Oculis Holding Update Summary Company Overview - **Company**: Oculis Holding AG - **Ticker**: NasdaqGM: OCS - **Industry**: Biopharmaceuticals focusing on neuro-ophthalmology - **Market Potential**: Over $25 billion in neuro-ophthalmology with specific indications for OCS-05 targeting acute optic neuritis (AON) and non-arteritic anterior ischemic optic neuropathy (NAION) [4][12][14] Key Developments - **FDA Interaction**: Successful meeting with the U.S. FDA allowing OCS-05 to advance into the registration phase for AON and NAION [5][6] - **Registration Trials**: - **Pioneer 1**: Planned to start in Q4 2025 for AON - **Pioneer 2**: Planned to start in the first half of 2026 for AON - **Pioneer 3**: Planned to start in mid-2026 for NAION [6][7][15] Clinical Trial Design - **Pioneer Trials**: - Pioneer 1 and 2 will mirror the successful Phase 2 Acuity trial with the same dose and patient population [6][9] - Primary endpoint: Change from baseline in Low Contrast Visual Acuity (LCVA) at month three [10][12] - Secondary endpoints include the proportion of 15-letter gainers at month three and change from baseline in LCVA at month six [10][12] Market Opportunity - **Acute Optic Neuritis (AON)**: - Estimated 30,000 cases per year in the U.S. - Potential market size of over $3 billion with treatment costs between $100,000 to $400,000 per year [12][13] - **Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)**: - Estimated 30,000 to 35,000 cases per year in the U.S. - Potential market size of over $4 billion [14][15] Financial Position - **Balance Sheet**: Strong with no debt and cash runway extending to the end of 2027 without utilizing loan facilities [5] Strategic Focus - **Pipeline**: Multiple pivotal milestones focusing on significant unmet medical needs in neuro-ophthalmology [15][16] - **Future Plans**: - Launching Predict, a Phase 3 trial in genotype-based development for dry eye [15] - Aiming to leverage data from AON trials for potential MS relapse indications [9][15] Regulatory and Clinical Insights - **Regulatory Pathway**: Full alignment with FDA on trial designs and IND submissions for both AON and NAION [5][6] - **Patient Population**: Trials will include both MS and non-MS patients, with a focus on all-comers for AON [9][12] - **Treatment Window**: Treatment should ideally start within 12 days of symptom onset, with an average of 9.5 days observed in previous studies [61] Community Engagement - **Feedback from Neuro-Ophthalmologists**: Positive reception and engagement from the medical community regarding OCS-05, with plans for strong presence at upcoming medical congresses [73][74] Conclusion - Oculis is positioned to be a leader in neuro-ophthalmology with a robust pipeline and significant market opportunities in AON and NAION, aiming to address critical unmet medical needs while maintaining a strong financial foundation [15][16][60]

Privosegtor Development and Clinical Trials - Privosegtor is advancing to registrational programs in Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)[8] - PIONEER-1 registrational trial for AON is scheduled to start in Q4 2025[9, 16] - PIONEER-2 registrational trial for AON is scheduled to start in 1H 2026[9, 16] - PIONEER-3 registrational trial for NAION is scheduled to start in mid-2026[9, 16] - The registrational trials PIONEER-1 and PIONEER-2 in AON will enroll 140-160 patients[17] Market Opportunity and Potential - The overall portfolio has a significant market potential of approximately $25 billion[8] - The U S market potential for Acute Optic Neuritis (AON) is estimated to be over $3 billion, with an incidence of over 30,000 patients per year[30, 31] - The U S market potential for Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) is estimated to be over $4 billion, with an incidence of over 30,000 patients[43, 45] Oculis' Strategy and Pipeline - Oculis plans to cross-reference the Privosegtor AON IND for a new IND submission in MS Relapses in 2026[15, 50] - OCS-01 eye drops are in registrational trials with readouts anticipated in Q2 2026, potentially as the first non-invasive treatment for DME[8, 50] - Oculis has a strong balance sheet with no debt and a cash runway into 2H 2027 without utilizing the loan facility[8]

Core Insights - Oculis Holding AG has advanced its candidate Privosegtor into a registrational program for neuro-ophthalmology indications following a positive meeting with the FDA, marking a significant milestone for the company [2][3][7] - The PIONEER Program will include multiple global trials aimed at supporting registrations for Privosegtor in Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) [1][3][5] Company Overview - Oculis is a global biopharmaceutical company focused on innovations addressing neuro-ophthalmic diseases with significant unmet medical needs [2][16] - The company is led by an experienced management team and supported by international healthcare investors [16] Product Development - Privosegtor is a novel peptoid small molecule candidate that has the potential to be the first neuroprotective therapy for AON and NAION [3][12] - The PIONEER program will consist of three pivotal trials: PIONEER-1 and PIONEER-2 for AON, and PIONEER-3 for NAION, with the first trial expected to start in Q4 2025 [4][5][8] Clinical Trials - PIONEER-1 and PIONEER-2 will evaluate Privosegtor in patients with AON, measuring low-contrast visual acuity at 3 months as the primary endpoint [4][5] - PIONEER-3 will evaluate Privosegtor after the acute onset of NAION, sharing core design elements with the other two trials [5] Market Potential - AON and NAION are rare neuro-ophthalmic diseases with high unmet medical needs for therapies that can provide neuroprotection and preserve vision [6][15] - The CEO of Oculis highlighted that the PIONEER program positions the company as a leader in ophthalmic neuroprotection drug development, targeting multi-billion-dollar markets [7][12] Financial Position - As of September 30, 2025, Oculis reported approximately $182 million in cash, cash equivalents, and short-term investments, with a cash runway expected into the second half of 2027 [9]

