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Oculis Reports Q2 2026 Financial Results and Provides Company Update

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Oculis (Nasdaq/XICE: OCS) reported Q2 2026 results and pipeline progress. Cash, cash equivalents and short‑term investments were CHF 228.3 million ($282.3 million) as of June 30, 2026, with the company stating this provides cash runway into the second half of 2029. For the six months ended June 30, 2026, Oculis reported a net loss of CHF 38.8 million versus CHF 58.6 million a year earlier, helped by a fair value gain on warrant liabilities and favorable foreign exchange.

The company highlighted its pivot to neuro‑ophthalmology, positioning Privosegtor as its lead late‑stage asset in the registrational PIONEER-1 trial in optic neuritis, with global site activation ongoing. FDA neurology guidance indicated no additional preclinical studies are required ahead of an IND for Privosegtor in acute multiple sclerosis (MS) relapses, and Oculis is targeting an IND submission in Q4 2026. The genotype‑based registrational PREDICT‑1 trial of Licaminlimab in dry eye disease has all planned sites activated and more than 45% of patients randomized, with topline results expected around year‑end. Oculis does not currently plan to pursue an FDA filing for OCS‑01 in diabetic macular edema following recent DIAMOND data.

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Positive

  • Cash and short-term investments CHF 228.3m ($282.3m) with runway into 2H 2029
  • Net loss H1 2026 CHF 38.8m, improved from CHF 58.6m in H1 2025
  • PIONEER-1 registrational trial for Privosegtor in optic neuritis actively progressing in multiple regions
  • FDA neurology guidance requires no additional preclinical studies before Privosegtor IND for acute MS relapses
  • PREDICT-1 Licaminlimab trial has all sites activated and >45% of patients randomized
  • Basic and diluted loss per share H1 2026 CHF 0.65, reduced from CHF 1.16 in H1 2025

Negative

  • Operating loss H1 2026 CHF 45.3m, up from CHF 40.7m in H1 2025
  • Research and development expenses Q2 2026 CHF 15.3m, slightly higher than CHF 14.9m in Q2 2025
  • General and administrative expenses Q2 2026 CHF 8.6m, up from CHF 6.1m in Q2 2025
  • Accumulated losses CHF 423.3m as of June 30, 2026
  • Share capital and premium increased year‑to‑date, reflecting ordinary share sales under an at‑the‑market offering program
  • No FDA filing planned for OCS‑01 in diabetic macular edema at this time

News Explained

Oculis reports year-to-date sales of ordinary shares under its existing at-the-market program, alongside cash, cash equivalents and short-term investments of CHF 228.3 million at June 30, 2026 versus CHF 213.0 million at December 31, 2025. Because the program sells new shares, existing holders’ percentage ownership is reduced, although the release does not disclose the shares sold or total proceeds.

Market Context

The tag-specific earnings record averaged -1.44% across 5 events, adding mixed precedent to this Q2 ...
Analysis

The tag-specific earnings record averaged -1.44% across 5 events, adding mixed precedent to this Q2 update. The platform also shows low short positioning and an active F-3 resale registration; trial execution remains key context.

Key Figures

Cash and investments: $282.3 million PREDICT-1 randomization: >45% Planned enrollment: ~160 patients +5 more
8 metrics
Cash and investments $282.3 million June 30, 2026; runway into 2H 2029
PREDICT-1 randomization >45% Patients randomized in genotype-based registrational dry-eye trial
Planned enrollment ~160 patients PREDICT-1 trial
Specified genotype proportion approximately 2/3 PREDICT-1 planned enrollment
Primary endpoint threshold at least a 15-letter gain PIONEER-1 low-contrast visual acuity at Month 3
R&D expenses $19.3 million Q2 2026 versus $18.1 million in Q2 2025
G&A expenses $10.9 million Q2 2026 versus $7.4 million in Q2 2025
Net loss $49.3 million Six months ended June 30, 2026 versus $67.9 million in 2025

Previous Earnings Reports

5 past events · Latest: May 11 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
May 11 Q1 earnings report Positive -6.9% Pipeline progress, cash runway, and expected clinical milestones accompanied quarterly results.
Mar 03 FY2025 earnings report Positive +0.5% Cash position, clinical milestones, and registrational program launches supported the company update.
Nov 10 Q3 earnings report Positive -0.1% Financing, extended runway, and progress across Privosegtor, OCS-01, and Licaminlimab were reported.
Nov 04 Research award announcement Positive -1.1% Oculis and EURETINA recognized retinal research through the Ramin Tadayoni Award.
Aug 21 Q2 earnings report Positive +0.3% Cash position and late-stage clinical progress were detailed alongside quarterly financial results.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Tag-specific earnings reactions were mixed, with an average 24-hour move of -1.44% across five events.

