Core Insights - Oculis Holding AG announced the presentation of Phase 2 data for Privosegtor at the NANOS 52nd Annual Meeting, highlighting its commitment to addressing unmet medical needs in neuro-ophthalmology [1][2]. Company Overview - Oculis is a global biopharmaceutical company focused on innovations in ophthalmology and neuro-ophthalmology, with a late-stage clinical pipeline that includes three core product candidates: Privosegtor, OCS-01, and Licaminlimab [10]. - Privosegtor is a novel peptoid small-molecule candidate that has received Breakthrough Therapy designation from the FDA for optic neuritis (ON) and is entering registrational trials for ON and non-arteritic anterior ischemic optic neuropathy (NAION) [6][10]. Clinical Trial Results - The ACUITY Phase 2 trial results demonstrated significant improvements in low contrast visual acuity and neuroprotective effects in patients with optic neuritis, indicating Privosegtor's potential as the first neuroprotective therapy for this condition [4][6]. - The trial showed anatomical preservation of the retina and improvements in visual function after acute episodes of optic neuritis, with consistent results observed in animal models [6]. Event Participation - Oculis served as a Platinum Sponsor at the NANOS 2026 Congress, emphasizing its role in advancing scientific progress in neuro-ophthalmology [2][5]. - The presentation at NANOS represents a significant milestone for Oculis and the scientific community, showcasing groundbreaking data from the ACUITY trial [5]. Expert Involvement - Professor Martin Zinkernagel, a recognized expert in ophthalmology, presented the trial results, underscoring the importance of the findings in the context of neuro-ophthalmic science [5][7].

Summary of Oculis Holding AG Conference Call Company Overview - **Company**: Oculis Holding AG - **Industry**: Biopharmaceuticals, specifically focusing on ophthalmology Key Products and Programs 1. **OCS-01 for Diabetic Macular Edema (DME)** - **Phase**: Currently in Phase 3 trials (DIAMOND-1 and DIAMOND-2) with data expected in the second half of Q2 [3][19] - **Unique Selling Proposition**: First and only topical product for retina, allowing early intervention for naïve patients and combination treatment for those unresponsive to anti-VEGF [3][5] - **Market Potential**: Addresses a larger patient pool than current treatments, with over 40% of DME patients not responding to existing anti-VEGF therapies [4][5] - **Efficacy Data**: Phase 2 results showed a mean change in Best Corrected Visual Acuity (BCVA) of 7.8 letters at week 6, comparable to anti-VEGF treatments [10][11] - **Pricing Strategy**: Targeting a price of around $10,000 per year, which is competitive compared to existing treatments like Ozurdex priced between $8,000-$16,000 [71][75] 2. **Dry Eye Program** - **Focus**: Utilizing a genetic biomarker (TNFR1) to identify responsive patients, aiming to treat 20% of the dry eye population [96][100] - **Clinical Efficiency**: Reduced patient count in trials (160 patients) due to targeted approach, leading to higher probability of success [97] - **Compliance Improvement**: Expected compliance rate of 70% compared to the current 10%-15% for existing treatments, leading to increased patient value [100][142] - **Pricing**: Expected to be competitive with existing products like MIEBO, which costs around $11,000 per year [128][137] 3. **Privosegtor for Neuroprotection** - **Indication**: Targeting neurodegenerative diseases, with a focus on optic neuritis [168] - **Phase 2 Data**: Showed significant improvement in vision (doubling function) and preservation of retinal ganglion cells [176][177] - **Biomarkers**: Neurofilament levels will be used as a regulatory endpoint, indicating axonal damage [178][189] - **Pricing**: Anticipated treatment cost between $100,000 and $400,000, with a likely average around $150,000 to $200,000 [205][211] Market Strategy and Commercialization - **Commercialization Approach**: Aiming for a straightforward launch due to the existing awareness of DME among healthcare providers [61][70] - **Sales Force**: Planning to deploy a field force of 50-60 full-time equivalents (FTEs) for effective market penetration [54][55] - **Market Education**: No need for extensive education on DME, as the condition is well-known among practitioners [63][70] Additional Insights - **Regulatory Engagement**: Positive discussions with the FDA regarding the use of genetic biomarkers for patient selection in clinical trials [96] - **Patient-Centric Approach**: Emphasis on reducing trial-and-error in treatment for dry eye patients, enhancing the overall patient experience [99][100] - **Future Outlook**: Anticipation of positive data from ongoing trials, with plans for rapid filing post-results [40][41] This summary encapsulates the key points discussed during the conference call, highlighting Oculis Holding AG's innovative approaches in the biopharmaceutical sector, particularly in ophthalmology.

