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Oculis Holding AG Ordinary shares - OCS STOCK NEWS

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Oculis Holding AG (Nasdaq: OCS) is a leading global biopharmaceutical company dedicated to saving sight and enhancing eye care. Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is at the forefront of developing innovative treatments for serious eye diseases. The company's pipeline includes several promising candidates:

  • OCS-01: A topical eye drop for diabetic macular edema (DME) and post-cataract surgery inflammation and pain. OCS-01 has shown compelling Phase 3 data, making it a potential new standard of care for these conditions.
  • OCS-02: A topical biologic anti-TNFα eye drop for dry eye disease (DED) and non-infectious anterior uveitis. The OCS-02 RELIEF trial is in Phase 2b, with results eagerly anticipated.
  • OCS-05: A neuroprotective candidate for acute optic neuritis (AON) and other neuro-ophthalmic disorders such as glaucoma and diabetic retinopathy. The ACUITY trial is set to provide critical data by the end of the year.

Oculis recently announced its fourth-quarter and full-year 2023 financial results, highlighted by positive Phase 3 data for OCS-01 and the commencement of three clinical trials, including OCS-02's RELIEF trial. The company is on track for a catalyst-rich 2024 with significant upcoming milestones, including readouts from the RELIEF trial in Q2 and the OPTIMIZE-2 and ACUITY trials in Q4. These milestones are crucial for Oculis' plan to submit its first New Drug Application (NDA).

Under the leadership of CEO Riad Sherif, M.D., Oculis has achieved remarkable progress and continues to advance its diversified pipeline. The company is backed by leading international healthcare investors and boasts a seasoned management team with a strong track record of success.

Financially, Oculis has reported significant strides, supported by both new and existing investors. The company has dual listings on Nasdaq in the U.S. and Iceland, reflecting its robust financial health and market confidence.

For more information, please visit Oculis Holding AG's website. For investor and media inquiries, contact Ms. Sylvia Cheung, CFO at sylvia.cheung@oculis.com or Corey Davis, Ph.D. at LifeSci Advisors at cdavis@lifesciadvisors.com.

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Oculis Holding AG (Nasdaq: OCS) reported Q3 2024 financial results with cash position of $125.0 million, providing runway into 2H 2026. The company achieved significant enrollment progress in its DIAMOND Phase 3 trials, with ~70% enrolled in DIAMOND-1 and ~40% in DIAMOND-2. Research and development expenses increased to $15.0 million, up from $10.0 million in Q3 2023. The company reported a Q3 net loss of $23.3 million. Key upcoming milestones include OCS-05 Phase 2 ACUITY trial topline results expected in December 2024 and planned NDA submission readiness for OCS-01 in Q1 2025.

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Oculis Holding AG (Nasdaq: OCS) announces accelerated patient enrollment for its Phase 3 DIAMOND trials of OCS-01 eye drops in diabetic macular edema (DME). The DIAMOND program has made substantial progress, with ~70% of patients enrolled in DIAMOND-1 and ~40% in DIAMOND-2. The company has also expanded its DIAMOND program committees with globally renowned retina experts.

The DIAMOND trials are evaluating the efficacy and safety of OCS-01 eye drops in DME patients. If approved, OCS-01 could potentially transform the treatment paradigm as the first topical eye drop to treat DME. Results from Stage 1 of the program showed significant improvements in visual acuity and clinically meaningful reduction in macular edema for patients treated with OCS-01.

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Oculis Holding AG (Nasdaq: OCS) announces accelerated patient enrollment for both Phase 3 DIAMOND trials of OCS-01 eye drops in diabetic macular edema (DME). The DIAMOND-1 trial has enrolled ~70% of patients, while DIAMOND-2 has enrolled ~40%. The company has also expanded its DIAMOND program committees with globally renowned retina experts.

The DIAMOND program consists of two Phase 3, double-masked, randomized, multi-center trials evaluating the efficacy and safety of OCS-01 eye drops in DME patients. If approved, OCS-01 has the potential to be the first topical eye drop to treat DME, potentially transforming the treatment paradigm.

