Cambium Bio Advances Elate Ocular® with FDA Fast Track and A$3M Capital Raise
Cambium Bio has secured a A$3 million capital raise and achieved FDA Fast Track status for its lead ophthalmology product, Elate Ocular®, setting the stage for Phase 3 trials in mid-2025.
- FDA grants Fast Track designation for Elate Ocular®
- Successful A$3 million capital raise including strategic investor support
- Key scientific and board appointments strengthen leadership
- Phase 3 clinical trial preparations underway with CRO selection imminent
- Cash reserves at A$548,000 with funding to support upcoming milestones
Leadership and Strategic Board Enhancements
Cambium Bio Limited (ASX:CMB) has bolstered its leadership team with notable appointments during the December 2024 quarter. The addition of Dr. Louis Tong, a distinguished ocular immunology expert from Singapore, alongside Dr. ChiTai Chang and Clinical A/Prof Chandra Bala to the Board, signals a sharpened focus on clinical and commercial expertise. These appointments come as the company bids farewell to founding board member Professor Graham Vesey, marking a generational shift in governance.
Regulatory Milestone: FDA Fast Track Designation
A pivotal development for Cambium Bio was the FDA’s Fast Track designation granted to Elate Ocular® in December 2024. This status facilitates more frequent regulatory interactions and opens pathways for accelerated approval and rolling review, potentially expediting the product’s market entry. The company has also submitted a revised Phase 3 clinical trial protocol and scheduled a critical Type D meeting with the FDA in March 2025 to discuss the Potency Assurance Strategy, a key component for trial success.
Capital Raising and Financial Position
Financially, Cambium Bio completed a A$3 million capital raise at A$0.4637 per share, reflecting strong investor confidence. Strategic investment from major shareholder Zheng Yang Biomedical Technology accounted for A$1.75 million, complemented by contributions from directors and institutional investors. CEO Karolis Rosickas further demonstrated commitment by increasing his shareholding. Despite a cash outflow of $773,000 for the quarter, including merger-related and R&D prepayments, the company ended December with A$548,000 in cash reserves, supported by the initial tranche of the capital raise.
Progress on Elate Ocular® Development
On the product development front, Cambium Bio achieved a significant Chemistry, Manufacturing, and Controls (CMC) milestone by developing and qualifying the Elate Ocular® Bioactivity assay. Collaboration with a Contract Development and Manufacturing Organisation (CDMO) is advancing as planned to prepare for cGMP investigational drug manufacturing. The company is also in the final stages of selecting a Contract Research Organisation (CRO) to execute the Phase 3 clinical trials, with dosing anticipated to commence mid-2025.
Outlook and Upcoming Catalysts
Looking ahead, Cambium Bio is gearing up for several key events. An Extraordinary General Meeting scheduled for 4 March 2025 will seek shareholder approval for resolutions related to the recent capital raise. The March FDA Type D meeting will be critical in shaping the Phase 3 clinical program. Final CRO selection and trial preparations are expected to follow swiftly, maintaining the company’s timeline for Phase 3 initiation. These milestones collectively underscore Cambium Bio’s commitment to advancing Elate Ocular® toward regulatory approval and eventual commercialisation.
Bottom Line?
Cambium Bio’s strategic moves and regulatory progress position it well for a pivotal 2025, but funding and trial execution remain critical watchpoints.
Questions in the middle?
- Will shareholder approval at the March EGM unlock the full A$3 million capital raise?
- How will the FDA respond to Cambium Bio’s Potency Assurance Strategy in the upcoming Type D meeting?
- Which CRO will be selected to lead the Phase 3 trials, and how might this impact timelines?
