FSD Pharma Archives - Green Market Report

Debra BorchardtDebra BorchardtJuly 30, 2020
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4min13850

FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE.CN)announced that it has notified Health Canada of the company’s decision to forfeit the licenses of its wholly-owned subsidiary, FV Pharma, Inc. and suspend all activities by FV Pharma within 30 days of the notification date. FSD Pharma said it has begun the process of liquidating all FV Pharma assets, including the sale of the company’s cannabis production facility in Cobourg, Ontario.

Shareholders are apparently happy with the move as the stock is up over 60% on the news and was lately selling at $6.04.

“It is now clear to us that our shareholder value is best served in closing down our medicinal-grade cannabis operation in Cobourg, Ontario and reinforcing steps to advance pharmaceutical R&D efforts on our lead compound FSD201 (ultra-micronized PEA) and continuing to explore the acquisition of other compelling compounds to expand our drug development pipeline,” said Raza Bokhari, MD, Executive Co-Chairman & CEO.

“Our pharmaceutical R&D team led by Dr. Edward Brennan is actively working to submit an Investigational New Drug Application (IND) to the FDA for the use of FSD201 (ultra-micronized PEA) to treat hospitalized COVID-19 patients by down-regulating the over-expressed pro-inflammatory cytokine immune response to SARS-CoV-2 virus infection. We are hopeful to initiate the phase 2 clinical trial before the end of this year and remain cautiously optimistic that our study may improve treatment outcome for COVID-19 patients.”

The company said it is not making any express or implied claims that its product has the ability to eliminate, cure, or contain the COVID-19 (or SARS-2 Coronavirus) at this time.

COVID Pivot

In June, FSD said it was shifting its attention towards COVID. “Our immediate plans for FSD201 include submitting these Phase 1 trial results for publication in a peer-reviewed journal and advancing this compound into a Phase 2a proof-of-concept trial for the treatment of COVID-19,” said Dr. Bokhari. “The U.S. Food and Drug Administration recently gave the company permission to submit an Investigational New Drug Application for the use of FSD201 to treat COVID-19. We contacted the FDA after becoming aware that Italian physicians and scientists were advocating for use of ultramicronized PEA for patients suffering from symptoms of COVID-19, based on the drug’s mechanism of action as a potent and safe anti-inflammatory agent that reduces the production of pro-inflammatory cytokines and may help mitigate a cytokine storm.”

The company announced a $20 million at the market offering just a few weeks ago. The company said at the time that it would use the proceeds to continue the advancement of the near-term objectives with respect to its R&D program for the commercialization of ultramicronized-palmitoylethanolamide of FSD201.

 


StaffStaffJune 22, 2020
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4min5840

Canadian licensed producer FSD Pharma Inc. (Nasdaq: HUGE) has made a pivot in order to assist in the treatment of the deadly COVID-19 virus. The company announced favorable topline results from its Phase 1 randomized, double-blind, placebo-controlled study of ultramicronized palmitoylethanolamide (PEA), or FSD201. The company is hoping that with positive Phase 2 results, it can be used to treat COVID-19.

“We are delighted to be reporting favorable topline findings from our Phase 1 first-in-human safety and tolerability study with FSD201. I congratulate our pharmaceutical team, led by Dr. Edward Brennan. This study has also successfully validated the considerable scientific literature published over the years in Europe that claims safety and tolerability of micro-PEA,” said Raza Bokhari, MD, Executive Co-Chairman & CEO.

Historically (between 1969 and 1979), PEA used to treat patients with influenza and the common cold in Czechoslovakia. At the time, six randomized, double-blind, placebo-controlled clinical trials were conducted that demonstrated PEA was safe and effective for the treatment of respiratory infections. FSD Pharma attained the exclusive, worldwide rights (except for Italy and Spain) of PEA (which targets the CB2 receptor of the endocannabinoid system) through the acquisition of Prismic Pharmaceuticals in June 2019.

“Our immediate plans for FSD201 include submitting these Phase 1 trial results for publication in a peer-reviewed journal and advancing this compound into a Phase 2a proof-of-concept trial for the treatment of COVID-19,” continued Dr. Bokhari. “The U.S. Food and Drug Administration recently gave the Company permission to submit an Investigational New Drug Application for the use of FSD201 to treat COVID-19. We contacted the FDA after becoming aware that Italian physicians and scientists were advocating for use of ultramicronized PEA for patients suffering from symptoms of COVID-19, based on the drug’s mechanism of action as a potent and safe anti-inflammatory agent that reduces the production of pro-inflammatory cytokines and may help mitigate a cytokine storm.”

