Funding Needs Loom as Cambium Bio Prepares for Pivotal Phase 3 Trials

Regulatory Milestone Clears Path for Phase 3

Cambium Bio Limited (ASX:CMB), a Sydney-based clinical-stage regenerative medicine company, has marked a significant step forward in its development pipeline with the US Food and Drug Administration (FDA) formally clearing the company to commence patient dosing in its pivotal Phase 3 clinical trials for Elate Ocular®, its lead biologic targeting dry eye disease. This clearance, announced in July 2025, follows a series of regulatory achievements including Fast Track designation and protocol approvals earlier in the year.

The company targets first patient dosing in the CAMOMILE-2 and CAMOMILE-3 trials by the third quarter of calendar year 2026, with topline data expected around the same time in 2027. This progress positions Cambium Bio at the forefront of regenerative ophthalmology, addressing a significant unmet medical need.

Strategic Partnerships Expand Global Reach

During the half-year to December 2025, Cambium Bio executed three key Memoranda of Understanding (MOUs) that collectively establish a global manufacturing and commercialisation framework for Elate Ocular® and related biologics. These include:

• Keke Medtech: Exclusive worldwide rights to develop fibrin biologics for dental applications, with deal value exceeding US$2 million including milestone payments and royalties.
• Benta SAS: Exclusive rights for Elate Ocular® in Europe and the Middle East, leveraging Benta's established blood product manufacturing and ophthalmology presence across 40 countries.
• Locus Cell Co., Ltd.: Contract manufacturing agreement for the active biologic ingredient outside Europe and the Middle East, utilizing a new FDA-compliant GMP facility in Taiwan.

These partnerships not only validate Cambium Bio’s proprietary human platelet lysate platform but also strategically position the company for global commercialisation.

Financial Performance and Funding Strength

Financially, Cambium Bio reported a half-year loss of $1.46 million for the six months ending 31 December 2025, an improvement from a $1.72 million loss in the prior corresponding period. Revenue increased modestly to $327,000, primarily from royalties on fibrinogen-depleted human platelet lysate products. The company also benefited from a $584,000 R&D tax incentive refund, reflecting government support for its clinical development efforts.

Cash on hand stood at $774,000 at period end, bolstered by a fully subscribed placement in July 2025 that raised $2.17 million at a 60% premium to the prior share price. Further strengthening its financial position, Cambium Bio secured a $2.4 million strategic investment from major shareholder Zheng Yang Biomedical Technology Co., Ltd. (ZYBT) in January 2026, subject to shareholder approval. This investment underscores confidence in the company’s clinical and commercial prospects.

Outlook and Strategic Focus

Looking ahead, Cambium Bio is focused on completing scale-up manufacturing of its investigational drug product, activating clinical research organisations, and initiating patient enrolment in its Phase 3 trials. The company also plans to advance licensing discussions and explore additional strategic initiatives across the US, Europe, Middle East, and other regions to complement its clinical progress and maximise shareholder value.

While the company acknowledges the need for further capital to fully execute its Phase 3 program, it remains confident in its funding strategy, supported by multiple potential sources including further capital raises, licensing partnerships, royalty financing, and ongoing R&D incentives.