Oculis Reports Q3 2024 Financial Results and Provides Company Updates
Oculis Holding AG (Nasdaq: OCS) reported Q3 2024 financial results with cash position of $125.0 million, providing runway into 2H 2026. The company achieved significant enrollment progress in its DIAMOND Phase 3 trials, with ~70% enrolled in DIAMOND-1 and ~40% in DIAMOND-2. Research and development expenses increased to $15.0 million, up from $10.0 million in Q3 2023. The company reported a Q3 net loss of $23.3 million. Key upcoming milestones include OCS-05 Phase 2 ACUITY trial topline results expected in December 2024 and planned NDA submission readiness for OCS-01 in Q1 2025.
Oculis Holding AG (Nasdaq: OCS) ha riportato i risultati finanziari per il terzo trimestre del 2024, con una posizione di liquidità di 125,0 milioni di dollari, garantendo margine fino alla seconda metà del 2026. L'azienda ha registrato progressi significativi nell'iscrizione ai trial di Fase 3 DIAMOND, con circa il 70% degli iscritti in DIAMOND-1 e circa il 40% in DIAMOND-2. Le spese per ricerca e sviluppo sono aumentate a 15,0 milioni di dollari, rispetto ai 10,0 milioni del terzo trimestre del 2023. L'azienda ha riportato una perdita netta di 23,3 milioni di dollari per il terzo trimestre. I principali traguardi futuri includono i risultati preliminari del trial ACUITY fase 2 di OCS-05, attesi per dicembre 2024, e la preparazione per la presentazione della NDA per OCS-01 nel primo trimestre del 2025.
Oculis Holding AG (Nasdaq: OCS) informó los resultados financieros del tercer trimestre de 2024, con una posición de efectivo de 125,0 millones de dólares, lo que proporciona un margen hasta la segunda mitad de 2026. La compañía logró un progreso significativo en la inscripción de sus ensayos de Fase 3 DIAMOND, con aproximadamente el 70% de inscritos en DIAMOND-1 y alrededor del 40% en DIAMOND-2. Los gastos de investigación y desarrollo aumentaron a 15,0 millones de dólares, frente a los 10,0 millones en el tercer trimestre de 2023. La compañía reportó una pérdida neta de 23,3 millones de dólares en el tercer trimestre. Los hitos clave próximos incluyen los resultados preliminares del ensayo ACUITY fase 2 de OCS-05, que se esperan en diciembre de 2024, y la preparación para la presentación de la NDA de OCS-01 en el primer trimestre de 2025.
Oculis Holding AG (Nasdaq: OCS)는 2024년 3분기 재무 결과를 보고하며, 현금 보유액이 1억 2500만 달러로 2026년 하반기까지 운영할 수 있는 여력을 제공합니다. 이 회사는 DIAMOND 3상 시험의 등록에서 상당한 진행을 이루었으며, DIAMOND-1에 약 70%, DIAMOND-2에 약 40%가 등록되었습니다. 연구 및 개발 비용은 1500만 달러로 증가했으며, 이는 2023년 3분기의 1000만 달러에서 증가한 수치입니다. 이 회사는 3분기에 2330만 달러의 순손실을 기록했습니다. 주요 향후 이정표로는 2024년 12월에 예정된 OCS-05 2상 ACUITY 시험의 topline 결과와 2025년 1분기에 OCS-01의 NDA 제출 준비가 포함됩니다.
Oculis Holding AG (Nasdaq: OCS) a annoncé ses résultats financiers pour le troisième trimestre 2024, avec une position de trésorerie de 125,0 millions de dollars, offrant ainsi une marge jusqu'au second semestre 2026. L'entreprise a réalisé des progrès significatifs dans l'inscription à ses essais de Phase 3 DIAMOND, avec environ 70 % des participants dans DIAMOND-1 et environ 40 % dans DIAMOND-2. Les dépenses de recherche et développement ont augmenté à 15,0 millions de dollars, contre 10,0 millions de dollars au troisième trimestre 2023. L'entreprise a enregistré une perte nette de 23,3 millions de dollars pour le troisième trimestre. Les principales étapes à venir incluent les résultats préliminaires de l'essai ACUITY de phase 2 pour OCS-05, attendus en décembre 2024, et la préparation de la soumission NDA pour OCS-01 au premier trimestre 2025.
