Geographic Atrophy

MELBOURNE, Australia and PRINCETON, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT; NASDAQ:OPT; “Opthea”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, today announced it will host a virtual key opinion leader (KOL) event on Wednesday, April 3, 2024, from 10:00 to 11:30 am ET, featuring presentations from global retina experts: Arshad M. Khanani, MD, MA, FASRS, Sierra Eye Associates and University of Nevada, Reno School of Medicine Charles C. Wykoff, MD, PhD, Retina Consultants of Texas and Blanton Eye Institute, Houston Methodist Hospital Veeral S. Sheth, MD, MBA, FASRS, FACS, University Retina and Macula Associates, University of Illinois at Chicago This event will focus on the potential of sozinibercept to transform patient outcomes by delivering superior vision gains in wet age-related macular degeneration (wet AMD), with KOL perspectives on (1) the wet AMD treatment landscape and unmet medical need addressed by sozinibercept’s novel mechanism of action, (2) the Phase 2b data demonstrating superiority in combination with standard-of-care therapy, and (3) the company's two ongoing global Phase 3 registrational trials (COAST and ShORe) evaluating sozinibercept in combination with standard-of-care VEGF-A inhibitors. Additionally, Opthea will provide a strategic outlook. A live question and answer session will follow the formal presentations. To register for this live webcast, click here. A replay of the webcast will be made available on the Company’s website. About Arshad M. Khanani, MD, MA, FASRS Arshad M. Khanani, MD, MA, FASRS is dedicated to advancing innovative treatment options for patients suffering from retinal diseases. Over a decade ago, he established the clinical research department at Sierra Eye Associates, which has since evolved into one of the foremost clinical research sites nationwide. With a wealth of experience, he has assumed the role of principal investigator for more than 120 clinical trials, consistently ranking as a top enroller in the nation across multiple Phase 1-3 trials. Notably, Dr. Khanani recently chaired the Phase 3 GATHER2 steering committee for IZERVAY™, playing a pivotal role in IZERVAY's approval for geographic atrophy. His contributions extend to over 100 authored or contributed scientific publications in prominent ophthalmology journals. Dr. Khanani actively participates as a member of national and international clinical trial steering committees, in addition to serving on scientific advisory boards. Dr. Khanani also serves as the lead principal investigator for multiple national and global clinical trials. He is often sought after as a guest speaker and lecturer at prestigious national and international gatherings. In pursuit of advancements in vitreoretinal care, Dr. Khanani initiated the Clinical Trials at the Summit (CTS) meeting, aiming to foster dialogue on clinical trial execution, design, and data analysis. Dr. Khanani holds elected membership in esteemed organizations such as the Macula Society and Retina Society, in addition to being the recipient of numerous distinguished awards. In 2019, he was honored with the Nevada Business Magazine Healthcare Heroes Physician of the Year award in recognition of his unwavering commitment to the field of ophthalmology. Dr. Khanani has been bestowed with the Senior Honor Award from the American Society of Retina Specialists (ASRS) and was also awarded the prestigious ASRS Presidents’ Young Investigator Award in 2021. Furthermore, in 2023, he was invited to deliver the esteemed Ernst Bodenheimer Memorial Lecture at the Wilmer Eye Institute at Johns Hopkins University. In February 2024, Dr. Khanani joined Opthea as its Chief Medical Advisor, while retaining his practice, sponsorship, and research activities. Prior to his new role at Opthea, Dr. Khanani served as a principal investigator for Opthea’s ShORe Phase 3 pivotal trial. About Charles C. Wykoff, MD, PhD Charles C. Wykoff, MD, PhD is a board-certified Medical and Surgical Retina Specialist and ophthalmologist with Retina Consultants of Texas (RCTX). Leading a top international research facility for vitreoretinal diseases, Dr. Wykoff serves as Director of Research at RCTX and the Greater Houston Retina Research Foundation (GHRRF), and Chairman of the Research and Clinical Trials Subcommittee, Retina Consultants of America. In addition, he serves as the elected Deputy Chair of Ophthalmology for the Blanton Eye Institute, Houston Methodist Hospital. Dr. Wykoff has been awarded