Core Insights - Oculis Holding AG is advancing its position in neuro-ophthalmology and ophthalmology with a late-stage portfolio and significant market opportunities [2][6] - The company has received breakthrough therapy designation for its product Privosegtor, targeting optic neuritis, with a potential market opportunity exceeding $7 billion in the U.S. [2] - Oculis is set to present pivotal trial results for its product OCS-01 in diabetic macular edema (DME) in Q2 2026 [2] - The company is also developing Licaminlimab, a precision medicine approach for dry eye disease (DED) [2][6] Company Overview - Oculis is a global biopharmaceutical company focused on addressing unmet medical needs in neuro-ophthalmology and ophthalmology [6] - The company has a strong balance sheet and a robust pipeline, aiming to deliver six pivotal readouts with current funding [3] - Oculis is headquartered in Switzerland and operates in the U.S. and Iceland, led by an experienced management team [6] Upcoming Events - Oculis management will participate in the Leerink Global Healthcare Conference from March 8-11, with a presentation scheduled for March 10 [4] - The company will also engage in one-on-one meetings at the Leerink Partners Mountain Meeting from March 22-25 [5] - Additional one-on-one meetings are planned during the LifeSci Capital Biotech Forum on March 26 [5]

Core Insights - The company has filed its audited consolidated financial statements for the financial year 2025 with the SEC on form 20-F [1] Group 1 - The press release was published on March 3, 2026, indicating the company's commitment to transparency and regulatory compliance [1]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF ...

Oculis Holding AG (OCS) came out with a quarterly loss of $0.51 per share versus the Zacks Consensus Estimate of a loss of $0.43. This compares to a loss of $0.76 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -17.70%. A quarter ago, it was expected that this company would post a loss of $0.5 per share when it actually produced a loss of $0.4, delivering a surprise of +20%.Over the last four quarters, the company has surpasse ...

Core Insights - Oculis Holding AG has made significant clinical advancements in 2025, particularly in neuro-ophthalmology, with the FDA granting Breakthrough Therapy designation for Privosegtor in optic neuritis, leading to the launch of the PIONEER registrational program [2][4] - The company anticipates three major registrational milestones in 2026, including results from the DIAMOND-1 and DIAMOND-2 trials for OCS-01 in diabetic macular edema (DME) and the PREDICT-1 trial for Licaminlimab in dry eye disease [2][3] - Oculis has a strong financial position with cash and short-term investments of $268.7 million as of December 31, 2025, providing a cash runway into 2029 [3][5] Clinical Highlights - Privosegtor has shown promising Phase 2 ACUITY results, leading to its Breakthrough Therapy designation and a potential U.S. market opportunity exceeding $7 billion for optic neuropathies [3][4] - OCS-01 is nearing completion of Phase 3 DIAMOND trials, with over 800 patients enrolled and topline results expected in Q2 2026, targeting a DME market valued at approximately $3 billion [4][5] - Licaminlimab is positioned to transform treatment for dry eye disease with a precision medicine approach, with topline results from the PREDICT-1 trial expected in Q4 2026 [10] Financial Performance - As of December 31, 2025, Oculis reported a net loss of CHF 99.0 million ($119.1 million) for the year, an increase from CHF 85.8 million ($97.4 million) in 2024, primarily due to rising operating expenses [5][15] - Research and development expenses for Q4 2025 were CHF 13.3 million ($16.6 million), up from CHF 11.8 million ($13.4 million) in Q4 2024, reflecting advancements in clinical development [5][15] - General and administrative expenses also increased to CHF 7.8 million ($9.7 million) in Q4 2025 from CHF 5.5 million ($6.3 million) in the same period in 2024, driven by personnel and professional service costs [5][15]

