Oculis Reports Q2 2025 Financial Results and Provides Company Update

Rhea-AI Summary

Oculis (NASDAQ: OCS) reported Q2 2025 financial results and provided updates on its ophthalmology pipeline. The company maintained a cash position of $201.3 million as of June 30, 2025, with runway into early 2028, supplemented by a $123.7 million BlackRock loan facility.

Key pipeline developments include: OCS-01's Phase 3 DIAMOND trials completion of enrollment with over 800 patients for diabetic macular edema treatment, with topline results expected Q2 2026; Privosegtor (OCS-05) advancing to Phase 2/3 trial in acute optic neuritis in 1H 2026 following positive Phase 2 results; and Licaminlimab (OCS-02) preparing for genotype-based Phase 2/3 trial in dry eye disease in 2H 2025.

Financial results showed R&D expenses of $18.1 million for Q2 2025, slightly down from Q2 2024, and a year-to-date net loss of $67.9 million, increased from $41.5 million in the same period 2024.

Positive

• None.

Negative

• Increased year-to-date net loss to $67.9M from $41.5M in 2024
• $12.1M increase in non-cash fair value adjustment on warrant liabilities
• Key trial results for OCS-01 not expected until Q2 2026

Insights

Biotech Financial Analyst

Oculis shows strong pipeline progress with fully enrolled DME trials and promising neuroprotective candidates, while maintaining solid $201.3M cash position into 2028.

Oculis is making notable progress across its ophthalmology pipeline, with OCS-01 standing as its most advanced asset. Both Phase 3 DIAMOND trials for diabetic macular edema (DME) have completed enrollment with over 800 patients, positioning OCS-01 to potentially become the first topical eye drop for DME - addressing a substantial $5 billion market opportunity affecting 37 million people globally. Topline results are expected in Q2 2026.

The company's second key asset, Privosegtor (OCS-05), shows significant promise as a potential first-in-class neuroprotective therapy. Following positive Phase 2 ACUITY results in acute optic neuritis (AON), Oculis is expanding its clinical development into two additional indications: non-arteritic anterior ischemic optic neuropathy (NAION) and multiple sclerosis relapses. This strategic expansion leverages Privosegtor's neuroprotective mechanism to address multiple high-unmet-need conditions.

Their third program, Licaminlimab (OCS-02), is pioneering a genotype-based approach for dry eye disease with a Phase 2/3 trial set to begin in 2H 2025, representing an innovative personalized medicine approach in ophthalmology.

Financially, Oculis maintains a solid position with $201.3 million in cash, cash equivalents and short-term investments as of June 30, 2025. This provides runway into early 2028, further strengthened by access to an additional $123.7 million through a recently announced BlackRock loan facility. R&D expenses for Q2 were $18.1 million, showing slight decrease from $18.2 million in the same period last year, while G&A expenses decreased to $7.4 million from $6.9 million year-over-year. The six-month net loss increased to $67.9 million compared to $41.5 million in the same period in 2024, primarily due to clinical program advancements and a $12.1 million non-cash fair value adjustment on warrant liabilities.

With three differentiated clinical programs targeting significant unmet needs, substantial financial resources, and multiple upcoming catalysts, Oculis is well-positioned to advance its innovative ophthalmology and neuro-ophthalmology pipeline over the next 12-24 months.

Clinical Ophthalmology Specialist

Oculis' lead candidates show impressive clinical progress, particularly with first-ever eye drop for DME and novel neuroprotective mechanisms.

The clinical advancements in Oculis' pipeline represent potentially significant paradigm shifts in ophthalmology treatment. The OCS-01 program for diabetic macular edema is particularly noteworthy as it aims to introduce the first topical treatment option for a condition currently managed primarily through invasive intravitreal injections. The successful enrollment of both Phase 3 DIAMOND trials signals strong physician interest and recognition of the unmet need for less-invasive DME therapies.

