Core Insights - Oculis Holding AG is advancing its late-stage pipeline, particularly focusing on Privosegtor and OCS-01, which address significant unmet medical needs in ophthalmology and neuro-ophthalmology [1][6] Group 1: Privosegtor - Privosegtor has received breakthrough therapy designation from the U.S. FDA for treating optic neuritis, based on positive results from the ACUITY Phase 2 trial [2][10] - In the ACUITY trial, patients receiving Privosegtor showed an average gain of 18 letters in vision improvement compared to placebo, indicating a clinically meaningful two-fold improvement in visual resolution [3] - The PIONEER program has been launched to support registration for Privosegtor in optic neuritis and non-arteritic anterior optic neuropathy (NAION), with a potential market opportunity exceeding $7 billion in the U.S. [4][7] Group 2: OCS-01 - OCS-01 is in Phase 3 development as the first eye drop treatment for diabetic macular edema (DME), targeting a market opportunity of approximately $3 billion in the U.S. [5][15] - The diagnosed DME population in the U.S. is estimated to be around 1.8 million, highlighting the significant unmet medical need for effective treatments [5] - Topline results from the DIAMOND Phase 3 trials for OCS-01 are expected in Q2 2026, with an NDA submission planned for Q4 2026 [5][6] Group 3: Market Potential - The combined market potential for Oculis' neuroprotective therapies and DME treatments could exceed $30 billion, reflecting the substantial unmet needs in these areas [6][10] - The company is positioned to transform treatment landscapes in neuro-axonal diseases and diabetic eye conditions, which currently lack effective therapies [6][15]

Core Insights - Oculis Holding AG announced that its neuroprotective drug, Privosegtor, has received Breakthrough Therapy Designation from the FDA for the treatment of optic neuritis, addressing significant unmet medical needs in this area [1][7]. Company Overview - Oculis is a global biotechnology company focused on innovation for treating eye diseases, with a pipeline that includes three key development drugs: Privosegtor, OCS-01, and Licaminlimab [15]. - The company is headquartered in Switzerland and has operations in the United States and Iceland, backed by leading global healthcare investment funds [15]. Drug Development and Market Opportunity - Privosegtor is a small molecule peptide mimic that can cross the blood-brain and retinal barriers, potentially becoming the first neuroprotective treatment for optic nerve disorders, with a combined market opportunity of over $7 billion in the U.S. alone [2][5]. - The ACUITY Phase 2 study demonstrated significant improvements in visual acuity with Privosegtor, showing an average increase of 18 letters on the ETDRS visual acuity scale compared to placebo after three months [4][7]. Clinical Trial Insights - The ACUITY study involved 36 eligible patients aged 18 to 60 with recent onset optic neuritis, comparing Privosegtor with placebo alongside intravenous steroids [12][13]. - Results indicated that Privosegtor not only improved visual acuity but also maintained the structural integrity of the retina and optic nerve, which typically suffer damage during acute optic neuritis [4][9]. Regulatory Status - The Breakthrough Therapy Designation is intended to expedite FDA review for drugs that show substantial improvement over existing treatments for serious conditions [14]. - Following a successful meeting with the FDA in 2025, Oculis initiated the PIONEER program, which includes three registration studies to support the approval of Privosegtor for optic neuritis and NAION [5][6].

Core Insights - Oculis Holding AG's neuroprotective candidate Privosegtor has received Breakthrough Therapy Designation from the FDA for the treatment of optic neuritis, highlighting its potential as a first-of-its-kind therapy in this area [1][7]. Company Overview - Oculis is a global biopharmaceutical company focused on innovations in neuro-ophthalmology and ophthalmology, with a late-stage clinical pipeline that includes Privosegtor, OCS-01, and Licaminlimab [15]. Product Details - Privosegtor is a novel peptoid small molecule designed to penetrate both the blood-brain and retinal barriers, potentially addressing significant unmet medical needs in optic neuropathies, with a market opportunity estimated at $7 billion in the U.S. alone [2][5]. - The drug has shown substantial improvements in visual function, with an average gain of 18 letters in Low Contrast Visual Acuity (LCVA) compared to placebo in the Phase 2 ACUITY trial [4][7]. Clinical Trial Insights - The ACUITY trial demonstrated that Privosegtor not only improved visual function but also preserved anatomical structures of the retina and optic nerve, indicating its neuroprotective potential [3][4]. - The trial involved 36 patients with acute optic neuritis, showing that those treated with Privosegtor alongside IV methylprednisolone experienced significant visual improvements [12]. Regulatory and Market Implications - Following a successful meeting with the FDA, Oculis initiated the PIONEER program, which includes three pivotal trials aimed at supporting registration plans for Privosegtor in optic neuritis and non-arteritic anterior ischemic optic neuropathy (NAION) [5][6]. - The unmet medical needs in these conditions are significant, as there are currently no approved neuroprotective therapies available [10][11].

