Small Pharma Archives - Green Market Report

Dave HodesMay 24, 2022
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8min10160

As the industry matures, there are clear leaders in the pack of psychedelics companies who are positioned to continue driving industry development. Compass Pathways, Atai Life Sciences, and Cybin are generally considered the top three companies in the industry, asserting their dominance in the market, with Field Trip Health and Seelos Therapeutics as psychedelics companies to watch.

But there are other companies maybe not so well known that, for now, are under the radar for industry watchers but are still making news—some good, some bad. 

Here’s a list of three winners and three losers of these lesser-known psychedelics companies:

Three winners:

  1. Numinus Wellness, Inc. (TSX: NUMI) (OTC: NUMIF). This Vancouver-based company reported Q1 2022 revenue of $647,915, a 61.9 percent sequential increase from Q4 2021, and a 1,857.6 percent increase compared to $33,098 during the same period last year when Numinus had only one clinic. The company secured several additional strains of psychedelic mushroom species and has already begun genomic analysis of these spore prints for research purposes, according to a press release. In March, the company announced that it had advanced to the next implementation phase in the multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX), sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS).
  2. Small Pharma. London-based Small Pharma initiated a clinical program into DMT-assisted therapy in February 2021. This program includes a Phase I/IIa trial on the company’s lead candidate alongside the development of a pipeline of proprietary preclinical assets. It was the world’s first clinical trial for DMT-assisted therapy in major depressive disorder that showed the consistent quality of psychedelic response in Phase I, according to a press release.
  3. Intelgenx (TSXV: IGX) (OTCQB: IGXT). This Quebec-based company announced in May 2021, that it entered into a second feasibility agreement with Atai Life Sciences for the development of novel formulations of Salvinorin A, a naturally occurring psychedelic compound being developed for treatment-resistant depression and other indications. The first feasibility agreement between the companies was signed in August 2020. That was followed in March 2021 by IntelGenx and Atai announcing a strategic partnership, including a proposed equity investment in IntelGenx by Atai.

Three losers:

  1. MindCure Health, Inc. (CSE: MCUR) (OTCQX: MCURF) (FRA: 6MH): This Vancouver-based psychedelics company announced in March that the additional capital required to execute the company’s business plan is unlikely to be found under the current and foreseeable market conditions, and that “none of the strategic alternatives available to the company necessitated ongoing developmental expenditures.” The company’s board then immediately eliminated all expenditures outside those required to “preserve the value of the company’s assets.” MindCure then initiated a company-wide workforce reduction of all of its C-suite executives and employees, other than its CFO, the vice president of engineering, and certain administrative staff required to “wind-down the company’s operations and for limited care and maintenance of the company.” 
  2. Core One Labs (CSE: COOL), (OTCQB: CLABF): The Vancouver-based company is actively working to investigate investment and potential takeover opportunities by strategic psychedelics or pharmaceutical companies. Its stock price is currently down nearly 99 percent from a year ago. The company began trading on the OTCQB market in April in an effort to get increased corporate visibility in the U.S. marketplace. It also has the potential to significantly enhance its liquidity and broaden access to institutional and retail investors, according to a press release.
  3. Mindset Pharma (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF): The Toronto-based company is struggling—its stock price is down 50.97 percent today as compared to last year. A letter to shareholders in March brought what sounded like good news from CEO James Lanthier when he touted their partnership with McQuade Center for Strategic Research as a “major milestone” that represents the first partnerships with Big Pharma. But the company is trading at a five-year low of $0.33/share today.

Dave HodesMay 11, 2022
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12min8191

One of the most important aspects of the psychedelics business—and one that is becoming more contentious—is about securing and protecting the patent for the specific molecule or synthetic that a psychedelics company is banking on because it can essentially protect the investment of millions of dollars a startup spends on setting up and running clinical trials, hiring expensive medical staff and other business development expenses.

Patents give protections for making, using, or selling the patented inventions of a patent holder for 20 years. They are a form of government-granted monopoly. The public policy justification for patents rests on the theory that the right to exclude competitors incentivizes innovation and encourages inventors to disclose their inventions to the public, instead of maintaining them as trade secrets. 

But when it comes to an emerging industry like psychedelics, there are no clear-cut answers to what patents should do, what they can do, and who can own them.

