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OculisD
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2026-08-06
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Investor releaseQuarter not tagged2026-08-06

Oculis Reports Q2 2026 Financial Results and Provides Company Update

GlobeNewswire
ZUG, Switzerland, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Company pivot to neuro-ophthalmology continues with Privosegtor positioned as lead late-stage asset through the registrational PIONEER program with expansion potential in acute multiple sclerosis (MS) relapses following positive FDA pre-IND feedback Enrollment progressing as planned in the PREDICT-1 genotype-based registrational trial of Licaminlimab in dry eye disease with all planned sites activated and >45% patients randomized Cash, cash equivalents, and short-term investments of $282.3 million as of June 30, 2026, providing cash runway into 2H 2029 Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology, today announced results for the second quarter ended June 30, 2026, and provided an overview of the Company’s progress. Riad Sherif, M.D., Chief Executive Officer of Oculis, stated, “We continue to advance and expand the Privosegtor neuroprotection franchise, with PIONEER-1 on track in global site activations and positive regulatory momentum supporting our development strategy in acute multiple sclerosis relapses. Given the considerable unmet need for neuroprotective treatments, these achievements reinforce both our strategy to pivot to neuro-ophthalmology by exploring the clinical potential of Privosegtor and the substantial opportunity across multiple neuro-ophthalmic and neuro-axonal diseases. In parallel, with Licaminlimab PREDICT-1 genotype-based trial planned site activations complete and over 45% of patients enrolled, we expect to report topline results around year-end. With a strong balance sheet, we are well positioned to execute on our strategy, advance our registrational programs and deliver on upcoming value-driving milestones.” Recent Development Highlights and Upcoming Milestones: Privosegtor: Licaminlimab: OCS-01 Q2 2026 Financial Highlights: As of June 30, 2026, Oculis held cash, cash equivalents and short-term investments of CHF 228.3 million or $282.3 million, compared to CHF 213.0 million or $268.7 million as of December 31, 2025. The increase reflects proceeds from sales of ordinary shares year-to-date under the Company’s existing at-the-market offering program, offset by operating expenses. Research and development expenses were CH…Read full document

ZUG, Switzerland, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Company pivot to neuro-ophthalmology continues with Privosegtor positioned as lead late-stage asset through the registrational PIONEER program with expansion potential in acute multiple sclerosis (MS) relapses following positive FDA pre-IND feedback Enrollment progressing as planned in the PREDICT-1 genotype-based registrational trial of Licaminlimab in dry eye disease with all planned sites activated and >45% patients randomized Cash, cash equivalents, and short-term investments of $282.3 million as of June 30, 2026, providing cash runway into 2H 2029 Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology, today announced results for the second quarter ended June 30, 2026, and provided an overview of the Company’s progress. Riad Sherif, M.D., Chief Executive Officer of Oculis, stated, “We continue to advance and expand the Privosegtor neuroprotection franchise, with PIONEER-1 on track in global site activations and positive regulatory momentum supporting our development strategy in acute multiple sclerosis relapses. Given the considerable unmet need for neuroprotective treatments, these achievements reinforce both our strategy to pivot to neuro-ophthalmology by exploring the clinical potential of Privosegtor and the substantial opportunity across multiple neuro-ophthalmic and neuro-axonal diseases. In parallel, with Licaminlimab PREDICT-1 genotype-based trial planned site activations complete and over 45% of patients enrolled, we expect to report topline results around year-end. With a strong balance sheet, we are well positioned to execute on our strategy, advance our registrational programs and deliver on upcoming value-driving milestones.” Recent Development Highlights and Upcoming Milestones: Privosegtor: Licaminlimab: OCS-01 Q2 2026 Financial Highlights: As of June 30, 2026, Oculis held cash, cash equivalents and short-term investments of CHF 228.3 million or $282.3 million, compared to CHF 213.0 million or $268.7 million as of December 31, 2025. The increase reflects proceeds from sales of ordinary shares year-to-date under the Company’s existing at-the-market offering program, offset by operating expenses. Research and development expenses were CHF 15.3 million or $19.3 million for the three months ended June 30, 2026, compared to CHF 14.9 million or $18.1 million in the same period in 2025. General and administrative expenses were CHF 8.6 million or $10.9 million for the three months ended June 30, 2026, compared to CHF 6.1 million or $7.4 million in the same period in 2025. The increase in operating expenses was primarily driven by headcount-related costs, including share-based compensation expenses, to support and execute the Company’s development strategies. The Company’s net loss was CHF 38.8 million or $49.3 million for the six months ended June 30, 2026, compared to CHF 58.6 million or $67.9 million for the same period in 2025. The decrease was primarily due to the fair value gain on warrant liabilities in 2026 driven by decreased market value as well as a favorable foreign currency fluctuation resulting from favorable U.S. dollar versus Swiss Franc for U.S. dollar denominated transactions and assets, compared to a weaker U.S. dollar against the Swiss Franc in the prior year period. Key Upcoming Events: Medical Conferences Asia-Pacific Vitreo-Retina Society (APVRS) Congress; Aug. 28-30, Queensland, Australia The Retina Society 59th Annual Scientific Meeting; Sep. 23-26, Los Angeles, California, U.S. EURETINA 26th Annual Congress; Oct. 1-4, Vienna, Austria MS Toronto 2026 – 10th Joint ACTRIMS-ECTRIMS Meeting; Oct. 21-23, Toronto, Canada Investor Conferences Stifel Biotech Summer Summit; Aug. 10-12, Newport, Rhode Island, U.S. JPM Aspen Summit; Aug. 24-26, Aspen, Colorado, U.S. Pareto Healthcare Conference; Sep. 2, Stockholm, Sweden Wells Fargo Healthcare Conference; Sep. 8-10, Boston, Massachusetts, U.S. HCW Annual Global Investment Conference; Sep. 14-16, New York, New York, U.S. Baird 2026 Global Healthcare Conference; Sep. 15, New York, New York, U.S. Leerink Biopharma Summit; Sep. 23-25, Healdsburg, California, U.S. Condensed Consolidated Statements of Financial Position (Unaudited) Condensed Consolidated Statements of Loss (Unaudited) About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline focuses on two core product candidates. Privosegtor is a breakthrough neuroprotective candidate in the PIONEER program, which consists of studies intended to support registration plans for treatment of optic neuropathies, including optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION). Privosegtor also has potential to be developed for additional indications in other neuro-ophthalmic and neuro-axonal diseases. Licaminlimab is a novel, topical anti-TNFα in a registrational trial, and is being developed with a genotype-based approach for treating patients with dry eye disease (DED). Headquartered in Switzerland with operations in the U.S., Iceland and Switzerland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors. For more information, please visit: www.oculis.com Oculis ContactMs. Sylvia Cheung, [email protected] Investor Relations LifeSci AdvisorsCorey Davis, [email protected] Media RelationsICR HealthcareAmber Fennell / David Daley / Sean [email protected] Cautionary Statement Regarding Forward Looking Statements This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, including the potential of Privosegtor to become the first neuroprotective therapy for ON and other neuro-ophthalmic and neurological indications such as MS, including the potential to improve long-term outcomes for patients with these diseases, and the potential for Licaminlimab to redefine the treatment paradigm in dry eye disease with a precision medicine approach; the initiation, timing, progress and results of current and future clinical trials, including the planned IND submission for Privosegtor in acute MS relapses and the progress and timing of the PREDICT-1 trial of Licaminlimab and the PIONEER trials of Privosegtor; Oculis’ research and development programs, regulatory and business strategy; expected milestones; statements about market opportunity; and statements about cash runway, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors exhibit to Oculis’ Form 6-K filed on August 6, 2026 and any other documents filed with the SEC. Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. References(1) MS National Society https://www.nationalmssociety.org/about-the-society/who-we-are/research-we-fund/ms-prevalence(2) Wallin WT, et al., Neurology. 2019; 92:e1029-e1040(3) McGinley et al., JAMA. 2021, 325:765-779(4) Bigaut K, Kremer L, Fabacher T, Ahle G, Goudot M, Fleury M, Gaultier C, Courtois S, Collongues N, de Seze J. Ocrelizumab versus fingolimod after natalizumab cessation in multiple sclerosis: an observational study. J Neurol. 2022 Jun;269(6):3295-3300. (5) Hauser SL, Bar-Or A, Cohen JA, et al. Ofatumumab versus Teriflunomide in Multiple Sclerosis. N Engl J Med. 2020;383(6):546–557.(6) Jain H, et al. (2020): Dry eye disease landscape and forecast. Decision Resources Group (DRG). Prevalence for G7 countries: France, Germany, Italy, Japan, Spain, UK, and US.(7) Downs P. (2023): Dry Eye Products Market Report, Global Analysis for 2022 to 2028. Market Scope.(8) Mukamal, R. Why is Dry Eye So Difficult to Treat? 2021 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops(9) Mbagwu M. et al.: Characterization of Discontinuation and Switching Patterns of DED Medications Using Linked HER Registry and Claims Data. Presented at ASCRS Annual Meeting 2024. - ENDS- Attachments Oculis Q2 2026 MDA Oculis Q2 2026 Financial Statements