Small Study Group

FSD said that this was a single-site study conducted at the Alfred Hospital, part of the Alfred Health group of hospitals serving the state of Victoria in Australia and enrolled 48 healthy adult men and women. The trial sequentially tested single ascending doses ranging from 600 mg to 2400 mg tablets and multiple ascending doses ranging from 600 mg to 1200 mg tablets administered twice daily for 7 consecutive days. The single ascending dose subjects also were tested for food effects.

The study found ultramicronized PEA to be safe and well-tolerated. Mild and self-limiting side effects were reported and were deemed unlikely to be related to study drug. There were no abnormal laboratory findings or ECGs observed during the study and no serious adverse events were reported. No subjects withdrew due to an adverse event and all eligible subjects completed all doses. The pharmacokinetic profile of FSD201 in this study is still being analyzed. The study was led by principal researcher Jason Lickliter, MD, Chief Medical Officer of Nucleus Network, Australia.

The company is not making any express or implied claims that its product has the ability to eliminate, cure, or contain the Covid-19 (or SARS-2 Coronavirus) at this time.

 

 


Debra BorchardtDebra BorchardtJuly 2, 2019
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4min11350

R&D pharmaceutical company FSD Pharma Inc. (CSE: HUGE) (OTCQB: FSDDF) finalized its acquisition  of Prismic in a deal valued at approximately $17.5 million or C$23.4 million. The company said that the deal will be satisfied by the issuance of approximately 102.7 million Class B subordinate voting shares in the capital of FSD Pharma at a deemed price of CAD$0.2275 (US$0.1704) per FSD Share.

In addition, FSD Pharma said it has agreed to assume approximately $3.05 million of outstanding Prismic long- and short-term liabilities. All of the outstanding Prismic stock options and warrants have been converted into options and warrants to purchase FSD shares, with the number and exercise price of such securities having been adjusted in accordance with the exchange ratio under the agreement.

Dr. Raza Bokhari, Executive Co-Chairman and CEO said, “The Prismic acquisition represents strategic depth in the vision and mission of FSD Pharma and signals a paradigm shift in the overall outlook of the company. We are relying heavily on the expertise of Dr. Brennan, who is a seasoned pharmaceutical industry veteran with substantial experience from working at Glaxo Smith Kline and Johnson & Johnson to navigate us through the various stages of the FDA approval process for drug development, with the goal of eventually making synthetic cannabinoid prescription medications available for commercial use to help alleviate the pain and suffering of patients. We are confident, Peter Moriarty, another well-known pharmaceutical industry veteran, who was also one of the founders of Shire Pharmaceuticals, will make a meaningful contribution to the FSD Pharma story as the Chairman of the BioPharmaceutical industry advisory board.”

Prismic is a US-based specialty pharmaceutical company dedicated to addressing the opioid crisis by developing novel non-addictive prescription drugs for the treatment of pain, inflammation, and neurological disorders, based on formulations utilizing the company’s micro-PEA development platform (palmitoylethanolamide with particle sizes of 0.6 – 10 microns). Such formulations take advantage of micro-PEA’s “synergistic” or “entourage” effect on certain drugs impacting the endocannabinoid system. This means that lower doses of those drugs may be administered together with micro-PEA to achieve the desired therapeutic effect.

This includes the potential combination or concomitant use of micro-PEA formulations with drugs such as THC, CBD, certain anticonvulsants, and opioids where studies have indicated opioid-sparing and tolerance delaying properties of micro-PEA may impact the development of dependence in patients. Prismic’s first prescription drug candidate, PP-101, a 600 mg tablet of micro-PEA, is anticipated to commence a Phase 2/3 accelerated clinical development program in 2020 as a concomitant medication to be administered with pregabalin (Pfizer’s Lyrica®) for the treatment of fibromyalgia.

FSD Pharma will continue to be led by Raza Bokhari, MD, Executive Co-Chairman & CEO. Zachary Dutton, co-founder of Prismic, will continue to serve as the CEO of Prismic, reporting to Edward Brennan, Jr. MD, FACS, President of the FSD Biosciences Division. Peter Moriarty, co-founder and previous Chairman of the Board of Prismic, has been named Chairman of the newly-formed FSD BioPharmaceutical Industry Advisory Board.


