Global Medical Research Center

Reported lead product candidate OCS-01 eye drop met both primary endpoints in Phase 3 OPTIMIZE trial for inflammation and pain after cataract surgery following positive readout of Stage 1 of the Phase 3 DIAMOND trial for diabetic macular edema (DME)Enrolled first patient in the investigator-initiated LEOPARD trial evaluating OCS-01 for treatment of cystoid macular edema (CME)Cash and investments of $116.5 million adequately funded to deliver on key business and clinical milestones ZUG, Switzerland and BOSTON, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced third quarter financial results for the period ended September 30, 2023, and an overview of the Company’s progress. Riad Sherif M.D., Chief Executive Officer of Oculis: “In this quarter we advanced on our late stage clinical development programs for our leading assets. Following the two positive readouts for our lead product candidate OCS-01 eye drop, we initiated activities to commence Stage 2 of the Phase 3 DIAMOND 1 & 2 trials for DME and the second Phase 3 trial for inflammation and pain after cataract surgery. The LEOPARD study of OCS-01 in CME enrolled its first patient and enrollment is currently ongoing as planned. In addition, we started preparing for the Phase 2b trial of OCS-02, a novel biologic eye drop, in dry eye disease (DED). We look forward to enrolling the first patients in our planned and ongoing trials and anticipate having multiple readouts and value inflection points in 2024 across our innovative pipeline addressing key areas of high unmet patient need in Ophthalmology.” Q3 2023 Highlights Advanced Oculis’ lead product candidate 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: Reported positive topline results from Phase 3 OPTIMIZE trial of once daily OCS-01 for inflammation and pain following ocular surgery (August 2023). The trial met both hierarchical primary endpoints, showing a statistically significant higher percentage of patients with no inflammation at Day 15 and no pain at Day 4 following cataract surgery compared to vehicle.Enrolled the first patient in the investigator-initiated study LEOPARD to evaluate the efficacy and safety profile of OCS-01 eye drops for the treatment of two different forms of CME: uveitic macular edema (UME) and post-surgical macular edema (PSME). This study is sponsored by the Global Ophthalmic Research Center (Los Altos, California) and led by Quan Dong Nguyen, M.D., M.Sc., FAAO, FARVO, FASRS, Professor of Ophthalmology at the Byers Eye Institute, Stanford University School of Medicine with financial support provided by Oculis.Commenced start-up activities for Stage 2 of the Phase 3 DIAMOND trial (DIAMOND-1), the second pivotal Phase 3 trial for DME (DIAMOND-2) and the second Phase 3 trial for the treatment of inflammation and pain following cataract surgery (OPTIMIZE-2). Oculis anticipates first patient enrollment toward the end of 2023 and beginning of 2024 in all three pivotal trials. Commenced start-up activities for Phase 2b trial with OCS-02, a novel eye drop with potential to become the first approved topical anti-TNFα for DED. Oculis is on track to deliver the first patient first visit before the end of 2023 with clinical data readout expected in mid-2024.Strengthened the executive leadership team with the appointment of Rebecca Weil, Ph.D., a seasoned global ophthalmology commercial executive, as Chief Commercial Officer. Ms. Weil is building Oculis’ commercial organization readiness plan and preparing for its first potential launch in the U.S. with OCS-01 for the treatment of inflammation and pain following ocular surgery. Upcoming Clinical Milestones In the fourth quarter of 2023 the Company continues to focus on advancing its innovative pipeline and planned clinical development programs including: OCS-01 Following the positive readout in Stage 1, initiation of Stage 2 of the Phase 3 DIAMOND trial of OCS-01 for DME is underway. Stage 2 will include a 6-week induction phase, followed by 46-week maintenance phase of OCS-01 vs. vehicle. Consistent with Stage 1, the primary endpoint is change in best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score. 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). All endpoints will be evaluated at Week 52. The second Phase 3 trial for DME (DIAMOND-2) will follow shortly after.The second Phase 3 OPTIMIZE-2 trial to support the NDA submission is expected to start in the fourth quarter of 2023. 