Summary of Oculis Holding Conference Call Company Overview - Oculis Holding is an ophthalmology company that has transitioned to include neuro-ophthalmology as a key focus area, with two franchises: neuro-ophthalmology and ophthalmology [2][4] Key Programs and Indications Neuro-Ophthalmology - **Privosegtor**: A product showing promising results in treating acute optic neuritis, which is often a relapse of multiple sclerosis (MS). The product demonstrated an 18-letter improvement in visual function at three months compared to placebo plus steroid, and a 15-letter improvement at six months [8][9] - **Market Potential**: The total population of optic neuropathies in the US is estimated at 60,000-70,000 patients annually, with a potential market size of $7 billion due to the lack of competition [12] Ophthalmology - **DME (Diabetic Macular Edema)**: Oculis has two candidates in phase three trials, with the first eye drop for DME expected to read out in Q2 2026. The product targets two segments: early first-line patients (60% of diagnosed DME) and those not responding to VEGF treatments (40%) [4][12] Clinical Trials and Regulatory Support - **Pioneer Program**: Includes three clinical trials (Pioneer One, Two, and Three) targeting acute optic neuritis and NAION (Non-Arteritic Anterior Ischemic Optic Neuropathy). The FDA is supportive of the program, recognizing its potential impact [10][38] - **Enrollment and Community Support**: The medical community shows strong interest in participating in trials, with a response rate exceeding 20% from centers approached for participation [31][32] Product Development and Market Strategy - **OCS-01 for DME**: The product is designed to be a topical solution that allows for early intervention, potentially changing patient outcomes significantly compared to existing treatments [66][68] - **OCS-02 for Dry Eye Disease**: This product is being developed as a personalized medicine, targeting TNF-R1 positive patients, which could lead to a more efficient trial process and higher probability of success [96][97] Financial and Business Implications - The company anticipates significant business opportunities from its neuro-ophthalmology products, particularly given the lack of existing treatments and the high unmet medical need [12][38] - The innovative approach to personalized medicine in dry eye disease is expected to enhance market access and pricing strategies [97] Conclusion - Oculis Holding is positioned to make substantial advancements in both neuro-ophthalmology and ophthalmology, with promising clinical data and strong market potential. The company's focus on innovative treatments and personalized medicine could lead to transformative outcomes for patients and significant business growth [12][96]

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]

Core Viewpoint - Oculis Holding AG has announced the pricing of an offering of 5,432,098 ordinary shares at $20.25 per share, aiming to raise a total of $110 million before expenses, to support the development of its neuroprotective clinical candidate, Privosegtor, and for general corporate purposes [1][2]. Group 1: Offering Details - The financing consists of an underwritten offering of 4,691,358 ordinary shares and a registered direct offering of 740,740 ordinary shares, with the total expected to close around November 3, 2025 [3]. - Of the shares being offered, 2,635,801 are new shares issued from the Company's existing capital band, while 3,500,000 are treasury shares [3]. - The issuance of new shares will increase the total number of registered shares authorized by the Company to 57,169,475 [3]. Group 2: Use of Proceeds - The net proceeds from the financing will be utilized to advance the development of Privosegtor for treating acute optic neuritis (AON) and non-arteritic anterior ischemic optic neuropathy (NAION), along with working capital and general corporate purposes [2]. Group 3: Management and Advisors - J.P. Morgan, Leerink Partners, and Pareto Securities are acting as joint bookrunning managers for the underwritten offering, while Van Lanschot Kempen is the manager and Arctica Finance serves as a financial advisor [4]. Group 4: Company Overview - Oculis is a global biopharmaceutical company focused on innovations in neuro-ophthalmic conditions, with a late-stage clinical pipeline that includes three core product candidates: Privosegtor, OCS-01, and Licaminlimab [6]. - The company is headquartered in Switzerland and operates in the U.S. and Iceland, led by an experienced management team supported by international healthcare investors [6].

