Cambium Bio Raises A$10.85M to Launch Pivotal Phase 3 Trial of Elate Ocular in Dry Eye Disease
核心洞察
Cambium Bio (搜索) secured an A$10.85 million funding package to initiate its pivotal Phase 3 trial of Elate Ocular in moderate to severe dry eye disease (搜索).
The package includes A$7.1 million in firm commitments from strategic shareholders at a 4.3% premium and A$3.75 million in non-dilutive R&D tax incentive pre-financing.
CAMOMILE-2 is a single 475-patient Phase 3 study that the FDA has confirmed is sufficient to support a Biologics License Application.
Cambium Bio (搜索) Limited (ASX: CMB) has secured an A$10.85 million funding package to initiate its pivotal Phase 3 trial of Elate Ocular® in moderate to severe dry eye disease (搜索) (DED), the clinical-stage regenerative medicine company announced on 16 September 2026.
The Sydney-based company develops biologic therapies for ophthalmology and tissue repair using its proprietary human platelet lysate (搜索) platform. Elate Ocular is its lead investigational biologic for dry eye disease (搜索) and, to the Company's knowledge, has the potential to be the first biologic therapy approved for the indication.
Funding Structure
The package comprises A$7.1 million (US$5.0 million) in firm commitments from strategic shareholders through a placement priced at A$0.48 per share, representing a 4.3% premium to the last closing price. According to the company, this marks its fourth consecutive equity raise priced at a premium.
An additional A$3.75 million comes from a secured facility that pre-finances the Company's FY2027 Research and Development Tax Incentive refund, providing non-dilutive capital alongside the placement.
The placement remains conditional on shareholder approval at the Company's 2026 Annual General Meeting. Full details are contained in the Company's ASX announcement dated 16 September 2026.
Trial Design and Regulatory Path
The proceeds are expected to support initiation of CAMOMILE-2, designed as a single 475-patient Phase 3 trial evaluating Elate Ocular in moderate to severe dry eye disease (搜索). The U.S. Food and Drug Administration (搜索) has confirmed that this single pivotal study would be sufficient to support a Biologics License Application (BLA).
Cambium Bio (搜索) is targeting trial initiation in the fourth quarter of 2026, with topline results expected in late calendar 2027. Subject to the trial meeting its co-primary sign and symptom endpoints, the Company intends to submit a BLA to the FDA in 2028.
Elate Ocular holds FDA Fast Track designation. The company notes that no biologic therapy has been approved for the treatment of dry eye disease (搜索), framing the program as a potential first-in-class approach.
Management Commentary
Karolis Rosickas, Chief Executive Officer of Cambium Bio (搜索), said: "Our strategic shareholders have once again backed Cambium Bio at a premium to market, and that support now gives us the funding to start the pivotal trial of Elate Ocular®. Dry eye disease (搜索) still has no approved biologic therapy. With one pivotal trial agreed with the FDA, Fast Track designation and the funding in place to initiate that trial, our path is clear: topline data in late 2027 and a BLA filing in 2028."
Following the announcement, CMB.AX was trading at AUD 0.47, up 2.17%.