To Our Valued Shareholders,
As 2022 draws to a close, all of us here at Optimi Health are taking a moment to reflect on the accomplishments of the past 12 months as we prepare for an impactful 2023.
In that time, Optimi’s operational footprint has transitioned from vision to reality, inaugurating our cultivation and analytical facilities in Princeton, BC, entering into supply and distribution agreements, securing our Health Canada Dealer’s License (and subsequent amendments), and raising additional operating capital to name a few.
Our Promise remains the same: to make possible a future whereby psychedelic alternatives aid a wide variety of mental health conditions.
Our Purpose remains the same: to change lives through transformative human experiences safely and naturally.
Our Goal remains the same: to be the number one trusted, compassionate supplier of safe, natural GMP-grade psilocybin and synthetic psychedelics in the world.
These principles drive us daily, and they will continue to push us forward in 2023 as new opportunities materialize.
After 10 months of executing our plan to commercialize the Company for revenue success in 2023, we announced a private non-brokered deal in October with Mr. Chip Wilson (Wilson Capital – the Private Equity Division of Mr. Wilson’s family office). The Private Placement increases Mr. Wilson’s ownership of the Company to 9.5% on a fully diluted basis and gives Optimi the confidence and security it needs moving into 2023. Financial details can be found here.
Mr. Wilson is the founder of lululemon athletica inc., a passionate health and wellness advocate, and also serves as an advisor to Optimi. Along with all of our board members and advisors, we are incredibly grateful for Mr. Wilson’s financial support, and more importantly his confidence in Optimi to deliver a profitable, world-class psychedelics company.
End-to-End Makes Us Number One
Our goal to commercialize operations in 2022 was built on becoming the first end-to-end producer and supplier of natural and functional GMP mushrooms and synthetic psychedelics. It’s worth explaining why this is central to Optimi’s business development strategy.
First, it allows us a greater degree of stability and certainty in setting the price points for all of our products, benefiting clients by simplifying our supply chain and giving us complete control of production, distribution, and fulfillment logistics.
Second, it adds an element of security when dealing with GMP certified controlled substances that we feel is best practice for both quality assurance and compliance. We qualify all elements going into the production of our products from substrate through to bottles.
And third, our facility infrastructure from cultivation to analytical validation gives us a scalability advantage over our competitors as the demand for psilocybin, MDMA, and potentially other psychedelics increase in 2023.
To summarize: we are the only GMP compliant psychedelics company in North America built to scale and strictly focused on cultivating and formulating psychedelic products under the highest operational standards. No company in the space has invested more, and that’s because our strategy was built for long-term success while the regulatory landscape evolves.
Being an end-to-end supplier is how we plan to stand apart from the rest.
What should investors expect from Optimi in 2023?
When the psychedelics market was hot three years ago, our founders envisioned Optimi becoming the number one GMP cultivator and supplier of psilocybin and functional mushrooms in the world. Three years and a sluggish capital market later, much of the psychedelics space is still assessing where this nascent industry is headed.
To date, we have had some positive discussions with companies focused on large-scale clinical trials in the U.S. who require significant quantities of psilocybin biomass. Not only is this a priority and huge opportunity for Optimi, but it clearly sets us apart from our competitors who lack the critical infrastructure to supply GMP product at scale.
While some companies explore capital-intensive drug development for novel molecules, our goal for 2023 is simple: to grow and supply a lot of mushrooms, synthesize market-ready psychedelics, and turn our world-class facilities into revenue-generating assets that are frankly unmatched in the space.
Here’s how we plan to meet that goal:
- MDMA & Synthetic Psychedelic Supply Agreements
Led by Optimi Chief Science Officer, Justin Kirkland, who is arguably one of the brightest and hardest working scientists in psychedelics, we are pleased to announce that our proprietary MDMA formulation has been completed and will underpin both our revenue strategy and our portfolio of intellectual property in 2023.
We will be making a formal announcement in the coming weeks; however, with anticipated regulatory approvals from the FDA in late 2023 and/or early 2024, and the potential for MDMA to be used for authorized patients under Health Canada’s Special Access Program, Optimi is set to become the only psychedelics company in Canada with GMP MDMA that has been tested, analytically validated, and clinically trialled on healthy patients (therapists) for safety and efficacy.