Core Points - The notification pertains to trades executed by a Person Discharging Managerial Responsibilities (PDMR) of the Company under a 10b5-1 trading plan [1] - The trades were conducted in compliance with Rule 10b5-1(c)(1) of the Securities Exchange Act of 1934, as amended [1] Summary by Category - **Company Actions** - A PDMR of the Company has entered into trades as per a 10b5-1 trading plan [1] - **Regulatory Compliance** - The trades are in accordance with Rule 10b5-1(c)(1) of the Securities Exchange Act of 1934 [1]

Company Overview - Oculis Holding AG (OCS) shares increased by 6.7% to close at $17.73, following a period of 6.9% loss over the past four weeks, indicating a significant shift in investor sentiment [1][2]. Product Development - The rise in stock price is linked to growing optimism regarding three product candidates: OCS-01 for diabetic macular edema, OCS-05 for acute optic neuritis, and OCS-02 for personalized medicine in dry eye disease [2]. Financial Expectations - The company is projected to report a quarterly loss of $0.50 per share, reflecting a year-over-year increase of 9.1%. Expected revenues are $0.25 million, down 1.6% from the previous year [3]. - The consensus EPS estimate has been revised 7.3% higher in the last 30 days, suggesting potential price appreciation in the future [4]. Industry Context - Oculis Holding AG operates within the Zacks Medical - Biomedical and Genetics industry, where another company, Incyte (INCY), experienced a 2.1% decline in its stock price [5]. - Incyte's EPS estimate has increased by 0.4% to $1.64, representing a year-over-year change of 53.3% [6].

Core Insights - Oculis Holding AG announced positive results from the Phase 2 ACUITY trial for Privosegtor (OCS-05) in treating acute optic neuritis, showing improved low contrast visual acuity and preservation of retinal ganglion cells [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 three core product candidates: OCS-01, Privosegtor (OCS-05), and Licaminlimab (OCS-02) [6] Trial Details - The ACUITY trial was a multicenter randomized placebo-controlled double-masked study, with results indicating a clinically meaningful improvement in vision by 18 letters at 3 months, alongside a favorable safety profile [2][3] - The trial results will be presented at the ECTRIMS 2025 Congress, highlighting the potential of Privosegtor in neuroprotection and its applicability in various neurological diseases [2] Drug Information - Privosegtor (OCS-05) is a novel peptoid small molecule candidate with neuroprotective properties, showing anatomical preservation of the retina and improvements in visual function in patients with acute optic neuritis [3][4] - The drug has received orphan drug designation from both the FDA and EMA for acute optic neuritis, indicating its potential for broader applications in neuro-ophthalmic and neurological conditions [3] Condition Overview - Acute optic neuritis is a rare condition affecting up to 8 in 100,000 people globally, often serving as the first sign of multiple sclerosis, primarily affecting adults aged 20 to 40, with a higher prevalence in women [5]

