Core Insights - Oculis Holding AG is set to present results from its late-stage clinical trials, including the Phase 2 ACUITY trial for Privosegtor (OCS-05) and expanded data from the Phase 3 DIAMOND program for OCS-01 eye drops, at several upcoming ophthalmology conferences [1][2][3] Company Overview - Oculis is a global biopharmaceutical company focused on innovations for ophthalmic and neuro-ophthalmic diseases, with a late-stage clinical pipeline that includes OCS-01 for diabetic macular edema (DME) and Privosegtor for acute optic neuritis [22] Clinical Trial Highlights - The Phase 2 ACUITY trial for Privosegtor (OCS-05) demonstrated clinically meaningful visual function improvement and anatomical neuroprotection in patients with acute optic neuritis, indicating potential applications in various retinal and neurological conditions [3][19] - The Phase 3 DIAMOND program for OCS-01 eye drops aims to evaluate efficacy and safety in DME patients, with over 800 patients enrolled across two pivotal trials [18] Upcoming Presentations - Oculis will present at the Ophthalmology Futures Retina Forum and the EURETINA Congress, with specific sessions focusing on the efficacy and safety outcomes of OCS-01 in DME, highlighting its potential benefits for different patient profiles [2][9][10] Awards and Recognition - The annual Ramin Tadayoni Award, established by EURETINA in partnership with Oculis, will be announced during the EURETINA opening ceremony, recognizing outstanding postgraduate scholars in retinal disease research [4]

Core Insights - Oculis Holding AG is a global biopharmaceutical company focused on innovative solutions for ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs [5] - The management team will participate in several investor conferences in September 2025, including the Wells Fargo Healthcare Conference and H.C. Wainwright 27th Annual Global Investment Conference [2][3] Company Overview - Oculis has a differentiated late-stage clinical pipeline with three core product candidates: OCS-01 for diabetic macular edema, Privosegtor (OCS-05) for acute optic neuritis, and Licaminlimab (OCS-02) for dry eye disease [5] - The company is headquartered in Switzerland and has operations in the U.S. and Iceland, led by an experienced management team supported by international healthcare investors [5] Upcoming Events - Key events include: - Wells Fargo Healthcare Conference from September 3-5 in Boston, U.S. [2] - H.C. Wainwright 27th Annual Global Investment Conference from September 8-10 in New York, U.S. [3] - Baird Global Healthcare Conference on September 9-10 in New York, U.S. [3] - Pareto Securities 16th Annual Healthcare Conference on September 16 in Stockholm, Sweden [3] - Leerink Partners Biopharma Summit from September 17-19 in Healdsburg, U.S. [4] - The company will be available for one-on-one meetings during these conferences [4]

Core Insights - Oculis Holding AG has appointed Mark Kupersmith, M.D. as Chief Medical Advisor for Neuro-Ophthalmology and Sebastian Wolf, M.D., Ph.D. as Chief Medical Advisor for Ophthalmology, enhancing its leadership team to drive advancements in ophthalmic and neuro-ophthalmic diseases [1][5][6] Company Developments - Oculis has made significant progress in its clinical pipeline, completing enrollment in Phase 3 DIAMOND trials for OCS-01 targeting diabetic macular edema and aligning with the U.S. FDA on a genotype-based development program for Licaminlimab (OCS-02) in dry eye disease [2][4] - Positive topline results were announced for Privosegtor (OCS-05) in acute optic neuritis, marking a pivotal step towards new therapies for neuronal and axonal preservation [2][4] Leadership Expertise - Mark Kupersmith, M.D. brings over 40 years of experience in neuro-ophthalmology, with a focus on acute optic nerve disorders and significant contributions to clinical research [3][7][8] - Sebastian Wolf, M.D., Ph.D. is a distinguished expert in retina and imaging, with a strong background in clinical and scientific research, particularly in diabetic macular edema [4][10][11] Clinical Pipeline - Oculis' pipeline includes three core product candidates: OCS-01 for diabetic macular edema, Privosegtor (OCS-05) for acute optic neuritis, and Licaminlimab (OCS-02) for dry eye disease, with ongoing late-stage clinical trials [14]

