Regeneus and Cambium merge to refine dry eye treatment development

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By Colin Hay - 
Regeneus ASX RGS Cambium dry eye treatment

Australian regenerative medicine firm Regeneus (ASX: RGS) and US-headquartered Cambium Medical Technologies (CMT) have completed a merger that will see them combine to further develop a novel biologic treatment for dry eye disease.

Regeneus is a Sydney-based company focused on the development of innovative biologics for ophthalmology and tissue repair applications.

Cambium Medical is a specialist in regenerative therapy, with the use of healthy cells or cellular components to treat certain diseases and conditions associated with aging or damage.

In recent months, Regeneus and CMT teams have been working together on the development of Elate Ocular, a novel biologic for dry eye disease.

In mid-January, CMT received valuable feedback in a meeting with the US Food and Drug Administration (FDA) regarding the potency assay, implementation of a pathogen-inactivation step in the manufacturing process and requirements for a comparability study.

The CMT team has since developed a comprehensive plan to undertake the FDA suggestions and initiate registration-enabling phase 3 trials in mid-2025, subject to additional financing.

US merger completed

According to Regeneus, the merger has now been completed via the lodgement of the appropriate regulatory articles in the US state of Georgia.

The purchase consideration for the merger includes the issue of new ordinary “consideration” shares in Regeneus to existing CMT shareholders.

The consideration shares represent 50% plus one share of Regeneus’ post-transaction issued share capital.

In addition, CMT shareholders are entitled to a 5.5% revenue royalty from the existing version of Elate Ocular to treat dry eye disease if the future therapeutic development costs do not exceed an aggregate of $31 million.

Name change

Regeneus has obtained shareholder approval for a name change to Cambium Bio and has lodged notice of the change of name with the Australian Securities and Investment Commission (ASIC).

The change of name will take effect from the day on which ASIC alters the details of the company’s registration.

Following the change of name, the company will also request the Australian Securities Exchange for its ticker code to be changed to CMB.

Board restructure

The merger has also had an impact on Regeneus’ board of directors.

Terence Walts has been appointed as an executive director of the company and as chief executive officer of CMT, to oversee the company’s US activities.

Dr Edmund Waller has been appointed as an executive director of the company and as chief scientific officer, while Leo Yao Lee has resigned as a non-executive director.

Regeneus has also revealed it is in advanced discussions to obtain additional funding from CMT shareholders and other potential investors.