Oculis (NASDAQ: OCS) details late-stage eye drugs and cash runway into 2029
Rhea-AI Filing Summary
Oculis Holding furnished an updated corporate presentation outlining late-stage ophthalmic and neuro‑ophthalmic programs and projected funding capacity. The company highlights a strong balance sheet with no debt and a cash runway into 2H 2029, excluding a CHF100 million loan facility.
The presentation centers on two registrational‑stage candidates. Privosegtor, a neuroprotective small molecule for optic neuritis and other optic neuropathies, has FDA Breakthrough Therapy and EMA PRIME designations and a Special Protocol Assessment for the PIONEER‑1 Phase 3 trial. Phase 2 ACUITY data showed clinically meaningful low‑contrast visual acuity gains, anatomical preservation on retinal imaging, reduced neurofilament biomarkers, and no adverse events leading to drug withdrawal or study discontinuation.
Licaminlimab, a topical anti‑TNFα antibody fragment for dry eye disease, is being developed as a precision medicine guided by the TNFR1 genotype. Three Phase 2 trials reported consistent symptom and sign improvements, particularly in genotype‑positive patients, with good tolerability. The ongoing PREDICT‑1 registrational study targets topline results around year‑end 2026. The presentation outlines multiple anticipated milestones through 2027 across both programs.
Positive
- None.
Negative
- None.
Insights
Oculis updates investors on late-stage eye programs and long cash runway.
Oculis emphasizes having two registrational‑stage assets, Privosegtor and Licaminlimab, both targeting sizeable ophthalmic markets with limited treatment options. Privosegtor already carries FDA Breakthrough Therapy and EMA PRIME designations plus a Special Protocol Assessment, which together indicate intensive regulatory engagement.
ACUITY Phase 2 data for Privosegtor show clinically relevant low‑contrast visual acuity gains, structural retinal preservation, and neurofilament reduction, all with no drug‑related serious adverse events or discontinuations. Licaminlimab’s three Phase 2 studies support a genotype‑based strategy in dry eye disease, aligning with a precision‑medicine positioning.
The company also signals a cash runway into 2H 2029, excluding a CHF100 million loan facility, which suggests capacity to run multiple registrational programs in parallel. Upcoming milestones through 2027, including PIONEER‑1 enrollment completion and PREDICT‑1 topline results around year‑end 2026, will be key evidence points on whether these programs can sustain their current momentum.
Key Figures
Key Terms
Breakthrough Therapy Designation regulatory
PRIority MEdicines (PRIME) regulatory
Special Protocol Assessment regulatory
neurofilaments medical
topline results financial
precision medicine medical
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
For the Month of June 2026
(Commission File No. 001-41636)
Oculis Holding AG
(Translation of registrant's name into English)
Bahnhofstrasse 20
CH-6300
Zug, Switzerland
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ |
Form 40-F ☐ |
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On June 25, 2026, Oculis Holding AG (the "Registrant") updated its corporate presentation for use in meetings with investors, analysts and others. The presentation is attached hereto as Exhibit 99.1. The Registrant undertakes no obligation to update, supplement or amend the presentation.