According to an article in the Harvard Law Review, the sudden influx of psychedelic patents has prompted criticism from stakeholders including patient advocates, scientists, journalists, lawyers, and members of Indigenous communities. “Some claim patents on psychedelics monopolize products of nature that should remain affordable and widely available. They contend that patents can exploit the traditional knowledge of Indigenous communities without permission or adequate acknowledgment and compensation. Others argue psychedelic patents are making a small number of companies gatekeepers for the emerging psychedelics industry, which could inhibit research, stifle innovation, and restrict access to needed therapies.”

One of the unique difficulties in securing a patent in the psychedelics industry is making decisions based on “prior art”, defined as “references or documents which may be used to determine novelty and/or non-obviousness of claimed subject matter in a patent application.”

Psychedelics are so new that there really isn’t much prior art. And you can’t patent a plant. But those are just a few of the trapdoors of patents in psychedelics.

To explain the patent issue in more detail, Psychedealia talked with Peter Rands, a patent attorney, and the CEO and founder of biotech company Small Pharma (OTC: DMTTF), working on DMT assisted psychotherapy. He used DMT as an example. “DMT is a molecule that is a known compound. You cannot patent what is known,” Rands said. “The specific application of known compounds can be patented if there is something novel and non-obvious about it.”

The interesting thing about the psychedelics environment, he said, is that for the most part, the private companies that are developing proprietary medicines—the fundamental evidence that these molecules were effective as kind of antidepressant medicines, maybe expanding beyond depression into other mood disorders or other neurological conditions—was put into the public domain by academia, such as Johns Hopkins and Imperial College. “So no one has proprietorship either on the fundamental molecule or the specific applications,” he said. “This opens up the question of the value of secondary patents.”

An example of a secondary patent is the specific polymorph that one of the top psychedelics industry companies, Compass Pathways, has patented with their Compass360 psilocybin therapy, which is the company’s synthesized psilocybin formulation being developed for psilocybin therapy in treatment-resistant depression. “I worked for three years at a generics company, where what we were doing was finding ways around patents, or challenging them in court,” Rands said. “And a patent that covers a very narrow polymorph is really easy to design around.”

He said that he keeps an eye on patents in the psychedelics industry. “Absolutely. There have been some interesting ones. There are a lot of companies trying to come up with novel combinations. A lot of companies are finding the sort of specific ways to assess the subjects and see what they can get protection around with kind of a pre-screening mechanism, basically, for people that will be receptive or unreceptive to psychedelic therapy.”

He said that Small Pharma is specifically focusing on the manufacturing methods for producing their DMT, which they think is more efficient than any other producers. “We published it fully in our patent application. So you know, to the extent that it’s protectable, it is also in the public domain.”

Compass Pathways (NASDAQ: CMPS) is currently addressing a patent challenge from Freedom to Operate (FTO). FTO is a non-profit founded to advance science and education, specifically to support and facilitate scientific research, in the public interest and for the public benefit. 

FTO is currently challenging Compass Pathways’ first patent with claims covering its Form A hydrate psilocybin. The Form A hydrate is distinct from the anhydrate psilocybin for which the company has already been granted eight patents in the U.S., UK, Germany and Hong Kong. It is used in Comp360.

It’s the fifth time that FTO has challenged a Compass Pathways patent. FTO claims the patent on this form of crystalline psilocybin is invalid because the substance was publicly used prior to the date on which the patent for the claimed invention was first filed. 

FTO claims that the form of psilocybin had first been used as far back at 1963, according to an open letter on the subject. The challenge is expected to continue, but it has genuinely caught the attention of the psychedelics community.

Christian Angermayer, who founded Atai Life Sciences and helped found Compass Pathways, expressed his opinion about patents in an open letter, starting off with a sort of Patents 101 discussion: “Patents were actually implemented in the U.S. to reward innovators in the short term with a temporary monopoly,” he wrote. “Patents and any similar forms of protection like data exclusivity can be compared to a mortgage on a house. For a certain period of time, society has to pay back the mortgage (assuming the house is great, and people want to move in), but after that, society owns it and can live there rent-free.”