the American Academy of Ophthalmology Secretariat and Achievement Awards as well as the American Society of Retina Specialists Senior Honor and Young Investigator Awards. Dr. Wykoff serves as the Chief Investigator for Opthea’s COAST Phase 3 pivotal trial and is on Opthea’s Clinical Advisory Board. About Veeral S. Sheth, MD, MBA, FASRS, FACS Veeral Sheth, MD, MBA, FACS, is a native Chicagoan that specializes in diseases of the retina and vitreous. He also is a Clinical Assistant Professor at the University of Illinois at Chicago. Dr. Sheth completed his ophthalmology residency at the Illinois Eye and Ear Infirmary where he served as Chief Resident. After residency, Dr. Sheth completed his fellowship at the University of Chicago in Retinal Surgery. He completed his MBA at Northwestern University’s Kellogg School of Management. Dr. Sheth is a Partner at University Retina and Macula Associates. He is Director of Clinical Trials at one of the busiest clinical trial sites in the country. He has been principal investigator for over 60 clinical trials and has research interests in macular degeneration, diabetic retinopathy, vein occlusion, as well as surgical pathology. He is involved in clinical trials developing new drugs, delivery devices, and gene therapy. Dr. Sheth is an active member of the American Society of Retina Specialists, Retina Society, American Academy of Ophthalmology, The Association for Research in Vision and Ophthalmology, and the European Society of Retina Specialists. He is the Chairman Emeritus of the Board of Directors for Meals on Wheels Chicago. Dr. Sheth is fluent in English, Spanish, and Gujarati. Dr. Sheth is a principal investigator for Opthea’s ShORe Phase 3 pivotal trial. About Sozinibercept Sozinibercept (OPT-302) is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) expressed as an immunoglobulin G1 (IgG1) Fc-fusion protein. It binds and neutralizes the activity of VEGF-C and VEGF-D on their endogenous receptors, VEGFR-2 and VEGFR-3. Research indicates that targeted inhibition of VEGF-C and VEGF-D can prevent blood vessel growth and vascular leakage, which contribute to the pathophysiology of retinal diseases including wet AMD. Sozinibercept has received Fast Track Designation from the U.S. FDA for the treatment of wet AMD. Positive results from the Phase 2b study of sozinibercept, administered in combination with standard of care, LUCENTIS® (ranibizumab), for the treatment of wet AMD, published in Ophthalmology, met the pre-specified primary efficacy endpoint of a statistically superior gain in visual acuity at 24 weeks, compared to ranibizumab alone. In addition, secondary outcomes were positive for the combination therapy with sozinibercept, including more participants with gains in vision of 10 or more letters and improved anatomy, with a reduction in swelling and vascular leakage, with a favorable safety profile. About Opthea Opthea (ASX:OPT; NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea’s lead product candidate, sozinibercept, is being evaluated in two pivotal Phase 3 clinical trials (COAST, NCT04757636, and ShORe, NCT04757610,) for use in combination with standard-of-care anti-VEGF-A monotherapies to improve overall efficacy and deliver superior vision gains compared to the standard-of-care anti-VEGF-A agents. To learn more, visit our website and follow us on X and LinkedIn. IZERVAY™ is a registered trademark of Astellas Pharma Inc. LUCENTIS® is a registered trademark of Genentech USA, Inc. A member of the Roche Group. Authorized for release to ASX by Fred Guerard, CEO Investor Enquiries PJ Kelleher LifeSci Advisors Email: pkelleher@lifesciadvisors.com Phone: 617-430-7579 Media Silvana Guerci-Lena NorthStream Global Partners Email: silvana@nsgpllc.com Join our email database to receive program updates: Tel: +61 (0) 3 9826 0399 Email: info@opthea.com Source: Opthea Limited

