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Core One Labs Completes Acquisition of Ketamine Infusions Centers of Texas Representing the Company’s First Psychedelics Clinic in the U.S. and Announces Fast Entry Inclusion in The Horizons Psychedelic ETF

Vancouver, British Columbia, Canada – March 31, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (“Core One” or the “Company”), a research and technology company focused in life sciences and on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy, is pleased to announce it has completed the acquisition (the “Transaction”) of Ketamine Infusions Centers of Texas Inc. (“KICT”), a U.S.-based health and wellness clinic that provides ketamine infusion therapy. The Transaction marks the first health and wellness operation for the Company is the United States.

The acquisition of KICT establishes a roster of patients in Texas for psychedelic-assisted psychotherapy utilizing the Company’s novel delivery system and API grade psilocybin, upon legalization.  Ketamine has long been used as an anesthetic during surgery to calm your mind and also to relieve the pain associated with certain procedures.  Most recently ketamine has been successfully used as a treatment for severe depression, chronic pain and migraines. A few of the benefits of ketamine as an alternative treatment measure are its rapid onset and its capability in decreasing the need and dependance on narcotic painkillers.  In a world where opioid and narcotic dependency is increasing at an exponential rate, Ketamine and other psychedelic treatments are proving to be an alternative solution to traditional treatments.

KICT was established to address the growing problem of depression and other mental health issues that continue to plague our society.  KICT’s goal is to be known as a center of excellence in the management of treatment-resistant depression. KICT strives to achieve this by providing unparalleled and individualized care based on the uniqueness of each of its patients.  KICT offers ketamine treatments to individuals suffering from depression, bipolar disorder, post-traumatic stress disorder and obsessive-compulsive disorder. KICT combines their medical expertise with their passion to help patients reach optimal levels of health and vitality through intravenous therapy services and wellness programs.

Our acquisition of KICT represents Core One’s initial acquisition in the U.S. market and will enable us to implement our platform for psychedelic treatments as they are legalized.  Major depressive disorder affects almost 7% of adults in the U.S. (approximately 23 million adults).  Due to the COVID-19 pandemic, it is anticipated these numbers will increase substantially, and Core One, through its clinics, is poised to be at the forefront of addressing this potential,” stated Joel Shacker, CEO of the Company.

Transaction Structure

The Transaction was completed pursuant to a purchase agreement (the “Definitive Agreement”) among the Company, KICT and the unitholders of KICT (the “Vendors”) dated February 18, 2021. Pursuant to the Definitive Agreement, and in consideration for the acquisition of KICT, Core One issued 210,000 common shares (the “Consideration Shares”) to the Vendors.

The Consideration Shares are subject to a voluntary pooling arrangement and are subject to restrictions on resale until February 14, 2022.  In addition, the Consideration Shares are subject to a statutory hold period until July 30, 2021.

The Company is at arms-length from KICT and its shareholders. The Transaction neither constitutes a fundamental change, nor a change of business for the Company, nor has it resulted in a change of control of the Company within the meaning of applicable securities laws and the policies of the Canadian Securities Exchange.

The Company also paid a finder’s fee of 21,000 common shares to a third-party who introduced the Transaction to the Company (the “Finder’s Shares”), as well as 2,100 common shares as an administration fee to each of two parties that provided administrative support in connection with the Transaction. The Finder’s Shares will be subject to a four-month hold from the date of issuance pursuant to the policies of the Canadian Securities Exchange.

Horizons Psychedelic Stock Index EFT

In other news the Company announces that it has been added on a fast entry basis to the first ever psychedelics exchanged traded fund (ETF) – the Horizons Psychedelic Stock Index ETF (the “Horizons Psychedelic ETF”), effective March 19, 2021.

The Horizons Psychedelic ETF, launched by Horizons ETFs Management (Canada) Inc., on January 26, 2021, trades under the ticker “PSYK” on the NEO Exchange, and is comprised of 23 publicly listed companies trading on various exchanges in the U.S. and Canada, having significant business activities in, or significant exposure to, the psychedelics industry.

PSYK will track the underlying North American Psychedelics Index, and German-based Solactive AG is the independent calculation agent for the index.  Additional details on PSYK, including how it is weighted and conditioned can be found on the Horizons ETFs website.

Recent breakthroughs in research and increased support from the scientific and medical communities have led to a rapidly growing psychedelics as alternative treatment industry.  The Horizons Psychedelic ETF provides investors diversified exposure to the overall growth of the sector, which has gained tremendous interest from global investors and investment funds.  We are honored to be included in the PSYK ETF, and in the Company of some very well respected peers,” stated Joel Shacker. “The Company’s fast entry inclusion into the fund is a great milestone for us and signifies growing awareness and increasing confidence within the investment community about Core One Labs.  We look forward to growing our investor base and to the additional exposure we will witness as a result of this significant event.” stated Joel Shacker CEO of the Company.

About Core One Labs Inc.

Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release, including with respect to the business plans and operations of Core One and KICT, as well as the legalization of psychedelics in the United States and Canada. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

GREENBROOK TMS REPORTS FISCAL 2020 OPERATIONAL AND FINANCIAL RESULTS

March 30, 2021 – Toronto, Ontario – Greenbrook TMS Inc. (TSX: GTMS, NASDAQ: GBNH) (“Greenbrook” or the “Company”), today announced its fourth quarter 2020 (“Q4 2020”) and year-end 2020 (“Fiscal 2020”) operational and financial results. All values in this news release are in United States dollars, unless otherwise stated.

 

Bill Leonard, President and Chief Executive Officer of Greenbrook commented:

 

“We are very pleased with the growth of our business even as we battle the second wave of the COVID-19 pandemic, specifically our ability to continue to treat patients suffering from treatment-resistant depression at unprecedented levels. We managed to deliver strong year-over-year revenue growth of 21%, despite having to take a significant provision against revenue. While procedure volumes and new patient starts continue to grow at a record pace, our strong operational performance is not fully reflected in our revenues primarily as a result of provisions relating to changes in our credentialling process due to our move to credentialling on a state-wide credentialling basis. Delays in obtaining the necessary credentialling have resulted in slower claims processing which will require several months to clear, but we believe this delay to be short-term and will ultimately result in significant long-term gains with our enhanced credentialling process.”

 

 

FISCAL 2020 OPERATIONAL AND FINANCIAL HIGHLIGHTS

 

  • New patient starts increased by 33% to 5,445 from the 2019 fiscal year-end (“Fiscal 2019”) and TMS treatment volumes increased by 26% to 195,992 from Fiscal 2019, despite the impact of the COVID-19
  • Fiscal 2020 revenue increased by 21% to a record $43.1 million, up $7.4 million from Fiscal 2019, despite the provisions against
  • Deployed virtual access platform to provide greater access to patients with treatment-resistant depression and obsessive-compulsive disorder.
  • With the provisions against revenue, Fiscal 2020 resulted in an entity-wide regional operating loss of $0.6 million, down $5.0 million from Fiscal 2019.
  • Added 14 active TMS Centers during Fiscal 2020, with an additional nine TMS Centers in development, bringing the total Company network to 125 TMS Centers as at December 31, 2020, representing an increase of 5% as compared to Fiscal

 

FOURTH QUARTER 2020 OPERATIONAL AND FINANCIAL HIGHLIGHTS

  • New patient starts increased by 20% to 1,428 as compared to the fourth quarter of Fiscal 2019 (“Q4 2019”) and TMS treatment volumes increased by 6% to 54,408.
  • With the provisions against revenue, Q4 2020 revenue decreased by 21% to $9.9 million, down

$2.6 million from Q4 2019.

  • Absent the provisions against revenue, our average reimbursement rates remained
  • With the provisions against revenue, Q4 2020 resulted in an entity-wide regional operating loss of $2.1 million, down $4.2 million from Q4 2019.

 

 

 

SELECTED ANNUAL AND QUARTERLY FINANCIAL AND OPERATING RESULTS (1)

 

Selected Financial Results

 

(US$) (audited) Q4 2020   Q4 2019   Fiscal 2020   Fiscal 2019
Total Revenue 9,913,552   12,536,671   43,129,179   35,685,531
Regional Operating Income (loss) (2) (2,050,168)   2,056,836   (567,986)   4,456,815
Loss before income taxes (8,759,528)   (7,006,081)   (30,402,721)   (15,852,289)
Loss for the year and comprehensive loss  

(8,759,528)

   

(7,006,081)

   

(30,402,721)

   

(15,852,289)

Loss attributable to the common shareholders of Greenbrook  

(8,391,630)

   

(7,034,356)

   

(29,663,540)

   

(15,909,879)

Net loss per share (basic and diluted) (3) (0.60)   (0.62)   (2.32)   (1.48)

Notes:

  • Please note that additional selected consolidated financial information can be found at the end of this press
  • Regional operating income for Fiscal 2019 has been updated to exclude
  • On January 12, 2021, the shareholders of the Company approved a special resolution for an amendment to the Company’s articles and have authorized a consolidation (the “Share Consolidation”) of the Company’s outstanding common shares (Common Shares”) on the basis of a one (1) post-consolidation Common Share for every five (5) pre-consolidation Common Shares. The Share Consolidation was completed on February 1, 2021. The Company has retrospectively presented net loss per share calculations reflecting the number of Common Shares outstanding after giving effect to the Share

 

Selected Operating Results

 

  As at December 31,   As at December 31,
(unaudited)      
  2020   2019
Number of active TMS Centers(1) 116   102
Number of TMS Centers-in-development(2) 9   17
Total TMS Centers 125   119
Number of management regions 13   13
Number of TMS Devices installed 198   178
Number of regional personnel 305   273
Number of shared-services / corporate personnel(3) 49   44
Number of TMS providers(4) 117   109
 

Annual number of consultations performed

 

11,305

   

8,039

Annual number of patient starts 5,445   4,080
Annual number of TMS treatments performed 195,992   155,343
Annual average revenue per TMS treatment $220   $230
 

Quarterly number of consultations performed

 

3,587

   

2,479

Quarterly number of patient starts 1,428   1,192
Quarterly number of TMS treatments performed 54,408   51,247
Quarterly average revenue per TMS treatment $182   $245

Notes:

  • Active TMS Centers represent TMS Centers that have performed billable TMS (as defined below)
  • TMS Centers-in-development represents TMS Centers that have committed to a space lease agreement and the development process is substantially
  • Shared-services / corporate personnel is disclosed on a full-time equivalent The Company utilizes part-time staff and consultants as a means of managing costs.
  • Represents physician partners that are involved in the provision of TMS therapy services from our TMS

 

 

 

For more information, please refer to the Management’s Discussion & Analysis of Financial Condition and Results of Operations (“MD&A”) and the consolidated financial statements of the Company for the fiscal years ended December 31, 2020 and 2019. These documents, and the Company’s annual report on Form 40-F for the fiscal year ended December 31, 2020 (the “Annual Report”), will be available on the Company’s website at www.greenbrooktms.com, under the Company’s SEDAR profile at www.sedar.com and under the Company’s EDGAR profile at www.sec.gov. Shareholders may receive a hard copy of the Annual Report free of charge upon request.

