Silo Wellness Inc. (CSE: SILO) (OTCQB: SILFF) (FSE: 3K7A) ("Silo Wellness" or the "Company") is pleased to announce that the Jackson County Planning Commission recommended to the elected commissioners the adoption of an amended land use ordinance that would allow Oregon psilocybin therapy service centers in a nature retreat setting in rural Jackson County. "This is a minor victory for Silo Wellness and for potential patients across the nation," said Silo Wellness founder and CEO Mike Arnold, an Oregon attorney. "As previously drafted, service centers would have been relegated to urban areas. Highway noise and sirens aren't exactly the best setting for psychedelic therapy. But there's still one more vote to go."

Silo Wellness Announces LOI for Potentially Largest Psilocybin Retreat Center in Oregon and the World - If November's Election Is Favorable; and an Oregon Real Estate Law and Psilocybin Industry Primer
Silo Wellness Inc. (CSE: SILO) (OTCQB: SILFF) (FSE: 3K7A) ("Silo Wellness" or the "Company"), Oregon's only publicly traded psychedelics company, is pleased to announce it has executed a binding term sheet for a joint venture with New Frontier Ranch in the majestic Green Springs area of Jackson County Oregon, east of Ashland, pending the results of the opt-out ballot measure in the upcoming November 8th election. New Frontier Ranch is a 960-acre property that can potentially accommodate hundreds of guests at a time between the existing log cabins and court-approved campsites.
A one-of-kind destination guest recreation property among Oregon's restrictive and complex land use laws
"This property has an abundance of water rights in this drought-stricken portion of our beautiful state and has court-approved camping spots with room to expand due to a special court decree grandfathering in these property rights years ago," stated Silo Wellness founder and CEO Mike Arnold, an Oregon attorney. "Under Oregon's tough rural land use laws, this property is truly a gem that could allow for scaling for psychedelic retreats rather quickly at a lower price point. Absent full legality and total removal of the dead hand of the government - which is still necessarily present in this emerging market - scaling is the only way to make this industry affordable while ensuring client safety."
"My vision for this property is as a sacred sanctuary for holistic health and wellness," stated David Kaplan, New Frontier owner-operator. Mr. Kaplan has over 45-years' experience in the CPG space involving diet and nutrition, as well as the yoga and meditation space. "This property can truly be the marvel of holistic healing for the mind, body, and soul. Mushroom therapy is just one potential component of a much larger plan for rejuvenation and wellness. Living on this property for several years, I see so much potential for the land to be an eco-village destination location totally sustainable with organic agriculture, energy and building materials. The ranch has 287 days of year of sun per year and the most water in the area with ample wind and wood resources."
The unique property rights history of the ranch were solidified on May 17, 1976, when the Circuit Court for the State of Oregon for Jackson County approved a decree grandfathering in what would now be considered a "destination resort" under today's rules, which are nearly impossible to acquire in Jackson County and much of the rest of the state of Oregon. This historic approval is highly unique. According to the property's land use consultants, there is not another like it anywhere in the state of Oregon whereby a grandfathered-in resort is allowed to continue to develop.
In 2013 the decision went back to court yet again, ultimately to result in a non-expiring ranch resort. According to the site plan there are 34 existing sites which include 16 teepees, 6 wall tents and 12 additional sites. This would allow for an additional 26 sites to be developed to reach the total 60 allowable campground spaces per the decree allowing potentially hundreds of guests at a time. The decree, however, says that the campground can have potable water, bathrooms, showers and laundry facilities including washers and dryers and does not specify a limit on the number of these amenities that can be provided.
A destination lodge, including overnight guest accommodations, could also be constructed within the designated village boundary. It is not stated in the court decree that there is a limitation on the number of rooms that can be allowed.
Cost-Effective Psychedelic and Holistic Wellness Resort
Silo Wellness is the leading luxury psilocybin retreat company in the public markets which has been featured in Bloomberg, Fodor's Travel, The Evening Standard, Men's Health, The Washington Post, and Outside Magazine among others. However, Silo Wellness never intended to enter the luxury retreats space. "That wasn't my vision," continued Arnold. "Our mission is to put psychedelic healing into the hands of those suffering as quickly and inexpensively as possible. Nonetheless, the luxury model was necessary during COVID and has been very good to us and for our clients. However, it is not available to everyone due to the price point, which is a shame and also contrary to our mission.
"With this partnership and our partnership with Go Natural Jamaica," Arnold stated, "Silo Wellness intends to be able to drive down the lodging costs for psychedelic retreats. New Frontier Ranch may allow us to significantly undercut some of the out-of-state competition who may come to Oregon with the goals to make huge margins on expensive retreats. This is the people's medicine and shouldn't be held hostage in pharmacies or by out-of-state interests attempting to upsell Oregon's natural beauty."
About New Frontier Ranch
The New Frontier Ranch contains a 100-acre spring-fed meadow off of Highway 66 four miles from Tub Springs State Park and eight miles from the Cascade-Siskiyou National Monument. The three private log cabins feature knotty wood interiors, vaulted ceilings and decks with views. In addition to full kitchens, there are living rooms with wood-burning fireplaces and laundry rooms. Canvas tents and tipis are also available in three campground areas. The Great Western Hall is a grand barn with reclaimed wood walls, plank floors and a cathedral ceiling. Massive doors at each end open to bring the outdoors in. The upper mezzanine level has a private dressing room, and two large balconies overlooking the main floor. The Great Western Hall provides seating for up to 250 guests. There's also access to a water slide connected to a swimming and fishing pond and a rustic, barn-style banquet hall. "We caught six bass in six casts the last time we were there," Arnold said. "This property has unending recreational opportunities for nature retreats."
Meeting psychedelic clients where they are
"So many business models that are being pitched to me in Oregon are premised on the market being exclusively urban Portlanders or the psychedelic savvy," stated Arnold. "We believe that a significant part of the market will be from out of state and more culturally conservative than the traditional psychedelic consumer. Our real-time consumer research in the legal market over the last two years has shown that folks in the flyover states and in rural areas aren't typically looking for some 'new agey' encounter. They are already scared about the medicine but are also, quite frankly, afraid of Oregonians - or what they perceive to be Oregon, thinking that these services are run by crystal carrying pseudo-science hippies. That's just not universally going to be the case. This is largely a medically- and science-influenced industry as illustrated by our team at Silo Wellness, which includes leading experts in the space.
"At Silo Wellness we attempt to meet people where they are. Many of our clients come from more culturally traditional areas of the Midwest and Southeast. The New Frontier Ranch gives us many opportunities to provide services that meet their diverse backgrounds without a dogmatic approach to the medicine, including meditation areas, a hike to Mount Shasta views, yoga, and an industry leading Calvary cross Christian meditation trail. This property checks all the boxes for our retreat model: affordable lodging, Oregon nature, water access, nearby whitewater rafting, and spaces for spiritual growth to contemplate personal purpose and the 'whys and hows' of conscious awareness and existence."
Oregon's real estate problem: A significant barrier to entry for psilocybin service centers
A major barrier to entry in Oregon is the supply of psilocybin-ready real estate and the capital to achieve it. Psilocybin companies cannot operate on either federal land or on any property with a bank mortgage due to it being Schedule I and illegal federally; additionally, all traditional mortgage contracts preclude violating federal law. "From Oregon cannabis we learned that most of the attractive real estate in the premier areas is expensive and traditionally financed, often relegating early commercial dispensary operations to the dregs of the cities and strip malls to buy outright or to lease from unleveraged properties," stated Arnold.
"Psychedelic therapy is all about set and setting and strip malls do not necessarily fit the bill in the metro areas, making desirable space in short supply there. For retreats in beautiful areas, most of Oregon's wild areas are owned by the federal government and the rest are very expensive due to the rarity of commercial spaces in rural Oregon due to our Urban Growth Boundaries and preferential treatment for agriculture and forestry zoning."
One potential problem for Oregon psilocybin businesses, is that the longer a company waits to secure a property, the more of the margins/value will be realized by the landowners rather than the operators, as was seen in cannabis. Hence, the REIT model working out so well in the capital markets for cannabis investors. They owned the land and leased it to the operators. "We believe that Silo, as the first legal mover in Oregon psychedelics operationally and in the public markets, is well positioned with boots on the ground in Oregon," Arnold said.
Location, Location, Location: Jackson County as a potential leader in the psychedelic retreat space
This potential psilocybin retreat center location is less than an hour drive from the Medford airport. It's approximately an hour flight from Portland, a little over an hour from San Francisco and Seattle, and 4-hour drive from Portland and Sacramento. It borders BLM wildland and is near a national monument wilderness area. This allows patrons to access thousands of acres of wildlands with rare biodiversity. This area is the home to an extraordinary array of plants and animals in a rich mosaic of forests, woodlands, grasslands, wet meadows, and ponds. On a day hike it is possible to experience each of the distinct ecoregions and find plants and animals you cannot see anywhere else in the world. It is rare, vibrant and vital. New Frontier is also in the middle of the country's best whitewater, surrounded by several different watersheds (Scott, Cal-Salmon, Illinois, Rogue, Klamath, Smith and Umpqua), all within driving distance. It is also in the county that is the leading cannabis producer in Oregon and host of the world-renowned Shakespeare festival.
November's Opt-out Election: Voters' perceived harm by legal cannabis rollout
Jackson County capitalizing on the influx of psychedelic wellness tourism and having access to nearby psychedelic retreats is dependant on the November election. The County Commission referred an opt-out measure to voters due to an allowance for county and municipal prohibition under 2020's Ballot Measure 109. The County may end up opting out as it was a very close election in 2020 with only 51.19% voting yes. The under vote was only 3% of the total votes cast, illustrating the interest in this particular ballot measure.
"As advocates we may be spending too much time addressing the merits of psychedelic therapy and not focusing enough on the operational impact on these rural communities," Arnold opined. "Based on the conversations we have had with local voters, the efficacy of mushrooms is not their point of contention. They are most worried about the impact on their neighborhoods.
"Jackson County voters often feel that they were sold a bill of goods with the previous two controlled substances ballot measures. They were told that Oregon's recreational cannabis laws would help curtail black market trade. That ended up not being the case as we have seen with the recent cartel activity and the potential forced labor trafficking resulting from it."
Rural residents also didn't see much of the economic benefits promised beyond employment, since Oregon's recreational cannabis ballot measure didn't allow county governments to tax cannabis farms. They could only be taxed at the dispensary level. Since most dispensaries are located in cities, they received most of the law enforcement hassle with the farms and the increased vehicular traffic on rural roads and the now ubiquitous smell, but little of the tax benefits.
Fast forward to the implementation of Oregon's ground-breaking BM 110, which decriminalized hard drugs such as cocaine, meth and heroin. "Since Oregon has been slow to implement the treatment that was promised in that ballot measure, many rural Oregonians believe they have suffered from increased crime resulting from the now more open and notorious use of hard drugs in their communities," stated Arnold. "They often believe that the increased demand resulting from the decrease in legal risk from consumption has led to an increase in supply and the criminal consequences of that trade. The increased supply to meet this increased demand has to come from somewhere and it isn't some bucolic farm - it's from drug dealers with organized crime connections.
"Fortunately, these fears are not applicable to BM 109. First of all, this is a services industry not a product industry. The mushroom cultivation will be small and indoors with no smell, marginal water consumption, and no impact on the neighbors. Furthermore, there's no incentive for black market growers to seek a license since it would draw unwanted attention to them. You can already grow undetected in a closet in a rented apartment. Contrast this to cannabis grows which require lots of space, lots of water, lots of staff, and lots of sunshine or electricity. Also, black market operators using Oregon's cannabis law as cover were sending surplus or chemically tainted product out the backdoor to the black market. This simply is not a feasible business model for BM 109.
"Additionally, our experience operating legal retreats in Jamacia is that these have about as much community impact as a yoga or quilting retreat. They are centered around introspection through meditation, self-reflection, journaling, and group integration. The community impact is just not comparable to the effects of cannabis."
Urban Dilemmas: Set and Setting
Urban areas for psychedelic therapy can be a problem for two reasons. First, properties are expensive with dense commercial locations meaning you often can't get the beautiful expensive property as a tenant since it is mortgaged by the bank that cannot do Schedule I controlled substance business. Oregon is just a typical property-owning framework where real property is often leveraged. This means you have to own the property free of bank financing or lease the property from someone in that situation.
The second issue with urban areas is that the best practice for psychedelic therapy is set (mind set) and setting (location). Silo Wellness believes that the main differentiators for psychedelic retreats are price, experience, and location (setting). "Our market research from speaking to actual clients leads us to conclude that there's not a lot of people who can afford to travel to Oregon for therapy that are going to be staying at a Motel 6 and commuting to three sessions in a white walled doctor's office to take mushrooms," explained Arnold. "You couldn't pay me to do that. That sounds horrible. These are fully immersive experiences that are life changing and deserve to be done in the beauty of nature.