ROCKVILLIE, Md. and SUZHOU, China, March 18, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the primary endpoint has been met in the second Phase 2 clinical study of efdamrofusp alfa high-dose, a recombinant human VEGFR-Fc-Human CR1 fusion protein injection (R&D code: IBI302), in Chinese subjects with neovascular age-related macular degeneration (nAMD). According to the results of the two Phase 2 clinical studies conducted in more than 360 subjects of nAMD, compared with Aflibercept, IBI302 can be administrated in long-interval (every 12 weeks), while providing a stable and robust visual benefit and anatomic improvements, as well as potential inhibition effect in macular atrophy. Based on those results, Innovent advanced IBI302 8mg into a Phase 3 clinical study STAR in October 2023. This was a randomized, double-masked, active-controlled Phase 2 clinical study (NCT05403749), evaluating the longer interval of intravitreal injection of high-dose IBI302 in subjects with nAMD. A total of 132 subjects were randomized 1: 1: 1 to IBI302 6.4 mg group, IBI302 8.0 mg group, or Aflibercept 2.0 mg group. After the loading therapy, subjects in IBI302 6.4 mg group and 8.0 mg group were dosed with adjusted intervals of every 8 weeks (Q8W) or every 12 weeks (Q12W), depending on response to loading therapy. Subjects in Aflibercept 2.0 mg group were dosed Q8W after the loading therapy. The primary endpoint was the change in best corrected visual acuity (BCVA) in the study eye from baseline to week 40. The study lasted for 52 weeks. The results showed that the primary endpoint was successfully met: at week 40, the IBI302 6.4 mg and 8.0 mg groups showed non-inferior BCVA gains to the Aflibercept 2.0 mg group. The mean BCVA improvement from baseline was 10.5 ETDRS letters for the IBI302 6.4 mg group, 11.0 ETDRS letters for the IBI302 8.0 mg group, and 9.8 ETDRS letters for the Aflibercept 2.0 mg group at week 40. The mean change from baseline in central subfield thickness (CST) was -163.19 μm for the IBI302 6.4 mg group, -184.46 μm for the IBI302 8.0 mg group, and -108.23 μm for the Aflibercept 2.0 mg group at week 40. In addition, approximately 81%, 88% of subjects in 6.4 mg IBI302 groups and 8.0mg IBI302 groups respectively were able to extend dosing interval to Q12W, similar to that in the proportion of subjects dosed Q12W or longer with Aflibercept 8.0 mg (83% in PULSAR trial)1 or Faricimab (TENAYA & LUCERNE trial, with 79.7% and 77.8% respectively)2 by indirect comparison. Based on the excellent long-interval dosing performance in the Phase 2 studies, the Phase 3 study STAR added Q16W dosing interval regimen for IBI302. The overall safety profile of IBI302 was favorable, comparable to Aflibercept 2.0 mg, and consistent with previous studies. No new safety signals were identified. Detailed study data will be further analyzed and published in the near future. Professor Xiaodong Sun, Principal Investigator of the Study, Head of National Center for Clinical Ophthalmology, Shanghai General Hospital, stated: "Intravitreal injection of anti-VEGF drugs is currently the first-line treatment for nAMD, but there are still unmet clinical needs given their frequent intravitreal injection and gradual loss of visual benefits. Exploring longer interval dosing and anti-macular atrophy are necessary and urgent. IBI302 is a global first-in-class anti-VEGF-anti-complement bispecific molecule. As the principal investigator for IBI302 trials, I am very pleased to see that this Phase 2 study met the primary endpoint and demonstrated the potential for long-interval dosing. These results will be further validated in the pivotal trial of IBI302. I look forward to providing a new treatment option for nAMD patients." Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated: "There are two major trends in drug development for nAMD: extending dosing intervals and reducing the occurrence of macular atrophy. In the results of two Phase 2 studies, which enrolled over 360 subjects, IBI302 improved BCVA and macular edema in patients with nAMD significantly, extended dosing intervals, and had the potential to prevent the development of macular atrophy. Next, we will further investigate the long-interval dosing efficacy and safety of high-dose IBI302 in the Phase 3 STAR trial, hoping to bring a new generation of anti-VEGF agents to patients with nAMD." About neovascular age-related macular degeneration (nAMD) Age-related macular degeneration (AMD) is a progressive ocular disease involving the macular retina, leading to central visual impairment, the incidence of which increases with age. Neovascular age-related macular degeneration (nAMD) is one of the major forms of AMD, accounting for 15% to 20% of all AMD patients and is the leading cause of central vision loss in AMD patients over 65 years3. The incidence of AMD is increasing year by year in China, and it has become the third leading cause of blindness in China. The pathogenesis of nAMD has not been fully elucidated. It is generally accepted that angiogenesis induced by increased expression of VEGF is the main cause of nAMD, and inflammatory reaction mediated by