EXHIBIT INDEX
Exhibit |
|
Description |
99.1 |
|
Corporate Presentation dated June 2026 |
|
|
|
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
|
|
OCULIS HOLDING AG |
||
|
|
|
|
|||
Date: June 25, 2026 |
|
|
|
By: |
|
/s/ Riad Sherif |
|
|
|
|
|
|
Riad Sherif Chief Executive Officer |
Visionary Innovation June 2026
These slides and any accompanying oral presentation contain forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward-looking statements. For example, all statements we make regarding the initiation, timing, progress and results of our preclinical studies, our clinical studies, our research and development programs, our regulatory strategy, our future development plans, our ability to advance product candidates into, and successfully complete clinical studies, and the timing or likelihood of regulatory filings and approvals, our cash runway, and statements regarding the potential therapeutic benefits and market opportunities of our product candidates are forward looking. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that we expected. Oculis may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: the possibility that Oculis may be adversely affected by economic, business, and/or competitive factors; Oculis' estimates of expenses and profitability; Oculis' ability to develop, manufacture and commercialize the product candidates in its pipeline; actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; the ability of Oculis or its partners to enroll and retain patients in clinical studies; whether preclinical, interim or early-stage clinical data will be predictive of the final results of a trial or later-stage clinical trials; the ability of Oculis or its partners to gain approval from regulators for planned clinical studies, study plans or sites; Oculis' ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; the success of Oculis' current and future collaborations, joint ventures, partnerships or licensing arrangements; financial position, strategy and anticipated milestones; and other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Oculis may from time to time file or furnish with the SEC. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Certain information contained in these slides relates to or is based on studies, publications, surveys and other data obtained from third party sources, including Oculis’ own internal estimates and research. While Oculis believes these third-party sources to be reliable as of the date of these slides, Oculis has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third party sources. In addition, there can be no guarantee as to the accuracy or reliability of any assumptions or limitations that may be included in such third-party information. While Oculis believes its own internal research is reliable, such research has not been verified by any independent source. Cautionary note on forward-looking statements Copyright of this presentation is owned by Oculis. No part of this presentation may be reproduced in any manner without the permission of Oculis. Safe Harbor Statements
Global biopharma Nasdaq-listed company with two registrational-stage candidates Privosegtor: Neuroprotective candidate in development in optic neuropathies: Optic neuritis: FDA Breakthrough Therapy and EMA PRIME designations, as well as SPA agreement with FDA for the PIONEER-1 trial Non-arteritic anterior ischemic optic neuropathy Potential to expand into broader indications addressing neuro-axonal diseases Licaminlimab: A precision medicine, genotype-based development program in dry eye disease with topline results from the PREDICT-1 trial anticipated around year-end 2026 Financials: Strong balance sheet, no debt, and current cash runway into 2H 2029, excluding a CHF100m loan facility Late-stage neuro-ophthalmic and ophthalmic programs target significant market opportunities Oculis (Nasdaq / XICE: OCS) PRIME: priority medicines, SPA: special protocol assessment.