"Have you ever been on a vacation locked in a hotel room in downtown Random City that was life changing, where you were considering buying a vacation spot? Most people's experience in lifechanging trips involve beautiful locations close to nature (beaches, mountains, rivers, lakes, etc.). They sell timeshares to those folks because their mindset has changed due to their setting. This is even more so for psychedelics where the connection to nature is an essential part of the experience."
In order to make retreats affordable, the Silo hopes to leverage the ranch's campground as well as sponsor sliding scale rates with the margins subsidizing those in need or a scholarship model.
A Primer on Oregon's Land Use Laws and the Scarcity of Rural Retreat Properties
"The working assumption for the last few thousand years is that psychedelics are done in nature," stated Arnold. "And we are talking deep dives here: The transformational trips that people pay to travel to the only legal places in the US."
"Oregon has some of the nation's best (or worse, depending on your point of view) land use laws. First, we have urban growth boundaries that prohibit urban expansion. Any time in the last fifty years if you flew into an airport, the farmland nearby is still mostly farmland. Oregon's Willamette Valley (where 70% of the state lives) is some of the best farmland on planet earth due to a geographical freak accident in the last few ice ages. The Willamette Valley stole a lot of its topsoil from Idaho and eastern Washington when ancient glacial Lake Missoula's ice dam broke. During the ice ages, glaciers blocked the Rocky Mountains and periodically the dam broke scourging the bad lands in Idaho and ripping down the Columbia River. The last ice age flood was so devastating that it filled the Willamette Valley with water hundreds of feet high (you can see the vegetation line at the top of Mary's Peak near Corvallis) and roared upstream (uphill) along with all the topsoil (and icebergs clad in Rocky Mountain basalt).
"When the water receded back to Portland and then on to the ocean, it left behind up to 200 feet of soil in places. Hence, we have some of the best soil with some of the best irrigation and disease- and weather-free growing seasons on the planet. Oregon state laws jealously protect this non-renewable natural resource.
"What this means is we don't pave over farmland in Oregon, and we can only grow communities upwards into the air or closer together (through densely packed mixed zoning residential/commercial urban zoning and multi-family dwellings) within the urban growth boundaries. This is why property prices grow and grow in Oregon, because there is no more substantial development without legislative change. And in Blue State Oregon, this likely is not going to happen."
Mushroom Cultivation: A services industry versus product industry
Silo Wellness began legally harvesting mushrooms in Jamaica in 2019 and cultivating shortly thereafter. "We came to Jamaica to cultivate mushrooms out of necessity and then saw the writing on the wall regarding commoditization," explained Arnold. "We then taught a local family how to cultivate mushrooms and began partnering with other locals as they entered the space.
"I have heard a lot of entrepreneurs talking about their plans to be mushroom growers under Oregon law, which is concerning given how quickly this market may commoditize. The room you are in right now can almost grow enough mushrooms to dose an entire Oregon county. Five grams of dried biomass is often way too much for some people in a session and you can stack boxes or grow bags vertically. This will commoditize much faster than what it took for cannabis. That's a race to the bottom. You need a small room or outbuilding to grow enough mushrooms for an operation. Growing mushrooms is not the land grab issue like growing cannabis. You will not be seeing early-cannabis-like business valuations based on grow space square footage. This is about locations for the services, the team to safely conduct them, and the brand and marketing to attract clients."
Federal and State Government Property Rights
"That leaves you with finding a property that consumers want to visit (hence the above analysis about setting). Here's the rub in Oregon: 53% of the state is owned by the fellas that print the money (the Federal Government) and can't be used for cannabis or mushroom operations (federal crimes and state law prohibition). However, much more of the wildlands and beautiful spots are owned by the feds. This is great for preserving the outdoors but not so great for commercial operators, unless you won the family lottery ticket of owning one of these properties for generations. Also, the coast is owned by the state of Oregon up to the highwater lines. Additionally, the rivers are often bordered by residential ag/forestry or the feds.
"This is why New Frontier Ranch is such a unique gem."
Silo Wellness Requests Other Oregon Property Owner Expressions of Interest for Collaborating on Psilocybin Licensing
"Over the past months we have been touring properties with owners and realtors and have really turned up our search for properties that may be suitable for Oregon psilocybin as we await the final rules from the Oregon Health Authority and the outcome of the local opt-out elections," Arnold continued. "However, I also know that there are many property owners who may believe they are sitting on an ideal property for a facility with no interest in selling, but they may not have the legal expertise, network, or capital to make it happen. It is our goal to leverage our platform to help empower Oregonians who may each have a piece of the puzzle - facilitation experience, business experience, property, capital, or a passion for the medicine - and bring them together to help make this industry by Oregonians for Oregonians."
Parties who may be interested in entering the Oregon psilocybin industry are encouraged to contact Silo Wellness at oregon at silowellness dot com.
Terms of Agreement
The binding term sheet sets forth the intent of the parties for a potential joint venture between Silo Wellness and New Frontier. The parties intend to co-brand and market a resort/retreat location at the New Frontier Ranch, 16799 Hwy 66, Ashland, OR 97520 (the "Property"). The parties intend to finalize terms to potentially rebrand the Property or a portion of the Property to "New Frontier Ranch by Silo Wellness." The joint business plan is to market the Property or a portion of the Property being used for the "New Frontier Ranch by Silo Wellness" as the world's largest psychedelic ecotourism resort and retreat center for psychedelic therapy and the psychedelic curious. Additionally, the agreement sets forth that the parties may decide to pursue a purchase agreement, which would be dependent on financing. Additionally, binding terms include a "no shop, no solicit" clause and a prohibition against assignment.
ABOUT SILO WELLNESS
Silo Wellness is a growth-oriented holding company focused on psychedelic opportunities that benefit from a unified ecosystem and exceptional leadership. Founded in 2018 in Oregon and headquartered in Toronto, Silo Wellness has a presence in both Jamaica and Oregon. Silo Wellness is a publicly traded company on the Canadian (CSE: SILO) and Frankfurt (FSE: 3K7A) exchanges and trading on the OTCQB Venture Market (OTCQB: SILFF).
For more information about Silo Wellness or to book a Jamaican psychedelic retreat, please visit www.silowellness.com. For more information about Silo's recent acquisition, Dyscovry Science, visit www.Dyscovry.com.
Silo Wellness Company Contact:
Mike Arnold, President
541-900-5871
IR at silo wellness dot com
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION:
This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking statements") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates, and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. Forward-looking information may relate to anticipated events or results including, but not limited to the ability of the Company to finalize definitive documents and close on this potential partnership or transaction; the Company's ability to satisfy the Oregon licensing requirements and achieve a license in Oregon; the Company's ability to successful launch an Oregon operation, including hiring of qualified staff and getting access to mushrooms to sustain operations; and the Company's ability to fund operations as well as the company's pre-existing capital requirements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, regulatory, political and social uncertainties and the potential impact of COVID-19. Such risks and uncertainties include, among others, the risk factors included in Silo Wellness's continuous disclosure documents available on www.sedar.com. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Readers should not place undue reliance on the forward-looking statements and information contained in this news release. Silo Wellness assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
Silo Wellness
Overview
Psychedelics have long been believed to have medicinal value, and now a growing body of research supports that theory. Johns Hopkins has published over 60 peer-reviewed studies on the topic, reflecting research into how psychedelics can impact behavior, cognition and brain function. The University of Texas even opened a new center to study how psychedelics can be used to treat depression, PTSD and anxiety. Research paved the way for the cannabis industry, and now psychedelics are not far behind.
In the US, Oregon became the first state to legalize psychedelics in 2020 with Measure 109 for medicinal administration, and now other states are following suit. US Rep. Alexandria Ocasio-Cortez also filed a measure to remove a 90s-era provision on psychedelics. While it was rejected, the vote has never been closer — a sign that we may see the federal government reducing its restrictions on psychedelics soon. Companies pursuing the field of psychedelic medical treatment now are poised for success as legal barriers are removed, either at the state or federal level.
Silo Wellness (CSE:SILO, OTCQB:SILFF) is a psychedelic wellness company pursuing two parallel tracks to capitalize on the growing market fully. First, biotech research represents its long-term track, with the second track focusing on providing services in jurisdictions where legal barriers have been removed. The company, which was founded in Oregon by an Oregon lawyer, has previously launched Oregon’s first legal psychedelic retreats via ketamine (also a U.S. legal first). Silo Wellness is pursuing treatment programs in Oregon under Ballot Measure 109 and has a proof-of-concept center in Jamaica. Combined, the company has a unique combination of business lines for both near-term and long-term revenue.Oregon legalized psilocybin treatment in 2020 and Silo Wellness is the only public company with an established presence in the state. Public companies such as Field Trip and Cybin will not be able to participate directly in the U.S. market due to federal prohibition as that is not allowed by the NASDAQ and NYSE exchanges. In addition to being founded in Oregon, the company is pursuing creating wellness facilities within the state with Oregon legal protection. Additionally, the company presently offers Jamaican psilocybin and 5-Meo-DMT wellness retreats staffed by local experts, including Rastafari Indigenous leaders. The Jamaican retreats are paving the way for the company’s Oregon treatment facilities, creating near-term revenue opportunities and the people, processes, and procedures necessary to safely provide these services in a regulated market.
Silo Wellness recently acquired 100 percent of Dyscovry Science Ltd, a Toronto-based biotechnology company focused on biosynthetic manufacturing of psilocybin and its derivatives targeting a physiological condition, irritable bowel syndrome. Dyscovry has the IP, facilities, and public collaboration to allow Silo to fully pursue the development of a pharmaceutical treatment platform. The acquisition allows Silo Wellness to further its goal of covering both tracks of the psychedelic industry under one roof: psychedelic healing now via jurisdiction-by-jurisdiction "adult use" and pharmaceutical biotech.Silo Wellness founder Mike Arnold explained, “Psilocybin mushrooms changed my life. The first thing I thought of after my first dose was, ‘how can I get this treatment into the hands of people in need as quickly as possible?’ We can’t let this plant-based treatment get locked behind long trials and legal restrictions. Not psychedelic healing one day, but psychedelic healing right now.”
The company is led by an experienced team of scientists, researchers, and managers. Silo Wellness has all the right specialists in place to pursue its parallel track and achieve its ambitious goals of legal facilities and psilocybin-based pharmaceutical treatment.
Company Highlights
- Silo Wellness is a psychedelic wellness company with a parallel track focusing on developing wellness facilities and a psilocybin- or derivative-based treatment.
- Silo Wellness is the only publicly traded company with an operational foothold in Oregon that replicates its proof of concept for psilocybin in Jamaica.
- The company’s Jamaican psychedelic wellness retreats provide a current revenue stream.
- An experienced team of managers and scientists lead the company towards its goals of widespread treatment with psilocybin-based treatments.
- Silo Wellness recently acquired 100 percent of Dyscovry Science Ltd., a Toronto-based biotechnology company focused on biosynthetic manufacturing of psilocybin and its derivatives targeting irritable bowel syndrome.
Business Segments
Psilocybin Metered-Dose Nasal Spray
Silo Wellness developed a patent-pending metered-dose nasal spray with a July 2019 priority date to provide accurate dosing with a faster uptake speed than digestion. Additionally, ingesting psilocybin can often cause discomfort in patients. Silo’s product circumvents this problem entirely with nasal administration.
Project Highlights:
- Patent Pending: Silo has pending patent applications in the US and Canada that cover multiple methods of delivery and various psychedelic compounds.
- Metered for Patient Safety: Just like other medications, accurate dosing is essential to treatment. The nasal spray’s metered dosing system creates a faster uptake speed and prevents accidental stacking of doses.
- Focus on Gut Health: Silo Wellness, in a pending collaboration with Dyscovry Science, focuses on Irritable Bowel Syndrome specifically and inflammation generally. The ongoing research is exploring the objectively measurable physiological medicinal effects of psilocybin rather than the hard-to-measure subjective psychological benefits.
Psychedelic Wellness Retreats
The company presently operates psychedelic wellness retreats in Jamaica, where it conducts legal psilocybin-assisted treatments. The retreat system’s policies, procedures and protocols are directly transferable to its planned Oregon facility. Silo Wellness is the only publicly traded company with a presence in Oregon, having been founded there by an Oregon lawyer in 2018.
Project Highlights:
- Custom Intake Process: Silo Wellness has created an intake process to ‘meet clients where they are, which is generally a culturally traditional background from rural areas or the Midwest or South rather than more of a “new age” clientele. Its intake process focuses on understanding the needs of each client and taking a scientific approach to treatment.
- Working with Experts in Jamaica: Psilocybin has a long history in Jamaica, and Silo Wellness is working with local Jamaicans and Rastafari Indigenous leaders to administer treatment and facilitate healing.
- Oregon Facility is First Legal Psychedelic Retreat in the US: Silo Wellness held the United States’ first legal, psychedelic wellness retreats in Oregon with ketamine in 2021. The planned Oregon psilocybin system will import its policies and procedures from its pilot program in Jamaica.