Why is this important?
Earlier this year, psychedelic pioneer, Rick Doblin, claimed on Twitter that the Multidisciplinary Association for Psychedelic Studies (MAPS) was “aiming to train 25,000 therapists in MDMA-assisted therapy for PTSD by 2030.” He further hypothesized that potential clinical indications for MDMA (and psilocybin) could see more than 100,000 psychedelic therapists needing to be trained.
If the MAPS’ Phase III clinical trials continue to demonstrate safety and efficacy, and if regulatory agencies approve MDMA-assisted therapy as a legal treatment, a primary factor of patient access will be the number and availability of qualified practitioners ready to enter practice.
With our production infrastructure secured, and validation of our proprietary MDMA drug candidate scheduled for a Phase I clinical trial on therapists this spring, we are positioned to be the number one end-to-end GMP supplier of MDMA in North America, allowing us to immediately supply clinical trials and trainers who need access now.
2. Clinical Trial & Partnerships
In partnership with ATMA Journey Centers, who is the only Canadian organization to have completed – with positive results – a Phase I safety trial with natural psilocybin in healthy therapists, we expect to have our Phase I Clinical Trial assessing the safety of both our natural psilocybin and proprietary MDMA formulation in healthy patients (therapists) approved this spring and completed by summer 2023.
In order to further validate our combined offerings in a clinical setting, this historic trial will acquire data, including blood pressure, temperature, heart rate, and ECG readings, for dosages of Optimi’s proprietary formulation using 25mg of natural GMP psilocybin and 125mg of our proprietary MDMA drug candidate.
Why is this important?
- It validates the safety of our natural psilocybin biomass and proprietary MDMA drug candidate in healthy therapists;
- It confirms Optimi as the only psychedelic company in the world with two safety-validated drugs completed in a Phase I clinical trial for therapists; and,
- It removes barriers for us to supply every clinical trial available in 2023 and beyond.
3. Analytical Laboratory:
Optimi’s state of the art analytical laboratory was designed to analyze our psychedelic and functional products; however, in the process of validating our psychedelic formulations, we saw an opportunity to extend our expertise to other companies aiming to validate botanical products through Optimi’s GMP qualified, Health Canada authorized facility.
During 2023, our analytical laboratory will provide extensive drug analysis capabilities. The combination of our team’s experience and our cutting edge, GMP, Health Canada approved facilities will allow us to assist our clients to analyze botanicals and provide Certificates of Analysis (COAs).
4. Functional & Nutraceuticals
2023 will be an important year of growth for our Nutraceutical division. In 2022, we successfully launched our six encapsulated products and two protein powder skus into the Canadian marketplace. Our quality scores from satisfied customers are exceptionally high in the functional mushroom space and our protein powder is noted as being the best tasting in the category.
Continued growth will be fuelled primarily through acquiring new retail doors with the recent signing of a leading broker and distributor in the healthcare space. We will complement this effort with Amazon, which has just picked up distribution, and an active social media campaign to attract more clients to our brand.
Further, exploring new markets to export large quantities of natural psilocybin and functional biomass will be a priority in 2023.
Early trends driving growth include:
- The rise in veganism and animal conscious sustainability practices;
- The demand for mycelium-based products to be used as a substitute for wearables such as leather;
- The demand for low fat, low cholesterol food because of various health related problems like obesity and cancer;
- The rapid global expansion of the hotel/restaurant/catering sector; and,
- The increasing demand for functional mushrooms in the sports nutrition, pet care, and craft beer industries.
Optimi needs to be at the forefront of these emerging trends and will be aggressively pursuing customers in these expanding markets with a re-focused sales team.
As we continue to navigate the fledgling psychedelics industry, the only thing we can control is product development and finding innovative ways to get our product to market. That is our promise to shareholders who have been patient with us, and we will continue to push the Optimi story to those willing to do business with us in 2023.
Thank you for your continued support and belief in Optimi. Please have a safe and prosperous new year.
The Optimi Team