Zelira Therapeutics (ASX:ZLD) developing clinically validated medicinal cannabis products


by Rachael Jones

Zelira Therapeutics Limited (ASX:ZLD) Managing Director Ex USA, Dr Richard Hopkins talks about the company's pipeline of products in clinical development targeting insomnia, chronic pain and autism, its model for rapid commercialisation, its go-to-market strategy and first revenues from US licensing partners.

Rachael Jones: Hello. I'm Rachael Jones for the Finance News Network. Joining me from Zelira Therapeutics (ASX:ZLD) is Managing Director Dr Richard Hopkins. Richard, welcome to FNN.

Dr Richard Hopkins: Thanks, Rachael. It's lovely to be joining you today.

Rachael Jones: First up, Richard, could you start by giving us an introduction to the company?

Dr Richard Hopkins: Sure can. Zelira is a publicly-listed biopharmaceutical company developing clinically validated cannabis medicines for global markets. We've got a footprint in the United States, in Australia and also the EU, which gives us access to the fastest-growing, but also the largest cannabis markets in the world, including the United States.

We've got a really powerful portfolio of branded pharmaceutical products that we're going to be launching into global markets in 2020. So, it's a very exciting time for the company. That's supported by our leading pipeline of candidates, which are undergoing clinical development for indications like insomnia, chronic pain and autism.

We've just announced our maiden revenues in Q1 2020 from our first US deal, and we're going to be continuing to roll out deals across the US over the next six months. We're really positioned at a very exciting phase of our development.

Rachael Jones: Thanks, Richard. You do have a very interesting product portfolio there. Can you tell us more, starting with insomnia?

Dr Richard Hopkins: Absolutely. We were really excited to announce a successful outcome to the world's first clinical trial that's been run to evaluate the efficacy of a proprietary cannabis formulation, which we own, against chronic insomnia. It's very interesting. People talk about the impact of cannabis and sleep. We're the first ones to validate that in a clinical trial.
We were delighted to announce that we met all of our primary and secondary endpoints. It was shown to be safe, and it worked very effectively to treat and improve the symptoms of insomnia. That's a first-in-class medication based on cannabis. We're going to be taking that into global markets.

Rachael Jones: Can you tell us a little bit more about the work you've been doing with autism?

Dr Richard Hopkins: This company has had a long history and interest in the field of autism, which clearly has significant unmet needs in terms of medications. We've been developing a portfolio of at least two products, and we're going to bring a third to the market alongside the existing portfolio that we have, called the HOPE range of products, which have been orientated and developed to address the needs of autistic patients.

That's launched in the United States in Pennsylvania, just over a year ago, in fact, and has proved to be incredibly successful. It's become one of the top-selling oils in all of Pennsylvania. We've rolled that out into Louisiana, and we're going to be continuing to roll that product out in other markets.

We're also bringing it to the Australian market in the third quarter of this year, where it's proved to be very effective with regard to the patients that have trialled it so far. We're really excited that that represents a highly differentiated range of products, which resonates loudly with the autistic community.

Rachael Jones: What can you tell me about chronic pain?

Dr Richard Hopkins: That's the granddaddy of indications and medicinal cannabis. That's the primary reason people are prescribing medicinal cannabis. We're due to announce the outcome from a Phase 1 trial from another one of our product lines, which is targeting chronic-pain patients who are on high levels of opioid medications. The question we're asking there is can cannabis help substitute away from the opioids onto our cannabis medication, which can, we think, be a much safer alternative compared to the existing medication. That result will be announced over the next month.

Rachael Jones: It all sounds very positive there. Can you provide an update on your go-to-market plans in 2020?

Dr Richard Hopkins: Yeah. We're really excited about this. If you look in the Australian market, we've just announced a major manufacturing deal with a local manufacturer in Australia, very high quality. They're going to be producing our insomnia products and also the portfolio of autism products, which will be rolling out into Australia in Q3, 2020.

Beyond that, we'll be going into global markets, such as Germany and the UK, focused very much there on generating revenues in those markets. In the United States, as I said before, we've already announced a deal in Louisiana.

There'll be more deal flow coming out for the HOPE range over the next few months. That will be supported by additional deals for insomnia, which will be the only clinically validated insomnia product on the market, globally.

Rachael Jones: And now let's talk about your strategy and finances. Can you tell us how you're going to fund growth?

Dr Richard Hopkins: We're in a pretty strong position, financially. We were fortunate to complete a financing of around five million dollars in January, just before the COVID crisis hit. We reported a cash position of around four million dollars at the last quarter. That's good enough to see us through to at least the end of the year. We've got a lot of options there. Given that in the intervening period we're going to be supporting that with revenues, we think we're in a very strong position at the moment from a capital market's perspective.

Rachael Jones: And to the last question now, Richard. Is there anything else you'd like to add?

Dr Richard Hopkins: Yeah. I think the face of medicinal cannabis is going to be changing over the next 12 to 18 months and we're going to be at the forefront of that. Ultimately, it's going to come down to the fact that these are prescription medicines, and the market's going to respond to companies that can deliver clinically validated formats that doctors will be able to prescribe with comfort.

I think the idea that we can take that back to the United States with a biotech-type model and tap into very sophisticated, I think, investor bases there, I think there's a lot of upside for this company in terms of the share price, but also the portfolio, in terms of when we want to take that into very sophisticated markets.

Rachael Jones: It's very exciting times, Dr Richard Hopkins. Thanks so much for the introduction.

Dr Richard Hopkins: Thanks, Rachael. It's been a pleasure.


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