Oculis Reports Q1 2025 Financial Results and Provides Company Update

Rhea-AI Summary

Oculis Holding AG (Nasdaq: OCS) reported Q1 2025 financial results and significant progress across its pipeline. The company ended Q1 with $206.3 million in cash, providing runway into early 2028, bolstered by a $100 million financing in February 2025. Key developments include:

- OCS-01: Completed enrollment of over 800 patients in Phase 3 DIAMOND trials for diabetic macular edema (DME), with topline results expected Q2 2026

- Licaminlimab (OCS-02): Aligned with FDA on genotype-based development plan for dry eye disease, with first registrational trial planned for 2H 2025

- Privosegtor (OCS-05): Reported positive Phase 2 ACUITY trial results in acute optic neuritis, showing neuroprotective benefits

Q1 2025 net loss was CHF 33.2 million ($36.9 million), or CHF 0.69 per share, compared to CHF 16.1 million in Q1 2024. R&D expenses increased to CHF 14.8 million, primarily due to clinical trial costs.

Positive

• Strong cash position of $206.3M providing runway into early 2028
• Successful completion of Phase 3 DIAMOND trials enrollment with over 800 patients for potential first eye drop DME treatment
• Positive Phase 2 ACUITY trial results showing neuroprotective benefits for Privosegtor
• FDA alignment on genotype-based development plan for Licaminlimab in dry eye disease

Negative

• Increased net loss to CHF 33.2M in Q1 2025 from CHF 16.1M in Q1 2024
• Higher R&D expenses at CHF 14.8M compared to CHF 10.9M in previous year
• CHF 8.8M increase in non-cash fair value adjustment on warrant liabilities

Insights

Pharmaceutical Industry Analyst

Oculis strengthened finances with $206.3M cash providing runway into 2028 while advancing three late-stage ophthalmology assets with near-term catalysts.

Oculis has significantly bolstered its financial position while making substantial clinical progress across its ophthalmology pipeline. The $100M February financing has extended cash runway into early 2028, with $206.3M in cash and investments as of March 31. This provides substantial operational flexibility to advance their three differentiated assets through key development milestones.

The standout development is Privosegtor's (OCS-05) positive Phase 2 ACUITY trial in acute optic neuritis, demonstrating neuroprotective effects on retinal ganglion cells and axons with functional vision improvement. The company is strategically expanding Privosegtor's development beyond acute optic neuritis into NAION and acute MS relapses, substantially broadening its market potential in neuro-ophthalmology. This represents entry into an area with significant unmet medical needs and limited treatment options.

For OCS-01, completing enrollment of over 800 patients in the Phase 3 DIAMOND trials marks a critical milestone. If successful in Q2 2026 readouts, OCS-01 would introduce the first topical, non-invasive treatment for diabetic macular edema - a condition affecting approximately 37 million people worldwide with an estimated $5 billion market opportunity. A non-invasive eye drop could significantly improve treatment accessibility compared to current injection-based therapies.

The company's genotype-based approach for Licaminlimab (OCS-02) in dry eye disease demonstrates innovative clinical strategy, potentially delivering precision medicine in ophthalmology with Phase 2/3 activities starting in 2H 2025.

While R&D expenses increased to CHF 14.8M (+35.8% year-over-year) and G&A expenses rose to CHF 5.5M, these reflect appropriate investment in advancing clinical programs. The CHF 33.2M net loss (CHF 0.69 per share) was significantly impacted by a CHF 11.9M non-cash fair value adjustment on warrant liabilities rather than operational spending.

With multiple value-driving catalysts ahead including FDA meetings for Privosegtor (Q3 2025), Licaminlimab Phase 2/3 initiation (2H 2025), and OCS-01 Phase 3 data (Q2 2026), Oculis is well-positioned to advance these potential first-in-class treatments while maintaining financial stability through early 2028.

• The recent R&D Day (replay) showcased material progress across all three core assets and highlighted potential first-in-class neuroprotection treatment in neuro-ophthalmology, an area of high unmet medical need, thanks to Privosegtor’s (OCS-05) positive results from the ACUITY trial in Acute Optic Neuritis
  
  
• OCS-01: DIAMOND Ph3 trials enrollment completed with over 800 patients randomized; topline results expected Q2 2026 for the first potential eye drop treatment for diabetic macular edema (DME)
  
  
• Licaminlimab (OCS-02) genotype-based development plan to drive a personalized medicine approach in dry eye disease (DED) aligned with FDA; first registrational trial initiation anticipated in 2H 2025
  
  
• Cash, cash equivalents and short-term investments of $206.3 million as of March 31, 2025, reflects proceeds from the $100.0 million financing in February 2025, providing cash runway into early 2028
  

ZUG, Switzerland, May 08, 2025 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / ICX: OCS.IC) (“Oculis” or the “Company”), a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, today announced results for the first quarter ended March 31, 2025 and provided an overview of the Company’s progress.

