A Randomised, Double-blind, Placebo-controlled, Single (SAD) and Multiple Ascending Dose (MAD) Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BN201 in Healthy Subjects

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of BN201 in healthy subjects.
This is a phase I, randomised, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of BN201 in healthy subjects following single ascending doses and two cohorts of multiple doses. The study will be conducted in two parts (Part A and Part B). Part A (up to 8 single ascending doses (SD)) will be conducted in 32 subjects (4 interlocking cohorts of 8 subjects). Part B (up to 2 multiple ascending doses (MD)) will be conducted in 16 subjects (2 cohorts of 8 subjects). Subjects in Part A will undergo a screening period (Day -28 to Day -2), two in-patient treatment periods compromising 3 overnight stays (from Day -1 to Day 3) with a wash out period of at least 14 days between dose administrations and a follow up visit 12 to 16 days following administration of IMP. Subjects in Part B will undergo a screening period (Day -28 to Day -2), an in-patient treatment period compromising 7 overnight stays (from Day -1 to Day 7) and a follow up visit 12 to 16 days following final administration of Investigational Medicinal Product (IMP).

Start Date27 May 2018

Sponsor / Collaborator

Accure Therapeutics SL

[+1]

NCT02126670

/ CompletedPhase 2

ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis

The purpose of this study is to determine whether or not ACT01 is effective and tolerable alone or when used in combination with Comp01, Comp02, Comp03 or Comp04 in patients with facial and/or scalp keratosis.

Start Date01 Apr 2014

Sponsor / Collaborator

Promius Pharma LLC

100 Clinical Results associated with Privosegtor

100 Translational Medicine associated with Privosegtor

100 Patents (Medical) associated with Privosegtor

Literatures (Medical) associated with Privosegtor

15 Jul 2024·INORGANIC CHEMISTRY

Computational Insights into the Intramolecular Aromatic C–C Coupling Catalyzed by the Cytochrome P450 Enzyme CYP121 from Mycobacterium tuberculosis

Article

Author: Zhang, Xue ; Zhao, Qian ; Liu, Yongjun

CYP121 is a P450 enzyme that catalyzes the intramolecular C-C coupling of its native substrate, dicyclotyrosine (cYY). According to previous suggestions, when the cosubstrate peracetic acid was used to generate Cpd I, the substrate cYY was suggested to participate in the cleavage of the O-O bond; however, whether cYY is involved in the formation of Cpd I and how two distant aromatic carbon atoms are activated are still unclear. Here, we constructed computational models and performed QM/MM calculations to clarify the reaction mechanism. On the basis of our calculation results, cYY is not involved in the formation of Cpd I, and the C-C coupling reaction starts from hydrogen abstraction. In the second stage, the substrate should first undergo a complex conformational change, leading to two phenolic hydroxyls of cYY close to each other. In the subsequent reaction, the resultant Cpd II again abstracts a hydrogen atom from the proximal tyrosine to generate the diradical intermediate. In addition, the C-C coupling occurs in the active site, but the final aromatization may be a nonenzymatic reaction. In general, the intramolecular C-C coupling requires two basic conditions, including the active site having good flexibility and the substrate itself having a suitable and rotatable skeleton.

01 Jun 2024·Food chemistry: X

Impact of steam cooking on the chemical profile of table-stock sweetpotatoes with different carotenoids content

Article

Author: Tang, Chaochen ; Li, Yanting ; Qiao, Yake ; Zhang, Rong ; Jiang, Xia ; Yao, Yanqiang ; Wang, Zhangying

Sweetpotatoes are a great source of carotenoids, which are important for human health and have attracted increasing attention. This study examined the impact of the steaming method on the contents of carotenoids, starch, soluble sugar, volatile organic compounds, and pasting properties of nine table-stock sweetpotatoes with different carotenoids content (from 3.21 to 233.46 μg/g). After steaming, carotenoids content was significantly decreased, among which G79 and P32 had the highest levels of 88.20 μg/g and 94.27 μg/g, respectively. The starch content of G42 decreased the most (20 %) with the highest peak viscosity (1764.33 cP), while the amylose content of P32 increased the most (12.59 %) with the lowest peak viscosity (441.33 cP). The contents of total starch and amylose were significantly correlated with sensory evaluation. G79 presented the best sensory evaluation and a sweet, delicious, and soft texture. A total of 57 volatile organic compounds were detected, among which benzene, a few aldehydes, and terpenoids contributed to the aroma of steamed sweetpotatoes. These results provide a theoretical foundation for future sweetpotato processing.