Management Team
Mike Arnold - Founder, CEO, Oregon lawyer
Mike is an experienced Oregon trial attorney (complex criminal defense and commercial litigation) and the founder of Silo Wellness. He serves as the company’s president and chairman of the board of directors. He is responsible for Ontario Securities Commission and Canadian Securities Exchange compliance, investor relations, financing, and corporate development. In the last five years he has successfully raised over $12M for his startups.
He was actively involved in the cannabis sector in Oregon, having defended cannabis farmers in both federal and state courts. Additionally, Mike was involved in cannabis regulatory work, drafting cannabis license applications, and securing land use approval for cannabis facilities as state regulations permitted. He is also an experienced farmer, having raised livestock and poultry and operated a commercial cannabis outdoor farming operation.
Mike developed the concept for Silo’s metered-dose psilocybin nasal spray in 2018 together with his co-inventor. In Jamaica, he has extracted psychedelic compounds from raw biomass and developed and quality tested products there prior to founding psilocybin retreats there and ketamine-assisted psychotherapy retreats in Oregon.
Winfield Ding - Chief Financial Officer, CPA, CGA
Mr. Ding has been CFO and director for a number of public companies in Canada. He is a seasoned senior finance executive with over twenty years of finance and operations experience. A former audit manager and currently a self-practitioner, he worked in audit, taxation and advisory roles across a wide range of industries with a focus on public issuers financial reporting and business advisory. Mr. Ding received his MBA from the Chinese University of Hong Kong. Mr. Ding replaces Ryan Ptolemy as the Chief Financial Officer of the Company.
Michael Hartman - Director, Psilocybin Nasal
Michael Hartman is an accomplished pharmaceutical product developer, a scientist and a Director of Silo Wellness. His expertise on respiratory drug delivery and creating formulations for pressurized metered-dose inhalers and dry powder inhalers helped release Silo’s metered nasal spray. Michael earned five patents in the field of pharmaceutical aerosol formulations.
Dr. Parag Bhatt, Ph.D - Pharmacologist Science Advisor
Dr. Bhatt is a co-inventor of the Silo Wellness “magic mushroom” nasal spray. He obtained his doctorate in Pharmacology and Physiology at Saint Louis University with a focus on the neuromodulatory roles of serotonin (5-HT) and dopamine (DA) on a developing neural circuit in Drosophila melanogaster, the fruit fly. He has extensively studied how deviations in the development of neural circuitry contribute to the development of effective neurological disorders.
Dr. Simon Bababeygy - Director, M.D.
Dr. Simon R. Bababeygy is an ophthalmologist in Los Angeles, California. He is affiliated with different medical institutions including Loma Linda University Medical Center and VA Long Beach Healthcare System. Dr. Simon received his medical degree from Stanford University School of Medicine and has been practicing for 20 years.
Silo Wellness Wins Amendment to Proposed Land Use Ordinance for Oregon Psychedelic Ranch; Corporate Update: Shareholder FAQs
Jackson County recently voted 52.7% against a psilocybin "opt out." Next up in the saga is the land use hearing before the Jackson County Commissioners next Wednesday, November 23rd at 1:30 p.m. They can choose to accept the ordinance or amend it in any fashion, including adopting its original form, which continues to be a risk factor of the Company's Jackson County plans. Advocates are invited to testify remotely or in person: https://jacksoncountyor.zoom.us/j/89523141457.
Psilocybin Home Occupations?
The new proposed ordinance, which can be downloaded here, would not only allow Oregon psilocybin therapy retreats at existing lodging locations, such as New Frontier Ranch, with whom Silo has an LOI, but also in enclosed outbuildings on residential farmland under statutory "home occupation" exemptions. "At the hearing I advocated that the county shouldn't just allow for commercial lodging locations for companies like us but should also allow for home occupations," stated Arnold. "This is a matter of fairness for Jackson County entrepreneurs but also is a matter of patient access. The more options for care and the more competition, the lower the price and the better the quality of services. A rising tide lifts all ships. Let's hope the commissioners agree."
What happens if the Oregon psychedelic ranch LOI is terminated due to next week's vote?
"I have been in Oregon for 24 years and a trial lawyer for most of my time here," stated Arnold. "Consequently, our network runs deep and so do our legal options.
"I chose New Frontier Ranch for several reasons. First, the property is amazing. Second, the property owner is a dear friend whom I trust. Third, the likely capital expenditures are low due to the potential joint venture. Fourth, it is already operating in a commercial capacity with lodging and event hosting. However, it's the court judgment that makes this property one of a kind because of the pre-code grandfather rights there. If the commissioners revert back to 'general commercial' zoning only for psilocybin, we will confer with the county for an exemption under the prior judgment. If they do not acquiesce, we intend to litigate.
"That would push out any potential launch down there for a longer period of time, if at all, due to the adversarial process but could potentially make us the only psilocybin service center in rural Jackson County. In the meantime, I will simply plan to move on to my second or third property options and begin to negotiate terms there.
"We remain undeterred in our plans to be a market leader in Oregon. I founded Silo in 2018, anticipating filing an Oregon license application in 2023. It's been a long road. To get to this point, we had to first cultivate mushrooms in Jamaica, then operate retreats there, but also raise capital and complete a public listing. But now here we are on the cusp of what we believe to be the last chance to be first to market in the plant medicine space. It's a very exciting time."
Other Corporate Updates - Shareholder/Investor FAQs
Silo Wellness receives many investor relations questions. Given the frequency of some of these questions, Silo Wellness will update its Investor FAQ page as follows:
How do retreats scale? Do you lease or own the locations where retreats are located?
In Jamaica, we neither own nor lease the space. As mentioned in previous MD&As, the Company uses agreements with third-party resorts. These agreements are non-material.
Booking different locations as we went along initially allowed the Company to build out the business model without having the capital risk associated with purchasing, running, and operating a resort. By not leasing the resorts, we do not take on the long-term risk of vacancies.
This booking model was very efficient during COVID when the supply of vacancies far exceeded demand for Jamaica resorts. However, with the rise of digital nomadism and increased tourism abroad, quality locations with the proper setting for psychedelics are rarer. Additionally, the previous model still had risk by booking an entire resort per retreat: If bookings don't meet the breakeven threshold, then a retreat could be operated at a loss.
This is a great deal for the resort but not so much for the Company. Yes, we get some economies of scale through discounts by booking an entire resort or block of rooms. However, those aren't the sort of collaborators we are looking for in the space. We are looking for friends and partners, not looking to be someone's customer. The resorts received all of the publicity of being associated with their customer (Silo) in a cutting-edge sector and thus received all of the earned media coverage that being a pubco and early mover leveraged. They also received the other marketing - with none of the cost. Then, the resort could turn around and market their resort to other psychedelic operators who would come to them thanks to us raising their profile. Exclusivity was not negotiated by previous leadership, nor was it even likely to be granted without considerable financial commitments by us given our smaller scale at that time. Essentially the Company was a glorified booking/marketing agency for the resorts with none of the risks shared by the resorts.
Property Collaborations. Consequently, since June 2022, under the new Silo Wellness leadership, the Company embarked to leverage relationships on the island to minimize risk by collaborating with other operators. On August 22, 2022, the Company announced the first of those collaborations involving Go Natural Jamaica. In that collaboration we book as we go with the risk shared by the operator. This is a fair deal for the resort in that they get the momentum of the psilocybin industry with the Silo Wellness psychedelic brand and risk mitigation process that invokes trust and safety. Additionally, they can still fill up their resorts with non-psychedelic customers when we are not hosting and thus do not have to share that revenue with us.
There are two things that clients are looking for when booking a retreat: cost and safety. They are afraid that they might break their brain. That's a horrible mindset to have when trying psychedelics for the first time. Most people are coming to fight fear (fear of the future and fear of what happens due to the regrets of the past), so introducing a new form of fear due to the medicine itself or the providers of the medicine is not necessarily very helpful.
We mitigate that fear by focusing on client safety. Clients come to us knowing that we have the intake team, protocols, and procedures in place to keep them safe.
Clients also know that we are a US and Canada-based company and not some perceived fly-by-night foreign operator. They have read the testimonials and watched TV interviews of past participants, and have seen the third-party validation from independent journalists (CNN, Outside Magazine, Bloomberg, Forbes, Fodor's Travel, Men's Health, Evening Standard, Washington Post, etc.). There's also the feeling of safety by booking with a Company that has the regulations and transparency that surround a publicly traded company. That's another layer of trust. They know that the buck stops somewhere.
We market, intake, prepare clients, administer the medicine, risk mitigate the ceremonies, and integrate clients. The resort operators do what they do best: run the hospitality side of resort accommodations (transportation to/from the airport, lodging, food, etc.).
The Hilton Hotel Model. This of course is all a short-term model. As we grow, this model scales similar to the hotel industry. If someone wants to book a stay anywhere in the world, they can always trust a minimum level of care by booking with someone like Hilton. The brand invokes trust and consistency of lodging and services. The local entrepreneurs and property owners can focus on the on-site client care and get the economies of scale that come with booking, protocols, procedures, etc. that the brand brings to the table.
So that begs the question: If psychedelic medicine is potentially a hotel-type model, then why isn't Hilton branding psychedelic retreats? Because it's federally illegal in the United States and traditional banks can't touch the space for now. This means capital is scarce and this is why the psychedelic industry (the cannabis industry before it) was funded by speculative private investors. They get the greater potential returns that come with a successful revenue-generating business that banks can't finance, but they can exit at any time due to having invested in a public stock. This may slightly cover their downside if they are good at predicting the future.
The long-term vision of Silo Wellness is to scale and enter markets one molecule and one jurisdiction at a time. The bigger you are, the easier it is to negotiate favorable contracts.
We started out with one person with a dream and a vision. That led to relationships with others who share the vision. That led to collaborations. This vision led to revenue. Competition leads to slim margins. New collaborators may see the upside with a recognized and experienced brand and terms may get better over time; and the cycle continues. The more you can offer a property owner or operator, the better the terms get. This is a long game for sure with a lot of risk, but the model was built out on an island off the coast of the greatest market and the greatest country on earth. Persistence, preserving capital, smart collaborations, and keeping the eye on revenue is the key.
Oregon Real Estate. The Company intends to scale where it is legal and where capital and relationships permit. Oregon differs from Jamaica in that the barrier to entry is the license which must be associated with a given location. We can't just bounce around to different resorts depending on terms. That makes the relationships or the capital (which of course come from relationships) ever more important. It also creates a lot of risk in the short term as local jurisdictions come up with their land use regulations. See the previous press releases relating to Oregon property risks.
Future Markets. The Company expects that legislation of similar design may be introduced in other jurisdictions in the coming years, such as Colorado, as well as additional ballot measures similar to Measure 109. The Company cannot comment on the regulatory framework in any such jurisdiction as it has not been created. The Company will assess its options to conduct legal business in such jurisdictions when State or Provincial, as applicable, and Federal regulations are established and may seek any required licenses or approvals at that time.
What happens to the retreat industry if the FDA reschedules and approves psychedelics such as psilocybin for prescriptions?
In the end, we contend that this is still a services industry, not a products industry. For the healing, you have to put in the work, and consumers are still going to want safety in a psychedelic experience. We believe that the brand that is in Oregon, Jamaica, Colorado, and wherever is next will be able to have some insurance coverage once it is rescheduled and will be immediately able to expand nationwide with the existing brand, processes, protocols, people and procedures. This has been our vision since 2018 and the voters haven't let us down yet.
ABOUT Silo Wellness
Silo Wellness is a growth-oriented holding company focused on psychedelic opportunities that benefit from a unified ecosystem and exceptional leadership. Founded in 2018 in Oregon and headquartered in Toronto, Silo Wellness has a presence in both Jamaica and Oregon. Silo Wellness is a publicly traded on the Canadian (CSE: SILO) and Frankfurt (FSE: 3K7A) exchanges and listed on the OTCQB Venture Market (OTCQB: SILFF).
For more information about Silo Wellness or to book a Jamaican psychedelic retreat, please visit www.silowellness.com. For more information about Silo's recent acquisition, Dyscovry Science, visit www.Dyscovry.com.