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 on Day 15 and absence of pain on Day 4.The investigator-initiated study of OCS-01 for the treatment of CME is advancing with all clinical sites activated and patient enrollment on track. Oculis anticipates topline readout in the fourth quarter of 2024. OCS-02 Phase 2b trial in DED is on track for first patient first visit in the fourth quarter of 2023. The trial will evaluate the safety and efficacy vs. vehicle in signs and symptoms, and further explore whether patients with a certain genotype (i.e., single-nucleotide polymorphism, SNP, related to the TNF receptor) respond better to OCS-02 than all comers. Another Phase 2b trial of OCS-02 for the treatment of uveitis is expected to follow thereafter. OCS-05 Phase 2a PoC ACUITY trial in France for OCS-05, a potential disease-modifying neuroprotective candidate for acute optic neuritis (AON), is ongoing. The trial evaluates the safety and tolerability of a once-daily injection of OCS-05 vs. placebo for 5 days, in addition to current standard of care and includes a follow-up period of 6 months. A topline readout is expected in the fourth quarter of 2024. Concurrently, the Company is working on IND enabling activities in the U.S. Q3 Financial Highlights Cash position: As of September 30, 2023, the Company had total cash, cash equivalents and short-term investments of CHF 106.6 million or $116.5 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 into late 2025.Research and development expenses were CHF 8.9 million or $10.0 million for the three-month period ending September 30, 2023, compared to CHF 4.6 million or $4.8 million in the same period in 2022. The increase was primarily due to clinical development activities, including the initiation of the Phase 3 DIAMOND Stage 2 program of OCS-01 in DME.General and administrative expenses were CHF 4.3 million or $4.9 million for the three-month period ending September 30, 2023, compared to CHF 2.5 million or $2.6 million in the same period in 2022. The increase was primarily due to costs related to becoming a public company.Q3 Quarter-to-date net loss was CHF 17.4 million or $19.7 million, or CHF 0.48 or $0.54 loss per share (basic and diluted), for the three-month period ending September 30, 2023, compared to CHF 10.0 million or $10.4 million, or CHF 2.88 or $2.98 loss per share (basic and diluted), in the same period in 2022. The increase in net loss was primarily driven by the increase in clinical development expenses.Q3 Year-to-date net loss was CHF 76.3 million or $84.5 million for the nine months ending September 30, 2023, or CHF 2.76 or $3.06 loss per share (basic and diluted) compared to CHF 29.5 million or $31.0 million, or CHF 8.71 or $9.15 loss per share (basic and diluted) for the nine months ended September 30, 2022. The increase in year-to-date net loss was primarily driven by the increase in clinical development expenses, expenses related to becoming a public company, merger and listing expense and the fair-value (non-cash) adjustment of outstanding warrants.Q3 Year-to-date Non-IFRS net loss was CHF 36.5 million or $40.4 million, or CHF 1.32 or $1.46 loss per share (basic and diluted), for the nine months ended September 30, 2023, compared to CHF 29.5 million or $31.0 million, or CHF 8.71 or $9.15 loss per share (basic and diluted), for the same period in 2022. The increase in non-IFRS net loss was primarily driven by increases in clinical development expenses, expenses related to becoming a public company, and an increase in the fair-value (non-cash) adjustment of outstanding warrants. Non-IFRS Financial InformationThis press release contains financial measures that do not comply with International Financial Reporting 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 and non-cash expense CHF 34.9 million or $38.2 million in the first quarter of 2023 and in the year-to-date total operating expenses.During the third quarter of 2023, the Company gave effect to the impending dissolution of its Merger Sub 2 entity pursuant to the Business Combination Agreement with EBAC, which is expected to be completed in the coming months. As a result, the cumulative translation adjustments related to Merger Sub 2 previously