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Revive Therapeutics Enters into Feasibility Agreement with LTS Lohmann to Develop Oral Psilocybin Thin Film Strip

TORONTO, May 17, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF, FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has entered into a feasibility agreement with LTS Lohmann Therapie-Systeme AG (“LTS”), a leader in pharmaceutical oral thin films, to develop and manufacture a proprietary oral psilocybin thin film strip for the Company’s clinical and commercial initiatives to evaluate in mental illness, neurological and substance abuse disorders.

“We are very excited to work with LTS, as one of the world’s largest innovators and suppliers of oral thin films, to develop our proprietary oral psilocybin thin film strip product for pharmaceutical use,” said Michael Frank, CEO of Revive. “Revive positioned itself as an innovator of novel uses and delivery forms of psilocybin, as a potential treatment for unmet medical needs. Revive, with our relationship with LTS, will be able to expedite its clinical and commercial ambitions with psilocybin as a pharmaceutical, globally.”

Over the last twelve months, the Company has been focused on creating relationships and building a robust psilocybin-based product pipeline that includes novel uses, formulations, oral thin film delivery and biosynthetic forms of psilocybin. The Company collaborated with University of Wisconsin-Madison to develop an oral thin film technology and is engaged with North Carolina State University to develop a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform developed by Dr. Gavin Williams. Also, Revive is working with the University of Wisconsin to evaluate psilocybin as a potential treatment of methamphetamine use disorder and it recently submitted an application with the U.S. Food and Drug Administration (“FDA”) to receive Orphan Drug Designation (“ODD”) for psilocybin to treat traumatic brain injury, based in part of the research program acquired from PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF).

There are a number of advantages and benefits of an orally dissolvable psilocybin thin film such as the rapid dissolving and onset of action to the bloodstream, the ease and convenience for patients to administer without the need of water, chewing or swallowing, the potential of improved therapeutic outcomes and efficacy for underserved diseases and disorders including the flexibility to create accurate dosing and tasteful options.

“At LTS, we are unrelenting in our commitment to make life better for patients,” comments Bas van Buijtenen, CEO of LTS. “Under this agreement, we will deploy our full expertise and experience to the development of new therapeutic options in an area that fits perfectly with our strategic focus. The cooperation with Revive is an opportunity to demonstrate once again how LTS creates commercial value at every stage of development.”

Under the terms of the Agreement, LTS shall perform certain formulation development of oral psilocybin thin films, to support preclinical studies for the product development, as well as GMP manufacturing of clinical trial supplies.

Revive cautions that psilocybin is still under early-stage research and development and is not making any express or implied claims as to their success in the treatment of mental illness, neurological and substance abuse disorders or commercial viability.

About LTS Lohmann Therapie-Systeme AG

LTS Lohmann Therapie-Systeme AG is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems such as Transdermal Patches (“TTS”) and Oral Thin Films (“OTF”) for the pharmaceutical industry. LTS’s commercial offering encompasses more than 20 marketed products and a diverse pipeline of more than 30 development projects targeting multiple disease indications. LTS’s innovation pipeline contains both partner-funded as well as proprietary, LTS-funded projects. LTS maintains its leading position through the continuous refinement of its core TTS and OTF technologies and by advancing emerging drug delivery technologies, including Micro Array Patches for the transdermal delivery of large molecule, biological actives. Founded in 1984, LTS operates today from two sites in Andernach, Germany and West Caldwell, NJ, USA and a representative office in Shanghai, China.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts 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” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive 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 Revive 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. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

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PharmaTher Announces FDA Approval of Ketamine IND In The Treatment of Parkinson’s Disease

TORONTO, May 17, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (CSE: PHRM) (OTCQB: PHRRF), a psychedelics biotech company, is pleased to announce that the U.S. Food and Drug Administration (“FDA”) has approved the Company’s Investigational New Drug (“IND”) application to proceed with a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease (“LID-PD”).  PharmaTher expects to begin enrolling patients in the Phase 2 clinical trial in Q3-2021.  Assuming the Phase 2 clinical trial is positive, the Company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study under the 505(b)(2) regulatory pathway next year.
Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “The FDA’s acceptance of our IND application for ketamine to treat Parkinson’s disease is a significant milestone for us.  The FDA IND is our first of many we will aim to obtain, and we are one of the few psychedelics-focused biotech companies that have an IND approved by the FDA for a recognized psychedelic drug.  The IND paves the way for us to expeditiously evaluate ketamine and other psychedelics via the FDA regulatory pathway in various mental illness, neurological and pain disorders.  We are committed to building a rich product pipeline of novel uses, formulations and delivery methods of psychedelics, and with our FDA IND in place, we now have the foundation in making PharmaTher a global leader in psychedelic-based therapeutics.”

Parkinson’s disease is a debilitating disorder that affects over 1 million people in the U.S. and more than 7 million people worldwide. There is currently no cure for Parkinson’s disease, although some drug combinations are used to treat the disease symptoms. The global Parkinson’s disease market is expected to grow from USD $5 billion in 2019 to USD $7.5 billion by the end of 2025 [360iResearch 2020] and it is estimated that the potential market opportunity for LID-PD to be over USD $3 billion in the U.S. alone.

