A new agreement between Emerald Health Therapeutics and Skye Bioscience will enable Phase II studies exploring the use of Skye’s proprietary synthetic cannabinoid-derivative therapeutic initially targeting glaucoma.
Glaucoma is the globe’s leading cause of irreversible blindness – affecting nearly 80 million people across the globe – and has no cure.
Skye Bioscience‘s lead programme, SBI-100 Ophthalmic Emulsion, is focused on treating glaucoma. SBI-100 OE is designed to improve the ocular solubility and permeability of a cannabinoid receptor-type 1 agonist.
So far, preclinical studies have demonstrated that topical application of the nanoemulsion results in enhanced therapeutic efficacy and duration of response, allowing for a potentially once-a-day application to the eye. The results showed superior lowering of intraocular pressure, a key risk factor in disease progression.
Under the new agreement, which would see Skye acquire all of the issued and outstanding shares of Emerald in a share-for-share-transaction, Skye expects to have funding for a Phase II study which is expected to begin in the fourth quarter of 2022, following a Phase I study beginning in the second quarter of 2022.
Chair of the Skye’s special committee and president, CEO and board member of Invectys, Inc., Praveen Tyle, Ph.D., commented: “Skye’s proposed acquisition of Emerald stands to strengthen its balance sheet and ability to advance its well-positioned technology and development platform that has generated promising preclinical data in the past year and a half.
“Despite the constraints of Covid on all facets of the life science industry, Skye has completed the preclinical preparation necessary to launch its first-in-human study of its lead drug, SBI-100 OE, in the second quarter of 2022.
“We expect regulatory approval to start our Phase I study and begin enrolling patients shortly. The transaction with Emerald is expected to provide funding into 2023 and, importantly, for our planned Phase II study starting in the fourth quarter of 2022.
“The shortcomings of today’s glaucoma drugs are significant for patients. Today we are focused on clinically validating what could potentially be an advantageous new class of therapeutic drug for glaucoma.
“With this in mind, we are actively designing a Phase II efficacy study to deliver potentially meaningful data, yet optimised to minimise time and cost. We believe we can see preliminary data from this study in 2023, and the nature of this data could be transformational from a validation and value creation perspective.
“Securing the capital to achieve these goals is vital. We believe that acquiring Emerald and its cash and non-cash assets would provide a more favourable capital cost for our shareholders compared to other alternatives in light of current investment market conditions.
“In addition, Emerald possesses a research and development facility in the greater Vancouver area licensed to undertake cannabinoid-related research under applicable Canadian law, which could be beneficial to Skye as we continue to progress our R&D efforts.”
Chair of the board’s Special Committee of Emerald Health Therapeutics, Bobby Rai, commented: “We are excited to present this opportunity with Skye to our shareholders. Since announcing the strategic pivot of Emerald last November, we have been working to wind down our past operations, monetise our non-cash assets, and apply our capital to a new investment opportunity. We have searched for a company with differentiated positioning and a pedigree of expertise and experience. We believe we have found it in Skye Bioscience.
“Emerald has always recognised the therapeutic potential of cannabinoids based on our experience with the body’s endocannabinoid system and its modulating and balancing activities in the body. We also recognise that the goal to clinically and commercially capitalise on the potential therapeutic benefits of cannabinoid-derived drugs may benefit from advanced technology and drug products with mechanisms of action or formulations enhanced to realise effects superior to not only natural cannabinoids but to existing approved classes of drugs and those under development.
“The beauty of this situation is that the underlying cannabinoid that Skye is working with has previously been shown through prior third-party research to have promising potential. And Skye’s recent preclinical work has shown improved delivery of the underlying cannabinoid to the back of the eye and notable effects in reducing intraocular pressure, which is a key risk factor of glaucoma.
“Skye Bioscience has proprietary technology, R&D initiatives to expand its therapeutic capabilities, a strong focus on IP, along with a management team, board, and advisory board with many decades of experience in pharmaceutical drug development and clinical practice, notably in ophthalmology and in fundamental cannabinoid research. This company is uniquely positioned to capitalise on the substantially untapped opportunities represented by the intersection of cannabinoids with modern science and traditional drug development.
“We believe this is an excellent opportunity for Emerald shareholders to potentially benefit from a new class of cannabinoid-derivative drug candidates.”