Riad Sherif M.D., Chief Executive Officer of Oculis: “We began 2025 with an exciting evolution of our portfolio, driven by strong execution and solid science. We’ve made significant advancements on all three of our highly differentiated assets: completing randomization of over 800 patients in both Phase 3 DIAMOND-1 and DIAMOND-2 trials with OCS-01; initiating the first-ever genotype-based development program in ophthalmology with Licaminlimab (OCS-02); and announcing promising neuroprotective data with Privosegtor in the ACUITY trial - a potentially transformative catalyst for our company. The ACUITY readout not only validates our approach in acute optic neuritis, but also allows us the ability to expand into neuro-ophthalmology and beyond, significantly increasing our potential addressable patient population by multiple folds. These advancements, combined with a strengthened financial position, have enabled us to expand our innovative pipeline. With several near-term value inflection points ahead, we are well-positioned to drive value creation, while bringing transformative treatments to those who need them most."

R&D Day Key Highlights:

• Privosegtor (OCS-05) – A new era in neuroprotection for acute optic neuritis and beyond: Additional analyses from the successful Phase 2 ACUITY trial further supported the previously announced neuroprotective effects on retinal ganglion cells and axons, as well as vision improvement in patients with acute optic neuritis. These analyses also revealed that Privosegtor led to lower neurofilament release, a prominent biomarker of reduced neuro-axonal damage in neurological disorders, including MS. Oculis is planning to pursue a global registration program in acute optic neuritis, and evaluate Privosegtor in NAION and as a treatment of acute MS relapses.
  
  
• OCS-01 – A non-invasive eye drop for DME: The Company has completed enrollment in the Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in DME, with over 800 patients randomized; topline results are expected in Q2 2026.
  
  
• Licaminlimab (OCS-02) – An innovative TNF inhibitor specifically design for ocular inflammation : An FDA meeting in Q1 2025 confirmed the path forward for genotype-based development with Licaminlimab (OCS-02) to deliver a precision medicine treatment in DED with initiation of the first phase 2/3 activities to start in 2H 2025.
  

Recent Clinical Highlights and Upcoming Milestones:

• OCS-01:
  • Phase 3 DIAMOND trials investigating OCS-01 in DME completed enrollment with over 800 patients randomized. DIAMOND is the first ever Phase 3 program investigating a topical, non-invasive treatment for DME.
  • DME is a progressive complication of diabetic retinopathy, estimated to affect around 37 million people worldwide currently representing a ~$5 billion market opportunity and the unmet needs for early intervention and patients with inadequate response to standard of care.
  • The topline results from both DIAMOND Phase 3 trials are expected in Q2 2026 with the NDA submission to the FDA for OCS-01 for the treatment of DME planned for 2H 2026.
• Licaminlimab (OCS-02):
  • Following three positive Phase 2 trials and a successful meeting with the FDA, a genotype-based development plan investigating Licaminlimab for the treatment of DED has been aligned with the Agency; a phase 2/3 is anticipated to initiate 2H 2025.
• Privosegtor (OCS-05):
  • Results from Phase 2 ACUITY trial investigating Privosegtor, a novel, first-in-class peptidomimetic small molecule in development for the treatment of acute optic neuritis, showed significant neuroprotective anatomical benefits and functional vision improvement.
  • Plan to meet with the FDA in Q3 2025 to discuss the development program for Privosegtor, including a registrational program for acute optic neuritis, expected to initiate in 1H 2026.
  • Privosegtor’s demonstration of neuroprotection in the ACUITY trial supports its potential for broad applicability in multiple neuro-ophthalmology and neurology indications. Oculis intends to expand its Privosegtor development program into NAION, an orphan indication often leading to permanent vision loss, for which there are no approved therapies and as a treatment of acute MS relapses. Pre-IND discussions with the FDA are planned for 2H 2025, to support applications relying on existing Privosegtor data.

Q1 2025 Financial Highlights

• Cash position: As of March 31, 2025, the Company had total cash, cash equivalents and short-term investments of CHF 181.9 million or $206.3 million, compared to CHF 98.7 million or $109.0 million as of December 31, 2024. The increase in cash position from December 31, 2024 reflected proceeds from the $100.0 million (CHF 90.2 million) equity financing in February 2025. Based on its current development plans, the Company’s cash balances are expected to fund operations into early 2028.
• Research and development expenses: The Company’s research and development expenses were CHF 14.8 million or $16.4 million for the three months ended March 31, 2025, compared to CHF 10.9 million or $12.4 million in the same period in 2024. The increase was primarily due to development costs associated with the Company’s active clinical trials, in particular the two DIAMOND Phase 3 trials, as well as personnel-related costs.
• General and administrative expenses: The Company’s general and administrative expenses were CHF 5.5 million or $6.1 million for the three months ended March 31, 2025, compared to CHF 4.7 million or $5.4 million in the same period in 2024. The increase was primarily driven by personnel-related costs.
• Q1 Net loss: The Company’s net loss was CHF 33.2 million or $36.9 million, or CHF 0.69 or $0.77 per share, for the three months ended March 31, 2025, compared to CHF 16.1 million or $18.4 million, or CHF 0.44 or $0.50 per share, for the same period in 2024. The increase was primarily driven by advancements in clinical development programs, G&A expenses, as well as a CHF 8.8 million or $9.8 million increase in the non-cash fair value adjustment on warrant liabilities.

