Xerophthalmia

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.

Treatment Resulted in Rapid, Clinically Meaningful, and Statistically Significant Improvements Across Multiple Signs and Symptoms in the Intention-to-Treat Population Complete Results to be Presented at the Association for Research in Vision and Ophthalmology Annual Meeting 2024 TL-925 is a First-in-Class Topical (Eye Drop) BTK Inhibitor Targeting Mast Cell-mediated Ocular Inflammation and Allergy REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Telios Pharmaceuticals, Inc., a clinical stage biopharmaceutical company committed to improving the lives of patients with inflammatory diseases, today announced topline results from its Phase 2 study assessing TL-925, a first-in-class topical Bruton’s tyrosine kinase (BTK) inhibitor for individuals with moderate to severe dry eye disease (DED). This proof-of-concept, multicenter, randomized, double-masked study evaluated the safety, tolerability, and efficacy of TL-925 versus vehicle control, when dosed twice daily for 28 days. A total of 107 subjects with moderate to severe DED were enrolled. TL-925 was safe and well tolerated and the intention-to-treat analysis demonstrated clinically meaningful and statistically significant efficacy relative to vehicle control across multiple signs and symptoms. The rapid onset of efficacy across multiple ocular regions, coupled with favorable and consistent results in different environments confirm TL-925’s differentiated pro a safe, well-tolerated, and effective treatment for patients with DED. Complete results will be presented at the upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2024, to be held from May 5-9, 2024, in Seattle, Washington. Poster: 2965 - A0124 Title: TL-925, a First-in-Class, Topical, Bruton’s Tyrosine Kinase Inhibitor in Subjects with Moderate to Severe Dry Eye Disease Session: 316 Date & Time: May 7, 2024, 08:30 - 10:15 “We are thrilled by these findings and honored to have been selected to share our groundbreaking research with the ophthalmology community at ARVO,” said Jesse McGreivy, CEO of Telios Pharma. “Our team is excited about advancing TL-925 through the next stages of clinical development with the aim of further demonstrating its ability to address the underlying cause of dry eye disease, an underdiagnosed and often poorly managed condition that affects many millions of people worldwide.” “I am highly encouraged by the breadth of positive results from this Phase 2 study and hopeful about the potential for TL-925 to impact the underlying pathology of DED,” said George Ousler, lead investigator and Senior Vice President at Ora Inc., the world’s leading full-service ophthalmic research organization, which oversaw the trial. “The results are among the most impressive that I have seen in my years working on dry eye clinical development programs. TL-925 is a promising and much needed novel approach for the treatment of DED.” A Phase 2b study of TL-925 in DED has been initiated based on these results and is currently enrolling patients. Consistent with TL-925’s efficacy in DED, a separate Phase 2 study evaluating the safety and efficacy of TL-925 in individuals with allergic conjunctivitis (AC) has recently shown clinically meaningful and statistically significant improvements in both itching and redness. These data will be presented at a medical congress later this year. “DED and AC are two of the most common ocular inflammatory disorders and often coexist, presenting unique treatment challenges,” said Gail Torkildsen, MD, a board-certified ophthalmologist at Andover Eye Associates and principal investigator in both studies. “Positive efficacy results in DED and AC demonstrate that TL-925 can effectively and rapidly halt the cycle of inflammation; these data also validate TL-925’s potential to target the underlying inflammatory mechanisms driving these diseases. It is increasingly apparent that TL-925 may represent a significant leap forward for the effective treatment of DED and AC.” About Telios Pharma, Inc. Telios Pharma is a privately held clinical stage biopharmaceutical company with a first-in-class topical and oral BTK program targeting mast cell-mediated inflammation and allergy. About TL-925 Dry eye disease, a chronic inflammatory disorder of the lacrimal unit, causes ocular discomfort, pain, and visual disturbances. Mast cells, found in the lacrimal functional unit, are key initiators and amplifiers of the inflammatory cascade. TL-925, an ophthalmic formulation of the potent, irreversible BTK inhibitor TL-895 prevents mast cell activation and degranulation, blocks the cytokine-driven inflammatory response, and restores lacrimal unit homeostasis, offering the potential for disease modification. Our novel approach to treating DED targets BTK, which has been shown to be critical for mast cell activation and immune response.

BERWYN, Pa.--(BUSINESS WIRE)-- Amring Pharmaceuticals Inc. (“Amring”) announces its name change to Nordic Pharma, Inc. on March 4, 2024, following the change in ownership of the company from SEVER Life Sciences, B.V. to Nordic Group, B.V., a subsidiary of SEVER Life Sciences B.V., which occurred on June 1, 2023. The change in the corporate name provides for better alignment strategically with the parent company headquartered in the Netherlands and its subsidiaries worldwide. Together, the companies look to expand the global footprint in Eye Care, Rheumatology, Woman’s Health, and Critical Care for branded products as well as strengthening their generic product business in the U.S. As part of this growth strategy, Nordic Pharma recently acquired Visant Medical, Inc., a leader in medical technology innovation in Dry Eye Disease (DED). The acquisition included the FDA cleared hyaluronic acid derivative LACRIFILL® canalicular gel, which is intended to temporarily block tear drainage by the occlusion of the canalicular system. Nordic Pharma will be launching LACRIFILL in the U.S. in Q2 2024 followed by a global rollout. Charlotte Phelps, CEO of Nordic Pharma said, “The strategic acquisition and merger of the US business unit is a cornerstone of Nordic Pharma's global expansion. With a range of ophthalmology products currently in phase II development, combining this with our existing assets and leveraging the expertise of our US leadership in ophthalmics is imperative for driving the success of these programs.” “I'm excited to be leading Nordic Pharma U.S. at this dynamic stage of the company as we continue focusing on providing quality generics to our customers and their patients in the U.S. while building out an innovative proprietary ophthalmic business,” said Philip Gioia, President of Nordic Pharma U.S. “The timing could not be better as new ophthalmic innovations are becoming near-term ready for commercialization and I believe Nordic Pharma can capitalize and compete effectively as a newer specialty ophthalmic player in the U.S. and globally.” About Nordic Group B.V. Nordic Group, B.V. is a privately owned, medium-size international pharmaceutical company which focuses on the development and commercialization of specialty products. Portfolio enhancement has been accomplished through targeted developments and focused acquisitions to build a foundation in Eye Care, Rheumatology and Women’s Health. Nordic Pharma has established deep roots throughout Europe, and more recently, expanded outside of Europe with increased acquisitions worldwide. Nordic Pharma is a part of SEVER Life Sciences, B.V., a holding company created in 2019 that brings together three diverse but complementary companies that offer a wide range of products, pharmaceutical development services and delivery technologies. About Nordic Pharma, Inc. Nordic Pharma, Inc., subsidiary of Nordic Group B.V., is partnered with well-established global biopharmaceutical companies and is uniquely positioned to leverage its expertise in bringing biotechnology derived medicines, sterile manufacturing and other state-of-the-art technologies to the marketplace. Safe Harbor This press release contains forward-looking statements, including, without limitation, statements related to Amring/Nordic Pharma’s business developments and the implementation of Amring/Nordic Pharma’s strategic initiatives. Because these statements reflect Amring/Nordic Pharma’s current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties that could cause actual developments and results to differ materially from Amring/Nordic Pharma’s expectations. These factors include, but are not limited to, general market conditions, regulatory trends, changes in the financial conditions of third parties dealing with Amring/Nordic Pharma, and other factors that could affect Amring/Nordic Pharma’s business and financial performance. Amring/Nordic Pharma does not assume any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.