NEURO-OPHTHALMOLOGY MS relapses NAION Optic Neuritis Candidate Phase 1 Phase 2 Phase 3 Upcoming Anticipated Value Catalysts Privosegtor Neuroprotective candidate PIONEER-1 enrollment completion in 2027 PIONEER-2 trial initiation in 2H 2026 PIONEER-3 trial initiation in 2H 2026 Cross-reference optic neuritis IND for new IND submission in MS relapses in 2H 2026 Licaminlimab First genotype-based development program PREDICT-1 TLR in around year-end 2026 Dry Eye Disease OPHTHALMOLOGY IND: investigational new drug, MS: multiple sclerosis, NAION: non-arteritic anterior ischemic optic neuropathy, PRIME: priority medicine, SPA: special protocol assessment, TLR: topline results. Privosegtor and Licaminlimab are investigational drugs, their safety or efficacy has not been established, and they have not received regulatory approval for commercial use in any country. Upcoming Value-Driving Milestones Across Our Targeted Registrational Programs Breakthrough Therapy and PRIME designations, SPA
Privosegtor Optic Neuritis
Privosegtor Is a Novel Neuroprotective Candidate with Broad Potential for Neuro-axonal Diseases SGK induces the cell protective phenotype of microglia (e.g., CNTF production) SGK promotes neuronal survival through Foxo3 NDRG1 activation by SGK induces oligodendrocyte precursors differentiation and myelination Cell Protective Microglia (M2) Oligodendrocyte Neuron Foxo3 CNTF NDRG1 SURVIVAL APOPTOSIS Privosegtor Peptoid small molecule that crosses the blood-brain and retinal barriers Selected by high-throughput screening (HTS) for its unique ability to promote neuro-axonal survival, validated across multiple in vitro and in vivo injury models: apoptosis, oxidation, and inflammation Confirmed neuro-axonal survival in glaucoma, MS, and optic neuritis in vivo models FDA Breakthrough Therapy Designation and EMA PRIority MEdicines (PRIME) designations granted for optic neuritis CNTF: ciliary neurotrophic factor; NDRG1: N-myc downstream regulated; MS: multiple sclerosis; SGK: serum glucocorticoid kinase
Compelling Preclinical Data Showed Neuroprotection Benefits with Neurons and Axons Preservation/Survival H&E: hematoxylin and eosin staining; RGC: retinal ganglion cell. Villoslada P, et al. Neurotherapeutics. 2019;16(3):808-827 Lysolecithin induced demyelinating model in rat (model of acute optic neuritis)- Assessment after 5-days of treatment High pressure Glaucoma rat model of neurodegeneration without inflammation Sham control Placebo Sham control Placebo Privosegtor - 70 mg/kg Privosegtor - 70 mg/kg *** *** *** *** Reduction of Optic Nerve Axonal Loss1,2 Reduction Optic Nerve Demyelination1,2 Optic nerve axonal loss after 5-days of treatment in optic neuritis rat model1,2 Area of axonal loss Protected axons H&E for RGC density at week 6 in high-pressure glaucoma rat model1,3 Eyedrops * * * *P < 0.0001 Prevention of RGC Damage1,2,3 *** P < 0.001 *** P < 0.001 Sham control Placebo Privosegtor - 70 mg/kg Visual of RGC Protection after 5-days of treatment in optic neuritis rat model1,2 Optic nerve demyelination after 5-days of treatment in optic neuritis rat model1,2
Neuroprotective Benefits of Privosegtor May Translate into Several Neuro-Ophthalmic Indications and Beyond Serious conditions in neuro-ophthalmology that can cause permanent visual deficits and even blindness: Glaucoma NAION Optic Neuritis Examples of acute & chronic indications >30k >30k >4m US patient population* *For acute conditions: number of acute episode per year, for chronic conditions, total number of patients affected. Weidong Gu et al. (2023) Incidence of Optic Neuritis and the Associated Risk of Multiple Sclerosis for Service Members of U.S. Armed Forces, Military Medicine, vol. 188, March/April 2023 Incidence of nonarteritic anterior ischemic optic neuropathy – PubMed and Incidence of nonarteritic anterior ischemic optic neuropathy: increased risk among diabetic patients – PMC and discussions with experts Ehrlich JR, Burke-Conte Z, Wittenborn JS, et al. Prevalence of Glaucoma Among US Adults in 2022. JAMA Ophthalmol. 2024;142(11):1046–1053. doi:10.1001/jamaophthalmol.2024.3884 ACUTE CHRONIC First wave of development focused on acute indications Broad potential may also apply to several neurological conditions due to lack of neuroprotective therapies including for the treatment of MS relapses (Second wave of development) Undisclosed ~Xm