 

CONFERENCE CALL AND WEBCAST

 

Fourth Quarter and Year End 2020 Conference Call Details:

Bill Leonard, President and Chief Executive Officer and Edwin Cordell, the Interim Chief Financial Officer, will host a conference call at 10:00 a.m. (Eastern Time) on March 31, 2021 to discuss the financial results for the fourth quarter and year end.

Toll Free North America: 1-866-521-4909 Toronto: 647-427-2311

Webcast:

For more information or to listen to the call via webcast, please visit: www.greenbrooktms.com/investors/events.htm

 

For those that plan on accessing the conference call or webcast, please allow ample time prior to the call time.

 

Conference Call Replay:

 

Toll Free (North America): 1-800-585-8367 Toronto: 416-621-4642

Passcode: 6797231

The conference call replay will be available from 1:00 p.m. ET on March 31, 2021, until 11:59 p.m. ET on April 30, 2021.

 

About Greenbrook TMS Inc.

 

Operating through 128 Company-operated treatment centers, Greenbrook is a leading provider of Transcranial Magnetic Stimulation (“TMS”) therapy, an FDA-cleared, non-invasive therapy for the treatment of Major Depressive Disorder and other mental health disorders, in the United States. TMS therapy provides local electromagnetic stimulation to specific brain regions known to be directly associated with mood regulation. Greenbrook has provided more than 560,000 TMS treatments to over 15,000 patients struggling with depression.

 

For further information please contact:

 

Glen Akselrod Investor Relations Greenbrook TMS Inc.

 

Contact Information:

 

 

 

investorrelations@greenbrooktms.com 1-855-797-4867

 

Cautionary Note Regarding Forward-Looking Information

 

Certain information in this press release, including with respect to the Company’s future financial or operating performance, constitute forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, “is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be achieved”. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.

 

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this press release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of the Company’s current annual information form and in the Company’s other materials filed with the Canadian securities regulatory authorities and the United States Securities and Exchange Commission from time to time, available at www.sedar.com and www.sec.gov, respectively. These factors are not intended to represent a complete list of the factors that could affect the Company; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

 

Cautionary Note Regarding Non-IFRS Measures

 

This press release makes reference to certain non-IFRS measures including certain metrics specific to the industry in which we operate. These measures are not recognized measures under International Financial Reporting Standards (“IFRS”), do not have a standardized meaning prescribed by IFRS and, therefore, may not be comparable to similar measures presented by other companies. Rather, these measures are provided as additional information to complement those IFRS measures by providing further understanding of our results of operations from management’s perspective. Accordingly, these measures are not intended to represent, and should not be considered as alternatives to, loss attributable to the common shareholders of Greenbrook or other performance measures derived in accordance with IFRS as measures of operating performance or operating cash flows or as a measure of liquidity. In addition to our results determined in accordance with IFRS, we use non-IFRS measures including, “EBITDA” and “Adjusted EBITDA”. These non-IFRS measures and industry metrics are used to provide investors with supplemental measures of our operating performance and thus highlight trends in our core business that may not otherwise be apparent when relying solely on IFRS measures. See the Company’s MD&A for a further discussion of these non- IFRS financial measures. Additionally, see the Company’s MD&A, along with the Company’s Management’s Discussion and Analysis of Financial Condition and Results of Operations for the quarters ended March 31, 2020 and March 31, 2019, June 30, 2020 and June 30, 2019, and September 30, 2020 and September 30, 2019 for a reconciliation of EBITDA and Adjusted EBITDA to loss attributable to the common shareholders of Greenbrook for each of the periods shown in the table below.

 

 

 

 

 

SELECTED CONSOLIDATED FINANCIAL INFORMATION

 

 

(US$) (audited) 2020   2019
Total revenue 43,129,179   35,685,531
Direct center and patient care costs 21,743,256   17,368,894
Regional employee compensation 9,798,901   7,122,556
Regional marketing expenses 6,446,798   2,705,891
Depreciation 5,708,210   4,031,375
Total direct center and regional costs 43,697,165    

31,228,716

Regional operating income(1) (567,986)   4,456,815
Center development costs 529,933   1,466,119
Corporate employee compensation 10,195,949   7,063,682
Corporate marketing expenses 1,030,196   1,934,227
Transaction costs   385,674
Other corporate, general and administrative expenses 3,919,216    

6,987,763

Share-based compensation 591,384   690,230
Amortization 463,332   122,269
Interest expense 2,806,286   1,822,442
Interest income (20,990)   (163,302)
Earn-out consideration 10,319,429  
Loss before income taxes (30,402,721)   (15,852,289)
Income tax expense  
Loss for the period and comprehensive loss (30,402,721)   (15,852,289)
(Loss) income attributable to non- controlling interest (739,181)   57,590
Loss attributable to the common shareholders of Greenbrook (29,663,540)   (15,909,879)
Net loss per share (basic and diluted) (2) (2.32)   (1.48)

Notes:

  • Regional operating income for the Fiscal 2019 has been updated to exclude amortization
  • The Company has retrospectively presented net loss per share calculations reflecting the number of Common Shares outstanding after giving effect to the Share

 

 

(US$) Q4 2020   Q3 2020   Q2 2020   Q1 2020   Q4 2019   Q3 2019   Q2 2019   Q1 2019
(unaudited)                              
Revenue 9,913,552   12,006,570   9,788,555   11,420,502   12,536,671   8,459,103   8,082,559   6,607,198
Regional operating income (loss)(1) (2,050,168)   967,584   (225,198)   739,796   2,056,836   770,813   1,002,166   627,000
Net loss attributable to shareholders of Greenbrook (8,391,630)   (7,636,132)   (9,477,505)   (4,158,274)   (7,034,356)   (3,431,009)   (2,874,092)   (2,570,422)
Adjusted EBITDA (4,223,446)   (937,073)   (1,665,672)   (1,648,053)   (1,296,201)   (1,033,876)   (957,428)   (827,557)
Net loss per share – Basic(2) (0.60)   (0.57)   (0.76)   (0.39)   (0.62)   (0.31)   (0.28)   (0.27)
Net loss per share – Diluted(2) (0.60)   (0.57)   (0.76)   (0.39)   (0.62)   (0.31)   (0.28)   (0.27)

Notes:

 

 

 

  • Regional operating income for the fourth quarter ended December 31, 2019 has been updated to exclude amortization
  • The Company has retrospectively presented net loss per share calculations reflecting the number of Common Shares outstanding after giving effect to the Share

Core One Labs Appoints Dr. Stephen Peach as Head of Patient Research

Vancouver, British Columbia, Canada – March 28, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company”) is pleased to announce that its wholly owned subsidiary Rejuva Mental Health Clinic (the “Clinic”) has retained Dr. Stephen Peach as Lead Physician.  Dr. Peach will be responsible for developing comprehensive patient intake and assessment protocols, with the goal of identifying individuals with a history of mental health disorders and addictions, that may benefit from alternative psychedelic medicines and the Clinic’s clinical trials.

Dr. Peach is a member of the College of Family Physicians of Canada.  Dr. Peach obtained his degree in medicine from Dalhousie University in 1995 and completed his residency in Family Medicine at Queen’s University in Kingston in 1997.

Dr. Peach has been practicing family and emergency medicine for nearly 20 years, commencing his career as a family physician in Glace Bay, Nova Scotia and moving to British Columbia in 2002 to continue his work in family practice, and also assume a position as an Emergency Room doctor at Peace Arch Hospital in White Rock, British Columbia.  In 2017 Dr. Peach transferred his family practice to the Coal Harbour Medical Clinic, in Vancouver, where he presently practices as a full-time family physician.

We are very excited to have Dr. Stephen Peach lead the Rejuva clinic”, stated the Company’s CEO, Joel Shacker.  “Dr. Peach has extensive experience in the medical field and through his practice in family and emergency medicine, he has witnessed firsthand the need for alternative medicines to address issues such as depression, anxiety and addiction. A growing number of clinical studies provide empirical support that  the use of psychedelics as an alternative medicine are providing mental health patients and those afflicted by addiction with sustained benefits, when combined with therapy.” stated Joel Shacker CEO of the Company.

Service Agreements

The Company also wishes to announce that it has retained Promethean Marketing, Inc. (“Promethean”), to provide the Company with strategic investor relations, market research, general brand awareness and communications services pursuant to an agreement dated effective March 15, 2021, and with an initial term ending in May 2021.  Promethean will assist the Company with designing, creating and distributing advertising content on behalf of the Company for total consideration of US$1,405,000 payable over successive months.

The Company further announces that it has retained Emerging Markets Consulting, LLC (“Emerging Markets”) to provide the Company with additional strategic investor relations, general awareness and communications services pursuant to an agreement dated effective March 10, 2021. The agreement with Emerging Markets agreement has a term of two months at a total up-front cost to the Company of US$150,000.

About Core One Labs Inc.

Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release, including with respect to the business plans and operations of Core One and KICT, as well as the legalization of psychedelics in the United States and Canada. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

Vireo Health Announces Fourth Quarter and Full Year 2020 Financial Results

— Full year GAAP revenue of $49.2 million increased 64% compared to full year 2019 —
— Q4 GAAP revenue increased 38% YoY and 46% excluding former Pennsylvania subsidiaries —
— Continued margin expansion reflects improved operating efficiencies across core markets —
— Incremental expansion projects in Arizona and Maryland scheduled to begin in second quarter —
— Potential reform in Company’s regulatory jurisdictions could accelerate revenue growth —

MINNEAPOLIS, March 25, 2021 /PRNewswire/ — Vireo Health International, Inc. (“Vireo” or the “Company”) (CSE: VREO; OTCQX: VREOF), the leading physician-led, science-focused multi-state cannabis company, today reported financial results for its fourth quarter and full year ended December 31, 2020. All currency figures referenced in this press release reflect U.S. dollar amounts.