Investor releaseQuarter not tagged2026-08-06

Oculis Reports Q2 2026 Financial Results and Provides Company Update

GlobeNewswire
Company pivot to neuro-ophthalmology continues with Privosegtor positioned as lead late-stage asset through the registrational PIONEER program with expansion potential in acute multiple sclerosis (MS) relapses following positive FDA pre-IND feedback Enrollment progressing as planned in the PREDICT-1 genotype-based registrational trial of Licaminlimab in dry eye disease with all planned sites activated and >45% patients randomized Cash, cash equivalents, and short-term investments of $282.3 million as of June 30, 2026, providing cash runway into 2H 2029 ZUG, Switzerland, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology, today announced results for the second quarter ended June 30, 2026, and provided an overview of the Company’s progress. Riad Sherif, M.D., Chief Executive Officer of Oculis, stated, “We continue to advance and expand the Privosegtor neuroprotection franchise, with PIONEER-1 on track in global site activations and positive regulatory momentum supporting our development strategy in acute multiple sclerosis relapses. Given the considerable unmet need for neuroprotective treatments, these achievements reinforce both our strategy to pivot to neuro-ophthalmology by exploring the clinical potential of Privosegtor and the substantial opportunity across multiple neuro-ophthalmic and neuro-axonal diseases. In parallel, with Licaminlimab PREDICT-1 genotype-based trial planned site activations complete and over 45% of patients enrolled, we expect to report topline results around year-end. With a strong balance sheet, we are well positioned to execute on our strategy, advance our registrational programs and deliver on upcoming value-driving milestones.” Recent Development Highlights and Upcoming Milestones: Privosegtor: The PIONEER-1 registrational trial is designed to investigate Privosegtor as a neuroprotective treatment for patients with optic neuritis (ON) across a broad population, including those with and without multiple sclerosis (MS). As established under a Special Protocol Assessment (SPA) agreement with the FDA, the primary endpoint is defined as the proportion of patients achieving at least a 15-letter gain from baseline in low-contrast visual acuity (LC…Read full document

Company pivot to neuro-ophthalmology continues with Privosegtor positioned as lead late-stage asset through the registrational PIONEER program with expansion potential in acute multiple sclerosis (MS) relapses following positive FDA pre-IND feedback Enrollment progressing as planned in the PREDICT-1 genotype-based registrational trial of Licaminlimab in dry eye disease with all planned sites activated and >45% patients randomized Cash, cash equivalents, and short-term investments of $282.3 million as of June 30, 2026, providing cash runway into 2H 2029 ZUG, Switzerland, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology, today announced results for the second quarter ended June 30, 2026, and provided an overview of the Company’s progress. Riad Sherif, M.D., Chief Executive Officer of Oculis, stated, “We continue to advance and expand the Privosegtor neuroprotection franchise, with PIONEER-1 on track in global site activations and positive regulatory momentum supporting our development strategy in acute multiple sclerosis relapses. Given the considerable unmet need for neuroprotective treatments, these achievements reinforce both our strategy to pivot to neuro-ophthalmology by exploring the clinical potential of Privosegtor and the substantial opportunity across multiple neuro-ophthalmic and neuro-axonal diseases. In parallel, with Licaminlimab PREDICT-1 genotype-based trial planned site activations complete and over 45% of patients enrolled, we expect to report topline results around year-end. With a strong balance sheet, we are well positioned to execute on our strategy, advance our registrational programs and deliver on upcoming value-driving milestones.” Recent Development Highlights and Upcoming Milestones: Privosegtor: The PIONEER-1 registrational trial is designed to investigate Privosegtor as a neuroprotective treatment for patients with optic neuritis (ON) across a broad population, including those with and without multiple sclerosis (MS). As established under a Special Protocol Assessment (SPA) agreement with the FDA, the primary endpoint is defined as the proportion of patients achieving at least a 15-letter gain from baseline in low-contrast visual acuity (LCVA) at Month 3, a clinically meaningful visual function endpoint in ON. The primary analysis will be conducted at Month 3, and patients will be followed through Month 12 to assess Privosegtor’s long-term safety and tolerability. Site activation is actively progressing across the U.S., Europe, Australia, and Canada, with an execution focus and priority on building a robust, multidisciplinary network connecting emergency room physicians, ophthalmologists, and neurologists. This integrated approach aims to optimize operational flows from patient identification to treatment, capitalizing on peak enrollment opportunities during the fall, winter, and spring to align with the natural seasonality of the disease. The FDA’s Division of Neurology provided guidance that no additional preclinical studies will be required ahead of an Investigational New Drug (IND) submission for Privosegtor in acute MS relapses, cross-referencing the data from the open ON IND residing in the Division of Ophthalmology. Constructive FDA feedback also supports the proposed clinical development strategy and regulatory pathway, which will include MS patients with both optic neuritis and other relapses, such as ambulatory relapses, in future trials. It also supports a primary endpoint as early as 3 months, with the same 3mg/kg dose administered daily for 5 days as in PIONEER-1. Oculis anticipates an IND submission for the treatment of acute MS relapses in the fourth quarter of 2026. MS is a chronic immune-mediated disease of the central nervous system affecting approximately 2.8 million people worldwide, including around 850,000 in the U.S. alone.1-3 There are two main types of MS: relapsing-remitting MS (RRMS) and progressive MS. While progressive MS remains a significant unmet medical need, RRMS is the most common type, representing ~85% of patients at initial diagnosis.2 Despite available therapies, relapses still persist for many patients, with an estimated 170,000 MS relapses occurring each year in the U.S.4,5 During an acute relapse, neurologists commonly use a short course of high-dose corticosteroids to reduce inflammation and shorten the episode, as is standard of care in optic neuritis. However, corticosteroids do not influence the frequency of future relapses or long-term disability, and recovery from relapses is often incomplete. There are currently no neuroprotective therapies approved for MS relapses, and there remains an urgent unmet medical need for treatments that can prevent central nervous system damage. The Company will host an R&D Day in Q4 to share key updates on Privosegtor’s ongoing clinical development in optic neuritis and acute MS relapses. Licaminlimab: Oculis is actively enrolling patients in the PREDICT-1 genotype-based registrational trial in dry eye disease (DED) evaluating Licaminlimab as a precision medicine treatment. All planned trial sites have been activated and >45% patients have been randomized. The PREDICT-1 trial is a randomized, multi-center, double-masked, vehicle-controlled study that plans to enroll ~160 patients of whom approximately 2/3 will have the specified TNFR1 genotype. The primary endpoint is the change from baseline to Day 29 in the global ocular discomfort severity score in patients with the specified TNFR1 genotype. The same outcome measure will be evaluated in the overall study population as a key secondary endpoint. While measurements of dry eye symptoms are inherently subjective, this precision medicine approach is designed to identify patients more likely to benefit from Licaminlimab. In the U.S., approximately 10 million diagnosed patients suffer from moderate to severe DED.6,7 Current disease management relies on a trial-and-error therapeutic approach, with a minority (~13%) of patients experiencing sustained relief,8 leading to an 85-90% discontinuation rate within the first 6 months,9 underscoring the significant unmet need for a targeted, effective treatment approach. If approved, Licaminlimab has the potential to transform the current DED treatment paradigm by providing a precision medicine approach with high efficacy, rapid onset of action, and a comfort level similar to artificial tears. OCS-01 Following the DIAMOND topline results announcement in May, at this time Oculis does not plan to pursue an FDA regulatory filing for OCS-01 in DME. Q2 2026 Financial Highlights: As of June 30, 2026, Oculis held cash, cash equivalents and short-term investments of CHF 228.3 million or $282.3 million, compared to CHF 213.0 million or $268.7 million as of December 31, 2025. The increase reflects proceeds from sales of ordinary shares year-to-date under the Company’s existing at-the-market offering program, offset by operating expenses. Research and development expenses were CHF 15.3 million or $19.3 million for the three months ended June 30, 2026, compared to CHF 14.9 million or $18.1 million in the same period in 2025. General and administrative expenses were CHF 8.6 million or $10.9 million for the three months ended June 30, 2026, compared to CHF 6.1 million or $7.4 million in the same period in 2025. The increase in operating expenses was primarily driven by headcount-related costs, including share-based compensation expenses, to support and execute the Company’s development strategies. The Company’s net loss was CHF 38.8 million or $49.3 million for the six months ended June 30, 2026, compared to CHF 58.6 million or $67.9 million for the same period in 2025. The decrease was primarily due to the fair value gain on warrant liabilities in 2026 driven by decreased market value as well as a favorable foreign currency fluctuation resulting from favorable U.S. dollar versus Swiss Franc for U.S. dollar denominated transactions and assets, compared to a weaker U.S. dollar against the Swiss Franc in the prior year period. Key Upcoming Events: Medical Conferences Asia-Pacific Vitreo-Retina Society (APVRS) Congress; Aug. 28-30, Queensland, Australia The Retina Society 59th Annual Scientific Meeting; Sep. 23-26, Los Angeles, California, U.S. EURETINA 26th Annual Congress; Oct. 1-4, Vienna, Austria MS Toronto 2026 – 10th Joint ACTRIMS-ECTRIMS Meeting; Oct. 21-23, Toronto, Canada Investor Conferences Stifel Biotech Summer Summit; Aug. 10-12, Newport, Rhode Island, U.S. JPM Aspen Summit; Aug. 24-26, Aspen, Colorado, U.S. Pareto Healthcare Conference; Sep. 2, Stockholm, Sweden Wells Fargo Healthcare Conference; Sep. 8-10, Boston, Massachusetts, U.S. HCW Annual Global Investment Conference; Sep. 14-16, New York, New York, U.S. Baird 2026 Global Healthcare Conference; Sep. 15, New York, New York, U.S. Leerink Biopharma Summit; Sep. 23-25, Healdsburg, California, U.S. About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline focuses on two core product candidates. Privosegtor is a breakthrough neuroprotective candidate in the PIONEER program, which consists of studies intended to support registration plans for treatment of optic neuropathies, including optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION). Privosegtor also has potential to be developed for additional indications in other neuro-ophthalmic and neuro-axonal diseases. Licaminlimab is a novel, topical anti-TNFα in a registrational trial, and is being developed with a genotype-based approach for treating patients with dry eye disease (DED). Headquartered in Switzerland with operations in the U.S., Iceland and Switzerland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors. For more information, please visit: www.oculis.com Oculis ContactMs. Sylvia Cheung, [email protected] Investor Relations LifeSci AdvisorsCorey Davis, [email protected] Media RelationsICR HealthcareAmber Fennell / David Daley / Sean [email protected] Cautionary Statement Regarding Forward Looking Statements This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, including the potential of Privosegtor to become the first neuroprotective therapy for ON and other neuro-ophthalmic and neurological indications such as MS, including the potential to improve long-term outcomes for patients with these diseases, and the potential for Licaminlimab to redefine the treatment paradigm in dry eye disease with a precision medicine approach; the initiation, timing, progress and results of current and future clinical trials, including the planned IND submission for Privosegtor in acute MS relapses and the progress and timing of the PREDICT-1 trial of Licaminlimab and the PIONEER trials of Privosegtor; Oculis’ research and development programs, regulatory and business strategy; expected milestones; statements about market opportunity; and statements about cash runway, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors exhibit to Oculis’ Form 6-K filed on August 6, 2026 and any other documents filed with the SEC. Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. References(1) MS National Society https://www.nationalmssociety.org/about-the-society/who-we-are/research-we-fund/ms-prevalence(2) Wallin WT, et al., Neurology. 2019; 92:e1029-e1040(3) McGinley et al., JAMA. 2021, 325:765-779(4) Bigaut K, Kremer L, Fabacher T, Ahle G, Goudot M, Fleury M, Gaultier C, Courtois S, Collongues N, de Seze J. Ocrelizumab versus fingolimod after natalizumab cessation in multiple sclerosis: an observational study. J Neurol. 2022 Jun;269(6):3295-3300. (5) Hauser SL, Bar-Or A, Cohen JA, et al. Ofatumumab versus Teriflunomide in Multiple Sclerosis. N Engl J Med. 2020;383(6):546–557.(6) Jain H, et al. (2020): Dry eye disease landscape and forecast. Decision Resources Group (DRG). Prevalence for G7 countries: France, Germany, Italy, Japan, Spain, UK, and US.(7) Downs P. (2023): Dry Eye Products Market Report, Global Analysis for 2022 to 2028. Market Scope.(8) Mukamal, R. Why is Dry Eye So Difficult to Treat? 2021 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops(9) Mbagwu M. et al.: Characterization of Discontinuation and Switching Patterns of DED Medications Using Linked HER Registry and Claims Data. Presented at ASCRS Annual Meeting 2024.