If approved, Privosegtor could be the first neuroprotective therapy to improve visual outcomes in optic neuropathies Privosegtor’s First Wave of Development Targets the Two Main Optic Neuropathies Under Same IND Weidong Gu et al. (2023) Incidence of Optic Neuritis and the Associated Risk of Multiple Sclerosis for Service Members of U.S. Armed Forces, Military Medicine, vol. 188, March/April 2023 Incidence of nonarteritic anterior ischemic optic neuropathy – PubMed and Incidence of nonarteritic anterior ischemic optic neuropathy: increased risk among diabetic patients – PMC and discussions with experts https://www.medicalmex.com/oxervate-cenegermin-bkbj/ Oxervate pricing in U.S. $96k-$120k https://iovs.arvojournals.org/article.aspx?articleid=2783085 Tepezza pricing in U.S. $386k Active members of the American Academy of Ophthalmology, self-reported subspecialty, EyeNet Media Kit 2025 Acute optic neuropathy market estimated for the US is based on rare disease price analogues ($100-$400k per treatment) and annual incidence of ON and NAION (each >30k) Rare diseases without approved therapies often under-diagnosed Price analogs: $100k-$400k per treatment3,4 Highly concentrated: ~450 neuro-ophthalmologists in U.S.5 Estimated U.S. Market Potential6 Estimated U.S. Patients per Year1,2 >$7B Optic Neuritis >30K NAION >30K
Orphan indication with ~ 65k patients per year (US/EU)1,2 Acute inflammation of the optic nerve impacting retinal ganglion cells and leading to vision loss Optic Neuritis, an Acute Inflammation of the Optic Nerve which Can Lead to Permanent Visual Impairment Inflammation in the optic nerve Type of neuropathy causing vision loss and pain, and can lead to permanent visual impairment Inflammation affects the signals through the optic nerve, which connects the eyes and the brain Mainly affecting young women with an average onset at age 323 Direct link with chronic conditions like multiple sclerosis (MS) and other autoimmune diseases Weidong Gu et al. (2023) Incidence of Optic Neuritis and the Associated Risk of Multiple Sclerosis for Service Members of U.S. Armed Forces, Military Medicine, vol. 188, March/April 2023 Martínez-Lapiscina EH, et al. (2014): Is the incidence of optic neuritis rising? Evidence from an epidemiological study in Barcelona (Spain) 2008-2012. J Neurol. 2014 Apr; 261(4): 759-767. Guier CP, Kaur K, Stokkermans TJ. Optic Neuritis. January 2025. StatPearls. https://www.ncbi.nlm.nih.gov/books/NBK557853 Retina Optic nerve Brain nucleus dendrite Soma Myelin Axon terminal Axon Anatomy of the Retina and retinal ganglion cell
Successful Phase 2 ACUITY Trial Investigated Safety and Efficacy of Privosegtor in Optic Neuritis Screening 5-day treatment 6-month evaluation period Privosegtor (3mg/kg n=15, 2mg/kg n=5) + steroid Placebo + steroid (n=16) M6 D15 M1 M3 Baseline = Once daily IV infusion for 5 days = Efficacy evaluation timepoints Randomization Randomized, double-masked, placebo-controlled study Multi-center, 6-month trial with 36 patients randomized (mITT: 33) Primary: Safety Secondary: Function: LCVA Anatomy: GCIPL and RNFL thickness Biology: Neurofilaments Unilateral optic neuritis with a demyelinating origin Onset of visual loss symptoms in the last 12 days before randomization Study Design Study Population Key Endpoints mITT: Modified Intent to Treat; LCVA: low contrast visual acuity; GCIPL: ganglion cell plus inner plexiform layer; RNFL: retinal nerve fiber layer; D: day; M: month https://clinicaltrials.gov/study/NCT04762017