Silo Wellness Company Contact:
Mike Arnold, President
541-900-5871
IR at Silo Wellness dot com
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION: This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking statements") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates, and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. Forward-looking information may relate to anticipated events or results including, but not limited to the ability of the Company to finalize definitive documents and close on the potential retreat center property partnership; the Company's ability to satisfy the Oregon licensing requirements and achieve a license in Oregon; the Company's ability to successful launch an Oregon operation, including hiring of qualified staff and getting access to mushrooms to sustain operations; and the Company's ability to fund operations as well as the company's pre-existing capital requirements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, regulatory, political and social uncertainties and the potential impact of COVID-19. Such risks and uncertainties include, among others, the risk factors included in Silo Wellness's continuous disclosure documents available on www.sedar.com. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Readers should not place undue reliance on the forward-looking statements and information contained in this news release. Silo Wellness assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/144752
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Silo Wellness to Testify on Oregon Psilocybin Therapy Land Use Restrictions at Jackson County Planning Commission's Thursday Hearing; Other Corporate Updates
Silo Wellness Inc. (CSE: SILO) (OTCQB: SILFF) (FSE: 3K7A) ("Silo Wellness" or the "Company"), an Oregon-based publicly traded psychedelics company, announced that its Chief Executive Officer Mike Arnold, an Oregon lawyer, will testify Thursday, November 3, 2022, at the Jackson County Oregon Planning Commission's 9:00 a.m. hearing regarding amendments to the Jackson County Land Development Ordinance to add psilocybin therapy and retreat time, place, and manner regulations.
Silo recently announced an intended Jackson County psychedelic ranch retreat center near Ashland, Oregon. One of the major risk factors in the Oregon psilocybin industry is the real-time evolution of the legal and regulatory framework. Several cities and counties around the Oregon are voting November 8 on whether or not to opt out of Oregon's Ballot Measure 109 Psilocybin Service Initiative system. The state regulators are to begin accepting psilocybin therapy and retreat license applications in January 2023. Oregon is the first state to legalize psychedelic therapy and retreat business activities with Colorado hopefully following suit in the election next week.
Arnold commented: "Even if a county has not opted out of Oregon's BM109, that doesn't mean it can't amend its land use rules to effectively exclude a property or class of properties from use an Oregon psilocybin clinic, therapy center or psychedelic retreat center. As a lawyer who assisted clients in the Oregon recreational cannabis industry, we frequently saw missteps where entrepreneurs secured properties by purchase or lease only to find out later that the county or city would not allow them to operate there due to new local land use laws. This is why Silo Wellness is attempting to secure LOIs for now before making risky long-term property commitments. The urban-rural divide in Oregon is real and the effect of local political considerations are notoriously difficult to predict around here. Afterall, Oregon's state motto is 'She flies with her own wings.'"
Silo Wellness encourages advocates to attend and testify at Thursday's hearing regarding the low impact of psilocybin activities on the community. Testimony is limited to five minutes per person and can be done remotely at https://jacksoncountyor.zoom.us/j/94440098728.
Silo Wellness Requests Oregon Property Owner Expressions of Interest for Collaborating on Psilocybin Licensing
Silo Wellness continues to tour Oregon properties and discuss collaboration opportunities with other entrepreneurs. The Company requests expressions of interest from Oregon property owners who may be considering participation in the regulatory regime under Oregon Ballot Measure 109.
Mike Arnold commented, "It is our goal to leverage our platform to help empower Oregonians who may each have a piece of the puzzle - facilitation experience, business experience, property, capital, or a passion for the medicine - and bring them together to help make this industry by Oregonians for Oregonians."
Parties who may be interested in entering the Oregon psilocybin industry are encouraged to contact Silo Wellness at oregon at Silo Wellness dot com.
Other Corporate Update: Debt Conversion
Silo Wellness intends to settle a total of CAD$81,682 of debt owed to an arms-length consulting services provider of the Company, through the issuance of an aggregate of 1,633,640 common shares of the Company at a deemed price of at a price of CAD$0.05 per share, being at a premium to the CAD$0.015 closing price of the common shares of the Corporation on October 28, 2022. Completion of the Shares for Services is subject to compliance with applicable regulations, including policies of the CSE.
ABOUT Silo Wellness
Silo Wellness is a growth-oriented holding company focused on psychedelic opportunities that benefit from a unified ecosystem and exceptional leadership. Founded in 2018 in Oregon and headquartered in Toronto, Silo Wellness has a presence in both Jamaica and Oregon. Silo Wellness is a publicly traded company on the Canadian (CSE: SILO) and Frankfurt (FSE: 3K7A) exchanges and trading on the OTCQB Venture Market (OTCQB: SILFF).
For more information about Silo Wellness or to book a Jamaican psychedelic retreat, please visit www.silowellness.com. For more information about Silo's recent acquisition, Dyscovry Science, visit www.Dyscovry.com.
Silo Wellness Company Contact:
Mike Arnold, President
541-900-5871
IR at Silo Wellness dot com
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION: This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking statements") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates, and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. Forward-looking information may relate to anticipated events or results including, but not limited to the Company's ability to satisfy arrearages due to Licensor and the Company's ability to fund operations as well as the company's pre-existing capital requirements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: the ability of the Company to finalize definitive documents and close on potential partnerships or transactions; the Company's ability to satisfy the Oregon licensing requirements and achieve a license in Oregon; the Company's ability to successful launch an Oregon operation, including hiring of qualified staff and getting access to mushrooms to sustain operations; and the Company's ability to fund operations as well as the company's pre-existing capital requirements, including but not limited to essential company operations and development of the company's intended pharmaceutical platform. Such risks and uncertainties include, among others, the risk factors included in Silo Wellness's continuous disclosure documents available on www.sedar.com. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Readers should not place undue reliance on the forward-looking statements and information contained in this news release. Silo Wellness assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/142414
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Silo Wellness Closes Acquisition of Dyscovry Science and Its Psilocybin Pharmaceutical Biosynthesis and Research Portfolio
Silo Wellness Inc. (CSE: SILO) (OTCQB: SILFF) (FSE: 3K7A) ("Silo Wellness" or the "Company"), Oregon's only publicly traded psychedelics company, is pleased to announce it has closed its acquisition of 100% of Dyscovry Science Ltd. ("Dyscovry"), a Toronto-based biotechnology company focused on biosynthetic manufacturing of psilocybin and its derivatives targeting a physiological condition, irritable bowel syndrome.
"Bringing the Dyscovry team into the Silo Wellness family is a key component to our pharmaceutical vision which began with our July 2019 priority date for our patent-pending metered-dosing modalities for psilocybin, mescaline, DMT, and 5-MeO-DMT," stated Silo Wellness founder and CEO Mike Arnold, an Oregon attorney. "With our presence and founding in Oregon along with our psychedelic retreat operational experience in Jamaica [with psilocybin and 5-MeO-DMT] and Oregon [with ketamine], Dyscovry's portfolio will allow us to further our goal of covering both tracks of the psychedelic industry under one roof: psychedelic healing now via jurisdiction-by-jurisdiction "adult use" and pharmaceutical biotech."
Terms of the transaction, which was an arm's length acquisition with no finder's fees paid, can be found in the Company's September 27, 2022 press release announcing the signing of the September 26, 2022, definitive agreement. Upon closing of the transaction, CFO Winfield Ding has resigned from the board of directors and Dyscovry founder Gerard Lee of Toronto has been appointed director. Winfield Ding will continue as Chief Financial Officer.
ABOUT DYSCOVRY
DYSCOVRY SCIENCE LTD is an innovative Toronto-based biotechnology company conducting research to establish a world-leading position in the development of fungal- and plant-derived therapeutics through its proven drug discovery and development processes, its growing intellectual property portfolio, and regulatory and manufacturing expertise.
Dyscovry is led by an experienced team with government, university and private collaborations focusing on biosynthesis of psilocybin and investigating a quantifiable anti-inflammatory effect of psychedelics - believed to be mediated through 5-HT2A activation - and how this relationship pertains to disorders that affect the large intestine. Dyscovry is focused on indications such as Irritable Bowel Syndrome (IBS) that inflict suffering on a double digit percentage of the entire human global population. This suffering includes the physiological symptoms but also the secondary psychological symptoms from living with this disease.
ABOUT Silo Wellness
Silo Wellness is a growth-oriented holding company focused on psychedelic opportunities that benefit from a unified ecosystem and exceptional leadership. Founded in 2018 in Oregon and headquartered in Toronto, Silo Wellness has a presence in both Jamaica and Oregon. Silo Wellness is a publicly traded company on the Canadian (CSE: SILO) and Frankfurt (FSE: 3K7A) exchanges and trading on the OTCQB Venture Market (OTCQB: SILFF).
For more information about Silo Wellness or to book a Jamaican psychedelic retreat, please visit www.silowellness.com.
Silo Wellness Company Contact:
Mike Arnold, President
541-900-5871
IR at Silo Wellness dot com
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION: This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking statements") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates, and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. Forward-looking information may relate to anticipated events or results including, but not limited to Dyscovry's development of certain technologies and products; Dyscovry's initiation of research, clinical trials and timing thereof; Dyscovry's successful completion of clinical trials; the Company's ability to fund Dyscovry's as well as the company's pre-existing capital requirements; and any potential success in perfecting any patent claims. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, regulatory, political and social uncertainties and the potential impact of COVID-19. Such risks and uncertainties include, among others, the risk factors included in Silo Wellness's continuous disclosure documents available on www.sedar.com. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Readers should not place undue reliance on the forward-looking statements and information contained in this news release. Silo Wellness assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/140629
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Silo Wellness Executes Definitive Agreement to Acquire Dyscovry Science and Its Psilocybin Pharmaceutical Biosynthesis and Research Portfolio
Silo Wellness Inc. (CSE: SILO) (OTCQB: SILFF) (FSE: 3K7A) ("Silo Wellness" or the "Company"), a leading global psychedelics company, and Dyscovry Science Ltd. ("Dyscovry"), a Toronto-based biotechnology company focused on biosynthetic manufacturing of psilocybin and its derivatives targeting a physiological condition, irritable bowel syndrome, today announced the companies have entered into a definitive share exchange agreement through which Silo acquires 100% of Dyscovry.
With Dyscovry's research collaboration with Canadian federal government research laboratories, Dyscovry intends to develop a biotechnological process for the production of psilocybin and its potentially novel molecule derivatives. This transaction affirms Silo's commitment to the psychedelic pharmaceutical space and is expected to add pharmaceutical R&D capabilities to Silo's patent-pending metered-dosing formulations for psilocybin, DMT, mescaline, and 5-MeO-DMT, and its psychedelic retreat expertise to help unlock the value of its strategicportfolio.
"We are joining two teams that share a passion and vision for developing differentiated psychedelic healing therapies that advance science and transform the lives of patients. I look forward to all that we intend to accomplish together as a combined organization," stated Brad Dottin, founder and president of Dyscovry. "With Dyscovry's collaborative partnerships with Canadian federal government research institutions, a Canadian Council on Animal Care (CCAC) certified university facility for animal studies, and an Ontario-based DEL facility for pre-clinical research, this merger will further enhance Silo's platform for continued growth by adding R&D capability and a team with early-stage research, translational and clinical development capabilities along with deep-rooted scientific knowledge in Irritable Bowel Syndrome (IBS) and severe inflammatory diseases," Mr. Dottin continued.
"The Dyscovry transaction has been highly anticipated by our shareholder base and a long time coming," commented Silo founder and CEO Mike Arnold, an Oregon lawyer. Silo previously announced in May a letter of intent to acquire Dyscovry. "As I have gotten to know the Dyscovry team over the last year, I have seen potential synergies far beyond what is within the four corners of the Dyscovry portfolio," said Arnold. "I am thrilled to bring our networks together to add value to what we have built in Jamaica and intend to build in our home state of Oregon."
Terms of Share Exchange Agreement
Pursuant to the terms of the Share Exchange Agreement, Silo will acquire 100% of the issued and outstanding shares of Dyscovry in exchange for 12,762,325 (for a total of 49% of the issued shares post-closing of the transaction) common shares in the capital of Silo (the "Payment Shares"). The Payment Shares issued for shares of Dyscovry shall be subject to restrictions on resale for a period of 36 months from closing of the Acquisition and shall be released on a schedule consistent with the release schedule for an "emerging issuer" prescribed by section 4.3 of National Policy 46-201- Escrow for Initial Public Offerings. Acceleration of the release from the lock-up may be on terms and conditions established in good faith between the Parties and based on the performance of the Purchased Shares on the CSE and at any time following Closing upon the unanimous approval of the board of directors of Silo.
Following closing, Dyscovry shall have the right to immediately nominate one director to the board of directors of Silo. Silo has also agreed to pay approximately CAD$120,000 of Dyscovry founder's debt in twelve equal monthly installments, and in any event, the total debt shall be paid no later than twelve months from the Closing Date. Closing of the Transaction is subject to customary closing conditions and applicable regulatory approvals, including the approval of the CSE and the shareholders of Dyscovry if required.
OTHER CORPORATE UPDATES
On July 26, 2022, the Company also granted 500,000 common shares purchase options to each of the five directors of the Company; each option entitles the holder to purchase one common share of the Company at CAD$0.025 until five years from the grant date. The options are subject to a four-month hold period.
