Cambium Bio Secures $2.12M to Power Phase 3 Trials of Elate Ocular
Cambium Bio has cleared key regulatory hurdles for its lead dry eye disease treatment, Elate Ocular, and strengthened its balance sheet with a $2.12 million placement to support upcoming Phase 3 trials.
- Ethics approvals obtained in Australia and US for Phase 3 trials
- First patient dosing on track for Q4 2025, top-line data expected Q4 2026
- Net operating cash outflow of A$1.1 million focused on R&D
- Closing cash balance low at A$0.166 million, bolstered by recent $2.12M placement
- Exploring additional funding via out-licensing and royalty financing
Regulatory Milestones Pave Way for Phase 3
Cambium Bio Limited (ASX, CMB) has made significant strides in advancing its lead biologic, Elate Ocular®, towards late-stage clinical development. The company secured ethics approvals from both Australian and US committees, clearing a critical path for its registration-enabling Phase 3 trials targeting dry eye disease. These approvals complement prior FDA clearances, including protocol acceptance and potency assay concurrence, underscoring regulatory confidence in the program.
With site feasibility assessments underway and a clinical research organisation (CRO) contract expected imminently, Cambium Bio aims to enrol its first patient in the CAMOMILE-2 and CAMOMILE-3 trials by the end of 2025. Top-line data from these pivotal studies is anticipated in late 2026, marking a key inflection point for the company’s clinical pipeline.
Financial Discipline Amidst Clinical Investment
Financially, Cambium Bio reported a net operating cash outflow of approximately A$1.1 million for the June quarter, with around 70% allocated to research and development activities. This includes ongoing GMP manufacturing and stability testing to support clinical trial supply. Personnel and administrative costs remain tightly controlled, reflecting a lean operational model focused on execution.
Despite a modest closing cash balance of A$0.166 million at quarter-end, the company has since completed a fully-subscribed placement raising A$2.12 million. This capital injection, combined with an expected R&D tax incentive refund of roughly A$0.9 million, provides a more robust financial runway to support imminent clinical milestones.
Strategic Funding and Future Outlook
Looking ahead, Cambium Bio is actively exploring additional funding avenues, including out-licensing partnerships and royalty financing, to secure non-dilutive capital. These efforts aim to underpin the company’s Phase 3 program and broader pipeline ambitions without excessive shareholder dilution.
The company’s management remains vigilant on expenditure, with the flexibility to phase R&D activities if market conditions necessitate. Key upcoming milestones include CRO contract execution and site activation in Q3 2025, first patient dosing in Q4 2025, and completion of enrolment by mid-2026.
Overall, Cambium Bio’s progress reflects a disciplined approach to advancing a promising regenerative medicine candidate while balancing financial prudence in a capital-intensive phase of development.
Bottom Line?
Cambium Bio’s successful capital raise and regulatory progress set the stage for a pivotal year ahead as Phase 3 trials commence.
Questions in the middle?
- Will Cambium Bio secure additional non-dilutive funding to extend its financial runway?
- How will patient enrolment rates impact the timeline for Phase 3 data readout?
- What are the prospects for out-licensing deals with global ophthalmology partners?