Vireo Logo (PRNewsfoto/Vireo Health, Inc.)

“Our fourth-quarter results continued to demonstrate good organic revenue growth trends, and we’re pleased to see improving consistency in margins as we benefit from recent initiatives to increase scale and achieve greater efficiency in operations,” said Chairman and Chief Executive Officer, Kyle Kingsley, M.D. “We spent most of 2020 focused on executing our core market strategy and positioning our portfolio of early-stage medical markets for profitable growth, and we expect that performance in fiscal year 2021 will highlight the strong upside potential we see in our business.”

Dr. Kingsley continued, “We have a healthy balance sheet and completed several expansion projects recently that should help drive stronger results, and we’re encouraged by progress toward policy reforms, which could significantly improve the overall trajectory of our performance. The improving regulatory climate at local and federal levels has given us confidence to continue making growth investments, and we plan to begin construction in early Q2 on incremental expansions of cultivation capacity at our facilities in Arizona and Maryland in addition to our ongoing initiatives to expand our retail dispensary footprint.”

Summary of Key Financial Metrics

Three Months Ended

Twelve Months Ended

December 31,

December 31,

US $ in millions

2020

2019

Variance

2020

2019

Variance

GAAP Revenue

$12.4

$9.0

38%

$49.2

$30.0

64%

Revenue (excl. former Pennsylvania subsidiaries)

$11.5

$7.9

46%

$42.2

$27.0

57%

GAAP Gross Profit

$5.3

$1.3

303%

$17.1

$7.3

133%

Gross Profit Margin

42.7%

14.6%

2,810 bps

34.8%

24.5%

1,030 bps

SG&A Expenses

$6.7

$9.2

-27%

$26.4

$25.0

5%

SG&A Expenses (% of Sales)

53.9%

102.2%

-4,830 bps

53.6%

83.6%

-3,000 bps

Adjusted EBITDA (non-GAAP)

$0.1

($7.3)

NM

($5.2)

($16.9)

NM

Adjusted EBITDA Margin (non-GAAP)

0.9%

(81.1%)

8,200 bps

(10.6%)

(56.4%)

4,580 bps

Full Year 2020 Business Highlights

  • Total revenue of $49.2 million increased 64.3 percent year-over-year, driven by organic growth and the successful execution of management’s core market strategies during the year. Excluding results from the Company’s former subsidiaries in Pennsylvania, revenue increased 57.0 percent to $42.2 million.
  • Gross profit increased by $9.8 million to $17.1 million, or 34.8 percent of sales as compared to $7.3 million, or 24.5 percent of sales in fiscal year 2019.
  • During the year, the Company completed the expansion of its Green Goods™ retail stores in the state of Minnesota. All eight of Vireo’s dispensary licenses in the state of Minnesota are now operational.
  • The Company opened 4 new Green Goods™ dispensaries in fiscal year 2020 and ended the year with 15 operational dispensaries across its nationwide operating footprint.
  • During the year, the Company divested its former subsidiaries in the state of Pennsylvania for total consideration of $26.0 million, including $21.2 million in cash. The Company utilized a portion of these proceeds to invest in more attractive opportunities in the Arizona and Maryland markets.
  • The Company ended fiscal year 2020 with $25.5 million in cash on its balance sheet.

Fourth Quarter 2020 Financial Summary

Total revenue, including the Company’s former subsidiaries in Pennsylvania, was $12.4 million in the fourth quarter, an increase of 37.9 percent as compared to Q4 2019. Excluding contributions from Pennsylvania, revenue increased 46.0 percent to $11.5 million. Retail revenue excluding Pennsylvania increased approximately 39.3 percent to $9.1 million in Q4 2020 and reflected growth in each market. Wholesale revenue excluding Pennsylvania increased by 78.6 percent to $2.4 million, driven by strong growth in the Arizona and Maryland markets.

Gross profit was $5.3 million, or 42.6 percent of revenue, as compared to gross profit of $1.3 million or 14.6 percent of revenue in the same period last year. The improvement in gross profit compared to the prior year was driven by higher unit volumes across all markets, which resulted in lower fixed production costs per unit, especially in the Maryland wholesale channel, which was operating below normalized capacity utilization rates in 2019.

Total operating expenses in the fourth quarter were $7.5 million, an improvement of $3.7 million or 33.0 percent as compared to $11.2 million in the fourth quarter of 2019. The reduction in operating expenses was primarily attributable to a reduction in share-based compensation expenses, lower salaries and wages, and a one-time adjustment related to inventory costing of labor in the prior-year quarter, partially offset by higher depreciation costs related to expanded operations. Excluding depreciation and share-based compensation, operating expenses in the fourth quarter of 2020 were $6.7 million, or 53.9 percent of sales, as compared to $9.2 million or 102.2 percent of sales in the fourth quarter of 2019.

Total other income was $2.0 million during Q4 2020, a favorable variance of $32.1 million compared to total other expense of $30.2 million in Q4 2019. This favorable variance is primarily attributable to an intangible asset impairment charge of $28.3 million in the prior-year quarter to reflect changing market valuations of cannabis businesses at that time, and a gain of $3.8 million on the divestiture of the Company’s former Pennsylvania Dispensary Solutions subsidiary in Q4 2020, partially offset by a loss on derivative liability of $1.2 million.

EBITDA, as described in accompanying disclosures and footnotes, was a gain of $1.2 million during Q4 2020, compared to a loss of $38.5 million in Q4 2019. Adjusted EBITDA was $112,652 in Q4 2020, as compared to a loss of $7.3 million in Q4 2019. Please refer to the Supplemental Information and Reconciliation of Non-GAAP Financial Measures at the end of this press release for additional information.

Net loss in Q4 2020 was $2.3 million, as compared to a net loss of $39.5 million in Q4 2019.  The favorable improvement in net loss was primarily the result of the non-recurrence of one-time impairment charges in the prior-year quarter, as well as improved revenue growth and efficiency of operations.

Subsequent Events

On January 7, 2021, the Company announced that it closed on its previously disclosed purchase of four cannabis licenses in Nevada. These licenses allow for the cultivation and production of cannabis products for both medical and adult-use purposes.

In March 2021, the Company completed and received regulatory approval of its 110,000 sq. ft. cultivation facility in Massey, Maryland, and opened its first retail dispensary in Maryland in the City of Frederick which brought its total number of operational dispensaries to 16.

On March 25, 2021, the Company expects to close on the first tranche of the previously announced senior secured, delayed draw term loan with Chicago Atlantic Group, an affiliate of Green Ivy Capital, and a group of lenders. The first tranche of $23.5 million, net of fees and closing costs, will be utilized to support the Company’s ongoing growth initiatives and working capital requirements.

Transition from IFRS to U.S. GAAP Reporting

The Company recently became a U.S. reporting company and registrant with the U.S. Securities and Exchange Commission. Vireo now presents its financial statements in accordance with generally accepted accounting principles in the United States (“GAAP”), rather than International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board. The Company incurred one-time expenses and professional fees related to this transition of approximately $0.5 million during the fourth quarter.

Balance Sheet and Liquidity

As of December 31, 2020, the Company had 113,016,459 equity shares issued and outstanding on an as-converted basis, and 157,274,493 shares outstanding on an as-converted, fully diluted basis.

As of December 31, 2020, total current assets were $47.0 million, including cash on hand of $25.5 million, excluding the expected proceeds of the first tranche of the previously disclosed credit facility. Total current liabilities were $19.9 million, with $1.1 million in debt due within 12 months.

Outlook Commentary

Given near-term uncertainties related to the timing and outcome of certain regulatory developments in several of its markets, the Company has not provided quantitative commentary regarding its revenue or profitability outlook for 2021. However, Vireo anticipates growth investments made in fiscal year 2020 and continued execution of its core market strategy will yield organic revenue growth for the foreseeable future. Stronger revenue growth, coupled with expectations for reduced SG&A expenses as a percentage of sales, should substantially reduce cash outflows from existing operations throughout 2021. Recent efforts to scale production and expand the Company’s retail dispensary footprint could also help drive improved financial performance through fiscal year 2022.

There is potential for several favorable regulatory developments across Vireo’s state-based operating footprint in the near-term. Following the recent enactment of the adult-use program in Arizona, Vireo’s markets in Maryland, New Mexico, and New York could all potentially enact adult-use legislation this year, and Minnesota could begin to allow the sale of raw cannabis flower within its medical program. Each of these outcomes could serve as a significant revenue growth catalyst for Vireo’s business.

The Company expects to open two additional retail dispensaries in New Mexico during the second quarter of 2021, and continue its ongoing initiative to rebrand its retail stores in New York to its Green Goods™ store concept.

Vireo anticipates making further investments to improve scale with additional facility build outs during fiscal year 2021. Specifically, the Company expects to begin incremental expansion projects of its cultivation facilities in Arizona and Maryland during the second quarter. In Arizona, the Company expects to invest approximately $3.0 million for the development of a dry-flower processing facility and a second nine-acre shade house adjacent to its existing operations, bringing the total size of its cultivation facilities in the state to approximately 18 acres. In Maryland, the Company expects to invest approximately $6.0 million for the development of an additional 75,000 sq. ft. of cultivation capacity at its existing 110,000 sq. ft. facility in the town of Massey. Both of these projects are expected to be complete before the end of the third quarter of 2021.

Conference Call and Webcast Information

Vireo Health management will host a conference call with research analysts today, Thursday, March 25, 2021 at 8:30 a.m. ET (7:30 a.m. CT) to discuss its financial results for its fourth quarter and full year ended December 31, 2020. Interested parties may register to attend the conference call via the following link:  http://www.directeventreg.com/registration/event/7871948.

Upon registration, each participant will be provided with call details and a registrant ID for Vireo’s conference ID number 7871948. A live audio webcast of this event will also be available in the Events & Presentations section of the Company’s Investor Relations website at https://investors.vireohealth.com and will be archived for one year.

