- Achieved two landmark milestones with OCS-01, Oculis’ lead product candidate as first investigational eye drop for both front and back of the eye indications: positive topline results in Phase 3 DIAMOND Stage 1 trial for diabetic macular edema (DME) announced in May, and in Phase 3 OPTIMIZE trial for inflammation and pain following cataract surgery announced in August
- Advancing clinical programs with OCS-01, OCS-02 and OCS-05, including first patient enrolled in the investigator-initiated LEOPARD trial evaluating OCS-01 for treatment of cystoid macular edema (CME)
- Successfully listed on NASDAQ and raised gross proceeds of approximately $146 million during the first half of 2023
Riad Sherif MD, Chief Executive Officer of Oculis: “This has been a very exciting period for Oculis. Following our successful listing on NASDAQ, we had two OCS-01 positive Phase 3 readouts with robust statistically significant results in two different indications, further validating the potential of OCS-01 to treat both back and front of the eye conditions. We are optimistic about our portfolio and remain on track for multiple readouts in 2024. We look forward to building upon the positive momentum we’ve achieved thus far in 2023 as we continue to execute on our strategic goals.”
First Half 2023 and Recent Corporate Developments
OCS-01: a novel high concentration preservative-free topical OPTIREACH formulation of dexamethasone with the potential to treat both front and back of the eye indications:
- Announced positive topline results in May 2023 from Stage 1 of the Phase 3 DIAMOND trial of OCS-01 in DME. The trial met its primary endpoint with robust statistical significance and allowed confirmation of the loading and maintenance dosing regimen to optimize Stage 2 of the trial. Further, OCS-01 met all functional, clinical and pharmacodynamic endpoints, including improvement in visual acuity, increase in the percentage of patients with a 3-line or greater gain in visual acuity, and reduction in macular edema as measured by optical coherence tomography (OCT) imaging compared to vehicle. OCS-01 was well-tolerated with no unexpected adverse events observed. Stage 2 of the Phase 3 program is expected to commence by the end of 2023.
- Reported positive topline results in August 2023 from Phase 3 OPTIMIZE trial of OCS-01 in treating inflammation and pain following ocular surgery. The trial met both hierarchical primary endpoints, showing a statistically significant higher percentage of patients with: 1) no inflammation at Day 15; and 2) no pain at Day 4 following cataract surgery compared to vehicle. The second Phase 3 trial is expected to commence before the end of 2023.
- Enrolled the first patient in August 2023 in an investigator-initiated trial LEOPARD with OCS-01 for the treatment of CME, a leading cause of vision loss worldwide. The trial is administratively sponsored by the Global Ophthalmic Research Center (Los Altos, California) and led by Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology at the Byers Eye Institute, Stanford University School of Medicine. The study will evaluate the efficacy and safety profile of OCS-01 eye drops for treatment of two different forms of CME: uveitic macular edema (UME) and post-surgical macular edema (PSME). Topline data are expected in 2024.
Key Operational Updates
- Successfully listed on NASDAQ in March 2023 after closing the business combination between European Biotech Acquisition Corp. and Oculis SA under the ticker symbol “OCS”, and raised gross proceeds of approximately $146 million during the first half of 2023.
- The Company expanded its U.S. presence and opened an office in Boston, Massachusetts in April 2023 as part of its continued expansion.
Awards and Company Recognition
- Oculis’ co-founders were selected as finalists in the 2023 European Inventor Award in recognition of their research developing the OPTIREACH solubilization formulation technology that is the basis of Oculis’ lead product candidate OCS-01.
- Won the 2023 Knowledge Award from the Icelandic Association of Business and Economics in recognition of the OPTIREACH technology developed in Oculis’ laboratory in Iceland by its co-founders, professors Einar Stefánsson and Thorsteinn Loftsson.
