{"success":true,"data":{"pressRelease":{"id":"114660","rtpr_id":"nPnbwV9QCa","ticker":"KOD","exchange":"NASDAQ","all_tickers":["KOD"],"title":"Kodiak Sciences Announces First Patients Enrolled in Global Phase 3 ALTO trial of KSI-501 in Patients with Diabetic Macular Edema","author":"PR Newswire","published_at":"2026-08-10T20:43:53.107Z","article_body":"Kodiak Sciences Announces First Patients Enrolled in Global Phase 3 ALTO trial of KSI-501 in Patients with Diabetic Macular Edema\n\nPR Newswire\n\nPALO ALTO, Calif., Aug. 10, 2026\n\n * Phase 3 ALTO trial designed to demonstrate superiority of KSI-501 versus\naflibercept in patients with diabetic macular edema\nPALO ALTO, Calif., Aug. 10, 2026 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq:\nKOD), a precommercial retina-focused biotechnology company committed to\nresearching, developing and commercializing transformative therapeutics, today\nannounced that the first patients have been enrolled in the global Phase 3\nALTO trial evaluating KSI-501 in patients with diabetic macular edema (DME).\nKSI-501 is an investigational, first-in-class bispecific therapy built on\nKodiak's ABC(®) Platform and designed to potently inhibit two complementary\npathways implicated in retinal vascular disease: interleukin (IL)-6-mediated\ninflammation and vascular endothelial growth factor (VEGF)-mediated vascular\npermeability and neovascularization.\n\nThe ALTO trial is designed to demonstrate the superiority of bispecific\n(anti-VEGF, anti-IL-6) KSI-501 versus monospecific (anti-VEGF) aflibercept in\npatients with DME. ALTO is the second registrational Phase 3 trial of KSI-501,\nfollowing the DAYBREAK study in patients with wet AMD.\n\nALTO explores whether dual inhibition of immune and vascular pathways can\ndeliver deeper and more sustained disease control for patients with DME and\nevaluates two dosing regimens, one regimen with intensive dosing and a second\nregimen with individualized dosing intervals of up to every six months.\n\n\"Initiating ALTO is an important next step for KSI-501 and for our broader\neffort to advance multifunctional retinal medicines that address disease\nbiology beyond VEGF alone,\" said Victor Perlroth, M.D., Chief Executive\nOfficer of Kodiak. \"Anti-VEGF therapies have transformed the treatment of DME,\nyet many patients continue to live with persistent retinal fluid, incomplete\nvisual recovery and the burden of frequent ongoing injections. We believe that\ninhibiting the immune-focused IL-6 pathway alongside the vessel-focused VEGF\npathway, further enhanced with the durability of our ABC Platform, may achieve\ndeeper and more sustained control of this disease.\"\n\n\"It has long been believed that there is more to be gained for patients with\nDME by targeting mechanisms beyond VEGF, and in particular by addressing the\nchronic, low-grade inflammatory state that often persists in patients who have\nsuboptimal response to anti-VEGF monotherapy,\" said Margaret Chang, M.D.,\nM.S., Co-Director of Clinical Research at Retina Consultants Medical Group.\n\"Recent results from the Phase 2 ALLUVIUM study demonstrated that IL-6\ninhibition alone can lead to clinically meaningful functional and anatomic\nbenefits in DME patients, providing evidence that the IL-6 pathway is\nbiologically active in diabetic eye diseases and operates independently of\nVEGF-driven pathology. Importantly, the recent Phase 2 BARDENAS study further\nsuggested that dual inhibition of VEGF and IL-6 may offer synergistic effects,\nwith the potential to deliver superior vision gains and improved fluid control\nversus targeting either pathway alone.\"\n\n\"DME is a multifactorial disease in which vascular leakage, blood-retinal\nbarrier dysfunction and immune signaling together drive retinal edema and\nvision loss,\" said J. Pablo Velazquez-Martin, M.D., Chief Medical Officer of\nKodiak. \"Our ALTO study is designed to rigorously evaluate whether dual\ninhibition of IL-6 and VEGF translates into meaningful benefit for patients,\nincluding the potential for better vision gains and greater fluid control, and\nthrough Kodiak's ABC biopolymer conjugate platform the potential for superior\ndurability. Alongside the primary visual acuity endpoint, the study is powered\nfor a key secondary endpoint of two-step or greater improvement on the\nDiabetic Retinopathy Severity Scale (DRSS), and it evaluates a regimen with\ndosing intervals extending to six months. Our objective is to characterize\nefficacy, anatomic response and durability in a single Phase 3 program.