29 Mar 2023·Scientific reports

A Phase 1 randomized study on the safety and pharmacokinetics of OCS-05, a neuroprotective disease modifying treatment for Acute Optic Neuritis and Multiple Sclerosis.

Article

Author: Villoslada, Pablo ; Masso, Mar ; Koch, Annelize ; Paris, Stephane ; Hutchings, Simon

OCS-05 (aka BN201) is a peptidomimetic that binds to serum glucocorticoid kinase-2 (SGK2), displaying neuroprotective activity. The objective of this randomized, double-blind 2-part study was to test safety and pharmacokinetics of OCS-05 administered by intravenous (i.v.) infusion in healthy volunteers. Subjects (n = 48) were assigned to receive placebo (n = 12) or OCS-05 (n = 36). , Doses tested were 0.05, 0.2, 0.4, 0.8, 1.6, 2.4 and 3.2 mg/kg in the single ascending dose (SAD) part. In the multiple ascending dose (MAD) part, 2.4 and 3.0 mg/kg doses were administered with 2 h i.v. infusion for 5 consecutive days. Safety assessments included adverse events, blood tests, ECG, Holter monitoring, brain MRI and EEG. No serious adverse events were reported in the OCS-05 group (there was one serious adverse event in the placebo group). Adverse events reported in the MAD part were not clinically significant, and no changes on the ECG, EEG or brain MRI were observed. Single-dose (0.05-3.2 mg/kg) exposure (C_max and AUC) increased in a dose-proportional manner. Steady state was reached by Day 4 and no accumulation was observed. Elimination half-life ranged from 3.35 to 8.23 h (SAD) and 8.63 to 12.2 h (MAD). Mean individual C_max concentrations in the MAD part were well below the safety thresholds. OCS-05 administered as 2-h i.v. infusions of multiple doses up to 3.0 mg/Kg daily for up to 5 consecutive days was safe and well tolerated. Based on this safety profile, OCS-05 is currently being tested in a phase 2 trial in patient with acute optic neuritis (NCT04762017, date registration 21/02/2021).

