CEO Communique

The Medlab story

Thursday 6TH December 2018

Looking back, a guide to looking forward

CEO Communique

CEO Communique

The history of biotech teaches us many lessons.

If you want to be successful, you can’t be a one product company and you need to be part of the mainstream of world health issues that surround us.

These considerations have shaped Medlab’s strategy and are borne out in our 2018 milestones.

We live in a world of chronic diseases, most brought on by our lifestyle, and medical science generally hasn’t come up with quick answers despite there being significant community need.

So, we’ve made this area our mission, looking for ways to combat depression and obesity, improve heart health and manage pain without opioids and their inherent side effects.

We’ve also adopted a portfolio approach to our R&D program, as a way of spreading risk to achieve returns.

This involves:

  • using our microbiome research to develop drug candidates and nutraceuticals, from which sales help to fund research,
  • developing cannabis-based medicines (NanaBisTM) as an alternative to opioids,
  • bringing in adjuvant therapy as appropriate
  • and developing a device for medicine delivery (NanoCelleTM).

Our commercial strategy also encompasses looking at markets beyond Australia and discussing with “big pharma” possibilities of partnerships to capture the full potential of our research.

This “Year in Review” table shows how we’re progressing along these lines:

Date

ASX Announcement

What it means

10 January 2018

Medlab Granted Licences-Sell or Supply Cannabis in Australia

Requires doctor request but allows opioid alternative

25 January 2018

Successful Completion of a Heavily Over-Subscribed Placement

Provides capital to fund research, development, and commercialisation programs

1 February 2018

Medlab Permitted to Sell or Supply Cannabis in QLD and ACT

Broadens doctor familiarisation of opioid alternatives

2 March 2018

Medlab’s Progress to Date on Cannabis Spray (NanaBis™)

Start of education program with doctors and pharmacists

15 May 2018

MDC Cannabis Shipment Completed and Trial Commencement

NanaBis™ provided to Royal North Shore Hospital to start trial

4 July 2018

Pain Trial on Schedule and Initial Doctor Feedback Positive

NanaBis™ and NanaBidial™ available to Australian patients under Government Special Access Scheme (SAS)

25 July 2018

Recruitment Begins – Phase 2A Trial for Depression Medicine

Trial commences at Queensland University Technology (QUT)

27 July 2018

Aphria Completes Largest Export Shipment to Date to Medlab

Confirms quality supply for NanaBis™ trial

27 August

Medlab Expands in Significant Area of Oncology with Trial

Trial of Medlab’s Multibiotic™ for mucositis, an outcome of chemotherapy

4 Sept 2018

Independent Research Validates Science around NanoCelle™

Tiny molecule components contain same properties and consistency

11 Sept 2018

Medlab granted a Licence to Export Cannabis

Opens pathway for overseas use of NanaBis™ and NanaBidial™

30 October 2018

Successful completion of Stage 1 of NanaBis™ Trial

Stage 2 is ready to commence

A couple of things the announcement schedule doesn’t cover are the way in which Medlab’s Nutraceutical range is being developed, nor the commencement of discussions with regulators in the US and Europe to initiate consideration of NanaBisTM for those markets.

The research-based nature of Medlab’s products makes them natural candidates for professional pharmacies, a market in which we’re expanding, along with other partnering opportunities.

Recent pathway meetings with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have opened up the potential for fast-tracking registration of NanaBisTM.

A feature of focusing on current chronic diseases is that governments are supportive of promising research in these areas and are prepared to consider fast-tracking of what in the past have been decade long clinical trial processes.

This is only available once human trials have begun and demonstrated safety and efficacy, a route Medlab is pursuing, creating more opportunities to report to you in the year ahead.

To all, have a safe and healthy festive season, looking forward to catching up in 2019.

Thank you for your support.

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Dr Sean Hall

Published 6TH December 2018



CEO Communique