\"\n\nAbout the ALTO Study\n\nThe ALTO Study (KSMP002-S1) is a global, multicenter, randomized,\ndouble-masked, active comparator-controlled Phase 3 study evaluating the\nefficacy and safety of intravitreal KSI-501 5 mg compared with intravitreal\naflibercept 2 mg in patients with visual impairment secondary to\ncenter-involved DME.\n\nApproximately 910 patients, treatment-naïve or previously treated, will be\nrandomized 5:3:5 to one of three arms:\n\n * Arm A: KSI-501 5 mg every 8 weeks, with monthly assessment for additional\nindividualized dosing, following six monthly loading doses\n * Arm B: KSI-501 5 mg on an individualized regimen of every 4 to 24 weeks,\nfollowing six monthly loading doses\n * Arm C: aflibercept 2 mg every 8 weeks, following five monthly loading doses\nThe primary endpoint is the mean change in best-corrected visual acuity from\nbaseline to the average of Week 48 and Week 52. The key secondary endpoint is\nthe proportion of patients improving two or more steps on the DRSS from\nbaseline at Week 48. Additional secondary and exploratory endpoints evaluate\nvisual function, retinal anatomy, treatment burden and durability, and safety.\n\nParticipants will be treated and followed for approximately 96 weeks.\nAdditional information about ALTO, also known as Study KSMP002-S1, is\navailable at https://clinicaltrials.gov/study/NCT07734844\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4749493-1&h=402200419&u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07734844&a=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07734844)\n.\n\nThe Potential of Dual IL-6 and VEGF Inhibition in DME\n\nVEGF is an established driver of vascular permeability and abnormal vessel\ngrowth in retinal vascular disease, and anti-VEGF therapy has revolutionized\nthe treatment of DME by reducing retinal fluid and delivering meaningful\nvision gains for the majority of patients. Yet significant room for\nimprovement remains. Across pivotal DME trials, a substantial proportion of\npatients have persistent edema despite ongoing treatment, and most patients do\nnot achieve 20/20 vision. While recent intravitreal biologics have extended\ndosing intervals, many patients still require frequent injections to sustain\ntheir best possible visual outcome.\n\nIL-6 is a pro-inflammatory cytokine and immune growth factor implicated in\ninflammatory signaling, endothelial dysfunction and disruption of the\nblood-retinal barrier. Ocular IL-6 is elevated in patients with DME, and\nhigher intraocular IL-6 levels have been associated with poorer visual\noutcomes in patients treated with anti-VEGF monotherapy.\n\nKSI-501 is designed to address these complementary mechanisms in a single\nintravitreal medicine. The VEGF-trap component mimics the native VEGF\nreceptors and is designed to inhibit VEGF-mediated vascular permeability and\nneovascularization. The anti-IL-6 antibody component is designed to inhibit\nIL-6-mediated inflammatory signaling and normalize the blood-retinal barrier.\nThe ABC Platform-based design, with its signature 20-day intraocular\nhalf-life, is intended to support sustained intraocular activity and extended\ndurability.\n\nIn preclinical models, KSI-501 was shown to be a potent inhibitor of both VEGF\nand IL-6 and to normalize the blood-retinal barrier, opening the possibility\nthat KSI-501 may be a disease-modifying therapy for retinal vascular diseases.\n\nAbout KSI-501\n\nKSI-501 is an investigational anti-IL-6, VEGF-trap bispecific therapy built on\nthe ABC platform and is being developed for high prevalence retinal vascular\ndiseases to address the leading unmet needs of extended durability and\ntargeting disease biology beyond VEGF for differentiated efficacy. KSI-501 is\ndesigned to provide high immediacy/efficacy, driven by the enhanced\nformulation, and high durability, driven by the ABC platform and our science\nof durability.