Core Insights - Oculis Holding AG has appointed Mark Kupersmith, M.D. as Chief Medical Advisor for Neuro-Ophthalmology and Sebastian Wolf, M.D., Ph.D. as Chief Medical Advisor for Ophthalmology, enhancing its leadership team during a critical phase of development [1][3][4] Company Developments - Oculis has made significant progress in its clinical pipeline, completing enrollment in Phase 3 DIAMOND trials for OCS-01 targeting diabetic macular edema and aligning with the U.S. FDA on a genotype-based development program for Licaminlimab (OCS-02) in dry eye disease [2][4] - Positive topline results were announced for Privosegtor (OCS-05) in acute optic neuritis, marking a pivotal advancement in neuroprotection therapies [2][6] Leadership Expertise - Mark Kupersmith, M.D. brings over 40 years of experience in neuro-ophthalmology, contributing critical expertise to Oculis' expansion into this field, particularly with the advancements in Privosegtor [3][6] - Sebastian Wolf, M.D., Ph.D. is recognized for his extensive background in retina and imaging, which will support the execution of the DIAMOND program and the development of OCS-01 [4][10] Clinical Pipeline - Oculis' pipeline includes three core product candidates: OCS-01 for diabetic macular edema, Privosegtor (OCS-05) for acute optic neuritis, and Licaminlimab (OCS-02) for dry eye disease, all addressing significant unmet medical needs [13]

分组1 - Oculis Holding AG reported a quarterly loss of $0.59 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.53, and compared to a loss of $0.56 per share a year ago, indicating an earnings surprise of -11.32% [1] - The company posted revenues of $0.32 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 28.54%, and this represents an increase from year-ago revenues of $0.27 million [2] - Oculis Holding AG shares have increased by approximately 3.2% since the beginning of the year, while the S&P 500 has gained 8.7% [3] 分组2 - The earnings outlook for Oculis Holding AG is mixed, with the current consensus EPS estimate for the coming quarter at -$0.54 on revenues of $0.25 million, and for the current fiscal year at -$2.44 on revenues of $0.82 million [7] - The Zacks Industry Rank for Medical - Biomedical and Genetics is in the top 42% of over 250 Zacks industries, indicating that the industry outlook can significantly impact stock performance [8]

Core Insights - Oculis Holding AG reported strong progress in its clinical pipeline, focusing on unmet medical needs in ophthalmology and neuro-ophthalmology, with significant advancements in its key product candidates [2][4][16] Clinical Development - OCS-01 is in pivotal Phase 3 DIAMOND trials, fully enrolled with over 800 patients across 119 global sites, aiming to be the first eye drop treatment for diabetic macular edema (DME), with topline results expected in Q2 2026 [4][5] - Privosegtor (OCS-05) has shown promising Phase 2 ACUITY trial results in acute optic neuritis, indicating significant improvements in visual function and neuroprotective benefits, with plans for a Phase 2/3 trial expected to initiate in 1H 2026 [4][5] - Licaminlimab (OCS-02) is preparing for a genotype-based Phase 2/3 trial in dry eye disease, expected to start in 2H 2025, following positive results from previous studies [4][5] Financial Overview - As of June 30, 2025, Oculis reported cash, cash equivalents, and short-term investments totaling $201.3 million, providing a cash runway into early 2028 [4][6] - Research and development expenses for Q2 2025 were $18.1 million, a decrease from $18.2 million in Q2 2024, primarily due to the timing of completed trials [6][13] - The year-to-date net loss for the first half of 2025 was $67.9 million, compared to $41.5 million for the same period in 2024, driven by advancements in clinical programs and adjustments in warrant liabilities [6][14] Market Potential - DME affects approximately 37 million people globally, representing a market opportunity of around $5 billion, highlighting the significant unmet medical needs for early intervention [5] - The neuroprotective potential of Privosegtor opens opportunities for various neuro-ophthalmology and neurology indications, addressing high unmet needs in these areas [5][16]