Additionally, the Company has entered into an agreement with Bolt Media, Inc. ("BM") to provide services relating to social media support and strategic media services for a six-month term beginning in September 2022. The Company has agreed to pay a total
of USD$8,833/month for the services to be provided during the term. In line with the Company's strategy for raising awareness, the Company has also retained Lifewater Media to introduce Silo and its services to the US investment community. The contract with Lifewater Media includes a USD$60,000 budget for newsletter and display advertising and copywriting and design fees. Lifewater Media are well known professionals in the media industry with more than 40 years of combined experience. Lifewater Media is a pioneer in US marketing strategy and digital marketing. Neither provides investor relations or market making services. One purpose of the campaign is to drive awareness to the Company's psychedelic vacations in Jamaica.
ABOUT DYSCOVRY
DYSCOVRY SCIENCE LTD is an innovative Toronto-based biotechnology company conducting research to establish a world-leading position in the development of fungal- and plant-derived therapeutics through its proven drug discovery and development processes, its growing intellectual property portfolio, and regulatory and manufacturing expertise.
Dyscovry is led by an experienced team with government, university and private collaborations focusing on biosynthesis of psilocybin and investigating a quantifiable anti-inflammatory effect of psychedelics - believed to be mediated through 5-HT2A activation - and how this relationship pertains to disorders that affect the large intestine. Dyscovry is focused on indications such as Irritable Bowel Syndrome (IBS) that inflict suffering on a double digit percentage of the entire human global population. This suffering includes the physiological symptoms but also the secondary psychological symptoms from living with this disease.
ABOUT Silo Wellness
Silo Wellness is a growth-oriented holding company focused on psychedelic opportunities that benefit from a unified ecosystem and exceptional leadership. Founded in 2018 in Oregon and headquartered in Toronto, Silo Wellness has a presence in both Jamaica and Oregon. Silo Wellness is a publicly traded company on the Canadian (CSE: SILO) and Frankfurt (FSE: 3K7A) exchanges and trading on the OTCQB Venture Market (OTCQB: SILFF).
For more information about Silo Wellness or to book a Jamaican psychedelic retreat, please visit www.silowellness.com.
Silo Wellness Company Contact:
Mike Arnold, President
541-900-5871
ir@silowellness.com
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION: This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking statements") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates, and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. Forward-looking information may relate to anticipated events or results including, but not limited to the successful completion of the Acquisition; Dyscovry's development of certain technologies and products; Dyscovry's initiation of research, clinical trials and timing thereof; Dyscovry's successful completion of clinical trials; the Company's ability to fund Dyscovry's as well as the company's pre-existing capital requirements; and any potential success in perfecting any patent claims. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, regulatory, political and social uncertainties and the potential impact of COVID-19. Such risks and uncertainties include, among others, the risk factors included in Silo Wellness's continuous disclosure documents available on www.sedar.com. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Readers should not place undue reliance on the forward-looking statements and information contained in this news release. Silo Wellness assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/138518
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Another Public Company First: Silo Wellness Opens Jamaican Ecotourism Psilocybin Microdosing Resort for the Psychedelic Curious; Shareholder Discounts for Psychedelic Vacations Available
Silo Wellness Inc. (CSE: SILO) (OTCQB: SILFF) (FSE: 3K7A) ("Silo Wellness" or the "Company"), a leading global psychedelics company, is pleased to announce that it has opened its first ecotourism microdosing psilocybin resort and retreat center at Go Natural Jamaica in Long Bay, Portland, Jamaica. "We have been bombarded by cost-conscious client inquiries wanting to explore nature with the help of psilocybin," explained Mike Arnold, an Oregon attorney and the founder of Silo Wellness. "They are what we consider 'psychedelic curious.' These are not looking to experiment with psychedelics for recreational purposes at a club or party. They are very intentional and mindful individuals looking to better understand themselves and their place in the universe. They aren't looking for mental health therapy or a deep dive ego death. They are wanting to learn about psilocybin while learning about themselves. This is an unmet need in the psychedelic space, and Silo Wellness is well positioned to assist.
One of Silo Wellness's most valuable assets is its data. From what the Company has learned from thousands of client inquiries and consumer comments on retreats is that not everyone is looking for the 'deep dive' or to treat mental illnesses. Many want to self-titrate on to mushrooms through serial microdosing. "Our Silonauts often want to be at a rustic seaside resort looking at shooting stars on a gram of mushrooms," stated Arnold. "Or they want to go for a snorkel on a 0.1 gram microdose. They crave an increased connection to nature."
Jamaica Luxury Psychedelic Retreats vs. Psilocybin Microdosing Retreats
Silo's "luxury" retreats have been featured in Bloomberg, Fodor's Travel, The Evening Standard, Men's Health and The Washington Post, among others. However, Silo Wellness never intended to enter the luxury retreats space. "That wasn't my vision," continued Arnold. "Our mission is to put psychedelic healing into the hands of those suffering as quickly and inexpensively as possible. Nonetheless, the luxury model was necessary during COVID and has been very good to us and for our clients. However, it is not available to everyone due to the price point, which is a shame and also contrary to our mission."
"The vision at our Go Natural Jamaica microdosing resort is to offer a lower price point with a seafront 'luxury view' but with more rustic accommodations," Arnold continued. "We can significantly lower the cost by making air conditioning optional, for example, or provide a dorm room with bunk beds right alongside a luxury villa on the same site. I myself prefer to suffer in nature while primitive camping, rafting, or waterfall exploring with or without psychedelics. I don't want to hear the buzz of the A/C at night. I want to hear the buzz of consciousness to the soundtrack of nature. I want to hear a tropical storm. I want to hear the whistling Jamaican tree frogs. I want to sleep under the stars while microdosing. And I want Silo's clients to enjoy this God-given luxury that experienced psychedelic users can do on their own, but in the safety and comfort of secure accommodations under the cover our of risk mitigation protocols."
Spiritual Ecotourism and Psychedelic Retreats in Oregon and Jamaica
Silo Wellness sees nature immersion as essential for human growth. Human consciousness is the most complicated and impressive thing to evolve out of nature - more complicated and inexplicable than a black hole. Silo sees it as incumbent on individuals to explore consciousness while exploring nature to get that reset along with a new purpose-driven download to be the best version of themselves.
In 2022, Silo's Oregon nature-immersion psychedelic retreat was featured in Outside Magazine's article, "The Future of Nature Therapy is Psychedelic." Its colorful narrative begins with an emotional play-by-play account of a ketamine deep-dive trip report by a brave participant with PTSD from sexual assault and depression: "[She] sees the blue pool, shimmering like a winter oasis. It sparkles below a snowy trail and rocky gray cliffs, the iridescent turquoise water rippling under the rushing downpour of Tamolitch Falls…[Her] otherworldly trip didn't happen in the flesh. It took place in her mind, after she'd taken ketamine…"
Beyond what Silo's cliffside beachfront resort has to offer, participants will have optional microdosing nature excursions that can include a waterfall swim, harvesting supper at a permaculture jungle farm, a bamboo raft river float, Caribbean boat tour and island picnic, etc.
Set, Setting, and Dosing: Perceptible Sub-psychedelic Microdosing in Nature
"This retreat isn't necessarily imperceptible microdoses," stated Arnold, "although clients are welcome to experience psychedelics for the first time in this way. Silo's self-titrating psilocybin protocols allow people to work their way up dosing in a controlled way to experience the sub-psychedelic effects.
"We want people to be able to commune with nature at sub-psychedelic but perceptible doses. We know that most of our clients are uncomfortable taking a 0.3 gram 'social dose' or a 0.7 to one gram 'hiker's dose' or 'museum dose' for the first time. Instead, we will provide the framework for them to slowly walk themselves up over time to these more advanced dosages. This prevents the 'cannabis edibles dilemma' of stacking doses with greater than expected effects."
Jamaica Psilocybin Microdosing Retreat Pricing and Shareholder/Owner Discounts
Silo's Labor Day retreat (September 3-6) has lodging and meals starting at $240/night for dorm lodging to $499.99/night for single occupancy with a three-night minimum. Double occupancy is also available. More information can be found at www.SiloWellness.com/jamaica-microdosing.
Farm-/field-/sea-/bush-to-table traditional natural Jamaican cuisine is included. Locally sourced psilocybin mushroom microdosing capsules are available on site for a nominal cash purchase. Applicants receive a one-on-one meeting with our experienced client journey planning team and an evaluation for appropriateness for retreat, contraindications, etc. by our Ph.D. pharmacologist and co-inventor of the world's first psilocybin nasal spray. Qualified participants will also be provided with recommended reading materials, journaling prompts, videos regarding retreat location, logistics, and how to make the most of the process to help them put in the work to reset and reprogram their minds. Additional services can be found on the website, including transportation to retreat, additional add-on lodging before or after retreat, air conditioning, healthful smoothies and natural snacks, yoga, and food upgrade of menu choices (although this is discouraged as we recommend a full emersion into a new lifestyle closer to the land in an authentic local Jamaican fashion).
For a limited time, Silo's shareholders may receive up to 20% off a retreat or priority booking for a private curated retreat for the owner and his or her guests. Owners may also request a special discount code to share on social media for up to 20% off for anyone in their network. Inquire for details and applicability.
Additional Corporate Updates
Since the May 2022 shareholder meeting, the Silo team has been working diligently to secure additional property partnerships in Jamaica to scale up retreats in order to reduce costs and to provide additional revenue through increased inventory. This strategy would provide the opportunity for the Company to negotiate longer-term staffing contracts at a lower price per retreat. In July, the Company successfully conducted a luxury retreat in Trelawny, Jamaica, with positive feedback from participants. The Company has also been working to best position itself for Oregon psilocybin by visiting rural retreat properties for potential purchase or joint venture and intends to purchase an urban retreat center.
The Company's May 2022 letter of intent with Dyscovry Science is still active and that transaction is still expected to close with documents being finalized by the respective attorneys. Additionally, following the 20-1 share consolidation that occurred at the May shareholders meeting, the Company has seen its total shares issued increase due to debt conversions from the first two funding tranches received from the financing announced in April. The Company is in active discussions with other potential finance groups regarding debt restructuring and a potential private placement which would be contingent on renegotiating the April debt financing terms. The company has retained three f The Company may also spinout retreat assets into a separate wholly-owned subsidiary for an Oregon-specific capital raise. Use of proceeds for that would be include closing on a psilocybin service center property, BM 109 licenses fees and expenses, property improvements necessary for licensing, legal fees, marketing, and other administrative and operations costs.
Additionally, the Company entered into an advertising and investor awareness campaign with Dig Media Inc. dba Investing News Network (INN). INN is a private company headquartered in Vancouver, Canada, dedicated to providing independent news and education to investors since 2007 at www.investingnews.com. Beginning today for a 12-month term of the agreement, INN will provide advertising on its website to increase awareness of the issuer. INN does not provide
Investor Relations or Market Making services. The cost of the campaign is $9,165/month. INN can be reached at 604-688-8231 or info@investingnews.com. One purpose of the campaign is to drive awareness to the Company's psychedelic vacations that are offered at a discount to shareholders/owners. Given the activist nature of plant medicine consumers, the Company's goal is to one day have all participants at retreats being shareholders. More information regarding investor discounts can be found at https://www.silowellness.com/benefits/.
ABOUT Silo Wellness
Silo Wellness is a growth-oriented holding company focused on functional mushroom and psychedelic opportunities that benefit from a unified ecosystem and exceptional leadership. Founded in 2018 and headquartered in Toronto, Silo Wellness has a presence in both Jamaica and Oregon. Silo Wellness is a publicly traded company on the Canadian (CSE: SILO) and Frankfurt (FSE: 3K7A) exchanges and trading on the OTCQB Venture Market (OTCQB: SILFF).
For more information about Silo Wellness or to book a Jamaican psilocybin retreat, please visit www.silowellness.com.
Silo Wellness Company Contact:
Mike Arnold, President
541-900-5871
IR at Silo Wellness dot com
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION: This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking statements") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates, and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. Forward-looking information may relate to anticipated events or results including, but not limited to the Company successfully launching Jamaica microdosing operations, possibly retreat spinout, alternative financing and other statements made in the Corporate Update, and the Company's future business plans. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, regulatory, political and social uncertainties and the potential impact of COVID-19. Such risks and uncertainties include, among others, the risk factors included in Silo Wellness's continuous disclosure documents available on www.sedar.com. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Readers should not place undue reliance on the forward-looking statements and information contained in this news release. Silo Wellness assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/134375
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Lobe Sciences, Ltd. Enters Collaborative Clinical Research Agreement with Integrative Headache Medicine of New York to Study the Effects of L-130 in the Treatment of Chronic Cluster Headache
Dr. Lauren R. Natbony to be Principal Investigator
lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical company committed to discovering and developing patient-focused psychedelic-derived medicines for neurologic and brain disease, today announced that it has signed an Investigator Initiated Research Agreement with Lauren R. Natbony, MD, FAHS, Founder and Medical Director of Integrative Headache Medicine of New York, to study the tolerability and efficacy of our proprietary psilocin compound L-130, in patients suffering from Cluster Headaches ("CH").