Oculis Holding AG (Nasdaq: OCS) hat die Finanzierungsergebnisse des dritten Quartals 2024 veröffentlicht, mit einer Liquidität von 125,0 Millionen Dollar, die bis zur zweiten Hälfte von 2026 reicht. Das Unternehmen erzielte bedeutende Fortschritte bei der Einschreibung seiner DIAMOND Phase 3 Studien, mit etwa 70% der Teilnehmer in DIAMOND-1 und etwa 40% in DIAMOND-2. Die Forschung- und Entwicklungsausgaben stiegen auf 15,0 Millionen Dollar, gegenüber 10,0 Millionen Dollar im dritten Quartal 2023. Das Unternehmen meldete einen Nettoverlust von 23,3 Millionen Dollar im dritten Quartal. Zu den bevorstehenden wichtigen Meilensteinen zählen die vorläufigen Ergebnisse der OCS-05 Phase 2 ACUITY-Studie, die im Dezember 2024 erwartet werden, sowie die geplante NDA-Einreichung für OCS-01 im ersten Quartal 2025.
- Strong cash position of $125.0 million providing runway into 2H 2026
- Significant enrollment progress in DIAMOND Phase 3 trials (70% in DIAMOND-1, 40% in DIAMOND-2)
- On track for NDA submission readiness in Q1 2025 for OCS-01
- Increased Q3 net loss to $23.3 million from $19.7 million year-over-year
- R&D expenses increased 50% to $15.0 million compared to Q3 2023
- General and administrative expenses rose to $6.2 million from $4.9 million year-over-year
Insights
The Q3 results highlight both strengths and challenges. The
Key pipeline developments include 70% enrollment in DIAMOND-1 and 40% in DIAMOND-2 trials. The upcoming OCS-05 Phase 2 ACUITY trial readout in December 2024 and planned NDA submission for OCS-01 in Q1 2025 represent significant near-term catalysts. The cash runway provides adequate buffer for these development programs.
The increased spending reflects investment in late-stage pipeline advancement, which is typical for a biotech company approaching potential commercialization. The balance sheet remains solid with minimal debt and strong liquidity.
The pipeline progress shows promising momentum across multiple programs. The DIAMOND trials for OCS-01 in DME are advancing well with robust enrollment rates. The upcoming ACUITY trial readout for OCS-05 in acute optic neuritis is particularly significant as it targets an underserved indication affecting up to 8 in 100,000 people, primarily young adults aged 20-40.
OCS-05's novel mechanism as a SGK-2 activator with neuroprotective properties, supported by positive preclinical data and clean Phase 1 safety profile, presents an innovative approach. The potential first-in-class status for OCS-02 in dry eye disease, with its precision medicine approach targeting specific TNFR1 genotypes, demonstrates strategic positioning in the ophthalmology space.
- Significant advancement on product portfolio, including enrollment in the OCS-01 DIAMOND Phase 3 program in DME and OCS-05 Phase 2 ACUITY trial in acute optic neuritis (AON) with topline readout anticipated in December 2024
- Leadership team bolstered with extensive experience in key areas as the Company advances its late-stage pipeline and prepares for commercial phase
- Cash, cash equivalents and short-term investments of
$125.0 million as of September 30, 2024, provides cash runway into 2H 2026
ZUG, Switzerland, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS; XICE: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced results for the quarter ended September 30, 2024, and provided an overview of the Company’s progress.
Riad Sherif M.D., Chief Executive Officer of Oculis: “During the quarter, we achieved excellent momentum in product pipeline development. We continue to accelerate recruitment for both Phase 3 trials in our core DIAMOND program with OCS-01 in DME and expanded this program’s committees with several world-renowned retina experts. Looking ahead, we are excited for the upcoming topline readout from the OCS-05 Phase 2 ACUITY trial in AON, anticipated in December 2024. The results will provide us with meaningful insights about the safety and tolerability of OCS-05, and its potential as a neuroprotective candidate in acute optic neuritis and other neuro-ophthalmic diseases. With a strengthened leadership team including recent appointments of Sharon Klier, M.D. as Chief Development Officer and Daniel S. Char as Chief Legal Officer, and a solid balance sheet, Oculis is well positioned to drive execution in pipeline development and create value for key stakeholders.”