Summary of Key Points from the Oculis Holding (OCS) Fireside Chat Industry Overview - The discussion revolves around advancements in therapies for retinal disorders, particularly focusing on dry age-related macular degeneration (AMD), Stargardt disease, retinitis pigmentosa, and diabetic macular edema (DME) [1][2][3][4][5]. Core Insights and Arguments Unmet Medical Needs - There is a pressing need for effective treatments for retinal disorders, especially for conditions like dry AMD, geographic atrophy (GA), and retinitis pigmentosa [3][4]. - Gene therapy has shown promise in treating inherited retinal diseases, with Luxturna being a notable example for RPE65 mutations [4]. Clinical Endpoints and Biomarkers - Key clinical endpoints for evaluating therapies include best corrected visual acuity, contrast sensitivity, and anatomical biomarkers assessed through OCT imaging [5][6][7]. - The ellipsoid zone is highlighted as a critical marker for photoreceptor health, with advancements in OCT technology enhancing its assessment [56]. Adoption Factors for Novel Therapies - Factors influencing the adoption of new retinal therapies include ease of administration, patient compliance, and payer reimbursement challenges [9][10][11][12]. - Non-invasive treatments, such as topical eye drops, are favored due to their convenience compared to invasive procedures like intravitreal injections [41][42]. Specific Drug Mechanisms and Developments - **Elamipretide** targets mitochondrial dysfunction in dry AMD, aiming to protect at-risk photoreceptors and potentially improve vision [14][15][16][20]. - **Telarabine** is designed to reduce toxic bisretinoids in Stargardt disease and GA, addressing a significant unmet need as there are currently no approved therapies for Stargardt disease [23][24][30]. - **MCO-10** is a mutation-agnostic gene therapy for retinitis pigmentosa and Stargardt disease, utilizing optogenetics to restore vision by targeting remaining bipolar cells [32][33][34]. Regulatory and Commercial Considerations - The FDA has provided feedback indicating that targeting mitochondria to reduce photoreceptor loss is an acceptable strategy for dry AMD treatment [18][19]. - The breakthrough therapy designation for telarabine is expected to facilitate a faster regulatory pathway, with an NDA submission anticipated in the first half of the following year [31][83]. Important but Overlooked Content - The socioeconomic factors affecting patient compliance and access to treatments are significant, with many patients facing logistical challenges in attending frequent treatment sessions [12][11][52]. - The potential for combination therapies, where different mechanisms may work synergistically, is acknowledged but requires further exploration [70][74]. Conclusion - The ongoing developments in retinal therapies present significant opportunities for addressing unmet medical needs in various retinal disorders. The focus on patient-centric approaches, including non-invasive delivery methods and robust clinical endpoints, is crucial for the successful adoption of these therapies in clinical practice [80][81].

