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New York, NY – September 1, 2022 – Young adults are using more hallucinogens than ever. According to a National Institute of Health survey, the amount of people between age 19 to 30 who reported using one or the other are at the highest rates since the survey began in 1988. The results come at a time when the global psychedelic drug industry is predicted to witness stunning growth at a CAGR of 13.3% from US$2.38 billion in 2021 up to US$6.4 billion by 2029. Some of the factors behind the projected growth include the prevalence of depression and other mental disorders worldwide, rising demand for alternative treatments and increased research and development in the psychedelic medicine space. Venture capitalists have also been turning their attention towards psychedelic medicine and investing in the space, creating an opportunity for companies like Optimi Health Corp. (CSE:OPTI) (OTCQX:OPTHF), Seelos Therapeutics (NASDAQ:SEEL), Numinus Wellness (TSX:NUMI) (OTCQX:NUMIF), ATAI Life Sciences (NASDAQ:ATAI), and Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP).
Optimi Health Corp. (CSE:OPTI) (OTCQX:OPTHF) is a homegrown Canadian company producing natural, scalable and accessible psychedelic and functional mushrooms and synthetic formulations for transformational human experiences.
On August 16, Optimi Health announced that it has received approval by Health Canada to produce and distribute additional psychedelic drugs, most notably MDMA.
Optimi will now serve as a wholesale supplier of MDMA and other synthetic psychedelic substances to authorized researchers and pharmaceutical manufacturers under the direction of Chief Science Officer Justin Kirkland.
With the prospect of the Biden Administration looking to regulate MDMA and psilocybin and 130 MDMA clinical trials currently listed between Canada and US, Optimi Health is preparing for future international and domestic regulatory movement that could positively impact the company.
This October, the company plans to start producing MDMA and conducting analytical tests in its recently finished EU-GMP pharmaceutical manufacturing facility.
According to Bill Ciprick, CEO of Optimi, the company is at the forefront of psychedelic commercial manufacture and delivery due to its internal capacity to produce a variety of scalable formulas.
Earlier this month, in partnership with psilocybin patient advocate Thomas Hartle, Optimi introduced Blue Serenity, Canada’s first natural therapeutic psilocybin product.
Optimi Labs Inc. in Princeton, British Columbia, has standardized Blue Serenity to contain 25 milligrammes of natural psilocybin in the form of EU-GMP biomass grown as Panaeolus cyanescens mushrooms. Hartle worked with Optimi‘s Todd Henderson, Head of Cultivation, and Chief Science Officer Justin Kirkland to produce a particular genetic strain based on Hartle’s prior medicinal experiences.
Patients, physicians, and researchers will get Blue Serenity in blister packs of eight psilocybin pills once health authorities have given it the all-clear under Canada’s Special Access Program (SAP) or an authorized clinical trial. Blue Serenity’s packaging complies with the rules and regulations in effect today for the production and marketing of pharmaceutical and medical products (EU-GMP).
The introduction of Blue Serenity, according to Optimi CEO Bill Ciprick, is an opportunity to pause and consider Thomas’ immense contributions to a world beyond psychedelics.
“Anyone who has entered the psychedelics space in the last two years will tell you that Thomas Hartle’s story of compassion and kindness inspired them in some way to want to make a difference,” Ciprick said. “We are tremendously excited to be partnering with Thomas to become the first Canadian company to launch a natural psilocybin product specifically to help patients seeking relief through the Special Access Program.”
Biopharma Companies Continue Their Psychedelic Programs
As the psychedelic market attracts more attention, companies within the space are continuing with research and development.
In July, Seelos Therapeutics (NASDAQ:SEEL) announced the administration of SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) to the first patient in an open-label basket study to treat people with amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) in Australia. With participants who have ALS, spinocerebellar ataxia, and Huntington’s disease, Seelos plans to carry out this 24-week, open-label basket research (ACTRN: 12621001755820) in Australia to assess SLS-005’s safety and tolerability as well as its impact on disease progression.
In Q3 2022, Numinus Wellness (TSX:NUMI) (OTCQX:NUMIF) revenue increased 31.8% year-over-year to $741,064 million, primarily due to the Mindspace and Toronto Neurology Center acquisitions. Sequentially, revenue decreased 5.7% from the prior quarter, entirely due Numinus Bioscience shifting strategic priorities – where analytical testing services for third-party enterprise customers ceased due to changing the dynamics of the sector. The loss was $7.0 million in Q3 2022, compared to a loss of $4.8 million in Q3 2021, partly due to business development and legal fees related to the acquisition of Novamind Inc. Numinus had a cash balance of $41.8 million as of May 31, 2022.
ATAI Life Sciences (NASDAQ:ATAI) reported research and development expenses of $17.9 million in the three months that ended June 30, 2022, compared to $16.0 million in the prior year. Net loss attributable to shareholders in Q2 2022 was $36.6 million (including non-cash stock-based compensation expense of $9.5 million) compared to $48.5 million (including non-cash stock-based compensation expense of $37.5 million) for the comparable period of the previous year. In the second quarter, the company continued to advance its programs and looks forward to furthering clinical milestones for the rest of 2022 and beyond. On August 15, ATAI entered into a term loan facility of up to $175 million with Hercules Capital, Inc.
On August 2, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced that it has received a Cooperative Agreement Grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). This grant supports the development of TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) for the treatment of cocaine intoxication. Tonix reported research and development (R&D) expenses for the quarter ended June 30, 2022, of $16.6 million, compared to $18.1 million for the same period in 2021. The company expects R&D spending to increase in 2022 as it advances its clinical development programs and invests in its development pipeline. Net loss available to common shareholders was $27.4 million, or $1.22 per share, basic and diluted, in Q2 2022, compared to a net loss of $23.6 million, or $2.25 per share, basic and diluted, in the prior-year quarter.
Optimi Health’s goal is to be the number one trusted, compassionate supplier of natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushroom across the world. The company’s products are grown at its two facilities which total 20,000 square feet in Princeton, BC, making it the largest psilocybin and MDMA cultivator in North America.
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