abnormal activation of complement is also considered to be an important cause of AMD. Ocular anti-VEGF agents have led to significant visual benefits and changed the course of nAMD, but the frequent dosing (every 4 or 8 weeks) currently places a heavy burden on patients, families and society. In addition, the visual benefits of anti-VEGF drug therapy are gradually diminished year by year. In approximately two thirds of nAMD patients with a follow-up for over 7 years, the visual gains from anti-VEGF treatment significantly diminish4. Macular atrophy or retinal fibrosis are important causes of vision loss after long-term anti-VEGF therapy. Currently, drug development for nAMD is mainly focusing on extending the dosing intervals, and there are few drugs under investigation for macular atrophy or retinal fibrosis. Two drugs targeting complement have been approved by the US FDA in 20235,6 for the treatment of geographic atrophy secondary to dry AMD. About Efdamrofusp Alfa (IBI302) IBI302 is a recombinant fully human bispecific fusion protein of Innovent Biologics with global proprietary rights. The N-terminus is a VEGF domain that can bind to the VEGF family, block VEGF-mediated signaling pathway, inhibit vascular epithelium proliferation and angiogenesis, and improve vasopermeability and reduce leakage. The C-terminus of IBI302 is the complement binding domain that can inhibit the activation of the classic pathway and alternative pathway of complement through the specific binding of C3b and C4b, and reduce the inflammatory response mediated by the complement. IBI302 may exert its therapeutic effect by inhibiting both VEGF-mediated angiogenesis and complement activation pathways. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies to treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 5 assets in Phase 3 or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or is otherwise inaccurate. SOURCE Innovent Biologics

A successful year including NASDAQ listing and positive results from two Phase 3 programs in OCS-01: Phase 3 Stage 1 DIAMOND trial for Diabetic Macular Edema (DME), and Phase 3 OPTIMIZE-1 trial for inflammation and pain following cataract surgery On-track to report topline data from OCS-02 (Licaminlimab) Phase 2b RELIEF trial in Dry Eye Disease (DED) in Q2 2024, OCS-01 Phase 3 OPTIMIZE-2 trial, and OCS-05 proof-of-concept ACUITY trial in Q4 2024 Cash, cash equivalents and short-term investments of $108.9 million funding operations and planned clinical trials, as well as advancements in DIAMOND-1 and DIAMOND-2 Phase 3 trials R&D Day held on February 28, 2024, showcasing OCS-01 DME and OCS-02 DED and their transformative treatment potentials ZUG, Switzerland and BOSTON, March 18, 2024 (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 fourth quarter and full year financial results for the period ended December 31, 2023, and an overview of the Company’s progress. Riad Sherif M.D., Chief Executive Officer of Oculis: “2023 was a remarkable milestone-rich year for Oculis. Following our listing on NASDAQ, we had two positive Phase 3 data readouts with OCS-01, the first topical candidate with compelling data in DME, and achieved a strong close of the year with the initiation of three clinical trials, including the OCS-02 Phase 2b RELIEF trial in DED. As our innovative and diversified pipeline continues to advance, we remain laser-focused on delivering our key programs: OCS-01 in DME, OCS-02 in DED and OCS-05 in Acute Optic Neuritis. We are confident and excited as we move into a catalyst-rich 2024 and look forward to updating everyone on the upcoming RELIEF trial readout planned in Q2, the second Phase 3 OPTIMIZE-2 trial readout of OCS-01 in ocular surgery in Q4, which will allow us to submit our first NDA, in addition to the ACUITY trial readout of OCS-05 in Acute Optic Neuritis, also planned in Q4. I would like to thank our exceptional team and all our partners for their great contribution but also for their commitment towards our mission to save sight and improve eye care.” Q4 2023 and Recent Highlights Advanced 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, in three ongoing pivotal trials: In DME, following the positive topline results from Stage 1 of Phase 3 DIAMOND program, the Company announced the first patient first visit in Stage 2 of the first Phase 3 DIAMOND-1 trial and in DIAMOND-2, the second Phase 3 trial required for registration. Following the positive topline results achieved in the Phase 3 OPTIMIZE-1 trial, the