About the Phase 2 Clinical Trial

The clinical trial is titled “A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease.” It is anticipated that up to eight clinical sites in the U.S. will randomize a total of up to 36 subjects to the investigational product (ketamine) or active control (midazolam). The primary end-point of the study is the change in the Unified Dyskinesia Rating Scale (“UDysRS”) total score from Baseline to Week 8. Secondary endpoints of the study include the change in Total Objective Scores of the UDysRS, total daily OFF times as assessed by subject-completed 24-hour diaries and change in the UPDRS total and sum scores of motor and dyskinesia from Baseline to Week 8. Because LID can markedly affect a Parkinson patient’s everyday activities, a reduction in LID could improve the patient’s quality of life.

The Company has assembled a prolific scientific and clinical team experienced in Parkinson’s disease, including Dr. Scott Sherman and Dr. Torsten Falk from the University of Arizona, Dr. Alberto Espay from the University of Cincinnati and Dr. Robert Hauser from the University of South Florida.

Ketamine’s Potential In Parkinson’s Disease

Ketamine is an FDA-approved N-methyl-D-aspartate (“NMDA”) receptor-modulating drug that is widely used as an anesthetic agent either alone or in combination with other anesthetic agents [Smith et al, 1987; Pacheco et al, 2014]. The possible therapeutic effect of low-dose ketamine on LID was noted in a retrospective analysis of PD patients who received ketamine for pain relief. During this analysis, it was observed that the patients experienced an improvement in LID lasting several weeks beyond treatment [Sherman et al, 2016]. These results were corroborated in a test of low-dose ketamine in a rodent LID model, and this possible effect has also been examined in a controlled study [Bartlett et al, 2016]. Ketamine may also have additional benefits in the treatment of pain [Niesters et al, 2014] and depression [Diamond et al, 2014; Murrough et al, 2013], which are frequent comorbidities of Parkinson’s disease.

About Parkinson’s Disease   

There is currently no cure for Parkinson’s disease. Although the etiology of Parkinson’s disease is not fully understood, it is thought to result from loss of pigmented dopaminergic neurons in the Substantia nigra and their striatal projections, leading to dopamine deficiency in the striatum [Schapira and Jenner, 2011]. This ultimately affects the cortico-striatal system that controls movement. As a progressive neurogenerative disorder of the central nervous system that primarily affects the motor nerve system, symptoms of Parkinson’s disease may emerge slowly and include tremors, rigidity, bradykinesia, and postural instability [Paulson and Stern, 2004]. Also, patients may experience non-motor symptoms such as autonomic dysfunction (orthostatic hypotension, constipation, bladder dysfunction), psychiatric (depression), cognitive and sensory symptoms (pain) [Olanow, et al, 2009]. These non-motor symptoms become more common as the disease progresses. Treatments, including levodopa and dopamine agonists, which restore the dopamine deficits in the brain, have been employed for almost 50 years. However, with continued treatment using levodopa, dose-limiting motor side-effects often emerge. This includes the emergence of abnormal involuntary movements termed Levodopa Induced Dyskinesias, which can be identified in about 50% of patients within five years after initiation of levodopa treatment and in almost all patients within ten years post-treatment initiation. These side effects often limit further dose increases in dopaminergic therapy.

There can be no assurance that the FDA will support any potential request for an expedited path to approval or further development for ketamine in the treatment of Parkinson’s disease.

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF) is a psychedelics biotech company focused on the research, development and commercialization of ketamine and novel microneedle patches for the delivery of psychedelics to treat mental illness, neurological and pain disorders.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

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 PharmaTher Holdings Ltd. (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 February 28, 2021 (“MD&A”), dated April 28, 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.

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GREENBROOK TMS REPORTS FIRST QUARTER OPERATIONAL AND FINANCIAL RESULTS

May 14, 2021 – Toronto, Ontario – Greenbrook TMS Inc. (TSX: GTMS, NASDAQ: GBNH) (“Greenbrook” or the “Company”), today announced its first quarter 2021 (“Q1 2021) operational and financial results. All values in this news release are in United States dollars, unless otherwise stated.

 

FIRST QUARTER 2021 OPERATIONAL AND FINANCIAL HIGHLIGHTS

  • New patient starts increased by 19% to 1,583 as compared to the first quarter of 2020 (“Q1 2020”) and 11% compared to the fourth quarter of 2020 (“Q4 2020”).
  • Treatment volumes decreased by 4% to 52,126 as compared to Q4 2020 due to typical seasonal factors, amplified by harsh winter weather in parts of the United States. Despite these factors, Greenbrook managed year-over-year growth of 9% as compared to Q1
  • Consultations performed, an important performance indicator for the Company, increased by 52% as compared to Q1 2020, which points to encouraging prospects for the remainder of 2021.
  • Quarterly revenue increased by 14% to $11.3 million as compared to Q4 2020 and decreased by 1% compared to Q1 2020. This is despite a series of significant weather events, which led to temporary closures of many of the Company’s TMS centers (“TMS Centers”).
  • Q1 2021 resulted in an entity-wide regional operating loss of $1.5 million as compared to an entity-wide regional operating loss of $2.1 million in Q4 2020 and entity-wide regional operating income of $0.7 million in Q1 2020.
  • Implemented the Spravato® (esketamine nasal spray) pilot program at select TMS Centers to treat adults with treatment-resistant depression and depressive symptoms in adults with Major Depressive Disorder (“MDD”) with suicidal thoughts or Based on the promising findings from the pilot program, the Company expects to expand its offering of Spravato® to an additional 5-6 TMS Centers, for a total of 10-12 TMS Centers offering Spravato®.
  • Added three newly active TMS Centers during Q1 2021, with an additional nine TMS Centers in development, bringing the total Company network to 128 TMS Centers as at March 31, 2021, representing an increase of 3% as compared to Q1