About Vireo Health International, Inc.

Vireo Health International, Inc. is a physician-led cannabis company focused on bringing the best of technology, science, and engineering to the cannabis industry. Vireo manufactures proprietary, branded cannabis products in environmentally friendly facilities, state-of-the-art cultivation sites and distributes its products through its growing network of Green Goods™ and other retail locations and third-party dispensaries. Vireo’s team of more than 400 employees, led by scientists, engineers, and cultivation experts, is focused on efficiency and the creation of best-in-class products, while driving scientific innovation within the cannabis industry and developing meaningful intellectual property. Today, Vireo is licensed to grow,  process, and/or distribute cannabis in nine markets and operates 16 dispensaries nationwide. For more information about Vireo Health, please visit www.vireohealth.com.

Additional Information

Additional information relating to the Company’s fourth quarter and full year 2020 results will be available on EDGAR and SEDAR no later than March 31, 2021. Vireo refers to certain non-GAAP and non-IFRS financial measures such as adjusted net income, Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) and adjusted EBITDA (defined as earnings before interest, taxes, depreciation, amortization, less certain non-cash equity compensation expense, one-time transactions, and other non-recurring non-cash items. These measures do not have any standardized meaning and may not be comparable to similar measures presented by other issuers. Please see the Supplemental Information and Reconciliation of Non-GAAP Financial Measures at the end of this news release for more detailed information regarding non-GAAP financial measures.

Contact Information

Investor Inquiries:

Media Inquiries:

Sam Gibbons

Albe Zakes

Vice President, Investor Relations

Vice President, Corporate Communications

samgibbons@vireohealth.com  

albezakes@vireohealth.com      

(612) 314-8995

(267) 221-4800

Forward-Looking Statement Disclosure

This press release contains “forward-looking information” within the meaning of applicable United States and Canadian securities legislation. To the extent any forward-looking information in this press release constitutes “financial outlooks” within the meaning of applicable United States or Canadian securities laws, such information is being provided as preliminary financial results and the reader is cautioned that this information may not be appropriate for any other purpose and the reader should not place undue reliance on such financial outlooks. Forward-looking information contained in this press release may be identified by the use of words such as “potential,” “could,” “will,” “should,” “encouraged,” “improving,” “trajectory,” “continue,” “plan,” “initiative,” “strategy,” “strategies,” “outlook,” “anticipates,” “foreseeable,” “future,” “expects,” “may,” “believe,” “should,” “seek,” “objective,” “appear,” “likely,” “appear,” “poised,” “might,” “perhaps,” “would,” “feel,” “look,” “expecting,” “opportunities,” “strategic,” “hope,” “initiatives,” and “expectations” or variations of such words and phrases.  Forward-looking information may include, without limitation, statements regarding the operations, business, financial condition, expected financial results, performance, prospects, opportunities, priorities, targets, goals, ongoing objectives, milestones, strategies and outlook of Vireo, and includes statements about, among other things, the value of assets, the amount of liabilities, the designation of certain businesses or assets as “core” or “non-core,” decisions about allocation of capital and other resources, future developments, the future operations, potential market opportunities and potential regulatory reform including the potential effects of the approval of adult-use cannabis in one or more markets, strengths and strategy of the Company. Forward-looking information is provided for the purpose of presenting information about management’s current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. These statements should not be read as guarantees of future performance or results. Forward-looking information includes statements with respect to the opportunities for the Company to leverage increasing scale to improve sales growth and operating performance; the anticipation that the medical-only state markets in which the Company’s subsidiaries operate could enact adult-use legislation over the near-to mid-term future; the anticipated benefits of strategic initiatives; improvement to unit economics; expansion of retail dispensaries in key markets; the expectation that such expansion will drive stronger revenue growth, operating margins and free cash flow; and updates on actual and proposed development initiatives, including estimates of the timing of completion of such initiatives. Forward-looking information includes both known and unknown risks, uncertainties, and other factors which may cause the actual results, performance or achievements of the Company or its subsidiaries to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements or information contained in this press release. Financial outlooks, as with forward-looking information generally, are, without limitation, based on the assumptions and subject to various risks as set out herein. Our actual financial position and results of operations may differ materially from management’s current expectations and, as a result, our revenue and cash on hand may differ materially from the revenue and cash values provided in this press release. Forward-looking information is based upon a number of estimates and assumptions of management, believed but not certain to be reasonable, in light of management’s experience and perception of trends, current conditions, and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment; and the availability of licenses, approvals and permits.

Although the Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because the Company can give no assurance that they will prove to be correct, including preliminary financial expectations regarding the annualized reduction of corporate overhead and SG&A expenses. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to, risks related to the timing of adult-use legislation in markets where the Company currently operates; current and future market conditions, including the market price of the subordinate voting shares of the Company; risks related to the COVID-19 pandemic; federal, state, local, and foreign government laws, rules, and regulations, including federal and state laws in the United States relating to cannabis operations in the United States; limited operating history; changes in laws, regulations, and guidelines; operational, regulatory and other risks; execution of business strategy; management of growth; difficulty to forecast; conflicts of interest; risks inherent in an agricultural business; liquidity and additional financing; and risk factors set out in the Company’s listing statement dated March 19, 2019, filed with the Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com and in the Company’s amended registration statement on Form 10, filed January 20, 2021 on EDGAR with the U.S. Securities and Exchange Commission.

The statements in this press release are made as of the date of this release. The Company disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results, or otherwise, other than as required by applicable securities laws.

Supplemental Information

The financial information reported in this press release is based on audited financial statements for the fiscal years ended December 31, 2019, and December 31, 2020. All financial information contained in this press release is qualified in its entirety with reference to such financial statements. To the extent that the financial information contained in this press release is inconsistent with the information contained in the Company’s audited financial statements, the financial information contained in this press release shall be deemed to be modified or superseded by the Company’s audited financial statements. The making of a modifying or superseding statement shall not be deemed an admission for any purposes that the modified or superseded statement, when made, constituted a misrepresentation for purposes of applicable securities laws.

VIREO HEALTH INTERNATIONAL, INC. 

CONSOLIDATED BALANCE SHEETS AS OF DECEMBER 31, 2020 AND 2019

December 31,

December 31,

(Amounts Expressed in United States Dollars, Except for Share Amounts)

2020

2019

Assets

Current assets:

Cash

$  25,513,180

$    7,641,673

Restricted cash

1,592,500

1,592,500

Accounts receivable, net of allowance for doubtful accounts of $132,490 and $278,309, respectively

696,994

1,025,963

Inventory

12,644,895

14,671,576

Prepayments and other current assets

1,552,278

2,285,548

Notes receivable

293,700

Deferred acquisition costs

28,136

28,136

Assets Held for Sale

4,596,445

Deferred financing costs

120,266

Total current assets

47,038,394

27,245,396

Property and equipment, net

30,566,259

34,544,127

Operating lease, right-of-use asset

8,163,844

7,306,820

Notes receivable, long-term

3,750,000

Intangible assets, net

8,409,419

9,001,237

Goodwill

3,132,491

3,132,491

Deposits

1,412,124

2,651,366

Deferred Loss on Sale Leaseback

30,481

Deferred tax assets

157,000

1,520,000

Total assets

$102,629,531

$  85,431,918

Liabilities

Current liabilities

Accounts Payable and Accrued liabilities

13,477,303

3,137,086

Right of use liability

857,294

619,827

Convertible notes, net of issuance costs

900,000

Long-Term debt, current portion

1,110,000

Liabilities held for sale

3,595,301

Total current liabilities

19,939,898

3,756,913

Right-of-use liability

20,343,063

30,929,230

Deferred Income Tax Liability

Convertible notes, net of issuance costs

950,001

Long-Term debt

1,110,000

Total liabilities

$  40,282,961

$  36,746,144

Stockholders’ equity

Subordinate Voting Shares ($- par value, unlimited shares authorized; 51,062,559 shares issued and outstanding)

Multiple Voting Shares ($- par value, unlimited shares authorized; 554,128 shares issued and outstanding)

Super Voting Shares ($- par value; unlimited shares authorized; 65,411 shares issued and outstanding, respectively)

Additional Paid in Capital

164,079,614

127,476,624

Accumulated deficit

(101,733,044)

(78,790,850)

Total stockholders’ equity

$  62,346,570

$  48,685,774

Total liabilities and stockholders’ equity

$102,629,531

$  85,431,918

 

VIREO HEALTH INTERNATIONAL, INC. 

CONSOLIDATED STATEMENTS OF OPERATIONS

YEARS ENDED DECEMBER 31, 2020 AND 2019

 December 31, 

December 31,

(Amounts Expressed in United States Dollars, Except for Share Amounts)

2020

2019

Revenue

$    49,211,329

$  29,956,172

Cost of sales

Product costs

31,109,224

21,754,487

Inventory valuation adjustments

974,384

865,405

Gross profit

17,127,721

7,336,280

Operating expenses:

Selling, general and administrative

26,365,182

25,045,229

Stock-based compensation expenses

12,777,474

3,303,297

Depreciation

413,092

491,170

Amortization

615,095

864,230

Total operating expenses

40,170,843

29,703,926

Loss from operations

(23,043,122)

(22,367,646)

Other income (expense):

Impairment of Intangible assets and goodwill

(28,264,850)

Loss on sale of property and equipment

(13,800)

Gain (Loss) on disposal of assets held for sale

20,253,177

Derivative loss

(6,260,480)

Interest expenses, net

(5,095,848)

(4,460,331)

Other income (expenses)

7,879

(1,800,485)

Other income (expenses), net

8,890,928

(34,525,666)

Loss before income taxes

(14,152,194)

(56,893,312)

Current income tax expenses

(7,427,000)

(2,231,000)

Deferred income tax recoveries (expense)

(1,363,000)

1,645,000

Net loss and comprehensive loss

(22,942,194)

(57,479,312)

Net loss per share – basic and diluted

$              (0.24)

$           (0.71)

Weighted average shares used in computation of net loss per share – basic and diluted

97,551,146

80,822,129

 

VIREO HEALTH INTERNATIONAL, INC. 