News (Medical) associated with Privosegtor

08 May 2025

·investors.oculis.com

Oculis Reports Q1 Financial Results and Provides Company Update

ZUG, Switzerland, May 08, 2025 (GLOBE NEWSWIRE) -- The recent R&D Day (replay) showcased material progress across all three core assets and highlighted potential first-in-class neuroprotection treatment in neuro-ophthalmology, an area of high unmet medical need, thanks to Privosegtor’s (OCS-05) positive results from the ACUITY trial in Acute Optic Neuritis OCS-01: DIAMOND Ph3 trials enrollment completed with over 800 patients randomized; topline results expected Q2 2026 for the first potential eye drop treatment for diabetic macular edema (DME) Licaminlimab (OCS-02) genotype-based development plan to drive a personalized medicine approach in dry eye disease (DED) aligned with FDA; first registrational trial initiation anticipated in 2H 2025 Cash, cash equivalents and short-term investments of $206.3 million as of March 31, 2025, reflects proceeds from the $100.0 million financing in February 2025, providing cash runway into early 2028 Oculis Holding AG (Nasdaq: OCS / ICX: OCS.IC) (“Oculis” or the “Company”), a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, today announced results for the first quarter ended March 31, 2025 and provided an overview of the Company’s progress. Riad Sherif M.D., Chief Executive Officer of Oculis: “We began 2025 with an exciting evolution of our portfolio, driven by strong execution and solid science. We’ve made significant advancements on all three of our highly differentiated assets: completing randomization of over 800 patients in both Phase 3 DIAMOND-1 and DIAMOND-2 trials with OCS-01; initiating the first-ever genotype-based development program in ophthalmology with Licaminlimab (OCS-02); and announcing promising neuroprotective data with Privosegtor in the ACUITY trial - a potentially transformative catalyst for our company. The ACUITY readout not only validates our approach in acute optic neuritis, but also allows us the ability to expand into neuro-ophthalmology and beyond, significantly increasing our potential addressable patient population by multiple folds. These advancements, combined with a strengthened financial position, have enabled us to expand our innovative pipeline. With several near-term value inflection points ahead, we are well-positioned to drive value creation, while bringing transformative treatments to those who need them most." R&D Day Key Highlights: Privosegtor (OCS-05) – A new era in neuroprotection for acute optic neuritis and beyond: Additional analyses from the successful Phase 2 ACUITY trial further supported the previously announced neuroprotective effects on retinal ganglion cells and axons, as well as vision improvement in patients with acute optic neuritis. These analyses also revealed that Privosegtor led to lower neurofilament release, a prominent biomarker of reduced neuro-axonal damage in neurological disorders, including MS. Oculis is planning to pursue a global registration program in acute optic neuritis, and evaluate Privosegtor in NAION and as a treatment of acute MS relapses. OCS-01 – A non-invasive eye drop for DME: The Company has completed enrollment in the Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in DME, with over 800 patients randomized; topline results are expected in Q2 2026. Licaminlimab (OCS-02) – An innovative TNF inhibitor specifically design for ocular inflammation : An FDA meeting in Q1 2025 confirmed the path forward for genotype-based development with Licaminlimab (OCS-02) to deliver a precision medicine treatment in DED with initiation of the first phase 2/3 activities to start in 2H 2025. Recent Clinical Highlights and Upcoming Milestones: OCS-01: Phase 3 DIAMOND trials investigating OCS-01 in DME completed enrollment with over 800 patients randomized. DIAMOND is the first ever Phase 3 program investigating a topical, non-invasive treatment for DME. DME is a progressive complication of diabetic retinopathy, estimated to affect around 37 million people worldwide currently representing a ~$5 billion market opportunity and the unmet needs for early intervention and patients with inadequate response to standard of care. The topline results from both DIAMOND Phase 3 trials are expected in Q2 2026 with the NDA submission to the FDA for OCS-01 for the treatment of DME planned for 2H 2026. Licaminlimab (OCS-02): Following three positive Phase 2 trials and a successful meeting with the FDA, a genotype-based development plan investigating Licaminlimab for the treatment of DED has been aligned with the Agency; a phase 2/3 is anticipated to initiate 2H 2025. Privosegtor (OCS-05): Results from Phase 2 ACUITY trial investigating Privosegtor, a novel, first-in-class peptidomimetic small molecule in development for the treatment of acute optic neuritis, showed significant neuroprotective anatomical benefits and functional vision improvement. Plan to meet with the FDA in Q3 2025 to discuss the development program for Privosegtor, including a registrational program for acute optic neuritis, expected to initiate in 1H 2026. Privosegtor’s demonstration of neuroprotection in the ACUITY trial supports its potential for broad applicability in multiple neuro-ophthalmology and neurology indications. Oculis intends to