Funding Crunch and Trial Risks Loom as Cambium Bio Prepares Phase 3
Cambium Bio reported a $3.84 million loss for FY25 but secured critical FDA approvals and ethics clearances to initiate Phase 3 trials of Elate Ocular®, supported by a $2.12 million capital raise.
- FY25 net loss of $3.84 million amid increased royalty revenue
- FDA Fast Track designation and Phase 3 protocol approvals secured
- Ethics approvals obtained in Australia and US for trial commencement
- Fully subscribed $2.12 million placement completed post year-end
- Board strengthened with new clinical and commercial expertise
Financial Performance and Funding
Cambium Bio Limited (ASX, CMB) closed the financial year ended 30 June 2025 with a net loss of $3.84 million, widening from a $2.26 million loss in FY24. This loss reflects the company’s strategic investment in advancing its lead product candidate, Elate Ocular®, towards late-stage clinical development. Revenue increased significantly to $670,000, primarily driven by royalty income from its partnership with Zheng Yang Biomedical Technology, marking a 419% rise over the prior year.
Despite limited cash reserves of $166,000 at year-end, Cambium Bio bolstered its balance sheet post period with a fully subscribed $2.12 million placement at a 60% premium to the prior share price. This capital injection, led by Da Jyun Capital Investment Corporation, aims to fund the initiation of Phase 3 trials and provide working capital, complemented by an anticipated $450,000 R&D tax incentive refund.
Regulatory and Clinical Milestones
The company achieved several critical regulatory milestones during FY25. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to Elate Ocular® in December 2024, facilitating accelerated review pathways. Subsequently, the FDA approved the Phase 3 clinical trial protocol in February 2025, endorsing the multi-regional trial design and endpoints targeting dry eye disease (DED).
Further regulatory progress included FDA concurrence on the product’s potency-assay strategy in March 2025, resolving key manufacturing and quality control issues ahead of trial commencement. Ethics approvals were secured in both Australia and the United States by mid-2025, clearing the way for patient enrolment. Post balance date, the FDA confirmed all Chemistry, Manufacturing and Controls (CMC) comparability requirements were met, formally authorizing the start of patient dosing anticipated in Q4 2025.
Leadership and Strategic Direction
Cambium Bio strengthened its governance and clinical expertise by appointing four new non-executive directors during FY25, including ophthalmology and clinical trial specialist A/Prof Chandra Bala, healthcare commercialisation expert Dr Chi-Tai Chang, experienced corporate leader Mr Li-Chien Chiu, and blood product research leader A/Prof Denese C Marks. These appointments align with the company’s transition into a pivotal clinical-stage biotech focused on delivering registration-enabling data for Elate Ocular®.
The Board reaffirmed Dr Edmund K. Waller as Chairman, leveraging his extensive scientific and clinical trial leadership to guide the company through Phase 3 execution. CEO Karolis Rosickas highlighted the company’s disciplined approach to funding and operational readiness, emphasizing the focus on rapid site activation and contract research organisation (CRO) engagement once financing is secured.
Outlook and Risks
Looking ahead, Cambium Bio aims to commence dosing in its CAMOMILE-2 and CAMOMILE-3 Phase 3 studies in late 2025, with top-line data expected in late 2026. The company plans to pursue strategic partnering or licensing opportunities to maximise the commercial potential of Elate Ocular® post-trial initiation.
However, material risks remain, including regulatory uncertainties, funding dependencies, clinical trial execution challenges, manufacturing complexities, intellectual property protection, and market acceptance. The company’s limited cash position underscores the importance of successful capital raises and milestone achievements to sustain operations and progress development.
Bottom Line?
Cambium Bio’s FY25 results underscore a critical juncture as it prepares to launch pivotal Phase 3 trials, with funding and regulatory momentum setting the stage for value creation amid inherent biotech risks.
Questions in the middle?
- Will Cambium Bio secure additional funding beyond the recent placement to sustain Phase 3 through to data readout?
- How will patient recruitment and trial execution progress across the multi-regional sites in Australia and the US?
- What strategic partnerships or licensing deals might emerge to support commercialisation post-Phase 3?