Dr. Arshad M. Khanani, DIAMOND Program Steering Committee Chairperson, highlighted promising results from Stage 1 of the DIAMOND Phase 3 program, showing significant improvements in visual acuity and clinically meaningful reduction in macular edema for patients treated with OCS-01.

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Oculis Holding AG (Nasdaq: OCS) announced that updates on its DIAMOND Phase 3 program for OCS-01, an OPTIREACH® formulation of high concentration dexamethasone eye drop for diabetic macular edema (DME), will be presented at two upcoming events. Dr. David Eichenbaum will present at Innovate Retina, while Dr. Riad Sherif, Oculis' CEO, will present at Eyecelerator 2024.

Both presentations will highlight the robust results from Stage 1 of the DIAMOND program at Week 12 and present the design of Stage 2, which will assess efficacy and safety at Week 52. The ongoing DIAMOND-1 and DIAMOND-2 Phase 3 trials aim to enroll 350 patients each. Additionally, Dr. Sherif will discuss upcoming milestones, including topline results from the ACUITY Phase 2 trial with OCS-05 for acute optic neuritis, expected before the end of 2024.

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Oculis Holding AG (Nasdaq: OCS), a global biopharmaceutical company focused on eye care, has appointed Daniel S. Char as Chief Legal Officer. Mr. Char brings over 35 years of global legal leadership experience in biotech and medical device companies. He will lead Oculis' legal, compliance, and corporate governance functions.

This appointment aligns with Oculis' strategic plan to advance its innovative pipeline, particularly OCS-01, the first topical eye drop in retina. Mr. Char's extensive expertise includes corporate governance, compliance, drug development and commercialization, financing, licensing, and M&A transactions.

Prior to joining Oculis, Mr. Char served as Chief Legal Officer at ImmunoGen and General Counsel at Evelo Biosciences. He has also held senior legal positions at Smith & Nephew, Targanta Therapeutics, and Biogen. Mr. Char holds a Juris Doctor from Harvard Law School and a Bachelor of Arts in Economics from Tufts University.

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Oculis Holding AG (Nasdaq: OCS) and EURETINA have announced Dr. Andrea Govetto as the winner of the inaugural Ramin Tadayoni Award. This award, established in memory of Oculis' late Chief Scientific Officer, aims to support outstanding retina research. Dr. Govetto's winning project focuses on developing a computational model of fluid flow and retinal tissue deformation in macular edema.

The award, presented at the EURETINA congress in Barcelona, includes €30,000 for research support and an additional €5,000 for the awardee. It recognizes promising ophthalmologists in retina research, honoring Prof. Tadayoni's legacy. Dr. Govetto, a vitreoretinal surgeon at Oftalmico-Fatebenefratelli Hospital in Milan, was selected from over 50 competitive submissions.

Oculis CEO, Dr. Riad Sherif, expressed pride in supporting the award and advancing retinal disease research. EURETINA President, Dr. Anat Loewenstein, congratulated Dr. Govetto and highlighted the award's significance in furthering Prof. Tadayoni's contributions to the field.

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Oculis Holding AG (Nasdaq: OCS), a global biopharmaceutical company focused on eye care, has announced its participation in three major investor conferences in September 2024:

1. Wells Fargo Healthcare Conference (September 4-6, Boston, MA)
2. H.C. Wainwright 26th Annual Global Investment Conference (September 9-11, New York, NY)
3. Baird Global Healthcare Conference (September 10-11, New York, NY)

Key presentations include CEO Riad Sherif at H.C. Wainwright on September 11 at 9:30 am ET, and CFO Sylvia Cheung at Baird on September 10 at 9:05 am ET. The company will be available for one-on-one meetings during these events. Presentation links will be posted on Oculis' website under the Investors & Media section.

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Oculis, a Swiss-based pharmaceutical company trading under the symbol OCS, has filed its Q2 Consolidated Financial Statements and Management's Discussion and Analysis (MD&A) with the SEC on Form 6-K. This follows an earlier press release announcing the same. The filings provide detailed financial information and management's perspective on the company's performance for the second quarter of 2024. Investors and analysts can now access these documents to gain deeper insights into Oculis's financial health, operational performance, and strategic direction.

