and diluted basis, for the third quarter of 2024. Net loss for the third quarter of 2025 included non-cash stock-based compensation expense of $14.0 million, as compared to $14.8 million for the third quarter of 2024. R&D Expenses Research and development ("R&D") expenses were $50.5 million for the third quarter of 2025, as compared to $31.9 million for the third quarter of 2024. R&D expenses for the third quarter of 2025 included non-cash stock-based compensation expense of $7.2 million, as compared to $6.3 million for the third quarter of 2024. The increase in R&D expenses in the third quarter of 2025 was primarily driven by increased clinical activities related to our active DAYBREAK and PEAK/PINNACLE studies and increased manufacturing activities across our Phase 3 programs. G&A Expenses General and administrative ("G&A") expenses were $11.9 million for the third quarter of 2025, as compared to $14.8 million for the third quarter of 2024. G&A expenses for the third quarter of 2025 included non-cash stock-based compensation expense of $6.9 million, as compared to $8.5 million for the third quarter of 2024. Additionally, sublease income from one of our corporate office buildings helped offset G&A expenses in the third quarter of 2025. About tarcocimab Tarcocimab is an investigational anti-VEGF therapy built on Kodiak's proprietary Antibody Biopolymer Conjugate ("ABC") Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing available agents. Tarcocimab is being developed as a mainstay intravitreal biologic monotherapy that provides high immediacy, driven by the enhanced formulation, and high durability, driven by the ABC® platform and our science of durability, with the ultimate objective of providing, once approved, a flexible 1-month through 6-month label for all patients with retinal vascular disease (treatment-naïve, treatment-experienced, mild patients, severe patients). To date, tarcocimab has completed three successful Phase 3 pivotal clinical studies: the Phase 3 GLOW1 study 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 study, tarcocimab successfully treated DR patients and prevented disease progression with 100% of patients on extended 6-month dosing. In the BEACON study, in the first 6 months tarcocimab-treated patients were dosed on every 8-week interval (as opposed to every 4-week interval for aflibercept) and in the second 6 months nearly half of tarcocimab patients did not require any treatment while achieving similar vision and anatomical outcomes as the aflibercept group at one year. In the DAYLIGHT study, tarcocimab demonstrated non-inferior efficacy results and compelling safety and tolerability on a once monthly dosing interval. Tarcocimab is currently being studied in two Phase 3 clinical trials, the GLOW2 study in DR and the DAYBREAK study in wet AMD. Both studies have completed enrollment. The GLOW2 study design mirrors that of our successful GLOW1 study in DR, with the advantage of a third monthly loading dose (baseline, Week 4, Week 8) to provide dosing flexibility to providers. All patients randomized to investigational therapy will receive tarcocimab on extended, 6-month dosing. Both GLOW2 and DAYBREAK use tarcocimab's enhanced 50 mg/mL formulation containing both conjugated and unconjugated antibody that is intended to balance immediacy and durability. About GLOW1 (complete) and GLOW2 (ongoing) The Phase 3 GLOW1 study demonstrated that with extended 6-month dosing in every patient, tarcocimab can achieve strong efficacy both in treating existing disease (primary endpoint) and preventing vision threatening complications and disease progression (key secondary endpoint). In GLOW1, tarcocimab met its primary endpoint of the proportion of patients with at least a 2-step improvement on the Diabetic Retinopathy Severity Scale ("DRSS") score with 41.1% of tarcocimab-treated patients demonstrating at least a 2-step improvement vs. 1.4% of patients in the sham group, a 29-fold increased response rate ratio (p-value less than 0.0001). Tarcocimab 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, achieving 21.0% versus 2.3% (p-value less than 0.0001). Tarcocimab also showed a 95% risk reduction in the development of DME, versus sham, from 13.7% on sham versus 0.7% on tarcocimab. The Phase 3 GLOW2 study is a prospective, randomized, double-masked, multi-center pivotal superiority study designed to evaluate the efficacy and safety of tarcocimab tedromer in treatment-naïve patients with DR. Patients are randomized 1:1 and receive either sham injections or tarcocimab via intravitreal injection at baseline, Week 4, Week 8, Week 20 and Week 44. The primary endpoint is the proportion of eyes improving ≥2 steps on 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 GLOW2 (also called Study KS301P108) can be found on www.clinicaltrials.gov under Trial Identifier NCT06270836 (https://clinicaltrials.gov/show/NCT06270836). About DAYBREAK and tarcocimab The Phase 3 DAYBREAK study is a non-inferiority study evaluating parallel investigational arms of tarcocimab and KSI-501 against active comparator aflibercept. The DAYBREAK study incorporates learnings from prior pivotal trials of tarcocimab and was designed to maximize the probability of meeting the primary endpoint of non-inferiority in visual acuity gains. Patients randomized to tarcocimab 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 tarcocimab is determined by a treat-to-dryness proactive approach using presence of retinal fluid as a disease activity marker, which resembles retina specialists' practice and optimizes each patient's treatment instead of a combination of central subfield thickness ("CST") and vision loss. The objectives for tarcocimab 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 tarcocimab 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). 