Condensed Consolidated Statements of Financial Position (Unaudited)
(Amounts in CHF thousands)	As of March 31,			As of December 31,
	2025			2024
ASSETS
Non-current assets
Property and equipment, net	364			385
Intangible assets	13,292			13,292
Right-of-use assets	1,218			1,303
Other non-current assets	508			476
Total non-current assets	15,382			15,456
Current assets
Other current assets	5,931			5,605
Accrued income	930			629
Short-term financial assets	122,055			70,955
Cash and cash equivalents	59,873			27,708
Total current assets	188,789			104,897
TOTAL ASSETS	204,171			120,353
EQUITY AND LIABILITIES
Shareholders' equity
Share capital	555			446
Share premium	464,190			344,946
Reserve for share-based payment	18,642			16,062
Actuarial loss on post-employment benefit obligations	(1,646)			(2,233)
Treasury shares	(35)			(10)
Cumulative translation adjustments	(310)			(271)
Accumulated losses	(318,770)			(285,557)
Total equity	162,626			73,383
Non-current liabilities
Long-term lease liabilities	799			865
Defined benefit pension liabilities	1,294			1,870
Total non-current liabilities	2,093			2,735
Current liabilities
Trade payables	4,351			5,871
Accrued expenses and other payables	19,860			18,198
Short-term lease liabilities	304			315
Warrant liabilities	14,937			19,851
Total current liabilities	39,452			44,235
Total liabilities	41,545			46,970
TOTAL EQUITY AND LIABILITIES	204,171			120,353

Condensed Consolidated Statements of Loss (Unaudited)
(Amounts in CHF thousands, except per share data)		For the three months ended March 31,
		2025			2024
Grant income		285			222
Operating income		285			222
Research and development expenses		(14,771	)		(10,856	)
General and administrative expenses		(5,488	)		(4,694	)
Operating expenses		(20,259	)		(15,550	)
Operating loss		(19,974	)		(15,328	)
Finance income		493			581
Finance expense		(247	)		(41	)
Fair value adjustment on warrant liabilities		(11,911	)		(3,069	)
Foreign currency exchange loss, net		(1,567	)		1,794
Finance result, net		(13,232	)		(735	)
Loss before tax for the period		(33,206	)		(16,063	)
Income tax expense		(7	)		(30	)
Loss for the period		(33,213	)		(16,093	)
Loss per share:
Basic and diluted loss attributable to equity holders		(0.69	)		(0.44	)

About Oculis
Oculis is a global biopharmaceutical company (Nasdaq: OCS / XICE: OCS) focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs. Oculis’ highly differentiated pipeline of multiple innovative product candidates in clinical development includes: OCS-01, a topical eye drop candidate for diabetic macular edema (DME); Privosegtor (OCS-05), a neuroprotective candidate for acute optic neuritis with potentially broad clinical applications in other neuro-ophthalmic diseases; and Licaminlimab (OCS-02), a topical biologic anti-TNFα eye drop candidate for 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 is 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 Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com

Media Relations
ICR Healthcare
Amber Fennell / David Daley / Sean Leous
oculis@icrhealthcare.com

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 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 the key financial results for Oculis (OCS) in Q1 2025?

Oculis reported cash position of $206.3M, net loss of CHF 33.2M ($36.9M), and R&D expenses of CHF 14.8M. The company secured $100M financing in February 2025, extending cash runway into early 2028.

What is the status of Oculis's DIAMOND Phase 3 trials for DME treatment?

Oculis completed enrollment with over 800 patients randomized in the DIAMOND-1 and DIAMOND-2 Phase 3 trials for OCS-01 in diabetic macular edema. Topline results are expected in Q2 2026.

What were the results of Oculis's Privosegtor ACUITY trial?

The Phase 2 ACUITY trial showed significant neuroprotective anatomical benefits and functional vision improvement in acute optic neuritis patients, with reduced neurofilament release indicating decreased neuro-axonal damage.

What is Oculis's development timeline for Licaminlimab (OCS-02)?

Following FDA alignment on the genotype-based development plan for dry eye disease treatment, Oculis plans to initiate the first registrational trial for Licaminlimab in 2H 2025.

How long will Oculis's current cash runway last?

With $206.3M in cash, cash equivalents and short-term investments as of March 31, 2025, Oculis expects to fund operations into early 2028 based on current development plans.