\n\nKodiak has advanced KSI-501 into the registrational Phase 3 study DAYBREAK to\nevaluate its efficacy and safety in wet AMD. DAYBREAK uses KSI-501's enhanced\n50 mg/mL formulation containing both conjugated and unconjugated antibody that\nis intended to balance immediacy and durability. DAYBREAK has completed\nenrollment. Topline data for the one-year primary endpoint in DAYBREAK are\nexpected in September 2026.\n\nKodiak has also advanced KSI-501 into the registrational Phase 3 ALTO study\ndesigned to demonstrate the superiority of bispecific KSI-501 (anti-VEGF,\nanti-IL-6) versus monospecific aflibercept (anti-VEGF) in patients with\ndiabetic macular edema. The ALTO study is now enrolling patients.\n\nAbout Kodiak Sciences Inc.\n\nKodiak Sciences (Nasdaq: KOD) is a pre-commercial retina-focused\nbiotechnology company committed to researching, developing and commercializing\ntransformative therapeutics. We are focused on bringing new science to the\ndesign and manufacture of next-generation retinal medicines to prevent and\ntreat the leading causes of blindness globally. We are developing a portfolio\nof three late-stage clinical programs. Zenkuda™ (tarcocimab tedromer) has a\nBLA-ready profile in diabetic retinopathy, retinal vein occlusion and wet AMD,\nand, together with KSI-501, is being explored in the BLA-facing Phase 3\nDAYBREAK wet AMD study, with topline data expected in September 2026. Zenkuda\nand KSI-501 target the $15 billion anti-VEGF market across retinal vascular\ndiseases. KSI-101 is a bispecific protein being explored in two BLA-facing\nPhase 3 studies in Macular Edema Secondary to Inflammation (MESI). Topline\ndata for Pivotal Analysis 1 (PEAK) are expected in December 2026 and Pivotal\nAnalysis 2 (PEAK+PINNACLE) in 2Q 2027.\n\nForward-Looking Statements\n\nThis press release contains \"forward-looking statements\" within the meaning of\nSection 27A of the Securities Act of 1933, Section 21E of the Securities\nExchange Act of 1934, and the Private Securities Litigation Reform Act of\n1995. These forward-looking statements are not based on historical fact and\ninclude, but are not limited to, statements regarding: the ability to\ndemonstrate the superiority of KSI-501 over aflibercept in patients with DME;\nthe potential for dual inhibition of the IL-6 and VEGF pathways to deliver\ndeeper and more sustained disease control for patients with DME; the\npossibility that KSI-501 may be a disease-modifying therapy for retinal\nvascular diseases. Forward-looking statements generally include statements\nthat are predictive in nature and depend upon or refer to future events or\nconditions, and include words such as \"may,\" \"will,\" \"should,\" \"would,\"\n\"could,\" \"expect,\" \"plan,\" \"believe,\" \"intend,\" \"pursue,\" \"anticipate,\" and\nother similar expressions, among others. Any forward-looking statements are\nbased on management's current expectations of future events and are subject to\na number of risks and uncertainties that could cause actual results to differ\nmaterially and adversely from those set forth in or implied by such\nforward-looking statements. These risks and uncertainties include, but are not\nlimited to: the risk that the Phase 3 ALTO trial may not achieve its primary\nor key secondary endpoints or may not do so on the anticipated timeline; the\nrisk that dual inhibition of IL-6 and VEGF may not translate into the clinical\nbenefits observed or suggested in earlier studies, including the Phase 2\nALLUVIUM and BARDENAS studies; as well as the other risks identified in the\nsection entitled \"Risk Factors\" in Kodiak's most recent Annual Report on Form\n10-K, as well as discussions of potential risks, uncertainties, and other\nimportant factors in Kodiak's subsequent filings with the Securities and\nExchange Commission. These forward-looking statements speak only as of the\ndate of this press release, and Kodiak undertakes no obligation to update or\nrevise any forward-looking statements, whether as a result of new information,\nfuture events, or otherwise. Readers are cautioned not to place undue reliance\non such forward-looking statements.\n\nView original\ncontent:https://www.prnewswire.com/news-releases/kodiak-sciences-announces-first-patients-enrolled-in-global-phase-3-alto-trial-of-ksi-501-in-patients-with-diabetic-macular-edema-302847506.html\n(https://www.prnewswire.com/news-releases/kodiak-sciences-announces-first-patients-enrolled-in-global-phase-3-alto-trial-of-ksi-501-in-patients-with-diabetic-macular-edema-302847506.html)\n\nSOURCE Kodiak Sciences Inc.