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]

Core Viewpoint - Oculis Holding AG has amended its loan facility with BlackRock, increasing its borrowing capacity to CHF 75 million, potentially up to CHF 100 million, providing significant financial flexibility as the company advances its clinical pipeline and prepares for key regulatory milestones [1][2][3][4]. Financial Agreement - The Amended Loan Agreement replaces a previous loan agreement from May 29, 2024, and includes three tranches of CHF 25 million each, with an additional loan of up to CHF 25 million available under mutually agreed terms [2]. - No amounts were drawn at the signing of the agreement, indicating that the company is maintaining its current cash reserves while securing additional funding [2]. Clinical Development and Milestones - The additional capital will support Oculis in achieving key milestones, including regulatory discussions with the FDA for three indications of Privosegtor (OCS-05) in the second half of 2025, and the initiation of Phase 2/3 trials for Licaminlimab (OCS-02) and Privosegtor (OCS-05) in 2H 2025 and 1H 2026, respectively [3]. - The company anticipates topline results from the OCS-01 Phase 3 DIAMOND trials in Q2 2026, with a potential NDA filing in 2H 2026 if results are positive [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 three core product candidates: OCS-01, Privosegtor (OCS-05), and Licaminlimab (OCS-02) [5]. - 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 [5].

Core Points - Oculis Holding AG held its 2025 Annual General Meeting on June 4, 2025, where all agenda items were approved by shareholders [1] - The company reported a standalone statutory financial loss of CHF 5,179,000 for the financial year ended December 31, 2024, with an accumulated balance sheet loss of CHF 46,577,000 to be carried forward [2] - The Board of Directors and Executive Committee received discharge for their activities in 2024 [2] Board and Compensation - Anthony Rosenberg was re-elected as chairperson of the Board of Directors, along with the re-election of other board members and the Compensation Committee [3] - PricewaterhouseCoopers SA was re-elected as Statutory Auditors, and PST Legal AG was re-elected as Independent Proxy [3] - Shareholders approved the compensation for non-executive members of the Board of Directors and the Executive Committee, along with a non-binding advisory vote on the 2024 Compensation Report [4][8] Capital and Share Issuance - A capital band of 27,266,837 registered shares was approved, resulting in a capital band between CHF 545,336.74 and CHF 818,005.11 [5] - Conditional share capital for employees and individuals in comparable positions was approved, allowing for the issuance of 12,480,000 registered shares with a maximum amount of CHF 124,800 [6] Company Overview - Oculis is a global biopharmaceutical company focused on innovations for ophthalmic and neuro-ophthalmic diseases, with a pipeline including OCS-01 for diabetic macular edema, OCS-05 for acute optic neuritis, and OCS-02 for dry eye disease [7]

Company Overview - Oculis Holding AG is a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs [4] - The company has a differentiated pipeline including OCS-01 for diabetic macular edema, Privosegtor (OCS-05) for acute optic neuritis, and Licaminlimab (OCS-02) for dry eye disease [4] - Oculis is headquartered in Switzerland and has operations in the U.S. and Iceland, led by an experienced management team [4] Upcoming Events - Oculis will participate in the Goldman Sachs Annual Healthcare Conference from June 9-11, 2025, in Miami, FL, with a fireside chat featuring CEO Riad Sherif on June 10 from 9:20 to 9:55 am ET [1] - The company will also attend the J.P. Morgan European Healthcare Conference on June 12, 2025, in London, U.K., with opportunities for one-on-one meetings [2] - Webcast links for these events will be available on the Oculis website under the Events & Presentation page [2]

Summary of Oculus Fireside Chat Company Overview - **Company**: Oculus - **Industry**: Ophthalmology and Neuro-Ophthalmology - **Key Focus**: Development of a diversified and unique ophthalmology pipeline addressing unmet needs in ophthalmology and neuro-ophthalmology diseases with novel assets [1][2] Core Assets 1. **OCS O1**: - Based on OptiReach technology, designed for diabetic macular edema (DME) - Targets early intervention and non-responders among the 1.8 million diagnosed patients, with only 500,000 currently treated [4][34] - Aims to address the 1.3 million patients not receiving adequate treatment [4][36] 2. **OCS O2 (Lickamimab)**: - First precision medicine for dry eye disease, targeting patients with TNF R1 genotype - Approximately 10 million patients suffer from moderate to severe dry eye, with 20% having the TNF R1 gene, showing significantly better responses [5][44] 3. **OCS O5 (Privel Sector)**: - A novel neuroprotective treatment for acute optic neuritis, an orphan disease with no current neuroprotective treatments available - Positive data from Phase 2 ACUITY trial showing biological, anatomical, and functional efficacy [6][9][11] Market Dynamics - **DME Market**: - Current treatments are invasive (anti-VEGF and steroid implants), leading to low compliance; 60% of diagnosed patients are untreated [33] - OCS O1 aims to fill the treatment void for early-stage patients and provide a non-invasive option for those already treated [34][36] - **Acute Optic Neuritis**: - Estimated 65,000 patients in the US and Europe, with no approved products currently available [20] - OCS O5 is positioned to improve low contrast visual acuity (LCVA) and preserve neuronal health [20][24] Clinical Development and Regulatory Pathways - **OCS O5**: - Moving towards registrational studies based on positive Phase 2 results, with FDA interactions planned for the second half of the year [27][28] - **OCS O1**: - Phase 3 trial ongoing with over 800 patients, expecting results in Q2 of next year [39][41] - **Dry Eye Program**: - Phase 3 study design approved by the FDA, focusing on TNF R1 positive patients with a primary endpoint of global ocular discomfort score [42][44] Upcoming Catalysts - Regulatory interactions with the FDA for OCS O5 across three indications (acute optic neuritis, MS relapses, NAION) [47] - Top-line results from the DME trial expected in Q2 of next year [48] - Dry eye study results anticipated in the second half of next year [48] Additional Insights - The company emphasizes the importance of non-invasive treatments in improving patient compliance and outcomes in ophthalmology [35][41] - The potential for OCS O5 to expand into other indications beyond acute optic neuritis, such as glaucoma, is acknowledged [18][24]