depression Archives - Green Market Report

Adam JacksonMarch 14, 2023


Psychedelic clinical research firm Reunion Neuroscience Inc. (NASDAQ: REUN) is taking Mindset Pharma Inc. (OTCQB: MSSTF) to federal court over claims that the company copied its main psychedelic formula and presented it as its own invention while applying for a patent.

Reunion filed a lawsuit against Mindset in the U.S. District Court for the District of New Jersey and is seeking to have its Chief Scientific Officer, Nathan Bryson, added as an inventor of the RE104 compound patent.

The company is also making claims for co-ownership of the patent, unfair conduct in the patent application process, and breach of contract.

“Reunion is proud of its inventions to further its mission to improve the lives of patients and families who suffer from depression and other mental health disorders and intends to vigorously protect its intellectual property position to the fullest extent,” it said in a Tuesday morning statement.


Reunion said it had been developing RE104 to treat postpartum depression and other mental health conditions and was given a patent by the U.S. Patent and Trademark Office (PTO) in April 2022, allowing the company the exclusive right to make and sell the composition until 2041. The patent made public the composition of Reunion’s psychedelic compound.

According to court documents, Reunion alleges that Mindset, another clinical psychedelics firm, copied RE-104 after it saw it in the patent approval and presented it as its own invention to the PTO in June, a few months after the Reunion’s chemical composition was made public.

It claims Mindset named two of its employees as co-inventors of RE-104, even though Bryson was the sole inventor, the company said. Reunion accused Mindset of misrepresentation and fraudulently omitted Bryson’s involvement.

Reunion alleges that Mindset “brazenly” told Reunion that it needed a license from Mindset to use the compound. Wanting to avoid litigation, the two sides agreed to meet to resolve the conflict. Reunion also noted in the court documents that the issue was affecting its third-party funding and wanted to resolve the issue so that its funding could move forward.

The filing stated, “The parties orally agreed on the timing, form, and amount of upfront payments, milestone payments, and royalties.”

After the meeting between the two companies, the CEOs shook hands on an agreement, but the case accuses Mindset of later walking back on the deal.

Reunion said it is suing Mindset to protect its intellectual property and hold it liable for purposely hurting the company.

In a statement released shortly after Reunion made the case public on Tuesday, Mindset said that it “disagrees with and denies the allegations set forth by Reunion.”

“The company plans to vigorously defend itself against this lawsuit,” it said.

What Reunion wants

Reunion requested a variety of remedies from the court. The company wants the inventorship of the Mindset’s patent to be corrected, meaning that the actual inventors of the patent are recognized, and for the director of the PTO to issue a certificate of correction reflecting this change.

Reunion also wants a declaration that states that it co-owns Mindset’s patent and the inventions claimed within it, and a separate declaration that Mindset engaged in conduct that makes the patent legally unenforceable.

The company is also seeking financial compensation such as its lawyers to be paid, damages resulting from Mindset flipping its position after an oral deal was made, and damages for its interference with Reunion’s ability to profit.

Drug Development

In January, Reunion completed an interim analysis of its phase 1 clinical trial of RE104. The trial involved 32 healthy volunteers who were given ascending doses of RE104, with two of eight subjects receiving a placebo in each cohort.

The drug was found to be safe and well tolerated with no severe adverse events, and showed robust and pervasive pharmacodynamic effects with a shorter duration of psychedelic experience compared to psilocybin.

The company said that it identified a dose level at which most participants achieved a “complete mystical experience,” which has been shown to correlate with psychedelic treatment responses in clinical trials of patients with depression, anxiety, and substance use disorder.

Reunion said it had moved to submit the data to the FDA as part of a pre-Investigational New Drug meeting in preparation for phase 2 trial development.

Adam JacksonOctober 24, 2022


Canadian clinical stage drug development company, Algernon Pharmaceuticals Inc. (CSE: AGN) (OTCQB: AGNPF), has entered a clinical trial agreement with Yale University to study DMT for the treatment of depression.

Algernon will provide DMT for the study in return for intellectual property rights with Yale around the clinical use of the drug. The company will also have the option to negotiate licenses to both IP developed jointly and IP developed solely by Yale — subject to rights reserved by the US government in conjunction with publicly funded research.

“The study may enhance our current understanding of the dosing regimen in the subjective effects induced by DMT,” said Deepak D’souza, the trial’s principal investigator and professor of psychiatry and director of Schizophrenia Neuropharmacology Research Group at the Yale University School of Medicine.

D’Souza is an experienced researcher with DMT and other controlled substances.

Algernon will also receive data from the study that it could use for its DMT stroke research program.

“After careful consideration, we chose to support Dr. D’Souza’s clinical DMT study and work with Yale University,” said Christopher Moreau, CEO of Algernon Pharmaceuticals. “Although the treatment of psychiatric disorders with DMT is not the company’s current focus, we have patents pending on novel forms of DMT which could potentially be used across a broad range of diseases. In addition, we believe the data generated from this study may help inform Algernon’s stroke research program.”

“A rising tide lifts all boats, and we feel a corporate responsibility as well to improve global awareness and support psychedelic medicine research when possible. It is in that spirit that we also chose to become the lead sponsor of Wonderland, the world’s largest conference on psychedelic medicine to be held November 3-5 in Miami.”

N, N-Dimethyltryptamine, or DMT, is a hallucinogenic tryptamine drug producing effects similar to those of other psychedelics like LSD and psilocybin. DMT occurs naturally in many plant species and animals including humans and has been used in religious ceremonies as traditional spiritual medicine by indigenous people in the Amazon. DMT can also be synthesized in a laboratory.

