Salute e Benessere
Oculis Reports Q3 2025 Financial Results and Provides Company Update
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.
“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.”
Privosegtor:
OCS-01:
Licaminlimab:
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.
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
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com
ICR Healthcare
Amber Fennell / David Daley / Sean Leous
oculis@icrhealthcare.com
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.
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