expand its Privosegtor development program into NAION, an orphan indication often leading to permanent vision loss, for which there are no approved therapies and as a treatment of acute MS relapses. Pre-IND discussions with the FDA are planned for 2H 2025, to support applications relying on existing Privosegtor data. Phase 3 DIAMOND trials investigating OCS-01 in DME completed enrollment with over 800 patients randomized. DIAMOND is the first ever Phase 3 program investigating a topical, non-invasive treatment for DME. DME is a progressive complication of diabetic retinopathy, estimated to affect around 37 million people worldwide currently representing a ~$5 billion market opportunity and the unmet needs for early intervention and patients with inadequate response to standard of care. The topline results from both DIAMOND Phase 3 trials are expected in Q2 2026 with the NDA submission to the FDA for OCS-01 for the treatment of DME planned for 2H 2026. Following three positive Phase 2 trials and a successful meeting with the FDA, a genotype-based development plan investigating Licaminlimab for the treatment of DED has been aligned with the Agency; a phase 2/3 is anticipated to initiate 2H 2025. Results from Phase 2 ACUITY trial investigating Privosegtor, a novel, first-in-class peptidomimetic small molecule in development for the treatment of acute optic neuritis, showed significant neuroprotective anatomical benefits and functional vision improvement. Plan to meet with the FDA in Q3 2025 to discuss the development program for Privosegtor, including a registrational program for acute optic neuritis, expected to initiate in 1H 2026. Privosegtor’s demonstration of neuroprotection in the ACUITY trial supports its potential for broad applicability in multiple neuro-ophthalmology and neurology indications. Oculis intends to expand its Privosegtor development program into NAION, an orphan indication often leading to permanent vision loss, for which there are no approved therapies and as a treatment of acute MS relapses. Pre-IND discussions with the FDA are planned for 2H 2025, to support applications relying on existing Privosegtor data. Q1 2025 Financial Highlights Cash position: As of March 31, 2025, the Company had total cash, cash equivalents and short-term investments of CHF 181.9 million or $206.3 million, compared to CHF 98.7 million or $109.0 million as of December 31, 2024. The increase in cash position from December 31, 2024 reflected proceeds from the $100.0 million (CHF 90.2 million) equity financing in February 2025. Based on its current development plans, the Company’s cash balances are expected to fund operations into early 2028. Research and development expenses: The Company’s research and development expenses were CHF 14.8 million or $16.4 million for the three months ended March 31, 2025, compared to CHF 10.9 million or $12.4 million in the same period in 2024. The increase was primarily due to development costs associated with the Company’s active clinical trials, in particular the two DIAMOND Phase 3 trials, as well as personnel-related costs. General and administrative expenses: The Company’s general and administrative expenses were CHF 5.5 million or $6.1 million for the three months ended March 31, 2025, compared to CHF 4.7 million or $5.4 million in the same period in 2024. The increase was primarily driven by personnel-related costs. Q1 Net loss: The Company’s net loss was CHF 33.2 million or $36.9 million, or CHF 0.69 or $0.77 per share, for the three months ended March 31, 2025, compared to CHF 16.1 million or $18.4 million, or CHF 0.44 or $0.50 per share, for the same period in 2024. The increase was primarily driven by advancements in clinical development programs, G&A expenses, as well as a CHF 8.8 million or $9.8 million increase in the non-cash fair value adjustment on warrant liabilities. Condensed Consolidated Statements of Financial Position (Unaudited) Condensed Consolidated Statements of Loss (Unaudited) -ENDS- About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS / XICE: OCS) focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs. Oculis’ highly differentiated pipeline of multiple innovative product candidates in clinical development includes: OCS-01, a topical eye drop candidate for diabetic macular edema (DME); Privosegtor (OCS-05), a neuroprotective candidate for acute optic neuritis with potentially broad clinical applications in other neuro-ophthalmic diseases; and Licaminlimab (OCS-02), a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis 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 ContactsMs. Sylvia Cheung, CFOsylvia.cheung@oculis.com Investor Relations LifeSci AdvisorsCorey Davis, Ph.D.cdavis@lifesciadvisors.com Media RelationsICR HealthcareAmber Fennell / David Daley / Sean Leousoculis@icrhealthcare.com Cautionary Statement Regarding Forward Looking Statements This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, the timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy, including planned interactions with the FDA; Oculis’ future development plans; the timing or likelihood of regulatory filings and approvals; and the Company’s expected financial position and cash runway 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 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.