William SumnerWilliam SumnerJune 13, 2019
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5min13820

Although adult-use cannabis is legal in nine U.S. states, problems persist with companies trying to gain access to capital and essential financial services. Consequently, the industry has devised a series of methods and institutions to circumvent these difficulties; from credit unions to keeping their funds in a giant safe. Another unique way that the cannabis industry has adapted to the issue has been connecting companies with private capital investment through investor forums. A perfect example of this is the MJMicro Conference planned for June 25, 2019, in New York City.

MJMicro is an invitational investor forum aimed at connecting high net worth investors with C-level executives of cannabis companies that have proof of concept, revenue streams, audited financials, and valuations justified by public markets.

The conference is hosted by MjLink.com Inc., a wholly-owned subsidiary of Social Life Networks, Inc. (OTC: WDLF).  George Jage is President of MjLink.com, which is an A.I. and Blockchain powered cannabis social network technology company that launched one of the first cannabis social network platforms in the United States and Canada, back in early 2013.

In addition to a fireside chat with two of the leading cannabis companies in the industry, Canopy Growth (NYSE: CGC) and Acreage Holdings (OTCMKTS: ACRGF), several companies have been selected to host spotlight presentations during the conference. Those companies include Emerald Health Therapeutics (CVE: EMH), FSD Pharma (OTCMKTS: FSDDF), and Helix TCS (OTCMKTS: HLIX).

Emerald Health Therapeutics is a medical cannabis company licensed to operate in Canada. The company’s subsidiary, Emerald, both produces and sells medical cannabis and has a stake in a company that produces, cultivates and distributes wholesale cannabis and cannabis extracts for both adult-use and medicinal purposes.

Most recently, Emerald Health was appointed by the American Trade Association for Cannabis and Hemp (ATACH) to lead its International Affairs Council on CBD and Hemp in ATACH’s engagement with the US Food & Drug Administration’s public hearing on CBD regulations.

Acting as a subsidiary of FV Pharma Inc., FSD Pharma focuses on developing high quality indoor-grown medical cannabis and the development of novel cannabinoid-based treatments for several central nervous system disorders. The company is currently engaged in expanding its 25,000 square foot cultivation facility in Ontario.

Helix TCS provides infrastructure services for the cannabis industry. Though the company may not be a household name, several of its subsidiaries are more recognizable; including Helix Security, Cannabase, and the seed-to-sale tracking software company BioTrackTHC. Tracking over $18 billion in legal cannabis sales, Helix TCS’s products are used in six countries, 36 U.S. states, and over 2,000 licensed retail locations.

In addition to the spotlight presentations by Emerald Health, FSD Pharma, and Helix TCS; several notable cannabis companies are also set to present at MJMicro. Those companies include MJ Freeway, Dixie Brands., Vireo Health, and more.

Jage was the lead executive and driving force behind the development of Marijuana Business Daily and the success of MJBizCon from 2014 through 2017 and most recently he took the helm at Dope Media and successfully negotiated the acquisition by the High Times Holding Corp. His events have been recognized by Tradeshow Week (2006, 2008, 2009) and Tradeshow Executive (2016, 2017) as one of the fastest growing events in the U.S.  He has been awarded UNLV’s Jerry Valen Award of Distinction (2010) and the Nevada Entrepreneur Award (2008), and named as the Trade Show Elite (2013) and Gourmet News’s Top 20 Under 40 (2006).

Green Market Report is a media partner of this event.


Debra BorchardtDebra BorchardtFebruary 8, 2019
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4min8242

FSD Pharma Inc. (FSDDF) and Auxly Cannabis Group Inc. (AXLY) have terminated their agreement to work together. The divorce is anything but friendly so far.

The first shot was fired on Wednesday when  FSD Pharma said that Dr. Raza Bokhari, Executive Co-Chairman, had been appointed interim Chief Executive Officer of FSD Pharma following the termination of Rupert Haynes. The statement went on to say that it terminated its agreement with Auxly and that Auxly was obligated to develop all aspects of the company’s cannabis cultivation facility in mutually agreed upon staged phases. However, it didn’t go into any detail.

On Thursday, Auxly said that it was FSD that breached the agreement and when notified and asked to comply with the agreement, FSD didn’t and then tried to control the message by announcing it had terminated first.

Auxly gave much more detail saying, “The joint venture was formed with the intention of developing a portion of FSD Pharma’s cannabis cultivation facility located in Cobourg, Ontario in mutually agreed staged phases. Auxly was supposed to receive a 49.9% stream of all cannabis produced at the JV Facility; the first phase of the JV Facility Development was to be the construction of an approximately 220,000 square foot self-contained cultivation facility.” Auxly said it has invested $7.5 million in the development and construction of the facility.

