Key Takeaways; Cannabis Sector

• Curaleaf completed the $210 million acquisition of Bloom Dispensaries in Arizona.
• Canadian retail cannabis sales fell 3% from October in November, rising 36% from a year ago.

Key Takeaways; Psychedelic Sector

• Awakn signs MOU with MAPS: The company also announced publication of paper; “Debunking the myth of ‘Blue Mondays’.”
• Numinus announced key milestones in MAPS-sponsored MDMA-AT for PTSD trial; the company also reported Q1 2022 results.
• BetterLife obtained positive preclinical data: Additionally, it received FDA response on pre-IND application.

Top Marijuana Company for Week

#1: Curaleaf

Curaleaf Holdings, Inc. (OTC: CURLF), a marijuana multistate operator, completed the previously announced acquisition of Bloom Dispensaries, a vertically integrated Arizona cannabis company.

According to a news release issued on Wednesday, January 19 2022, the addition of Bloom’s four Arizona retail outlets gives Curaleaf a total of 13 marijuana businesses in the state. This in turn means that in Arizona, Curaleaf gains two cultivation and processing facilities.

The total sale value was $211 million, with $51 million in cash upon closing. The remaining $160 million will be paid by Curaleaf issuing promissory notes payable on the first, second, and third anniversaries of the transaction. The third promissory note, valued at $13.85 per share, may be paid in Curaleaf shares.

Additionally, Bloom’s income in 2021 is expected to be over $66 million, according to Curaleaf.

“Arizona represents a significant market opportunity with strong long-term growth potential, and we believe the combination of our two companies will enable Curaleaf to accelerate our growth strategy in the state,” Curaleaf CEO Joseph Bayern said in a statement.

Curaleaf Holdings, Inc. is a fully integrated medical and wellness cannabis company. Cannabis Operations and Non-Cannabis Operations are the two segments in which it works. The Cannabis Operations segment is responsible for the cultivation and distribution of marijuana through retail and wholesale channels.

The Massachusetts based multistate operator, trades as CURA on the Canadian Securities Exchange and as CURLF on over-the-counter (OTC) markets in the United States.

Top Psychedelic Companies for Week

#1: Awakn

On January 19, 2022, Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF), a biotechnology company developing and delivering psychedelic therapeutics (medicines and therapies) to treat Addiction, announced that it had signed a Memorandum of Understanding (“MOU”) with the Multidisciplinary Association for Psychedelic Studies (MAPS) to explore a partnership to use MDMA-assisted therapy to treat Alcohol Use Disorder (AUD)

Under the terms of this MOU, Awakn will explore a data licensing agreement with MAPS to support Awakn’s Phase IIb and anticipated Phase III studies for MDMA-assisted therapy for AUD in Europe.

Awakn and MAPS will also consider forming a partnership in order to obtain marketing authorization and regulatory clearance for the ethical commercialization of MDMA-assisted therapy for the treatment of AUD in Europe.

AUD is a chronic condition that affects 40 million Europeans and 390 million individuals worldwide. Alcohol use is one of the top five causes of the disease and disability in the majority of European countries, making it a ubiquitous and chronic public health issue. And for every AUD sufferer, there is a friend, a partner, or a family member who is also badly affected by it.

Awakn published the favorable results of the BIMA Phase IIa study studying MDMA-assisted therapy for the treatment of AUD in February 2021, citing a 21% relapse rate at 9 months compared to a 75% relapse rate in a separate observational group.

Additionally, MAPS reported in May 2021 that the first of two Phase III trials for MDMA-assisted therapy for the treatment of severe persistent PTSD had yielded positive findings. In this study, 88 percent of patients who had three MDMA-assisted therapy sessions, as well as twelve 90-minute non-drug preparation and integration therapy sessions, saw clinically relevant improvements in their symptoms. 67 percent of those who took part no longer met the criteria for a PTSD diagnosis.

In addition to this news, Awakn also announced the publication of a paper supporting the overall safety and tolerability of clinically administered MDMA and debunking the myth of ‘Blue Mondays’.

#2: BetterLife

BetterLife Pharma Inc. (OTCQB: BETRF), an emerging biotech company focused on the development and commercialization of 2nd-generation non-hallucinogenic psychedelic analogs for the treatment of neuropsychological disorders, reported on January 18, that an in vivo oral bioavailability and food-effect pharmacokinetic (PK) study on BETR-001 in beagle dogs had yielded positive results.

BETR-001 (2-bromo-LSD, formerly TD-0148A) is a lysergic acid diethylamide derivative that is non-hallucinogenic (LSD). BETR-001’s PK has never been studied before in a published study. It was also unknown whether the presence of meals would influence the bioavailability of BETR-001 when taken orally.

Additionally, on January 20, the company announced that it had received a written response from the US Food and Drug Administration (FDA) on its pre-investigational new drug (pre-IND) application for BETR-001’s treatment of MDD.

BETR-001 (2-bromo-LSD, formerly TD-0148A) is a non-hallucinogenic lysergic acid diethylamide (LSD) derivative that is now conducting IND-enabling non-clinical investigations as well as GMP manufacture in preparation for clinical trials.

The FDA’s answer is generally in line with the Company’s planned approach for the development of BETR-001, and it offers advice on the BETR-001 IND-enabling non-clinical toxicological studies, manufacturing strategy, and initial suggested clinical trial parameters.

#3: Numinus

Numinus Wellness Inc. (TSX: NUMI), a leader in psychedelics-focused mental healthcare, announced on January 19, that it had completed key steps to prepare to enroll participants at its clinics in the Multidisciplinary Association for Psychedelic Studies (MAPS) “A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX)”.

The Canadian study sites, led by MAPS Public Benefit Corporation (MAPS PBC) as study sponsor, have recently received regulatory approval from Health Canada, ethical approval from an Institutional Review Board (IRB), and a Section 56 exemption from the Controlled Drug and Substance Act (Canada), which will allow the use of MDMA throughout the duration of the trial.

Numinus will host the MAPPUSX Canadian sites, which will be handled through Numinus’ two newly acquired, purpose-designed clinics, allowing the Canadian phase of the MAPS-sponsored study to be completed quickly.

In other news, on Jan 20 2022, the company announced its fiscal first quarter results for the three months ended November 30, 2021.