CONSOLIDATED STATEMENTS OF OPERATIONS

THREE MONTHS ENDED DECEMBER 31, 2020 AND 2019

(Amounts Expressed in United States Dollars, Except for Share Amounts)

Q4 2020

Q4 2019

Revenue

$12,401,615

$  8,991,909

Cost of sales

Product costs

6,616,393

7,335,957

Inventory valuation adjustments

489,814

343,179

Gross profit

5,295,408

1,312,773

Operating expenses:

Selling, general and administrative

6,687,250

9,192,976

Stock-based compensation expenses

532,062

2,616,429

Depreciation

152,367

80,993

Amortization

153,358

(648,545)

Total operating expenses

7,525,037

11,241,853

Loss from operations

(2,229,629)

(9,929,080)

Other income (expense):

Impairment of Intangible assets and goodwill

(28,264,850)

Gain (Loss) on disposal of assets held for sale

3,815,548

Derivative loss

(1,227,943)

Interest expenses, net

(846,758)

(1,628,867)

Other expenses (income)

212,940

(263,517)

Other expenses (income), net

1,953,787

(30,157,234)

Loss before income taxes

(275,842)

(40,086,314)

Current income tax expenses

(2,852,000)

(1,301,000)

Deferred income tax recoveries (expense)

862,000

1,893,000

Net loss and comprehensive loss

(2,265,842)

(39,494,314)

Net loss per share – basic and diluted

$          (0.02)

$         (0.46)

Weighted average shares used in computation of net loss per share – basic and diluted

103,862,278

85,243,627

 

VIREO HEALTH INTERNATIONAL, INC. 

CONSOLIDATED STATEMENTS OF CASH FLOWS

YEARS ENDED DECEMBER 31, 2020 AND 2019

December 31,

December 31,

(Amounts Expressed in United States Dollars, Except for Share Amounts)

2020

2019

CASH FLOWS FROM OPERATING ACTIVITIES

Net loss

$  (22,942,194)

$  (57,479,312)

Adjustments to reconcile net loss to net cash used in operating activities:

Inventory valuation adjustments

974,384

865,405

Depreciation

413,092

491,170

Depreciation capitalized into inventory

2,067,991

1,755,809

Non-cash operating lease expense

1,243,047

877,514

Amortization of intangible assets

615,095

864,230

Share-based payments

12,777,474

3,303,297

Impairment of goodwill

8,538,414

Impairment of intangible assets

19,726,436

Gain/loss

19,330

Deferred income tax

1,363,000

(1,645,000)

Deferred Gain/Loss Sale Leaseback

30,481

Accrued interest

9,861

Acquisition costs

739,880

Accretion

544,492

501,540

Loss on Sale of Property and Equipment

13,800

Derivative Loss

6,260,480

Loss on disposal of business HG

272,723

Gain on disposal of PDS

(3,402,794)

Gain on disposal of business MWH

(7,038)

Gain on disposal of business PAMS

(17,116,068)

Change in operating assets and liabilities:

Accounts Receivable

(396,974)

1,478,191

Prepaid expenses

462,083

(1,315,536)

Inventory

(2,661,090)

(6,834,419)

Accounts payable and accrued liabilities

8,680,476

421,346

Deferred acquisition costs

775,000

Change in assets and liabilities held for sale

(124,843)

Net cash used in operating activities

$  (10,932,383)

$  (26,906,844)

CASH FLOWS FROM INVESTING ACTIVITIES:

Proceeds from Sale of PPE

$                  –

$     1,000,257

PP&E Additions

(8,449,097)

(7,690,753)

Proceeds from sale of PAMS net of cash 

16,408,411

Proceeds from sale of HG net of cash 

(17,945)

Proceeds from sale of PDS

4,745,294

Acquisition of High Gardens

(250,000)

Acquisition of Silver Fox

(1,924,305)

Acquisition of Mayflower

(1,045,207)

Acquisition of XAAS Agro

(918,501)

Acquisition of Midwest Hemp

(12,229)

Acquisition of Elephant Head

(10,159,493)

Deposits

249,008

(214,470)

Net cash provided by (used in) investing activities

$   12,935,671

$  (21,214,701)

CASH FLOWS FROM FINANCING ACTIVITIES

Proceeds from issuance of shares

$     7,613,490

$   48,213,438

Deferred financing costs

(120,266)

Proceeds from long-term debt

100,000

Proceeds from warrant exercises

9,857,498

Proceeds from option exercises

94,050

Lease payments

(1,576,553)

(581,830)

Net cash provided by financing activities

$   15,868,219

$   47,731,608

Net change in cash and restricted cash

$   17,871,507

$       (389,937)

Cash and restricted cash, beginning of year

$     9,234,173

$     9,624,110

Cash and restricted cash, end of year

$   27,105,680

$     9,234,173

Reconciliation of Non-GAAP Financial Measures

EBITDA and Adjusted EBITDA are non-GAAP measures and do not have standardized definitions under GAAP. The following information provides reconciliations of the supplemental non- GAAP financial measures, presented herein to the most directly comparable financial measures calculated and presented in accordance with GAAP. The Company has provided the non- GAAP financial measures, which are not calculated or presented in accordance with GAAP, as supplemental information and in addition to the financial measures that are calculated and presented in accordance with GAAP. These supplemental non- GAAP financial measures are presented because management has evaluated the financial results both including and excluding the adjusted items and believe that the supplemental non- GAAP financial measures presented provide additional perspective and insights when analyzing the core operating performance of the business. These supplemental non- GAAP financial measures should not be considered superior to, as a substitute for or as an alternative to, and should be considered in conjunction with, the GAAP financial measures presented.

Reconciliation of Net Loss to EBITDA and Adjusted EBITDA

Three Months Ended

Twelve Months Ended

December 31,

December 31,

2020

2019

2020

2019

Net income (loss)

$ (2,265,842)

$ (39,494,314)

$ (22,942,194)

$ (57,479,312)

Interest expense, net

846,758

1,628,867

5,095,848

4,460,331

Income taxes

1,990,000

(592,000)

8,790,000

586,000

Depreciation & Amortization

305,725

(567,552)

1,028,187

1,355,400

Depreciation included in cost of goods sold

304,123

508,436

2,067,991

1,755,809

EBITDA (non-GAAP)

$  1,180,764

$ (38,516,563)

$   (5,960,168)

$ (49,321,772)

Derivative Loss

1,227,943

6,260,480

Inventory adjustment

489,814

343,179

974,384

865,405

Share-based compensation

532,062

2,616,429

12,777,474

3,303,297

Severance Expense

339,997

Impairment of intangible assets and goodwill

28,264,850

28,264,850

Gain on sale of discontinued operations

(3,815,548)

(20,253,177)

Costs associated with IFRS to GAAP transition

497,617

630,282

Adjusted EBITDA (non-GAAP)

$     112,652

$   (7,292,105)

$   (5,230,728)

$ (16,888,220)

 

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SOURCE Vireo Health International, Inc.

PharmaTher Advancing Research for Novel Microneedle Delivery of Ketamine

Represents a potential next-generation treatment for neuropsychiatric, neurodegenerative and pain disorders
TORONTO, March 24, 2021 /CNW/ – Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), today announced that its wholly-owned subsidiary, PharmaTher Inc. (“PharmaTher”), a psychedelics biotech company, has entered into a sponsored research agreement with The Queen’s University of Belfast (“QUB”) for the development of a patented hydrogel-forming microneedle (“MN”) patch to deliver ketamine and the PharmaTher’s proprietary ketamine formulation, KETABET™”. This advance represents a potential next-generation treatment for neuropsychiatric, neurodegenerative and pain disorders.
The research will be led by Professor Ryan Donnelly, a world leader in the research of microneedle delivery technologies. Most recently, Professor Donnelly’s lab successfully completed research and published a paper titled Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery. His research validates the delivery of esketamine, the S(+) enantiomer of ketamine, in a novel microneedle patch which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format.1

The proposed ketamine and KETABET™ MN patch offer a potential game-changing therapeutic solution for various unmet medical needs. Ketamine is becoming an emerging treatment option for major depressive disorder2, bipolar depression3, depression with suicidal ideation4 and post-traumatic stress disorder5. Despite its potential, ketamine has the potential for abuse and misuse—leading to problems such as dissociative, hallucinogenic and amnesic effects6. These risks have led to its limited clinical use and discontinuation.​

KETABET™ has shown in clinical research to enhance the antidepressant effect while having the potential to significantly reduce the known negative side effects of ketamine.7

PharmaTher’s patented MN technology consists of hydrogel-forming microneedle arrays and accompanying reservoir (Figure #1) which will overcome any limitations by the quantity of drug that can be loaded into the needles or onto the needle surfaces. As such, the MN technology can greatly increase the amount of drug that can permeate through the microneedle array and into the skin8.

As a result, PharmaTher’s KETABET™ MN patch aims to empower patients to dose their medication remotely, safely and conveniently rather than being under supervision by a healthcare provider at a certified medical office. KETABET™ MN patch has the potential for enabling continuous delivery of KETABET™ (without pain) with minimal formulation manipulation into systemic circulation while maintaining constant plasma levels for more than 24 hours that will improve efficacy and compliance for patients.1,8

Also, PharmaTher’s KETABET™ MN patch will incorporate anti-tampering and anti-abuse features. The combined presence of ketamine and betaine and the delivery format of the product would parallel the approach used by tamper-resistant transdermal fentanyl patches.

Ketamine was approved by the FDA in 1970 and is clinically used for analgesia, sedation, and anesthetic induction. The FDA granted Fast Track and Breakthrough Therapy designations for SPRAVATO® (esketamine) nasal spray and in March 2019 approved SPRAVATO®, in conjunction with an oral antidepressant, for treatment-resistant depression to Janssen Pharmaceuticals, Inc. SPRAVATO® requires numerous administration sessions in a certified medical office under medical supervision by a health care provider.9 An equity analyst predicted that SPRAVATO® could generate $3 billion in peak sales.10

“The potential for ketamine is significant and we are leading the way to develop a better ketamine solution to treat these unmet medical needs,” said Fabio Chianelli, CEO of PharmaTher.  “We believe that ketamine and our proprietary ketamine formulation, KETABET™, delivered in the patented microneedle patch could potentially change the ways that mental health, neurodegenerative and pain disorders are treated.  We are pursuing the clinical development of KETABET™ MN patch to overcome the current limitations of ketamine and to unlock the known potential therapeutic value of ketamine as a prescription for regulatory approval worldwide. We look forward to working with Professor Donnelly in delivering the next generation ketamine solution.”

