Cash Crunch Eased: Cambium Bio Raises Funds Amid Tight Liquidity Ahead of Trials
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?