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. A completed Phase 1 multiple ascending dose study demonstrated that repeated monthly dosing of KSI-501 was well tolerated and achieved clinically meaningful and sustained improvement in visual acuity and fluid reduction in patients with diabetic macular edema. Kodiak has advanced KSI-501 into a 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. About DAYBREAK and KSI-501 The DAYBREAK study is a non-inferiority study evaluating parallel investigational arms of KSI-501 and tarcocimab 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 4 monthly loading doses. Patients randomized to aflibercept will be dosed per label. Using the same treat-to-dryness approach as tarcocimab, 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. Additional information about DAYBREAK can be found on www.clinicaltrials.gov under Trial Identifier NCT06556368 (https://clinicaltrials.gov/study/NCT06556368). About KSI-101 KSI-101 is a novel, potent and high strength (100 mg/mL) bispecific protein targeting IL-6 and VEGF. We are developing KSI-101 for patients with macular edema (retinal fluid) secondary to inflammation (MESI). MESI is a heterogenous group of diseases that clinically present with macular edema and visual impairment which are caused by a common pathophysiology of inflammation and blood retinal barrier disruption. The clinical presentation of retinal fluid and visual impairment is a mainstay in these patients, irrespective of the location of the inflammation inside of the eye (anterior, intermediate, posterior or all intraocular compartments) or the specific etiology (defined autoimmune associated, idiopathic, post-procedural, or inflammatory choroidal neovascularization). Currently there are no available intravitreal biologic therapies addressing the spectrum of MESI diseases. We believe that MESI represents a new market segment separate from the established anti-VEGF market. We have completed enrollment in our dose-finding Phase 1b study APEX. The APEX study evaluates KSI-101 in two cohorts, Cohort 1 in patients with diabetic macular edema ("DME") and Cohort 2 in patients with macular edema secondary to inflammation ("MESI"). APEX demonstrated that KSI-101 provides meaningful visual and anatomical gains in both DME and MESI and that KSI-101 is well tolerated. Meaningful treatment responses were seen in the MESI population, irrespective of the location of inflammation and specific MESI etiology, opening up the potential for KSI-101 to become a unifying treatment for this patient population. Based on APEX, the top two dose levels tested were selected to advance into the Phase 3 program. The PEAK and PINNACLE Phase 3 studies are actively enrolling MESI subjects at the 5 mg and 10 mg dose levels versus sham. About PEAK and PINNACLE The PEAK and PINNACLE studies are superiority studies evaluating two dose levels of KSI-101 (5 mg and 10 mg) compared to sham treatment in patients with MESI. PEAK and PINNACLE are identical in study design with key differences in patient population. PEAK includes patients with more severe disease (moderate to severe macular edema and vision impairment) and PINNACLE includes patients with milder disease (mild macular edema and any vision impairment), as well as patients with moderate to severe macular edema with good vision. Together, PEAK and PINNACLE are designed to enroll complementary patient populations and to cover a wide spectrum of MESI patients. Patients randomized to the KSI-101 treatment arms will receive fixed monthly dosing for 6 doses (from Day 1 to Week 20), with subsequent individualized dosing (up to monthly dosing) for 6 additional visits (Week 24 to Week 44). Patients in the sham arm will receive monthly sham dosing for 6 doses followed by sham PRN. The primary and key secondary endpoints will be evaluated at Week 24. PEAK and PINNACLE are now actively enrolling patients. Additional information about PEAK and PINNACLE can be found on www.clinicaltrials.gov under Trial Identifiers NCT06990399 and NCT06996080, respectively (https://clinicaltrials.gov/study/NCT06990399; https://clinicaltrials.gov/study/ NCT06996080). 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. Our ABC® Platform uses molecular engineering to merge the fields of protein-based and chemistry-based therapies and has been at the core of Kodiak's discovery engine. We are developing a portfolio of three late-stage clinical programs. Tarcocimab and KSI-501 are being explored in two BLA-facing Phase 3 studies in the retinal vascular diseases, targeting the $15 billion anti-VEGF marketplace, with topline data readouts expected in 1Q 2026 and 3Q 2026. KSI-101 is a bispecific protein being explored in two Phase 3 studies in Macular Edema Secondary to Inflammation (MESI), with topline data readouts expected in 4Q 2026 (PEAK) and 1Q 2027 (PINNACLE). For more information, please visit www.kodiak.com. Kodiak®, Kodiak Sciences®, ABC®, ABC Platform®, ABCD™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions. Forward-Looking Statements This 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: timing of topline data; timing of upcoming studies; planned regulatory submissions; the potential for Kodiak to achieve sustained scientific and pipeline leadership; the potential benefits of and market opportunities for tarcocimab, KSI-501 and KSI-101; maximizing the probability of meeting the primary endpoint of DAYBREAK and demonstrating additional efficacy benefits of tarcocimab; the commercial opportunity and high unmet need for KSI-101; the ABC platform science continuing to advance a next set of investigational therapies for high prevalence retinal diseases; the ultimate objective of tarcocimab to provide a flexible 1-month through 6-month label for all patients with retinal vascular disease; and tarcocimab's potential to achieve strong efficacy both in treating existing disease and preventing vision threatening complications and disease progression. 