Professor Ryan Donnelly commented, “Our lab has successfully delivered esketamine using our patented microneedle technology, which shows the potential of an alternative delivery method that can overcome the limitations of current ketamine delivery options without comprising the safety and compliance of patients. We are excited to work with PharmaTher in their quest to develop a next generation ketamine solution that could help the millions of people who suffer from mental health worldwide.”

PharmaTher will focus on developing a microneedle patch for FDA approval to better deliver psychedelics that may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems.

About PharmaTher Inc.
PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals for FDA approval to treat neuropsychiatric, neurodegenerative and pain disorders.

Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Newscope Capital Corporation’s (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of November 30, 2020 (“MD&A”), dated January 27, 2021, which is available on the Company’s profile at www.sedar.com.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
References:
1. Courtenay, et al. Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery, Journal of Controlled Release, Volume 322, 2020, Pages 177-186.
2. Murrough et al. 2013Wan et al. 2014
3. Ionescu et al. 2015Nugent et al. 2014Rybakowski et al. 2013
4. Aligeti et al. 2014Thakurta et al. 2012Zigman and Blier 2013
5. Feder et al. 2020
6. Krystal et al. 1994Perry et al. 2007
7. J.-C. Lin, M.-Y. Lee, M.-H. Chan, Y.-C. Chen, H.-H. Chen, Betaine enhances antidepressant-like, but blocks psychotomimetic effects of ketamine in mice, Psychopharmacology (Berl). 233 (2016) 3223–32.
8. Donnelly R.F. Hydrogel-forming microneedles prepared from “super swelling” polymers combined with lyophilised wafers for transdermal drug delivery. PLoSONE. 2014 doi: 10.1371/journal.pone.0111547.
9.https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified
10.https://www.fiercepharma.com/pharma/j-j-s-depression-nasal-spray-spravato-carrying-big-expectations-and-restrictions-scores-fda

Core One Labs Files Application to List its Common Shares on NASDAQ

Vancouver, British Columbia, Canada – March 20, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (“Core One” or the “Company”) is pleased to announce that it has filed an application to list its common shares on the Capital Market tier of The NASDAQ Stock Market LLC (“Nasdaq”).  Nasdaq is ranked as the second-largest exchange by market capitalization in the world and Core One expects the listing to increase both investor awareness generally and market liquidity for the Company’s current and future shareholders.

The listing of Core One’s shares on Nasdaq is subject to the Company’s satisfaction of a number conditions, including registration of Core One’s common shares with the U.S. Securities and Exchange Commission (the “SEC”) and a determination by the Nasdaq Listing Qualifications Staff that Core One satisfies all applicable criteria for initial listing on the Capital Market tier.  Pending consideration of the Company’s listing application by Nasdaq, Core One’s common shares will continue to trade on the Canadian Securities Exchange (“CSE”) under the ticker symbol “COOL” and on the U.S. OTC Markets’ Pink Information Tier under the ticker symbol “CLABF.”

“Given our plans for continued expansion of our geographic footprint of operations in the U.S., we want to make sure that our access to investors keeps pace with the underlying growth and expansion of our business.  We view the Nasdaq listing as an important next step in growing our capital base, supporting our current investor base as well as future investors” stated Joel Shacker, CEO of the Company.

Readers are cautioned that although Core One has submitted an application to list its common shares on Nasdaq, the successful completion of the Nasdaq listing process is subject the Company’s receipt of certain regulatory approvals and satisfaction of all applicable qualitative and quantitative criteria for initial listingon Nasdaq.  Furthermore, the Company believes  it will ultimately require consolidation of its outstanding share capital to satisfy Nasdaq’s market-related price  requirements.  There can be no assurance that a U.S. listing will be obtained.  In any event, however, whether listed on Nasdaq or not, the Company expects that its common shares will continue to trade in Canada on the CSE.

About Core One Labs Inc.

Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

The Window of Opportunity is Here

Published at smallcapexclusive.com

 

Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FRA:0NFA) Continues to Advance Research & Development Initiatives in the Field of Natural Medicines

 

Prior  to his monumental comeback at the age of 54, former World Heavyweight Boxing Champion Mike Tyson was delivered a message from a frog.

More precisely, he received the message from a psychedelic sourced from the venomous Colorado River Toad, also known as the Sonoran Desert Toad, known as 5-MeO-DMT (aka “5-MeO” or “frog venom”).

“I took the [5-MeO-DMT] and the medicine told me to get into shape,” Tyson said to USA Today.[1] “It really blew my mind. It told me to come back and start getting in shape.”

With the help of the psychedelic, Tyson lost more than 100 pounds for a major exhibition bout against Roy Jones Jr.—his first fight in 15 years.

Said to be more transcendent and less visual than its plant-based cousin DMT, 5-MeO-DMT can be a stronger experience for some.

Most 5-MeO trips are kept to under an hour, and require far smaller dose sizes than other psychedelics.

But even more impressive is the fast-acting psychedelic’s potential, which researchers at Johns Hopkins have discovered can bring about improvements in depression and anxiety.[2]

The potential for psychedelics to treat mental health issues is truly on the precipice of a major breakout—especially as acceptance of this once taboo form of treatment begins to make its way into mainstream medicine conversations.

Tyson is not alone, being among elite athletes who have looked to psychedelics to turn their life around.

Former Los Angeles Lakers star Lamar Odom successfully used the psychedelic drugs ketamine and ibogaine to combat his drug addiction[3]—crediting the drugs with saving his life.

There are other success stories, including those of NHL Enforcers Riley Cote[4] and Daniel Carcillo,[5] former NFL player Kerry Rhodes,[6] and former UFC MMA Fighters Ian McCall[7] and Dean Lister,[8] utilizing previously taboo treatments such as ayahuasca, ketamine, ibogaine, psilocybin, MDMA, and now 5-MeO-DMT.

Now these treatments are shifting from anecdotal to potential alternative medicinal reality, with the advent of clinical trials being advanced by some of the world’s top psychedelic and mental health professionals, including doctors, scientists, and molecular researchers.

Some analysts are projecting the psychedelics medicine industry to reach $6.85 billion by 2027.[9] As psychedelic companies gain acceptance within the investment community, there is an opportunity to review these companies in a new light.

Recently, a new psychedelics ETF began trading in January, and others are emerging to meet the demand, with two surpassing the US$1 billion market cap threshold.

Highlighted within this group of psychedelic companies is one company underpinned by thought leaders in medicine and science, warranting further due diligence and review: Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA).

The company recently announced and closed a bought deal financing of C$17.25 million, announced uplisting to the NASDAQ, and was just included in the inaugural psychedelics-inspired ETF.

With several clinical trials announced in 2020 and early 2021, including involvement with the first lab-based study co-sponsored by the National Institute for Health Research at Imperial College of London, and a Phase 2A clinical study on PTSD in veterans, EMS, and front-line workers, Mydecine continues to approach research and development with cautious optimism as their programs develop.

7 Reasons Why We’re Watching Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA)

  1. World-Renowned Medical and Scientific Advisory is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems.
  2. Exclusive Access to a Full cGMP Certified Pharmaceutical Manufacturing Facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada.
  3. Operates Out of a State-of-the-Art Mycology Lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms
  4. Seven Patent Pending Applications That Represent Thousands of Inventions with multiple layers of protection on the company’s proprietary medical development pipeline.
  5. Proprietary Digital Health Platform, Mindleap, allows Mydecine to generate revenue in the fast-growing US$41.4 billion telemedicine market
  6. Numerous Clinical Trials are currently underway, including a Phase 2A clinical trial on PTSD in Veterans, EMS, and Front Line Workers, a First-of-its-Kind Microdose Study, and Preclinical Animal Work for a Late-State Addiction Study aiming at a Mechanistic Understanding of Psilocybin.
  7. Numerous Novel Next Generation Drugs Under Development: Mydecine is currently developing numerous novel next generation drugs for the treatment of various indications to improve upon the first generation of psychedelic medicines

 

Combatting the Mental Health Crisis with Psychedelics

COVID-19 is taking its toll on all of us, including rising deaths of despair[10] and an urgent mental health crisis among health workers.[11]

A recent study that screened 402 survivors of COVID-19 found that 55% presented a clinical score for at least one mental disorder, including anxiety (42%), insomnia (40%), depression (31%), PTSD (28%), and OCD (20%).[12]

Anxiety disorders are the most common mental illness in the US, affecting 40 million adults—or 18.1% of the population every year.[13]

Sadly, only 36.9% of those suffering receive treatment, and MORE THAN HALF of people who take antidepressants never get relief.[14]

In cases of Veterans with PTSD, several patients are put on SSRIs, however, only 20-30% of patients achieve complete remission.[15]

SOMETHING needs to change.

Thankfully, we’re witnessing what’s being deemed a “Paradigm Shift in Psychiatric Research and Development.”[16]

That paradigm shift is coming from PSYCHEDELICS.

Now, we’re seeing mainstream coverage being given to the novel mental health approach on 60 Minutes,[17] Forbes,[18] Fox Business,[19] NPR,[20] and Today.[21]

A new wave of mental health sufferers are turning towards small doses of psychedelics, known as “micro-dosing”, to cope with depression and anxiety,[22] or even to achieve higher levels of concentration and creativity,[23] as experts are saying that “legalization is inevitable” for treatments involving psilocybin and other psychedelic treatments.

Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) is establishing psychedelic-based therapies, and addressing the unmet needs of high-risk constituents.[24]

The concept is to assist those who have been failed by the current regime of SSRIs and other established antidepressants.