 

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

 

“We are very pleased with our start to 2021, with a return in consolidated revenue to pre-COVID-19 levels in Q1 2021. We experienced record monthly highs in new patient starts and treatment volumes in March 2021 despite temporary closures of some of our TMS Centers due to significant weather events in the first half of the quarter, and the continuing challenges of the COVID-19 pandemic. We believe the improved operational performance in March 2021 positions us well for a strong second quarter. We have also successfully rolled-out the Spravato® Pilot Program, building on our long-term business plan of utilizing our TMS Centers as platforms for the delivery of innovative treatments to patients suffering from MDD and other mental health disorders, and we look forward to making this treatment option available at additional centers.”

 

 

 

SELECTED FIRST QUARTER FINANCIAL AND OPERATING RESULTS (1)

Selected Financial Results

 

(US$) Q1 2021   Q1 2020
Total revenue 11,313,175   11,420,502
Regional operating income (loss) (1,492,118)   739,796
Loss before income taxes (7,836,166)   (4,240,797)
Loss for the year and comprehensive loss (7,836,166)   (4,240,797)
Loss attributable to the common shareholders of Greenbrook (7,626,554)   (4,158,274)
Net loss per share (basic and diluted)(2) (0.56)   (0.39)

Notes:

  • Please note that additional selected consolidated financial information can be found at the end of this press
  • On January 12, 2021, the shareholders of the Company approved a special resolution for an amendment to the Company’s articles and 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 March 31,   As at March 31,   As at December 31,
(unaudited)          
  2021   2020   2020
Number of active TMS Centers(1) 119   110   116
Number of TMS Centers-in-development(2) 9   14   9
Total TMS Centers 128   124   125
Number of management regions 13   13   13
Number of TMS Devices installed 201   189   198
Number of regional personnel 317   302   305
Number of shared-services / corporate personnel(3) 49   47   49
Number of TMS providers(4) 116   117   117
Number of consultations performed(5) 3,591   2,360   11,305
Number of patient starts(5) 1,583   1,326   5,445
Number of treatments performed(5) 52,126   47,970   195,992
Average revenue per treatment(5) $217   $238   $220

Notes:

  • Active TMS Centers represent TMS Centers that have performed billable TMS
  • 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
  • Figure calculated for the applicable period

 

For more information, please refer to the Management’s Discussion & Analysis of Financial Condition and Results of Operations (“MD&A”) and the unaudited condensed interim consolidated financial statements of the Company for the three months ended March 31, 2021 and 2020. These documents 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.

 

 

 

CONFERENCE CALL AND WEBCAST

 

First Quarter Conference Call Details:

Bill Leonard, President and Chief Executive Officer, and Erns Loubser, the Chief Financial Officer, will host a conference call at 10:00 a.m. (Eastern Time) on Monday, May 17, 2021 to discuss the financial results for the quarter.

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: 6679987

The conference call replay will be available from 1:00 p.m. ET on May 17, 2021, until 11:59 p.m. ET on June 17, 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 620,000 TMS treatments to over 17,000 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 and the Company’s expectations regarding the expansion of the Spravato® pilot

 

 

 

program, constitute forward-looking information within the meaning of applicable securities laws in Canada and the United States, including the United States Private Securities Litigation Reform Act of 1995. 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 year ended December 31, 2020 and December 31, 2019 and the quarters ended 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$) Q1 2021

(unaudited)

   Q1 2020

(unaudited)
Total revenue 11,313,175   11,420,502
Direct center and patient care costs 6,360,023   5,881,290
Regional employee compensation 2,986,315   2,526,190
Regional marketing expenses 1,984,621   867,102
Depreciation 1,474,334   1,406,124
Total direct center and regional costs 12,805,293   10,680,706
Regional operating income (loss) (1,492,118)   739,796
Center development costs 280,433   229,507
Corporate employee compensation 2,886,584   2,623,430
Corporate marketing expenses 161,034   305,448
Other corporate, general and administrative expenses 1,668,464   947,618
Share-based compensation 205,970   109,405
Amortization 115,833   115,833
Interest expense 1,027,912   657,834
Interest income (2,182)   (8,482)
Loss before income taxes (7,836,166)   (4,240,797)
Income tax expense –   –
Loss for the period and comprehensive loss (7,836,166)   (4,240,797)
Loss attributable to non-controlling interest (209,612)   (82,523)
Loss attributable to the common shareholders of Greenbrook (7,626,554)   (4,158,274)
Net loss per share (basic and diluted) (1) (0.56)   (0.39)

Note:

(1) The Company has retrospectively presented net loss per share calculations reflecting the number of Common Shares outstanding after giving effect to the Share Consolidation.