Q3 2024 and Recent Highlights
Clinical Highlights:
- Substantial enrollment progress was achieved since the end of Q2 2024 through early October, with ~
70% of patients enrolled in the Phase 3 DIAMOND-1 trial, and ~40% of patients enrolled in the Phase 3 DIAMOND-2 trial. - Expanded DIAMOND program committees with leading retina experts announced for the Phase 3 program of OCS-01 in DME.
Presentations and Awards Highlights:
- David Eichenbaum, M.D., presented an update on the DIAMOND Phase 3 program with OCS-01, an OPTIREACH® formulation of high concentration dexamethasone eye drop, for DME at Innovate Retina, an event that focuses exclusively on game-changing innovations in medical and surgical retina care. His presentation highlighted the potential of OCS-01 to become the first non-invasive therapy for DME to address unmet medical needs for early treatment intervention and for patients inadequately controlled with current therapies.
- At the 2024 EURETINA congress, the inaugural Ramin Tadayoni Award, supported by Oculis, was awarded to Andrea Govetto, M.D., Ph.D. who is developing a computational model of fluid flow and retinal tissue deformation in macular edema. The Ramin Tadayoni Award, awarded by EURETINA, was established in partnership with EURETINA in memory of Oculis’ Chief Scientific Officer, EURETINA past President, and a world-renowned retina specialist in order to pay a lasting tribute to the legacy of Professor Tadayoni, who passed away unexpectedly earlier this year.
Company Updates and Upcoming Milestones
- OCS-01: Following a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) in August 2024 for post-operative pain and inflammation, the Company plans to be NDA submission ready in Q1 2025.
- OCS-02: The Company is planning to consult with the FDA in Q1 2025 to discuss the positive topline results from the Phase 2b RELIEF trial and next steps for OCS-02 (licaminlimab) development. If approved, OCS-02 (licaminlimab) has the potential to be the first precision medicine for DED given the predictive and more pronounced effects observed in a specific TNFR1 genotype population.
- OCS-05: Topline readout for the Phase 2 ACUITY trial in AON is on track for December 2024.
- OCS-05 is a peptidomimetic serum glucocorticoid kinase-2 (SGK-2) activator, a novel mechanism of action, with the potential to be a neuroprotective therapy for neuro-ophthalmic diseases.
- OCS-05 is being evaluated for the treatment of AON in the ACUITY Phase 2 trial, a randomized, double-blind, placebo-controlled, multi-center trial in France, designed to evaluate the safety and tolerability of OCS-05. Enrollment is complete with 36 patients randomized. The primary endpoint is safety, and additional exploratory measurements will be evaluated to explore the potential neuroprotective benefits of OCS-05 in AON patients.
- AON is a rare disease of an acute inflammation of the optic nerve that can lead to permanent visual impairment. AON mainly occurs in 20- to 40-year-old adults and affects up to 8 in 100,000 people worldwide1. While corticosteroids are used to treat the inflammation, there remains a critical unmet medical need for therapies that preserve vision or provide neuroprotection after an acute episode of optic neuritis.
- In animal models of neuroinflammation and neurodegeneration, OCS-05 has shown evidence of neuroprotective activity, including the prevention of retinal ganglion cell damage in glaucoma and AON models, and promotion of axonal sparing and reduction of demyelination in AON model.
- There were no drug-related side effects with OCS-05 reported from the Phase 1 randomized, double-blind, placebo-controlled, single and multiple ascending dose trial that was completed in 48 healthy adult volunteers (36 on OCS-05, 12 on placebo) in the U.K.