LCVA: Low-contrast visual acuity is often affected in patients with ON FUNCTION 7 letters (1.5 lines) change in LCVA has clinical relevance1 LCVA 2.5% ETDRS LCVA in the Affected Eye: MMRM, LS Mean Change From Baseline, mITT V3 M1 M3 M6 V1 +15 ETDRS Letters +18 ETDRS Letters *P = 0.004 *P = 0.012 Letters 1. https://pubmed.ncbi.nlm.nih.gov/28206829/, ETDRS: Early Treatment Diabetic Retinopathy Study; LCVA: low contrast visual acuity *Mixed Model for Repeated Measures (MMRM), Least-Squares Mean Change from Baseline: (2-sided nominal p-value), mITT population (affected eye): one placebo subject excluded from the mITT population in this analysis due to missing LCVA post-baseline assessments Patients in the Privosegtor 3mg/kg/day Arm Achieved Clinically Meaningful and Sustained Improvement in Visual Function
Privosegtor 3mg/kg/day + steroid Placebo + steroid Proportion of Participants with ≥15 LCVA Letter Gain from Baseline Privosegtor 3mg/kg/day + steroid Placebo + steroid Proportion of Participants with ≥30 LCVA Letter Gain from Baseline +51.7%* +107.7%* *P = 0.0691 *P = 0.0510 ETDRS: Early Treatment Diabetic Retinopathy Study; LCVA: low contrast visual acuity; *Fishers Exact Test: (2-sided nominal p-value), mITT population (affected eye): one placebo subject excluded from the mITT population in this analysis due to missing LCVA post-baseline assessments; 2.5% ETDRS LCVA, Relative Difference More Patients Achieved ≥15 and ≥30 ETDRS LCVA Letter Improvement with Privosegtor 3 mg/kg/day vs Placebo at Month 3 (Post Hoc Analysis)
Subgroup LSM difference at month 3 LS Mean difference (P-value*) LSM difference at month 6 LS Mean difference (P-value*) Overall Overall 18.15 (0.004) 14.76 (0.012) Diagnosis MS Non-MS 15.37 (0.049) 24.22 (0.045) 11.32 (0.042) 21.02 (0.093) AON HCVA <60 HCVA ≥60 22.27 (0.067) 8.97 (0.107) 18.46 (0.105) 5.47 (0.314) Privosegtor Arm Showed a Robust LCVA Improvement Across Subgroups and Maintained through Month 6 LCVA letters subgroup analyses of Privosegtor 3mg + steroid vs placebo + steroid *2-sided nominal p-value based on LSM difference. AON, acute optic neuritis; HCVA, high-contrast visual activity; LCVA, low-contrast visual acuity; LSM, least square mean; MS, multiple sclerosis; PL, placebo -20 0 20 40 60 PL + steroid better Privosegtor 3 mg + steroid better -20 0 20 40 60 PL + steroid better Privosegtor 3 mg + steroid better
Functional Improvement Correlated with Significant Preservation of Neurons in the Retina (RGCs) GCIPL and RNFL: layers of the retina measured by OCT to monitor nerve damage Decrease in GCIPL predicts poor LCVA, VF and CVA1 ANATOMY GCIPL thickness Axons RGCs (neurons) RNFL thickness V3 M1 M3 M6 V1 +43% +43% *P = 0.049 *P = 0.052 GCIPL Thickness in the Affected Eye: MMRM, LS Mean Change From Baseline, mITT 1. Gabilondo et al. Ann Neurol. 2015 Mar;77(3):517-28. GCIPL; ganglion cell plus inner plexiform layer. RNFL: retinal nerve fiber layer. OCT: optical coherence tomography. LCVA: low-contrast visual acuity, VF: visual field, CVA: color visual acuity. *Mixed Model for Repeated Measures (MMRM); Least-Squares Mean Change from Baseline: (1-sided directional nominal p-value), mITT population (affected eye)
Functional Improvement Correlated also with Significant Preservation of Axons (RNFL Thickness) GCIPL and RNFL: layers of the retina measured by OCT to monitor nerve damage RNFL indicates damage or loss of retinal ganglion cell axons ANATOMY GCIPL thickness Axons RGCs (neurons) RNFL thickness V3 M1 M3 M6 V1 +30% +28% GCIPL; ganglion cell plus inner plexiform layer. RNFL: retinal nerve fiber layer. OCT: optical coherence tomography. *Mixed Model for Repeated Measures (MMRM); Least-Squares Mean Change from Baseline: (1-sided directional nominal p-value), mITT population (affected eye). RNFL Thickness in the Affected Eye: MMRM, LS Mean Change from Baseline, mITT *P = 0.045 *P = 0.033
Neuroprotective Benefits with Privosegtor Also Observed in Biological Sign of Neuronal and Axonal Death BIOLOGY Neurofilaments: Released into CSF and blood as a result of axonal and neuronal death1 Biomarker for regulatory approval of neurodegenerative disease2 time Mean (SE) Visit 15 10 5 V3 M1 M6 M3 pg/mL V1 8.6 6.6 14.6 14.5 11.7 9.3 7.6 7.7 5.9 5.8 Mean Neurofilaments Over Time, mITT -47% *Mixed Model for Repeated Measures (MMRM); Least-Squares Mean Change from Baseline: (2-sided nominal p-value), mITT population (affected eye). Gafson AR and al. Neurofilaments: neurobiological foundations for biomarker applications. Brain. 2020 Jul 1;143(7):1975-1998. Stern S and al. Trends in clinical studies evaluating neurofilament light chain as a biomarker. Biomark Med. 2025 Sep;19(17):813-823. *P = 0.046
