Research analysts covering Oculis Holding.
Recent press releases and 8-K filings for OCS.
Oculis Highlights Late-Stage Pipeline Progress and Strong Financial Position
OCS
New Projects/Investments
Guidance Update
Product Launch
- Oculis (OCS), a Nasdaq-listed global biopharma company, is advancing three registrational-stage candidates targeting a market opportunity exceeding $25 billion.
- Key upcoming catalysts include topline results for OCS-01 (DME) in Q2 2026 and Licaminlimab (Dry Eye Disease) in Q4 2026. An NDA submission for OCS-01 in DME is planned for Q4 2026.
- The company's third candidate, Privosegtor, a neuroprotective therapy with Breakthrough Therapy Designation for Optic Neuritis, has registrational trials (PIONEER-1, PIONEER-2, PIONEER-3) ongoing or starting through mid-2026.
- Oculis maintains a strong balance sheet with no debt and a cash runway extending into 2029.
Jan 14, 2026, 9:30 PM
Oculis Highlights Late-Stage Pipeline Progress and Strong Financial Position
OCS
New Projects/Investments
Product Launch
- Oculis anticipates key readouts for its late-stage pipeline, including OCS-01 (non-invasive eye drop for DME) in Q2 2026 with planned submission in Q4 2026 and approval in 2027, and Licaminlimab (precision medicine for dry eye disease) in Q4 2026.
- The company's neuro-ophthalmology candidate, OCS-05 (Privosegtor), recently received Breakthrough Therapy Designation and has Phase III trials (PIONEER 1, 2, and 3) underway, with PIONEER 1 results expected in 2027 and PIONEER 3 starting in mid-2026.
- Oculis maintains a strong financial position with no debt and sufficient cash to fund operations into 2029, excluding a CHF 100 million facility loan with BlackRock.
Jan 14, 2026, 9:30 PM
Oculis Provides Pipeline Updates and Financial Outlook at J.P. Morgan Healthcare Conference
OCS
New Projects/Investments
Guidance Update
- Oculis, a Nasdaq-listed biopharma company, reported a strong balance sheet with no debt and a cash runway extending into 2029.
- The company expects top-line results for its OCS-01 (DME eye drop) program in Q2 2026, with submission planned for Q4 2026 and approval anticipated in 2027.
- For its dry eye disease program, Licaminlimab, Oculis anticipates readout for the first phase 3 trial (Predict One) in Q4 2026.
- Privosegtor, a neuroprotective candidate, received Breakthrough Therapy Designation and has phase 3 trials (Pioneer 1 for optic neuritis, Pioneer 3 for NAION) with readouts expected in 2027 and initiation in mid-2026, respectively. The company also plans to meet with the FDA in 2026 to discuss broadening Privosegtor's use for all types of MS relapse.
Jan 14, 2026, 9:30 PM
Oculis Provides Update on Late-Stage Pipeline and Financial Position at J.P. Morgan Healthcare Conference
OCS
New Projects/Investments
Guidance Update
- Oculis, a Nasdaq-listed biopharma company, reported a strong balance sheet with no debt and cash projected into 2029, excluding a CHF 100 million (or $125 million) facility loan with BlackRock.
- The company expects key readouts for its ophthalmology pipeline in 2026: OCS-01 (DME) in Q2 2026 with submission planned for Q4 2026, and Licaminlimab (dry eye disease) in Q4 2026.
- Privosegtor, a neuroprotective candidate, received Breakthrough Therapy Designation and has multiple Phase 3 trials underway or starting in 2026 for optic neuritis and NAION, with a readout for Pioneer 1 expected in 2027.
- Oculis plans to focus its commercial efforts on the US market and seek partners for ex-US commercialization.
Jan 14, 2026, 9:30 PM
Oculis Provides Update on Neuro-ophthalmology and Ophthalmology Pipeline
OCS
Product Launch
New Projects/Investments
- Oculis has two main franchises: neuro-ophthalmology and ophthalmology.
- The neuro-ophthalmology program, Privosegtor, showed positive results in acute optic neuritis (AON) and is advancing to Phase 3 studies (Pioneer One and Two), with a Phase 2/3 study (Pioneer Three) also planned for NAION. The potential market for AON and NAION in the US is estimated at $7 billion with no current competition.
- In ophthalmology, Oculis's OCS-01 for Diabetic Macular Edema (DME) has completed enrollment for its Diamond One and Diamond Two Phase 3 trials, with a readout planned for Q2 2026. OCS-01 previously demonstrated 7.6 letters improvement, comparable to Lucentis without injections.
