Helius Therapeutics CEO, Paul Manning, speaks with patient advocacy organisation, Medicinal Cannabis Awareness New Zealand, about building a preeminent cannabis biotech company.
Q1. Who are you, where are you based and what do you do?
Helius is one of New Zealand’s largest licensed medical cannabis companies and we exist to improve quality of life. Our first priority is to provide high-quality, affordable medicinal cannabis to kiwi patients across the country.
We have a bold vision, to become a world leader in the research and development of safe and efficacious medical cannabis products. Our scientific team are exploring the vast potential of cannabis-based treatments. Future targets will extend beyond symptom relief into disease modification, particularly in the treatment of inflammatory and neurodegenerative conditions.
Based in East Tamaki, Auckland, Helius is the first medicinal cannabis brand to be certified as New Zealand Grown. We are near completion of a state-of-the-art vertically integrated facility in Auckland with indoor controlled growing systems, extraction site, advanced cannabinoid research and analytics laboratories, manufacturing operations, logistics and security.
We’re also New Zealand’s most valuable medicinal cannabis company, with a current market capitalisation of $105m. Helius remains 100% kiwi-owned.
As New Zealand’s regulatory environment changes, Helius will continue to lead education amongst healthcare professionals, undertake clinical trials here in New Zealand, and set the standard for effective, accessible medicinal cannabis products.
We're also the foundation sponsor of MedCan 2020, the country's first medicinal cannabis conference, coming upon 9-10 November at Auckland's Aotea Centre.
Q2. Will you offer compassionate discounts, (community service card holders, pensioners etc)?
Yes, in fact we already have a program dedicated to improving accessibility of medicinal cannabis for those who are most in need. We call this program, Helius Assist, which has been on our website for a year or so. We will provide compassionate access for holders of a Community Services Card or Gold Card.
As part of our ongoing commitment to improving our patients’ experience, Helius Assist will also provide cover for veterans who have served in the New Zealand Armed Forces and Emergency Services. We are working with the government and pharmacies now and we plan to activate Helius Assist in New Zealand next year.
Unfortunately, the regulations do not allow us to communicate details of products or pricing, so that’s about all we can say on this topic for now.
Q3. Do you have plans for trials regarding chronic pain?
Yes. Last year we signed a Memorandum of Understanding (MoU) with one of New Zealand’s leading clinical trial groups. It’s no secret that clinical trials are expensive so, with support from our wonderful group of kiwi investors, we have just raised an additional $20M, largely to fund clinical trials. This work includes a clinical trial in chronic pain and will be completed here in New Zealand. All patients will be recruited locally.
We have Phase I clinical studies being prepared now, which are focused on establishing the safety of our preparations. After these are complete, we will move into four Phase II studies which include pain along with an adjunct study on the opioid sparing qualities of cannabinoids.
Q4. What certification programs, i.e. organic and others, are you or the industry planning to belong to?
Helius operates a GMP (Good Manufacturing Practice) facility, which is a system that ensures our medicines are consistently produced and controlled according to the regulator’s quality standards. It is designed to minimise the risks involved in medicines production that cannot be eliminated through testing the final product.
Our cultivation facility is operating under GACP (Good Agricultural and Collection Practices) which is a quality program covering growing (seeds and propagation material), collection, harvest, processing, packaging, personnel, equipment, and documentation.
We use no pesticides in our cultivation operations.
At least one of our grow facilities will be certified organic. Our primary facility includes a precision-controlled indoor canopy, so it’s extremely clean and pesticide-free.
Q5. How do you manage your pest/weed regime?
Our primary cultivation facility in East Tamaki is a precision-controlled indoor environment. We have no weeds and we do not use pesticides. Our cultivation team also utilise beneficial insects as a preventative measure in the facility.
Q6. Will you your plants see the light of the sun, and will they be grown in soil? vs indoor & hydroponic growing
Helius has two cultivation sites. Our primary site is in East Tamaki and is a is a climate controlled indoor cultivation facility and utilises hydroponic cultivation methodology. It has been designed to provide the highest possible precision and consistency, from tissue culture to flower.
