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

   -- 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 

ZUG, Switzerland, March 11, 2025 (GLOBE NEWSWIRE) -- 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 $(DME.AU)$. 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. 

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 
 
 (Amounts in CHF thousands)     As of December 31,  As of December 31, 
                                ------------------  ------------------ 
                                       2024                2023 
                                ------------------  ------------------ 
 ASSETS 
 
 Non-current assets 
 Property and equipment, net                   385                 288 
 Intangible assets                          13,292              12,206 
 Right-of-use assets                         1,303                 755 
 Other non-current assets                      476                  89 
 Total non-current assets                   15,456              13,338 
                                ------------------  ------------------ 
 
 Current assets 

 Other current assets                        5,605               8,488 
 Accrued income                                629                 876 
 Short-term financial assets                70,955              53,324 
 Cash and cash equivalents                  27,708              38,327 
 Total current assets                      104,897             101,015 
                                ------------------  ------------------ 
 
 TOTAL ASSETS                              120,353             114,353 
                                ==================  ================== 
 
 EQUITY AND LIABILITIES 
 
 Shareholders' equity 
 Share capital                                 446                 366 
 Share premium                             344,946             288,162 
 Reserve for share-based 
  payment                                   16,062               6,379 
 Actuarial loss on 
  post-employment benefit 
  obligations                              (2,233)             (1,072) 
 Treasury shares                              (10)                   - 
 Cumulative translation 
  adjustments                                (271)               (327) 
 Accumulated losses                      (285,557)           (199,780) 
 Total equity                               73,383              93,728 
                                ------------------  ------------------ 
 
 Non-current liabilities 
 Long-term lease liabilities                   865                 431 
 Long-term payables                              -                 378 
 Defined benefit pension 
  liabilities                                1,870                 728 
 Total non-current liabilities               2,735               1,537 
                                ------------------  ------------------ 
 
 Current liabilities 
 Trade payables                              5,871               7,596 
 Accrued expenses and other 
  payables                                  18,198               5,948 
 Short-term lease liabilities                  315                 174 
 Warrant liabilities                        19,851               5,370 
 Total current liabilities                  44,235              19,088 
                                ------------------  ------------------ 
 
 Total liabilities                          46,970              20,625 
                                ------------------  ------------------ 
 
 TOTAL EQUITY AND LIABILITIES              120,353             114,353 
                                ==================  ================== 
 
 
 
 
 
 
 
                  Consolidated Statements of Loss 
 
(Amounts in CHF 
thousands, 
except per share   For the three months ended   For the years ended 
data)                     December 31,              December 31, 
                   --------------------------  --------------------- 
                       2024          2023         2024       2023 
                   ------------  ------------  ----------  --------- 
Grant income                  3           185         686        883 
Operating income              3           185         686        883 
                   ------------  ------------  ----------  --------- 
Research and 
 development 
 expenses              (11,763)       (8,029)    (52,083)   (29,247) 
General and 
 administrative 
 expenses               (5,500)       (4,340)    (21,807)   (17,487) 
Merger and 
 listing expense              -             -           -   (34,863) 
Operating 
 expenses              (17,263)      (12,369)    (73,890)   (81,597) 
                   ------------  ------------  ----------  --------- 
 
Operating loss         (17,260)      (12,184)    (73,204)   (80,714) 
                   ------------  ------------  ----------  --------- 
 
Finance income              371           656       2,168      1,429 
Finance expense           (247)          (12)       (639)    (1,315) 
Fair value 
 adjustment on 
 warrant 
 liabilities           (13,387)         1,207    (15,531)    (3,431) 
Foreign currency 
 exchange loss, 
 net                      1,630       (2,179)       1,269    (4,664) 
Finance result, 
 net                   (11,633)         (328)    (12,733)    (7,981) 
                   ------------  ------------  ----------  --------- 
 
Loss before tax 
 for the period        (28,893)      (12,512)    (85,937)   (88,695) 
                   ------------  ------------  ----------  --------- 
 
Income tax 
 expense                    238            13         160      (107) 
 
Loss for the 
 period                (28,655)      (12,499)    (85,777)   (88,802) 
                   ============  ============  ==========  ========= 
 
Loss per share: 
Basic and diluted 
 loss 
 attributable to 
 equity holders          (0.67)        (0.34)      (2.12)     (2.97) 
 
 
 
Reconciliation of Non-IFRS 
Measures (Unaudited) 
 
(Amounts in CHF thousands, 
except per share data) 
                                For the years ended December 31, 
                              ------------------------------------ 
                                    2024              2023 
                              ----------------  ---------------- 
IFRS loss for the period              (85,777)          (88,802) 
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          (85,777)          (48,961) 
----------------------------  ----------------  ---------------- 
 
IFRS basic and diluted loss 
 attributable to equity 
 holders                                (2.12)            (2.97) 
Non-IFRS basic and diluted 
 loss attributable to equity 
 holders                                (2.12)            (1.64) 
----------------------------  ----------------  ---------------- 
 
IFRS weighted-average number 
 of shares used to compute 
 loss per share basic and 
 diluted                            40,406,551        29,899,651 
----------------------------  ----------------  ---------------- 
 
(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 dissolution of Merger Sub 2. 
 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 / 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-TNF<ALPHA> 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, CFO

sylvia.cheung@oculis.com

Investor & Media Relations

LifeSci Advisors

Corey 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.

(END) Dow Jones Newswires

March 11, 2025 16:30 ET (20:30 GMT)