Investor releaseQuarter not tagged2026-08-05

Earnings To Watch: Oculis Holding AG (OCS) Reports Q2 2026 Result

GuruFocus.com

This article first appeared on GuruFocus. Oculis Holding AG (NASDAQ:OCS) is set to release its Q2 2026 earnings on Aug 6, 2026. The consensus estimate for Q2 2026 revenue is 0.18 million, and the earnings are expected to come in at -0.5 per share. The full year 2026's revenue is expected to be $0.95 million and the earnings are expected to be $-2.26 per share. More detailed estimate data can be found on the Forecast page Warning! GuruFocus has detected 1 Warning Sign with OCS. Is OCS fairly valued? Test your thesis with our free DCF calculator. Over the past 90 days, revenue estimates for Oculis Holding AG (NASDAQ:OCS) have declined from $7.44 million to $0.95 million for the full year 2026, and from $48.23 million to $5.33 million for 2027. During the same period, earnings estimates have declined from $-2.14 per share to $-2.26 per share for the full year 2026, while remaining flat at $-2.28 per share for 2027. In the previous quarter of 2026-03-31, Oculis Holding AG's (NASDAQ:OCS) actual revenue was $0.26 million, which met analysts' revenue expectations. Oculis Holding AG's (NASDAQ:OCS) actual earnings were $-0.61 per share, which missed analysts' earnings expectations of $-0.503 per share by -20.68%. After releasing the results, Oculis Holding AG (NASDAQ:OCS) was up by 0.03% in one day. Based on the one-year price targets offered by 9 analysts, the average target price for Oculis Holding AG (NASDAQ:OCS) is $38.21 with a high estimate of $44.85 and a low estimate of $25.91. The average target implies an upside of 218.93% from the current price of $11.98. Based on the consensus recommendation from 11 brokerage firms, Oculis Holding AG's (NASDAQ:OCS) average brokerage recommendation is currently 1.5, indicating a "Buy" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Investor releaseQuarter not tagged2026-08-03

Vertex Pharmaceuticals (VRTX) Q2 Earnings Lag Estimates

Zacks
Vertex Pharmaceuticals (VRTX) came out with quarterly earnings of $4.73 per share, missing the Zacks Consensus Estimate of $4.79 per share. This compares to earnings of $4.52 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -1.25%. A quarter ago, it was expected that this drugmaker would post earnings of $4.23 per share when it actually produced earnings of $4.47, delivering a surprise of +5.67%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Vertex, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $3.33 billion for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 3.32%. This compares to year-ago revenues of $2.96 billion. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Vertex shares have added about 5.2% since the beginning of the year versus the S&P 500's gain of 9.4%. While Vertex has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Vertex was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy)…Read full document

Vertex Pharmaceuticals (VRTX) came out with quarterly earnings of $4.73 per share, missing the Zacks Consensus Estimate of $4.79 per share. This compares to earnings of $4.52 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -1.25%. A quarter ago, it was expected that this drugmaker would post earnings of $4.23 per share when it actually produced earnings of $4.47, delivering a surprise of +5.67%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Vertex, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $3.33 billion for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 3.32%. This compares to year-ago revenues of $2.96 billion. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Vertex shares have added about 5.2% since the beginning of the year versus the S&P 500's gain of 9.4%. While Vertex has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Vertex was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $4.94 on $3.34 billion in revenues for the coming quarter and $19.15 on $13.06 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 37% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Oculis Holding AG (OCS), has yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $0.48 per share in its upcoming report, which represents a year-over-year change of +18.6%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Oculis Holding AG's revenues are expected to be $0.26 million, down 17.8% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Vertex Pharmaceuticals Incorporated (VRTX) : Free Stock Analysis Report Oculis Holding AG (OCS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-05-29

Oculis Announces Topline Results from DIAMOND Phase 3 Trials with OCS-01 in Diabetic Macular Edema

GlobeNewswire
The primary endpoint of mean change in best corrected visual acuity (BCVA) from baseline to week 52 in both Phase 3 trials was not met The secondary endpoint of retinal thickness showed a substantial and persistent reduction with OCS-01 vs vehicle in both trials Oculis will focus its developmental efforts and financial resources on the ongoing Privosegtor PIONEER registrational program in optic neuropathies and the Licaminlimab PREDICT-1 registrational trial in dry eye disease Financial position remains strong with $278 million in cash, cash equivalents, and short-term investments as of March 31, 2026, providing cash runway into 2H 2029Conference call today at 4:30 pm ET ZUG, Switzerland, May 29, 2026 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology, today announced topline results from its Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in patients with diabetic macular edema (DME). The DIAMOND (DIAbetic Macular edema patients ON a Drop) program consisted of two Phase 3, double-masked, randomized, multi-center trials to evaluate the efficacy and safety of OCS-01 eye drops in patients with DME following 52 weeks of treatment. Over 800 patients were enrolled across both pivotal trials at 119 investigational sites throughout the United States and several other countries. The primary endpoint, mean change in best corrected visual acuity early treatment diabetic retinopathy study (BCVA ETDRS) letter score at Week 52, was not met in both trials. The secondary endpoint of retinal thickness, as measured by OCT, showed a substantial and persistent reduction with OCS-01 vs vehicle at all visits in DIAMOND-2 and at all visits except Week 52 in DIAMOND-1. The key secondary endpoint of the proportion of patients with ≥15-letter gain in BCVA was not met in both trials. OCS-01 was well tolerated, with no unexpected adverse events observed, and the overall safety profile was consistent with that of previous trials. Based on the results, at this time, Oculis does not plan to pursue an FDA regulatory filing for OCS-01 in DME. Riad Sherif, M.D., Chief Executive Officer of Oculis, said: “We are naturally disappointed that the substantial and sustained reduction in retinal thickness observe…Read full document