Key Terms

special protocol assessment, low-contrast visual acuity, investigational new drug, double-masked, +1 more
5 terms
special protocol assessment regulatory
"As established under a Special Protocol Assessment (SPA) agreement with the FDA"
A special protocol assessment is a formal, written agreement between a drug or device developer and a health regulator about the design, size and analysis plans of a pivotal clinical trial or study. It matters to investors because it reduces regulatory uncertainty—like getting a signed blueprint before building—by signaling that if the study follows the agreed plan and meets its goals, the regulator is unlikely to reject the results solely for design reasons, though it does not guarantee approval.
low-contrast visual acuity medical
"gain from baseline in low-contrast visual acuity (LCVA) at Month 3"
Low-contrast visual acuity is a clinical measure of how well a person can see objects that blend into their background, like reading light-gray print on a slightly darker page or spotting a foggy road sign. It matters to investors because it is often used as an outcome in drug and device trials, influences regulatory approval and labeling, and affects real-world performance and market demand for therapies, diagnostic tools, and vision-related products.
investigational new drug regulatory
"ahead of an Investigational New Drug (IND) submission"
An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.
double-masked technical
"a randomized, multi-center, double-masked, vehicle-controlled study"
Double-masked describes a clinical study setup where neither the people receiving treatments nor the researchers who administer or assess them know who gets the active therapy versus a placebo or comparison. This reduces conscious or unconscious bias and makes results more reliable for regulators and doctors. For investors, double-masked trials carry more credibility—like a taste test where neither the tasters nor the servers know which sample is which—so positive outcomes and approvals are taken more seriously.
anti-tnfα medical
"Licaminlimab is a novel, topical anti-TNFα"
Anti-TNFα refers to drugs that block the activity of tumor necrosis factor alpha, a protein that drives inflammation in conditions like rheumatoid arthritis and inflammatory bowel disease. For investors, these therapies matter because they represent large, durable drug markets, carry distinct regulatory and safety risks, and face competition from new entrants and lower-cost biosimilars—factors that directly affect revenue, approval timelines, and long-term profitability.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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ZUG, Switzerland, Aug. 06, 2026 (GLOBE NEWSWIRE) --

  • Company pivot to neuro-ophthalmology continues with Privosegtor positioned as lead late-stage asset through the registrational PIONEER program with expansion potential in acute multiple sclerosis (MS) relapses following positive FDA pre-IND feedback
  • Enrollment progressing as planned in the PREDICT-1 genotype-based registrational trial of Licaminlimab in dry eye disease with all planned sites activated and >45% patients randomized
  • Cash, cash equivalents, and short-term investments of $282.3 million as of June 30, 2026, providing cash runway into 2H 2029

Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology, today announced results for the second quarter ended June 30, 2026, and provided an overview of the Company’s progress.

Riad Sherif, M.D., Chief Executive Officer of Oculis, stated, “We continue to advance and expand the Privosegtor neuroprotection franchise, with PIONEER-1 on track in global site activations and positive regulatory momentum supporting our development strategy in acute multiple sclerosis relapses. Given the considerable unmet need for neuroprotective treatments, these achievements reinforce both our strategy to pivot to neuro-ophthalmology by exploring the clinical potential of Privosegtor and the substantial opportunity across multiple neuro-ophthalmic and neuro-axonal diseases. In parallel, with Licaminlimab PREDICT-1 genotype-based trial planned site activations complete and over 45% of patients enrolled, we expect to report topline results around year-end. With a strong balance sheet, we are well positioned to execute on our strategy, advance our registrational programs and deliver on upcoming value-driving milestones.”

Recent Development Highlights and Upcoming Milestones:

 Privosegtor:

    • The PIONEER-1 registrational trial is designed to investigate Privosegtor as a neuroprotective treatment for patients with optic neuritis (ON) across a broad population, including those with and without multiple sclerosis (MS). As established under a Special Protocol Assessment (SPA) agreement with the FDA, the primary endpoint is defined as the proportion of patients achieving at least a 15-letter gain from baseline in low-contrast visual acuity (LCVA) at Month 3, a clinically meaningful visual function endpoint in ON. The primary analysis will be conducted at Month 3, and patients will be followed through Month 12 to assess Privosegtor’s long-term safety and tolerability. Site activation is actively progressing across the U.S., Europe, Australia, and Canada, with an execution focus and priority on building a robust, multidisciplinary network connecting emergency room physicians, ophthalmologists, and neurologists. This integrated approach aims to optimize operational flows from patient identification to treatment, capitalizing on peak enrollment opportunities during the fall, winter, and spring to align with the natural seasonality of the disease.
    • The FDA’s Division of Neurology provided guidance that no additional preclinical studies will be required ahead of an Investigational New Drug (IND) submission for Privosegtor in acute MS relapses, cross-referencing the data from the open ON IND residing in the Division of Ophthalmology. Constructive FDA feedback also supports the proposed clinical development strategy and regulatory pathway, which will include MS patients with both optic neuritis and other relapses, such as ambulatory relapses, in future trials. It also supports a primary endpoint as early as 3 months, with the same 3mg/kg dose administered daily for 5 days as in PIONEER-1. Oculis anticipates an IND submission for the treatment of acute MS relapses in the fourth quarter of 2026.
    • MS is a chronic immune-mediated disease of the central nervous system affecting approximately 2.8 million people worldwide, including around 850,000 in the U.S. alone.1-3 There are two main types of MS: relapsing-remitting MS (RRMS) and progressive MS. While progressive MS remains a significant unmet medical need, RRMS is the most common type, representing ~85% of patients at initial diagnosis.2 Despite available therapies, relapses still persist for many patients, with an estimated 170,000 MS relapses occurring each year in the U.S.4,5 During an acute relapse, neurologists commonly use a short course of high-dose corticosteroids to reduce inflammation and shorten the episode, as is standard of care in optic neuritis. However, corticosteroids do not influence the frequency of future relapses or long-term disability, and recovery from relapses is often incomplete. There are currently no neuroprotective therapies approved for MS relapses, and there remains an urgent unmet medical need for treatments that can prevent central nervous system damage.
    • The Company will host an R&D Day in Q4 to share key updates on Privosegtor’s ongoing clinical development in optic neuritis and acute MS relapses.

Licaminlimab:

    • Oculis is actively enrolling patients in the PREDICT-1 genotype-based registrational trial in dry eye disease (DED) evaluating Licaminlimab as a precision medicine treatment. All planned trial sites have been activated and >45% patients have been randomized. The PREDICT-1 trial is a randomized, multi-center, double-masked, vehicle-controlled study that plans to enroll ~160 patients of whom approximately 2/3 will have the specified TNFR1 genotype. The primary endpoint is the change from baseline to Day 29 in the global ocular discomfort severity score in patients with the specified TNFR1 genotype. The same outcome measure will be evaluated in the overall study population as a key secondary endpoint. While measurements of dry eye symptoms are inherently subjective, this precision medicine approach is designed to identify patients more likely to benefit from Licaminlimab.
    • In the U.S., approximately 10 million diagnosed patients suffer from moderate to severe DED.6,7 Current disease management relies on a trial-and-error therapeutic approach, with a minority (~13%) of patients experiencing sustained relief,8 leading to an 85-90% discontinuation rate within the first 6 months9, underscoring the significant unmet need for a targeted, effective treatment approach. If approved, Licaminlimab has the potential to transform the current DED treatment paradigm by providing a precision medicine approach with high efficacy, rapid onset of action, and a comfort level similar to artificial tears.

OCS-01

    • Following the DIAMOND topline results announcement in May, at this time Oculis does not plan to pursue an FDA regulatory filing for OCS-01 in DME.


Q2 2026 Financial Highlights:

As of June 30, 2026, Oculis held cash, cash equivalents and short-term investments of CHF 228.3 million or $282.3 million, compared to CHF 213.0 million or $268.7 million as of December 31, 2025. The increase reflects proceeds from sales of ordinary shares year-to-date under the Company’s existing at-the-market offering program, offset by operating expenses. Research and development expenses were CHF 15.3 million or $19.3 million for the three months ended June 30, 2026, compared to CHF 14.9 million or $18.1 million in the same period in 2025. General and administrative expenses were CHF 8.6 million or $10.9 million for the three months ended June 30, 2026, compared to CHF 6.1 million or $7.4 million in the same period in 2025. The increase in operating expenses was primarily driven by headcount-related costs, including share-based compensation expenses, to support and execute the Company’s development strategies. The Company’s net loss was CHF 38.8 million or $49.3 million for the six months ended June 30, 2026, compared to CHF 58.6 million or $67.9 million for the same period in 2025. The decrease was primarily due to the fair value gain on warrant liabilities in 2026 driven by decreased market value as well as a favorable foreign currency fluctuation resulting from favorable U.S. dollar versus Swiss Franc for U.S. dollar denominated transactions and assets, compared to a weaker U.S. dollar against the Swiss Franc in the prior year period.

