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Health How Incannex is positioning to be the ‘next GW Pharma’, with CEO Joel Latham

03:35  28 april  2021
03:35  28 april  2021 Source:   stockhead.com.au

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CEO Joel Latham said the IHL board is “delighted with the positive feedback and encouragement from the FDA”, allowing the company to “now move forward with conviction on our clinical programs”. The update marks another step forward for the company, following a steady stream of positive developments (and the addition of a psychedelic project with Monash University) which has seen IHL shares rise by The 505(b)(2) provides guidance for how safety and efficacy information on active ingredients can be approved by historical studies – rather than having to be conducted by Incannex .

Jazz Pharmaceuticals Plc JAZZ, +0.30% said Wednesday it has agreed to acquire GW Pharmaceuticals Plc GWPH, +0.04% in a cash-and-stock deal valued at .2 billion. Under the terms of the deal The deal is expected to close in the second quarter, to boost profit in the first year after close and to drive double-digit revenue growth. GW is a leader in therapies based on its proprietary cannabinoid product platform to treat a number of diseases. The company was the first to receive FDA approval for a CBD-based treatment for severe forms of childhood epilepsy in its Epidiolex lead product.

Incannex provides investors the best of breed for medicinal cannabis and psychedelic therapy development – and they’re looking at an excursion to the USA

a man riding a wave on a surfboard in the ocean: Incannex Healthcare GW Pharma, Addressable market, US Opportunity © Stockhead Australia Incannex Healthcare GW Pharma, Addressable market, US Opportunity

For Incannex Healthcare (ASX:IHL) CEO Joel Latham, 2021 is shaping up as a big year as IHL builds upon clinical backing for six different proprietary treatments and works on a US listing.

Latham caught up with Stockhead this week to discuss the near-term outlook, as well as IHL’s longer-term goals around clinical approval for medical cannabis – a strategy pursued with success by GW Pharma. He also gives us some insight on their psychedelic medicine partnership and clinical trial with Monash University.

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Realistically, GW Pharma is more a biotech company than a cannabis company. And with the addition of two big pharma /healthcare professionals to the board of directors or the combined entity, Parallel is positioning to be more than just another MSO but a leader in life science and cannabinoid It has been said that the GW Pharma acquisition was undervalued due to the potential future growth of its products and revenues. Not including future revenues, the expectation is the transaction was more based on the depth of GW 's intellectual property of 62 U.S. patents and 76 pending U.S. patent

IHL's cannabinoid drug discovery brand Incannex Pharmaceuticals is a collaboration with an EU-based cannabinoid drug design company named Linnea SA. The EU-based company will serve as IHL's supply partner for the base cannabinoid materials in four novel cannabinoid formulations. Any financial product advice provided in this website is general in nature. Content on this website does not take into account the objectives, financial situation or needs of any person, or purport to be comprehensive or constitute investment advice and should not be relied upon as such.

Biotech readers would be familiar with the UK-based company GW Pharma, which became the first business globally to get FDA approval for a clinically proven cannabinoid treatment.

Following the in-market success of its Epidiolex product, GW Pharma was acquired this year by the Nasdaq-listed Jazz Pharmaceuticals in a $US7.2 billion deal.

Multiple pathways and diversified asset base

While GW Pharma was successful with a sole product, Latham said IHL’s value proposition is based on a multi-channel approach.

The company has six different treatments in various stages of clinical development – five for IHL’s range of proprietary cannabinoid combination drugs, plus a separate study (in conjunction with Monash University) using the psychedelic compound psilocybin.

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Just as GW Pharma did, IHL is targeting unmet medical conditions which means it qualifies for fast-tracked regulatory approval with the US FDA.

And Incannex benefits from that accelerated pathway for six treatments, not just one.

“One characteristic that sets us apart is that we have six programs running in parallel, knowing they all qualify for the accelerated 505(b)(2) commercialisation pathway with the FDA. This affords us the opportunity to achieve new drug registrations in a significantly shorter period of time,” Latham said.

“The company has completed rigorous due-diligence, pre-clinical studies and examined extensive pre-existing data to de-risk our projects for our shareholders. And, as we’ve previously announced, we are also looking at another psychedelic medicine program, which would take our project count to seven in total”.

Addressable market

While the development of multiple drug treatments de-risks IHL’s pathways to clinical approval, it’s also potentially more lucrative.

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GW Pharma (GWPH) will report its fiscal fourth-quarter results next week. Investors focus is expected to be on commercialization plan for Epidiolex. Zacks Rank: GW Pharma currently has a Zacks Rank #3. The combination of a positive Earnings ESP and a favorable Zacks Rank makes us reasonably confident of an earnings beat. Note that we caution against stocks with a Zacks Rank #4 or 5 (Sell rated) going into an earnings announcement, especially when the company is seeing negative estimate revisions.

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Latham said that across the six proprietary development programs, the total addressable market is in excess of $US130 billion per annum, where there are currently no existing pharmaceutical therapies available.

“As we continue to experience research success and implement our commercialisation strategy for each drug asset, the company will be providing pharmaceutical treatment options to global markets in excess of $US130 billion on an annual basis,” Latham said.

And with so many projects underway, IHL is looking forward to presenting a steady flow of market updates for the foreseeable future, he added.

“Some programs are at different stages of the clinical development pathway,” he said.

As an example, IHL’s Phase 2 trial to assess the safety and efficacy of its IHL-42X sleep apnoea treatment is underway right now.

“With a partnership in place with The Alfred Hospital, our IHL-42X OSA Phase 2 study is underway with patient dosing taking place. Additionally, we are in the process of assessing the pre-clinical results we’re received our various other development programs and the company will continue to build robust clinical development programs delivering near- and long-term value for shareholders,” Latham said.

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US opportunity

Having gained accelerated development pathway eligibility for each of its drug formulations in the US market, IHL is now looking to leverage that traction by exploring opportunities for a US listing – specifically the NYSE or Nasdaq.

And Latham said the basis for those talks progressing is the fact that IHL’s development model is viewed favourably by US investors.

“The feedback we have received from the US market and investment banks is that they see Incannex as a unique value proposition, particularly when looking at comparable companies in the US market, which are valued at over $US1 billion,” Latham said.

He cited the example of two North American clinical psychedelic research companies – Compass Pathways and MindMed – both of which already have a market cap of more than $US1bn.

Mindmed received its pre-IND feedback from the FDA for its proposed Phase 2 trial for LSD and anxiety in December 2020. IHL isn’t far behind as it’s in the process of compiling its own FDA pre-IND meeting package for a Phase 2 trial using psilocybin in patients with generalised anxiety disorder.

“For us, looking to list on a US main market is really about taking advantage of a global pool of investors who are interested in what we’re doing and to expand upon our ASX listing by attracting sophisticated investors globally,” Latham said.

Ultimately, the company’s standing in the psychedelic and cannabinoid research space is the “truly appreciated value driver” behind IHL, he added.

“We have secured IP protection, created and implemented a robust FDA regulatory strategy and US investors are starting to understand the upside potential of Incannex, simply due to targeting unmet medical conditions providing the company with significant commercial opportunity.”

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

The post How Incannex is positioning to be the ‘next GW Pharma’, with CEO Joel Latham appeared first on Stockhead.

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