Patient groups are key to a thriving cannabis industry
Patient advocacy groups have called for more support from those in the cannabis industry.
It’s time the cannabis industry gave advocacy groups the support they deserve, argue campaigners, after all, they are the ones driving the sector forward.
Representatives from some of the UK and Europe’s leading cannabis advocacy groups have called for more support from those in the industry, highlighting the vital contribution they make to the development of the sector.
Speaking on a panel at Cannabis Europa in London on Wednesday 29 June, several leading campaigners said the industry had taken the efforts of patients for granted for too long.
In the words of Mary Biles, author and moderator of the event, it is the patients who “forged ahead and created this industry”.
It wasn’t the tireless efforts of CEOs which changed the law in November 2018, opening up a potentially highly profitable market – but also what many saw as an opportunity to make a “quick buck”.
It was the mothers and families, whose children were sick, who were full-time carers, surviving on just £62 a week from the government. It was the patients who put themselves at risk to educate others and call for change, despite their own limitations.
Jacqueline Poitras, founder of patient group MAMAKA and representative of the IACM Patient Council, is the campaigner responsible for changing the law in Greece, after fighting for her daughter to access medical cannabis.
“Our advocacy organisation started the ball rolling in 2016,” said Poitras.
“As in so many other countries, it was the patients who asked the politicians to change in law. What we have done ever since then is fill the role of everybody else who’s not in the value chain at the moment.”
The bridge between patients and industry
In the years since the law change, organisations such as Medcan Support and PLEA (Patient-Led Engagement for Access) in the UK, and the IACM Patient Council internationally, have become a vital bridge between the patients they support and the big businesses producing their medicine.
Medcan Support now has over 500 members, most of whom are parents and family members of children with severe epilepsy who are desperate for help and seeking advice, having heard that cannabis might help them.
PLEA has over 1,200 members and is run entirely by patients, all of whom are living with chronic conditions.
It is these organisations which take the lead on liaising with the private sector, lobbying for better standards for medical cannabis patients, educating clinicians and cannabis naive patients and even building the evidence base.
They are support workers, social media managers, campaigners, educators and consultants. And yet the majority, if not all, are volunteers.
“We all happened into this,” said Poitras.
“We were called to it and it’s not something that we can walk away from. If we don’t do it, nobody else is going to do it. We are convincing people and politicians that cannabis can help them. We are the bridge between companies and customers.”
She added: “But how much longer do I have to continue working at something on a volunteer basis?”
Representatives from PLEA revealed they work up to 40 hours a week behind the scenes, all for free. Its chairperson Lorna Bland has spent 40 years working in the voluntary sector having recently received a Royal Voluntary Service Award for the Platinum Jubilee.
Matt Hughes, co-founder of Medcan Support has a full-time job in IT, and a disabled son to care for. But he spends his evenings responding to questions from other families. He isn’t going to ignore them, he has been there himself after all.
On top of that him and his small team are organising and hosting webinars, creating social media content and acting as the vital go-between for private clinics and regulators.
“This is the core of what patient groups do, it’s not just social media and what people see from the outside, we’re usually the ones sorting out the issues in the private sector when the industry isn’t,” he told Cannabis Health.
“We do a huge amount that goes unnoticed, acting as a key link between patients and the industry. If a product is stopped leaving patients at risk of being left without medication, we are the ones sorting it out. If Medcan didn’t exist and we didn’t do all the work, who would?”
The value of lived-experience
When industry players do want to listen to the patients, they are usually expected to share their valuable insights and lived-experience for free.
“All of the information and experience that [advocacy groups] have gathered over the years, in the thousands of hours that have been invested into this and the patients around us, is valuable information for these companies,” said Poitras.
Co-founder of Medcan Support and director of Maple Tree Consultants, Hannah Deacon set up an initiative called Patients First with Volteface, earlier this year, which pays patients to participate in focus groups.
“What concerns me is that people see medical cannabis as a commodity and a way to make a quick buck,” she said.
“It’s not going to be sustainable. You need to listen to patients, because that’s how you develop a robust business.”
Deacon continued: “This is very personal. Businesses must not try to access this sort of information for free, because it’s very valuable and it’s a commercial thing that they are trying to achieve. If you are trying to do that, then you should help the people running those organisations. There are companies doing that, but not enough.”
Patients at the heart of everything
One company which is doing so is medical cannabis distributor, Chilam. Its co-founder and CEO, Monique Ellis, is a cannabis patient herself, having battled with endometriosis for over 20 years.