Mydecine’s (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) ongoing research to date includes clinicals using psilocybin therapy for PTSD[25] (which has been featured in FORBES[26]), a clinical trial initiative with leading European Research Institute Leiden University Medical Center of the Netherlands,[27] and the first lab-based study of established microdosers at Macquarie University in Australia.[28]

An Evolving Industry Gaining Traction

While therapists are looking at innovative therapies to treat patients, the investment communities within Wall Street and Silicon Valley are also investigating new ways to approach the psychedelic sector. [29]

Naysayers of whether this type of “new medicine” could ever get mainstream acceptance were silenced, when Compass Pathways (backed by ATAI Life Sciences AG), received FDA breakthrough therapy designation on a psilocybin treatment, perhaps better known as the active medical ingredient in magic mushrooms.[30]

ATAI has raised more than US$100 million from major investors such as PayPal co-founder Peter Thiel—and later this year, they are expected to go public at a valuation of US$1-2 billion.[31]

Mydecine continues to expand its technical platforms and outreach with its available and downloadable app: MindLeap.

Through its proprietary Mindleap platform, Mydecine is also giving practitioners the ability to aid their patients better through telehealth abilities and an AI-powered progress monitoring program.

Mindleap is an after-care smart app platform that not only connects patients with their therapists, but also can significantly improve upon monitoring progress, provide follow-up treatment, and give patients other beneficial activities such as meditationbreathing work, and yoga instruction.

Mindleap currently has over 60 specialists with thousands of downloads to date, and is available on both iOS and Android devices.

Comparing Mental Health Psychedelic Stocks

At the end of 2020, the first-ever Psychedelics ETF was announced, which includes 17 companies in the US and Canada, and began trading on January 26, 2021, under the ticker PSYK on the NEO exchange. Announced among and included in that group of 17 was Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA).

Let’s take a look at some of the other Big Pharma/Mental Health Medicine Stocks.

*Market cap and share price taken from Yahoo Finance on March 9, 2021

 

As you can see, Mydecine (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) is already far along in the licensing process when compared to its peers.

 

Economic Advantages from Mushroom Research

Out of all of Mydecine’s advantages in the field of developing new medicines, perhaps its largest is its relationship with the University of Alberta, which holds an 11-year-old aged Schedule I license to research, develop, and produce a number of unique APIs (Active Pharmaceutical Ingredients) from their naturally-sourced cGMP psychedelic extracts.

Through this partnership, Mydecine (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) has established the World’s First Natural-Sourced cGMP Psilocybin supply for Global Research, Sales, and Distribution.[35]

Currently, scientists are paying $7,000 to $10,000 per gram[36] for synthetic mushroom ingredients—whereas MYCO can legally derive and produce the real organic version of the same ingredients for significantly lower than what is currently available.

Mydecine’s Upcoming Timeline

Mydecine’s Thought Leadership

Mydecine (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) has assembled a talented team of thought leaders, whose accomplishments include:

  • 100+ published peer-reviewed studies/papers
  • World-class team coming from Pfizer, Novartis, Yale, Imperial College, and Canadian, US, and EU Militaries
  • Proven medical development and approval experience
  • 30+ years of combined psychedelic industry experience
  • Accomplished entrepreneurs, multiple successful exits
  • 7-Nobel Peace Prize Nominee

Joshua Bartch, Director, CEO & Co-Founder Bartch’s entrepreneurial career took off in 2009 when he co-founded AudioTranscriptionist.com and founded the Denver-based dispensary, Doctors Orders. Following these ventures, Mr. Bartch founded a boutique investment firm that operated throughout the US and Canadian markets. In 2014, Bartch co-founded Cannabase.io, the USA’s most significant legal and sophisticated pot wholesale platform. In 2015, Cannabase.io was acquired by Helix TCS.

Damon Michaels, Director, COO & Co-Founder Prior to joining MIG, Michaels was consulting for various hemp businesses through his company, Emerald Baron. Before that, he served as GM for the leading multi-platform cannabinoid research and technology firm based in Colorado called ebbu, which was acquired by Canopy Growth for CA$429 million in November 2018. Michaels developed a national snowboard brand with his team, was one of four entrepreneurs who created Colorado’s first-ever glass recycling company, and was on the business development team for a Google Ventures Company.

Robert Roscow, MA – CSO & Co-Founder With expertise in genomics, evolution, and molecular biology, Roscow has previously worked at both Canopy Growth and ebbu, where he ran the genetics divisions. He has filed multiple patents and holds numerous publications under his belt, including Nature and Rolling Stone.

Professor Eric Vermetten MD, Ph.D. Colonel, an internationally recognized leader in the treatment of PTSD and other mental disorders and an active Colonel of the Dutch military. He is also professor of Medical-Biological and Psychiatric Aspects of Psychotrauma, LUMC/University of Leiden. The chair was established by Arq Psychotrauma Research and the Dutch Ministry of Defense. Eric Vermetten is an active clinical psychiatrist at the MGGZ in Utrecht (Military Mental Health care). From 1991 he has been linked to several universities as a researcher, including Stanford University, Yale University, and Emory University.

Dr. Vermetten has published over 300 articles and book chapters on topics ranging from large longitudinal studies following soldiers’ deployments to innovative approaches to treatment. He continues to be a leader within the international psych traumatology community within NATO and beyond.

Dr. Rakesh Jetly, OMM, CD, MD, FRCPC is currently the Head of the Centre of Excellence on Mental Health in Ottawa, Ontario, and an associate professor of psychiatry at Dalhousie University, and the University of Ottawa. He has published numerous articles in professional journals and presents nationally and internationally on such topics as post-traumatic stress disorder and operational psychiatry.

Carl Castro is the research director for the USC Center for Innovation and Research on Veterans and Military Families. Castro has authored more than 150 scientific articles and reports in numerous areas and currently serves as chair of a NATO research group on military mental health training. He serves as an advisor for several Department of Defense research panels focused on psychological health.

7 Investment Highlights of Mydecine Innovations Group Inc. (CSE:MYCO) (OTCQB:MYCOF) (FRA: 0NFA)

  1. Management, research teams, partners (military, scientists, researchers) and one of the original senior marketing executives that launched Red Bull in the US
  2. Substances Dealer’s Licenses from Health Canada that allow Mydecine (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) the ability to cultivate, import, export, extract, and commercialize psilocybin and other functional mushroom products.
  3. Technology and Analytics from the Mindleap platform that’s connected to clinics across the globe, providing TONS of data that’s privacy protected, and can improve upon the AI capabilities of this state-of-the-art telemedicine service.
  4. Equipped for industry leading research through 7,500 sq ft Colorado Lab
  5. Access to Top 15 Global Research through the University of Alberta.
  6. Low-cost cultivation that’s capable of deriving APIs from mushrooms at a cost of pennies per gram when scientists are currently paying $7,000-$10,000 per gram for synthetically derived ingredients, giving HUGE leverage to complete clinical studies.

First-of-its-Kind clinical trials (featured in Forbes), with a current pipeline of 8 studies lined up through 2021, through 7 different respected research institutions.

[1] https://www.usatoday.com/story/sports/boxing/2020/11/27/mike-tyson-roy-jones-jr-fight-psychedelic-drugs/6442985002/

[2] https://www.hopkinsmedicine.org/news/newsroom/news-releases/fast-acting-psychedelic-associated-with-improvements-in-depressionanxiety

[3] https://psychedelicspotlight.com/how-psychedelics-saved-former-nba-star-lamar-odom-from-drug-addiction/

[4] https://psychedelicspotlight.com/how-psychedelics-helped-riley-cote/

[5] https://www.forbes.com/sites/amandasiebert/2020/11/26/these-four-former-pro-athletes-are-using-psychedelics-to-heal-their-brain-injuries/?sh=33302f5c70d7

[6] https://www.forbes.com/sites/amandasiebert/2020/11/26/these-four-former-pro-athletes-are-using-psychedelics-to-heal-their-brain-injuries/?sh=33302f5c70d7

[7] https://www.msn.com/en-us/sports/mma-ufc/ufc-eyes-psychedelics-as-therapy-for-fighters-brain-injuries/ar-BB1cLl7N

[8] https://www.forbes.com/sites/amandasiebert/2020/11/26/these-four-former-pro-athletes-are-using-psychedelics-to-heal-their-brain-injuries/?sh=33302f5c70d7

[9] https://www.prnewswire.com/news-releases/psychedelic-drugs-market-projected-to-reach-6-85-billion-by-2027–301082594.html

[10] https://www.sciencenews.org/article/deaths-of-despair-depression-mental-health-covid-19-pandemic

[11] https://abcnews.go.com/US/urgent-mental-health-crisis-health-workers-facing-immense/story?id=75925696

[12] https://www.ctvnews.ca/health/coronavirus/mental-disorders-affect-more-than-half-of-covid-19-survivors-study-1.5050969

[13] https://adaa.org/understanding-anxiety/facts-statistics

[14] https://www.sciencedaily.com/releases/2009/10/091023163346.htm

[15] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5047000/

[16] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6041963/

[17] https://www.cbsnews.com/news/psilocybin-active-agent-in-magic-mushrooms-could-treat-addiction-depression-and-anxiety-60-minutes-2019-10-10/

[18] https://www.forbes.com/sites/robinseatonjefferson/2019/09/12/magic-mushrooms-as-medicine-johns-hopkins-scientists-launch-center-for-psychedelic-research-say-psychedelics-could-treat-alzheimers-depression-and-addiction/#3ec549efc171

[19] https://video.foxbusiness.com/v/6085830149001/#sp=show-clips

[20] https://www.npr.org/2019/10/01/766057380/how-magic-mushrooms-can-help-smokers-kick-the-habit?fbclid=IwAR0HsI05xIPrh8cl3CiJj1SD-lVKZ8wXXEDQfs2TEwfqKit9hUyYSPfeOfM&utm_campaign=storyshare&utm_medium=social&utm_source=facebook.com

[21] https://www.today.com/video/could-psychedelic-drugs-be-a-cure-for-depression-71467589539

[22] https://globalnews.ca/news/7610610/pandemic-mushrooms-anxiety-micro-dosing/

[23] https://futurism.com/neoscope/nose-spray-microdosing-psilocybin

[24] https://www.prnewswire.com/news-releases/psychedelic-compounds-could-be-used-in-mental-healthcare-301093625.html

[25] https://www.globenewswire.com/news-release/2020/08/13/2077822/0/en/Mydecine-Innovations-Group-Featured-in-Forbes-for-the-First-Of-Its-Kind-Clinicals-Using-Psilocybin-Therapy-For-PTSD.html

[26] https://www.forbes.com/sites/javierhasse/2020/08/12/psilocybin-trial-ptsd-veterans/#33e5b34b4601