Angermayer then added that he feels that the patent discussion is mixed up with other societal issues. “Many use this discussion to express their discomfort with current FDA regulations,” he wrote, commenting on the burdens and expense of trials. Others, he wrote, use the patent discussion to express their discomfort with capitalism itself. “I personally believe that capitalism—though it has its flaws—is by far the best economic system tried to date and that many, especially young people who flirt with socialism at the moment, forget the destruction, pain and death socialism has brought for hundreds of millions of people over the years. I would be interested in having this discussion, but…it’s not a psychedelic discussion.”

So what can be done? A more preventative approach to improving the quality of psychedelic patents involves bolstering the prior art search by creating prior art repositories, according to the Harvard Law Review. Another potential assistance would be tightening up U.S. patent law requirements for novelty and non-obviousness. 

Some call for patent pledges in the psychedelics industry. And some say that this industry should not use patents at all. “Because psychedelics represent the most innovative approach to mental healthcare in decades, and the most promising potential solution to the mental health crisis, they are too important to be monopolized,” the Harvard Law Review concluded. “Keeping psychedelics in the public domain, off-limits to the patent system, may be akin to prohibiting patents on abstract ideas, products of nature, and natural phenomena, because they are fundamental tools of scientific inquiry.”


Dave HodesMay 4, 2022
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6min9960

Small Pharma (OTC: DMTTF), a London-based neuropharmaceutical company focused on psychedelic-assisted therapies, made big news recently with the announcement of the first clinical trial in February 2021, using N, N-Dimethyltryptamine (DMT) to treat major depressive disorder. “We’re doing it in combination with psychotherapy, because we have reasons to believe that what psychedelics really do is enhance the potential for psychotherapy to improve the condition,” Small Pharma CEO Peter Rands told Psychedealia

“We conducted a phase 1 clinical study in 2021, completed in September, that assessed four different dose levels of DMT in 32 psychedelic naïve volunteer subjects because the majority of major depression sufferers will be psychedelics naïve,” Rands said.

DMT is a very short and intense experience and is given by interjection, that lasts about 20 minutes. “What we’re trying to demonstrate with the patient study, and where we’ve taken the sort of optimal base, is to give a fully psychedelic experience to everyone that participated,” he said. “They would have a full psychedelic experience and a very good tolerability, which was largely what we’re trying to assess in psychedelic subjects, as well as DMT being their first psychedelic experience.”

They are in the next phase of the clinical study, initiating the blinded, randomized, placebo-controlled, proof-of-concept Phase IIa study in 42 patients with major depressive disorder. 

That study is being held at two UK clinical trial sites—Hammersmith Medicines Research and MAC Clinical Research—and has been modeled on an ayahuasca case study, Rands said. DMT is often associated with ayahuasca because it is the brew’s main psychoactive ingredient. 

Results are anticipated sometime this year. “The critical difference is that ayahuasca creates a long-lasting psychedelic experience, which is made orally available,” he said, noting that DMT is not normally orally active, but it can be drunk. “If we’re successful, then we will take this to phase 2b, and we will progress our pipeline,” Rands said. 

Small Pharma began in 2015 when Rands and his team were looking for viable projects they could initiate based on known active ingredients with some sort of proprietary and innovative profile. “That took us to mental health, and specifically the role of ketamine in treating depression,” Rands said. “We discovered reading in the literature that there was very promising preclinical data supporting a rapid-acting antidepressant quality of one of the ketamine metabolites. It didn’t have the same abuse potential that ketamine has, which at the time was a big question about the commercial viability of ketamine as a treatment.”

He said that they started with that project, but two years later, with the data coming out about psychedelics, they switched focus. “We thought what would really change patients’ outcomes will be the psychedelic space not the sort of non-psychedelic headspace, as it were.” 

Why the name Small Pharma? Rands wrote on the company website that they called themselves Small Pharma because they “knew more what we weren’t than what we were. We weren’t deep-pocketed or well known, which meant we were unencumbered by legacy pipelines or mismanaged expectations.

He explained further: “We are focused at the stage of development where Big Pharma typically struggles to innovate these days,” he said. “We don’t consider ourselves different, fundamentally, from Big Pharma. It’s all the same people who work in these companies,” Rands said. “What does separate us is the mission. So we can and should work on higher risk programs, that if they succeed, we’ll have a very strong value increase up until the stage where it can be passed on to big pharma company.”

Rands said that while Small Pharma hasn’t partnered with any big pharma companies yet because they feel that there is more clinical work they can do before entering a deal. But that it’s “always been on our radar.”


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