Q3 2024 Financial Highlights
- Cash position: As of September 30, 2024, the Company had total cash, cash equivalents and short-term investments of CHF 105.5 million or
$125.0 million , compared to CHF 91.7 million or$109.0 million as of December 31, 2023. The increase in cash position from December 31, 2023 reflects proceeds from the registered direct offering in the second quarter of 2024. Based on its current development plans, the Company’s cash balances are expected to fund operations into the second half of 2026. - Research and development expenses were CHF 13.0 million or
$15.0 million for the three-months ended September 30, 2024, compared to CHF 8.9 million or$10.0 million in the same period in 2023. The increase was primarily due to higher clinical trial expenses in the ongoing OCS-01 DIAMOND Stage 2 trials and OCS-05 ACUITY trial. - General and administrative expenses were CHF 5.3 million or
$6.2 million for the three-months ended September 30, 2024, compared to CHF 4.3 million or$4.9 million in the same period in 2023. The increase was primarily due to stock-based compensation expenses. - Q3 Quarter-to-date Net loss was CHF 20.2 million or
$23.3 million for the third quarter ended September 30, 2024, compared to CHF 17.4 million or$19.7 million for the same period in 2023. The increase was primarily driven by increases in OCS-01 clinical development related expenses. - Q3 Year-to-date net loss was CHF 57.1 million or
$64.8 million for the nine months ended September 30, 2024, compared to CHF 76.3 million or$84.5 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 increases in clinical development costs and expenses incurred to operate as a public company. - Q3 Year-to-date Non-IFRS net loss was CHF 57.1 million or
$64.8 million , or CHF 1.44 or$1.63 per share, for the nine months ended September 30, 2024, compared to CHF 36.5 million or$40.4 million , or CHF 1.32 or$1.46 per share, for the same period in 2023. The increase in non-IFRS net loss was primarily driven by advances of clinical development programs.
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 non-cash expense CHF 34.9 million or
$38.2 million in total operating expenses in the nine months ended September 30, 2023. - 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 was ultimately completed in April 2024. As a result, the cumulative translation adjustments related to Merger Sub 2 previously reported in equity and recognized in other comprehensive loss, were reclassified from equity to the Condensed Consolidated Interim Statement of Loss for the three and nine months ended September 30, 2023. The resulting non-cash foreign exchange impact of such reclassification amounted to CHF 5.0 million or
$5.7 million for the three and nine months ended September 30, 2023.
| Condensed Consolidated Statements of Financial Position (Unaudited) | ||||||
| (Amounts in CHF thousands) | As of September 30, | As of December 31, | ||||
| 2024 | 2023 | |||||
| ASSETS | ||||||
| Non-current assets | ||||||
| Property and equipment, net | 366 | 288 | ||||
| Intangible assets | 12,206 | 12,206 | ||||
| Right-of-use assets | 1,386 | 755 | ||||
| Other non-current assets | 159 | 89 | ||||
| Total non-current assets | 14,117 | 13,338 | ||||
| Current assets | ||||||
| Other current assets | 4,450 | 8,488 | ||||
| Accrued income | 1,568 | 876 | ||||
| Short-term financial assets | 69,841 | 53,324 | ||||
| Cash and cash equivalents | 35,632 | 38,327 | ||||
| Total current assets | 111,491 | 101,015 | ||||
| TOTAL ASSETS | 125,608 | 114,353 | ||||
| EQUITY AND LIABILITIES | ||||||
| Shareholders' equity | ||||||
| Share capital | 429 | 366 | ||||
| Share premium | 340,645 | 288,162 | ||||
| Reserve for share-based payment | 13,319 | 6,379 | ||||
| Actuarial loss on post-employment benefit obligations | (1,919 | ) | (1,072 | ) | ||
| Treasury shares | (10 | ) | - | |||
| Cumulative translation adjustments | (334 | ) | (327 | ) | ||
| Accumulated losses | (256,902 | ) | (199,780 | ) | ||
| Total equity | 95,228 | 93,728 | ||||
| Non-current liabilities | ||||||
| Long-term lease liabilities | 929 | 431 | ||||
| Long-term payables | - | 378 | ||||
| Defined benefit pension liabilities | 1,734 | 728 | ||||
| Total non-current liabilities | 2,663 | 1,537 | ||||
