Oculis Reports Q3 2024 Financial Results and Provides Company Updates

Significant advancement on product portfolio, including enrollment in the OCS-01 DIAMOND Phase 3 program in DME and OCS-05 Phase 2 ACUITY trial in acute optic neuritis (AON) with topline readout anticipated in December 2024Leadership team bolstered with extensive experience in key areas as the Company advances its late-stage pipeline and prepares for commercial phaseCash, cash equivalents and short-term investments of $125.0 million as of September 30, 2024, provides cash runway into...

ZUG, 07/11/2024 (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 quarter ended September 30, 2024, and provided an overview of the Company's progress.

Riad Sherif M.D., Chief Executive Officer of Oculis : “During the quarter, we achieved excellent momentum in product pipeline development. We continue to accelerate recruitment for both Phase 3 trials in our core DIAMOND program with OCS-01 in DME and expanded this program's committees with several world-renowned retina experts. Looking ahead, we are excited for the upcoming topline readout from the OCS-05 Phase 2 ACUITY trial in AON, anticipated in December 2024. The results will provide us with meaningful insights about the safety and tolerability of OCS-05, and its potential as a neuroprotective candidate in acute optic neuritis and other neuro-ophthalmic diseases. With a strengthened leadership team including recent appointments of Sharon Klier, M.D. as Chief Development Officer and Daniel S. Char as Chief Legal Officer, and a solid balance sheet, Oculis is well positioned to drive execution in pipeline development and create value for key stakeholders.”

Q3 2024 and Recent Highlights

Clinical Highlights:

Presentations and Awards Highlights:

Company Updates and Upcoming Milestones

Q3 2024 Financial Highlights

Non-IFRS Financial Information

This press release contains financial measures that do not comply with International Financial Reporting Standards (IFRS) including non-IFRS 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:

Condensed Consolidated Statements of Financial Position (Unaudited)

Condensed Consolidated Statements of Loss (Unaudited)

Reconciliation of Non-IFRS Measures (Unaudited)

-ENDS-

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 (licaminlimab), 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.

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, including patient impact and market opportunity; 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; the timing of clinical data readouts; the timing or likelihood of regulatory filings and approvals; and the Company's expected 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 (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.

Martínez-Lapiscina et al. J Neurol. 2014 Apr;261(4):759-67