In the second half of 2023 the Company is focused on advancing its innovative pipeline and planned clinical development programs including:
- Commence Phase 3 DIAMOND Stage 2 trial of OCS-01 in DME. The trial will include a 6-week loading phase, followed by 46-week maintenance phase of OCS-01 vs. vehicle arm following solid validation in stage 1. The primary endpoint is change in best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score at Week 52 compared to vehicle. Secondary endpoints include percentage of patients with ≥ 3-line gain in BCVA and change in central subfield thickness (CST) as measured by spectral domain optical coherence tomography (SD-OCT) as compared to vehicle at Week 52.
- Initiate second OPTIMIZE Phase 3 trial to support an NDA submission (anticipated in late 2024) of OCS-01 for treating inflammation and pain following ocular surgery. Patients in the trial will be treated with once-daily OCS-01 vs. vehicle arm for 2 weeks. Hierarchical primary endpoints are the absence of anterior chamber cells at Day 15 and absence of pain at Day 4.
- Advance OCS-02, the first investigational biological eye drop, into a Phase 2b trial initially for dry eye disease (DED) evaluating the safety and efficacy vs. vehicle, and furthermore exploring whether patients with a certain genotype (i.e. single-nucleotide polymorphism, SNP, related to the TNF receptor) respond better to OCS-02 than patients who do not carry the SNP. The first patient's first visit is expected in late 2023. A Phase 2b trial for OCS-02 in the treatment of uveitis is expected to follow thereafter.
- Progress OCS-05, a disease modifying candidate for acute optic neuritis (AON) into a proof-of-concept (PoC) ACUITY trial in France. The trial will evaluate the safety and tolerability of a once daily intravenous infusion of OCS-05 vs. placebo for 5 days in addition to current standard of care and includes a follow up period of 6 months. Concurrently, the Company is working on planned IND enabling activities in the U.S.
- Cash position: As of June 30, 2023, the Company had total cash, cash equivalents and short-term investments of CHF 114.0 million or $127.0 million, compared to CHF 19.8 million or $21.4 million as of December 31, 2022. The increase in cash position reflects proceeds from financing transactions during the first half of 2023. Based on our current development plans, we expect our cash runway to fund operations to the end of 2025.
- Research and development expenses were CHF 6.2 million or $6.9 million for the three-month period ending June 30, 2023, compared to CHF 6.7 million or $6.9 million in the same period in 2022. The decrease was primarily due to timing of clinical development spending related to the Company’s two Phase 3 trials for DME and ocular surgery. Both trials concluded in 2023 and achieved positive topline results as announced in May and August of 2023.
- General and administrative expenses were CHF 4.8 million or $5.3 million for the three-month period ending June 30, 2023, compared to CHF 2.8 million or $2.9 million in the same period in 2022. The increase was primarily due to costs related to becoming a public company.
- Q2 Net loss was CHF 12.9 million or $14.3 million, or CHF 0.38 or $0.42 per share, for the three-month period ending June 30, 2023, compared to CHF 12.3 million or $12.8 million, or CHF 3.64 or $3.77 per share, in the same period in 2022. The increase in net loss was primarily driven by an increase in operating expenses.
- Merger and listing expense was CHF 34.9 million or $38.2 million in the first quarter of 2023, reflected in the year-to-date total operating expenses. This one-time and non-cash expense is the result of accounting for the business combination with EBAC as the equivalent of Oculis issuing shares for the net assets of EBAC at the acquisition closing date, accompanied by a recapitalization.
- 1H Net loss was CHF 58.9 million or $64.6 million for the six months ending June 30, 2023, or CHF 2.53 or $2.77 loss per share (basic and diluted) compared to CHF 19.6 or $20.8 million, or CHF 5.84 or $6.18 loss per share (basic and diluted) for the first six months of 2022.
- 1H Non-IFRS net loss was CHF 24.0 million or $26.3 million, or CHF 1.03 or $1.13 per share, for the six months ended June 30, 2023, compared to CHF 19.6 million or $20.8 million, or CHF 5.84 or $6.18 per share, for the same period in 2022. The increase in non-IFRS net loss was primarily driven by increases in clinical development expenses, listing and related expenses, and increase in fair-value (non-cash) adjustment of outstanding warrants.