The “double-blind, placebo-controlled, crossover-controlled” study will compare different bolus and constant infusion dosing regimens of DMT in healthy control participants and individuals with depression.

Algernon has active research programs for idiopathic pulmonary fibrosis (IPF) with chronic cough, chronic kidney disease and a psychedelic program investigating a proprietary form of DMT for stroke.

Adam JacksonAugust 4, 2022


Braxia Scientific Corp. (CSE: BRAX) (OTC: BRAXF), acquired KetaMD, Inc. in a bid to expand ketamine-based psychedelic treatment for depression and other mental health challenges. The overall value of the deal is $6.2 million in a combination of common shares and convertible notes. KetaMD was founded by psychedelic pioneers Zappy Zapolin and Warren Gumpel, along with mindfulness instructor and brand experience expert Kaia Roman and the company’s President and Chief Operating Officer, Leann Taylor.

Braxia said it plans to utilize KetaMD’s end-to-end telemedicine platform to provide access to at-home ketamine treatments for people suffering from depression and related mental health conditions. Treatments are medically supervised, guided virtually by registered nurses with mental health expertise, and are backed by psychiatrists and researchers in depression.

This comes as the use of ketamine as a fast-acting antidepressant in treatment-resistant patients has piqued the interest of experts both in psychiatry and in the wider area of neuroscience.

The deal allows Braxia to offer both patient-centric in-person and digital telehealth ketamine treatments. Braxia said it plans to build upon the KetaMD platform through new clinical trials in the U.S. and Braxia’s growing patient dataset to “support potential future development of digital therapeutics in the management of depression and other related mental health conditions.”

“Today marks a notable step forward in bringing awareness, accessibility, and scalability of the benefits of ketamine and psychedelics generally for those suffering from depression and other mood disorders,” said CEO Roger McIntyre. “We’ve seen improved outcomes firsthand from ketamine treatment in our clinics and in our clinical trials. Adding digital telehealth capabilities through KetaMD’s highly anticipated online and mobile platform strengthens our position to lead the medical use of evidence-based psychedelics, while accelerating our ability to get treatment to those in need, safely and quickly across the U.S. and Canada, and globally in the future.”

KetaMD is currently available in Florida but said it plans to roll the platform out to other key states this year.

The deal comes as a growing shortage of mental health specialists in the U.S. leaves many people with unmet mental health needs.

Braxia said the acquisition of KetaMD addresses this access gap, enabling the company to reach more people in need by uniting in-person clinics with telemedicine for innovative, effective, and legal treatments.

“Following the acquisition of KetaMD, Braxia is a well-positioned vertically-integrated psychedelic medicine company,” said Zappy Zapolin, Co-Founder of KetaMD. “Combined, Braxia and KetaMD now have operations ranging from clinics to bioscience R&D to an at-home telemedicine platform, overseen by Dr. McIntyre, one of the foremost authorities in mood disorders and treatments.”

Year-end Earnings

Last week, Braxia released its year-end financial report card alongside its fourth quarter results ending March 31, 2022.

The company posted revenue of $1.49 million for the fiscal 2022 year ending March 31, 2022, a 47.5% gain versus $1.008 million in the previous year. In the fourth quarter of fiscal 2022, the company recorded revenue of $369,654, a 49.9% gain versus $246,673 in the same quarter the previous year.

The increase in revenue primarily reflects an increase in the number of treatments from the administering of ketamine at the Braxia Health clinics in Ontario, the release said.

The company saw net losses of $12.1 million for the year and an 86% decrease versus $88.8 million in a net loss in the previous year. The net loss includes a non-cash, share-based compensation of $2,422,562 (2021 – $2,874,857) and goodwill impairment of $5,275,374 (2021- $nil) related to the acquisition of the Canadian Rapid Treatment Center of Excellence CRTCE.

In the previous year, Braxia had completed a reverse-take over, the acquisition of CRTCE, and completed a brokered private placement which led to an overall increase in expenditures as the business evolved. The company’s management team said it has focused on cutting costs and reducing certain operating expenditures to focus on its core business.

Braxia’s cash and cash equivalents in the fourth quarter totaled $8.6 million, an 11.2% gain versus $7.64 million in the third quarter.

In addition to ketamine, Braxia said it has focused on researching and providing patients access to psilocybin for depression. Braxia Health, a wholly-owned subsidiary, commenced the first Health Canada approved multi-dose psilocybin-assisted therapy clinical trial last July and dosed its first participant that following November.

In connection with this clinical trial, the company reported positive preliminary results from its ongoing multi-dose psilocybin trial. The company reported meaningful improvements in depression severity observed — as measured by the Montgomery-Åsberg depression rating scale. Braxia said that the trial will be completed by December this year “at which point the full analysis will be completed and submitted for publication.”

Braxia Health also recently received approval from Health Canada for the Special Access Program (SAP) to provide psilocybin-assisted psychotherapy for a patient with Major Depressive Disorder in Ontario, according to the release. The SAP was amended on January 5 to include access to psychedelic compounds on a case-by-case basis outside of clinical trials. Braxia Health said it has since received SAP approvals for additional patients.

The company said it has also successfully recruited and trained medical and research staff as part of Braxia Institute to provide psilocybin-assisted therapy with high-quality safety monitoring. The program included 20 therapists licensed to practice in Ontario with specialized training in psilocybin-assisted therapy. All therapists were trained by the Braxia Institute and served as study therapists for the active psilocybin clinical trial, the release said.

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