ketamine Archives - Green Market Report

Adam JacksonSeptember 15, 2022
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3min1440

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) posted positive results as revenue rose along with patients — showing the growing demand for psychedelics-centered therapy to treat addictions. The Canadian biotechnology company released its financial report card for the second quarter ending July 31.

Awakn posted revenues of C$339,872 via Awakn’s clinics for the second quarter, versus no revenue in the prior year. The second quarter revenue is up C$86,718, or 34% over the quarter.

The company said that revenue “during the seasonally quietest period of the year for our services” was primarily driven by the provision of ketamine-assisted therapies at the London, Bristol and Oslo Awakn clinics. These clinics were not open during the equivalent period last year.

“Today’s results and revenue growth demonstrate the continued momentum building in our business and the successful execution of our business plan in both pillars of the business: R&D and Commercialization,” CEO Anthony Tennyson said.

Over the quarter, Awakn received approval for its Phase III clinical trial for ketamine-assisted therapy for the treatment of Alcohol Use Disorder. This is the first time a government agency has funded a Phase III trial in psychedelics.

The company received C$2.5 million from U.K.’s National Institute for Heal and Care Research to cover 66% of the costs of the trial. The company will bankroll the rest.

“We have also made excellent progress in strengthening the IP moats for our ketamine and MDMA programs,” Tennyson said, referring to the competitive advantage of its intellectual property.

The company had C$481,830 in cash. It also announced the closing of a private placement – issued 1,880,454 units at a price of C$0.55 per unit raising gross proceeds of C$1,034,250.

“We have also successfully launched our licensing partnership business into the U.S. and Canada, putting us in the unique position of being a biotech with commercial operations in four territories, the U.K., the U.S., Canada and Norway, in only our second full financial year,” Tennyson said

Through the rest of the fiscal year, Awakn said it anticipates receiving regulatory and ethics approval for its Phase III clinical trial for ketamine-assisted therapy, as well as completing its behavioral study of ketamine in gambling addiction.

The company will also look to further its therapeutics commercialization through acquiring more licensing partners utilizing the company’s intellectual property moat ketamine-assisted therapy for treatment of Alcohol Use Disorder in the U.S. and Canada.


StaffAugust 4, 2022
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8min1550

The Daily Hit is a recap of cannabis business news for August 4, 2022.

ON THE SITE

Innovative Industrial Beats On Revenue Gains, Bets On Growth

Innovative Industrial Properties, Inc. (NYSE: IIPR) posted positive results as it continues to inject capital into the cannabis real estate landscape. The real estate trust released results for the second quarter ending June 30, 2022. The company saw $70.5 million in total revenue this quarter, a 44% gain from $48.9 million for the same quarter last year. The increase was mostly due to the acquisition and leasing of new properties, additional improvement allowances and construction funding at existing properties resulting in adjustments to base rent as well as contractual rental escalations at certain properties. Read more here.

CBD Company Ordered To Pay Clint Eastwood $2 Million

A California-based CBD company was ordered by a judge to pay actor Clint Eastwood $2,029,245.07 on August 2, 2022, according to a report by Law360. The company Garrapata, LLC filed a Complaint against Norok Innovation, Inc. and Eric Popowicz and others alleging trademark infringement. Garrapata holds all trademarks related to Mr. Eastwood and Mr. Eastwood’s name and persona rights apart from those he grants in connection with the promotion and exploitation of the films he makes. Read more here.

GrowGeneration Posts Quarterly Sales That Fall Short Of Expectations

GrowGeneration Corp. (NASDAQ: GRWG) slumped in late trading on Thursday after second-quarter results missed expectations — showing that consumer demand for hydroponics in the nation remained muted as a lack of regulatory guidance and recessionary pressures in the sector persist. The company released its financial results for the second quarter ending June 30, 2022. Read more here.

Compass Names New CEO, On Track For Phase 3 Study

Psychedelic drug company Compass Pathways plc (Nasdaq: CMPS) reported its financial results for the second quarter 2022 and gave an update on recent progress across its business. Compass delivered a net loss for the quarter of $21.0 million, or $0.50 loss per share (including non-cash share-based compensation expense of $3.2 million), compared with $17.5 million or $0.44 loss per share, during the same period in 2021 (including non-cash-share-based compensation expense of $1.9 million). The stock was trading higher in early trading rising by 3% to sell at roughly $16.65. Read more here.

Brazia Buys KetaMD In Deal Valued At $6.2 Million

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. Read more here.

