Psyched: Canada's Psychedelic Therapy Guidelines, $39M Series B For Next-Gen Drugs, Mexico's Ancestral Roots & More

Canada: Fed Guidelines For Psychedelic Therapy, Quebec Treatment Costs, Access And Magic Mushrooms Dispensaries

The agency regulating all things related to psychedelic-assisted therapy (PAT), Health Canada released a notice to stakeholders on risk-management measures for clinical trials, a seemingly supporting move towards future government-supported access. 

As stated, the purpose of notice 22-111811-471 is to outline Health Canada’s expectations regarding the implementation of risk-management measures by clinical trial sponsors and reflect on the “best practices emerging in the literature” of PAT in a context where there are no established clinical practice guidelines set yet. 

Separately, two Quebec-based doctors have successfully been paid by the Canadian province after completing psilocybin-assisted psychotherapy treatment for a mental health patient with Health Canada-granted access.

The case is the first in which the government’s healthcare system covers psychedelic-assisted treatment and a sign that ongoing efforts to remove legal barriers to access are slowly yet steadily thriving.

On the other hand, this November, the Canadian non-profit advocate organization TheraPsil joined patients and healthcare professionals in Ottawa to demand increased, more compassionate access to psilocybin after requesting a meeting with federal health ministers Jean-Yves Duclos and Carolyn Bennett. 

Though a formal meeting with the health ministers was denied, once in Ottawa the delegation spoke with the press, interested people and other government representatives to raise awareness of psilocybin’s medical benefits as well as educate and recommend a clean regulatory approach for medical access to the psychedelic.

Continue reading HERE.

Psychedelics Biotech Company Raises $39M To Develop Next-Gen Treatment For Depression

Psychedelics biotech company Gilgamesh Pharmaceuticals announced the closing of a $39 million Series B financing round led by Prime Movers Lab and joined by Alumni Ventures, Palo Santo, Negev Capital, Route 66, JLS Fund, Satori Capital and Gron Ventures. 

The new funding, which adds to the $27 million raised in a 2021 Series A financing, is set to support the progress of two programs into Phase 1 clinical trials testing safety and efficacy, as well as the development of a pipeline of novel preclinical assets.

Gilgamesh is one of the companies advancing the field of so-called “next-generation” psychedelics, that is, novel drugs that mimic the effects of more well-known psychedelics that are easier to patent compared to the latter, which gives the company a better commercial outlook.

The company’s initial focus is set on depression, yet it has stated that it aims to treat other mental health conditions with its novel compounds as well.

Continue reading HERE.

EXCLUSIVE: Meet Quetzalli, The New Non-Profit Supporting Mexico's Ancestral Roots

In the midst of the ongoing psychedelic renaissance, provider of wellness, education and sustainability Kaivalya Kollectiv is launching a non-profit organization called Quetzalli. The group will provide programs that will focus on medicinal plant preservation, cultural preservation, ecosystem regeneration and public education. 

Kaivalya and its subsidiaries perform their psychedelic retreats and provide information on these substances based on the direct access to traditional ceremonial knowledge offered by local communities and practitioners.

Quetzalli’s mission involves honoring Mexico’s ancient ancestral wisdom and preserving Indigenous practices through programs focused on medicinal plant and cultural preservation, ecosystem regeneration and public education on wellness and sustainability.

As such, its first initiatives will include supporting the local Wixárika tribe in building greenhouses and germination equipment to ensure an adequate supply of Peyote cacti in its native habitat. They will also educate local families and farmers in Indigenous techniques for sustaining biodiversity in food production and forestry. 

Founder of Isla Urbana and Quetzalli’s partner Ha Ta Tukari, Enrique Lomnitz said that he's been working with Indigenous communities in Mexico for over 12 years.

"Today, these ancient lineages of Native Mexican plant medicine and sacred knowledge are under greater pressure than ever, threatened by ecological and cultural destruction, cartel violence, and crass commercialism,” Lomnitz said. 

Continue reading HERE.

The Milestone Round

Each week, we learn about new clinical trials, the creation of psychedelic-based compounds and novel potential treatments for those suffering from mental and physical health conditions.

Most companies have already closed their financial quarters but their activity continues to move forward. Such is the case with Core One Labs CLABF, which recently announced the upcoming commercial production of clinical-grade psilocybin in Jan.’23.

In the clinical trials front, two important Phase 2 trials have hit the news: Small Pharma DMTTF completed a study testing its proprietary DMT compound administered intravenously in participants with Major Depressive Disorder, and Beckley Psytech initiated a trial on intranasal 5-MeO-DMT synthetic compound in participants with Treatment-Resistant Depression.

On the other hand, atai ATAI’s Phase 1 clinical trial testing atypical opioid receptor modulator KUR-101 towards Opioid Use Disorder treatment has provided mixed results, which seem to have impacted on the company’s market value. 

Finally, our recommendation for the holidays: Erasmo De La Parra’s imagined post-Apocaliptic world featuring humans addicted to ‘Mickey’.  

Access the prior week’s roundup HERE.

Psychedelics EFTs Weekly Performance

This is how the sector’s major EFTs performed in the week spanning December 19-23.

• AdvisorShares Psychedelics PSIL opened Monday, Dec. 19 at $1.95, following a descendent trend after prior week’s opening at $2.18 and closing at $2.04. Former December weekly opening was set at $2.35 (Mon. 5). After a small peak at $2.01 achieved on Wed. 21, the number went all the way down to closing price at $1.87 on Fri. 23. This week was the yearly lowest in price for this stock so far.
  The highest point achieved in December so far corresponds to Friday 2, at $2.42.
  For this EFT, the yearly price range is set between $6.26 and $1.82, mere $0.05 lower than the week’s closing price.

The Elemental Advisors PSYK EFT PSYK opened Monday, Dec. 19 at $16.96, considerably lower than former weeks’ openings at $18.15 (Dec. 12) and $18.68 (Dec. 5), as well as Nov. 28’s $17.95 and Nov. 21’s $17.62. A small upward trend ended on Wed. 21 (reaching $17.26) then dropping to closing price $16.70 On Fri. 23, considerably lower than Fri.16’s closing at $17.46, Fri. 9’s closing at $17.67, certainly lower than Dec. 2’s extraordinary closing at $19.15, and also lower than Nov. 25’s closing at $18.22.
For this EFT, the yearly price range is set between $23.32 and $16.70, which corresponds to the current stock price at the time of closing.