This level of control is important to us because we are developing clinically-proven, full spectrum cannabis medicines where the consistency of starting material is extremely important. These plants are grown under lights supported with a solar energy array. This facility is partially operational now and will be completed by mid-2020. From a cultivar (strain) perspective, this facility is focused on high-THC, balanced, and minor cannabinoids, as well as terpenes.
We also have an exclusive collaboration with BioLumic, a kiwi agritech start-up, and are developing a proprietary UV treatment technology. Early tests as part of this R&D program suggest the unique technology is capable of improving plant vitality and increasing cannabis yield by up to 30%. We’re excited to monitor how this progresses as we shift into commercialisation.
Our second site, Helius West, is located in Kumeu, Auckland. This site has been designed with several high-tech glass houses. The glasshouse environment provides a lower level of control, while taking direct advantage of the sun and some energy efficiencies. The main purpose of Helius West is to grow low-cost, high-CBD cultivars. This site is expected to be operational in late 2021.
Both sites are hydroponic and overseen by our Cultivation Mananger, Kai Keli’iho’omalu, a third-generation cannabis grower, who is originally from Hawaii.
Q7. Are you planning on including animals who would benefit from CBD for various ailments eg. epilepsy?
Yes. Helius has just acquired a significant stake in a local animal health and veterinary medicines business and together we have established Helius Animal Health. This business is focused on developing quality cannabis-based therapeutics to companion animals who, like humans, have an endogenous cannabinoid system.
Common health conditions that CBD may be used to treat range from pain to anxiety, stress, nausea, skin conditions and seizures. We believe that having high-quality, locally-produced therapeutic cannabis products readily available in New Zealand will be a game-changer for many Kiwi pet owners. This business has significant funding in place for product development and veterinary clinic trials in New Zealand and Australia. Helius Animal Health is led by Managing Director and co-founder, Leila de Koster.
Q8. Are you focusing on any particular terpenes?
Terpenes are of particular interest to Helius, and our team have previously utilised four different methodologies to extract terpenes from cannabis flower. We believe that terpenes are a critical component of the synergistic effect of cannabis, contributing to what is commonly called the ‘entourage effect’. As such, Helius will be extracting cannabis derived terpenes for use in our formulations, and we believe full spectrum preparations provide unique benefits for consumers and patients.
Q9. Do you have plans for phase 2 trials, if so, for what conditions?
Absolutely. We are not yet ready to announce these details, but we have set aside significant funding for Phase II trials with patients in New Zealand.
Q10. CO2 or Ethanol extraction?
Both. We already have our commercial scale CO2 and Cryo-Ethanol extraction facility operational at East Tamaki under our License to Deal in Controlled Drugs.
Q11. Will you have a recommended retail price so that customers can have price certainty and consistency as well as setting a reasonable price?
We will have RRPs for all our products, but ultimately pharmacies set their own pricing for what they sell. We are investigating ways to ensure greater pricing consistency, however regulations make this difficult to achieve. As competition ramps up, we expect pricing across the board to reduce then stabilise in New Zealand.
Q12. What is your best yielding variety so far?
We can’t comment on that right now, sorry. It’s commercially sensitive.
Q13. What strains will be available now and in the future?
Helius is licensed to cultivate over 40 cultivars and we’re operating an advanced cannabis breeding program in coordination with a Crown Research Institute. We have a range of high-THC, balanced and high-CBD cultivars in our facility, as well as several exotic varietals, bred to express minor cannabinoids and other desirable attributes. We can’t comment any further on specific products due to regulatory restrictions.
Q14. How is GMP tested?
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.
Q15. What does a typical day in the office look like at the moment?
We have a diverse team, including research & development, quality, analytics, extraction, manufacturing, cultivation, operations, marketing, legal, finance, administration and security. We also have a large property team who are managing the build-out of our primary site in East Tamaki.