DEA’s Psychedelic ‘To-Do’ List Is Growing

The pressure is ramping up on the U.S. Drug Enforcement Administration (DEA) as more lawyers, clinicians, researchers, investors and business owners working in the psychedelics industry are demanding clear answers about how the DEA should be evolving on its drug scheduling and enforcement strategy. Read more here.

IN OTHER NEWS

Akerna

Akerna (Nasdaq: KERN), an enterprise software company and developer of technology infrastructure, ecosystem, and compliance engine for the global cannabis industry, today announced the release of its annual mid-year review. This report highlights the current state of the cannabis industry. It takes a look at the needs of growing cannabis operators, and how technology drives that growth and supports the maturation of the industry. Read more here.

High Tide Inc.

High Tide Inc. (Nasdaq: HITI) (TSXV: HITI) (FSE: 2LYA), a retail-focused cannabis company with bricks-and-mortar as well as global e-commerce assets, announced that further to its press release dated July 7, 2022, the company has completed its acquisition through companies’ creditors arrangement act proceedings, of eight operating retail cannabis stores in British Columbia and Alberta for CAD$4.2 Million. The company intends to complete the acquisition of the ninth store in Niagara, Ontario, pending regulatory approvals. Read more here.

Entourage Health Corp., Irwin Naturals Inc.

Entourage Health Corp. (TSX-V:ENTG) (OTCQX:ETRGF) (FSE:4WE), a Canadian producer and distributor of cannabis products, announced it has entered into an exclusive licensing, manufacturing and distribution agreement with Irwin Naturals Inc. (CSE: IWIN) (FRA: 97X), a nutraceuticals and herbal supplement formulator of branded wellness products sold across North America. The new line of CBD and THC products to be produced under the agreement, curated by Entourage alongside Irwin’s wholly owned subsidiary Irwin Naturals Cannabis, are expected to launch first on Entourage’s Starseed Medicinal channel in Q4, 2022, with eventual expansion into retail markets across Canada. Read more here.

MariMed, Inc., Emack & Bolio®

MariMed, Inc. (CSE: MRMD), (OTCQX: MRMD), a multi-state cannabis operator, today announced the availability of a new cannabis-infused ice cream. MariMed collaborated with the legendary Boston ice cream brand Emack & Bolio’s® to develop and market new and innovative vegan and dairy ice cream in outrageous flavors. The ice cream is an extension of MariMed’s top-selling and award-winning Betty’s Eddies infused fruit chews brand and shares the brand’s commitment to being hand-crafted and using all-natural ingredients. Read more here.

Jones Soda Co.

Jones Soda Co. (CSE: JSDA, OTCQB: JSDA), the original craft soda known for its unconventional flavors and user-submitted photo labels, announced its financial results for the second quarter ended June 30, 2022. Read more here.


Adam JacksonAugust 4, 2022
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10min2090

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.


Dave HodesApril 5, 2022
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8min66580

Most people in the psychedelics industry believe that the growing superstar of psychedelic medicines is psilocybin—the “psychedelic du jour” as one scientist put it to Psychedelia.

But ketamine is quickly changing that perception.

Ketamine was introduced to the market in 1970 as a U.S. Food and Drug Administration (FDA) approved anesthetic after clinical trials that began following its formulation in 1962. More than 20,000 research papers have been published on ketamine since 1965, mostly about its use as an anesthetic, according to a study

From the 1970s through the 1990s, ketamine usage increased both medically and recreationally.

In the late ‘90s and early 2000s, ketamine began to show evidence as an effective antidepressant. Since 2006, 225 random controlled trials, 51 meta-analyses, and more than 565 reviews have reported on ketamine’s effectiveness at alleviating refractory depression and anxiety, and more recently, suicidality and pain management.

Ketamine is also being investigated for use with eating disorders (though researchers say that more empirical research is needed).

The biggest advantage of ketamine is that it is generally believed to be an FDA-approved drug for psychedelic therapy. But an FDA alert issued in February stated that ketamine is not FDA-approved for the treatment of any psychiatric disorder, blurring the understanding of exactly how it should be used. 

However, the “S” form of ketamine, which is derived from ketamine and known as Johnson and Johnson’s Spravato (esketamine), is a Schedule III controlled substance that was approved by FDA in 2019 as a nasal spray for treatment-resistant depression in adults, and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior.

What’s more, questions about the efficacy of ketamine have arisen from research that suggests ketamine use can create psychiatric, cardiovascular, neurological, and other side effects. 

But those issues haven’t stopped its growing popularity as a treatment for depression and other neurological disorders. It makes ketamine a target for more research. And that is happening.