\n\n\n\nKodiak Contact: John Borgeson, Chief Financial Officer, Tel (650) 281-0850, ir@kodiak.com\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPnbwV9QCa","title":"Kodiak Sciences Announces First Patients Enrolled in Global Phase 3 ALTO trial of KSI-501 in Patients with Diabetic Macular Edema","author":"PR Newswire","ticker":"KOD","created":"2026-08-10T20:43:53.107Z","tickers":["KOD"],"exchange":"NASDAQ","article_body":"Kodiak Sciences Announces First Patients Enrolled in Global Phase 3 ALTO trial of KSI-501 in Patients with Diabetic Macular Edema\n\nPR Newswire\n\nPALO ALTO, Calif., Aug. 10, 2026\n\n * Phase 3 ALTO trial designed to demonstrate superiority of KSI-501 versus\naflibercept in patients with diabetic macular edema\nPALO ALTO, Calif., Aug. 10, 2026 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq:\nKOD), a precommercial retina-focused biotechnology company committed to\nresearching, developing and commercializing transformative therapeutics, today\nannounced that the first patients have been enrolled in the global Phase 3\nALTO trial evaluating KSI-501 in patients with diabetic macular edema (DME).\nKSI-501 is an investigational, first-in-class bispecific therapy built on\nKodiak's ABC(®) Platform and designed to potently inhibit two complementary\npathways implicated in retinal vascular disease: interleukin (IL)-6-mediated\ninflammation and vascular endothelial growth factor (VEGF)-mediated vascular\npermeability and neovascularization.\n\nThe ALTO trial is designed to demonstrate the superiority of bispecific\n(anti-VEGF, anti-IL-6) KSI-501 versus monospecific (anti-VEGF) aflibercept in\npatients with DME. ALTO is the second registrational Phase 3 trial of KSI-501,\nfollowing the DAYBREAK study in patients with wet AMD.\n\nALTO explores whether dual inhibition of immune and vascular pathways can\ndeliver deeper and more sustained disease control for patients with DME and\nevaluates two dosing regimens, one regimen with intensive dosing and a second\nregimen with individualized dosing intervals of up to every six months.\n\n\"Initiating ALTO is an important next step for KSI-501 and for our broader\neffort to advance multifunctional retinal medicines that address disease\nbiology beyond VEGF alone,\" said Victor Perlroth, M.D., Chief Executive\nOfficer of Kodiak. \"Anti-VEGF therapies have transformed the treatment of DME,\nyet many patients continue to live with persistent retinal fluid, incomplete\nvisual recovery and the burden of frequent ongoing injections. We believe that\ninhibiting the immune-focused IL-6 pathway alongside the vessel-focused VEGF\npathway, further enhanced with the durability of our ABC Platform, may achieve\ndeeper and more sustained control of this disease.\"\n\n\"It has long been believed that there is more to be gained for patients with\nDME by targeting mechanisms beyond VEGF, and in particular by addressing the\nchronic, low-grade inflammatory state that often persists in patients who have\nsuboptimal response to anti-VEGF monotherapy,\" said Margaret Chang, M.D.,\nM.S., Co-Director of Clinical Research at Retina Consultants Medical Group.\n\"Recent results from the Phase 2 ALLUVIUM study demonstrated that IL-6\ninhibition alone can lead to clinically meaningful functional and anatomic\nbenefits in DME patients, providing evidence that the IL-6 pathway is\nbiologically active in diabetic eye diseases and operates independently of\nVEGF-driven pathology. Importantly, the recent Phase 2 BARDENAS study further\nsuggested that dual inhibition of VEGF and IL-6 may offer synergistic effects,\nwith the potential to deliver superior vision gains and improved fluid control\nversus targeting either pathway alone.\"\n\n\"DME is a multifactorial disease in which vascular leakage, blood-retinal\nbarrier dysfunction and immune signaling together drive retinal edema and\nvision loss,\" said J. Pablo Velazquez-Martin, M.D., Chief Medical Officer of\nKodiak. \"Our ALTO study is designed to rigorously evaluate whether dual\ninhibition of IL-6 and VEGF translates into meaningful benefit for patients,\nincluding the potential for better vision gains and greater fluid control, and\nthrough Kodiak's ABC biopolymer conjugate platform the potential for superior\ndurability. Alongside the primary visual acuity endpoint, the study is powered\nfor a key secondary endpoint of two-step or greater improvement on the\nDiabetic Retinopathy Severity Scale (DRSS), and it evaluates a regimen with\ndosing intervals extending to six months. Our objective is to characterize\nefficacy, anatomic response and durability in a single Phase 3 program.