Mr. Philip J. Young, Chairman and Chief Executive Officer of the Company, stated, "This is an exciting opportunity to evaluate L-130's effect on the intensity, frequency, and duration of these debilitating headaches. One in every thousand people suffers from this condition, also called "Suicide Headaches," due to the pain, frequency of attacks, and lack of effective treatments. Partnering with Dr. Natbony is a great opportunity for Lobe. As a board-certified neurologist and fellowship-trained headache specialist, she has dedicated her career to treating chronic headache and facial pain disorders, including cluster headache. We anticipate Dr. Natbony will file a physician-initiated IND, and when cleared by the US FDA, she can begin dosing CH patients with L-130 to evaluate safety, tolerability, and efficacy. CH is recognized as an Orphan Drug indication, which we intend to pursue."
Dr. Natbony stated, "We are very excited to evaluate the impact of Lobe's psilocin compound, L-130, in treating these devastating headaches. Data reported in the literature supports the use of psilocybin in these patients. Since L-130 is the active metabolite of psilocybin, it appears to be an efficient way of delivering non-psychedelic doses of psilocin with potentially better bioavailability and consistency. Using sub-psychedelic dosing may allow physicians a therapeutic solution to a devastating condition where treatment options are limited."
About Cluster Headaches
Cluster headache is a rare but severe primary headache disorder, impacting 0.1% of the general population, and characterized by excruciating one-sided pain around the eye. The pain is so intense that it usually causes restlessness and agitation during an attack with the need to pace or rock in place. Attacks can happen up to eight times a day and last between 15 minutes and 3 hours. Accompanying the attacks are one-sided autonomic symptoms, such as eye redness, eye tearing, nasal congestion, runny nose, or a droopy eyelid. Cluster headache, in its episodic form, occurs in episodes lasting between 7 days and one year with pain-free periods lasting at least three months. In contrast, cluster headache is classified as chronic once attacks are present for more than one year, either without interruption or with short intermissions lasting less than three months. Chronic cluster headache is more resistant to current prophylactic pharmaceutical treatments, thus resulting in profound limitations in normal daily functioning. To learn more about Dr. Natbony please click www.integrativeheadacheny.com.
About lobe sciences ltd.
Lobe Sciences is a biopharmaceutical company focused on developing patient-friendly, practical psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using sub-hallucinatory doses of psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness. Each of our New Chemical Entities, L-130 and L-131, are being developed to address unmet medical needs in neurological therapeutic applications.
About Integrative Headache Medicine of New York, PLLC
Integrative Headache Medicine of New York (IHMNY), founded and directed by Dr. Lauren R. Natbony, is a comprehensive, multidisciplinary, and cutting-edge institute dedicated to treating patients with complex headache and facial pain disorders. Dr. Natbony is an internationally recognized expert in headache medicine and established IHMNY to offer traditional medical therapies in conjunction with evidence-based complementary and integrative modalities. Integrative Headache Medicine of New York is committed to providing personalized patient care, educating the public about headache medicine, and developing groundbreaking therapies for treating chronic, disabling headaches.
For further information please contact:
lobe sciences ltd.
Philip J Young, CEO
info@lobesciences.com
Tel: (949) 505-5623
NEITHER THE CSE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE.
This does not constitute an offer to sell or a solicitation of offers to buy any securities.
Forward-Looking Statements
This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact included in this news release (including, without limitation, statements regarding the future plans and objectives of the Company, research and development using psychedelic compounds, and the development of innovative devices and delivery mechanisms to improve mental health and wellness) are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including changes to the regulatory environment; that the Company's drug research and development activities may be unsuccessful; that drugs and medical devices produced by, or on behalf of, the Company, may not work in the manner intended or at all, and may subject the Company to product liability or other liability claims; that the Company may not be able to attain the Company's corporate goals and objectives; and other risk factors detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at www.sedar.com. As a result, the Company cannot guarantee that any forward-looking statement will materialize and the reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws.
Drug development involves long lead times, is very expensive and involves many variables of uncertainty. Anticipated timelines regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the Company. Every patient treated on future studies can change those assumptions either positively (to indicate a faster timeline to new drug applications and other approvals) or negatively (to indicate a slower timeline to new drug applications and other approvals). This news release may contain certain forward-looking statements regarding anticipated or possible drug development timelines. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company's development efforts to date. In addition to the risk factors set out above and those detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at www.sedar.com, other factors not currently viewed as material could cause actual results to differ materially from those described in the forward-looking statements. Although Lobe has attempted to identify important risks and factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors and risks that cause actions, events or results not to be anticipated, estimated or intended. Accordingly, readers should not place any undue reliance on forward-looking statements.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/152553
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Lobe Sciences Board of Directors Elects to Receive Shares in Lieu of Cash for All Board Fees
- Endorsement underscores transition into a fully integrated biotechnology company
lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American biopharmaceutical company committed to discovering and developing psychedelic derived medicines for neurologic and brain disease today announced its Board of Directors voted to receive shares in Lobe in lieu of the traditional cash renumeration.
Philip J. Young, Chairman and Chief Executive Officer of the Company stated, "This is a tremendous endorsement of our progress and industry leading clinical development plans for 2023 and beyond. Lobe Sciences is proud of our transition into a fully integrated Biotechnology company that has developed the end-to-end capabilities to discover and produce pharmaceutical products. We have the capabilities for cGMP manufacturing, product development combined with industry leading expertise in the regulatory and clinical development of our proprietary psilocin drugs, L-130 and L-131."
"Lobe's leadership in neurological conditions and brain disease continues to grow as evidenced by its proprietary platform of differentiated tryptamine-based analogues. The Board looks forward to seeing the advancement of these novel compounds in clinical trials in the first half of 2023. Collectively, we will continue to offer our industry expertise and strategic support to Lobe as the Company emerges into a leader in neurologic conditions on a global scale."
About lobe sciences ltd.
Lobe Sciences is a life sciences company focused on developing patient friendly practical psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using sub hallucinatory doses of psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.
For further information please contact:
lobe sciences ltd.
Philip J Young, CEO
info@lobesciences.com
Tel: (949) 505-5623
NEITHER THE CSE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE.
This does not constitute an offer to sell or a solicitation of offers to buy any securities.
Forward Looking Statements
This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact included in this news release (including, without limitation, statements regarding the future plans and objectives of the Company, research and development using psychedelic compounds, and the development of innovative devices and delivery mechanisms to improve mental health and wellness) are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including changes to the regulatory environment; that the Company's drug research and development activities may be unsuccessful; that drugs and medical devices produced by, or on behalf of, the Company, may not work in the manner intended or at all, and may subject the Company to product liability or other liability claims; that the Company may not be able to attain the Company's corporate goals and objectives; and other risk factors detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at www.sedar.com. As a result, the Company cannot guarantee that any forward-looking statement will materialize and the reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws.
Drug development involves long lead times, is very expensive and involves many variables of uncertainty. Anticipated timelines regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the Company. Every patient treated on future studies can change those assumptions either positively (to indicate a faster timeline to new drug applications and other approvals) or negatively (to indicate a slower timeline to new drug applications and other approvals). This news release may contain certain forward-looking statements regarding anticipated or possible drug development timelines. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company's development efforts to date. In addition to the risk factors set out above and those detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at www.sedar.com, other factors not currently viewed as material could cause actual results to differ materially from those described in the forward-looking statements. Although Lobe has attempted to identify important risks and factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors and risks that cause actions, events or results not to be anticipated, estimated or intended. Accordingly, readers should not place any undue reliance on forward-looking statements.
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Lobe Sciences Provides Update For 2023 Milestones
lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical company committed to discovering and developing patient focused psychedelic derived medicines for neurologic and brain disease today announced an updated overview for 2023.
Mr. Philip Young, Chairman and Chief Executive Officer of the Company, stated, "2022 was a productive year for Lobe Sciences. We increased our intellectual property portfolio with several new chemical entities (NCEs) derived from well-known psychedelic compounds, adding two of these, L-130 and L-131, to our development program. We solidified relationships with outstanding research and development teams, who affirmed their support for Lobe by taking an equity stake in the Company. Research collaborations with contract research organizations (CRO) were penned and we began work on a human Phase I Safety and Pharmacokinetics program to ascertain the bioavailability and metabolism of L-130. This trial will be the first of three similar trials that will determine the highest concentration of this NCE without an hullucinagenic effect. International Regulatory filings were completed and accepted in 2022. We expect to begin enrollment in early 2023."
The Company presented the following timeline for 2023:
L-130
In January 2023, obtain cGMP clinical supplies and transfer these supplies to the international CRO for oral administration to humans in Phase I studies.
In the first quarter of 2023, commence Phase I Safety and Pharmacokinetics Studies. Data is expected to be available in early in the second quarter of 2023.
In the first quarter of 2023, commence USFDA required preclinical studies which are expected to be completed by the end of the second quarter of 2023. We have executed a contract with our international preclinical CRO and the active pharmaceutical ingredient (API) export license from US DEA is awaited. Our manufacturing partner has manufactured sufficient quantities of L-130 which will be shipped once required DEA export documents are approved.
A pre-IND submission package will be filed to confirm that our entire regulatory pathway, which utilizes the 505(b)2 route to approval is appropriate.
In anticipation of a successful identification of the highest dose having minimal or no hallucinogenic effect, the Company has begun preparation of the Phase II protocol which will utilize that dose. Initial designs for the study are being refined with a second international CRO (iNGEnu).
In the 2023, the Company anticipates a US IND filing.
L-131
Synthesis of L-131 has produced sufficient material for preclinical investigation in a pediatric neurological orphan drug application.
In the first half of 2023, an efficacy evaluation of L-131 utilizing a validated model of the orphan disease application will be initiated following receipt of the DEA export license the preclinical CRO.
In the second half of 2023, an Orphan Drug Designation filing and a Priority Review Application (a pediatric application of L-131) will be submitted to US FDA following successful completion of the preclinical investigation noted above.
In the first half of 2023, a pre-IND filing to US FDA will occur to confirm the regulatory strategy being planned for L-131 and its orphan application.
Preclinical safety and toxicokinetic studies will be initiated following the completion of preclinical pharmacology late in the first half or early in the second half of the year.
The Company expects to file an IND with the USFDA in the second half of the year. In a final comment, Mr. Young said, "Our plans for 2023 are ambitious but doable. By year end, we should have two active INDs, one of which may be designated as an orphan drug and an ongoing Phase II trial assessing L-130 as a therapeutic to treat a refractive neurological disorder. We will release details of each of these trials and the indication being treated as our patents are published."
About lobe sciences ltd.
Lobe Sciences is a biopharmaceutical company focused on developing patient friendly practical psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using sub hallucinatory doses of psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness. Each of our New Chemical Entities; L-130 and L-131, are being developed to address unmet medical needs in neurological therapeutic applications. Refer to forward looking statements for information related to the compounds currently in development or under consideration for development.
For further information please contact:
lobe sciences ltd.
Philip J Young, CEO
info@lobesciences.com
Tel: (949) 505-5623
NEITHER THE CSE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE.
This does not constitute an offer to sell or a solicitation of offers to buy any securities.
Forward-Looking Statements
This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact included in this news release (including, without limitation, statements regarding the future plans and objectives of the Company, research and development using psychedelic compounds, and the development of innovative devices and delivery mechanisms to improve mental health and wellness) are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including changes to the regulatory environment; that the Company's drug research and development activities may be unsuccessful; that drugs and medical devices produced by, or on behalf of, the Company, may not work in the manner intended or at all, and may subject the Company to product liability or other liability claims; that the Company may not be able to attain the Company's corporate goals and objectives; and other risk factors detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at www.sedar.com. As a result, the Company cannot guarantee that any forward-looking statement will materialize and the reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws.
The Company makes no medical, treatment or efficacy claims about its compounds currently in development or under consideration for development. The U.S. Food and Drug Administration, Health Canada or other global regulatory authorities have not evaluated claims regarding our psilocin compounds. The safety and efficacy of such products have not been confirmed by controlled clinical trials. There is no assurance that the use of our psilocin compounds will decrease the severity of, cure, or prevent disease. Geography specific preclinical research controlled clinical trials with validated endpoints are needed to be successfully completed in order to submit applications for potential regulatory clearance. Lobe has not conducted clinical trials for the use of its proposed products and references to. If Lobe cannot obtain the regulatory approvals or complete the research necessary to commercialize its psilocin compounds it may have a material adverse effect on Lobe's performance and operations. Lobe conducts all manufacturing and clinical research through licensed laboratories and CROs in the jurisdictions in which the CRO operates. These companies abide by all applicable regulations regarding the handling of psychedelic compounds and if applicable are regularly inspected by the applicable authorities in their respective geographies.
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Trippy Trading: Top Psychedelic Stocks For 2023
(NewsDirect)
When psychedelics were first studied more than 50 years ago, researchers discovered that they were useful in assisting people in exploring a greater sense of self. After a half-century hiatus, scientists are once again investigating psychedelics and other mind-altering substances such as MDMA, psilocybin, and ketamine as treatments for depression, PTSD, anxiety, and other mental health conditions.