reported in equity and recognized in other comprehensive loss, were reclassified from equity to the Condensed Consolidated Interim Statement of Loss for the three and nine months ended September 30, 2023. The resulting non-cash foreign exchange impact of such reclassification amounted to CHF 5.0 million or $5.7 million for the three and nine months ended September 30, 2023. The non-IFRS measures presented here are also unlikely to be comparable with non-IFRS disclosures released by other companies. See the “Reconciliation of Non-IFRS Measures (Unaudited)” table below for a reconciliation of these non-IFRS measures to the most directly comparable IFRS measures. Condensed Consolidated Statements of Financial Position (Unaudited) (Amounts in CHF thousands)As of September 30, As of December 31, 2023 2022ASSETS Non-current assets Property and equipment, net312 365Intangible assets12,206 12,206Right-of-use assets798 758Other non-current assets129 74Total non-current assets13,445 13,403 Current assets Other current assets7,276 2,959Accrued income1,625 912Short-term financial assets75,871 -Cash and cash equivalents30,724 19,786Total current assets115,496 23,657 TOTAL ASSETS128,941 37,060 EQUITY AND LIABILITIES Shareholders' equity Share capital366 39Share premium288,030 10,742Reserve for share-based payment5,337 2,771Actuarial loss on post-employment benefit obligations (560) (264)Treasury shares- (1)Cumulative translation adjustments (289) (300)Accumulated losses (187,281) (110,978)Total equity105,603 (97,991) Non-current liabilities Long-term lease liabilities505 491Long-term financial debt- 122,449Long-term payables377 -Defined benefit pension liabilities305 91Total non-current liabilities1,187 123,031 Current liabilities Trade payables6,712 3,867Accrued expenses and other payables8,680 8,011Short-term lease liabilities182 142Warrant liabilities6,577 -Total current liabilities22,151 12,020 Total liabilities23,338 135,051 TOTAL EQUITY AND LIABILITIES128,941 37,060 Condensed Consolidated Statements of Loss (Unaudited) (Amounts in CHF thousands, except per share data) For the three months ended September 30, For the nine months ended September 30, 2023 2022 2023 2022Grant income 219 202 698 698Operating income 219 202 698 698Research and development expenses (8,872) (4,592) (21,218) (15,335)General and administrative expenses (4,306) (2,483) (13,147) (6,626)Merger and listing expense - - (34,863) -Operating expenses (13,178) (7,075) (69,228) (21,961) Operating loss (12,959) (6,873) (68,530) (21,263) Finance income 520 61 773 70Finance expense (11) (1,834) (1,303) (5,119)Fair value adjustment on warrant liabilities (2,434) - (4,638) -Foreign currency exchange gain (loss), net (2,645) (1,302) (2,485) (3,134)Finance result, net (4,570) (3,075) (7,653) (8,183) Loss before tax for the period (17,529) (9,948) (76,183) (29,446) Income tax benefit (expense) 116 (6) (120) (69) Loss for the period (17,413) (9,954) (76,303) (29,515) Loss per share: Basic and diluted loss attributable to equity holders (0.48) (2.88) (2.76) (8.71) Reconciliation of Non-IFRS Measures (Unaudited) (Amounts in CHF thousands, except per share data) For the three months ended September 30, For the nine months ended September 30, 2023 2022 2023 2022IFRS loss for the period (17,413) (9,954) (76,303) (29,515)Non-IFRS adjustments: Merger and listing expense (i)- - 34,863 -Merger Sub 2 reclassification from equity to foreign exchange loss (ii)4,978 - 4,978 -Non-IFRS loss for the period (12,435) (9,954) (36,462) (29,515) IFRS basic and diluted loss attributable to equity holders (0.48) (2.88) (2.76) (8.71)Non-IFRS basic and diluted loss attributable to equity holders (0.34) (2.88) (1.32) (8.71) IFRS weighted-average number of shares used to compute loss per share basic and diluted36,330,836 3,461,666 27,673,950 3,387,614 (i) Merger and listing expense is the difference between the fair value of the shares transferred and the fair value of the EBAC net assets per the Business Combination Agreement. This merger and listing expense is non-recurring in nature and represented a share-based payment made in exchange for a listing service and does not lead to any cash outflows.