Key Upcoming Events:

Medical Conferences

  • Asia-Pacific Vitreo-Retina Society (APVRS) Congress; Aug. 28-30, Queensland, Australia
  • The Retina Society 59th Annual Scientific Meeting; Sep. 23-26, Los Angeles, California, U.S.
  • EURETINA 26th Annual Congress; Oct. 1-4, Vienna, Austria
  • MS Toronto 2026 – 10th Joint ACTRIMS-ECTRIMS Meeting; Oct. 21-23, Toronto, Canada

Investor Conferences

  • Stifel Biotech Summer Summit; Aug. 10-12, Newport, Rhode Island, U.S.
  • JPM Aspen Summit; Aug. 24-26, Aspen, Colorado, U.S.
  • Pareto Healthcare Conference; Sep. 2, Stockholm, Sweden
  • Wells Fargo Healthcare Conference; Sep. 8-10, Boston, Massachusetts, U.S.
  • HCW Annual Global Investment Conference; Sep. 14-16, New York, New York, U.S.
  • Baird 2026 Global Healthcare Conference; Sep. 15, New York, New York, U.S.
  • Leerink Biopharma Summit; Sep. 23-25, Healdsburg, California, U.S.


Condensed Consolidated Statements of Financial Position (Unaudited)

(Amounts in CHF thousands) As of
 June 30,
 As of December 31,
  2026 2025
ASSETS    
     
Non-current assets    
Property and equipment 482 534
Intangible assets 13,292 13,292
Right-of-use assets 2,648 2,463
Other non-current assets 847 785
Total non-current assets 17,269 17,074
     
Current assets    
Other current assets 3,216 4,883
Accrued income 1,526 993
Short-term financial assets 166,710 131,684
Cash and cash equivalents 61,614 81,329
Total current assets 233,066 218,889
     
TOTAL ASSETS 250,335 235,963
     
EQUITY AND LIABILITIES    
     
Shareholders' equity    
Share capital 679 587
Share premium 605,937 551,731
Reserve for share-based payment 38,133 30,387
Actuarial loss on post-employment benefit obligations (1,595) (1,634)
Treasury shares (62) (7)
Cumulative translation adjustments (419) (480)
Accumulated losses (423,336) (384,514)
Total equity 219,337 196,070
     
Non-current liabilities    
Long-term lease liabilities 1,792 1,811
Defined benefit pension liabilities 1,283 1,335
Total non-current liabilities 3,075 3,146
     
Current liabilities    
Trade payables 2,683 1,800
Accrued expenses and other payables 16,670 19,967
Short-term lease liabilities 751 502
Warrant liabilities 7,819 14,478
Total current liabilities 27,923 36,747
     
Total liabilities 30,998 39,893
     
TOTAL EQUITY AND LIABILITIES 250,335 235,963


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,
  2026 2025 2026 2025
Grant income 310 261 519 545
Operating income 310 261 519 545
Research and development expenses (15,283) (14,909) (29,329) (29,680)
General and administrative expenses (8,595) (6,120) (16,486) (11,608)
Operating expenses (23,878) (21,029) (45,815) (41,288)
         
Operating loss (23,568) (20,768) (45,296) (40,743)
         
Finance income 592 520 959 1,013
Finance expense (309) (183) (482) (430)
Fair value adjustment on warrant liabilities 12,100 (234) 4,117 (12,145)
Foreign currency exchange gain (loss) 1,221 (4,734) 1,788 (6,301)
Finance result 13,604 (4,631) 6,382 (17,863)
         
Loss before tax for the period (9,964) (25,399) (38,914) (58,606)
         
Income tax benefit (expense) (6) 24 92 17
         
Loss for the period (9,970) (25,375) (38,822) (58,589)
         
Loss per share:        
Basic and diluted loss attributable to equity holders (0.16) (0.49) (0.65) (1.16)
          


About Oculis

Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline focuses on two core product candidates. Privosegtor is a breakthrough neuroprotective candidate in the PIONEER program, which consists of studies intended to support registration plans for treatment of optic neuropathies, including optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION). Privosegtor also has potential to be developed for additional indications in other neuro-ophthalmic and neuro-axonal diseases. Licaminlimab is a novel, topical anti-TNFα in a registrational trial, and is being developed with a genotype-based approach for treating patients with dry eye disease (DED). Headquartered in Switzerland with operations in the U.S., Iceland and Switzerland, 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 Contact
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, including the potential of Privosegtor to become the first neuroprotective therapy for ON and other neuro-ophthalmic and neurological indications such as MS, including the potential to improve long-term outcomes for patients with these diseases, and the potential for Licaminlimab to redefine the treatment paradigm in dry eye disease with a precision medicine approach; the initiation, timing, progress and results of current and future clinical trials, including the planned IND submission for Privosegtor in acute MS relapses and the progress and timing of the PREDICT-1 trial of Licaminlimab and the PIONEER trials of Privosegtor; Oculis’ research and development programs, regulatory and business strategy; expected milestones; statements about market opportunity; and statements about 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 exhibit to Oculis’ Form 6-K filed on August 6, 2026 and any other documents filed with 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.

