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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.
Oculis Holding AG (Nasdaq: OCS) has announced the pricing of an oversubscribed offering of 5,000,000 ordinary shares at $20.00 per share, raising total gross proceeds of $100 million. The offering is expected to close around February 18, 2025.
The new shares will be issued from the Company's existing capital band, increasing the total authorized registered shares to 53,943,700. The proceeds will be used to advance and accelerate Oculis' clinical development pipeline, particularly the development of its novel neuroprotective candidate Privosegtor (OCS-05), as well as for working capital and general corporate purposes.
BofA Securities and Leerink Partners are serving as joint bookrunning managers, with Pareto Securities as lead manager and Arctica Finance as financial advisor for the offering.
Oculis Holding AG (Nasdaq: OCS) has announced the pricing of an oversubscribed offering of 5,000,000 ordinary shares at $20.00 per share, raising total gross proceeds of $100 million. The offering is expected to close around February 18, 2025.
The new shares will be issued from the company's existing capital band, bringing total authorized registered shares to 53,943,700. The proceeds will be used to advance and accelerate Oculis's clinical development pipeline, particularly the development of its novel neuroprotective candidate Privosegtor (OCS-05), as well as for working capital and general corporate purposes.
BofA Securities and Leerink Partners are serving as joint bookrunning managers, with Pareto Securities as lead manager and Arctica Finance as financial advisor for the offering.
On February 8, 2025, Oculis, based in Zug, Switzerland, announced notifications regarding transactions involving earnout shares for several persons discharging managerial responsibilities. The notifications specifically detail the vesting of earnout shares and the removal of restrictions on ordinary shares. The transactions involve four individuals: Anthony Rosenberg, Pall Johanesson, Riad Sherif, and Sylvia Cheung.
Oculis Holding AG (Nasdaq: OCS; XICE: OCS) has issued 2,500,000 new registered ordinary shares with a nominal value of CHF 0.01 each from its existing capital band. These shares are currently recorded as treasury shares. The company's total registered shares now stand at 48,943,700, with approximately 43 million shares outstanding. Following this issuance, treasury shares represent 7.2% of the company's registered shares.
The new shares were issued in connection with an at-the-market (ATM) offering program established through a sales agreement with Leerink Partners on May 8, 2024. Under this program, Oculis may offer and sell ordinary shares worth up to $100 million through Leerink Partners as its sales agent. The newly issued shares have not been sold under the ATM program and are being held in reserve as treasury shares.
In a brief announcement dated January 21, 2025, Oculis, based in Zug, Switzerland, has disclosed a notification regarding major changes in voting rights. The changes involve Íslandsbanki, though specific details about the nature and extent of these changes were not provided in the announcement.
On January 20, 2025, Oculis announced the publication of a Notification of Major Changes in Voting Rights in Zug, Switzerland. The notification specifically relates to changes involving Íslandsbanki. No further details about the nature or extent of the voting rights changes were provided in the announcement.
Oculis announced positive topline results from its Phase 2 ACUITY trial for OCS-05, a potential first-in-class neuroprotective therapy for acute optic neuritis. The trial met its primary safety endpoint and achieved statistical significance on key efficacy endpoints.
The randomized, double-blind study evaluated 33 patients receiving OCS-05 (2mg/kg/day or 3mg/kg/day) administered intravenously for five days. Key results include:
- 43% improvement in GCIPL thickness at 3 months for OCS-05 (3mg/kg/day)
- 28-30% improvement in RNFL thickness at 3-6 months
- Approximately 18 letters improvement in visual function at 3 months
The treatment showed a favorable safety profile with no serious adverse events or discontinuations. The FDA has granted orphan drug designation and cleared the IND application, enabling U.S. clinical development. The company reports approximately $105-110 million in cash and equivalents.
Oculis (Nasdaq: OCS) announced positive topline results from its Phase 2 ACUITY trial for OCS-05, a neuroprotective therapy candidate for acute optic neuritis. The trial met its primary safety endpoint and achieved statistical significance on key efficacy endpoints. The study demonstrated a 43% improvement in GCIPL thickness and 28% improvement in RNFL thickness with OCS-05 (3mg/kg/day) plus steroid versus placebo at 3 months.
The trial involved 36 randomized patients, with 33 included in the modified intent-to-treat analysis. Visual function improvements showed approximately 18 letters improvement at month 3 and 15 letters at month 6. No drug-related serious adverse events were reported, with headache and acne (10.5% each) being the most common side effects.
OCS-05 has received orphan drug designation from both FDA and EMA, and its IND application has been cleared by the FDA. The company reports approximately $105-110 million in cash and equivalents entering 2025.
On January 4, 2025, Oculis Holding AG announced a significant change in its voting rights structure. The change occurred due to Brunnur vaxtarsjóður slhf distributing its shares in Oculis to its own shareholders. This redistribution of shares represents a major shift in the company's ownership structure.
Oculis has published notifications regarding transactions by individuals with managerial responsibilities. The notifications pertain to the vesting and settlement of Restricted Stock Units (RSUs) previously granted to the company's directors.
The attached documents detail the transactions for two directors:
- Anthony Rosenberg - December 2024
- Arshad Khanani - December 2024