- OCS-02, a topical anti-TNF for dry eye disease, is being developed as a personalized medicine targeting TNF-R1 positive patients, enabling a smaller and more efficient Phase 3 study.
Nov 12, 2025, 7:00 PM
Oculus Highlights Phase III Pipeline, Upcoming Milestones, and Strong Financial Position
OCS
New Projects/Investments
Guidance Update
- Oculus, a biopharma company, has three candidates in Phase III across neuro ophthalmology and ophthalmology, with upcoming milestones including readouts for OCS-01 in DME in Q2 2026 and Lecamilab in dry eye disease in H2 2026.
- The company's lead asset, Prevo sector, is in Phase III for acute optic neuritis (AON), targeting a $6-7 billion market with no current competition, and is also being developed for NAON.
- Oculus reports a strong balance sheet with sufficient cash to fund all six planned Phase III trials until 2029.
Nov 11, 2025, 5:30 PM
Oculis Holding AG Reports Q3 2025 Financial Results and Provides Pipeline Update
OCS
Earnings
Guidance Update
New Projects/Investments
- Oculis Holding AG reported a net loss of CHF 75.4 million for the nine months ended September 30, 2025, with CHF 49.6 million in cash outflow from operations during the same period.
- As of September 30, 2025, the company's cash, cash equivalents, and short-term financial assets totaled CHF 145.2 million (or $182.2 million).
- The company's cash runway has been extended into 2029 due to recent financing, including a CHF 90.2 million (or $100.0 million) follow-on offering in February 2025 and an additional $110 million financing.
- Key pipeline advancements include Privosegtor (OCS-05) moving into a pivotal program for Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) following a positive FDA meeting, and OCS-01 Phase 3 trials for diabetic macular edema (DME) remaining on track for topline results in Q2 2026. The Licaminlimab PREDICT-1 registrational trial for dry eye disease is also expected to commence in Q4 2025.
Nov 10, 2025, 9:07 PM
Oculis Holding AG Announces $110 Million Financing
OCS
New Projects/Investments
- Oculis Holding AG announced an oversubscribed $110 million financing to accelerate Privosegtor development.
- The financing involves the pricing of 5,432,098 ordinary shares at $20.25 per share, consisting of an underwritten offering of 4,691,358 shares and a registered direct offering of 740,740 shares.
- The company granted underwriters a 30-day option to purchase up to an additional 703,703 ordinary shares at the same price.
- If the underwriters' option is fully exercised, the total gross proceeds from the offerings would be approximately $124.2 million.
- Oculis intends to use the net proceeds to advance and accelerate the development of Privosegtor and fund operations until late 2028.
Oct 31, 2025, 8:55 PM
Oculis Advances Privosegtor into Registrational Trials
OCS
New Projects/Investments
Guidance Update
- Oculis Holding AG is advancing its neuroprotective candidate, Privosegtor, into registrational trials for acute optic neuritis (AON) and non-arteritic anterior ischemic optic neuropathy (NAION) following a positive meeting with the FDA.
- The company will launch the PIONEER program, which includes three pivotal trials: PIONEER-1 (AON) starting in Q4 2025, PIONEER-2 (AON) in 1H 2026, and PIONEER-3 (NAION) in mid-2026.
- Privosegtor is positioned as a potential first-in-class neuroprotective therapy for AON and NAION, addressing high unmet medical needs in these rare neuro-ophthalmic diseases.
- As of September 30, 2025, Oculis reported preliminary unaudited cash, cash equivalents, and short-term investments of approximately $182 million, with a cash runway expected into 2H 2027 to support the Privosegtor development program.
Oct 6, 2025, 8:40 PM
Oculis Provides Update on Registrational Programs and Financial Position
OCS
New Projects/Investments
Guidance Update
- Oculis successfully concluded a meeting with the U.S. FDA, enabling the advancement of its Privosegtor candidate into registrational phases for Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION).
- The PIONEER-1 registrational trial for AON is slated to commence in Q4 2025, with PIONEER-2 following in 1H 2026, and the PIONEER-3 trial for NAION expected to start in mid-2026.
- Readouts for OCS-01 eye drops in Diabetic Macular Edema (DME) are anticipated in Q2 2026, with a New Drug Application (NDA) submission targeted for 2H 2026.
- Oculis reports a strong balance sheet with no debt and a cash runway extending into 2H 2027 without utilizing its loan facility.
Oct 6, 2025, 12:30 PM
Ask Fintool AI Agent
Get instant answers from SEC filings, earnings calls & more