The primary endpoint of mean change in best corrected visual acuity (BCVA) from baseline to week 52 in both Phase 3 trials was not met The secondary endpoint of retinal thickness showed a substantial and persistent reduction with OCS-01 vs vehicle in both trials Oculis will focus its developmental efforts and financial resources on the ongoing Privosegtor PIONEER registrational program in optic neuropathies and the Licaminlimab PREDICT-1 registrational trial in dry eye disease Financial position remains strong with $278 million in cash, cash equivalents, and short-term investments as of March 31, 2026, providing cash runway into 2H 2029Conference call today at 4:30 pm ET ZUG, Switzerland, May 29, 2026 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology, today announced topline results from its Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in patients with diabetic macular edema (DME). The DIAMOND (DIAbetic Macular edema patients ON a Drop) program consisted of two Phase 3, double-masked, randomized, multi-center trials to evaluate the efficacy and safety of OCS-01 eye drops in patients with DME following 52 weeks of treatment. Over 800 patients were enrolled across both pivotal trials at 119 investigational sites throughout the United States and several other countries. The primary endpoint, mean change in best corrected visual acuity early treatment diabetic retinopathy study (BCVA ETDRS) letter score at Week 52, was not met in both trials. The secondary endpoint of retinal thickness, as measured by OCT, showed a substantial and persistent reduction with OCS-01 vs vehicle at all visits in DIAMOND-2 and at all visits except Week 52 in DIAMOND-1. The key secondary endpoint of the proportion of patients with ≥15-letter gain in BCVA was not met in both trials. OCS-01 was well tolerated, with no unexpected adverse events observed, and the overall safety profile was consistent with that of previous trials. Based on the results, at this time, Oculis does not plan to pursue an FDA regulatory filing for OCS-01 in DME. Riad Sherif, M.D., Chief Executive Officer of Oculis, said: “We are naturally disappointed that the substantial and sustained reduction in retinal thickness observed across both trials didn’t translate into BCVA improvement at week 52. In these two trials, our team partnered with 119 global sites across multiple countries and demonstrated excellent execution. We thank the patients, investigators, and all clinical experts who participated in the DIAMOND program. Our strong financial position allows us to execute on our robust late-stage development portfolio. While we finalize the review of DIAMOND program data, we will strategically focus resources on advancing our late-stage portfolio, including the Privosegtor platform, starting with the PIONEER program for Privosegtor in optic neuropathies, and the PREDICT-1 trial for Licaminlimab to drive precision medicine in dry eye disease.” Analyst and investor callThe Oculis management team will host an analyst and investor call today at 4:30 pm U.S. Eastern Time, to review the topline results and provide a pipeline update. Interested parties may participate in the call via the following webcast link: https://viavid.webcasts.com/starthere.jsp?ei=1765661&tp_key=0d6c454cfe Or use the following dial-in options: US-based Investors: 1-877-407-4018International Investors: 1-201-689-8471Conference ID: 13760937 A replay of the webcast and accompanying slides will be available for 90 days following the event through the “Events and Presentations” page of the “Investors and Media” section of the company’s website. About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline focuses on two core product candidates. Privosegtor is a breakthrough neuroprotective candidate in the PIONEER program, which consists of studies intended to support registration plans for treatment of optic neuropathies, including optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION). Privosegtor also has potential to be developed for additional indications in other neuro-ophthalmic and neurological diseases. Licaminlimab is a novel, topical anti-TNFα in a registrational trial, and is being developed with a genotype-based approach for treating patients with dry eye disease (DED). Headquartered in Switzerland with operations in the U.S., Iceland and Switzerland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors. For more information, please visit: www.oculis.com Oculis ContactMs. Sylvia Cheung, [email protected] Investor Relations LifeSci AdvisorsCorey Davis, [email protected] Media RelationsICR HealthcareAmber [email protected] Cautionary Statement Regarding Forward Looking Statements This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, the initiation, timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy; Oculis’ future development plans; the timing or likelihood of regulatory filings and approvals; and Oculis’ cash runway are forward-looking. The clinical trial results presented in this press release are topline and preliminary and subject to change, as analysis is ongoing. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the SEC. Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Investor releaseQuarter not tagged2026-05-15

Oculis Publishes Results of 2026 Annual General Meeting and Announces Election of Gregory D. Perry to its Board of Directors

GlobeNewswire
ZUG, Switzerland, May 14, 2026 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis” or the “Company”), today announced the results from its 2026 Annual General Meeting held on May 13, 2026 at Ochsen-Zug, Kolinplatz 11, CH-6300 Zug, Switzerland, at 12:00 p.m. CEST, including the election of Gregory D. Perry to its Board of Directors. 2026 Annual General Meeting Results The Company’s shareholders approved all agenda items. The shareholders approved the 2025 Annual Report including the 2025 Annual (Statutory) Financial Statements and the 2025 Consolidated Financial Statements. The shareholders acknowledged that on a standalone statutory financial statement basis, the Company incurred a loss of CHF 33,670,000 with respect to the financial year ended December 31, 2025, and resolved that the accumulated balance sheet loss of CHF 80,247,000 shall be carried forward to the new accounts. The members of the Board of Directors and the Executive Committee were granted discharge for their activities in 2025. Anthony Rosenberg was re-elected as member and chairperson of the Board of Directors. Christina Ackermann, Lionel Carnot, Arshad M. Khanani, Martijn Kleijwegt, Geraldine O’Keeffe, Riad Sherif and Robert K. Warner were re-elected as members of the Board of Directors. Gregory D. Perry was elected as a member of the Board of Directors. Lionel Carnot, Geraldine O'Keeffe and Gregory D. Perry were elected as members of the Compensation Committee. PricewaterhouseCoopers SA (Lausanne) was re-elected as Statutory Auditors. Blum & Partner AG (Zug) was elected as Independent Proxy. The shareholders approved the compensation for the non-executive members of the Board of Directors: Total maximum amount of fixed (non-performance-related) compensation for the non-executive members of the Board of Directors until the end of the Company’s 2027 Annual General Meeting: USD 572,000. Maximum value of equity or equity-based compensation for eight non-executive members of the Board of Directors until the end of the Company's 2027 Annual General Meeting: USD 2,150,000 (excluding employer social security and pension contributions). The shareholders approved the compensation for members of the Executive Committee: Total maximum amount of fixed (non-performance-related) compensation for three members of the Executive Committee for the calendar year 2027 and payable in 2027…Read full document

ZUG, Switzerland, May 14, 2026 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis” or the “Company”), today announced the results from its 2026 Annual General Meeting held on May 13, 2026 at Ochsen-Zug, Kolinplatz 11, CH-6300 Zug, Switzerland, at 12:00 p.m. CEST, including the election of Gregory D. Perry to its Board of Directors. 2026 Annual General Meeting Results The Company’s shareholders approved all agenda items. The shareholders approved the 2025 Annual Report including the 2025 Annual (Statutory) Financial Statements and the 2025 Consolidated Financial Statements. The shareholders acknowledged that on a standalone statutory financial statement basis, the Company incurred a loss of CHF 33,670,000 with respect to the financial year ended December 31, 2025, and resolved that the accumulated balance sheet loss of CHF 80,247,000 shall be carried forward to the new accounts. The members of the Board of Directors and the Executive Committee were granted discharge for their activities in 2025. Anthony Rosenberg was re-elected as member and chairperson of the Board of Directors. Christina Ackermann, Lionel Carnot, Arshad M. Khanani, Martijn Kleijwegt, Geraldine O’Keeffe, Riad Sherif and Robert K. Warner were re-elected as members of the Board of Directors. Gregory D. Perry was elected as a member of the Board of Directors. Lionel Carnot, Geraldine O'Keeffe and Gregory D. Perry were elected as members of the Compensation Committee. PricewaterhouseCoopers SA (Lausanne) was re-elected as Statutory Auditors. Blum & Partner AG (Zug) was elected as Independent Proxy. The shareholders approved the compensation for the non-executive members of the Board of Directors: Total maximum amount of fixed (non-performance-related) compensation for the non-executive members of the Board of Directors until the end of the Company’s 2027 Annual General Meeting: USD 572,000. Maximum value of equity or equity-based compensation for eight non-executive members of the Board of Directors until the end of the Company's 2027 Annual General Meeting: USD 2,150,000 (excluding employer social security and pension contributions). The shareholders approved the compensation for members of the Executive Committee: Total maximum amount of fixed (non-performance-related) compensation for three members of the Executive Committee for the calendar year 2027 and payable in 2027: USD 2,500,000. Total maximum amount of variable compensation for three members of the Executive Committee for the calendar year 2026 and payable in 2027 of USD 1,800,000. Maximum value of equity-based compensation for three members of the Executive Committee until the end of the calendar year 2027: USD 18,000,000 (excluding employer social security and pension contributions). The shareholders approved, in a non-binding advisory vote, the 2025 Compensation Report of the Company. The shareholders approved a capital band of 31,020,888 registered shares resulting in a capital band between CHF 620,417.76 and CHF 930,626.64, and the related amendment of paragraphs 1 through 3 of article 3a of the articles of association in the form that will be published on the website of the Company at https://investors.oculis.com/corporate-governance following their registration with the Zug Commercial Register. The shareholders approved a conditional share capital for employees and individuals of comparable positions in the maximum amount of CHF 126,777.00 by the issuance of 12,677,700 registered shares and the related amendment of article 3c, paragraph 1 of the articles of association in the form that will be published on the website of the Company at https://investors.oculis.com/corporate-governance following their registration with the Zug Commercial Register. Detailed voting results will be available on the website of the Company at https://investors.oculis.com/events-presentations. New Director Gregory D. Perry Gregory D. Perry served as Chief Financial Officer of Merus N.V. from June 2023 until January 2026, following its acquisition by Genmab in December 2025. Mr. Perry also served as audit committee chair at Merus from May 2016 to June 2023. From May 2018 until his retirement in April 2022, Mr. Perry served as the Chief Financial Officer at Finch Therapeutics Group. Mr. Perry served as the Chief Financial and Administrative Officer of Novelion Therapeutics Inc. from November 2016 to December 2017. Prior to Novelion, Mr. Perry was Chief Financial Officer of Aegerion Pharmaceuticals Inc. from July 2015 until its merger with Novelion in November 2016. He has also served as CFO of several additional biotechnology companies, and earlier in his career he held various financial leadership roles within ImmunoGen, Domantis Ltd., Transkaryotic Therapeutics, Honeywell and General Electric. Mr. Perry received a B.A. in Economics and Political Science from Amherst College. Anthony Rosenberg, Chairman of Oculis’ Board of Directors, commented: “On behalf of the Board, I am pleased to welcome Gregory Perry to Oculis. Greg is a seasoned financial leader and strategic architect with more than two decades of experience across the transatlantic biotech sector. His ‘dual-market’ fluency and proven ability to guide European-based companies through the rigorous expectations of the U.S. capital markets, particularly Nasdaq, set him apart. He brings a unique combination of governance maturity, financial expertise, and a strong track record of scaling innovative companies within complex capital markets regulatory frameworks. Greg’s international perspective and strategic foresight will be invaluable as we continue to execute our strategy, drive long-term shareholder value, and advance transformative treatment candidates for patients with ophthalmic and neuro-ophthalmic diseases.” Articles of Association; Treasury Shares Following the filing of the Company's updated Articles of Association on May 13, 2026, the total number of registered shares as set forth therein increased to 62,041,776. This number of shares includes the issuance of 2,872,301 registered shares, reflecting settlement of 795,013 shares issued in connection with the exercise or vesting of equity awards under the Company's Stock Option and Incentive Plan Regulation 2023 and 2,077,288 shares issued through EBAC warrant exercises pursuant to the Company's Articles of Association during the period from January 1, 2025 to March 31, 2026. This increase will be registered with the Zug Commercial Register following the processing of the filing containing the Company's updated Articles of Association dated May 13, 2026. On May 13, 2026, the Company's Board of Directors approved the issuance of 5,750,400 registered ordinary shares out of the capital band approved by the shareholders, to be recorded as treasury shares (the "New Shares") to enable future sales, if any, under the existing sales agreement with Leerink Partners LLC relating to the Company's at-the-market ("ATM") offering program or for other offerings under the Company's existing registration statement on Form F-3. Upon implementation of the above decision, the total number of registered shares as set forth in the Company's Articles of Association will be brought up to 67,792,176. The New Shares, once issued, will not be immediately sold under the ATM offering program or otherwise, and will be held in reserve as treasury shares at which point the Company will own 9.15% of its registered shares. About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline includes three core product candidates: OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); Licaminlimab, a novel, topical anti-TNFα in registrational trial, which is being developed with a genotype-based approach to drive precision medicine in dry eye disease (DED), and Privosegtor, a breakthrough neuroprotective candidate in the PIONEER program which consists of studies intended to support registration plans for treatment in optic neuropathies like optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potentially broad clinical applications in various other neuro-ophthalmic and neurological diseases. Headquartered in Switzerland with operations in the U.S., Iceland and Switzerland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors. For more information, please visit: www.oculis.com Oculis Contacts Ms. Sylvia Cheung, CFO [email protected] Investor Relations LifeSci Advisors Corey Davis, Ph.D. [email protected] Media Relations ICR Healthcare Amber Fennell / David Daley / Sean Leous [email protected]