Safety Profile Reported in ACUITY Phase 2 Trial Showed No AEs Leading to Drug Withdrawal or Study Discontinuation SAE, serious adverse event; TEAE, treatment emergent adverse event. Two (2) unrelated SAEs: Hospitalization due to MS relapse (Privosegtor (OCS-05 + steroid) and due to myelitis (placebo + steroid) Event, n (%) Privosegtor + steroid Placebo + steroid (N = 14) 2 mg/kg/day (N = 4) 3 mg/kg/day (N = 15) Pooled (N = 19) At least one TEAE Related to study treatment 4 (100.0%) 4 (100.0%) 12 (80.0%) 6 (40.0%) 16 (84.2%) 10 (52.6%) 14 (100.0%) 6 (42.9%) At least one grade ≥2 TEAE Related to study drug 2 (50.0%) 0 9 (60.0%) 2 (13.3%) 11 (57.9%) 2 (10.5%) 6 (42.9%) 0 At least one serious TEAE Related to study drug 0 0 1 (6.7%) 0 1 (5.3%) 0 1 (7.1%) 0 At least one SAE leading to death 0 0 0 0 At least one TEAE leading to a dose reduction 0 0 0 0 At least one TEAE leading to a dose interruption 0 0 0 0 At least one TEAE leading to a drug withdrawn 0 0 0 0 At least one TEAE leading to premature discontinuation of the study 0 0 0 0 No AEs leading to drug withdrawal or study discontinuation No drug-related serious adverse events (SAEs)
PIONEER-1 Registrational Trial Aligned with FDA under Special Protocol Assessment Screening 5-day treatment 3-month evaluation period Privosegtor + steroid (n = 140) Placebo + steroid (n = 70) Month 1 Month 3 Primary & Secondary Endpoints Baseline LCVA Randomization D0 Randomization 2:1 Once daily IV infusion for 5 days Long-term safety follow-up timepoints Primary: Proportion (%) of ≥15 letter gainers at Month 3 Secondary: Proportion (%) of ≥30 letter gainers at Month 3 LCVA mean change from baseline at Month 3 GCIPL mean change from baseline at Month 3 sNfL mean change from baseline at Month 3 All comers: including MS and non-MS optic neuritis Privosegtor treatment within 12 days from the first onset of symptoms Study Design Study Population Key Efficacy Endpoints Additional 9-month safety follow-up IV: intravenous, GCIPL: ganglion cell-inner plexiform layer, LCVA: low-contrast visual acuity, MS: multiple sclerosis, PL: placebo, SoC: standard of care, sNfL: Serum Neurofilaments Month 6 Month 9 Month 12 Efficacy evaluation timepoints Day 20 Randomized, multicenter, double-masked, placebo-controlled study Primary analysis at Month 3; Safety follow-up through Month 12 N: ~210, 2:1 randomization Privosegtor 3mg/kg/day + SoC (IV Methylprednisolone) vs. placebo + SoC
Privosegtor Driving Multiple Anticipated Milestones in the Next 18 Months PIONEER-1 in optic neuritis enrollment completion PIONEER-2 in ON and PIONEER-3 in NAION trials initiation 2H 2026 2027 Three Registrational trials in optic neuritis and NAION Breakthrough Therapy and PRIME designations granted Q1 2026 MS relapses IND submission planned PIONEER-1 in optic neuritis initiated Q4 2025 Special Protocol Assessment agreement with FDA Q2 2026 2H 2026
Licaminlimab Dry Eye Disease
Licaminlimab is a Novel Anti-TNFα Eye Drop for Ocular Inflammation Enhanced ocular penetration Lower molecular weight, enhanced ocular penetration and higher concentration Proprietary genetic biomarker Associated with Licaminlimab response highlights opportunity to drive precision medicine in DED Innovative Antibody Fragment Technology Validated MoA Anti-inflammation and anti-apoptosis MoA approved as systemic treatment for ocular disease and with transformative impact in other areas Licaminlimab is an anti-TNFα antibody fragment specifically formulated for topical delivery Topical Biologic Candidate 149 kDa 26 kDa Framework for Licaminlimab optimized for stability and other drug-like properties IgG Regions that bind to neutralize TNFα scFv (Licaminlimab) DED: dry eye disease; MoA: mechanism of action.