Financial Data and Key Metrics Changes - The company has a cash runway that extends to the beginning of 2028, which will support the completion of the DME program and the first phase three trial for acute optic neuritis [68] - The company expects readout for the Diamond studies in Q2 next year, with over 800 patients enrolled [8][10] Business Line Data and Key Metrics Changes - OCS-01 is in phase three for DME, showing a 7.26 letter gain at week 12 in BCVA, with over 27% of patients gaining more than 15 letters [8][11] - OCS-02 (Licaminlimab) targets dry eye disease with a unique genotype-based development approach, aiming to address the unmet need where 86% of patients are dissatisfied with current treatments [50][53] - OCS-05 (Privosegtor) has shown significant results in acute optic neuritis, with an 18-letter gain in LCVA at the primary endpoint [32][34] Market Data and Key Metrics Changes - In the U.S., 60% of diagnosed DME patients are untreated, representing a significant market opportunity [10] - The potential patient population for OCS-01 includes 1.3 million diagnosed but untreated patients in the U.S. [11] - The dry eye market has around 30 to 35 million patients in the U.S., with 2 million being TNFR1 positive and moderate to severe [54] Company Strategy and Development Direction - The company aims to leverage its unique technologies to address significant unmet medical needs in ophthalmology and neuro-ophthalmology [70] - The strategy includes focusing on early treatment for DME and addressing patients who do not respond to anti-VEGF therapies [23][25] - The company plans to broaden its neuro-ophthalmic programs beyond acute optic neuritis to include other relapses of multiple sclerosis [43] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing trials and the unique positioning of their products in the market [9][70] - The company is optimistic about the upcoming discussions with the FDA regarding the registrational trial for Privosegtor [38] - Management highlighted the importance of patient compliance, noting an 85% compliance rate in phase two trials for OCS-01 [20] Other Important Information - The company has a clear plan for the development of Licaminlimab, with a focus on a genotype-based approach to improve the probability of success in clinical trials [53] - The company is preparing for the launch of DME and subsequent trials for dry eye and multiple sclerosis relapses, pending FDA feedback [68] Q&A Session Summary Question: Can you discuss the results of the Diamond stage one? - The Diamond stage one showed a 7.26 letter gain in BCVA at week 12, with 27% of patients gaining more than 15 letters, consistent with anti-VEGF results [8][11] Question: What is the expected compliance for the eye drop regimen? - Compliance was measured at 85% in phase two trials, and management is confident it will remain high in real-world applications [20] Question: How does the company plan to address the unmet need in dry eye disease? - The company aims to leverage a genetic biomarker to identify patients who will respond well to Licaminlimab, addressing the dissatisfaction of 86% of current dry eye patients [50][53] Question: What is the expected timeline for the registrational trial for Privosegtor? - The company plans to clarify next steps with the FDA and hopes to initiate phase three trials as soon as possible [38] Question: How many patients are affected by acute optic neuritis? - There are approximately 30,000 to 35,000 new cases of acute optic neuritis in the U.S. each year, primarily affecting young patients [40]

Summary of Oculis Holding FY Conference Call Company Overview - **Company**: Oculis Holding AG - **Ticker**: NasdaqGM: OCS - **Date of Conference**: September 08, 2025 Key Clinical Programs 1. **OCS-01 for Diabetic Macular Edema (DME)** - First eye drop treatment for DME, currently in Phase 3 with enrollment completed - Expected readout in Q2 2026 - Market potential in the U.S. is estimated at $3 billion, targeting a patient pool twice the size of current treatments [3][4] - Primary endpoint: mean change of Best Corrected Visual Acuity (BCVA) compared to placebo [10] - Secondary endpoint: percentage of patients gaining 15 letters in BCVA [10] - Positioned as a first-line treatment for DME [13] 2. **OCS-02 (Licaminlimab) for Dry Eye Disease** - Utilizing a genotype-based approach to identify patients likely to respond to treatment - Current market for dry eye is underserved, with a low renewal rate of first prescriptions at 14% [6][7] - Expected initiation of trials this year, with readout in the second half of next year [40] 3. **OCS-05 (Privosergtor) for Acute Optic Neuritis (AON)** - Phase 2 data showed significant functional improvement, with an 18-letter difference in vision [5] - Plans to consult with the FDA regarding registration for AON and initiate new programs for NAION and MS relapse [6][21] - AON will be the lead indication for Phase 3 trials [23] Market Position and Competitive Landscape - Oculis aims to address unmet medical needs in DME, with over 60% of diagnosed patients currently untreated [11] - OCS-01 shows comparable or superior efficacy to existing treatments like Lucentis and Ozurdex [12] - The company is focused on execution and has clear regulatory support from the FDA [18] Financial Overview - Current cash runway extends to early 2028, financing DME and dry eye trials until NDA submission [42] - The company is exploring potential licensing or co-development opportunities but cannot disclose specifics [41] Upcoming Catalysts - Regulatory clarifications for Privosergtor in AON and IND submissions for NAION and MS relapse [43] - Phase 3 readout for DME expected in the first half of next year and for dry eye in the second half [43] Additional Insights - The company emphasizes the importance of execution in clinical trials, acknowledging inherent risks [18] - The genotype-based approach in ophthalmology is a novel strategy, potentially leading to more efficient trials [37][38] This summary encapsulates the critical points discussed during the conference call, highlighting Oculis Holding's strategic focus on its clinical programs, market positioning, financial health, and upcoming milestones.

Core Insights - Oculis Holding AG announced the winner of the Ramin Tadayoni Award 2025, recognizing contributions in retinal research [1][2] - The award honors Dr. Prithvi Ramtohul for his significant work in retinal imaging and diseases [3][4] - Oculis is committed to advancing retinal research and honoring the legacy of Professor Ramin Tadayoni [4] Company Overview - Oculis is a global biopharmaceutical company focused on innovations for ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs [6] - The company has a late-stage clinical pipeline that 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 [6] - Oculis is headquartered in Switzerland and operates in the U.S. and Iceland, led by an experienced management team [6]

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]