MAGELLAN APPOINTS NEW SHARE REGISTRY

Magellan is pleased to announce that we have appointed Bio101 – a leading provider of financial, accounting, and company secretarial services to the biotechnology and life sciences sector – to provide our new secure share registry office service.

The registry will hold details of members’ shareholdings as well as a library of relevant Magellan documents of importance and interest to shareholders. It will also hold newsletters and shareholder updates.

Shareholders will be able to access the registry via a protected password.

As Magellan has grown rapidly over the past two-to-three years, it is appropriate for shareholders to be provided with this specialised service. Bio101 applies total discretion and confidentiality to all corporate matters under its protection.

This service will become available to Magellan shareholders in the next month or so. Shareholders will be contacted to assist them with access to the registry.

DONOR RECRUITMENT

In preparation for Magellan’s Phase Three trial, it is necessary to conduct a review in accordance with the quality accreditation cycle. That includes reviewing Magellan’s policies and procedures regarding donor recruitment.

To date, Magellan has recruited five donors. Donor cells are tested to identify differences in cell lines and the cells are assessed for genetic stability, sterility and undergo up to 30 doublings to ensure that when these cells are expanded they maintain their potency and efficacy.

Donor participation in the trial is strictly voluntary.

TRIAL PREPARATIONS UNDERWAY

Magellan’s product development team has been working intently on preparations for the Phase Three allogeneic stem cell trial which we expect to commence in mid-2024.

With feedback from Australia’s Therapeutic Goods Administration (TGA) and the regulators in the UK, EU and US we now have a regulatory and scientific understanding of what is required for each jurisdiction.

This will help facilitate registration of Magellan’s off-the-shelf stem-cell treatment for osteoarthritis, MAG200, upon successful completion of the trial.
TESTING PROTOCOLS

Magellan’s dedicated Laboratory team – led by Head Scientific Officer, Ms. Kiran Shah – are working through various testing protocols that are required as part of the Phase Three trial process.

The cells Magellan will use for the trial need to be collected in a method compliant with TGA regulations and to be tested for a range of qualities, such as potency, sterility, and genetic stability.

The above processes and testing are on schedule and will be completed at our new R&D lab at Braeside later this year. We monitor trial progress using a detailed Gantt chart that plots activities against a timeline.

FROM THE CHAIR

The past few months have seen good progress in a number of areas for Magellan. The Laboratory build is progressing ahead of schedule and the research and development laboratory is near completion.

Magellan contracted “MST Access” to produce an independent analysis of Magellan’s operation and this document is now available upon request for shareholders. The report contains not just information about the operations and plans of Magellan but also a valuation of the business. The report also includes a comparison with like stem cell companies. Magellan stacks up well with such comparisons. Should you like to see a copy of this report please click here and request a copy.

The Directors continue to seek out new investment partners via our tranche 2 fundraising and we are currently on track to achieve our goals.

With feedback from the US Food and Drug Administration (FDA) on our planned Phase Three trial program we are now ready to finalise the trial protocol in preparation for submission to the Human Research Ethics Committee.

I am satisfied with where Magellan is positioned in its overall development.

Yours sincerely

Lou Panaccio
Chair
Magellan Stem Cells