Large Unsatisfied Market with Only 13% of Patients Experiencing Lasting Relief After 12 Months with Current Treatments1 Health Union Community Editorial Team. 2021 In America Survey Findings: Living With Chronic Dry Eye. Chronic Dry Eye. 2021. https://chronicdryeye.net/infographic/in-america-findings. DRG Dry Eye Disease Landscape and Forecast 2020 (estimated U.S. market value in 2024) IQVIA DED report, data on file. Prescriptions volume in DED March 2024 for split per drug class Mbagwu M, et al. Characterization of Discontinuation and Switching Patterns of Dry Eye Disease Medications Using Linked EHR Registry and Claims Data. Presented at: ASCRS Annual Meeting 2024 https://ophthalmology360.com/study-finds-high-discontinuation-rate-of-dry-eye-medications/ Discontinuation & switching are commonplace in DED4 53% – 70% discontinued after a single script 85% – 90% discontinued within 180 days DED expert’s perspective: Dr. Anat Galor Driven by trial and error with significant unmet needs Establishing Licaminlimab as a precision-based approach, in a market with high failure and discontinuation rates, is expected to provide a clear option for physicians and payors for TNFR1 genotype patients
Licaminlimab: Three Positive DED Phase 2 Trials Completed with Consistent Results and Potential for Precision Medicine Approach DED#1 and DED#3: Data on file DED #2: Sheetle L, et al. Clin. Ophthalmol. 2022; 16:2167-2177 Phase 2 Randomized Controlled Studies in DED Consistent positive results across studies and unique genotype-based development opportunity DED#1 Symptoms 85 patients Phase 2 PoC DED#2 Symptoms 134 patients Phase 2 PoC DED#3 (RELIEF) Signs 122 patients Phase 2b 01 02 Meaningful and rapid treatment effect in signs and symptoms More pronounced treatment effect in TNFR1 genotype positive (5X in signs and 7X in symptoms) 03 Well-tolerated, drop comfort like artificial tears DED expert’s perspective: Dr. Anat Galor
*Global discomfort score is a composite of discomfort frequency and severity as assessed by a visual analog scale. DED: dry eye disease. FDA: Food and Drug Administration. TID: Three times a day. TNFR1: Tumor necrosis factor receptor 1 Licaminlimab First Genotype-based Development to Drive Precision Medicine in DED Day -45 to -15 Day -14 Day 1 Day 15 Day 29 Licaminlimab (TID) N=~80 Run-in phase Screening Treatment phase N=~160 Vehicle (TID) N=~80 Phase 2/3 Study Design Randomized, multicenter, double-masked, vehicle-controlled, 6-week study N= ~160 patients, 1:1 randomization Key Efficacy Endpoints Primary endpoint: Global ocular discomfort score* at Day 29 in patients with TNFR1 genotype positive Key secondary endpoint: Global ocular discomfort score at Day 29 in all patients Study Population TNFR1 genotype: ~2/3 positive Diagnosis of DED of at least 6 months Global ocular discomfort score of ≥ 60 Artificial tears TID for 14 days PREDICT-1 Registrational Trial Enrollment Ongoing Day 43 Follow-up
Conclusion
NEURO-OPHTHALMOLOGY MS relapses NAION Optic Neuritis Candidate Phase 1 Phase 2 Phase 3 Upcoming Anticipated Value Catalysts Privosegtor Neuroprotective candidate PIONEER-1 enrollment completion in 2027 PIONEER-2 trial initiation in 2H 2026 PIONEER-3 trial initiation in 2H 2026 Cross-reference optic neuritis IND for new IND submission in MS relapses in 2H 2026 Licaminlimab First genotype-based development program PREDICT-1 TLR in around year-end 2026 Dry Eye Disease OPHTHALMOLOGY IND: investigational new drug, MS: multiple sclerosis, NAION: non-arteritic anterior ischemic optic neuropathy, PRIME: priority medicine, SPA: special protocol assessment, TLR: topline results. Privosegtor and Licaminlimab are investigational drugs, their safety or efficacy has not been established, and they have not received regulatory approval for commercial use in any country. Upcoming Value-Driving Milestones Across Our Targeted Registrational Programs Breakthrough Therapy and PRIME designations, SPA
Thank you