Auxly said it identified contractual breaches relating to FSD Pharma’s management and staffing obligations of the facility, as well as significant concerns regarding certain aspects of the buildings’ infrastructure. Auxly said it told FSD Pharma of the breaches in the hopes that FSD Pharma would work with toward a resolution. Auxly said FSD Pharma failed to remedy its breaches and instead purported to terminate the agreement effective February 6, 2019. Auxly then terminated the agreement effective February 7, 2019.

On Friday, FSD said that it hadn’t breached any of its contractual obligations and instead blamed Auxly for the problems in the agreement. “FSD Pharma strongly denies that it caused any breaches of the Streaming Agreement relating to its management and staffing obligations or otherwise, and rejects the claim that there are material issues with the infrastructure of its cultivation facility in Cobourg, Ontario.”

The company said that “As disclosed on Wednesday, February 6, FSD terminated the Definitive Agreement with Auxly. FSD believes that Auxly was under clear obligation to develop all aspects of the Company’s cannabis cultivation facility in mutually agreed upon staged phases. Auxly issued a press release on July 3, 2018, in which they anticipated that the first phase of construction would be completed and ready for Health Canada approval by the end of December 2018. We simply couldn’t wait any longer for our vendor to perform its obligations and therefore we terminated the agreement,” said Dr Raza Bokhari, Executive Co-chairman & Interim CEO.

Dr. Bokhari continued, “under the terms and conditions of the Streaming Agreement, FSD Pharma and Auxly are subject to a number of non-disclosure obligations that survive the termination. FSD Pharma intends to continue to live up to its surviving obligations, we are hopeful that Auxly will do the same.”


StaffStaffJuly 3, 2018
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5min10560

It’s time for your Daily Hit of cannabis financial news for July 3, 2018.

On The Site

Aurora Cannabis Inc. 

Aurora Cannabis Inc.  (ACBFF) gave several updates on different pieces of the company. The Aurora Vie production facility in Point-Claire Quebec got its sales license from Health Canada. The company said that this facility is on target to produce high-quality cannabis at a rate of 4,000 kg per year y October 2018 and that multiple harvests have been completed to date. Aurora has also modified the facility to produce softgel products. Its partner Capcium, is now installing equipment to commence high-volume production of these cannabis softgels.

Aurora also gave an update on the CanniMed company it acquired. The integration of the two companies is now complete. In addition, Aurora has received its Health Canada license for the production of encapsulated oil for its Mountain facility.

In Other News

RISE Life Science Corp.

RISE Life Science Corp. (CSE: RLSC) announced that it has closed a non-brokered private placement through the issuance of an aggregate of 4,824,399 units at a price of $0.30 per Unit for gross proceeds of $1,447,319.70. Each Warrant entitles the holder thereof to purchase one Common Share for a period of 24 months from the date of closing at a price of $0.45 per common share. The proceeds of the offering will be used for general working capital purposes.

MedMen Enterprises Inc.

MedMen Enterprises Inc. (MMEN.CN) (MMNFF), completed its first harvest at its cultivation and production facility outside Reno, Nevada. The test crop was only a fraction of the facility’s 10,000 pounds planned annual production capacity, but it went very smoothly and all systems functioned as designed, according to Dan McClure, MedMen’s vice president of agronomy.

Body and Mind Inc.

Body and Mind Inc. (BMMJ) announced approval of the final building inspection for the Phase II expansion from the Clark County Department of Building and Fire Prevention. The company initiated the Phase II expansion plans in early 2018 and is on time and budget to complete the increased production space, additional trim area, dry room and expanded packaging area.

CannaRoyalty Corp.

CannaRoyalty Corp. (CNNRF)  closed the previously announced acquisition of FloraCal Farms, a licensed premium craft cannabis producer located in Sonoma County, California. FloraCal has a temporary medium indoor cultivation license from the state of California, as well a Type 6 non-volatile manufacturing permit in Sonoma County. FloraCal is building its Sonoma County facility in three Phases and has been designed to comply with cGMP* standards.

FSD Pharma Inc.

FSD Pharma Inc. (CSE:HUGE) said that its first phase of the buildout of the FV Pharma facility in Cobourg, Ontario has been approved in an updated construction and development budget provided by Auxly. Of the current 620,000 square feet of building space available, 220,000 square feet will be developed and fully funded. As part of this project, Auxly will contribute $55,000,000 to buildout the Facility.

 

The markets will be closed on Wednesday for the Fourth of July and there will be no Daily Hit.



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