| Current liabilities | ||||||
| Trade payables | 4,892 | 7,596 | ||||
| Accrued expenses and other payables | 14,704 | 5,948 | ||||
| Short-term lease liabilities | 314 | 174 | ||||
| Warrant liabilities | 7,807 | 5,370 | ||||
| Total current liabilities | 27,717 | 19,088 | ||||
| Total liabilities | 30,380 | 20,625 | ||||
| TOTAL EQUITY AND LIABILITIES | 125,608 | 114,353 | ||||
| Condensed Consolidated Statements of Loss (Unaudited) | ||||||||||
| (Amounts in CHF thousands, except per share data) | For the three months ended September 30, | For the nine months ended September 30, | ||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||
| Grant income | 216 | 219 | 683 | 698 | ||||||
| Operating income | 216 | 219 | 683 | 698 | ||||||
| Research and development expenses | (12,999) | (8,872) | (40,320) | (21,218) | ||||||
| General and administrative expenses | (5,348) | (4,306) | (16,307) | (13,147) | ||||||
| Merger and listing expense | - | - | - | (34,863) | ||||||
| Operating expenses | (18,347) | (13,178) | (56,627) | (69,228) | ||||||
| Operating loss | (18,131) | (12,959) | (55,944) | (68,530) | ||||||
| Finance income | 556 | 520 | 1,797 | 773 | ||||||
| Finance expense | (264) | (11) | (392) | (1,303) | ||||||
| Fair value adjustment on warrant liabilities | (445) | (2,434) | (2,144) | (4,638) | ||||||
| Foreign currency exchange gain (loss), net | (1,888) | (2,645) | (361) | (2,485) | ||||||
| Finance result, net | (2,041) | (4,570) | (1,100) | (7,653) | ||||||
| Loss before tax for the period | (20,172) | (17,529) | (57,044) | (76,183) | ||||||
| Income tax expense | (18) | 116 | (78) | (120) | ||||||
| Loss for the period | (20,190) | (17,413) | (57,122) | (76,303) | ||||||
| Loss per share: | ||||||||||
| Basic and diluted loss attributable to equity holders | (0.48) | (0.48) | (1.44) | (2.76) | ||||||
| Reconciliation of Non-IFRS Measures (Unaudited) | |||||||||||
| (Amounts in CHF thousands, except per share data) | |||||||||||
| For the three months ended September 30, | For the nine months ended September 30, | ||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||
| IFRS loss for the period | (20,190 | ) | (17,413 | ) | (57,122 | ) | (76,303 | ) | |||
| Non-IFRS adjustments: | |||||||||||
| Merger and listing expense (i) | - | - | - | 34,863 | |||||||
| Merger Sub 2 reclassification from equity to foreign exchange loss (ii) | 4,978 | 4,978 | |||||||||
| Non-IFRS loss for the period | (20,190 | ) | (12,435 | ) | (57,122 | ) | (36,462 | ) | |||
| IFRS basic and diluted loss attributable to equity holders | (0.48 | ) | (0.48 | ) | (1.44 | ) | (2.76 | ) | |||
| Non-IFRS basic and diluted loss attributable to equity holders | (0.48 | ) | (0.34 | ) | (1.44 | ) | (1.32 | ) | |||
| IFRS weighted-average number of shares used to compute loss per share basic and diluted | 41,807,918 | 36,330,836 | 39,659,305 | 27,673,950 | |||||||
| (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; XICE: 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 (licaminlimab), a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED) and for non-infectious anterior uveitis; and OCS-05, a neuroprotective candidate for acute optic neuritis (AON). Headquartered in Switzerland and with operations in the U.S. and Iceland, Oculis’ goal is to improve the health and quality of life of patients worldwide. The company is led by an experienced management team with a successful track record and is supported by leading international healthcare investors.
For more information, please visit: www.oculis.com
Oculis Contacts
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 the Company’s product candidates, including patient impact and market opportunity; 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; the timing of clinical data readouts; 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 any other documents filed with the U.S. Securities and Exchange Commission (the “SEC”). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
1 Martínez-Lapiscina et al. J Neurol. 2014 Apr;261(4):759-67
FAQ
What was Oculis (OCS) cash position in Q3 2024?
What is the enrollment status of Oculis (OCS) DIAMOND Phase 3 trials?
When will Oculis (OCS) report topline results for the OCS-05 ACUITY trial?