Phase 3Phase 2Clinical ResultFinancial StatementNDA

11 Mar 2025

·investors.oculis.com

Oculis Reports Q4 and Full Year 2024 Financial Results and Provides Company Update

ZUG, Switzerland, March 11, 2025 (GLOBE NEWSWIRE) -- Successful 2024 marked by significant clinical advancements across Oculis’ late-stage and highly differentiated clinical pipeline targeting retina (OCS-01 in diabetic macular edema), neuro-ophthalmic (Privosegtor, OCS-05, in acute optic neuritis) and precision medicine (Licaminlimab, OCS-02, in dry eye disease) treatments Recent positive topline results in the ACUITY Phase 2 trial showed Privosegtor (OCS-05)’s neuroprotective benefits in anatomical preservation of the retina and visual function improvements in acute optic neuritis Oversubscribed $100 million equity financing completed to support the advancement of Oculis’ late-stage clinical portfolio Upcoming R&D Day planned on April 15, 2025, to showcase pipeline potential and company strategy Cash, cash equivalents and short-term investments of $109 million as of December 31, 2024, together with approximately $93 million net proceeds of recent financing provides cash runway into early 2028 Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis” or the “Company"), a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, today announced results for the quarter and full year ended December 31, 2024, and provided an overview of the Company’s progress. Riad Sherif M.D., Chief Executive Officer of Oculis: “We had a momentous year in 2024, and a strong start to 2025. We delivered two positive Phase 2 topline readouts from the ACUITY Privosegtor (OCS-05) trial in acute optic neuritis showing neuroprotective effects and the RELIEF trial of Licaminlimab (OCS-02) in dry eye disease (DED) with a precision medicine approach. In addition, we are on track to complete enrollment in the coming months for both Phase 3 DIAMOND trials of OCS-01 in diabetic macular edema (DME). The recent $100 million equity financing is another significant milestone for Oculis to propel its pipeline. As we continue to execute on our vision to be a leader in ophthalmic and neuro-ophthalmic fields and to bring innovative sight-saving treatments to market, 2025 will be a year in which we remain focused on execution to advance our late-stage clinical portfolio. We look forward to sharing updates on our portfolio strategy at our upcoming R&D Day.” Q4 2024 and Recent Highlights Clinical Highlights and Upcoming Milestones: OCS-01: On-track to complete enrollment in Phase 3 DIAMOND program in DME with top-line data readout expected in first half of 2026. NDA submission readiness for post-ocular surgery also on track in Q1 2025. Privosegtor (OCS-05): Positive topline results from the Phase 2 ACUITY trial in patients with acute optic neuritis where Privosegtor (OCS-05) achieved primary endpoint of safety and three secondary efficacy endpoints demonstrating improvement for Privosegtor (OCS-05) compared to placebo in objective structural measures of retinal thickness and functional vision improvement. FDA interactions are planned for the second half of 2025 to discuss the ACUITY trial results and align on the next steps, including a registrational development program for acute optic neuritis. Licaminlimab (OCS-02): Positive readout from the Phase 2b RELIEF trial in signs of DED and FDA interaction conducted in Q1 2025 confirmed development path forward with a precision medicine approach. On-track to complete enrollment in Phase 3 DIAMOND program in DME with top-line data readout expected in first half of 2026. NDA submission readiness for post-ocular surgery also on track in Q1 2025. Positive topline results from the Phase 2 ACUITY trial in patients with acute optic neuritis where Privosegtor (OCS-05) achieved primary endpoint of safety and three secondary efficacy endpoints demonstrating improvement for Privosegtor (OCS-05) compared to placebo in objective structural measures of retinal thickness and functional vision improvement. FDA interactions are planned for the second half of 2025 to discuss the ACUITY trial results and align on the next steps, including a registrational development program for acute optic neuritis. Positive readout from the Phase 2b RELIEF trial in signs of DED and FDA interaction conducted in Q1 2025 confirmed development path forward with a precision medicine approach. Further business and pipeline development updates to be provided during the R&D Day on April 15, 2025 in New York City. Q4 and Full Year 2024 Financial Highlights Cash position: As of December 31, 2024, the Company had total cash, cash equivalents and short-term investments of CHF 98.7 million or $109.0 million, compared to CHF 91.7 million or $108.9 million as of December 31, 2023. The increase in cash position from December 31, 2023 reflects the proceeds from the registered direct offering in the second quarter of 2024. Based on its cash, cash equivalents and short-term investments at December 31, 2024 and approximately $93 million in net proceeds received from the recent financing, and its development plans, the Company’s cash balances are expected to fund operations into early 2028. Research and development expenses were CHF 11.8 million or $13.4 million for the three-months ended December 31, 2024, compared to CHF 8.0 million or $9.0 million in