[27] https://www.newswire.ca/news-releases/mydecine-innovations-group-inc-announces-neuropharm-inc-commences-ptsd-clinical-trial-initiative-with-leading-european-research-institute-852788451.html

[28] https://www.mydecine.com/news/mydecine-innovations-group-sponsors-first-lab-based-study-of-established-microdosers-at-macquarie-university-in-australia

[29] https://www.wsj.com/articles/silicon-valley-and-wall-street-elites-pour-money-into-psychedelic-research-11597941470

[30] https://compasspathways.com/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression/

[31] https://www.cnbc.com/2020/11/23/peter-thiel-backs-psychedelics-startup-atai.html

[32]https://www.globenewswire.com/news-release/2020/08/18/2079824/0/en/Mydecine-Launches-World-s-First-Natural-Sourced-cGMP-Psilocybin-for-Global-Research-Sales-and-Distribution-Enterprise.html

[33]https://mindmed.co/news/press-release/mindmed-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-project-lucy

[34]https://compasspathways.com/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression/

[35] https://finance.yahoo.com/news/mydecine-launches-worlds-first-natural-113000629.html

[36] https://qz.com/1235963/scientists-who-want-to-study-psychedelic-mushrooms-have-to-pay-7000-per-gram/

TRYP THERAPEUTICS ANNOUNCES PROVISIONAL PATENT FILING FOR IMPROVED ADMINISTRATION OF PSYCHEDELICS

La Jolla, California–(Newsfile Corp. – March 18, 2021) –  Tryp Therapeutics (CSE: TRYP), a pharmaceutical company focused on developing clinical-stage compounds for diseases with unmet medical needs, announced today that it has submitted a provisional patent (US 63/161,070) to improve how psychedelics are administered across a broad range of indications.

The provisional patent describes novel methods for the formulation, delivery, and dosing of psychedelics resulting in a potential reduction in the time spent by patients in the dissociative state. These proprietary methods represent the foundational elements of the comprehensive medical treatment program Tryp is developing for a wide variety of conditions. This filing is expected to be the first of a series of patent filings to enhance the effectiveness of psychedelics and to further differentiate Tryp’s intellectual property position.

The filing includes a method for measuring the response to psychedelic therapeutics, further supporting a more controlled psychedelic experience. The patent application also covers unique methods to manufacture the active pharmaceutical ingredient, novel formulations, methods to enhance the safety profile of treatments, and methods to reduce risk of abuse and addiction.

“We are seizing the opportunity to further differentiate our intellectual property position in psychedelics through core improvements to the formulating, delivery, and dosing of active ingredients,” said Jim Gilligan, Ph.D., President and Chief Science Officer of Tryp Therapeutics. “I am continually impressed with the ingenuity and determination of our world-class team of scientists and advisors. Their innovations are empowering Tryp’s work to significantly expand the availability of treatment options for those patients with unmet medical needs by demonstrating the safety and efficacy of our psychedelic drug programs.”

About Tryp Therapeutics:

Tryp Therapeutics is a pharmaceutical company focused on developing compounds with known activity and safety profiles for the treatment of rare and other diseases with unmet medical needs. Tryp’s psilocybin-for-neuropsychiatric disorders, or PFN™, program is focused on the development of synthetic psilocybin as a new class of drug for the treatment of certain neuropsychiatric-based disorders. Tryp’s lead PFN™ drug candidate is TRP-8802 for the treatment of fibromyalgia, a chronic pain syndrome estimated to affect more than 5 million people in the United States. The Company is also preparing to initiate a Phase 2a clinical study for eating disorders in partnership with the Dr. Jennifer Miller at the University of Florida.

In addition to its PFN™ Program, Tryp is developing TRP-1001, an oral formulation of razoxane for the treatment of soft tissue sarcoma. Soft tissue sarcomas are a rare and diverse group of tumors that account for about 1% of all cancers in adults and 7% in children. Based on the prevalence of soft tissue sarcomas in the United States, Tryp believes it is a rare disease and that TRP-1001 should qualify for Orphan Drug status.

For inquiries, please contact us at:
T: 1-833-811-TRYP (8797)
E: investors@tryptherapeutics.com
W: www.tryptherapeutics.com

Forward-Looking Information

Certain information in this news release, including statements relating to the anticipated closing date of the Placement, constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, “is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be achieved”. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of Tryp’s final prospectus available at www.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

Mydecine Innovations Group Provides Update on European Operations

Published at Yahoo!Finance

Company Appoints Former Novartis Norway CEO as President of European Operations, and Partners with Dr. David Erritzoe in the set up of a novel collaborative psychopharmacology/psychedelic research clinic between Imperial College London and a major mental health NHS Trust in London

DENVER, March 16, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced therapeutic medicine for mainstream use, announced that it has appointed Michel Rudolphie, former CEO and President of Make-A-Wish International and former Novartis Norway CEO, as President of the Company’s European Operations. In addition to adding new leadership, the Company also announces that it has partnered with Principal Investigator Dr. David Erritzoe at Imperial College London (ICL) to conduct leading research in the expanding field of psychedelics, as well as the creation of a novel collaborative psychopharmacology/psychedelic research clinic between ICL and a major mental health NHS Trust in London.

In an effort to further develop the Company’s international footprint and expand upon its existing clinical research efforts, Michel has been appointed to develop and lead Mydecine’s strategy, business development and comprehensive success across Europe. In addition, he will oversee Mydecine’s European clinical research initiatives and partnerships including its current Phase 2a clinical trials of psilocybin-assisted psychotherapy to treat chronic PTSD in veterans and EMS personnel at Leiden University Medical Centre in the Netherlands.

Michel, a Dutch citizen with a MSc and MBA in Healthcare Management and Policy from Erasmus University in Rotterdam, has an impressive career record in the healthcare industry, with a succession of leadership positions at Novartis for 14 years, including four years serving as CEO of Novartis Norway.

“We have significant plans in 2021 to capitalize on the international renaissance for psychedelics-based therapies amongst the medical community and researchers. European universities and other research organizations, particularly those in the U.K. and Netherlands, have shown great enthusiasm and determination to better understand the science of how these drugs work and how they can be utilized to help people suffering from PTSD,” said Josh Bartch, CEO of Mydecine. “In our conversations with Michel, it quickly became clear that his extensive experience in the international pharmaceutical space coupled with his knowledge of developing and executing partnerships with both non-profit and for-profit organizations would be a great asset to our growth. His impressive personal qualifications and as importantly, his demonstrated passion and commitment to advocating for enhanced PTSD treatment for uninformed individuals, perfectly aligns with the vision and mission of Mydecine and we are thrilled to add him to our senior management team.”

In 2018, Michel joined Make-A-Wish International as CEO and President and was responsible for moving the international headquarters from Phoenix, Arizona to the Netherlands, in addition to assembling a new team and developing the foundation’s internal and external strategy. Prior to joining Make-A-Wish, he served as the CEO and President of the Dutch Cancer Society, the largest health charity in the Netherlands. He has also previously served in a number of senior management roles within the healthcare industry including as CEO of Bioness and Vice President of European Operations for Nucletron, a global medical device company specializing in innovative products used for cancer treatment.

“Throughout my career, I have leveraged my experiences in the healthcare sector to advance both start up and mature companies through their various stages of development,” said Michel. “I’m very excited to join the Mydecine team, which has outstanding expertise in new approaches to innovative solutions for treating mental health and enhancing vitality. Having built a culture of scientific excellence, and building a global network among leading research collaborators, Mydecine is poised for its next evolution in meeting compelling patient needs in mental illness and mental disorder.”

With regard to Mydecine’s work with ICL and Dr. Erritzoe, the research to be undertaken in the new NHS-based research clinic is set out to cover:

  • Experimental psychopharmacology research in healthy populations and in addictions, obsessive compulsive disorder, eating disorders, and affective disorders;
  • Proof of concept studies and clinical trials testing efficacy, safety and mechanisms using a range of doses from micro- to macro-doses of psychedelics and associated compounds;
  • Use of multimodal human brain imaging to investigate mechanisms behind the actions of classic psychedelics and ketamine.

Part of Dr. Erritzoe’s current work includes studies that evaluate the science and efficacy of different doses of psychedelics in order to uncover mechanisms of actions and effects on brain plasticity, and cognitive and emotional processes. “The research of Dr. Erritzoe, who has published extensively on the science of psychedelics and microdosing, is critical to advancing the scientific efficacy of psychedelic medicines, and the results of studies from his team will be of critical importance as we develop the drug design and protocols for future controlled studies led by Mydecine,” said Mr. Bartch. “We are honored to be working with the Centre for Psychedelic Research and the new NHS-based research clinic as they progress and collect this important information to ensure safe use of psychedelics with the goal of producing the best possible outcomes for patients.”

Dr. Erritzoe is a Clinical Senior Lecturer in Psychiatry at Imperial College London. Alongside his clinical work in medicine/psychiatry, he conducts psychopharmacological research, using brain-imaging techniques such as PET and MRI. He was trained in PET imaging at Columbia University in New York and later undertook a PhD at University Hospital Rigshospitalet in Copenhagen. Since 2009 he has been involved in post-doc imaging research in the neurobiology of addictions and major depression at Imperial, and, together with Professor David Nutt and Dr. Carhart-Harris, he investigates mechanisms and therapeutic potential of MDMA and classic psychedelics.

“It is a very interesting time for psychedelic science and we are privileged and thankful to have received support to start an exciting new research clinic based at St Charles Hospital in CNWL Mental Health NHS Foundation Trust that will allow us to expand our clinical psychopharmacological research conducted from the Centre for Psychedelic Research at Imperial,” said Dr. Erritzoe. “Mydecine supports the expansion of ongoing work in the Centre at ICL and their contributions and enthusiasm for furthering this important work.”

About Mydecine Innovations Group
Mydecine Innovations Group™ (CSE: MYCO) (OTC:MYCOF) (FSE:0NFA) is an emerging biotech and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing vitality. The company’s world-renowned medical and scientific advisory board is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada. Mydecine also operates out of a state-of-the-art mycology lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms.

At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.

Learn more at: https://www.mydecine.com/ and follow us on FacebookTwitter, and Instagram.

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.