Company started the second Phase 3 OPTIMIZE-2 trial of OCS-01 for the treatment of inflammation and pain following cataract surgery. Achieved a record completion of patient enrolment for the Phase 2b RELIEF trial of OCS-02 (Licaminlimab), a specifically designed ophthalmic formulation of a TNFα inhibitor, eye drop formulation specifically designed with a proprietary antibody fragment technology to treat ocular inflammation. The trial, initiated in November 2023, is evaluating the efficacy and safety of OCS-02 (Licaminlimab) vs. vehicle in signs of inflammation in DED, and is further exploring its potential unique benefit in patients with a certain genotype (i.e., single-nucleotide polymorphism, SNP, related to the TNF receptor). Hosted an R&D day on February 28, 2024, with over 100 participants that featured 10 leading experts in retina and anterior segments covering OCS-01 and OCS-02 clinical programs. Presented the Phase 3 DIAMOND Stage 1 positive results of OCS-01 in DME as late-breaking abstracts at the 23rd EURETINA Congress and at the American Academy of Ophthalmology. Upcoming Clinical Milestones In 2024, the Company is focused on advancing its innovative pipeline and planned clinical development programs including: Q2 2024 OCS-02: The Phase 2b RELIEF trial evaluating topical anti-TNFα OCS-02 (Licaminlimab) efficacy and safety in DED is on track for topline results readout in Q2 2024. Q4 2024 OCS-01: Topline results from the second Phase 3 OPTIMIZE-2 trial evaluating OCS-01 once daily eye drop for the treatment of inflammation and pain following cataract surgery are anticipated by the end of 2024. If positive, the data from this trial, together with the positive results from the first Phase 3 OPTIMIZE-1 trial, are expected to support the first NDA submission of the Company. OCS-05: A serum glucocorticoid kinase-2 (SGK-2) activator and potentially disease-modifying neuroprotective candidate is initially being developed for AON. The Phase 2a PoC ACUITY trial is designed to evaluate the safety and tolerability of a once-daily injection of OCS-05 vs. placebo for 5 days, in addition to current standard of care. The trial is on track for topline readout in the fourth quarter of 2024.The Company aims to achieve IND status for OCS-05 in the U.S. in 2024. Q4 and Full Year 2023 Financial Highlights Cash position: As of December 31, 2023, the Company had total cash, cash equivalents and short-term investments of CHF 91.7 million or $108.9 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 completed in 2023. Based on its current development plans, cash runway is expected to fund operations into late 2025. Research and development expenses were CHF 8.0 million or $9.0 million for the three-months ended December 31, 2023, compared to CHF 6.9 million or $7.1 million in the same period in 2022. The increase was primarily due to the commencement of three clinical trials during the fourth quarter of 2023: DIAMOND-1 Stage 2, OPTIMIZE-2 and RELIEF. General and administrative expenses were CHF 4.3 million or $4.9 million for the three-months ended December 31, 2023. G&A expenses remained in-line with the same period in 2022, which was CHF 4.4 million or $4.6 million. Q4 Net loss was CHF 12.5 million or $14.1 million for the fourth quarter ended December 31, 2023, compared to CHF 9.2 million or $9.5 million in the fourth quarter of 2022. The increase in net loss was primarily driven by increases in clinical development expenses, partially offset by changes in the fair value (non-cash) adjustment of outstanding warrants. FY2023 Net loss was CHF 88.8 million or $98.8 million for the year ended December 31, 2023, or CHF 2.97 or $3.31 loss per share (basic and diluted) compared to CHF 38.7 million or $40.5 million, or CHF 11.32 or $11.86 loss per share (basic and diluted) in the year ended December 31, 2022. The increase in net loss was primarily driven by the non-recurring merger and listing expense in Q1 2023, increases in clinical development expenses, public company expenses, and the fair value (non-cash) adjustment of outstanding warrants. FY2023 Non-IFRS net loss was CHF 49.0 million or $54.5 million, or CHF 1.64 or $1.83 per share, for the year ended December 31, 2023, compared to CHF 38.7 million or $40.5 million, or CHF 11.32 or $11.86 per share, for the year ended December 31, 2022. The increase in non-IFRS net loss was primarily driven by increases in clinical development expenses, G&A expenses related to operating as a public company, and an increase in the fair value (non-cash) adjustment of outstanding warrants. Non-IFRS Financial Information This press release contains financial measures that do not comply with International Financial Reporting Standards (IFRS) including non-IFRS net loss for the full year 2023, and non-IFRS net loss per common share for the same period. 