Core Insights - Oculis Holding AG is showcasing its innovative late-stage pipeline at Eyecelerator and the American Academy of Ophthalmology (AAO) Annual Meeting, highlighting significant advancements in treatments for ophthalmic diseases [1][2]. Company Developments - The CEO of Oculis, Riad Sherif, will present updates on the late-stage pipeline, including the acceleration of Privosegtor into registrational trials for acute optic neuritis and non-arteritic anterior ischemic optic neuropathy after a positive FDA meeting [2]. - The Phase 3 DIAMOND program for OCS-01 eye drops targeting diabetic macular edema is expected to provide topline readouts in Q2 2026 [2]. - A registrational trial for Licaminlimab in dry eye disease is anticipated to start in Q4 2025, utilizing a genotype-based approach [2]. Industry Context - Oculis is actively participating in multiple events at the AAO, including discussions on the role of eye drops like OCS-01 in treating diabetic macular edema, indicating a shift towards non-invasive treatment options [3][4]. - The company’s pipeline includes Privosegtor, which has shown neuroprotective effects in acute optic neuritis, and OCS-01, which aims to transform treatment paradigms for diabetic macular edema [6][10]. Product Information - Privosegtor is a novel peptoid small molecule candidate with potential applications in neuro-ophthalmic diseases, having received Orphan Drug designation from both the FDA and EMA [6]. - OCS-01 is an investigational high-concentration dexamethasone eye drop designed to treat diabetic macular edema non-invasively, addressing limitations of current treatments that require invasive delivery methods [10][12]. Market Need - There is a significant unmet medical need for effective treatments for conditions like acute optic neuritis and diabetic macular edema, with millions affected globally [8][12].

Core Insights - Oculis Holding AG is showcasing its innovative late-stage pipeline at Eyecelerator and the American Academy of Ophthalmology (AAO) Annual Meeting, highlighting significant advancements in treatments for ophthalmic diseases [1][2]. Company Developments - The CEO of Oculis, Riad Sherif, will present updates on the late-stage pipeline, including the acceleration of Privosegtor into registrational trials for acute optic neuritis and non-arteritic anterior ischemic optic neuropathy after a positive FDA meeting [2]. - The Phase 3 DIAMOND program for OCS-01 eye drops targeting diabetic macular edema is expected to provide topline readouts in Q2 2026 [2]. - A registrational trial for Licaminlimab in dry eye disease is anticipated to start in Q4 2025, utilizing a genotype-based approach [2]. Industry Participation - Oculis will participate in multiple events at the AAO, including Innovate Retina and the Society for Artificial Intelligence in Vision and Ophthalmology (SAIVO), discussing the future of eye drop treatments for diabetic macular edema [3][4]. - The company will also support the COPhy Satellite Symposium during the AAO Annual Meeting [5]. Product Pipeline - Privosegtor is a novel peptoid small molecule candidate showing potential as the first neuroprotective therapy for acute optic neuritis, with positive results from the ACUITY Phase 2 trial indicating neuroprotective effects [7]. - OCS-01 is an investigational high-concentration dexamethasone eye drop designed to treat diabetic macular edema non-invasively, aiming to transform treatment paradigms in this area [11][12]. - Licaminlimab is being developed as a topical anti-TNFα treatment for dry eye disease, currently in Phase 2 trials [14]. Market Context - Diabetic macular edema affects approximately 37 million people globally, with projections indicating an increase to 53 million by 2040, highlighting the urgent need for effective treatments [13]. - Acute optic neuritis and non-arteritic anterior ischemic optic neuropathy represent significant unmet medical needs, with no approved therapies currently available [9][10].