If you’ve ever had dry itchy eyes, you’re not alone. In just the United States, there are more than 17 million people suffering from dry eye disease (DED) which Cambium Bio is seeking to address through Phase 3 clinical trials that will be assisted by access to new capital as an ASX-listed company upon completion of their merger with Regeneus (ASX: RGS). 

Cambium Bio, a biotechnology company specialising in regenerative medicine, is set to join the ASX through the merger agreement which is subject to shareholder approval sought at a General Meeting in March 2024. 

If approved by shareholders, Regeneus will acquire Cambium Medical Technologies, LLC (CMT). Post-transaction, existing CMT shareholders will hold approximately 50% plus one share of Regeneus’ issued share capital. This move will result in a significant increase in Regeneus’ post-merger shares outstanding.

Moreover, existing CMT shareholders will be entitled to a 5.5% revenue royalty from the existing version of Elate Ocular to treat dry eye disease, subject to future therapeutic development costs not exceeding USD $20.5 million. However, Regeneus will also indirectly assume CMT’s current liabilities, totaling approximately USD $680k. 

Key shareholders of CMT will enter into voluntary restriction deeds, preventing them from selling Regeneus shares for 12 months after the acquisition. Additionally, the merger will bring changes to Regeneus’ board of directors, with prominent individuals from CMT joining the leadership team.

Karolis Rosickas will continue to serve as CEO of the merged entity, while Terence A. Walts, co-founder and CEO of CMT, will oversee its US activities. Edmund K. Waller, MD, PhD, a scientific co-founder of CMT, will join as Chief Scientific Officer, and Neera Jagirdar, MD, MPH, will serve as Director of Medical, Clinical, and Regulatory Affairs.

Furthermore, the merged company will be rebranded as Cambium Bio Limited, subject to shareholder approval. Future funding considerations include immediate capital needs to support Cambium Bio’s activities, including Phase 3 trials for Elate Ocular with future capital raising already flagged by CMT. 

The merger aligns with Cambium Bio’s strategic focus on addressing unmet medical needs, particularly in dry eye disease. DED affects over 17 million adults in the USA alone, with the current market for prescription drugs exceeding USD $2 billion. Elate Ocular, Cambium Bio’s lead asset, offers a promising solution, utilising allogeneic biologic technology to provide off-the-shelf treatment for DED.

Elate Ocular’s potential lies in its ability to offer superior symptom relief compared to existing treatments, with proven safety and efficacy demonstrated in Phase 1/2 clinical trials. 

Additionally, with two IND Application approvals from the FDA for Phase 3 trials, Elate Ocular represents a late-stage, Phase 3-ready opportunity for investors.