Corporate Highlights

• Raised gross proceeds of $59 million in an oversubscribed registered direct offering, with participation from new Icelandic institutional and existing investors. Concurrently, the Company listed on the Nasdaq Iceland Main Market in addition to Nasdaq Global Market in the U.S.

• Snehal Shah, Pharm. D., was appointed as President of Research & Development strengthening the Company’s R&D capabilities.

• Robert K. Warner, M.B.A. and Arshad M. Khanani, M.D., M.A., FASRS elected as members of the Board of Directors, bolstering its development and commercial expertise.

• Baruch D. Kuppermann, M.D., Ph.D. and Frank G. Holz, M.D., Ph.D. appointed as members of the Scientific Advisory Board, and working closely with senior management team as the Company advances both Phase 3 DIAMOND trials with OCS-01 eye drops in DME.

Presentations and Awards Highlights

• Presented the Phase 3 OPTIMIZE-1 positive results with OCS-01 for treating inflammation and pain following cataract surgery at the 2024 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.

• Established the Ramin Tadayoni Award together with EURETINA in memory of the Company’s late Chief Scientific Officer and a world-renowned retina expert.

Recent Updates and Upcoming Milestones

• Pre-NDA meeting conducted as planned in August 2024 to seek alignment with the FDA on the regulatory submission for once daily OCS-01 for the treatment of post-operative inflammation and pain following ocular surgery. FDA confirmed that the completed Phase 3 OPTIMIZE-1 trial, along with the completed Phase 2 SKYGGN trial and safety data from completed trials in ocular surgery and diabetic macular edema, are sufficient to support an NDA submission in Q1 2025. The Company will close the Phase 3 OPTIMIZE-2 trial due to a third-party administrative error which affected the conduct of the trial and prevents analysis of trial results. If approved, OCS-01 with its OPTIREACH^? formulation would become the first once-daily, preservative-free steroid for treating inflammation and pain following ocular surgery.

• Topline readout for the Phase 2 ACUITY trial with OCS-05 is anticipated in the fourth quarter of 2024. The ACUITY trial is a randomized, double-blind, placebo-controlled, multi-center trial in France designed to evaluate the safety and tolerability of OCS-05, a novel serum glucocorticoid kinase-2 (SGK-2) activator and potentially neuroprotective candidate in AON. Enrollment is completed with 36 patients randomized. In addition to safety, an objective measurement of retinal thickness, as assessed by optical coherence tomography (OCT), will be evaluated as an exploratory efficacy endpoint. OCS-05 was granted orphan drug designation by FDA in the U.S. and by the European Medicine Agency (EMA) in Europe for AON, a disease characterized by acute inflammation and demyelination of the optic nerve, often affecting young adults, in which retinal thinning is directly associated with vision loss and permanent visual impairment. This study seeks to explore the potential neuroprotective benefits of OCS-05 on preserving retinal thickness in AON patients. To date there is no specific therapy approved for AON and unmet needs remain for therapies that can prevent vision loss after an acute episode of optic neuritis. In addition to AON, a neuroprotective treatment could have wide applicability in neuro-ophthalmic diseases where protecting neural retina is key to preserving patients’ sight such as glaucoma, geographic atrophy, diabetic retinopathy and also for other ophthalmic indications where other nerves are impacted like neurotrophic keratitis. Additionally, the Company is on track to complete an IND submission for OCS-05 in the U.S. by fall 2024.

• The Company is planning to consult with the FDA in Q1 2025 to discuss next steps for the  OCS-02 (licaminlimab) program in DED.

Q2 2024 Financial Highlights

• Cash position: As of June 30, 2024, the Company had total cash, cash equivalents and short-term investments of CHF 117.9 million or $131.2 million, compared to CHF 91.7 million or $109.0 million as of December 31, 2023. The increase in cash position from December 31, 2023 reflects proceeds from the registered direct offering in the second quarter of 2024. Based on its current development plans, the Company’s cash balances are expected to fund operations into the second half of 2026.

• Research and development expenses were CHF 16.5 million or $18.2 million for the three-month ended June 30, 2024, compared to CHF 6.2 million or $6.9 million in the same period in 2023. The increase was primarily due to increases in clinical trial expenses related to the ongoing OCS-01, OCS-02 (licaminlimab) and OCS-05 clinical trials, including positive advancements in DIAMOND-1 and DIAMOND-2 Phase 3 DME trials.

• General and administrative expenses were CHF 6.3 million or $6.9 million for the three-month ended June 30, 2024, compared to CHF 4.8 million or $5.3 million in the same period in 2023. The increase was primarily due to increases in personnel costs as well as certain non-recurring non-capitalized transaction costs associated with the registered direct offering in April 2024.

• Q2 Net loss was CHF 20.8 million or $23.0 million for the second quarter ended June 30, 2024, compared to CHF 12.9 or $14.3 million in the second quarter of 2023. The increase was primarily driven by increases in clinical development expenses.

• Q2 Year to date net loss was CHF 36.9 million or $41.5 million for the six months ended June 30, 2024, compared to CHF 58.9 or $64.6 million for the same period in 2023. The decrease was primarily due to a non-recurring and non-cash merger and listing expense recorded in 2023, partially offset by increases clinical development costs and costs incurred to operate as a public company.

• Q2 Year to date non-IFRS net loss was CHF 36.9 million or $41.5 million, or CHF 0.96 or $1.08 per share, for the six months ended June 30, 2024, compared to CHF 24.0 million or $26.3 million, or CHF 1.03 or $1.13 per share, for the same period in 2023. The increase in non-IFRS net loss was primarily driven by increases in development expenses.

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 merger and listing expense, which was a one-time non-cash expense CHF 34.9 million or $38.2 million in the six months ended June 30, 2023 total operating expenses.

 

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
[email protected]

Investor & Media Relations

LifeSci Advisors
Corey Davis, Ph.D.
[email protected]
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; expected future milestones and catalysts; 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; the timing or likelihood of regulatory filings and approvals; and the Company’s expected cash runway are forward-looking. Certain clinical trial results presented in this press release are topline and preliminary and subject to change, as analysis is ongoing. These topline results may not be reproduced in subsequent patients and clinical trials. 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

• Oculis Q2 2024 earnings PR

• Oculis_Q2 2024 PR_Financial Schedules