Privosegtor (OCS-05) demonstrates even more groundbreaking potential. The positive Phase 2 ACUITY results showing both functional visual improvements and anatomical/biological neuroprotective benefits in acute optic neuritis represent a significant breakthrough. True neuroprotective agents have been an elusive goal in neuro-ophthalmology for decades. If successful, Privosegtor could become the first therapy capable of preserving neurons and axons in conditions where irreversible vision loss typically occurs.

The expansion into non-arteritic anterior ischemic optic neuropathy (NAION) and multiple sclerosis relapses is clinically logical, as these conditions share pathophysiological mechanisms involving axonal damage and neurodegeneration. NAION currently has no approved treatments despite being the most common acute optic neuropathy in patients over 50, while visual pathway involvement in MS relapses represents a significant source of disability.

The Licaminlimab (OCS-02) genotype-based approach in dry eye disease also represents a significant advance in precision medicine for ophthalmology. Following three positive Phase 2 studies, this personalized approach could improve efficacy by targeting therapy to patients most likely to respond based on genetic markers. This would represent a major step forward in a condition notorious for heterogeneous treatment responses.

The clinical development timeline appears well-structured, with critical milestones for all three programs expected between late 2025 and 2026, potentially transforming treatment paradigms across multiple ophthalmologic and neuro-ophthalmologic conditions with significant unmet needs.

• Focused execution in Q2 2025 to advance Oculis’ pipeline in ophthalmology and neuro-ophthalmology
  
  
• OCS-01: Both pivotal Ph3 DIAMOND trials are fully enrolled, with topline results expected in Q2 2026 for the first potential eye drop to treat diabetic macular edema (DME)
  
  
• Privosegtor (OCS-05): Preparing to initiate Phase 2/3 trial in acute optic neuritis (AON) in 1H 2026 following positive Ph2 ACUITY results, and expanding clinical development into two new indications as the first potential neuroprotective treatment for non-arteritic anterior ischemic optic neuropathy (NAION) and multiple sclerosis relapses
  
  
• Licaminlimab (OCS-02): Preparing for first genotype-based Phase 2/3 trial in 2H 2025 to drive personalized medicine in dry eye disease (DED)
  
  
• Cash, cash equivalents and short-term investments of $201.3 million as of June 30, 2025, providing cash runway into early 2028; excludes the recently announced upsized loan facility with BlackRock, providing access up to $123.7 million
  

ZUG, Switzerland, Aug. 21, 2025 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2025 and provided an overview of the Company’s progress.

Riad Sherif, M.D., Chief Executive Officer of Oculis, states: “We maintain a strong focus on execution to advance our portfolio of highly differentiated assets in areas with significant unmet medical needs. The rapid enrollment in both Phase 3 DIAMOND trials highlights strong support from the medical community for OCS-01, which aims to become the first eye drop treatment for diabetic macular edema, with topline results expected in Q2 2026. We are also preparing Licaminlimab’s (OCS-02) genotype-based Phase 2/3 trial in 2H 2025 to deliver a first personalized medicine treatment in dry eye disease. Moreover, encouraging Phase 2 ACUITY trial results for Privosegtor (OCS-05) in acute optic neuritis, which showed significant improvement in visual function as well as anatomical and biological neuroprotective benefits, are unlocking a new era of potential therapies targeting neuronal and axonal preservation, and addressing a long-standing gap in neuroprotection for the first time. These strong efficacy signals open opportunities across ophthalmology, neuro-ophthalmology, and neurology.”