Core Insights - Oculis Holding AG has appointed Katie Kazem as Chief Legal Officer, enhancing its legal, compliance, and corporate governance functions [1][2] - The company is advancing its product Privosegtor into the PIONEER program and is expecting topline results for OCS-01 eye drops in diabetic macular edema (DME) in Q2 [2] - Oculis has a differentiated late-stage clinical pipeline, including three core product candidates: Privosegtor, OCS-01, and Licaminlimab [4] Company Overview - Oculis is a global biopharmaceutical company focused on innovations in neuro-ophthalmology and ophthalmology [4] - The company is headquartered in Switzerland and has operations in the U.S. and Iceland [4] - Oculis is supported by leading international healthcare investors and led by an experienced management team [4] Product Pipeline - Privosegtor is a neuroprotective candidate in the PIONEER program aimed at treating optic neuropathies [4] - OCS-01 is in pivotal registration studies to become the first non-invasive topical treatment for DME [4] - Licaminlimab is a novel topical anti-TNFα in Phase 2, focusing on precision medicine for dry eye disease [4] Leadership and Expertise - Katie Kazem brings over 15 years of experience in corporate and securities law, particularly in life sciences [2][5] - She has a strong background in advising on IPOs, capital raising, M&A, and regulatory compliance [2][5] - Kazem has previously served as external legal counsel to Oculis since its NASDAQ listing in March 2023 [2]

Company Overview - Oculis is a global biopharma company listed on NASDAQ, focusing on ophthalmology and neuro-ophthalmology with late-stage registrational candidates [2] - The company has three candidates in Phase III trials and two main franchises [2] Product Pipeline - The first franchise includes OCS-01, which is the first noninvasive self-administered eye drop for diabetic macular edema (DME), with a readout planned for Q2 of this year [3] - The second candidate in this franchise is Licaminlimab, aimed at treating dry eye disease, with a readout expected in Q4 2026 [3] Neuro-Ophthalmology Franchise - The second franchise focuses on neuro-ophthalmology, featuring privosegtor, which is the first product to demonstrate effectiveness in neuroprotection [4] - Privosegtor has shown consistent results in preserving neurons across all endpoints, including functional, anatomical, and biological measures [4]

Summary of Oculis Conference Call Company Overview - **Company**: Oculis - **Industry**: Biopharmaceuticals, specifically in ophthalmology and neuro-ophthalmology - **Stock Exchange**: Nasdaq-listed - **Financial Position**: Strong balance sheet with no debt, cash runway until 2029 excluding a facility loan of CHF 100 million ($125 million) [2][3] Key Products and Pipeline Ocular Franchise - **OCS-01**: - First non-invasive self-administered eye drop for diabetic macular edema (DME) - Phase 3 readout planned for Q2 2023 - Targets a market of 1.8 million diagnosed patients in the US, with only half currently treated [2][5][6] - Demonstrated a 7.6 letters gain in best-corrected visual acuity (BCVA) at week 12 in trials, with 27% of patients gaining more than 15 letters [10] - Expected submission for approval in Q4 2023, with potential approval in 2027 [12] - **Licaminlimab**: - First precision medicine in ophthalmology for dry eye disease - Utilizes a biomarker to identify high responders, allowing for smaller and more efficient Phase 3 trials [12][13] - Expected top-line results in Q4 2026 [41] Neuro-Ophthalmology Franchise - **Privosegtor**: - First product in neuroprotection, targeting optic neuritis and NAION - Received Breakthrough Therapy Designation - Demonstrated preservation of retinal and ganglion cells in trials, with significant functional improvements [16][21] - Market potential of $7 billion for optic neuritis and NAION, with no current solutions available [18] - Phase 3 trials (Pioneer 1 and Pioneer 2) expected to start in 2026, with readouts planned for 2027 [23][35] Market Opportunity - **DME Market**: - Significant unmet medical need with a large patient pool, as DME is the leading cause of blindness in the working-age population in the US [34] - OCS-01 aims to address both early intervention and patients not responding to current treatments [7][9] - **Neuro-Ophthalmology Market**: - High potential due to the lack of existing treatments for conditions like optic neuritis and NAION, which are closely linked to multiple sclerosis (MS) [19][20] - Plans to expand treatment to all types of MS relapses, significantly increasing the addressable market [40] Strategic Focus - **Commercial Strategy**: - Focus on the US market for launch, with potential partnerships for ex-US markets [26] - Emphasis on innovative and differentiated product profiles to ensure successful commercial launches [26] - **Execution and Risk Management**: - Acknowledgment of execution risk as a primary concern, with a commitment to high-quality trial execution [31][32] - Confidence in the biological efficacy of products based on consistent preclinical and clinical data [39] Manufacturing and Partnerships - **Manufacturing Strategy**: - Oculis does not have in-house manufacturing capabilities; instead, it partners with established global manufacturers to maintain flexibility and quality [44] Conclusion - Oculis is positioned to make significant advancements in the ophthalmology and neuro-ophthalmology sectors with its innovative product pipeline, addressing critical unmet medical needs and leveraging a strong financial position for future growth [25]