The need is clear, since the WHO says that mental health disorders are the leading cause of disability around the world and nearly a billion people have some kind of mental illness.
There are many psychedelic pharmaceutical companies developing drugs that follow the legal regulatory pathway to approval. Several of these drugmakers are publicly traded, and they're receiving increased attention from investors. We've seen a similar phenomenon with marijuana stocks over the past several years. Cannabis was once on the fringe but is now a significant and growing industry.
This article will discuss four psychedelic therapy stocks that could see significant price increases in 2023.
lobe sciences ltd. (OTC: LOBEF)(CNSX:LOBE) is a life sciences company focused on practical psychedelic medicines. Lobe Sciences works with industry leaders to do research and development on proprietary patent drugs psychedelic compounds, and ways to deliver drugs that will Its overall goal is to allow Family Physicians to treat patients without the induction of hallucinations improving mental health and wellness.
Lobe Sciences' main goal is to create new patient focused medicines, PTSD, to treat neurological disorders including Pediatric Orphan Indications. At the moment, the company has filed for a total of 16 provisional patents and on the precipice of initiating its first in man Phase 1 studies.
At the tail end of the previous year, the North American company provided an update on the most recent developments concerning its clinical trials. Psilocin is the source of the novel compound L-130, which is currently undergoing research and development for potential future use. According to the most recent report, we discovered that LOBE had successfully submitted the required documentation in order to import L-130.
Lobe Sciences stated in their plan that the first phase 1 clinical trials would make use of Clearway Global's network of contract research organizations, and that they would begin their first subject trial in the month of December 2022. This indicates that preliminary data will be accessible in the first quarter of 2023. Astute investors will be watching for LOBEF to announce the trial results.
CSO of Lobe Sciences Maghsoud Dariani remarked, "It is important to remember that in just 12 months, Lobe has transformed into a fully integrated virtual drug development company. We now have multiple New Chemical Entities' (NCE's) including L-130 that is entering human trials. L-131 is entering pre-clinical trials as we prepare a pediatric Orphan Drug Application with the potential of receiving a Priority Review Voucher for L-131. All of this positions Lobe Sciences among the leaders in the small group of companies who are in clinical development of psychedelic drugs."
LOBEF has the potential to make a splash this year given that the psychedelic therapy industry is positioned for significant expansion in 2023. Smart investors should put this stock on their watchlist because there is a good potential for significant updates throughout the year as the company continues to make progress with clinical trials.
Atai Life Sciences (NASDAQ: ATAI) is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders.
In the first week of the new year, the stock plummeted when the failed results of ATAI's NYC-based subsidiary, Perception Neuroscience's Phase 2a study of proprietary R-ketamine PCN-101 on patients with treatment-resistant depression (TRD), were released.
The company said that the compound showed efficacy signals at all time points, but the trial did not meet its primary endpoint of a statistically significant change from baseline in participants' MADRS (Montgomery-Sberg Depression Rating Scale) scores at 24 hours when compared to a placebo. MADRS is a widely used clinician-rated measure of depressive severity.
In response to the results that were shared, ATAI said that it would continue to look at the study data and work with Perception to figure out what to do next, which could include "seeking strategic partnership options."
While the company's stock plunged on the news, down 30% to $1.86 per share, do not count ATAI out, as this study of R-ketamine PCN-101 is one of many ongoing trials the company is working on.
2023 could be a make or break year for the company.
Mind Medicine Inc. (NASDAQ: MNMD) is a biotech company that discovers, develops, and commercializes psychedelically inspired medicines and therapies to treat addiction and mental illness. The company is putting together a strong drug development pipeline based on psychedelic drugs like psilocybin, LSD, MDMA, DMT, and 18-MC, which is a derivative of Ibogaine.
Mind Medicine CEO Rob Barrow is looking forward to 2023 and the plans for the company. Recently, he commented, "Following a year of continued strong execution, our progress in 2022 has set the stage for a meaningful 2023, a year in which we plan to further elucidate the potential of our MM-120 product candidate in generalized Anxiety Disorder (GAD) and initiate the first clinical trial for our MM-402 program."
MM-402's preclinical results are expected in the first half of 2023, and the company plans to start the first clinical trial this year to assess tolerability, PK, and PD, as well as early efficacy on core ASD symptoms.
With a plan set in place for the new year, investors should look for big news coming from MNMD throughout 2023, making it a top runner in the psychedelic stock sector.
Cybin Inc. (AMEX: CYBN) is a biopharmaceutical company focused on developing safe and effective therapeutics for patients suffering from a variety of mental health issues. The company develops proprietary drug discovery platforms, drug delivery systems, formulation methods, and mental health disorder treatment regimens to advance psychedelics as therapeutics.
CYBN is working on developing a proprietary psilocybin analog known as CYB003. This potential treatment for Major Depressive Disorder is currently being assessed in a phase 1/2a study.
Another proprietary psychedelic that CYBN is working on in 2023 is CYB004. This is an intravenous (IV) DMT deuterate, designed for the treatment of anxiety disorders that is being tested in a Phase 1 trial for safety and dosing optimization.
Traditional DMT cannot be taken orally because it is metabolized. As preclinical results show, CYBN and CYB004 are working to improve oral and pulmonary bioavailability, onset with lower doses, inter-subject variability, and dose titration for fewer side effects than oral and IV DMT.
With multiple trials underway, this stock is another to keep an eye on as 2023 continues.
Conclusion
It is difficult to deny the striking similarities between the expansion of the medical cannabis market and that of the psychedelics market. Both were once thought to be only for drug addicts and dropouts, but new research has shown that each can treat conditions that traditional drugs can't reach.
The overall sentiment toward these medicines is changing, as they clearly have a place in the medical landscape. Investors hoping to get in and benefit should pay close attention to news and advances that these biotech companies make as their clinical research continues.
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FREE 2023 Psychedelics Investor Report
Find out what is in store for psychedelics in 2023!
The Investing News Network (INN) spoke with analysts, market watchers and insiders about which trends will impact psychedelics in the year ahead.
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A Sneak Peek At What The Insiders Are Saying
"I think right now and into the next year will be a great market for new (psychedelics) investors."
— Maria Velkova, Tabula Rasa Ventures
“We've now seen a real focus (among psychedelics companies) in prioritizing what is really going to create value."
— Payton Nyquvest, Numinus Wellness
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Psychedelics Outlook 2023
Table of Contents
Psychedelics Market Update: H1 2022 in Review
Psychedelics Market 2022 Year-End Review
Psychedelics Market Forecast: 3 Top Trends That Will Affect Psychedelics in 2023
Psychedelics Market Update: H1 2022 in Review
Click here to read the latest psychedelics market update.
While the first half of 2022 didn't bring forth the clinical trial approvals investors are eager to see, psychedelics companies continue to move along as the market gears up for this milestone.
The industry's progress has been stunted, however, by the increasingly difficult market conditions caused by a global economic downturn that is affecting all industries.
Here the Investing News Network (INN) provides an update on the state of the psychedelics investment market at the halfway mark of the year with commentary from experts.
Psychedelics market update: 2022 prediction panning out
Coming into 2022, INN asked Andrew Charrette, director of regulatory affairs and psychedelic advisor with KGK Science, if change in the market would require a significant regulatory approval.
“It'll be difficult, and it's going to be difficult for even the best companies as they're still flying blind right now,” he said at the time. That projection has panned as 2022 has brought market difficulties across the board.
It's clear that the macroeconomic conditions affecting virtually every sector in the investment landscape are impacting the current financial reality for psychedelics stocks.
Jim Gilligan, chief scientific officer and interim CEO at Tryp Psychedelics (CSE:TRYP,OTCQB:TRYPF), said a variety of companies, including his own, have seen significant valuation declines “despite making advances,” explaining that these drops have been based on nothing coming out of company pipelines.
“There have been changes in market dynamics in biotech and psychedelics in particular that are sort of outside of our control,” Gilligan said. He was referring to the immense pressures created by the poor economic conditions at large, which are sending markets across the board into a decline.
Payton Nyquvest, founder and CEO of Numinus Wellness (TSX:NUMI,OTCQX:NUMIF), told INN he has seen several cycles of new capital coming into the market. Right now he is encouraged by what he described as a new level of knowledge. From his perspective as the founder of one of the first psychedelics firms to hit the public market, investors are more educated now than they were during the initial wave of hype.
That rush led to “not completely clear business plans,” which according to Nyquvest have fueled a consolidation trend in the space. “We've now seen a real focus in prioritizing what is really going to create value,” he said.
Psychedelics market update: Not all companies will be winners
Evan Levine, CEO of PsyBio Psychedelics (TSXV:PSYB,OTCQB:PSYBF), told INN he is worried about the value proposition of the entire psychedelics sector based on how little time companies have been around.
“A lot of these companies were formed just using the word 'psychedelic,' in my opinion,” Levine said.
Investors will have to be more cautious than ever before with the names they pick in psychedelics, according to the PsyBio executive. “Do I think our sector is a screaming buy? No, I don't,” he said. “I think that there's a few companies out there that have a real shot at succeeding within our industry.”
Levine agreed with Gilligan’s assessment that macroeconomics are having a significant impact on the progress and valuation of the psychedelics category.
“There's not a lot of value in a lot of the companies out there,” Levine said.
Psychedelics market update: 2022 studies show market progress
The psychedelics industry has grown thanks to the progress of clinical trials, which are adding to the medical promise of substances that were previously thought of as dangerous.
The development of these studies has become pivotal for the overall health of the market, with players on the sidelines looking forward to the first approval just as much as drug makers themselves.
Experts have previously told INN that the market is expected to see a slew of new studies launch this year. And when it comes to the studies everyone is watching in 2022, some have already brought promising data readouts.
Gilligan and Levine both told INN they are keeping a close eye on the progress of COMPASS Pathways' (NASDAQ:CMPS) primary study evaluating the company's lead psilocybin candidate.
In May, COMPASS shared an update on its Phase IIb study at the American Psychiatric Association's annual meeting, and said it plans to begin the critical third phase in H2 2022.
Psychedelics market update: Regulatory progress updates
Nyquvest told INN there’s never been more clarity when it comes to the psychedelics industry and regulators.
Aside from medical regulators who oversee the progress of clinical studies with substances like MDMA and psilocybin, there have been more changes for regulation at the policy maker level. The Numinus executive pointed to moves from the states of Oregon and Colorado, as well as new policies from Health Canada.
For his part, Gilligan told INN he is hoping for an efficiency upgrade over the application of rules by federal regulators in the US, the home of the most prominent psychedelics studies.
The Drug Enforcement Agency (DEA) and US Food and Drug Administration play key roles in the progress of psychedelic medicines, and with the recent explosion of companies launching studies, there’s been a need to adjust the previous understanding surrounding these substances.
“They're becoming more comfortable with the administration of psychedelics,” Gilligan said.
The executive said there are still frustrations with the licensing lag created by the DEA’s role when it comes to psychedelic studies. “Performing clinical studies that involve a multitude of states, you need to have a multitude of DEA approvals … and there's tremendous variability in state to state.”
The executive remains hopeful that thanks to the uptick in studies, the DEA is becoming more comfortable with the rules surrounding psychedelics.
“What we're hoping is that there'll be this realization that they really should not be scheduling (drawings), and that will facilitate and make it much easier to do your clinical research,” Gilligan said.
Psychedelics market update: Investor takeaway
The psychedelics investment proposition finds itself in a unique place right now as the market anticipates the eventual arrival of massive catalysts by way of drug approvals.
While investors wait, there has been a drag in valuations and stock prices that is also connected to current market pressures at a bigger level outside of just biotech and pharmaceuticals.
Investors are more educated than ever when it comes to psychedelics, and will have to use those skills regularly as they try to pick winners while watching out for companies that may be on the way out in 2022.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.
Additional information on investing in psychedelics stocks — FREE
Psychedelics Market 2022 Year-End Review
After a promising beginning, the psychedelics investment story may be facing fatigue until major catalysts hit the market.
The psychedelics sector continued to wait for its first major drug approval in 2022, while at the same time macroeconomic factors put pressure on investments in this up-and-coming drug development industry.
Here the Investing News Network (INN) offers investors a recap of the most significant psychedelics events of the year.
Investors switch to long-term mindset
The first publicly traded psychedelics company reached the capital markets in 2019, and shortly after that the industry saw a significant burst of new players declare their intentions to focus on the space.
These psychedelics stocks came onto the scene near the end of the "green rush," a period when cannabis companies saw significant valuation jumps. Although the two industries are vastly different in many ways, the success initially seen in cannabis created unrealistic expectations in the psychedelics investment community.