\"\n\nAbout the ALTO Study\n\nThe ALTO Study (KSMP002-S1) is a global, multicenter, randomized,\ndouble-masked, active comparator-controlled Phase 3 study evaluating the\nefficacy and safety of intravitreal KSI-501 5 mg compared with intravitreal\naflibercept 2 mg in patients with visual impairment secondary to\ncenter-involved DME.\n\nApproximately 910 patients, treatment-naïve or previously treated, will be\nrandomized 5:3:5 to one of three arms:\n\n * Arm A: KSI-501 5 mg every 8 weeks, with monthly assessment for additional\nindividualized dosing, following six monthly loading doses\n * Arm B: KSI-501 5 mg on an individualized regimen of every 4 to 24 weeks,\nfollowing six monthly loading doses\n * Arm C: aflibercept 2 mg every 8 weeks, following five monthly loading doses\nThe primary endpoint is the mean change in best-corrected visual acuity from\nbaseline to the average of Week 48 and Week 52. The key secondary endpoint is\nthe proportion of patients improving two or more steps on the DRSS from\nbaseline at Week 48. Additional secondary and exploratory endpoints evaluate\nvisual function, retinal anatomy, treatment burden and durability, and safety.\n\nParticipants will be treated and followed for approximately 96 weeks.\nAdditional information about ALTO, also known as Study KSMP002-S1, is\navailable at https://clinicaltrials.gov/study/NCT07734844\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4749493-1&h=402200419&u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07734844&a=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07734844)\n.\n\nThe Potential of Dual IL-6 and VEGF Inhibition in DME\n\nVEGF is an established driver of vascular permeability and abnormal vessel\ngrowth in retinal vascular disease, and anti-VEGF therapy has revolutionized\nthe treatment of DME by reducing retinal fluid and delivering meaningful\nvision gains for the majority of patients. Yet significant room for\nimprovement remains. Across pivotal DME trials, a substantial proportion of\npatients have persistent edema despite ongoing treatment, and most patients do\nnot achieve 20/20 vision. While recent intravitreal biologics have extended\ndosing intervals, many patients still require frequent injections to sustain\ntheir best possible visual outcome.\n\nIL-6 is a pro-inflammatory cytokine and immune growth factor implicated in\ninflammatory signaling, endothelial dysfunction and disruption of the\nblood-retinal barrier. Ocular IL-6 is elevated in patients with DME, and\nhigher intraocular IL-6 levels have been associated with poorer visual\noutcomes in patients treated with anti-VEGF monotherapy.\n\nKSI-501 is designed to address these complementary mechanisms in a single\nintravitreal medicine. The VEGF-trap component mimics the native VEGF\nreceptors and is designed to inhibit VEGF-mediated vascular permeability and\nneovascularization. The anti-IL-6 antibody component is designed to inhibit\nIL-6-mediated inflammatory signaling and normalize the blood-retinal barrier.\nThe ABC Platform-based design, with its signature 20-day intraocular\nhalf-life, is intended to support sustained intraocular activity and extended\ndurability.\n\nIn preclinical models, KSI-501 was shown to be a potent inhibitor of both VEGF\nand IL-6 and to normalize the blood-retinal barrier, opening the possibility\nthat KSI-501 may be a disease-modifying therapy for retinal vascular diseases.\n\nAbout KSI-501\n\nKSI-501 is an investigational anti-IL-6, VEGF-trap bispecific therapy built on\nthe ABC platform and is being developed for high prevalence retinal vascular\ndiseases to address the leading unmet needs of extended durability and\ntargeting disease biology beyond VEGF for differentiated efficacy. KSI-501 is\ndesigned to provide high immediacy/efficacy, driven by the enhanced\nformulation, and high durability, driven by the ABC platform and our science\nof durability.