Investor releaseQuarter not tagged2026-05-12

Oculis Reports Q1 2026 Financial Results and Provides Company Update

GlobeNewswire
Pipeline Advancing as Planned, Leading with OCS-01 Key Milestone Completion of LPLV in Both DIAMOND Phase 3 Trials; Data Readout on Track for June 2026 Licaminlimab PREDICT-1 Trial in Active Site Recruitment Phase, Pioneering a Genotype-Driven Path to Precision Medicine in Dry Eye Disease Privosegtor Regulatory Path Cleared via FDA SPA; PIONEER-1 Phase 3 Trial Advances with Ongoing Site Activation Cash, cash equivalents, and short-term investments of $277.6 million as of March 31, 2026, providing cash runway into 2H 2029 ZUG, Switzerland, May 11, 2026 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced results for the first quarter ended March 31, 2026, and provided an overview of the Company’s progress. Riad Sherif, M.D., Chief Executive Officer of Oculis, stated, “We began 2026 with strong execution momentum across our late-stage clinical trials. We are positioned for a pivotal year, with key readouts for OCS-01 in diabetic macular edema (DME) expected in June and Licaminlimab in dry eye disease (DED) around year-end, while the Privosegtor PIONEER program is making significant progress, including PRIME designation in Europe and an agreement with the FDA on the Special Protocol Assessment (SPA) regarding PIONEER-1 and ongoing centers activation. Driven by a mission to restore vision, we are targeting global market opportunities exceeding $30 billion.” Recent Development Highlights and Upcoming Milestones: OCS-01: Last patient last visit (LPLV) completed in the DIAMOND (DIAbetic Macular edema patients ON a Drop) program, consisting of two Phase 3, double-masked, randomized, multi-center trials to evaluate the efficacy and safety of OCS-01 eye drops in patients with DME following 52-weeks of treatment. Topline results are expected to readout in June 2026, and, if positive, an NDA submission to the FDA is planned for Q4 2026. The DME AWARE Delphi study results were recently presented at the 17th annual congress on Controversies in Ophthalmology (COPHy) and at the Association for Research in Vision and Ophthalmology (ARVO) 2026 annual meeting. In this study, supported by Oculis, 25 leading global retina and ophthalmology experts were surveyed to establish consensus on un…Read full document

Pipeline Advancing as Planned, Leading with OCS-01 Key Milestone Completion of LPLV in Both DIAMOND Phase 3 Trials; Data Readout on Track for June 2026 Licaminlimab PREDICT-1 Trial in Active Site Recruitment Phase, Pioneering a Genotype-Driven Path to Precision Medicine in Dry Eye Disease Privosegtor Regulatory Path Cleared via FDA SPA; PIONEER-1 Phase 3 Trial Advances with Ongoing Site Activation Cash, cash equivalents, and short-term investments of $277.6 million as of March 31, 2026, providing cash runway into 2H 2029 ZUG, Switzerland, May 11, 2026 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced results for the first quarter ended March 31, 2026, and provided an overview of the Company’s progress. Riad Sherif, M.D., Chief Executive Officer of Oculis, stated, “We began 2026 with strong execution momentum across our late-stage clinical trials. We are positioned for a pivotal year, with key readouts for OCS-01 in diabetic macular edema (DME) expected in June and Licaminlimab in dry eye disease (DED) around year-end, while the Privosegtor PIONEER program is making significant progress, including PRIME designation in Europe and an agreement with the FDA on the Special Protocol Assessment (SPA) regarding PIONEER-1 and ongoing centers activation. Driven by a mission to restore vision, we are targeting global market opportunities exceeding $30 billion.” Recent Development Highlights and Upcoming Milestones: OCS-01: Last patient last visit (LPLV) completed in the DIAMOND (DIAbetic Macular edema patients ON a Drop) program, consisting of two Phase 3, double-masked, randomized, multi-center trials to evaluate the efficacy and safety of OCS-01 eye drops in patients with DME following 52-weeks of treatment. Topline results are expected to readout in June 2026, and, if positive, an NDA submission to the FDA is planned for Q4 2026. The DME AWARE Delphi study results were recently presented at the 17th annual congress on Controversies in Ophthalmology (COPHy) and at the Association for Research in Vision and Ophthalmology (ARVO) 2026 annual meeting. In this study, supported by Oculis, 25 leading global retina and ophthalmology experts were surveyed to establish consensus on unmet needs in DME. Among other results, the DME AWARE Delphi study revealed broad consensus on the need for novel therapies to enable early treatment. In fact, consensus was reached: 70% of respondents agreed they would initiate therapy with a non-invasive treatment following a 5-letter BCVA vision loss, compared with 5% with the current standard of care, intravitreal treatments. This strongly aligns with our efforts to develop OCS‑01 eye drops and our ambition to potentially bring to market the first non‑invasive topical treatment for DME. Despite available therapies, in the U.S. alone, an estimated 1 million patients out of the 1.8 million people diagnosed with the disease remain untreated with mild to moderate vision impairments, or are inadequately responding to the current standard of care.1,2,3 OCS-01 is intended to be strategically positioned to capture this significant opportunity by providing a non-invasive, topical eye drop for those requiring early intervention and a versatile option for patients who do not respond to existing injections. Licaminlimab: In prior Phase 2 studies, Licaminlimab showed a substantially greater treatment effect in patients carrying a specific TNFR1 genotype, with profound improvements ranging from 5-fold greater in signs to 7-fold greater in symptoms. PREDICT-1 is designed to leverage these findings to deliver potentially the first precision medicine treatment in ophthalmology and topline results (TLR) are expected to read out around year end. In the U.S. alone, approximately 10 million patients suffer from moderate to severe DED.4 Current disease management relies on trial and error, with a minority (~13%) of patients reporting sustained relief,5 leading to an 85-90% discontinuation rate within the first 6 months, underscoring the strong need for a targeted, effective treatment approach.6 Licaminlimab has the potential to transform the current DED treatment paradigm by providing a precision medicine approach with high efficacy, rapid onset of action, and a comfort level similar to artificial tears. Privosegtor: Privosegtor was granted PRIME (PRIority MEdicines) designation by the EMA (European Medicines Agency), a highly selective process to provide early and proactive support to developers of promising medicines that may offer a major therapeutic advantage over existing treatments or provide benefits to patients without treatment options. These medicines are considered priority medicines by the EMA, which aims to optimize development plans and expedite evaluations so that medicines addressing significant unmet medical needs can reach patients faster. This follows the recent granting of Breakthrough Therapy designation for Privosegtor for the treatment of optic neuritis (ON) by the U.S. Food and Drug Administration (FDA), reinforcing global regulatory support for this unique neuroprotective asset. Special Protocol Assessment (SPA) agreement received from the FDA regarding the design of the PIONEER-1 (Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research) registrational trial of Privosegtor in ON. The SPA agreement established a clear pathway to NDA and validates that the clinical trial protocol, size, planned analysis and endpoints are adequate to address scientific and regulatory requirements to support marketing approval, subject to a successful outcome of the trial and review of all data in the NDA. The design of PIONEER-2 is planned to be identical to PIONEER-1. With no currently approved neuroprotective treatments for ON, this SPA agreement is a critical step toward aligning with the FDA on our PIONEER development program. Oculis’ PIONEER program, supported by the positive Phase 2 ACUITY trial, includes three registrational trials in ON and non-arteritic anterior ischemic optic neuropathy (NAION). These two optic neuropathies can cause permanent visual impairments and represent a potential market opportunity estimated at $7+ billion in the U.S. alone. Q1 2026 Financial Highlights: As of March 31, 2026, Oculis held cash, cash equivalents and short-term investments of CHF 222.0 million or $277.6 million, compared to CHF 213.0 million or $268.7 million as of December 31, 2025. The increase in cash, cash equivalents, and short-term investments was primarily due to proceeds received from sales under the Company’s existing at-the-market offering program during the quarter, offset by planned operating expenses. Research and development expenses were CHF 14.0 million or $17.9 million for the three months ended March 31, 2026, compared to CHF 14.8 million or $16.4 million in the same period in 2025. The decrease was primarily due to a reduction in spending on external service providers as the DIAMOND program approaches completion and topline data readout. General and administrative expenses were CHF 7.9 million or $10.1 million for the three months ended March 31, 2026, compared to CHF 5.5 million or $6.1 million in the same period in 2025. The increase was primarily driven by share-based compensation expense due to the increased value of awards granted after Q1 2025. The Company’s net loss was CHF 28.9 million or $36.8 million for the quarter ended March 31, 2026, compared to CHF 33.2 million or $36.9 million for the same period in 2025. The decrease was primarily due to a CHF 3.9 million or $5.0 million lower non-cash fair value loss on warrant liabilities resulting from decreased warrant shares outstanding compared to Q1 2025, and a favorable foreign currency fluctuation due to favorable U.S. dollar versus Swiss Franc spot rates for U.S. dollar denominated transactions and assets, compared to a weaker U.S. dollar against the Swiss Franc in the prior year period. Upcoming Events: Medical Conferences and Industry Events European Neuro-Ophthalmology Society Annual Meeting, June 4-6, Milan, Italy Clinical Trial at the Summit, June 13, Las Vegas, NV, U.S. EuDEC Meeting, June 18-20, Milan, Italy European Academy of Neurology (EAN) 12th Congress, June 27-30, Geneva, Switzerland American Society of Retina Specialists, July 15-18, Montreal, Canada About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline includes three core product candidates: OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); Licaminlimab, a novel, topical anti-TNFα in registrational trial, which is being developed with a genotype-based approach to drive precision medicine in dry eye disease (DED), and Privosegtor, a breakthrough neuroprotective candidate in the PIONEER program which consists of studies intended to support registration plans for treatment in optic neuropathies like optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potentially broad clinical applications in various other neuro-ophthalmic and neurological diseases. Headquartered in Switzerland with operations in the U.S., Iceland and Switzerland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors. For more information, please visit: www.oculis.com Oculis Contact Ms. Sylvia Cheung, CFO [email protected] Investor Relations LifeSci Advisors Corey Davis, Ph.D. [email protected] Media Relations ICR Healthcare Amber Fennell / David Daley / Sean Leous [email protected] Cautionary Statement Regarding Forward Looking Statements This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, the initiation, timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy; Oculis’ future development plans; the timing or likelihood of regulatory filings and approvals; statements about market opportunity, and the Company’s expected financial position and cash runway, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the SEC. Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. References:

Investor releaseQuarter not tagged2026-05-06

Oculis Holding AG (OCS) Q1 2026 Earnings Report Preview: What To Expect

GuruFocus.com

This article first appeared on GuruFocus. Oculis Holding AG (NASDAQ:OCS) is set to release its Q1 2026 earnings on May 7, 2026. The consensus estimate for Q1 2026 revenue is $0.27 million, and the earnings are expected to come in at -$0.52 per share. The full year 2026's revenue is expected to be $8.60 million and the earnings are expected to be -$2.21 per share. More detailed estimate data can be found on the Forecast page. Warning! GuruFocus has detected 2 Warning Sign with OCS. Is OCS fairly valued? Test your thesis with our free DCF calculator. Revenue estimates for Oculis Holding AG (NASDAQ:OCS) have increased from $7.87 million to $8.60 million for the full year 2026 and declined from $78.17 million to $49.93 million for 2027 over the past 90 days. Earnings estimates for Oculis Holding AG (NASDAQ:OCS) have increased from -$2.40 per share to -$2.21 per share for the full year 2026 and increased from -$2.61 per share to -$2.35 per share for 2027 over the past 90 days. In the previous quarter of 2025-12-31, Oculis Holding AG's (NASDAQ:OCS) actual revenue was $0.53 million, which beat analysts' revenue expectations of $0.17 million by 214.97%. Oculis Holding AG's (NASDAQ:OCS) actual earnings were -$0.54 per share, which met analysts' earnings expectations. After releasing the results, Oculis Holding AG (NASDAQ:OCS) was down by -3.64% in one day. Based on the one-year price targets offered by 10 analysts, the average target price for Oculis Holding AG (NASDAQ:OCS) is $47.79 with a high estimate of $55.69 and a low estimate of $38.47. The average target implies an upside of 69.52% from the current price of $28.19. Based on GuruFocus estimates, the estimated GF Value for Oculis Holding AG (NASDAQ:OCS) in one year is $0, suggesting a downside of -100% from the current price of $28.19. Based on the consensus recommendation from 11 brokerage firms, Oculis Holding AG's (NASDAQ:OCS) average brokerage recommendation is currently 1.5, indicating a "Buy" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Investor releaseQuarter not tagged2026-05-06

TG Therapeutics (TGTX) Q1 Earnings Lag Estimates

Zacks
TG Therapeutics (TGTX) came out with quarterly earnings of $0.17 per share, missing the Zacks Consensus Estimate of $0.23 per share. This compares to earnings of $0.03 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -26.88%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.35 per share when it actually produced earnings of $0.14, delivering a surprise of -60%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. TG Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $204.92 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 2.81%. This compares to year-ago revenues of $120.86 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. TG Therapeutics shares have added about 21.1% since the beginning of the year versus the S&P 500's gain of 6%. While TG Therapeutics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for TG Therapeutics was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #5 (Strong Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the c…Read full document

TG Therapeutics (TGTX) came out with quarterly earnings of $0.17 per share, missing the Zacks Consensus Estimate of $0.23 per share. This compares to earnings of $0.03 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -26.88%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.35 per share when it actually produced earnings of $0.14, delivering a surprise of -60%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. TG Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $204.92 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 2.81%. This compares to year-ago revenues of $120.86 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. TG Therapeutics shares have added about 21.1% since the beginning of the year versus the S&P 500's gain of 6%. While TG Therapeutics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for TG Therapeutics was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #5 (Strong Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.26 on $216.09 million in revenues for the coming quarter and $1.32 on $903.62 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 40% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Oculis Holding AG (OCS), another stock in the same industry, has yet to report results for the quarter ended March 2026. This company is expected to post quarterly loss of $0.49 per share in its upcoming report, which represents a year-over-year change of +36.4%. The consensus EPS estimate for the quarter has been revised 0.4% lower over the last 30 days to the current level. Oculis Holding AG's revenues are expected to be $0.32 million, up 0.6% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report TG Therapeutics, Inc. (TGTX) : Free Stock Analysis Report Oculis Holding AG (OCS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-03-04

Oculis Reports Q4 and Full Year 2025 Financial Results and Provides Company Update

GlobeNewswire
ZUG, Switzerland, March 03, 2026 (GLOBE NEWSWIRE) -- Significant achievements in 2025, enabling multiple near-term clinical milestones across late-stage portfolio, starting with the forthcoming topline results from DIAMOND Phase 3 trials with OCS-01 eye drops in diabetic macular edema (DME) in Q2 2026 Key expansion in neuro-ophthalmology with Breakthrough Therapy designation granted to Privosegtor, propelling the PIONEER registrational program in optic neuropathies with a potential U.S. market opportunity of over $7 billion Cash, cash equivalents, and short-term investments of $268.7 million as of December 31, 2025, providing cash runway into 2029 Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced results for the fourth quarter and full year ended December 31, 2025, and provided an overview of the Company’s progress. Riad Sherif, M.D., Chief Executive Officer of Oculis, stated “Oculis has delivered a transformative 2025, marked by significant clinical progress across our late-stage portfolio and a strategic expansion into neuro-ophthalmology. The compelling Phase 2 ACUITY results for Privosegtor in optic neuritis led to a pivotal FDA Breakthrough Therapy designation and anchored the launch of our global PIONEER registrational program. We believe Privosegtor holds immense potential as a first-in-class neuroprotective platform for a range of neuro-axonal diseases. 2026 is positioned to be a landmark year for the company with a roadmap featuring three major expected registrational milestones: the DIAMOND-1 and DIAMOND-2 trials readout with OCS-01, a potential first-in-class eye drop in DME, anticipated in Q2, the PREDICT-1 trial results for Licaminlimab with a precision medicine approach in dry eye disease planned in Q4, and the commencement of three registrational trials with Privosegtor as part of the PIONEER program. The operational excellence and significant milestones we achieved in 2025 have uniquely positioned Oculis to drive innovation in areas of high unmet medical need, a potential market opportunity of over $30 billion, with the aim of redefining the standard of care in ophthalmology and neuro-ophthalmology.” Recent Clinical Highlights and Upcoming Milestones: Privosegtor: Break…Read full document