References
(1) MS National Society https://www.nationalmssociety.org/about-the-society/who-we-are/research-we-fund/ms-prevalence
(2) Wallin WT, et al., Neurology. 2019; 92:e1029-e1040
(3) McGinley et al., JAMA. 2021, 325:765-779
(4) Bigaut K, Kremer L, Fabacher T, Ahle G, Goudot M, Fleury M, Gaultier C, Courtois S, Collongues N, de Seze J. Ocrelizumab versus fingolimod after natalizumab cessation in multiple sclerosis: an observational study. J Neurol. 2022 Jun;269(6):3295-3300. 
(5) Hauser SL, Bar-Or A, Cohen JA, et al. Ofatumumab versus Teriflunomide in Multiple Sclerosis. N Engl J Med. 2020;383(6):546–557.
(6) Jain H, et al. (2020): Dry eye disease landscape and forecast. Decision Resources Group (DRG). Prevalence for G7 countries: France, Germany, Italy, Japan, Spain, UK, and US.
(7) Downs P. (2023): Dry Eye Products Market Report, Global Analysis for 2022 to 2028. Market Scope.
(8) Mukamal, R. Why is Dry Eye So Difficult to Treat? 2021 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops
(9) Mbagwu M. et al.: Characterization of Discontinuation and Switching Patterns of DED Medications Using Linked HER Registry and Claims Data. Presented at ASCRS Annual Meeting 2024.

- ENDS-

Attachments


FAQ

How did Oculis (OCS) perform financially in Q2 2026?

Oculis reported a Q2 2026 operating loss of CHF 23.6 million and a quarterly net loss of CHF 10.0 million. For the first half of 2026, according to Oculis, the net loss was CHF 38.8 million, an improvement from CHF 58.6 million in the prior-year period.

What is Oculis (OCS) cash position and runway as of June 30, 2026?

As of June 30, 2026, Oculis held CHF 228.3 million (about $282.3 million) in cash, cash equivalents and short‑term investments. According to Oculis, this balance, supported by at‑the‑market share sales, provides a cash runway into the second half of 2029 to fund operations and development plans.

What progress has Oculis (OCS) reported on the Privosegtor PIONEER-1 trial?

PIONEER-1 is a registrational trial evaluating Privosegtor as a neuroprotective treatment in optic neuritis, with global site activation progressing. According to Oculis, the primary endpoint is a Month 3 low‑contrast visual acuity response, and patients are followed through Month 12 for long‑term safety and tolerability assessments.

What FDA feedback did Oculis (OCS) receive on Privosegtor for acute MS relapses?

The FDA’s neurology division indicated no additional preclinical studies are required before an IND submission for acute MS relapses, referencing the existing optic neuritis IND. According to Oculis, FDA feedback supports the proposed development strategy, including a primary endpoint at three months and a 3 mg/kg dosing schedule.

How is the Licaminlimab PREDICT-1 trial advancing for Oculis (OCS)?

PREDICT-1 is a genotype‑based registrational trial of Licaminlimab in dry eye disease, planning to enroll about 160 patients. According to Oculis, all sites are activated and more than 45% of patients are randomized, with topline results expected around year‑end, focusing on ocular discomfort improvement.

What decision did Oculis (OCS) make regarding OCS-01 in diabetic macular edema?

Following DIAMOND trial topline results announced in May 2026, Oculis currently does not plan to pursue an FDA regulatory filing for OCS‑01 in diabetic macular edema. According to Oculis, the company is instead prioritizing Privosegtor and Licaminlimab as its core late‑stage assets.

How have operating expenses and losses changed for Oculis (OCS) in H1 2026?

Operating expenses for the first half of 2026 were CHF 45.8 million, up from CHF 41.3 million a year earlier, mainly from higher R&D and G&A. According to Oculis, the H1 2026 operating loss was CHF 45.3 million, while net loss declined due to warrant valuation gains and favorable currency effects.