Psyched: MindMed And Compass Q1 Earnings, FDA Approves Therapists Taking MDMA, Wesana Health Goes Public

Two of the most prominent companies in the psychedelics space released their financials for the first quarter of 2021.

Compass Pathways CMPS and MindMed MNMD remain the only two companies in psychedelics to reach a major U.S. stock exchange. Both companies presented net losses associated with R&D expenses, as entities in the space race towards gaining ground in a sector that still hasn’t reached early maturity or profitability.

Both companies presented strong cash positions to advance their research pipelines.

Compass, Pressing On Psilocybin: Compass highlighted the issuing of two new patents and a post-quarter equity financing round of $144 million.

The company is currently pushing psilocybin through a phase 2b clinical trial. In March, Compass was granted two new patents.

Compass reported a net loss for the first quarter of $12.7 million. R&D expenses were $6.9 million and general and administrative expenses were $6.7 million.

Compass’s cash position was $179.5 million as of March 31, but the company completed a new raise in May, with a public offering for total gross proceeds of $144 million.

MindMed Betting On Expanded R&D Pipeline: Mindmed also announced its financials for the first quarter of 2021, with total assets as of March 31 at $201 million. 

Cash represents $160 million the total, which includes an upsized financing of $73 million and a private placement of $15.4 million, raised in the first quarter of this year.

The company reported $10 million in net spendings on operating activities for the quarter, with net and comprehensive loss reaching $14 million.

MindMed closed the acquisition of HealthMode, a machine learning and digital therapeutics company.

The company made significant advancements in its R&D pipeline, launching a clinical trial which combines MDMA and LSD in collaboration with the Liechti Lab at Basel, Switzerland. It also entered a partnership with MindShift Compounds AG, a Swiss startup working in the development of second generation psychedelic molecules.

FDA Approves New MDMA Therapist Training Study

The Food and Drug Administration has issued a new authorization, allowing therapists involved in MDMA-assisted psychotherapy to participate in a phase 1 trial using MDMA themselves, as part of an MDMA Therapy Training Program developed by the Multidisciplinary Association of Psychedelic Studies (MAPS).

The approval came after an appeal by MAPS, following a 20-month pause on the trials imposed by the FDA.

“This is MAPS at its best, negotiating with the FDA in an evidence-based manner with existing and new data that we analyzed specifically for our response,” said MAPS Executive Director Rick Doblin.

The appeal was backed by the fact that the FDA had already approved a similar MAPS-sponsored study in 2009, after which therapists stated “the experience was an invaluable part of their training.”

Providing therapists with personal knowledge of the treatment via a firsthand experience is believed to be an integral part of the MDMA training program.

A press release said that the FDA’s Office of Neuroscience granted the appeal “on the grounds of scientific merit, the absence of unreasonable risk to participants, and appropriate investigator qualifications.”

Last year Health Canada, the FDA’s Canadian counterpart, issued a similar authorization, allowing therapists to use psilocybin as part of a training program.

Wesana Health Goes Public, Strikes Research Deal With World Boxing Council

Wesana Health Holdings Inc. announced that its shares began trading on the Canadian Securities Exchange under the ticker symbol “WESA.”

The company, founded by former NHL left-winger Daniel Carcillo, is focused on finding novel solutions for treating traumatic brain injury (TBI) through psychedelics and naturally sourced therapies.

Last month, the company announced the closing of a CA$16.1 million ($13.3 million) private placement.

“The company was born out of a space of necessity, based off of my personal journey, not only with TBI but ultimately finding psychedelics that saved my life,” Carcillo said in an interview with Benzinga.

The company also announced a new joint research project with the World Boxing Council, to analyze the therapeutic potential of psilocybin in treating symptoms of traumatic brain injury in boxers.

The Council will provide Wesana with TBI data from voluntary current and former boxers, through a multi-year research partnership.

Silo Wellness To Offer 5-MeO-DMT At Retreats

Silo Wellness Inc. (Canadian Securities Exchange: SILO) will expand its portfolio of psilocybin and ketamine product and retreat offerings to include 5-MeO-DMT, through a partnership with Kaivalya Kollectiv, a Los Angeles-based wellness company that conducts psychedelic-integrated spiritual coaching and facilitated retreats in Mexico, Jamaica and Costa Rica.

Through the agreement, Silo Wellness will integrate the 5-MeO-DMT experience into two new Jamaican retreats featuring yoga, meditation, breath work and spiritual coaching.

“Now more than ever, people are struggling with mental health issues and prioritizing their mental and physical wellbeing. We are pleased to expand our portfolio of psychedelic wellness retreats to include 5-MeO-DMT, which is known for creating truly transformative and spiritual experiences that can be deeply healing," Douglas K. Gordon, chief executive officer of Silo Wellness, told Benzinga.

The Milestone Round:

• Havn Life Sciences Inc. HAVN HAVLF announced the development of a rapid testing method that enables precise and accurate measurement of psilocybin content in less than 5 minutes, as part of a series of efforts to produce standardized, quality-controlled analyses of therapeutic compounds derived from Psilocybe mushrooms.
• IntelGenx Technologies Corp. IGX IGXT, a drug delivery company focused on the development and manufacturing of pharmaceutical films and Atai Life Sciences have joined forces with a $12 million investment from Atai into IntelGenx. With this investment, Atai now holds approximately 25% of IntelGenx stock.
• Wake Network Inc. is getting closer to becoming the first entity to perform a randomized, placebo-controlled, double-blind clinical trial on psilocybin microdosing. The company has received conditional approval from the Jamaican Ministry of Health and Wellness’ ethics board to conduct a phase 2b study with the University of the West Indies in Kingston, Jamaica.
• Braxia Scientific Corp. BRAX SHRMF, formerly known as Champignon Brands, announced the opening of its fourth clinic in Canada under its wholly owned subsidiary, Canadian Rapid Treatment Center of Excellence Inc. The clinic will operate under the name of Braxia Health.