The landscape for success with psychedelics companies is still shaping up, with more companies getting into the space or developing partnerships to help them grow faster and do more with their resources.
The year 2022 has been a story of shifting personnel, big buyouts and collaborations, new clinical trial launches, and strategic money moves.
Here’s a snapshot of five of the top 48 publicly traded psychedelics companies and how they fared this year, with a quick peek about what is coming up for them in 2023.
Atai Life Sciences (Nasdaq: ATAI)
Always at the top of the list of psychedelics companies on the move, Atai Life Sciences launched a Phase 1 study of an MDMA derivative focusing on post-traumatic stress disorder in September.
On Nov. 10, the company entered into an agreement with Jefferies LLC as sales agent for common shares of the company, which are currently valued at a total of $150 million. Under the sales agreement, Atai will set the parameters for the sale of common shares, the number of common shares to be issued, the dates on which such sales are anticipated to be made, any limitation on the number of common shares to be sold in any one day, and any minimum price below which sales may not be made.
Atai intends to use the net proceeds from the sales to advance the clinical development of its product candidates and programs, and for working capital and general corporate purposes.
Also in November, Dr. Sahil V. Kirpekar was hired as chief business officer, a newly created role. Kirpekar, formerly with Otsuka Pharmaceutical, will be responsible for Atai’s pipeline strategy, building out its commercial and market access functions, and leading its global business development efforts, including in- and out-licensing, M&A, and strategic investments.
A peek into 2023: Eight compounds are now in clinical development at Atai, paving the way for significant additional value inflection points over the next 6-12 months. This includes the dosing of the final patient in the Phase 2a proof-of-concept (PoC) trial of PCN-101 for treatment-resistant depression.
Additionally, Atai is working with Massachusetts General Hospital – Harvard Medical School’s largest teaching hospital – to begin a study to identify changes in the brain at baseline, 24-48 hours post-treatment and two weeks after ketamine administration.
Awakn Life Sciences (NEO: AWKN) (OTCQB: AWKNF)
Awakn Life Sciences initiated two feasibility studies in 2022. The first study investigates a market-ready proprietary formulation of MDMA for the treatment of addiction. The second study, with a leading European pharmaceutical company, investigates a market-ready proprietary formulation of esketamine. If successful, either study – or both – could lead to exclusive licensing agreements.
The company also announced the Phase III clinical trial of their lead program, Project Kestrel, which will be delivered in the U.K.’s public health care system. The U.K. government agencies provided grant funding for 66% of the cost of that trial.
Awakn clinics delivered continued strong revenue growth of 27% over the last quarter of 2022, and the company launched its licensing partnership business into the U.S. and Canada, signing three partners in the third quarter, which provided Awakn with two distinct revenue streams across four territories.
Peek into 2023: In November, Awakn Clinics signed a five-year lease for a larger addiction treatment facility in Oslo, marking the first stage of Awakn’s Nordic expansion plans. The clinic is expected to finish the completion of renovations in early 2023, with the opening expected soon after that. The next stage is expected to be a clinic opening in Trondheim, in central Norway, sometime next year.
Cybin (NEO: CYBN) (NYSE AMERICAN: CYBN)
Cybin provided a progress update on its CYB004-E Phase 1 trial evaluating N,N-dimethyltryptamine (DMT). Dosing was completed for four out of five participants with no clinically significant safety or tolerability issues. It’s the company’s largest Phase 1 DMT trial conducted to date.
The company also strengthened its drug discovery platform and intellectual property portfolio through multiple licensing arrangements, which includes a catalog of tryptamine-based molecules acquired from Mindset Pharma. Cybin now has access to more than 35 patents and applications through a combination of internal filings and licensing arrangements.
Peek into 2023: Under terms of an equity program, as of Nov. 14, Cybin can issue and sell up to an additional $28.9 million of common shares. Depending on market conditions, this will allow Cybin to access additional cash for growth opportunities and working capital.
Also, the CYB004E Phase 1 DMT study is expected to be completed in the first half of 2023.
Field Trip (now Reunion Neuroscience) (TSX: REUN) (Nasdaq: REUN)
In August, the company completed corporate reorganization, separating the Field Trip Discovery and Field Trip Health divisions into two separate companies:
- Field Trip Discovery, which was renamed Reunion Neuroscience Inc., based in Toronto, and will remain listed on the Nasdaq Stock Market and Toronto Stock Exchange under new ticker symbol REUN. (Field Trip Psychedelics was later combined with Field Trip Discovery in October.)
- Field Trip Health was renamed Field Trip Health & Wellness Ltd. and listed in the Toronto Stock Exchange Venture under new ticker symbol FTHW. Field Trip transferred the entirety of its ketamine-assisted therapy clinics in Canada, United States, and the Netherlands, plus its botanical research in Jamaica and part of its corporate operations in Canada and United States, to the newly-formed Field Trip H&W.
The first day of trading for both Reunion and Field Trip H&W was Aug. 17.
On July 21, Reunion announced the successful first dosings in the company’s Phase 1 clinical study of its first novel psychedelic molecule, RE104 (formerly FT-104, which was Field Trip’s first molecule in development), being conducted in Australia.
Peek into 2023: Reunion expects to report results from the RE104 study in the first quarter of 2023 and is planning to seek FDA guidance on Phase 2 studies planned for next year.
Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF)
Tryp Therapeutics experienced a series of developments throughout 2022.
In April, the company had its first patient dosed with psilocybin in a phase II clinical trial for its lead candidate, TRP-8802, intended to serve as a potential treatment of binge eating disorder (results were announced in June).
In May, Tryp hired Chris Ntoumenopoulos to the board of directors, who is a seasoned biotech and financial consultant working in the financial markets in both raising capital and developing corporate strategy.
Then in October, the World Intellectual Property Organization (WIPO) published Tryp’s international patent application covering the intravenous administration of psilocybin and psilocin.
Peek into 2023: Tryp Therapeutics is planning a Phase 2a, open-label, pilot study of TRP-8802 to assess the safety and efficacy of it at as treatment for fibromyalgia, as administered with psychotherapy. The clinical trial is expected to begin in the first half of 2023, with a primary completion date scheduled for November 2023.