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," and other similar expressions among others. Any forward-looking statements are based on management's current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially and adversely from those in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that cessation, modification or delay of any of the ongoing clinical studies and our development of tarcocimab, KSI-501 or KSI-101 may occur; the risk that results of our clinical studies may not provide the evidence, insights, or benefits as anticipated; the risk that safety, efficacy, and durability data observed in our product candidates in current or prior studies may not continue or persist; the risk that the results of the tarcocimab Phase 3 studies may not be sufficient to support a single BLA submission for wet AMD, retinal vein occlusion and diabetic retinopathy; the risk that a BLA may not be accepted by, or receive approval from, the FDA or foreign regulatory agencies when expected, or at all; future potential regulatory milestones of tarcocimab or KSI-501 or KSI-101, including those related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval; the risk that our research and development efforts and our ability to advance our product candidates into later stages of development may fail; the risk that any one or more of our product candidates may not be successfully developed, approved or commercialized; our manufacturing facilities may not operate as expected; the risk that adverse economic conditions may significantly impact our business and operations, including our clinical trial sites, and those of our manufacturers, contract research organizations or others with whom we conduct business; the risk that sufficient capital may not be available as expected, or at all, to complete the development of any products; as well as the other risks identified in our filings with the Securities and Exchange Commission (SEC). For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the sections entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2024, our subsequent Quarterly Reports in Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof and Kodiak undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. View original content:https://www.prnewswire.com/news-releases/kodiak-sciences-announces-recent-business-highlights-and-third-quarter-2025-financial-results-302615021.html

Kodiak Sciences (KOD) just shared encouraging Phase 3 clinical trial data at the American Academy of Ophthalmology meetings. The results suggest their IL-6 inhibitor could offer significant vision improvements for patients with uveitic macular edema. See our latest analysis for Kodiak Sciences. Kodiak Sciences has been catching investors’ attention, as its latest clinical progress seems to have sparked a wave of optimism. The stock’s share price has surged with a 65% return over the past month and is now up 128% year-to-date. The one-year total shareholder return stands at a remarkable 286%. Momentum is clearly building following this encouraging Phase 3 news and ongoing advancements in their pipeline. If you’re interested in spotting more high-upside biotechnology and pharma names making similar moves, check out See the full list for free. With the stock soaring and optimism reaching new highs, the question now is whether Kodiak Sciences is genuinely undervalued or if the market has already priced in all of its future growth potential. Is there still a buying opportunity here? Kodiak Sciences is trading at a price-to-book ratio of 14.7x, which is notably higher than its industry peers and the broader biotech sector. With the last close at $19.63, the company’s valuation stands well above conventional comparables on this metric. The price-to-book ratio compares a company’s market value to its book value, providing insight into whether the stock is valued higher than the assets on its balance sheet. For early-stage or unprofitable biotech firms, this ratio can reflect investor expectations around future breakthroughs or pipeline successes, rather than current earnings. In Kodiak Sciences’ case, a 14.7x price-to-book ratio is significantly more expensive than peers, with the US Biotechs industry averaging 2.5x. The peer group average is even negative at -4.6x, emphasizing the premium investors are paying for Kodiak’s potential. This suggests the market is factoring in ambitious growth scenarios, despite the company’s current unprofitability and lack of revenue. If the market’s high hopes prove warranted, valuation levels could remain elevated, but the industry average shows what “normal” could look like if sentiment changes. See what the numbers say about this price — find out in our valuation breakdown. Result: Price-to-Book Ratio of 14.7x (OVERVALUED) However, ongoing losses and zero current revenue remain key risks. Any clinical or commercial setbacks could quickly reverse optimistic market sentiment. Find out about the key risks to this Kodiak Sciences narrative. If you see things differently or want to explore the data firsthand, you can shape your own analysis in just a few minutes. Do it your way A great starting point for your Kodiak Sciences research is our analysis highlighting 4 important warning signs that could impact your investment decision. Amplify your strategy and stay ahead by checking out compelling stock ideas curated by Simply Wall Street. Don’t let the chance to uncover tomorrow’s potential winners slip through your fingers. Tap into income-generating opportunities with stable companies by reviewing these 15 dividend stocks with yields > 3%, which offer attractive yields above 3%. Seize the potential of future tech trends by uncovering these 26 AI penny stocks, which are at the forefront of breakthroughs in artificial intelligence and automation. Spot market inefficiencies by evaluating these 872 undervalued stocks based on cash flows, identified through cash flow analysis that highlights promising hidden gems. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include KOD. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]