For example, in November 2021, Yale Department of Psychiatry researchers were awarded a $2 million grant from the Michael J. Fox Foundation for Parkinson’s Research to conduct a clinical trial of ketamine to treat depression in people with Parkinson’s disease. It is the first investigation of ketamine as an antidepressant in a neurological disorder.

Research and development activities for ketamine companies is on the rise as well.

PharmaTher (OTCQB: PHRRF) (CSE: PHRM), created to develop and commercialize specialty ketamine pharmaceuticals for mental health, is planning a Phase 3 clinical study to allow for FDA approval of Ketarx, their ketamine treatment for Parkinson’s disease.

Seelos Therapeutics (US:SEEL) is currently pursuing a two-part Phase 2 clinical trial for intranasal delivery of ketamine, with results expected in December 2022.

Atai Life Sciences N.V. (Nasdaq: ATAI), a clinical-stage biopharmaceutical company, announced in January that the FDA has given Investigational New Drug (IND) clearance to conduct a clinical study of ketamine. Atai plans to initiate the study early this year through its platform company, Perception Neuroscience.

Field Trip Health, (NASDAQ: FTRP) the largest provider of psychedelic-assisted therapies in Canada, continues to open ketamine clinics for therapeutic use across the U.S. and Canada, with the goal of opening up to 75 ketamine clinics by 2023 to join Field Trip clinics that are already operating in such locations as downtown New York and Los Angeles (both cities also have multiple private ketamine therapy businesses not associated with Field Trip). 

Field Trip began operations in March 2020. They recently applied to the Canadian government to legally use psilocybin and MDMA-assisted therapies under Canada’s Special Access Program.

The use of ketamine as a fast-acting antidepressant in treatment-resistant patients has boosted the interest in the mechanism of action both in psychiatry and in the wider area of neuroscience. “Ketamine can make a genuine leap forward in the therapy of depression,” a study concluded. “Its clear effectiveness in reducing symptoms of depression and suicidal ideation, either after a single administration, or especially when administered repeatedly in addition to another antidepressant, is an extremely promising factor in the treatment of depression. Furthermore, research on new molecules designed to reproduce the rapid and sustained antidepressant effects of ketamine, without its adverse effects, allows us to assume that a new era in the pharmacology of antidepressants has already begun.”


StaffMarch 7, 2022
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3min1440

 Seelos Therapeutics, Inc. (Nasdaq: SEEL) announced its year-end 2021 business and clinical update. In the second half of 2021, Seelos said it had achieved several major clinical and financial milestones and continued to make progress on its multiple clinical-stage development programs. As of year-end 2021, Seelos had $78.7mm of cash.

SLS-002 (intranasal racemic ketamine)

  • In July, Seelos began dosing patients in Part 2 of the registration-directed, double-blind, placebo-controlled cohort in Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).
  • In June, based on feedback from a Type C meeting with the FDA, Seelos is planning to expand the size of the trial and number of sites now that this trial has been labeled registration directed.
  • In October, Seelos presented a poster titled “A Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with Major Depressive Disorder at Imminent Risk of Suicide”, at the 2021 IASR/AFSP International Summit on Suicide Research Virtual Conference. SLS-002 demonstrated rapid, robust and sustained reductions on the Montgomery-Åsberg Depression Rating Scale (MADRS), the Clinical Global Impression of Severity for Suicidal Ideation and Behavior, the Patient Global Impression of severity for Suicidal Ideation and Behavior, and the Sheehan-Suicidality Tracking Scale. Additionally, the group mean met the MADRS remission criteria initially on day 6 after only 2 doses of SLS-002.

“In the second half of 2021, we continued to accomplish several significant milestones and continued to execute in the face of one of the most difficult environments for publicly-traded biotech companies that I’ve seen in my career,” said Raj Mehra Ph.D., Chairman and CEO of Seelos. “We began the placebo-controlled Part 2 of the registration directed study of SLS-002 and plan to enroll in over 30 sites. The SLS-005 IV trehalose program’s registrational study in ALS, which was accepted into the HEALEY ALS Platform Trial at Harvard, commenced dosing participants in February 2022 and our IND was accepted to study SLS-005 in spinocerebellar ataxia and its Phase IIb/III pivotal study should begin dosing in Q2 2022. We have begun additional in vivo studies with our Parkinson’s disease-focused gene therapy program SLS-004 after demonstrating its capability of reducing alpha-synuclein expression. We look forward to continuing to provide meaningful updates on the current state of progress on all of our programs as well as additional initiatives.”


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