You are currently viewing Psychedelic Bulletin #112 – Inside the DEA Challenge; Second Psychedelics Company Enters Death Spiral Financing

Psychedelic Bulletin #112 – Inside the DEA Challenge; Second Psychedelics Company Enters Death Spiral Financing

This Week:

  • đź“° Our Special Report: Inside the Challenge to DEA’s Proposed Scheduling of 5 Psychedelic Tryptamines
  • 📉 Second Psychedelics Company Enters Into Death Spiral Financing
  • đź“ş Disturbing Documentary from Down Under

and more…

Psychedelic Sector News

Special Report: Inside the Challenge to DEA’s Proposed Scheduling of 5 Psychedelic Tryptamines

Last week, the DEA ditched plans to place five tryptamines on Schedule I after a small group of researchers, psychedelic startups and lawyers challenged the agency.

Psychedelic Alpha was presented with around 200 documents pertaining to the docket, including evidence that was set to have its day in court on August 22nd. We sifted through these documents, along with public comments, to parse out some key takeaways from the proceedings.

In our Special Report, we dip in and out of some of what we deemed to be the most salient arguments and most interesting wrinkles in the proceedings. We certainly don’t cover everything.

Themes include…

  • The true costs of schedule I: how the bureaucratic baggage associated with the toughest schedule can make-or-break efforts to develop new therapeutics.
  • Why these low-profile tryptamines are worth fighting for, according to their proponents: from their therapeutic potential to their use as building blocks for further research. And then there’s the matter of precedent.
  • “Six lab rats in Texas get to determine that all psychedelics are too dangerous”: we take a look at a few of the arguments used to critique the DEA’s evidence base, which rested on decade-old analyses.
  • Judge’s “frustration” as DEA appears to flout the rules: in a transcript viewed by Psychedelic Alpha, Administrative Law Judge Wallbaum called out a DEA supervisor over an apparent attempt to ignore her order came straight from the top.

Second Psychedelics Company Enters Into Death Spiral Financing

We explained Death Spiral Financings back in May, when Silo Wellness announced a CAD ~$6m deal with “alternative financing solutions” provider Alpha Blue Ocean (ABO).

Distressed financings like these were common in the cannabis space as companies ran out of cash. The emergence of deals like these in the psychedelics space should serve as a warning to investors and other stakeholders in companies with short cash runways, especially companies with tiny market caps like Silo.

Last Thursday, Vancouver-based Havn Life Sciences became the latest company to announce such a financing, announcing that it had entered into a CAD $9m financing arrangement with ABO.

We weren’t entirely surprised to see this: according to our data, Havn has been running on fumes for months.

Nonprofit That Failed to Institute Post-grant Reviews of COMPASS Patents Requests Reconsideration

Freedom to Operate (FTO) has filed requests for reconsideration with the U.S. Patent Trial and Appeal Board (PTAB) regarding its denial of both petitions for post-grant reviews of COMPASS’ Polymorph A psilocybin patents.

Founder and director of FTO, Carey Turnbull, explained:

“We maintain our belief that the specifics of PTAB’s decisions have rendered the Compass patents of little practical value as a tool to stifle competition. At the same time, an important policy function is advanced when bad patents are challenged and invalidated. On this basis, we are asking the PTAB to reconsider its decisions as is provided for under U.S. patent law.”

In an analysis of the PTAB’s denial of FTO’s petitions published earlier this week, a quartet of Finnegan IP lawyers dissected the decision. 

Yesterday, COMPASS announced the launch of its Phase II clinical trial of psilocybin therapy in anorexia nervosa. The study will employ COMP360, the company’s synthetic psilocybin formulation.

Eagle-eyed (or, eared) viewers of a video released by the company on LinkedIn will notice COMPASS’ Chief Medical Officer Dr Guy Goodwin manages to slip the phrase, “freedom to operate” in. Goodwin suggests that psilocybin “seems to unblock certain kinds of rigid ways of thinking,” before going on to say that, “it seems to give people a freedom to operate, if you might say, cognitively.”

Psychedelic Investor Survey Results

ICYMI: we published the results of the inaugural Psychedelic Investor Pulse Survey.

We found investor sentiment is generally positive and optimistic, and is most positive among institutional-type investors. In our full analysis we explore investors’ willingness to hold onto their psychedelic investments.

We also found that larger investors intend to stick around. There is clear staying power among investors who have written larger cheques in the past 12 months (>$500,000), but those that made mid-sized allocations ($10,000 – $250,000) are expected to reduce their exposure to the space going forward.

The vast majority of investors are willing to wait over three years to see a return on their investments, with most respondents believing that the present level of interest in psychedelics is sustainable.

You can read the high-level findings, and download a 40-page report, on our dedicated webpage.

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Weekend Reading

Disturbing Documentary from Down Under

Australia’s public broadcaster, ABC, released a documentary via its Four Corners documentary brand that was teased by an article titled The mind field. The investigation revealed some disturbing allegations, to say the least.

The 50-minute doc, titled Psyched Up: The race to make psychedelic drugs part of mainstream medicine, can be streamed for free via the outlet’s website.

The coverage painted a troubling picture of the state of psychedelics down under, but it’s not all bad in Oz…

  • The chief executive of one of Australia’s largest health insurance firms told Perth Now that his organisation wants to be at the “forefront” of helping members access psychedelic-assisted therapies should they be approved. He also said that his organisation will look to partner with manufacturers and providers to bring down costs.
  • Josh Ismin and Sam Banister are developing psychedelic-inspired medicine for mental illness via PSYLO.
  • Paul Liknaitzky runs the Clinical Psychedelic Research lab at Monash.
  • And, the country’s national science agency (CSIRO) has started working on medicinal psychedelics, primarily via public-private partnerships. Remember that last spring the Australia government earmarked $15m for psychedelic research.

Other Reads

The Intercept reports that the Biden Administration “anticipates” approvals of MDMA and psilocybin within the next two years. A letter from SAMHSA suggests the organisation is “exploring the prospect of establishing a Federal Task Force to monitor and address the numerous complex issues assoicated with emerging substances,” the bucket in which MDMA and psilocybin are counted. Arguably demonstrating more spin than a Newport Beach SoulCycle class, atai founder Christian Angermayer responded to the news by tweeting at both Secretary Becerra and President Biden to thanks them for “endorsing” atai and COMPASS’ drug pipeline. 

YouGov Poll shows that just 18% of Americans oppose research into psychedelics.

Rolling Stone asks: Can Psychedelics Avoid the Mistakes of the Cannabis Industry? 

Shayla Love (Vice) explores the “long, strange relationship between psychedelics and telepathy.”

Crunchbase explores psychedelics as a “new frontier for venture funding.”

CBC reports that Health Canada has completed its review of all active MDMA-assisted therapy trials in the country. One study, sponsored by the Remedy Institute, has been suspended, while the MAPS-sponsored study will continue with corrective changes.

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