the same period in 2023. Research and development expenses for the year ended December 31, 2024 were CHF 52.1 million or $59.1 million, compared to CHF 29.2 million or $32.6 million in the previous year. The increase was primarily due to clinical development expenses for the active clinical trials for OCS-01 in DME, Privosegtor (OCS-05) in acute optic neuritis and Licaminlimab (OCS-02) in DED. General and administrative expenses were CHF 5.5 million or $6.3 million for the three-months ended December 31, 2024, compared to CHF 4.3 million or $4.9 million in the same period in 2023. General and administrative expenses for the year ended December 31, 2024 were CHF 21.8 million or $24.8 million, compared to CHF 17.5 million or $19.5 million in the previous year. The increase was primarily due to share-based compensation expenses. Q4 net loss was CHF 28.7 million or $32.6 million for the fourth quarter ended December 31, 2024, compared to CHF 12.5 million or $14.1 million for the same period in 2023. The increase was primarily driven by changes in the fair value (non-cash) of outstanding warrants, increased clinical development costs and increased share-based compensation expenses. FY2024 net loss was CHF 85.8 million or $97.4 million for the year ended December 31, 2024, compared to CHF 88.8 million or $98.8 million for the same period in 2023. The decrease was primarily due to a non-recurring and non-cash merger and listing expense recorded in 2023 of CHF 34.9 million or $38.2 million, partially offset by changes in the fair value of outstanding warrants, increases in clinical development costs and expenses incurred to operate as a dual-listed public company. FY2024 non-IFRS net loss was CHF 85.8 million or $97.4 million, or CHF 2.12 or $2.41 per share, for the year ended December 31, 2024, compared to CHF 49.0 million or $54.5 million, or CHF 1.64 or $1.83 per share, for the same period in 2023. The increase in non-IFRS net loss was primarily driven by changes in the fair value of outstanding warrants and the advancement of clinical development programs during the year, including the Phase 3 DIAMOND-1 and DIAMOND-2 trials for DME, Phase 2 ACUITY trial for acute optic neuritis, and Phase 2 RELIEF trial for DED. Non-IFRS Financial Information This press release contains financial measures that do not comply with International Financial Reporting Standards (IFRS) including non-IFRS loss, and non-IFRS loss attributable to equity holders per common share. These non-IFRS financial measures exclude the impact of items that the Company’s management believes affect comparability or underlying business trends. These measures supplement the Company’s financial results prepared in accordance with IFRS. The Company’s management uses these measures to better analyze its financial results and better estimate its financial outlook. In management’s opinion, these non-IFRS measures are useful to investors and other users of the Company's financial statements by providing greater transparency into the ongoing operating performance of the Company and its future outlook. Such measures should not be deemed to be an alternative to IFRS requirements. The non-IFRS measures for the reported periods reflect adjustments made to exclude: Merger and listing expense, which was a one-time and non-cash expense of CHF 34.9 million or $38.2 million in the year-to-date 2023 total operating expenses. During the third quarter of 2023, the Company gave effect to the dissolution of its Merger Sub 2 entity pursuant to the Business Combination Agreement with EBAC. 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. Consolidated Statements of Financial Position Consolidated Statements of Loss Reconciliation of Non-IFRS Measures (Unaudited) -ENDS- About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS / XICE: OCS) purposefully driven to save sight and improve eye care. Oculis’ highly differentiated pipeline of multiple innovative product candidates in clinical development includes: OCS-01, a topical eye drop candidate for diabetic macular edema (DME); Privosegtor (OCS-05), a neuroprotective candidate for acute optic neuritis with potentially broad clinical applications in other neuro-ophthalmic diseases; and Licaminlimab (OCS-02), a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and is supported by leading international healthcare investors. For more information, please visit: www.oculis.com Oculis Contacts Ms. Sylvia Cheung, CFOsylvia.cheung@oculis.com Investor & Media Relations LifeSci AdvisorsCorey Davis, Ph.D.cdavis@lifesciadvisors.com Cautionary Statement Regarding Forward Looking Statements This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, the timing, progress and results of current and future clinical trials, including the Company’s Phase 3 DIAMOND program in DME, Oculis’ research and development programs, regulatory and business strategy, future development plans; the timing or likelihood of regulatory filings and approvals; and the Company’s expected cash runway 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 other documents filed with the U.S. Securities and Exchange Commission (the “SEC”). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. Attachments Oculis 2024 Consolidated IFRS Financial Statements Oculis 2024 MD&A Oculis Q4 2024 - Press Release Oculis ESEF reporting