Chilam has put patients at the heart of its business strategy, investing in a comprehensive research and development programme before it’s even properly off the ground.
But Ellis doesn’t see this as a luxury, or a token gesture, rather a necessity that will set the company in good stead for the long haul.
“We’ve taken the view that the patient is at the absolute heart of everything we do,” said Ellis.
“It needs to be front and centre in your business model. It is sometimes described as a luxury to be able to roll out an R&D programme before you’re profitable or are trying to complete a funding round, but it’s not a luxury, it’s a must-have. You need to invest in it, it needs to be a core dimension to the business plan and you need to make those budget considerations.”
Ellis continued: “We need to make sure that we’re engaging with advocacy groups, and not just within the cannabis industry. We’ve got to think about cannabis naive patients that exist outside of the kind of small embryonic industry that we’re working with.
“That means that we need to give financial support to charities – it should be built into your social impact strategy. If these are not the values that are underpinning the way that you operate as a business, then you don’t have something that’s scalable and you won’t have patients for life.”
The key to developing the market
There are now said to be around 17,500 people with a legal prescription for cannabis in the UK. According to polls, 1.4 million people are self-medicating, suggesting the legal market has only fulfilled a tiny proportion of its potential.
There are just 110 doctors prescribing out of thousands on the specialist register who could legally do so.
Advocacy groups are the key to reaching those people.
“Keeping advocacy groups going is absolutely vital to this developing market,” said Deacon.
“I fear that we live in this bubble at the moment. The only way we’re going to reach the millions and millions of people in this country who could benefit, is by supporting advocacy groups who can get out and talk to naive patients, attend conferences and create education.
“Companies can’t do that, but we can and that’s why we are vital to the development of this sector. But we are volunteers and we cannot expand the work we do without being supported by the industry.”
The bottom line
We’re not talking about huge investments here. According to Deacon just £200 a month would allow Medcan Support to do more – and if 10 companies stumped up the cash, they could afford to employ someone to work full-time.
Poitras ended by urging cannabis businesses to reach out to patient groups in their country, she said: “Everything has to be built around this and if you’re not doing it at the moment, take a very critical look at your company and see where this can be placed within your system.”
Deacon added: “Every day that you go into the office, you need to think about who you’re working for. Who is your stakeholder?
“If you’re focused on your margins, then you’re not doing it for the right reasons. You need to be focused on who you serve, which is your patients and your doctors. I think when you start doing that, you’ll start winning.”
Khiron reports 65 per cent boost in revenue as it eyes up global expansion
Khiron has posted record 2022 Q1 numbers that included revenue of $4.6 million, a 65 per cent increase from Q1 2021.
Global medical cannabis company Khiron Life Sciences is continuing its expansion throughout Latin America and Europe as it grows its global network of medical cannabis treatment clinics.
Khiron has posted record 2022 Q1 numbers that included revenue of $4.6 million, a 65 per cent increase from Q1 2021, as well as record revenue in medical cannabis of over $2.6 million in Q1 2022, a 470 per cent increase from the prior year. Q1 2022 showed an operating cash outflow of 2.8 million against a total receivable of 4.4 million.
Khiron continues to grow with some of its newer operations already becoming profitable and EBITDA positive. Khiron says it is reducing expenses, selling high-margin products and taking a “disciplined” approach to its expansion.
Khiron is serving a record number of patients as it recently reached a cumulative stock of more than 100,000 bottles of medical cannabis sold. In countries such as Colombia and Germany, Khiron is benefiting from patients’ ability to utilise their health insurance for treatment in its medical cannabis clinics.
In the UK, Khiron has established market leadership with its first two products on the market. The company’s 20/1 THC-predominant strain is one of the best-selling medically prescribed products in the UK.
The wider European market poses an opportunity for Khiron as further countries beyond the UK are legalising medical cannabis. The company currently has its sights set on Germany, which has the potential to have over a million patients by 2024.
In Q1 2022, the UK and Germany represented 53 per cent of all medical cannabis revenue for the firm, compared to 10 per cent in Q1 2021.
The launch of a new product the THC-dominant full-spectrum extract KHIRIOX 25/1 is also on the horizon and will be available to pharmacies and patients in Germany and the UK in the near future. KHIRIOX 25/1 combines the medicinal properties of the established THC isolate formulations (dronabinol) with the specific advantages of a full-spectrum extract, which may have fewer side effects and be better tolerated by patients.