 

 

 

(US$) Q1 2021   Q4 2020   Q3 2020   Q2 2020   Q1 2020   Q4 2019   Q3 2019   Q2 2019
(unaudited)                              
Revenue 11,313,175   9,913,552   12,006,570   9,788,555   11,420,502   12,536,671   8,459,103   8,082,559
Regional operating income (loss)(1) (1,492,118)   (2,050,168)   967,584   (225,198)   739,796   2,056,836   770,813   1,002,166
Net loss attributable to common shareholders of Greenbrook (7,626,554)   (8,391,630)   (7,636,132)   (9,477,505)   (4,158,274)   (7,034,356)   (3,431,009)   (2,874,092)
Adjusted EBITDA (4,013,910)   (4,223,446)   (937,073)   (1,665,672)   (1,648,053)   (1,296,201)   (1,033,876)   (957,428)
Net loss per share – Basic(2) (0.56)   (0.60)   (0.57)   (0.76)   (0.39)   (0.62)   (0.31)   (0.28)
Net loss per share – Diluted(2) (0.56)   (0.60)   (0.57)   (0.76)   (0.39)   (0.62)   (0.31)   (0.28)

Notes:

  • Regional operating income (loss) for the fourth quarter ended December 31, 2019 has been updated to exclude
  • The Company has retrospectively presented net loss per share calculations reflecting the number of Common Shares outstanding after giving effect to the Share
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Vireo Health Announces First Quarter 2021 Financial Results

— Q1 GAAP revenue of $13.2 million increased 9% compared to Q1 2020 —
— Excluding former PA subsidiaries, Q1 revenue increased 30% YoY and 14% sequentially —
— Gross profit margin of 42.6% reflects improving efficiency of operations across core markets —

MINNEAPOLIS, May 14, 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 first quarter ended March 31, 2021. All currency figures referenced in this press release reflect U.S. dollar amounts.

Vireo Logo (PRNewsfoto/Vireo Health, Inc.)

“Our first-quarter results are consistent with the trends from last quarter. We continued to see double-digit sequential revenue growth excluding our former Pennsylvania subsidiaries, and substantial improvement in our gross margin due to our focus on operational efficiencies,” said Chairman and Chief Executive Officer, Kyle Kingsley, M.D. “Wholesale performance in Maryland was temporarily impacted by the move to our recently-completed 110,000 square foot cultivation facility in Massey, but our increased scale in this market will drive stronger revenue growth and profitability in the second half of the year.”

Dr. Kingsley continued, “The phase two expansion projects we discussed last quarter in Arizona and Maryland are underway, and our teams are now aggressively focused on finalizing our expansion plans in New York. The recent passage of adult-use legislation in New York and New Mexico has improved our outlook for both of these markets, and further potential for regulatory change at local and federal levels could meaningfully impact the trajectory of our performance. We are excited by all the growth opportunity we see across our core markets, and look forward to sharing more details on our long-term outlook at our upcoming Investor Day events which we plan to announce in the coming weeks.”

Summary of Key Financial Metrics

Three Months Ended

US $ in millions

March 31,

2021

2020

Variance

GAAP Revenue

$13.2

$12.1

8.8%

Revenue (excl. former PA subsidiaries)

$13.2

$10.2

29.8%

GAAP Gross Profit

$5.6

$3.3

71.3%

Gross Profit Margin

42.6%

27.0%

1,560 bps

SG&A Expenses

$8.0

$6.9

16.9%

SG&A Expenses (% of Sales)

60.9%

56.7%

420 bps

Adjusted EBITDA (non-GAAP)

($1.8)

($3.1)

NM

Adjusted EBITDA Margin (non-GAAP)

(13.5%)

(25.7%)

1,220 bps

First Quarter Business Highlights

  • Total revenue of $13.2 million increased 8.8 percent year-over-year. Excluding results from the Company’s former subsidiaries in Pennsylvania, revenue increased 29.8 percent compared to Q1 2020.
  • Gross profit increased by $2.3 million to $5.6 million, or 42.6 percent of sales as compared to $3.3 million, or 27.0 percent of sales in Q1 2020.
  • During the quarter, the Company 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.
  • The Company also 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 closed on the first tranche of a 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 $23.0 million, net of all fees and closing costs, will be utilized to support the Company’s ongoing growth initiatives and working capital requirements.
  • On March 31, the Company closed on the previously announced transaction to divest its former affiliate, Ohio Medical Solutions, Inc. In connection with the closing of the transaction, Vireo received cash proceeds of $1.15 million, and was relieved of $3.6 million in right of use liabilities affiliated with lease obligations.

First Quarter Financial Summary

Total revenue was $13.2 million in the first quarter, an increase of 8.8 percent as compared to Q1 2020, including the Company’s former subsidiaries in Pennsylvania. Excluding contributions from Pennsylvania, revenue increased 29.8 percent. Retail revenue excluding Pennsylvania increased 33.7 percent to $10.4 million in Q1 2021 and reflected growth in each of the Company’s retail markets. Wholesale revenue, excluding Pennsylvania increased by 17.4 percent to $2.8 million, driven by strong growth in the Arizona market.

Gross profit was $5.6 million, or 42.6 percent of revenue, as compared to gross profit of $3.3 million or 27.0 percent of revenue in Q1 last year. The improvement in gross profit compared to the prior year was driven by stronger performance in Minnesota where the Company recently opened four additional Green Goods™ retail dispensaries, as well as higher throughput across all markets which led to lower fixed costs per unit.

Total operating expenses in the first quarter were $10.7 million, an increase of $0.9 million or 9.8 percent as compared to $9.8 million in the first quarter of 2020. The increase in total expenses was attributable to an increase in selling, general and administrative expenses of $1.1 million. The increase in SG&A expenses was driven by operational expansion in Arizona, Maryland, and New Mexico, as well as the addition of four new retail dispensaries in Minnesota.