Everybody’s day is different, depending on their role in the business. Most days start with team stand-up meetings, where managers review progress and lay out the tasks and objectives for the day. We’re a fairly flat organisation, meaning we’re not big on hierarchy. Everybody has a voice and we encourage inputs from the whole team.
We’re still doing a lot of foundational work, establishing Standard Operating Procedures (SOPs), testing and validating equipment, developing methods and optimising our operations. The cultivation team, which currently includes 5 people, are constantly improving our grow, keeping a close eye on plant health, vitality and yield among other things.
Helius is a very rewarding place to work. We’ve been successful because we have a very clear strategy.
Our purpose is to unleash the extraordinary potential of cannabis to improve quality of life.
Our ambition is to help create a world where medicinal cannabis has become the new normal in treating conditions with proven efficacy, advancing health for all humanity.
And our strategy is to be the most innovative medicinal cannabis company: Innovating to create the most efficacious and safe cannabis medicines in the world.
We have six values that influence everything we do:
First explorers of a new world: Together we’ve set off on one of our generation’s greatest adventures. Bravely going into the unknown, tackling every challenge and having each other’s back.
Make an outlasting difference: The quality of life of generations of people we may never know will be improved by the work we’re doing now.
Good is the enemy of great: ‘The most efficacious cannabis medicines in the world’ doesn’t have a ‘nearly’ in it anywhere.
Care at our core: Our patient comes first. And their safety comes first-first. No matter what.
Be the entourage effect: When cannabis compounds work together, they have a therapeutic super-effect. People are the same. Don’t be a single compound.
The faster we work, the sooner they’re well: We have a duty to our patients to move faster than normal companies.
Q16. What prompted you to get involved in the MC industry?
Prior to founding Helius, we were working in the corporate world, having built business in other industries, such as consulting, advertising, property, hospitality and software. We had successful careers, but were each looking for a new challenge – something with meaning. Initially, we were attracted to the medicinal cannabis industry because it offered an unusual balance of generating positive economic and social impact, in equal measure.
It’s not often you get the opportunity to work in a start-up business, in a start-up industry. Let alone one that requires disrupting one of the biggest and most powerful sectors in the world: pharmaceuticals. We knew that to be successful, a medicinal cannabis business would need entrepreneurial skills and commercial acumen, as well as grass-roots expertise in the area of cultivation, and an extraordinary depth of talent in science, quality systems and manufacturing. So, we had to build this world-class team with diverse local and international experience.
We’ve been creating a medicines company from the ground up, alongside a horticultural operation involving a ‘prohibited plant’, on a massive scale. It’s complicated. But we love it.
Today, about 2.5 years into our journey, I can tell you the challenge remains as exciting as it was at the beginning. But what has really moved me as been the patient stories. It didn’t take long for the entrepreneurial opportunity to give way to a fascination for helping people with this extraordinary plant. We’ve seen first-hand how cannabis is improving lives in New Zealand and, in some cases, saving them.
Since late last year I’ve watched a close friend suffering with terminal cancer, using a cannabis extract made by a wonderful compassionate producer in Northland – a ‘green fairy’ as they’re affectionately known. He had two months to live, six months ago. Today, he has reduced his opioids by about 50%, has regained a lot of his appetite (despite ongoing chemo) and, at the very least, has already extended his life in a meaningful way so he can spend more quality time with his family.
Watching his journey first hand is incredibly heart-warming. It’s a constant reminder of the good Helius can do in the world, with the team we have and the opportunity we’ve been given.
Q17. Do you intend to conduct trials for conditions where there is already evidence of efficacy?
Yes, we do.
Q18. When do you plan to have product ready for market?
Well, before the COVID-19 pandemic, we were targeting late 2020. This will likely be delayed now as our building works were suspended during the Alert Level 4 lockdown. Also, the processing of commercial licensing applications, under the Medicinal Cannabis Scheme, were delayed.
New Zealand made products will become available early next year.
This interview was published by MCANZ at https://mcanz.org.nz/spotlight-helius/