Khiron recently acquired Pharmadrug GmbH, which has provided Khiron with a European manufacturing and distribution centre for cannabinoid-based medicines. Keeping its wholesale fees in-house, the company expects the acquisition to have a direct positive impact on revenues and gross margins.
Headquartered in Bogata, Colombia, Khiron is also expanding its footprint in Latin America where it remains a market leader in medical cannabis, operating across Colombia, Peru, Mexico and Brazil.
With the election of a new pro-cannabis president, Gustavo Petro, Khiron foresees a positive environment for cannabis companies in Colombia. As the only country in Latin America with universal health insurance coverage for medical cannabis, over 82 per cent of Khiron sales were sold through insurance coverage and over 84 per cent of sales were sold to returning patients.
Sales of its products in Peru have grown more than 75 per cent from Q4 in 2021 to Q1 in 2022. Now, Khiron is launching its products in drugstores and pharmacies.
In March 2022, Khiron signed a partnership with Teleton pharmacies in Mexico, allowing it to establish its medical cannabis clinics within Teleton’s network across the country and distribute products in its pharmacies. Teleton has 24 Medical Centers including 22 rehabilitation centres, one autism centre and 1 Children’s Hospital for Cancer) located across the country, and around 600,000 patients with disability, cancer and autism conditions.
Brazil is the most recent market for Khiron’s Latin American expansion. Between late Q2 and early Q3 2022, Khiron will open its first clinic in Rio de Janeiro and expects to achieve its first import of high THC later in the year.
First export licence for medical cannabis approved in Isle of Man
The letter of approval will allow GrowLab Organics to cultivate, extract, manufacture, import and export medicinal cannabis.
The Isle of Man Government’s Department for Enterprise has confirmed that GrowLab Organics (GLO) has been offered the first conditional medicinal cannabis licence for export in the Isle of Man.
The Isle of Man Gambling Supervision Commission (GSC) has issued the first letter of approval in principle to GrowLab Organics to cultivate, extract, manufacture, import and export medicinal cannabis from the Isle of Man.
GLO is a British cannabis company founded in 2018 and headquartered in the Isle of Man. The company expects to create more than 50 jobs on the island within the next three years.
“The emerging cannabis sector is potentially the most exciting global development of this generation and has the capability to transform the quality of life for millions of people,” Alex Fray, Chief Executive Officer at GLO, commented. “GLO’s mission is to help people live better through the power of cannabis, whilst reducing the need for people to source cannabis from illicit sources for medicinal purposes. Our unique and innovative approach will improve the quality, consistency and range of products available to patients.
In early 2021 the Isle of Man Government introduced a regulatory framework to allow commercial operators to grow, manufacture, distribute and export cannabis products under licence from the Isle of Man. The initiative, which was supported by the Economic Recovery Group and Business Isle of Man, saw the Isle of Man Gambling Supervision Commission (GSC) appointed as the Regulator. Licence applications were opened in June.
The first licence has been issued conditionally and will enable the successful applicant to operate in the medicinal cannabis sector in the Isle of Man provided they meet the requirements outlined by the licence offer.
Minister for enterprise Tim Crookall said: “The Isle of Man has a rich history of innovation in developing new sectors, and our Department plan clearly sets out ambitious targets through the Business Agency to fully realise the potential of this market in the Island.
“This first offer letter represents the dawn of a new economic sector in the Isle of Man, which will drive high-value economic diversification across existing local sectors, stimulate job and training opportunities for Manx workers and encourage inward investment.
“I am optimistic that this will play a key part in the Isle of Man’s economic future and look forward to working with the Business Agency to continue to support and develop the highest calibre of companies establishing in the Island within the medicinal cannabis sector.”
The Isle of Man’s new medicinal cannabis industry is regulated by the GSC. Since applications opened last year, the organisation has worked closely with a wide range of stakeholders to develop and agree a licensing framework that will enable a well-regulated sector to grow on the island.
“Historically cannabis was woven into the fabric of Manx agriculture with hemp being grown on the island for rope and sail cloth,” Crookall added. “Now it’s back, with a continuation of the island’s history of innovation and economic diversity and as part of that we expect to create over 50 jobs within the next 3 years.”