Total other expenses were $373,842 during Q1 2021, a reduction of $219,766 compared to $593,608 in Q1 2021. The decrease was primarily attributable to the gain on the divestiture of Ohio Medical Solutions, Inc. during the quarter.

EBITDA, as described in accompanying disclosures and footnotes, was a loss of $3.6 million during Q1 2021, compared to a loss of $5.0 million in Q1 2020. Adjusted EBITDA was a loss of $1.8 million in Q1 2021, as compared to a loss of $3.1 million in Q1 2020. 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 Q1 2021 was $7.0 million, as compared to a net loss of $7.5 million in Q1 2020. The improvement in net loss was primarily the result of the gain on the divestiture of the Company’s former affiliate, Ohio Medical Solutions, Inc.

Subsequent Events

On April 14, the Company announced the completion of a planned expansion of its cultivation and processing facility in New Mexico, which is now operating following the receipt of regulatory approval. The Company also announced that two recently completed retail dispensaries in Albuquerque and Las Cruces are ready to open, pending regulatory approval. Once approved, Vireo will have four operating dispensaries in the state of New Mexico.

On April 29, the Company announced the launch of ground medical cannabis flower in the state of New York. The ground flower line is being sold in 3.5-gram and 7-gram jars and will be expanded to feature indica, sativa, and hybrid strains such as Killer Kush, Wedding Cake, and a Kosher-approved Tangie Kush. The new line of ground flower will be available at all four of the Company’s dispensaries in New York and via Home Delivery.

Balance Sheet and Liquidity

As of March 31, 2021, the Company had 125,196,702 equity shares issued and outstanding on an as-converted basis, and 153,577,058 shares outstanding on an as-converted, fully diluted basis.

As of March 31, 2021, total current assets were $58.6 million, including cash on hand of $40.6 million. Total current liabilities were $24.1 million, with $2.0 million in debt due within 12 months.

Conference Call and Webcast Information

Vireo Health management will host a conference call with research analysts today, Friday, May 14, 2021 at 8:30 a.m. ET (7:30 a.m. CT) to discuss its financial results for its first quarter ended March 31, 2021. Interested parties may register to attend the conference call via the following link:  http://www.directeventreg.com/registration/event/2254847.

Upon registration, each participant will be provided with call details and a registrant ID for Vireo’s conference ID number 2254847. 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 450 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 eight 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 first quarter 2021 results will be available on EDGAR and SEDAR later today. Vireo refers to certain non-GAAP financial measures such as 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 “trends,” “initiatives,” “expected,” “opportunities,” “potential,” “could,” “look forward,” “outlook,” “will,” “should,” “encouraged,” and “pending,” ” or variations of such words and phrases.  These statements should not be read as guarantees of future performance or results. 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. 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 and any changes to such laws; 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 Annual Report on Form 10-K for the year ended December 31, 2020, which is available on EDGAR with the U.S. Securities and Exchange Commission and filed with the Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com.

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 news release is based on audited financial statements for the fiscal year ended December 31, 2020 and unaudited condensed interim consolidated financial statements for the fiscal quarter ended March 31, 2021. All financial information contained in this news release is qualified in its entirety with reference to such financial statements. To the extent that the financial information contained in this news release is inconsistent with the information contained in the Company’s audited financial statements, the financial information contained in this news 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 3/31/21 AND 12/31/20
(Amounts expressed in USD, except for share amounts, unaudited and condensed)

March 31, 

December 31, 

2021

2020

Assets

Current assets:

Cash

$

40,561,051

$

25,513,180

Restricted cash

—

1,592,500

Accounts receivable

867,593

696,994

Inventory

14,532,336

12,644,895

Prepayments and other current assets

2,458,295

1,552,278

Notes receivable

198,471

293,700

Deferred acquisition costs

—

28,136

Assets Held for Sale

—

4,596,445

Deferred financing costs

—

120,266

Total current assets

58,617,746

47,038,394

Property and equipment, net

35,923,904

30,566,259

Operating lease, right-of-use asset

8,833,728

8,163,844

Notes receivable, long-term

3,750,000

3,750,000

Intangible assets, net

11,388,112

8,409,419

Goodwill

3,132,491

3,132,491

Deposits

1,413,719

1,412,124

Deferred tax assets

392,000

157,000

Total assets

$

123,451,700

$

102,629,531

Liabilities

Current liabilities

Accounts Payable and Accrued liabilities

15,675,443

13,477,303

Right of use liability

1,197,597

857,294

Convertible notes, net of issuance costs

900,000

900,000

Long-Term debt, current portion

1,110,000

1,110,000

Liabilities held for sale

—

3,595,301

Warrant Liability

5,237,230

—

Total current liabilities

24,120,270

19,939,898

Right-of-use liability

21,479,700

20,343,063

Long-Term debt

17,646,501

—

Total liabilities

$

63,246,471

$

40,282,961

Stockholders’ equity

Subordinate Voting Shares ($- par value, unlimited shares authorized; 72,660,602 shares issued and outstanding)

—

—

Multiple Voting Shares ($- par value, unlimited shares authorized; 459,950 shares issued and outstanding)

—

—

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

—

—

Additional Paid in Capital

168,924,845

164,079,614

Accumulated deficit

(108,719,616)

(101,733,044)

Total stockholders’ equity

$

60,205,229

$

62,346,570

Total liabilities and stockholders’ equity

$

123,451,700

$

102,629,531

 

