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].

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 - 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]

Visionary Innovation Riad Sherif, M.D. Chief Executive Officer J.P. Morgan Healthcare Conference January 14, 2026 Safe Harbor Statements Cautionary note on forward-looking statements These slides and the accompanying oral presentation contain forward-looking statements and information. 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 identi ...

Core Insights - Oculis Holding AG is advancing its position in ophthalmology and neuro-ophthalmology with a focus on innovative treatments addressing significant unmet medical needs [2][13] - The company has secured funding to support three pivotal trials for its product Privosegtor, targeting a market opportunity of approximately $7 billion in the U.S. [2][4] Financial Overview - As of September 30, 2025, Oculis reported cash, cash equivalents, and short-term investments totaling $182.2 million, with a recent capital raise increasing this amount to nearly $300 million [4][7] - Research and development expenses for Q3 2025 were $17.6 million, up from $15.0 million in Q3 2024, primarily due to increased product development activities [7] - The year-to-date net loss for the nine months ended September 30, 2025, was $89.7 million, compared to $64.8 million for the same period in 2024, driven by advancements in clinical development programs [7][12] Clinical Developments - Oculis is conducting Phase 3 trials for OCS-01 eye drops in diabetic macular edema (DME), with topline results expected in Q2 2026 [3][4] - The company is initiating the PIONEER program for Privosegtor, which includes three pivotal trials for acute optic neuritis (AON) and non-arteritic anterior ischemic optic neuropathy (NAION) [5][6] - Licaminlimab, a novel treatment for dry eye disease (DED), is set to enter a registrational trial in Q4 2025, following positive Phase 2 results [6][13] Market Opportunity - DME affects approximately 37 million people globally, representing a market opportunity of around $5 billion, highlighting the need for early intervention and effective treatments [6] - The potential market for Privosegtor in optic neuropathies is estimated at $7 billion in the U.S., with no current available therapies [2][4]

Core Insights - Oculis Holding AG is advancing its late-stage portfolio in neuro-ophthalmology and ophthalmology, entering a pivotal phase for growth and innovation [2][9] - The company is set to present at multiple investor conferences in November, highlighting its commitment to engaging with investors [4][5][6][7] Company Developments - Oculis is progressing its Privosegtor program into registrational trials for acute optic neuritis and non-arteritic anterior ischemic optic neuropathy (NAION) after a positive meeting with the FDA [2] - Topline results for OCS-01, targeting diabetic macular edema, are expected in Q2 2026 as part of its DIAMOND registrational trials [2] - Licaminlimab is anticipated to enter the PREDICT-1 registrational trial for dry eye disease (DED), marking a significant step in precision medicine [2][9] Financial Position - The company maintains a strong balance sheet and a robust pipeline, positioning it to deliver six pivotal readouts with current funding [3] Upcoming Events - Oculis will participate in the Guggenheim Securities 2nd Annual Healthcare Innovation Conference from November 10-12, featuring a fireside chat with the CEO [4] - The Stifel Healthcare Conference will take place from November 11-13, with another fireside chat scheduled [5] - Management will also engage in one-on-one meetings at the LifeSci Capital and Sofinnova Partners Growth & Innovation Summit on November 17 [6] - A panel discussion featuring the CEO is planned for the ICR Healthcare Conference on November 17 [7]

Core Insights - Oculis Holding AG is advancing its late-stage portfolio in neuro-ophthalmology and ophthalmology, entering a pivotal phase to become a leader in these fields [2][8] - The company is preparing for registrational trials for its key product candidates, including Privosegtor for acute optic neuritis and NAION, with positive feedback from the FDA [2][8] - Oculis has a strong balance sheet and is positioned to deliver six pivotal readouts with current funding, aiming to improve eye care with innovative treatments [3] Upcoming Events - Oculis management will participate in several investor conferences in November, including the Guggenheim Securities Healthcare Innovation Conference and the Stifel Healthcare Conference [4][5] - Riad Sherif, M.D., CEO of Oculis, will engage in fireside chats and panel discussions at these conferences, providing insights into the company's strategies and developments [4][5][7] - The company will also hold one-on-one meetings with investors during these events, facilitating direct engagement [6][7] Product Pipeline - Oculis' late-stage clinical pipeline includes three core product candidates: - Privosegtor, targeting optic neuropathies with broad clinical applications [8] - OCS-01, aiming to be the first non-invasive topical treatment for diabetic macular edema, with topline results expected in Q2 2026 [2][8] - Licaminlimab, a novel anti-TNFα treatment for dry eye disease, developed with a genotype-based approach [2][8]