Summary of Oculus Conference Call Company Overview - Oculus is a global biopharma company listed on Nasdaq, focusing on innovative ophthalmology and neuro-ophthalmology candidates targeting significant market opportunities [3][4] Core Assets 1. **OCS-01 (OptiReach)**: A high concentration dexamethasone eye drop for diabetic macular edema (DME), currently in phase three with readout expected in 2026 [3][4] 2. **Privelceptor (OCS-05)**: A first-in-class neuroprotective candidate for acute optic neuritis, currently in development [4][13] 3. **Lickamenimab (OCS-02)**: A novel topical anti-TNF candidate for dry eye disease, starting phase two/three trials in the second half of the year [4][28] Market Insights - **Diabetic Macular Edema (DME)**: - Affects 37 million patients globally, expected to grow to over 50 million by 2045 [6] - Current treatments are invasive, leading to low patient compliance; 56% of diagnosed patients are untreated [6][7] - The U.S. addressable patient population for OCS-01 is estimated at 1.3 million, with a market value of approximately $3 billion [12] - **Acute Optic Neuritis (AON)**: - No approved treatments currently exist; estimated 65,000 patients in the U.S. [15] - High unmet need for neuroprotective therapies [16][24] - **Multiple Sclerosis (MS)**: - Affects approximately 2.8 million worldwide, with a market valued above $20 billion [24] - Oculus aims to address relapses and neuroprotection during acute periods [25] - **Dry Eye Disease**: - A large and unsatisfied market; only 13% of patients experience lasting relief after 12 months [30] - Lickamenimab shows five times better efficacy in signs and seven times better in symptoms for patients with the TNF-R1 genotype [31][32] Clinical Trial Results - **OCS-01**: - Achieved 7.6 letter gains in best corrected visual acuity (BCVA) at week 12 [11] - 27.4% of patients had a 15-letter gain by week 12 [11] - Well tolerated with no unexpected adverse events [11] - **Privelceptor**: - Achieved primary safety endpoint and significant improvements in visual function and neuroprotection in the ACQUITY trial [20][21] - 43% improvement in GCIPL thickness and 30% in RNFL thickness at month six [20][21] - **Lickamenimab**: - Demonstrated rapid treatment effects in both signs and symptoms of dry eye disease [31] - Well tolerated with low incidence of adverse events [34] Future Plans - Anticipate top-line results from OCS-01 phase three program in 2026, with NDA filing in the second half of 2026 [41] - Plans to initiate phase two/three trials for AON and dry eye disease in upcoming quarters [41] - Strong balance sheet to support ongoing development activities [41] Conclusion - Oculus is positioned with a robust portfolio of differentiated products addressing significant unmet needs in ophthalmology and neuro-ophthalmology [40] - Upcoming catalysts across multiple assets and indications are expected to drive growth and shareholder value [40][41]

Core Insights - Oculis Holding AG is participating in the H.C Wainwright 5th Annual Ophthalmology Virtual Conference on August 13, 2025, highlighting its focus on ophthalmic and neuro-ophthalmic conditions with significant unmet medical needs [1][4] Company Overview - Oculis is a global biopharmaceutical company with a focus on innovations for ophthalmic and neuro-ophthalmic conditions [4] - The company has a differentiated late-stage clinical pipeline that includes three core product candidates: - OCS-01, an eye drop in pivotal registration studies aimed at becoming the first non-invasive topical treatment for diabetic macular edema - Privosegtor (OCS-05), a neuroprotective candidate in Phase 2 for acute optic neuritis, with potential applications in various neuro-ophthalmic and neurological diseases - Licaminlimab (OCS-02), a novel topical anti-TNFα in Phase 2, developed with a genotype-based approach for personalized medicine in dry eye disease [4] Upcoming Events - Sylvia Cheung, CFO of Oculis, will present a corporate update available for replay via webcast at 7:00am ET - Snehal Shah, President of R&D, will participate in a live panel discussion on Pivotal-Stage Assets for Retinal Disorders from 11:00am to 12:00pm ET, which will also be available for replay [5]

Company Overview - Oculis Holding AG is a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic conditions with significant unmet medical needs [3] - The company has a differentiated late-stage clinical pipeline that includes three core product candidates: OCS-01, OCS-05, and OCS-02 [3] Product Pipeline - OCS-01 is an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema [3] - OCS-05 is a neuroprotective candidate in Phase 2 for acute optic neuritis, with potential applications in various neuro-ophthalmic and neurological diseases [3] - OCS-02 is a novel topical anti-TNFα in Phase 2, developed with a genotype-based approach for personalized medicine in dry eye disease [3] Upcoming Events - Oculis management will participate in the H.C. Wainwright 5th Annual Ophthalmology Virtual Conference on August 13, 2025 [1] - A corporate update presentation will be available for replay via webcast at 7:00am ET, and a live panel discussion on pivotal-stage assets for retinal disorders will occur from 11:00am to 12:00pm ET [4]