VIREO HEALTH INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2021 AND 2020
(Amounts expressed in USD, except for share amounts, unaudited and condensed)

Three Months Ended March 31,

2021

2020

Revenue

$

13,189,889

$

12,118,567

Cost of sales

Product costs

7,506,048

8,701,653

Inventory valuation adjustments

68,000

139,008

Gross profit

5,615,841

3,277,906

Operating expenses:

Selling, general and administrative

8,035,991

6,877,125

Stock-based compensation expenses

2,314,575

2,735,938

Depreciation

171,562

2,966

Amortization

206,443

154,190

Total operating expenses

10,728,571

9,770,219

Loss from operations

(5,112,730)

(6,492,313)

Other income (expense):

Gain on disposal of assets held for sale

437,107

—

Derivative gain

158,529

1,325,928

Interest expenses, net

(1,026,146)

(1,450,264)

Other income (expenses)

56,668

(469,272)

Other expenses, net

(373,842)

(593,608)

Loss before income taxes

(5,486,572)

(7,085,921)

Current income tax expenses

(1,735,000)

(505,100)

Deferred income tax recoveries 

235,000

78,000

Net loss and comprehensive loss

(6,986,572)

(7,513,021)

Net loss per share – basic and diluted

$

(0.06)

$

(0.08)

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

116,103,635

88,519,845

 

VIREO HEALTH INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
THREE MONTHS ENDED MARCH 31, 2021 AND 2020
(Amounts expressed in USD, except for share amounts, unaudited and condensed)

Three Months Ended March 31,

2021

2020

CASH FLOWS FROM OPERATING ACTIVITIES

Net loss

$

(6,986,572)

$

(7,513,021)

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

Inventory valuation adjustments

68,000

139,009

Depreciation

171,562

2,966

Depreciation capitalized into inventory

508,358

474,903

Non-cash operating lease expense

286,296

297,406

Amortization of intangible assets

206,443

154,190

Share-based payments

2,314,575

2,735,938

Deferred income tax

(235,000)

(78,000)

Deferred Gain/Loss Sale Leaseback

—

30,481

Accretion

91,507

149,309

Loss on Sale of Property and Equipment

—

13,800

Derivative Loss

(158,529)

(1,325,928)

Gain on disposal of OMS

(437,107)

—

Change in operating assets and liabilities:

Accounts Receivable

(52,521)

166,751

Prepaid expenses

(886,714)

1,133,567

Inventory

(1,875,784)

(385,647)

Accounts payable and accrued liabilities

1,885,815

1,270,264

Change in assets and liabilities held for sale

124,843

—

Net cash used in operating activities

$

(4,974,828)

$

(2,734,012)

CASH FLOWS FROM INVESTING ACTIVITIES:

PP&E Additions

$

(4,922,251)

$

(506,336)

Proceeds from sale of OMS net of cash

1,150,000

—

Deposits

(1,595)

25,000

Net cash provided by (used in) investing activities

$

(3,773,846)

$

(481,336)

CASH FLOWS FROM FINANCING ACTIVITIES

Proceeds from issuance of shares

$

—

$

7,613,490

Deferred financing costs

(865,769)

—

Proceeds from long-term debt

24,028,295

—

Proceeds from option exercises

966,156

—

Lease payments

(332,137)

(309,949)

Net cash provided by financing activities

$

23,796,545

$

7,303,541

Net change in cash and restricted cash

$

15,047,871

$

4,088,193

Cash and restricted cash, beginning of period

$

25,513,180

$

7,641,673

Cash and restricted cash, end of period

$

40,561,051

$

11,729,866

 

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 

March 31, 

2021

2020

Net income (loss)

$

(6,986,572)

$

(7,513,021)

Interest expense, net

1,026,146

1,450,264

Income taxes

1,500,000

427,100

Depreciation & Amortization

378,005

157,156

Depreciation included in cost of goods sold

508,359

474,903

EBITDA (non-GAAP)

$

(3,574,062)

$

(5,003,598)

Derivative Gain

(158,529)

(1,325,928)

Inventory adjustment

68,000

139,008

Share-based compensation

2,314,575

2,735,938

Severance Expense

—

339,997

Gain on sale of discontinued operations

(437,107)

—

Adjusted EBITDA (non-GAAP)

$

(1,787,123)

$

(3,114,583)

 

CisionView original content to download multimedia:http://www.prnewswire.com/news-releases/vireo-health-announces-first-quarter-2021-financial-results-301291462.html

SOURCE Vireo Health International, Inc.

Posted on

CORE ONE LABS INC. PROVIDES UPDATE ON DEFAULT ANNOUNCEMENT PURSUANT TO NATIONAL POLICY 12-203 – MANAGEMENT CEASE TRADE ORDERS

Vancouver, British Columbia, Canada – May 13, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company” or ”Core One”).  The Company is providing this bi-weekly update on the status of the management cease trade order granted on May 3, 2021 (the “MCTO”) by its principal regulator, the British Columbia Securities Commission under National Policy 12-203 – Management Cease ‎Trade Orders (“NP 12-203”), following the Company’s announcement on April 29, 2021 (the “Default Announcement”) that it was unable to file its audited annual financial statements for the year ‎ended December 31, 2020, and accompanying management’s discussion and analysis, annual information form and related certifications ‎‎(collectively, the “Documents”) on or before April 30, 2021, as required under applicable securities laws. The MCTO does ‎not affect the ability of investors who are not insiders to trade in the securities of the Company.‎

In follow up to the original Default Announcement the Company reports that it anticipates filing the Documents before the end of the month.