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 year ended December 31, 2023. The resulting non-cash foreign exchange impact of such reclassification amounted to CHF 5.0 million or $5.7 million for the year ended December 31, 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. Consolidated Statements of Financial Position (Amounts in CHF thousands) As of December 31, As of December 31, 2023 2022 ASSETS Non-current assets Property and equipment, net 288 365 Intangible assets 12,206 12,206 Right-of-use assets 755 758 Other non-current assets 89 74 Total non-current assets 13,338 13,403 Current assets Other current assets 8,488 2,959 Accrued income 876 912 Short-term financial assets 53,324 - Cash and cash equivalents 38,327 19,786 Total current assets 101,015 23,657 TOTAL ASSETS 114,353 37,060 EQUITY AND LIABILITIES Shareholders' equity Share capital 366 39 Share premium 288,162 10,742 Reserve for share-based payment 6,379 2,771 Actuarial loss on post-employment benefit obligations (1,072) (264) Treasury shares - (1) Cumulative translation adjustments (327) (300) Accumulated losses (199,780) (110,978) Total equity 93,728 (97,991) Non-current liabilities Long-term lease liabilities 431 491 Long-term financial debt - 122,449 Long-term payables 378 - Defined benefit pension liabilities 728 91 Total non-current liabilities 1,537 123,031 Current liabilities Trade payables 7,596 3,867 Accrued expenses and other payables 5,948 8,011 Short-term lease liabilities 174 142 Warrant liabilities 5,370 - Total current liabilities 19,088 12,020 Total liabilities 20,625 135,051 TOTAL EQUITY AND LIABILITIES 114,353 37,060 Consolidated Statements of Loss (Amounts in CHF thousands, except per share data) For the three months ended December 31, For the years ended December 31, 2023 2022 2023 2022 Grant income 185 214 883 912 Operating income 185 214 883 912 Research and development expenses (8,029) (6,889) (29,247) (22,224) General and administrative expenses (4,340) (4,438) (17,487) (11,064) Merger and listing expense - - (34,863) - Operating expenses (12,369) (11,327) (81,597) (33,288) Operating loss (12,184) (11,113) (80,714) (32,376) Finance income 656 56 1,429 126 Finance expense (12) (1,323) (1,315) (6,442) Fair value adjustment on warrant liabilities 1,207 - (3,431) - Foreign currency exchange gain (loss), net (2,179) 3,183 (4,664) 49 Finance result, net (328) 1,916 (7,981) (6,267) Loss before tax for the period (12,512) (9,197) (88,695) (38,643) Income tax benefit (expense) 13 14 (107) (55) Loss for the period (12,499) (9,183) (88,802) (38,698) Loss per share: Basic and diluted loss attributable to equity holders (0.34) (2.62) (2.97) (11.32) Reconciliation of Non-IFRS Measures (Unaudited) (Amounts in CHF thousands, except per share data) For the years ended ended December 31, 2023 2022 2021 IFRS loss for the period (88,802) (38,698) (18,552) Non-IFRS adjustments: Merger and listing expense (i) 34,863 - - Merger Sub 2 reclassification from equity to foreign exchange loss (ii) 4,978 - - Non-IFRS loss for the period (48,961) (38,698) (18,552) IFRS basic and diluted loss attributable to equity holders (2.97) (11.32) (5.84) Non-IFRS basic and diluted loss attributable to equity holders (1.64) (11.32) (5.84) IFRS weighted-average number of shares used to compute loss per share basic and diluted 29,899,651 3,417,521 3,175,340 (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 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 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 disease modifying candidate for acute optic neuritis (AON) and other neuro-ophthalmic disorders such as glaucoma, diabetic retinopathy, geographic atrophy, and neurotrophic keratitis. Headquartered in Switzerland and with operations in the U.S., 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: 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 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, including the timing of completing enrolment in the RELIEF trial, topline results for OPTIMIZE-2 and ACUITY trials and IND status for OCS-05; 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, Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.