Oculis Reports Q1 2024 Financial Results and Provides Company Updates

Clinical programs progressing as planned with initiation of second OCS-01 Phase 3 DIAMOND-2 trial in Diabetic Macular Edema (DME) and completion of enrollment in OCS-02 (licaminlimab) Phase 2b RELIEF trial in Dry Eye Disease (DED); RELIEF topline results anticipated in Q2 2024Completed $59 million registered direct equity offering and concurrent listing on Nasdaq Iceland Main Market in April 2024, extending cash runway into the second half of 2026Strengthened executive leadership team and U...

ZUG, 08/05/2024 (informazione.it - comunicati stampa - salute e benessere)

Oculis Holding AG (Nasdaq: OCS; XICE: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced results for the three-month period ended March 31, 2024, and an overview of the Company's progress.

Riad Sherif M.D., Chief Executive Officer of Oculis : “We delivered a very successful first quarter and made significant strides toward achieving our strategic goals. The strong support from new and existing investors enabled a $59 million financing and dual listing on Nasdaq in Iceland in addition to the U.S. Furthermore, the continued advancement of our late-stage pipeline in Q1 and the strengthened leadership team with the appointments of Snehal and Virginia position us well for the future. I look forward to providing an update on the anticipated RELIEF Phase 2b clinical readout in DED with OCS-02 before the end of the quarter, and on other key milestones as the year progresses.”

Q1 2024 and Recent Highlights

Clinical Highlights

Corporate Highlights

Events & Presentations Highlights

Upcoming Clinical Milestones
The Company continues to advance its innovative and differentiated pipeline and planned clinical development programs including:

Q1 2024 Financial Highlights

Non-IFRS Financial Information
This press release contains financial measures that do not comply with IFRS Accounting Standards (“IFRS”) including non-IFRS year-to-date loss, and non-IFRS loss attributable to equity holders per common share. These non-IFRS financial measures exclude the impact of items that the Company's management believes affect comparability or underlying business trends. These measures supplement the Company's financial results prepared in accordance with IFRS. The Company's management uses these measures to better analyze its financial results and better estimate its financial outlook. In management's opinion, these non-IFRS measures are useful to investors and other users of the Company's financial statements by providing greater transparency into the ongoing operating performance of the Company and its future outlook. Such measures should not be deemed to be an alternative to IFRS requirements.

The non-IFRS measures for the reported periods reflect adjustments made to exclude merger and listing expense, which was a one-time non-cash expense CHF 34.9 million or $38.2 million in the first quarter of 2023 total operating expenses.

 

Condensed Consolidated Statements of Financial Position (Unaudited)

 

Condensed Consolidated Statements of Operations (Unaudited)

 

Reconciliation of Non-IFRS Measures (Unaudited)

 

About Oculis

Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) purposefully driven to save sight and improve eye care. Oculis' highly differentiated pipeline comprises multiple innovative product candidates in development. It includes OCS-01, a topical eye drop candidate for diabetic macular edema (DME) and for the treatment of inflammation and pain following cataract surgery; OCS-02, a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED) and for non-infectious anterior uveitis; and OCS-05, a neuroprotective candidate for acute optic neuritis (AON). Headquartered in Switzerland and with operations in the U.S. and Iceland, Oculis' goal is to improve the health and quality of life of patients worldwide. The company is led by an experienced management team with a successful track record and is supported by leading international healthcare investors.

OCS-01, OCS-02 and OCS-05 are investigational drugs and have not received regulatory approval for commercial use in any country.

For more information, please visit: www.oculis.com

Oculis Contact:

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 OCS-01, OCS-02 and OCS-05, including patient impact and market opportunity; the potential of OCS-01 for the treatment of DME and inflammation and pain following ocular surgery; the potential of OCS-02 for treating DED; the potential of OCS-05 for treating AON and other neuro-ophthalmic disorders; expected cash runway; expected future milestones and catalysts, including the timing of topline results for RELIEF, OPTIMIZE-2 and ACUITY trials; the initiation, timing, progress and results of Oculis' clinical and preclinical studies; Oculis' research and development programs, regulatory and business strategy, future development plans, and management; Oculis' ability to advance product candidates into, and successfully complete, clinical trials; and the timing or likelihood of regulatory filings and approvals, 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 (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.

Attachments