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Oculis Holding AG (Nasdaq: OCS; XICE: OCS) reported Q2 2024 financial results and provided company updates. Key highlights include:

1. Positive topline results from Phase 2b RELIEF trial of OCS-02 for Dry Eye Disease
2. Phase 2 ACUITY trial of OCS-05 for acute optic neuritis on track for Q4 2024 readout
3. Pre-NDA meeting with FDA completed for OCS-01 in post-operative inflammation and pain
4. Cash position of $131.2 million as of June 30, 2024, providing runway into 2H 2026
5. Q2 net loss of $23.0 million, compared to $14.3 million in Q2 2023
6. Raised $59 million in an oversubscribed registered direct offering

The company continues to advance its clinical programs, with strong momentum in DIAMOND-1 and DIAMOND-2 trials for DME.

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Oculis Holding AG (Nasdaq: OCS; XICE: OCS) reported Q2 2024 financial results and provided a company update. Key highlights include:

1. Positive topline results from Phase 2b RELIEF trial of OCS-02 for Dry Eye Disease

2. Phase 2 ACUITY trial of OCS-05 for acute optic neuritis on track for Q4 2024 readout

3. Pre-NDA meeting completed for OCS-01 in post-operative inflammation and pain, with NDA submission planned for Q1 2025

4. Cash position of $131.2 million as of June 30, 2024, providing runway into 2H 2026

5. Q2 net loss of $23.0 million, primarily due to increased clinical development expenses

6. Continued progress in Phase 3 DIAMOND trials for OCS-01 in diabetic macular edema

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FAQ

What is the current stock price of Oculis Holding Ordinary shares (OCS)?

The current stock price of Oculis Holding Ordinary shares (OCS) is $16.309 as of November 8, 2024.

What is the market cap of Oculis Holding Ordinary shares (OCS)?

The market cap of Oculis Holding Ordinary shares (OCS) is approximately 684.6M.

What is Oculis Holding AG?

Oculis Holding AG is a global biopharmaceutical company focused on developing treatments for serious eye diseases, including diabetic macular edema and dry eye disease.

What products are in Oculis' pipeline?

Oculis' pipeline includes OCS-01 for diabetic macular edema, OCS-02 for dry eye disease, and OCS-05 for acute optic neuritis and other neuro-ophthalmic disorders.

Where is Oculis headquartered?

Oculis is headquartered in Switzerland, with additional operations in the U.S. and Iceland.

What recent achievements has Oculis made?

In 2023, Oculis had positive Phase 3 results for OCS-01 and initiated three clinical trials, including the OCS-02 Phase 2b RELIEF trial for dry eye disease.

Who leads Oculis Holding AG?

Oculis is led by CEO Riad Sherif, M.D., alongside an experienced management team with a successful track record and support from leading international healthcare investors.

What are the upcoming milestones for Oculis in 2024?

Upcoming milestones include the RELIEF trial readout for OCS-02 in Q2, and Phase 3 readouts for OCS-01 and OCS-05 in Q4, along with the submission of the first NDA.

How did Oculis perform financially in 2023?

Oculis reported strong financial results for 2023, supported by significant investor backing and a successful dual listing on Nasdaq in the U.S. and Iceland.

What conditions does OCS-01 treat?

OCS-01 is a topical eye drop candidate for treating diabetic macular edema (DME) and for post-cataract surgery inflammation and pain.

What is the OCS-02 RELIEF trial?

The OCS-02 RELIEF trial is a Phase 2b clinical study evaluating the efficacy of OCS-02, a topical biologic anti-TNFα eye drop, for treating dry eye disease (DED).

How can I contact Oculis for investor or media inquiries?

For inquiries, you can contact CFO Sylvia Cheung at sylvia.cheung@oculis.com or Corey Davis, Ph.D., at cdavis@lifesciadvisors.com.

Oculis Holding AG Ordinary shares

Nasdaq:OCS

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