ZUG, Switzerland, March 03, 2026 (GLOBE NEWSWIRE) -- Significant achievements in 2025, enabling multiple near-term clinical milestones across late-stage portfolio, starting with the forthcoming topline results from DIAMOND Phase 3 trials with OCS-01 eye drops in diabetic macular edema (DME) in Q2 2026 Key expansion in neuro-ophthalmology with Breakthrough Therapy designation granted to Privosegtor, propelling the PIONEER registrational program in optic neuropathies with a potential U.S. market opportunity of over $7 billion Cash, cash equivalents, and short-term investments of $268.7 million as of December 31, 2025, providing cash runway into 2029 Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced results for the fourth quarter and full year ended December 31, 2025, and provided an overview of the Company’s progress. Riad Sherif, M.D., Chief Executive Officer of Oculis, stated “Oculis has delivered a transformative 2025, marked by significant clinical progress across our late-stage portfolio and a strategic expansion into neuro-ophthalmology. The compelling Phase 2 ACUITY results for Privosegtor in optic neuritis led to a pivotal FDA Breakthrough Therapy designation and anchored the launch of our global PIONEER registrational program. We believe Privosegtor holds immense potential as a first-in-class neuroprotective platform for a range of neuro-axonal diseases. 2026 is positioned to be a landmark year for the company with a roadmap featuring three major expected registrational milestones: the DIAMOND-1 and DIAMOND-2 trials readout with OCS-01, a potential first-in-class eye drop in DME, anticipated in Q2, the PREDICT-1 trial results for Licaminlimab with a precision medicine approach in dry eye disease planned in Q4, and the commencement of three registrational trials with Privosegtor as part of the PIONEER program. The operational excellence and significant milestones we achieved in 2025 have uniquely positioned Oculis to drive innovation in areas of high unmet medical need, a potential market opportunity of over $30 billion, with the aim of redefining the standard of care in ophthalmology and neuro-ophthalmology.” Recent Clinical Highlights and Upcoming Milestones: Privosegtor: Breakthrough Therapy designation recently granted by the FDA for treatment of optic neuritis (ON), a sight-threatening neuro-ophthalmic condition that is often the first clinical manifestation of multiple sclerosis. Designation is supported by the Phase 2 ACUITY trial results, in which Privosegtor + steroid showed substantial improvements in vision and consistent anatomical and biological neuroprotective benefits compared with placebo + steroid. These novel findings reinforced Privosegtor’s potential as a neuroprotective treatment across both neuro-ophthalmic and neurological diseases. Following a successful meeting with the FDA in the fall of 2025, Oculis launched the PIONEER program, which includes three pivotal trials in ON and non-arteritic anterior ischemic optic neuropathy (NAION). These two optic neuropathies represent a market opportunity estimated at $7+ billion in the U.S. alone. The first registrational trial in the program, PIONEER-1 in ON, was initiated in Q4 of 2025, with clinical sites activation progressing as planned. OCS-01: Both Phase 3 DIAMOND trials with OCS-01, which aims to be the first eye drop therapy for DME, have enrolled over 800 patients and are nearing completion. Topline results are expected in Q2 2026, and, if positive, a subsequent NDA submission to the FDA is planned for Q4 2026. While the U.S. DME market is currently valued at approximately $3 billion, only a fraction of the 1.8 million people diagnosed1,2,3 with the disease are successfully managed. This leaves a staggering 1.3 million patients underserved by the current standard of care1,2,3. OCS-01 is intended to be strategically positioned to capture this 'lost' majority by providing a non-invasive, topical eye drop for those requiring early intervention and a versatile option for patients who do not respond to existing injections. Licaminlimab: Oculis recently initiated the first genotype-based registrational trial, PREDICT-1, to drive precision medicine in dry eye disease (DED) with Licaminlimab. In prior Phase 2 studies, Licaminlimab showed a substantially greater treatment effect in patients carrying a specific TNFR1 genotype, with profound improvements ranging from five-fold greater in signs and seven-fold greater in symptoms. Topline results from PREDICT-1 are expected in Q4 2026. In the U.S. approximately 10 million patients suffer from moderate to severe DED. Current disease management relies on trial and error, and only 13% of patients experience sustained relief, leading to high discontinuation rates within the first six months, underscoring the strong need for a targeted, effective treatment approach. Licaminlimab has the potential to transform the current treatment paradigm by providing a precision medicine approach with efficacy, rapid onset of action, and a comfort level similar to artificial tears. Q4 and Full Year 2025 Financial Highlights: As of December 31, 2025, Oculis held cash, cash equivalents and short-term investments of CHF 213.0 million or $268.7 million, compared to CHF 98.7 million or $109.0 million as of December 31, 2024. The increase in cash, cash equivalents and short-term investments was primarily due to equity financings closed in February and November 2025 for aggregate gross proceeds of $210.0 million (CHF 178.9 million). Research and development expenses were CHF 13.3 million or $16.6 million for the three months ended December 31, 2025, compared to CHF 11.8 million or $13.4 million in the same period in 2024. The increase was primarily due to advancements in clinical development activities of our late-stage portfolio and associated personnel expenses. General and administrative expenses were CHF 7.8 million or $9.7 million for the three months ended December 31, 2025, compared to CHF 5.5 million or $6.3 million in the same period in 2024. The increase was primarily driven by personnel expenses and external professional services costs. Year-to-date net loss was CHF 99.0 million or $119.1 million for the year ended December 31, 2025, compared to CHF 85.8 million or $97.4 million for the same period in 2024. The increase was primarily due to an increase in operating expenses driven by the OCS-01 Phase 3 DIAMOND trials, increased personnel costs and a CHF 7.4 million or $8.9 million increase in foreign exchange revaluation loss, offset by a CHF 3.2 million or $3.9 million decrease in the non-cash fair value adjustment on warrant liabilities resulting from warrant exercises during the year offset by increases in the fair value of outstanding warrants. Issuance of New Treasury Shares The Company has today issued 2,000,000 registered ordinary shares (nominal value CHF 0.01 per share) out of its existing capital band (Kapitalband), recorded as treasury shares (the “New Shares”), to enable future sales, if any, under the existing sales agreement with Leerink Partners LLC relating to the Company's at-the-market (“ATM”) offering program. The total number of registered shares issued by the Company as per its Articles of Association is now 59,169,475. The New Shares have not been sold under the ATM offering program and will be held in reserve as treasury shares. For more details on the ATM offering program, please refer to the Company's previous press release dated May 17, 2024, and to the Company's SEC filings. Upcoming Events: Medical Conferences and Industry Events COPHy Annual Congress, Mar. 20-21, Krakow, Poland NANOS Annual Meeting, Mar. 20-24, Boston, MA, U.S. AAN Annual Meeting, Apr. 18-21, Chicago, IL, U.S. Eyecelerator, May 1, Denver, CO, U.S. ARVO, May 3-7, Denver, CO, U.S. Investor Conferences Leerink Partners Global Healthcare Conference, Mar. 8-11, Miami, FL, U.S. Leerink Partners Mountain Meeting, Mar. 22-25, Jackson Hole, WY, U.S. Needham Healthcare Conference, Apr. 13-16, Virtual Van Lanschot Kempen Life Sciences Conference, Apr. 15-16, Amsterdam, Netherlands Consolidated Statements of Financial Position (Unaudited) Consolidated Statements of Loss (Unaudited) - ENDS- About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline includes three core product candidates: Privosegtor, a breakthrough neuroprotective candidate in the PIONEER program which consists of studies intended to support registration plans for treatment in optic neuropathies like optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potentially broad clinical applications in various other neuro-ophthalmic and neurological diseases; OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); and Licaminlimab, a novel, topical anti-TNFα in registrational trial, which is being developed with a genotype-based approach to drive precision medicine in dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors. For more information, please visit: www.oculis.com Oculis Contact Ms. Sylvia Cheung, CFO [email protected] Investor Relations LifeSci Advisors Corey Davis, Ph.D. [email protected] Media Relations ICR Healthcare Amber Fennell / David Daley / Sean Leous [email protected] Cautionary Statement Regarding Forward Looking Statements This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, the initiation, timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy; Oculis’ future development plans; the timing or likelihood of regulatory filings and approvals; statements about market opportunity, and the Company’s expected financial position and cash runway, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the SEC. Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. References:

Investor releaseQuarter not tagged2026-03-02

Earnings To Watch: Oculis Holding AG (OCS) Reports Q4 2025 Result

GuruFocus.com

This article first appeared on GuruFocus. Oculis Holding AG (NASDAQ:OCS) is set to release its Q4 2025 earnings on March 3, 2026. The consensus estimate for Q4 2025 revenue is $0.17 million, and the earnings are expected to come in at -$0.55 per share. The full year 2025's revenue is expected to be $1.01 million and the earnings are expected to be -$2.49 per share. More detailed estimate data can be found on the Forecast page. Warning! GuruFocus has detected 2 Warning Sign with OCS. Is OCS fairly valued? Test your thesis with our free DCF calculator. Over the past 90 days, revenue estimates for Oculis Holding AG (NASDAQ:OCS) have declined from $1.13 million to $1.01 million for the full year 2025, and from $10.10 million to $8.00 million for 2026. During the same period, earnings estimates have increased from -$2.51 per share to -$2.49 per share for 2025, and from -$2.54 per share to -$2.44 per share for 2026. In the previous quarter ending on September 30, 2025, Oculis Holding AG's (NASDAQ:OCS) actual revenue was $0.32 million, which beat analysts' revenue expectations of $0.25 million by 27.94%. Oculis Holding AG's (NASDAQ:OCS) actual earnings were -$0.42 per share, which beat analysts' earnings expectations of -$0.54 per share by 22.39%. After releasing the results, Oculis Holding AG (NASDAQ:OCS) was up by 0.41% in one day. Based on the one-year price targets offered by 10 analysts, the average target price for Oculis Holding AG (NASDAQ:OCS) is $44.22, with a high estimate of $55.28 and a low estimate of $29.15. The average target implies an upside of 50.88% from the current price of $29.31. Based on GuruFocus estimates, the estimated GF Value for Oculis Holding AG (NASDAQ:OCS) in one year is $0, suggesting a downside of -100% from the current price of $29.31. Based on the consensus recommendation from 11 brokerage firms, Oculis Holding AG's (NASDAQ:OCS) average brokerage recommendation is currently 1.5, indicating a "Buy" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Investor releaseQuarter not tagged2025-11-11

Oculis Reports Q3 2025 Financial Results and Provides Company Update

GlobeNewswire
Oculis accelerates its portfolio development with Privosegtor moving into the PIONEER pivotal program in Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) following positive FDA meeting OCS-01 DIAMOND Phase 3 trials in diabetic macular edema (DME) remain on track for topline results expected in Q2 2026 Licaminlimab PREDICT-1 registrational trial, the first genotype-based trial to drive precision medicine in dry eye disease (DED), expected to start in Q4 2025 Cash, cash equivalents and short-term investments of $182.2 million as of September 30, 2025 plus recent $110 million financing, extend cash runway into 2029 ZUG, Switzerland, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced results for the third quarter ended September 30, 2025, and provided an overview of the Company’s progress. Riad Sherif, M.D., Chief Executive Officer of Oculis, stated: “Oculis has entered a pivotal stage in its transformation into a leader in ophthalmology and neuro-ophthalmology, powered by its differentiated and innovative portfolio. We are excited about several key developments: OCS-01 eye drops Phase 3 in DME with anticipated readout in Q2 2026, the initiation of a first in class registrational trial with Licaminlimab in precision medicine for DED, and, very importantly, we are thrilled with our positive discussions with the U.S. Food and Drug Administration (FDA), which paved the way to accelerate Privosegtor development in key unmet medical needs. Our recent financing now secures the resources needed for three pivotal trials in optic neuropathies, a potential market opportunity representing approximately $7 billion in the U.S. alone, with no available therapies. Supported by a strong balance sheet and a robust late-stage pipeline, we are well-positioned to achieve 6 pivotal readouts with the current funding, reinforcing our commitment to delivering groundbreaking treatments.” Recent Clinical Highlights and Upcoming Milestones: Privosegtor: Following a successful meeting with the FDA, Oculis announced the launch of the PIONEER program, which will include three pivotal trials to support registration plans for Privosegtor in AON and…Read full document

Oculis accelerates its portfolio development with Privosegtor moving into the PIONEER pivotal program in Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) following positive FDA meeting OCS-01 DIAMOND Phase 3 trials in diabetic macular edema (DME) remain on track for topline results expected in Q2 2026 Licaminlimab PREDICT-1 registrational trial, the first genotype-based trial to drive precision medicine in dry eye disease (DED), expected to start in Q4 2025 Cash, cash equivalents and short-term investments of $182.2 million as of September 30, 2025 plus recent $110 million financing, extend cash runway into 2029 ZUG, Switzerland, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced results for the third quarter ended September 30, 2025, and provided an overview of the Company’s progress. Riad Sherif, M.D., Chief Executive Officer of Oculis, stated: “Oculis has entered a pivotal stage in its transformation into a leader in ophthalmology and neuro-ophthalmology, powered by its differentiated and innovative portfolio. We are excited about several key developments: OCS-01 eye drops Phase 3 in DME with anticipated readout in Q2 2026, the initiation of a first in class registrational trial with Licaminlimab in precision medicine for DED, and, very importantly, we are thrilled with our positive discussions with the U.S. Food and Drug Administration (FDA), which paved the way to accelerate Privosegtor development in key unmet medical needs. Our recent financing now secures the resources needed for three pivotal trials in optic neuropathies, a potential market opportunity representing approximately $7 billion in the U.S. alone, with no available therapies. Supported by a strong balance sheet and a robust late-stage pipeline, we are well-positioned to achieve 6 pivotal readouts with the current funding, reinforcing our commitment to delivering groundbreaking treatments.” Recent Clinical Highlights and Upcoming Milestones: Privosegtor: Following a successful meeting with the FDA, Oculis announced the launch of the PIONEER program, which will include three pivotal trials to support registration plans for Privosegtor in AON and NAION (management webcast available here for replay): The first two trials, PIONEER-1 and PIONEER-2, will evaluate Privosegtor following the acute onset of optic neuritis in a broad population consisting of patients with multiple sclerosis (MS) and those without MS. Primary endpoint will be low-contrast visual acuity (LCVA) at 3 months. Dosing and patient enrollment criteria will mirror the positive Phase 2 ACUITY trial, which demonstrated improvement in visual function and anatomical preservation of the retina in patients with AON. PIONEER-1 is expected to initiate in Q4 2025, with PIONEER-2 planned to follow in the first half of 2026. The third trial in the PIONEER program, PIONEER-3, will evaluate Privosegtor after the acute onset of NAION. This study shares the core design and operational elements with PIONEER-1 and PIONEER-2 and is expected to initiate in mid-2026. Running the PIONEER trials concurrently is expected to generate operational synergies, cost efficiencies, and to speed up Privosegtor development timelines. Oculis will cross-reference the existing Privosegtor AON Investigational New Drug (IND) when submitting a new IND to the FDA for the acute treatment of relapses in multiple sclerosis (MS). Successful ACUITY Phase 2 trial results in patients with AON were presented in late-breaking abstract sessions at the European Society of Retina Specialists (EURETINA) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) congresses. OCS-01: DIAMOND Phase 3 trials with OCS-01, aims to be the first eye drop for DME, are fully enrolled with over 800 patients across both trials. Topline results from both DIAMOND Phase 3 trials are expected in Q2 2026 with NDA submission to the FDA planned for 2H 2026. DME affects approximately 37 million people worldwide and represents a ~$5 billion market opportunity with high unmet medical needs for early intervention and for patients with inadequate response to standard of care. Licaminlimab: Aligned with the FDA on the genotype-based development plan to drive precision medicine in DED. Registrational trial expected to initiate in Q4 2025 following three positive Phase 2 studies previously completed, including the demonstration of profound effects on TNFR1-positive patients. Q3 2025 Financial Highlights As of September 30, 2025, Oculis held cash, cash equivalents and short-term investments of CHF 145.2 million or $182.2 million. Following the October capital raise, the Company’s cash, cash equivalents and short-term investments was close to $300 million, before disbursing offering expenses. Research and development expenses were CHF 14.1 million or $17.6 million for the three months ended September 30, 2025, compared to CHF 13.0 million or $15.0 million in the same period in 2024. The increase was primarily due to increase in product development activities and associated personnel expenses. General and administrative expenses were CHF 6.4 million or $8.0 million for the three months ended September 30, 2025, compared to CHF 5.3 million or $6.2 million in the same period in 2024. The increase was primarily driven by share-based compensation expense and external professional services costs. Year-to-date net loss was CHF 75.4 million or $89.7 million for the nine months ended September 30, 2025, compared to CHF 57.1 million or $64.8 million for the same period in 2024. The increase was primarily driven by advancements in clinical development programs, in particular the Phase 3 DIAMOND trials, and a CHF 6.9 million or $8.2 million increase in the non-cash fair value adjustment on warrant liabilities as a result of appreciation of underlying warrant fair value. Condensed Consolidated Statements of Loss (Unaudited) About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on innovations addressing neuro-ophthalmic conditions with significant unmet medical needs. Oculis’ highly differentiated late-stage clinical pipeline includes three core product candidates: Privosegtor, a neuroprotective candidate in the PIONEER program which consists of studies intended to support registration plans for treatment in optic neuropathies like acute optic neuritis (AON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potentially broad clinical applications in various other neuro-ophthalmic and neurological diseases; OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); and Licaminlimab, a novel, topical anti-TNFα in Phase 2, which is being developed with a genotype-based approach to drive personalized medicine in dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors. For more information, please visit: www.oculis.com Oculis Contact Ms. Sylvia Cheung, CFO [email protected] Investor Relations LifeSci Advisors Corey Davis, Ph.D. [email protected] Media Relations ICR Healthcare Amber Fennell / David Daley / Sean Leous [email protected] Cautionary Statement Regarding Forward Looking Statements This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, the initiation, timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy, including planned interactions with the FDA; Oculis’ future development plans; the timing or likelihood of regulatory filings and approvals; statements about market opportunity, and the Company’s expected financial position and cash runway, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the U.S. Securities and Exchange Commission (SEC). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

As of 2026-09-05 • Updated weeklySource: Earnings sourceIngestion runbook