\n\nKodiak has advanced KSI-501 into the registrational Phase 3 study DAYBREAK to\nevaluate its efficacy and safety in wet AMD. DAYBREAK uses KSI-501's enhanced\n50 mg/mL formulation containing both conjugated and unconjugated antibody that\nis intended to balance immediacy and durability. DAYBREAK has completed\nenrollment. Topline data for the one-year primary endpoint in DAYBREAK are\nexpected in September 2026.\n\nKodiak has also advanced KSI-501 into the registrational Phase 3 ALTO study\ndesigned to demonstrate the superiority of bispecific KSI-501 (anti-VEGF,\nanti-IL-6) versus monospecific aflibercept (anti-VEGF) in patients with\ndiabetic macular edema. The ALTO study is now enrolling patients.\n\nAbout Kodiak Sciences Inc.\n\nKodiak Sciences (Nasdaq: KOD) is a pre-commercial retina-focused\nbiotechnology company committed to researching, developing and commercializing\ntransformative therapeutics. We are focused on bringing new science to the\ndesign and manufacture of next-generation retinal medicines to prevent and\ntreat the leading causes of blindness globally. We are developing a portfolio\nof three late-stage clinical programs. Zenkuda™ (tarcocimab tedromer) has a\nBLA-ready profile in diabetic retinopathy, retinal vein occlusion and wet AMD,\nand, together with KSI-501, is being explored in the BLA-facing Phase 3\nDAYBREAK wet AMD study, with topline data expected in September 2026. Zenkuda\nand KSI-501 target the $15 billion anti-VEGF market across retinal vascular\ndiseases. KSI-101 is a bispecific protein being explored in two BLA-facing\nPhase 3 studies in Macular Edema Secondary to Inflammation (MESI). Topline\ndata for Pivotal Analysis 1 (PEAK) are expected in December 2026 and Pivotal\nAnalysis 2 (PEAK+PINNACLE) in 2Q 2027.\n\nForward-Looking Statements\n\nThis press release contains \"forward-looking statements\" within the meaning of\nSection 27A of the Securities Act of 1933, Section 21E of the Securities\nExchange Act of 1934, and the Private Securities Litigation Reform Act of\n1995. These forward-looking statements are not based on historical fact and\ninclude, but are not limited to, statements regarding: the ability to\ndemonstrate the superiority of KSI-501 over aflibercept in patients with DME;\nthe potential for dual inhibition of the IL-6 and VEGF pathways to deliver\ndeeper and more sustained disease control for patients with DME; the\npossibility that KSI-501 may be a disease-modifying therapy for retinal\nvascular diseases. Forward-looking statements generally include statements\nthat are predictive in nature and depend upon or refer to future events or\nconditions, and include words such as \"may,\" \"will,\" \"should,\" \"would,\"\n\"could,\" \"expect,\" \"plan,\" \"believe,\" \"intend,\" \"pursue,\" \"anticipate,\" and\nother similar expressions, among others. Any forward-looking statements are\nbased on management's current expectations of future events and are subject to\na number of risks and uncertainties that could cause actual results to differ\nmaterially and adversely from those set forth in or implied by such\nforward-looking statements. These risks and uncertainties include, but are not\nlimited to: the risk that the Phase 3 ALTO trial may not achieve its primary\nor key secondary endpoints or may not do so on the anticipated timeline; the\nrisk that dual inhibition of IL-6 and VEGF may not translate into the clinical\nbenefits observed or suggested in earlier studies, including the Phase 2\nALLUVIUM and BARDENAS studies; as well as the other risks identified in the\nsection entitled \"Risk Factors\" in Kodiak's most recent Annual Report on Form\n10-K, as well as discussions of potential risks, uncertainties, and other\nimportant factors in Kodiak's subsequent filings with the Securities and\nExchange Commission. These forward-looking statements speak only as of the\ndate of this press release, and Kodiak undertakes no obligation to update or\nrevise any forward-looking statements, whether as a result of new information,\nfuture events, or otherwise. Readers are cautioned not to place undue reliance\non such forward-looking statements.