Except as noted, the Company further reports that: (i) there are no changes to the information contained in the bi-weekly status updated dated April 29, 2021, that would reasonably be expected to be material to an investor; (ii) the Company is satisfying and confirms that it intends to continue to satisfy the provisions of the alternative information guidelines under NP 12-203 and issue bi-weekly default status reports for so long as the delay in filing the Documents is continuing, each of which will be issued in the form of a press ‎release; (iii) there has not been any other specified default by the Company under NP 12-203, and, except as set forth below, no such other default is anticipated; (iv) the Company is not subject to any insolvency proceedings; ‎and (v) there is no material information concerning the affairs of the Company that has not been generally ‎disclosed.

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.

Posted on

TRYP THERAPEUTICS PARTNERS WITH CLINLOGIX FOR CLINICAL TRIAL SUPPORT

San Diego, California – May 10, 2021 – Tryp Therapeutics (CSE:TRYP; OTCQB:TRYPF, FRA:8FW) (“Tryp”), a pharmaceutical company focused on developing clinical-stage compounds for diseases with unmet medical needs, announced today a master service agreement with Clinlogix, a Contract Research Organization (CRO), to support Tryp’s clinical development of its Psilocybin-for-Neuropsychiatric Disorders (PFNTM) program.

Clinlogix has global experience with providing CRO services for the development of novel pharmaceutical products. The company will collaborate with Tryp and its clinical partners in a number of areas including medical writing, biostatistical analysis, data management, and trial monitoring.

“Clinlogix is pleased to partner with Tryp Therapeutics in support of their next stage in clinical development. We look forward to leveraging our core expertise in clinical research to advance this novel technology,” said JeanMarie Markham, Founder & CEO of Clinlogix. “Sharing a common goal to deliver innovative solutions for unmet medical needs, Clinlogix is proud to support Tryp in advancing their novel treatments through the clinical trial process. We look forward to a collaborative and successful partnership!”

Tryp’s collaboration with Clinlogix will initially focus on supporting Tryp’s upcoming Phase 2a clinical trials for eating disorders and fibromyalgia. These studies are being conducted at leading academic centers, including the University of Florida, with deep expertise in their respective disease areas. Eating disorders such as binge eating and hypothalamic obesity that Tryp is targeting in its Phase 2a clinical study are often poorly addressed by currently available therapies. And Tryp’s upcoming Phase 2a clinical trial for fibromyalgia is aimed at providing an additional treatment option for the nearly one-third of patients suffering from the condition that rely on opioids to address their symptoms.

“The proper execution of a clinical study is of paramount importance in order to achieve clinical success; working with the team from Clinlogix provides Tryp with key elements needed for the conduct of a successful clinical study,” commented Jim Gilligan, Ph.D., President and Chief Science Officer of Tryp.

About Tryp Therapeutics

Tryp Therapeutics is a pharmaceutical company focused on developing clinical-stage compounds for the treatment diseases with unmet medical needs through accelerated regulatory pathways. 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 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 sarcomas. 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 that TRP-1001 should qualify for orphan status with the FDA.

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

About Clinlogix

Founded in 1999, Clinlogix has helped companies conduct complex, next-generation research and find success in new frontiers of health and medicine. By pairing world-class scientific and regulatory leadership with a robust project management approach, the company ensures proper strategic guidance and execution through the entire program. From concept to commercialization, we leverage the expertise of a thoroughly vetted global network of scientific advisors and thought leaders to ensure excellence in every project.  Clinlogix is headquartered in Lower Gwynedd, Pennsylvania, and has offices in Japan, Germany, and Colombia to support global product development programs.

www.clinlogix.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.

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Mydecine to Participate in the Benzinga Global Small Cap Conference on May 13th

Published at globenewswire.com

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DENVER, May 10, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: 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 medicine for mainstream use, today announced that Josh Bartch, CEO of Mydecine, will participate in the Benzinga Global Small Cap Conference to be hosted virtually on Thursday, May 13, 2021.

Mr. Bartch will speak on the panel titled Investing in the Mental Health Crisis Through Psychedelics at 4:15 p.m. ET. To attend, register here.

For more information about the conference, or to schedule a one-on-one meeting with Mydecine management, please contact KCSA Strategic Communications at MYCO@kcsa.com.

About Mydecine Innovations Group

Mydecine Innovations Group™ (NEO: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.

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.

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.

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Core One Labs Commences Development on Patent Pending Psychedelic Drug Formulation for the Treatment of Alzheimer’s Disease

Vancouver, British Columbia, Canada – May 6, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company” or “Core One”) is pleased to announce that its wholly owned subsidiary Akome Biotech Ltd. (“Akome”) has commenced the development of its next-generation patent pending psychedelic drug formulation for the treatment of Alzheimer’s Disease (“Alzheimer’s”).

Akome’s ‘next-generation’ psychedelic drug formulation, also known as AKO002, is comprised of the psychedelic compound psilocybin and a plant bioactive, which when combined together are believed to be complementary and/or synergistic in the treatment of Alzheimer’s. A provisional matter of composition patent application for AKO002 has been filed with the United States Patent and Trademark Office (USPTO) under application number 63123838.