Clinical ResultFinancial StatementPhase 2Phase 3

14 Feb 2025

·endpts.com

Otsuka makes pipeline changes; Oculis reveals $100M offering

Plus, news about Aardvark’s IPO: Otsuka cuts cancer programs: The drugmaker is stopping development of OPB-111077, an oral STAT inhibitor, for hematological cancers in the US. It also terminated several cancer drugs it was developing in Japan for cancers like myelodysplastic syndromes, diffuse large B cell lymphoma and urothelial cancer. — Max Gelman Oculis announces $100M offering: The cash is expected to help develop the company’s OCS-05 program, which is being developed for a rare eye disease called acute optic neuritis. OCS-05 passed a Phase 2 test in France last month, and the FDA has said Oculis can begin clinical trials in the US. — Max Gelman Aardvark Therapeutics CEO on its IPO: The metabolic biotech went public on Thursday, and CEO Tien Lee told Endpoints News that the company made the decision to do so in October. It had the money to support a Phase 3 trial in Prader-Willi syndrome, but it also needed additional capital to cushion the start of Phase 2 trials later this year in obesity-related conditions. The company has a “complementary and orthogonal” approach to GLP-1s with its hunger-suppressing assets rather than appetite-tampering ones. Lee believes ARD-201, which will be a fixed-dose combination with Merck’s diabetes drug Januvia, can lead to better quality weight loss, meaning less loss of muscle mass. Its share price $AARD is down about 9% since the Nasdaq debut. — Kyle LaHucik

IPOPhase 2

100 Deals associated with Privosegtor

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Multiple Sclerosis	Phase 2	France	Bionure Farma SL	11 Feb 2021
Optic Neuritis	Phase 2	France	Oculis SA	11 Feb 2021
Optic Neuritis	Phase 2	France	Bionure Farma SL	11 Feb 2021
Neuromyelitis Optica	Phase 1	United Kingdom	Accure Therapeutics SL	27 May 2018
Glaucoma	Preclinical	Switzerland	Oculis SA	10 Apr 2023
Neurotrophic keratitis	Preclinical	Switzerland	Oculis SA	10 Apr 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04762017 (ACUITY, GlobeNewswire) Manual	Phase 2	Optic Neuritis	36	OCS-05 2mg/kg/day + steroid	bskhsnujgp(kynzdqmzgz) = None cspsorolub (bvujqijfwf ) View more	Positive	06 Jan 2025
				OCS-05 3mg/kg/day + steroid
NCT03630497 (2017-001202-14, ECTRIMS2021)	Phase 1	Optic Neuritis \| Multiple Sclerosis	48	ACT-01	ecfqjbigdx(eqzqbnqiop) = dhqxdivljx jrztdnglwr (omdukyubdc )	-	12 Oct 2021
NCT02126670 (CTgov)	Phase 2	Actinic Keratosis	100	Comp01+ACT01 (ACT01 Plus Comp01)	vlgjjwwdqd = xcjzpsjgsb nxiapfjldu (mutoemeqsx, osyzctpmop - wqboxrzdyr) View more	-	22 Feb 2016
				Comp02+ACT01 (ACT01 Plus Comp02)	vlgjjwwdqd = nbwgqngxqs nxiapfjldu (mutoemeqsx, cytgwdwzer - ayctlbgovo) View more

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