\n\nView original\ncontent:https://www.prnewswire.com/news-releases/kodiak-sciences-announces-first-patients-enrolled-in-global-phase-3-alto-trial-of-ksi-501-in-patients-with-diabetic-macular-edema-302847506.html\n(https://www.prnewswire.com/news-releases/kodiak-sciences-announces-first-patients-enrolled-in-global-phase-3-alto-trial-of-ksi-501-in-patients-with-diabetic-macular-edema-302847506.html)\n\nSOURCE Kodiak Sciences Inc.\n\n\n\nKodiak Contact: John Borgeson, Chief Financial Officer, Tel (650) 281-0850, ir@kodiak.com\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-08-10T20:43:53.180251603Z","server_sent_at_ms":1786394633180},"received_at":"2026-08-10T20:43:53.239Z","source_url":"https://www.prnewswire.com/news-releases/kodiak-sciences-announces-first-patients-enrolled-in-global-phase-3-alto-trial-of-ksi-501-in-patients-with-diabetic-macular-edema-302847506.html"},"analysis":{"id":"103663","press_release_id":"114660","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Kodiak Sciences has enrolled the first patients in the global Phase 3 ALTO trial evaluating KSI-501 for diabetic macular edema.\n\nThe study is designed to demonstrate the superiority of the bispecific therapy versus aflibercept and aims to enroll approximately 910 patients across three dosing arms.\n\nKSI-501 targets both IL-6 and VEGF pathways using Kodiak's ABC Platform, potentially offering extended durability with dosing intervals up to every six months.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Phase 3 ALTO initiation advances the dual-pathway KSI-501 against the standard of care in DME."},"keyFigures":{"drugName":"KSI-501","phaseOfTrial":"Phase 3","customDimensions":{"patient_count":910,"primary_endpoint_weeks":"48 and 52","market_size_opportunity":"$15 billion"}},"quotedText":"ALTO is the second registrational Phase 3 trial of KSI-501, following the DAYBREAK study in patients with wet AMD.","namedEntities":{"people":[{"name":"Victor Perlroth","role":"Chief Executive Officer"},{"name":"Margaret Chang","role":"Co-Director of Clinical Research at Retina Consultants Medical Group"},{"name":"J. Pablo Velazquez-Martin","role":"Chief Medical Officer"}],"products":["KSI-501","aflibercept","Zenkuda"],"companies":[{"name":"Kodiak Sciences Inc.","ticker":"KOD"},{"name":"Retina Consultants Medical Group","relationship":"partner"}],"dollarAmounts":[{"amount":"$15 billion","context":"anti-VEGF market across retinal vascular diseases"}]},"materialImpact":{"score":3,"reasoning":"Initiation of a registrational Phase 3 trial for a key pipeline asset represents a significant de-risking milestone and operational progress toward potential commercialization."},"tickerRelevance":{"others":[],"primary":"KOD"},"globalImportance":30,"audienceRelevance":25,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small/mid-cap","eventGravity":"Phase 3 initiation","sectorWeight":"biotech"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"Kodiak Sciences has enrolled the first patients in the global Phase 3 ALTO trial evaluating KSI-501 for diabetic macular edema.\n\nThe study is designed to demonstrate the superiority of the bispecific therapy versus aflibercept and aims to enroll approximately 910 patients across three dosing arms.\n\nKSI-501 targets both IL-6 and VEGF pathways using Kodiak's ABC Platform, potentially offering extended durability with dosing intervals up to every six months.","key_figures":{"drugName":"KSI-501","phaseOfTrial":"Phase 3","customDimensions":{"patient_count":910,"primary_endpoint_weeks":"48 and 52","market_size_opportunity":"$15 billion"}},"named_entities":{"people":[{"name":"Victor Perlroth","role":"Chief Executive Officer"},{"name":"Margaret Chang","role":"Co-Director of Clinical Research at Retina Consultants Medical Group"},{"name":"J. Pablo Velazquez-Martin","role":"Chief Medical Officer"}],"products":["KSI-501","aflibercept","Zenkuda"],"companies":[{"name":"Kodiak Sciences Inc.","ticker":"KOD"},{"name":"Retina Consultants Medical Group","relationship":"partner"}],"dollarAmounts":[{"amount":"$15 billion","context":"anti-VEGF market across retinal vascular diseases"}]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-11T00:55:17.430Z","global_importance":30,"audience_relevance":25,"importance_components":{"tickerTier":"small/mid-cap","eventGravity":"Phase 3 initiation","sectorWeight":"biotech"}},"durationMs":164093,"modelName":"glm-4.7"}}