Recent Clinical Highlights and Upcoming Milestones:

• OCS-01:
  • Phase 3 DIAMOND trials completed enrollment with over 800 patients across 119 global sites; if approved, OCS-01 has the potential to be the first topical treatment for DME.
  • DME affects approximately 37 million people worldwide and represents a ~$5 billion market opportunity with high unmet medical needs for early intervention and for patients with inadequate response to standard of care.
  • Topline results from both trials are expected in Q2 2026 with NDA submission planned for 2H 2026.
• Privosegtor (OCS-05):
  • Privosegtor is a neuroprotective candidate with the potential to become a first-in-class therapy for AON, an acute inflammation of the optic nerve that can lead to permanent visual impairment and may be the first sign of multiple sclerosis.
  • Phase 2 ACUITY trial results showed significant improvement in visual function as well as anatomical and biological neuroprotective benefits.
  • FDA interactions are planned for Q3 2025 to discuss the development program for Privosegtor, including a Phase 2/3 trial for AON, expected to initiate in 1H 2026.
  • Privosegtor’s neuroprotective benefit opens broad potential clinical applications for multiple neuro-ophthalmology and neurology indications with high unmet need, including in the two new indications to be investigated: NAION and multiple sclerosis relapses.
    
    
• Licaminlimab (OCS-02):
  
  
  • Genotype-based development plan in dry eye disease aligned with FDA to deliver a first personalized medicine treatment in dry eye disease; Phase 2/3 trial to be initiated in 2H 2025 following three positive Phase 2 studies previously completed.

Second Half 2025 Financial Results

As of June 30, 2025, Oculis held cash, cash equivalents and short-term investments of CHF 160.3 million or $201.3 million. Research and development expenses were CHF 14.9 million or $18.1 million for the three-months ended June 30, 2025, compared to CHF 16.5 million or $18.2 million in the same period in 2024. The decrease was primarily due to the timing of two completed trials in 2024, partially offset by ongoing trials and increased R&D personnel-related costs. General and administrative expenses were CHF 6.1 million or $7.4 million for the three-months ended June 30, 2025, compared to CHF 6.3 million or $6.9 million in the same period in 2024. The decrease was primarily driven by a reduction in external professional services costs incurred in the prior year period. Year-to-date net loss was CHF 58.6 million or $67.9 million for the six months ended June 30, 2025, compared to CHF 36.9 million or $41.5 million for the same period in 2024. The increase was primarily driven by advancements in clinical development programs and a CHF 10.4 million or $12.1 million increase in the non-cash fair value adjustment on warrant liabilities as a result of appreciation of underlying warrant fair value.

Upcoming Events:

Medical Conferences and Industry Events

• Ophthalmology Futures Retina Forum; Sep. 3, Paris, France
• EURETINA Innovation Spotlight; Sep. 3, Paris, France
• EURETINA Annual Meeting; Sep. 4 - 7, Paris, France
• Retina Society Annual Meeting; Sep. 10 - 13, Chicago, IL, US
• Ophthalmology Futures European Forum; Sep. 11, Copenhagen, Denmark
• ESCRS Annual Congress; Sept. 12 - 16, Copenhagen, Denmark
• ECTRIMS Annual Meeting; Sep. 24 - 26, Barcelona, Spain
  

Investor Conferences

• Wells Fargo Healthcare Conference; Sep. 3 - 5, Boston, MA, US
• HCW 27^th Annual Global Investment Conference; Sep. 8 - 10, New York City, NY, US
• Baird 2025 Global Healthcare Conference; Sep. 9 - 10, New York City, NY, US
• Pareto Securities Healthcare Conference; Sep. 16, Stockholm, Sweden
• Leerink Biopharma Summit; Sep. 17 - 19, Healdsburg, CA, US