(ii) The reclassification of cumulative translation adjustments from equity to foreign exchange loss results from the impact of the impending dissolution of Merger Sub 2, which is expected to occur in the coming months. This exchange loss is non-recurring in nature and does not lead to any cash outflows. About Oculis Oculis (Nasdaq: OCS) is a global biopharmaceutical company purposefully driven to save sight and improve eye care. Oculis’ highly differentiated clinical-stage pipeline comprises multiple innovative product candidates in development for eye diseases of high unmet need. It includes OCS-01 eye drops, a topical candidate in Phase 3 development for diabetic macular edema (DME) and inflammation and pain following ocular surgery; OCS-02 eye drops, a topical biologic candidate in Phase 2 development for dry eye disease (DED) and uveitis; and OCS-05, a disease-modifying candidate for acute optic neuritis (AON) and other neuro-ophthalmic disorders, such as glaucoma, diabetic retinopathy, geographic atrophy, and neurotrophic keratitis. The first in-patient, proof-of-concept trial with OCS-05 is currently ongoing in France. Headquartered in Switzerland and with operations in the US, Oculis’ goal is to deliver life-changing eye treatments to patients worldwide. The company is led by an experienced management team with a successful track record in the pharmaceutical industry, supported by leading international healthcare investors. For more information, please visit: www.oculis.com Oculis Contacts Ms. Sylvia Cheung, CFOsylvia.cheung@oculis.com Investor & Media Relations LifeSci AdvisorsCorey Davis, Ph.D.cdavis@lifesciadvisors.com1-212-915-2577 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 treating front- and back-of-the-eye diseases; the potential for OCS-01 to become a new standard of care with the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery; the potential of OCS-01 for the treatment of DME, inflammation and pain following ocular surgery and CME; the potential of OCS-02 for treating DED; the potential of OCS-02 to become the first approved topical anti-TNFα for DED; the potential of OCS-05 for treating AON and other neuro-ophthalmic disorders; expected cash runway; 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; 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.

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 AugustAdvancing 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 ZUG, Switzerland, and BOSTON, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced second quarter and first half 2023 financial results for the period ended June 30, 2023, and an overview of the Company’s progress. 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 Clinical DevelopmentsOCS-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. Upcoming Milestones 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. Financial Highlights 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. Non-IFRS Financial InformationThis press release contains financial measures that do not comply with International Financial Reporting Standards (IFRS) including non-IFRS loss for the period, 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 and non-cash expense CHF 34.9 million or $38.2 million in the first quarter of 2023 and in the year-to-date total operating expenses. The non-IFRS measures presented here are also unlikely to be comparable with non-IFRS disclosures released by other companies. See the “Reconciliation of Non-IFRS Measures (Unaudited)” table below for a reconciliation of these non-IFRS measures to the most directly comparable IFRS measures.Condensed Consolidated Balance Sheets (Unaudited)(Amounts in CHF thousands) As of June 30, As of December 31, 2023 2022 ASSETS Non-current assets Property and equipment, net321 365 Intangible assets12,206 12,206 Right-of-use assets835 758 Other non-current assets113 74 Total non-current assets13,475 13,403 Current assets Other current assets6,063 2,959 Accrued income1,296 912 Short-term financial assets72,078 - Cash and cash equivalents41,932 19,786 Total current assets121,369 23,657 TOTAL ASSETS134,844 37,060 EQUITY AND LIABILITIES Shareholders' equity Share capital364 39 Share premium286,696 10,742 Reserve for share-based payment4,136 2,771 Actuarial loss on post-employment benefit obligations(539) (264)Treasury shares- (1)Cumulative translation adjustments(3,591) (300)Accumulated losses(169,870) (110,978)Total equity117,196 (97,991) Non-current liabilities Long-term lease liabilities539 491 