Alzheimer’s is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and, eventually, the ability to carry out the simplest tasks. It is a progressive neurological disorder characterized by extracellular amyloid protein deposition and intracellular tau protein aggregates that, in accumulation, are associated with a variety of pathological processes including microtubular damage, axonal transport disruption and, ultimately, cell death. The hippocampus, a key structure in the ability to learn and retain information and a site for neurogenesis, is particularly vulnerable to Alzheimer’s pathology, including increased inflammation, and one of the earliest parts of the brain to be affected by the disease.

Current approaches of treating Alzheimer’s focus mainly on treating symptoms of the disease, however available drugs do not change the underlying disease process.  Currently there are no disease-modifying treatments for Alzheimer’s.  Akome’s data analysis and mapping reveals anecdotal evidence that psychedelics have positive effects in the promotion of neuroplasticity and neurogenesis  and act as agonists  at serotonin receptors, including the 5HT2A receptors (5HT2A-R), that appear in high concentrations, in regions of the brain that  are vulnerable to Alzheimer’s, such as the hippocampus.  Additionally, psychedelics have been shown to have potent anti-inflammatory properties and, given their affinity for the 5HT2A-R, may represent a unique anti-inflammatory overwhelmingly targeted to brain tissue. Akome’s plant bioactive seems to work in a complementary way with the psilocybin compound, as it has several mechanisms of action including β-amyloid reduction and increased cerebral blood flow.

Akome will continue to develop on its initial data mapping, and analysis of its bioactive-psilocybin, as it sets the process for stage two of its novel AKO002 psychedelic drug formulation and its advancement for the treatment of Alzheimer’s Disease.

“Akome’s novel drug formulation for the treatment of Alzheimer’s could be a revolutionary development for the world of neurological science, and a life changer for the millions of people who are suffering from this devastating disease.  We are very excited at the prospect of this drug formulation, as it reaches a relatively untapped patient base for psychedelic treatment.”  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. 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.

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Core One Labs has initiated the development of patent-pending drug formulation that uses psilocybin to treat the underlying cause of Alzheimer’s Disease

Core One Labs Commences Development on Patent Pending Psychedelic Drug Formulation for the Treatment of Alzheimer’s Disease

Akome Biotech Ltd., a subsidiary of Core One Labs Inc. (COOL), has initiated the development of patent-pending drug formulation made of psilocybin and a plant bioactive compound, which is believed to help treat Alzheimer’s Disease. While current Alzheimer’s treatments focus on treating symptoms of the disease, the new drug formulation known as AKO002 aims to treat the underlying cause of the disease by targeting serotonin receptors in the hippocampus. Data mapping reveals that psychedelics like psilocybin have “positive effects in the promotion of neuroplasticity and neurogenesis” and have “potent anti-inflammatory properties”.

PDF of article

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World Renowned Physician Joins Core One Labs as Chief Medical Officer

Vancouver, British Columbia, Canada – May 5, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company” or “Core One”) is pleased to announce it has appointed Dr. Santiago Ferro, Chief Executive Officer of Akome Biotech Ltd. (“Akome”), as Chief Medical Officer of the Company.  Dr. Ferro will lead the Company through clinical trials and commercialization of its psychedelic products.

Dr. Ferro is a graduate of Javeriana University Medical School in his native Bogotá, Colombia, where he specialized in Internal Medicine, and received his sub-specialty training in Infectious Diseases at University of Toronto. Following completion of his medical and specialty training, Dr. Ferro returned to Bogotá and established a private practice in both Internal Medicine and Infectious Diseases, while at the same time held academic positions at different teaching hospitals.

Dr. Ferro is a world-renowned physician with over 20 years’ experience in pharmaceuticals, biologicals and biotech industries. Throughout his career, Dr. Ferro has held many prestigious senior research and development management positions with global responsibilities for clinical development programs, design, implementation, and analysis of clinical trials data, and has a proven record of generating and building relationships, managing projects from concept to completion, as well as designing clinical plans to meet market targets and bringing products to success.

Dr. Ferro’s impressive resume includes appointments as Chief of Internal Medicine at Central Military Hospital in Bogotá, President of the Colombian Infectious Disease Society, Clinical Team Leader for new vaccines at Sanofi Pasteur in Toronto, Infectious Disease Expert  at Novartis Pharmaceuticals in New Jersey – where, he was also member of the internal Scientific Review Board and deeply involved in drug development – and Medical Director at PATH’s Malaria Vaccine Initiative in Bethesda, Maryland where he led a team of clinical researchers, which jointly worked with Glaxo Smith Klein’s team  to implement a large phase 3 clinical trial for a malaria vaccine candidate in 7 Sub-Saharan African countries. Dr. Ferro was also VP Clinical Affairs at  Fio Corporation, where he led the clinical research and field implementations of the Fionet system in multiple countries in Africa and Latin America. Dr. Ferro also has an esteemed reputation in his fields of study, and has  presented in multiple international scientific conferences, and has over twenty-five scientific publications in peer reviewed journals and medical textbooks.

“I would like to welcome Dr. Ferro to the Core One team.  Dr. Ferro’s breadth of experience in leading teams through product development, clinical and regulatory environments with major pharmaceutical companies, such as Sanofi Pasteur, Novartis and Glaxo Smith Klein are an invaluable asset to our team.  We look forward to his leadership as we work towards the commercialization of psychedelic medicines,” 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. 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.