Condensed Consolidated Statements of Financial Position (Unaudited)
(Amounts in CHF thousands)	As of June 30,		As of December 31,
	2025		2024
ASSETS
Non-current assets
Property and equipment	441		385
Intangible assets	13,292		13,292
Right-of-use assets	1,155		1,303
Other non-current assets	533		476
Total non-current assets	15,421		15,456
Current assets
Other current assets	4,721		5,605
Accrued income	1,179		629
Short-term financial assets	96,035		70,955
Cash and cash equivalents	64,265		27,708
Total current assets	166,200		104,897
TOTAL ASSETS	181,621		120,353
EQUITY AND LIABILITIES
Shareholders' equity
Share capital	558		446
Share premium	466,438		344,946
Reserve for share-based payment	22,363		16,062
Actuarial loss on post-employment benefit obligations	(1,620)		(2,233)
Treasury shares	(35)		(10)
Cumulative translation adjustments	(462)		(271)
Accumulated losses	(344,146)		(285,557)
Total equity	143,096		73,383
Non-current liabilities
Long-term lease liabilities	720		865
Defined benefit pension liabilities	1,259		1,870
Total non-current liabilities	1,979		2,735
Current liabilities
Trade payables	1,204		5,871
Accrued expenses and other payables	19,922		18,198
Short-term lease liabilities	310		315
Warrant liabilities	15,110		19,851
Total current liabilities	36,546		44,235
Total liabilities	38,525		46,970
TOTAL EQUITY AND LIABILITIES	181,621		120,353

Condensed Consolidated Statements of Loss (Unaudited)
(Amounts in CHF thousands, except per share data)	For the three months ended June 30,				For the six months ended June 30,
	2025		2024		2025		2024
Grant income	261		245		545		467
Operating income	261		245		545		467
Research and development expenses	(14,909)		(16,465)		(29,680)		(27,321)
General and administrative expenses	(6,120)		(6,265)		(11,608)		(10,959)
Operating expenses	(21,029)		(22,730)		(41,288)		(38,280)
Operating loss	(20,768)		(22,485)		(40,743)		(37,813)
Finance income	520		660		1,013		1,241
Finance expense	(183)		(87)		(430)		(128)
Fair value adjustment on warrant liabilities	(234)		1,370		(12,145)		(1,699)
Foreign currency exchange loss, net	(4,734)		(267)		(6,301)		1,527
Finance result, net	(4,631)		1,676		(17,863)		941
Loss before tax for the period	(25,399)		(20,809)		(58,606)		(36,872)
Income tax expense	24		(30)		17		(60)
Loss for the period	(25,375)		(20,839)		(58,589)		(36,932)
Loss per share:
Basic and diluted loss attributable to equity holders	(0.49)		(0.51)		(1.16)		(0.96)

About Oculis

Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on innovations addressing ophthalmic and neuro-ophthalmic conditions with significant unmet medical needs. Oculis’ highly differentiated late-stage clinical pipeline includes three core product candidates: OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema; Privosegtor (OCS-05), a neuroprotective candidate in Phase 2 for acute optic neuritis, with potentially broad clinical applications in various neuro-ophthalmic and neurological diseases; and Licaminlimab (OCS-02), a novel topical anti-TNFα in Phase 2, being developed with a genotype-based approach to drive personalized medicine in dry eye disease. 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

Oculis Contacts
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com

Investor & Media Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com
1-212-915-2577

Cautionary Statement Regarding Forward-Looking Statements

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; 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 other documents filed with the U.S. Securities and Exchange Commission (the “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.

FAQ

What were Oculis (OCS) Q2 2025 financial results?

Oculis reported cash and investments of $201.3 million, R&D expenses of $18.1 million, and a year-to-date net loss of $67.9 million. The company secured additional access to $123.7 million through a BlackRock loan facility.

When will Oculis (OCS) report Phase 3 DIAMOND trial results for OCS-01?

Oculis expects to report topline results from both Phase 3 DIAMOND trials in Q2 2026, with NDA submission planned for 2H 2026.

What is the market opportunity for Oculis' OCS-01 in diabetic macular edema?

The diabetic macular edema market represents a ~$5 billion opportunity, affecting approximately 37 million people worldwide. OCS-01 aims to be the first topical treatment for this condition.

What are the next steps for Oculis' Privosegtor (OCS-05) development?

Oculis plans FDA interactions in Q3 2025 to discuss the development program, including a Phase 2/3 trial for acute optic neuritis starting in 1H 2026. The company is also expanding development into NAION and multiple sclerosis relapses.

How long will Oculis' current cash runway last?

Oculis' current cash position of $201.3 million, excluding the BlackRock loan facility, provides runway into early 2028.