Long-term financial debt- 122,449 Defined benefit pension liabilities305 91 Total non-current liabilities844 123,031 Current liabilities Trade payables3,920 3,867 Accrued expenses and other payables8,407 8,011 Short-term lease liabilities177 142 Warrant liabilities4,300 - Total current liabilities16,804 12,020 Total liabilities17,648 135,051 TOTAL EQUITY AND LIABILITIES134,844 37,060 Condensed Consolidated Statements of Operations (Unaudited)(Amounts in CHF thousands, except per share data) For the three months ended June 30, For the six months ended June 30, 2023 2022 2023 2022 Grant income250 240 479 496 Operating income250 240 479 496 Research and development expenses(6,198) (6,702) (12,346) (10,743)General and administrative expenses(4,797) (2,776) (8,840) (4,143)Merger and listing expense- - (34,863) - Operating expenses(10,995) (9,478) (56,049) (14,886) Operating loss(10,745) (9,238) (55,570) (14,390) Finance income216 7 253 8 Finance expense(17) (1,665) (1,297) (3,285)Fair value adjustment on warrant liabilities(2,625) - (2,203) - Foreign currency exchange gain (loss), net408 (1,406) 161 (1,832)Finance result, net(2,018) (3,064) (3,086) (5,109) Loss before tax for the period(12,763) (12,302) (58,656) (19,499) Income tax expense(114) (42) (236) (64) Loss for the period(12,877) (12,344) (58,892) (19,563) Loss per share: Basic and diluted loss attributable to equity holders(0.38) (3.64) (2.53) (5.84) Reconciliation of Non-IFRS Measures (Unaudited)(Amounts in CHF thousands, except per share data) For the three months ended June 30, For the six months ended June 30, 2023 2022 2023 2022 IFRS loss for the period(12,877) (12,344) (58,892) (19,563)Non-IFRS adjustments: Merger and listing expense (i)- - 34,863 - Non-IFRS loss for the period(12,877) (12,344) (24,029) (19,563) IFRS basic and diluted loss attributable to equity holders(0.38) (3.64) (2.53) (5.84)Non-IFRS basic and diluted loss attributable to equity holders(0.38) (3.64) (1.03) (5.84) IFRS weighted-average number of shares used to compute loss per share basic and diluted33,565,542 3,392,346 23,274,136 3,350,458 (i) Merger and listing expense is the difference between the fair value of the shares transferred and the fair value of the EBAC net assets per the Business Combination Agreement. This merger and listing expense is non-recurring in nature and represented a share-based payment made in exchange for a listing service and does not lead to any cash outflows. About Oculis Oculis (Nasdaq: OCS) is a global biopharmaceutical company purposefully driven to save sight and improve eye care. Oculis’s highly differentiated clinical-stage pipeline comprises multiple innovative product candidates in development for eye diseases of high unmet need. It includes OCS-01 eye drops, a topical candidate in Phase 3 development for diabetic macular edema (DME) and inflammation and pain following ocular surgery; OCS-02 eye drops, a topical biologic candidate in Phase 2 development for dry eye disease (DED) and uveitis; and OCS-05, a disease modifying candidate for acute optic neuritis (AON) and other neuro-ophthalmic disorders, such as glaucoma, diabetic retinopathy, geographic atrophy, and neurotrophic keratitis. The first in-patient, proof-of-concept trial with OCS-05 is currently ongoing in France. Headquartered in Switzerland and with operations in the US, Oculis’ goal is to deliver life-changing eye treatments to patients worldwide. The company is led by an experienced management team with a successful track record in the pharmaceutical industry, supported by leading international healthcare investors. For more information, please visit: www.oculis.com Oculis Contacts Mrs. Sylvia Cheung, CFOsylvia.cheung@oculis.com Investor & Media Relations LifeSci AdvisorsCorey Davis, Ph.D.cdavis@lifesciadvisors.com1-212-915-2577 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, including patient impact and market opportunity; the potential of OCS-01 for treating front- and back-of-the-eye diseases; the potential for OCS-01 to become a new standard of care with the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery; the potential of OCS-01 for the treatment of DME, inflammation and pain following ocular surgery and CME; expected cash runway; 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; 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.