According to one expert, those expectations affected the early stages of the psychedelics market, but now there has been a real change of guard when it comes to knowledge of the space. “I've seen a shift, and I've seen the majority transition, yes,” Najla Guthrie, CEO of Wellbeing Digital Sciences (NEO:MEDI), told INN at this year's Wonderland conference.
Guthrie was referencing a change in psychedelics investors from people with an interest in day-to-day trading to more established market participants with their eyes on the long-term outlook for the industry.
One sign of this change was the publication of the first note on the space by Morgan Stanley (NYSE:MS). While the firm has not begun coverage on any companies, its broad sector observations point to a positive outlook on the industry.
“You're still going to have, you know, that fringe element that still thinks it's going to be … like cannabis, but I think those are the minority today,” Guthrie explained to INN.
The expert said she is encouraged by the data being produced by the top drug makers in the psychedelics space.
“I'm looking forward to seeing a lot of those come through the pipeline,” Guthrie said. “I'm very, very excited and encouraged about where we're headed, and how we're transitioning.”
Economic headwinds cause psychedelics stocks to drag
Despite a recognized shift in the psychedelics investor base, this year has been a real test for stakeholders.
As of November 30, the Horizons Psychedelic Stock Index ETF (NEO:PSYK), which includes some of the biggest psychedelics companies, along with pharmaceutical stocks connected to the industry, was down 56.54 percent.
Companies like ATAI Life Sciences (NASDAQ:ATAI), COMPASS Pathways (NASDAQ:CMPS) and Cybin (NYSEAMERICAN:CYBN), standard bearers for the market, have all seen share price declines of over 50 percent each.
Before allowing panic to settle in, one expert told INN that investors need to recognize how much broad world events have impacted most industries, especially emerging sectors.
“Macro forces are not only affecting psychedelics, but all kinds of early risky assets,” Maria Velkova, managing partner at Tabula Rasa Ventures, told INN during the Wonderland conference.
The financial expert said the previous hype cycle seen in psychedelics will play a role in determining what the downturn will amount to. “I think (the downturn is) fitting well with the natural progression of the hype downturn as well,” she said.
Clinical data affecting psychedelics investment story
This past year offered a substantial amount of new clinical data and progress for the biggest psychedelics studies.
As these studies become more prominent and regulators engage with more of them, an added level of comfort has been created surrounding psychedelic substances and potential drug products.
Velkova told INN that regulators are in charge as strict overseers of the data produced from these studies.
“The data is the data,” Velkova said. “This is why the (US Food and Drug Administration) was set up — to ensure that companies that are developing medicines are collecting the right data.”
Velkova spent a decade in the pharmaceutical industry before stepping into psychedelics.
When asked for a theme indicative of the capital market's progress in 2022, Guthrie said it’s been very difficult.
“It's been a painful transition for a lot of companies in the sector; (they) have lost a lot of their value,” the expert explained, adding that this is a symptom of where the capital markets are right now.
Guthrie told INN that a lot of the initial capital raised for the sector came with “unrealistic expectations” for the drug pipeline timeline. In addition, the market has taken a beating from the effects of inflation in the global economy, supply chain problems affected by lingering COVID-19 issues and the aggravated results of the war caused by Russia’s invasion of Ukraine.
Velkova also thinks companies listing at early stages will affect the current flow of psychedelics companies. The expert expressed reservations about early stage drug development companies going public, a trend seen in the psychedelics space.
“But you know, people have made decisions,” she said. “And now they're trying to kind of deal with the consequences of the market forces, which are outside of their hands.”
Velkova told INN she has seen a slowdown in investment momentum alongside a stabilization in valuations. “I do think that they were way out of proportion before; there's still a lot of unanswered questions, and a lot of uncertainty in the space,” she said.
She doesn't doubt the effectiveness of these substances as novel drugs, but when it comes to the investment storyline, the expert questions whether there have been complete answers about the commercial rollout of these potential drugs.
Investor takeaway
There are clear signs that the psychedelic drug market is on the way to potentially revolutionizing the entire medical industry. But until that day begins to materialize, there will still be down periods, with even the biggest companies seeing severe stock losses.
Experts in the space have said this waiting period can offer opportunities to investors, but patience will be needed before the industry takes off in a significant way.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.
Additional information on investing in psychedelics stocks — FREE
Psychedelics Market Forecast: 3 Top Trends That Will Affect Psychedelics in 2023
Pull quote was provided by Awakn Life Sciences. This article is not paid-for content.
Before the psychedelics industry can deliver on the promise of its potential, the sector will need to overcome challenges and achieve milestones, with drug approvals currently at the top of the list.
What does 2023 have in store for stakeholders in this up-and-coming drug industry?
Here the Investing News Network (INN) presents a look at what may be on the horizon for the psychedelics investment market, with expert opinions on trends and key catalysts to watch in the next year.
1. If a psychedelic drug is approved, what's next?
Clinical trials have a gigantic role to play in the progress of the psychedelics business. These trials are set to essentially make or break the industry's viability, and have the potential to generate huge momentum for publicly traded companies.
Right now, the industry is waiting for companies to receive their first approvals so that they can move past clinical trials and forward to the next stage of drug development: commercial availability.
Maria Velkova, managing partner at Tabula Rasa Ventures, told INN a lot of uncertainty is still present in the story for psychedelic medicines. The investment expert, who has a decade-long background in the pharmaceutical industry, said since so much attention is paid to drug development, commercial rollout can be cast aside despite being just as important.
“Most people in the space have never launched a drug before or haven't worked in Big Pharma,” Velkova said.
She expects the rollout of psychedelic drugs to be the biggest challenge yet for the industry.
When asked if difficulties caused by a lack of experience in drug rollout could be eased by acquisitions from pharmaceutical corporations, Velkova said the Big Pharma model has morphed into a commercial engine rather than a drug development model.
“I think Big Pharma is really waiting for us to build out the entire infrastructure, because this is a completely new infrastructure … there are so many aspects of the psychedelic-assisted therapy process that are not just a drug,” she told INN.
Broad questions about the psychedelic drug business model remain, according to the expert, such as how insurance payments will work. “We're literally building out novel ways of stakeholder alignment that haven't naturally been seen in the past,” she said.
2. Psychedelics legality making progress, but still murky
The psychedelics industry is also facing uncertainty when it comes to the legality of medicines.
Top regulators like the US Food and Administration (FDA) have drugs under examination, which may open the doors to limited access to these substances, but broader framework changes are in the works as well.
Both the US and Canada have seen recent political adjustments geared at getting a better understanding of the work being done within the psychedelics industry. As part of this year's US midterm elections, the state of Colorado voted to decriminalize the use of psychedelic mushrooms in drug centers for people 21 and older.
The policy will come into effect in 2024, and an advisory board may add more psychedelic drugs to the legal system in 2026.
Colorado will join Oregon to become the second state to allow the medical use of psychedelic substances.
One drug policy lawyer told INN that a grassroots state-by-state approach to psychedelics policy will be vital, but federal policy will also be needed at some point. “It is going to take change at the federal level, but I don't think we can get there … without this local grassroots movement,” Courtney Barnes, a partner and lawyer with Barnes Caplan, said.
The lawyer said there could be a domino effect as states approach legalization programs for psychedelic drugs, and this could lead up to federal change. “I'm very grateful that we have a state regulatory pathway available,” she told INN.
3. Expert wants psychedelics industry to band together
Najla Guthrie, CEO of Wellbeing Digital Sciences (NEO:MEDI), told INN she wants to see more advocacy within the psychedelics space. In Canada, she hopes to build a coalition to unify a variety of interested parties.
“We need the regulatory framework to happen responsibly,” Guthrie said. The expert hopes for this coalition to lobby the Canadian government for “evidence-based change” as the market continues to grow.
When asked how comfortable regulators and the Canadian government are with the use and administration of psychedelic substances, Guthrie explained that these authorities are looking forward to receiving official data; however, the groundwork is being laid right now when it comes to their future actions.
“I think the government is looking for some guidance on what makes the most sense,” the expert said.
That’s where she hopes her association can come in and represent the sector as a whole. “I think we as an industry need to do a better job of having one voice, or being on the same page and being aligned with what we want to see happen,” Guthrie said.
Investor takeaway
Psychedelics investors have been impacted by 2022's broad financial downturn, but there's light on the horizon in 2023.
“I think there are deals still being done, depending on the opportunities that are out there … (a) different type of investor is now at the table,” Guthrie said, referring to more established players with longer-term views.
For her part, Velkova told INN that due to the economic downturn, many companies are desperate for new capital to come into play. “I think right now and into the next year will be a great market for new investors to come.”
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.
Additional information on investing in psychedelics stocks — FREE
Psychedelics Market Forecast: 3 Top Trends That Will Affect Psychedelics in 2023
Pull quote was provided by Awakn Life Sciences. This article is not paid-for content.
Before the psychedelics industry can deliver on the promise of its potential, the sector will need to overcome challenges and achieve milestones, with drug approvals currently at the top of the list.
What does 2023 have in store for stakeholders in this up-and-coming drug industry?
Here the Investing News Network (INN) presents a look at what may be on the horizon for the psychedelics investment market, with expert opinions on trends and key catalysts to watch in the next year.
What are the top 3 trends that will affect psychedelics in 2023?
1. If a psychedelic drug is approved, what's next?
Clinical trials have a gigantic role to play in the progress of the psychedelics business. These trials are set to essentially make or break the industry's viability, and have the potential to generate huge momentum for publicly traded companies.
Right now, the industry is waiting for companies to receive their first approvals so that they can move past clinical trials and forward to the next stage of drug development: commercial availability.
Maria Velkova, managing partner at Tabula Rasa Ventures, told INN a lot of uncertainty is still present in the story for psychedelic medicines. The investment expert, who has a decade-long background in the pharmaceutical industry, said since so much attention is paid to drug development, commercial rollout can be cast aside despite being just as important.
“Most people in the space have never launched a drug before or haven't worked in Big Pharma,” Velkova said.
She expects the rollout of psychedelic drugs to be the biggest challenge yet for the industry.
When asked if difficulties caused by a lack of experience in drug rollout could be eased by acquisitions from pharmaceutical corporations, Velkova said the Big Pharma model has morphed into a commercial engine rather than a drug development model.
“I think Big Pharma is really waiting for us to build out the entire infrastructure, because this is a completely new infrastructure … there are so many aspects of the psychedelic-assisted therapy process that are not just a drug,” she told INN.
Broad questions about the psychedelic drug business model remain, according to the expert, such as how insurance payments will work. “We're literally building out novel ways of stakeholder alignment that haven't naturally been seen in the past,” she said.
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2. Psychedelics legality making progress, but still murky
The psychedelics industry is also facing uncertainty when it comes to the legality of medicines.
Top regulators like the US Food and Administration (FDA) have drugs under examination, which may open the doors to limited access to these substances, but broader framework changes are in the works as well.
Both the US and Canada have seen recent political adjustments geared at getting a better understanding of the work being done within the psychedelics industry. As part of this year's US midterm elections, the state of Colorado voted to decriminalize the use of psychedelic mushrooms in drug centers for people 21 and older.
The policy will come into effect in 2024, and an advisory board may add more psychedelic drugs to the legal system in 2026.
Colorado will join Oregon to become the second state to allow the medical use of psychedelic substances.
One drug policy lawyer told INN that a grassroots state-by-state approach to psychedelics policy will be vital, but federal policy will also be needed at some point. “It is going to take change at the federal level, but I don't think we can get there … without this local grassroots movement,” Courtney Barnes, a partner and lawyer with Barnes Caplan, said.
The lawyer said there could be a domino effect as states approach legalization programs for psychedelic drugs, and this could lead up to federal change. “I'm very grateful that we have a state regulatory pathway available,” she told INN.
3. Expert wants psychedelics industry to band together
Najla Guthrie, CEO of Wellbeing Digital Sciences (NEO:MEDI), told INN she wants to see more advocacy within the psychedelics space. In Canada, she hopes to build a coalition to unify a variety of interested parties.
“We need the regulatory framework to happen responsibly,” Guthrie said. The expert hopes for this coalition to lobby the Canadian government for “evidence-based change” as the market continues to grow.
When asked how comfortable regulators and the Canadian government are with the use and administration of psychedelic substances, Guthrie explained that these authorities are looking forward to receiving official data; however, the groundwork is being laid right now when it comes to their future actions.
“I think the government is looking for some guidance on what makes the most sense,” the expert said.
That’s where she hopes her association can come in and represent the sector as a whole. “I think we as an industry need to do a better job of having one voice, or being on the same page and being aligned with what we want to see happen,” Guthrie said.
Investor takeaway
Psychedelics investors have been impacted by 2022's broad financial downturn, but there's light on the horizon in 2023.
“I think there are deals still being done, depending on the opportunities that are out there … (a) different type of investor is now at the table,” Guthrie said, referring to more established players with longer-term views.
For her part, Velkova told INN that due to the economic downturn, many companies are desperate for new capital to come into play. “I think right now and into the next year will be a great market for new investors to come.”
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Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.
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