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Oculis Holding AG - 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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Sabre Gold announced the results of its 2024 Annual General Meeting, held on May 29, 2024. Shareholders approved all agenda items and elected new board members, including Robert K. Warner and Arshad M. Khanani. Additionally, Baruch D. Kuppermann and Frank G. Holz were appointed to the Scientific Advisory Board. The company established a CHF 50 million flexible loan facility with BlackRock, providing significant financial flexibility, though no amounts were drawn at signing. The shareholders approved compensation packages for the Board and Executive Committee, including non-performance-related and variable compensations, as well as equity-based incentives. The company reported a loss of CHF 41.4 million for 2023, which will be carried forward. Key amendments to the articles of association were also approved, including the creation of conditional share capital for bonds and employee incentives.

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Oculis Holding AG (Nasdaq: OCS) and EURETINA announced the establishment of the Ramin Tadayoni Award in memory of the late Chief Scientific Officer, Professor Ramin Tadayoni. The award, supported by Oculis, aims to recognize promising ophthalmologists in retina research. It includes €30,000 for research support and an additional €5,000 for the recipient. Applications will be accepted in June and July 2024, with the first award presented at the EURETINA Congress in September. This annual award honors Prof. Tadayoni's legacy and his significant contributions to ophthalmology.

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Oculis has announced positive topline results from its Phase 2b RELIEF trial on licaminlimab, an anti-TNFα biologic eye drop for dry eye disease (DED). The trial showed significant improvements in multiple efficacy endpoints, particularly in patients with a TNFR1 genetic biomarker. Rapid treatment effects on corneal inflammation were noted by Day 15, with statistical significance by Day 43. Licaminlimab was well tolerated with no serious adverse events. Oculis plans to discuss these findings with the FDA and move into Phase 3 development. An investor and analyst webcast is scheduled for today at 8:30 am US Eastern Time.

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Oculis has published notifications regarding transactions by its managerial staff. These transactions encompass annual equity incentive awards granted to company directors and one-time equity awards given to new directors upon their election to the board. The notifications cover the transactions of directors Ackermann, Khanani, Rosenberg, and Warner.

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Ecopetrol S.A. announced the registration of amendments to its bylaws with the Chamber of Commerce of Bogotá, effective March 29, 2024. Approved by the General Shareholders' Assembly on March 22, 2024, these amendments are recorded in Public Deed No. 3136, executed on May 21, 2024. These changes do not include the corporate purpose amendment previously approved. Ecopetrol, Colombia's largest company, plays a important role in hydrocarbon production and has significant stakes in energy, petrochemicals, and gas distribution. The company also holds substantial international assets, including energy transmission and road concessions in various countries. The press release includes forward-looking statements based on managerial expectations and is subject to market, regulatory, and economic conditions.

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Oculis announced the results of its 2024 Annual General Meeting held on May 29. Shareholders approved all agenda items, including the election of new Board members and the 2023 Annual Report. Robert K. Warner and Arshad M. Khanani joined the Board, while Baruch D. Kuppermann and Frank G. Holz were appointed to the Scientific Advisory Board. The company established a CHF 50 million flexible loan facility with BlackRock. Despite a CHF 41.4 million loss in 2023, shareholders approved compensations for Board and Executive Committee members. Key milestones for 2024 include developments in Dry Eye Disease and Acute Optic Neuritis treatments.

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On May 17, 2024, Oculis Holding announced updates to its at-the-market offering program. The company issued 1,000,000 new ordinary shares with a nominal value of CHF 0.01, recorded as treasury shares. The total number of registered shares is 46,443,700, with 41.7 million outstanding. This move follows a sales agreement with Leerink Partners on May 8, 2024, allowing Oculis to sell up to $100 million worth of shares. The company has no obligation to sell and can suspend or terminate the offering at any time. For more details, refer to Oculis' SEC filings.

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Oculis reported its Q1 2024 financial results and provided updates on its clinical programs, including the initiation of the second OCS-01 Phase 3 DIAMOND-2 trial in Diabetic Macular Edema and completion of enrollment in OCS-02 Phase 2b RELIEF trial in Dry Eye Disease. The company raised $59 million in a direct equity offering, listed on Nasdaq Iceland Main Market, and strengthened its executive team. Financially, Oculis had a cash position of CHF 79.9 million, with research and development expenses of CHF 10.9 million. The company reported a net loss of CHF 16.1 million for Q1 2024. Oculis is on track with its clinical milestones, with topline results anticipated in the second and fourth quarters of 2024.

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Oculis has completed enrollment in the Phase 2 ACUITY trial for OCS-05 in patients with Acute Optic Neuritis, with topline results expected in Q4 2024. The drug has received orphan drug designation in the US and Europe for AON. The trial aims to assess the safety and tolerability of OCS-05, offering potential neuroprotective benefits in ophthalmic diseases.

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Oculis Holding AG has published an invitation to its 2024 Annual General Meeting, scheduled for May 29, 2024, in Zug, Switzerland. The meeting details and materials are available on the company's website.

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FAQ

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

OTC:OCS

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539.91M
41.70M
6.49%
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0.06%
Medicinal and Botanical Manufacturing
Manufacturing
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United States of America
Zug