LEOPARD trial initiation follows recent positive data from OCS-01 eye drops from the Stage 1 Phase 3 DIAMOND trial in patients with Diabetic Macular Edema (DME)Cystoid Macular Edema (CME) can result from uveitis or from post-surgical complicationsCME is one of the most significant causes of vision loss after ocular surgery1 and approximately 28% of patients who undergo ocular surgery, including patients with diabetes, uveitis and other risk factors, have a higher risk of CME2. In addition, CME can also occur in about 40% of patients with posterior or pan-uveitis3 ZUG, Switzerland, and BOSTON, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, announces that the first patient has been enrolled in the investigator-initiated LEOPARD trial evaluating the potential of OCS-01 eye drops, Oculis’ novel high concentration preservative-free topical OPTIREACH formulation of dexamethasone, for the treatment of cystoid macular edema (CME). CME may occur as a complication of ocular conditions, including uveitis and ocular surgery, and is a leading cause of vision loss worldwide. It is one of the most significant causes of postoperative vision loss after cataract surgery1. Approximately 28% of patients who undergo ocular surgery, including patients with diabetes, uveitis and other risk factors, have a higher risk of developing CME following the procedure2. Up to 56% of high-risk patients may experience clinically significant CME following ocular surgery1. The LEOPARD trial, 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, aims to evaluate the efficacy and safety profile of OCS-01 eye drops in the management of two different forms of CME: Uveitic Macular Edema (UME) and Post-Surgical Macular Edema (PSME). It is a prospective, multi-center, open label, single-armed trial which plans on enrolling 24 eligible subjects (12 with UME and 12 with PSME). Two different doses will be used, and the total treatment period is 24 weeks. The primary endpoints, which will be assessed at 12 weeks, are improvement in central subfield thickness (CST) and visual acuity. CME is being explored with OCS-01 eye drops, in addition to diabetic macular edema (DME) and inflammation and pain post ocular surgery, both indications currently in Phase 3 clinical development. OCS-01 has demonstrated its potential to reduce macular edema as measured by improvements in retinal thickness in a pilot study with uveitic macular edema patients as well as in the recently completed Stage 1 of the Phase 3 DIAMOND trial in patients with DME. Professor Nguyen, who is a member of the Oculis Scientific Advisory Board, commented: “I am very excited to investigate the potential of OCS-01 eye drops for the treatment of cystoid macular edema, one of the most common causes of decreased vision in patients following cataract and other ophthalmic surgeries, and in uveitis patients. Given the recently announced DIAMOND Phase 3 Stage 1 data readout in DME, which showed statistically significant reduction in retinal thickness with OCS-01, we believe in its potential to provide a paradigm shift in the treatment of post-surgical and uveitic macular edema, in addition to DME.” Riad Sherif, M.D., Chief Executive Officer of Oculis, concluded: “Oculis is proud to support this investigator-initiated trial led by Professor Nguyen in cystoid macular edema with OCS-01 eye drops, to explore its potential in this vision-threatening eye condition. OCS-01 is Oculis’ lead compound currently being investigated in two Phase 3 clinical trials in DME as well as inflammation and pain following with ocular surgery with promising efficacy and safety data.” 1 Laura H.P. Wielders et al. Prevention of CME After Cataract Surgery, CRST Today Europe, 2013 https://crstodayeurope.com/articles/2013-julaug/prevention-of-cme-after-cataract-surgery2 Hennings et al. Prognostic determinants of postoperative pseudophakic macular oedema in a tertiary hospital setting ARVO Annual Meeting Abstract, June 2021, volume 62, Issue 8, https://iovs.arvojournals.org/article.aspx?articleid=27754753 Oren Tomkins-Netzer et al. Seven-year outcomes of uveitic macular edema: the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study results, Ophthalmology, May 2021 128 (5): 719-728 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7943640/ About Oculis Oculis is a global biopharmaceutical company (Nasdaq: 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 retinal candidate for diabetic macular edema (DME); OCS-02, a topical eye drop biologic candidate for dry eye disease (DED); and OCS-05, a disease modifying candidate for acute optic neuritis (AON) and other neuro-ophtha disorders such as glaucoma, diabetic retinopathy, geographic atrophy, and neurotrophic keratitis. Headquartered in Switzerland and with operations in the US, Oculis’ goal is to deliver life-changing treatments to 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 Mrs. Sylvia Cheung, CFOsylvia.cheung@oculis.com Investor & Media Relations LifeSci AdvisorsCorey Davis, Ph.D.cdavis@lifesciadvisors.com1-212-915-2577 Cautionary Statement Regarding Forward Looking Statements This press release contains forward-looking statements and information. For example, statements regarding 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; 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.