Cambium Bio Secures A$10.85 Million to Initiate Pivotal Phase 3 Trial of Elate Ocular®, a Potential First-in-Class Biologic for Dry Eye Disease

Strategic shareholders commit A$7.1 million at a premium to market, the Company’s fourth consecutive equity raise priced at a premium, alongside A$3.75 million of non-dilutive R&D Tax Incentive pre-financing

SYDNEY, Sept. 16, 2026 (GLOBE NEWSWIRE) -- Cambium Bio Limited (ASX: CMB) (“Cambium Bio” or the “Company”), a clinical-stage regenerative medicine company developing biologic therapies for ophthalmology, today announced that it 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 (“DED”). 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, a 4.3% premium to the last closing price, and an A$3.75 million secured facility that pre-finances the Company’s FY2027 Research and Development Tax Incentive refund.

Highlights

• Strategic capital at a premium. A$7.1 million committed by strategic shareholders, extending a track record of raising capital at a premium.
• Funding to initiate the pivotal trial. CAMOMILE-2 is a single 475-patient Phase 3 trial that the U.S. Food and Drug Administration (FDA) has confirmed is sufficient to support a Biologics License Application (BLA). Initiation is targeted for the fourth quarter of 2026.
• A potential first-in-class biologic. Elate Ocular^® is a biologic derived from human platelet lysate. To the Company’s knowledge, no biologic therapy has been approved for the treatment of dry eye disease, and Elate Ocular^® has the potential to be the first. The program holds FDA Fast Track designation.
• Clear path to registration. Topline data from the pivotal trial are targeted for late calendar 2027. Subject to the trial meeting its co-primary sign and symptom endpoints, the Company intends to file a BLA with the FDA in 2028.
  
  

Karolis Rosickas, Chief Executive Officer of Cambium Bio, 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 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.”

The placement is conditional on shareholder approval at the Company's 2026 Annual General Meeting. Full details are in the Company's ASX announcement dated 16 September 2026 at www.asx.com.au.

About Cambium Bio Limited

Cambium Bio Limited (ASX: CMB) is a Sydney-based clinical-stage regenerative medicine company developing biologics for ophthalmology and tissue repair from its proprietary human platelet lysate technology. Its lead product candidate, Elate Ocular^®, is being developed for moderate to severe dry eye disease.

Contact

Karolis Rosickas, Chief Executive Officer
info@cambium.bio