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Core One Labs to Move Its Psychedelic Formulations for the Treatment of Stroke and Depression Toward Clinical Development

Vancouver, British Columbia, Canada – August 7, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABD), (Frankfurt: LD6, WKN: A3CSSU) (“Core One” or the “Company”) is pleased to announce that the scientific team of its wholly owned subsidiary Akome Biotech Ltd. (“Akome”) has initiated the next step in their clinical development designs for the use of their patent pending psychedelic formulations AKO001 and AKO003, in the treatment of ischemic stroke and depression, respectively.  These studies will further enhance the Company’s knowledge supporting the use of psychedelics as strong candidates in the treatment of these serious neurological and mental health conditions.

As the next step in its clinical development design process, Akome is completing a comprehensive search and rigorous selection process, through which multiple commercial research organizations and academic centers are vetted, to determine a candidate organization to conduct the necessary in vitro and in vivo studies. Once a partner organization is chosen for both the in vivo and in vitro processes, studies can be conducted simultaneously to expedite the process.

Conducting in vitro and in vivo studies are essential in the development of any new pharmaceutical drug treatments. In vitro studies, determine whether a pharmaceutical candidate produces the desired changes on cell cultures and is conducted in test tubes. These studies are usually completed quickly and are designed based on information already presented in the provisional patents that have been filed.  In vivo studies test the pharmaceutical candidate in animals with a similar disease to the disease the pharmaceutical is intended to treat in humans. Once both studies are completed clinical trials on humans can begin.

“We are excited to announce we have started the process of moving forward in the next step of our clinical trials development for our stroke treatment drug formulation and our depression treatment drug formulation. Identifying a partner with experience, and knowledge of the targeted diseases, will allow Core One to efficiently complete well thought out, and detailed studies.” 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.

ON BEHALF OF THE BOARD OF DIRECTORS OF CORE ONE LABS INC.

Joel Shacker

Chief Executive Officer

FOR FURTHER INFORMATION:

Email: info@core1labs.com

Telephone: 1-866-347-5058

FOLLOW US:

Website: https://core1labs.com/

Twitter: https://twitter.com/Coreonelabs

Facebook: https://www.facebook.com/Core-One-Labs-Inc-100969251278277/

LinkedIn: https://www.linkedin.com/company/core-one-labs

Instagram: https://www.instagram.com/coreonelabsinc/

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 ACQUIRES FRONTIER MYCOLOGY

Vancouver, British Columbia, Canada – August 17, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (the “Company” or “Core One”) is a research and development company focused on bringing psychedelic medicines to market through the development and production of API grade psychedelic compounds, the advancement of psychedelic assisted treatments, and the integration of novel delivery system technology.  The Company is pleased to announce it has completed the acquisition (the “Transaction”) of all of the outstanding share capital of Frontier Mycology Corp. (“Frontier”).

Frontier, through its website MushroomNews.Org, is a compilation of the globe’s top mushroom news, providing compelling content, such as news and media coverage, financial analysis and relevant research on both functional and psychedelic mushrooms.   Frontier’s objective is to reduce the stigma towards psychedelic medicines by providing information and transparency on all aspects of the psychedelic industry, and to drive the psychedelics industry into the forefront of modern medicine. In addition to being a trusted information source in the psychedelics’ space, Frontier also embodies a  an e-commerce platform, with a growing selection of legal functional mushroom products.

Joel Shacker, CEO of the Company stated, “This acquisition further expands our presence in the psychedelic space, by allowing us access to potential investors who utilize this website as a tool for keeping up to date on this growing industry. The direct-to-consumer ecommerce platform for functional mushrooms, also allows the company to generate sales to consumers, who can then be converted to different products as the legalization of psychedelics progresses.”

Transaction Structure

The Transaction was completed pursuant to a share purchase agreement among the Company, Frontier and the shareholders of Frontier (the “Definitive Agreement”) dated effective August 16, 2021.  Pursuant to the Definitive Agreement, and in consideration for the acquisition of Frontier, the Company has issued 666,666 common shares and 634,920 share purchase warrants entitling the holders to acquire a further 634,920 common shares of the Company at a price of $6.50 per share until August 17, 2023.

The Company is at arms-length from Frontier 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 applicable securities laws and the policies of the Canadian Securities Exchange.  In connection with completion of the Transaction, the Company has issued 17,964 common shares to certain third-parties who provided administrative services necessary to complete the Transaction.

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 FURTHER INFORMATION:

Email: info@core1labs.com

Telephone: 1-866-347-5058

FOLLOW US:

Website: https://core1labs.com/

Twitter: https://twitter.com/Coreonelabs

Facebook: https://www.facebook.com/Core-One-Labs-Inc-100969251278277/

LinkedIn: https://www.linkedin.com/company/core-one-labs

Instagram: https://www.instagram.com/coreonelabsinc/

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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NeonMind Announces Corporate Update And Strategic Reorganization Of Its Pharmaceutical Division

  • Designed to Accelerate Execution of Integrated Drug Development Plan
    for NEO-001 to Treat Obesity
  • Establishes R&D Advisory Board, Appoints Philippe Martin as Chairman
  • Expands Regulatory Capabilities in Preparation for Proof-of-Concept Study

Vancouver, B.C. – August 5, 2021: NeonMind Biosciences Inc. (CSE: NEON) (OTC: NMDBF) (FFE: 6UF) (“NeonMind” or the “Company”), an integrated drug development and wellness company focused on the potential therapeutic uses of psilocybin for treating obesity and weight management conditions, announced today a strategic reorganization to focus on the execution of the Company’s integrated drug development plan (“IDP”) for its lead drug candidate targeting obesity, NEO-001.

This new structure reorganizes NeonMind’s business operations to focus on its core Pharmaceutical Division, and establishes resources to execute on the Company’s regulatory and clinical operations strategy. This includes the establishment of a Research and Development Advisory Board and the expansion of NeonMind’s regulatory team through the engagement of several key industry professionals. The reorganization will enable NeonMind to successfully execute its IDP by streamlining its corporate structure and leveraging the guidance of regulatory experts.

“These organizational changes will drive the advancement of our lead drug candidate, NEO-001, through the regulatory process,” said Robert Tessarolo, President & CEO of NeonMind. “Combined with our earlier initiatives, including the establishment of our Specialty Clinics Advisory Board, we have brought together an incredible team, all with proven expertise in executing regulatory, clinical, and commercial milestones across leading pharmaceutical organizations. We are excited to prepare NEO-001 for a phase 1/2 study in obese patients as we collaborate with the FDA and Health Canada on IND/CTA submissions.”

Key Appointments to Oversee Core Businesses

As part of the reorganization, Philippe Martin has been appointed Chairman of the Company’s R&D Advisory Board. Mr. Martin was instrumental in building NeonMind’s integrated development plan through the Company’s R&D Working Group. He has 20 years of biotechnology and pharmaceutical industry experience developing and commercializing innovative therapies in the fields of immunology, oncology/hematology, and neurology. Currently, he is the Chief of Development & Operations at Bioalta Inc. overseeing the development of pre-clinical and clinical assets. Previously, at Celgene, Mr. Martin led the development and commercialization of the blockbuster drug Otezla®. Prior to this, while at Schering-Plough, he oversaw the anti-TNF alpha collaboration with Johnson & Johnson and led the REMICADE lifecycle strategy and operations, as well as SIMPONI development, regulatory approvals, and preparation for launch in multiple indications.

In addition, NeonMind has expanded its regulatory team with the hiring of highly experienced regulatory consultants. They bring over 45 years of combined biopharmaceutical industry experience and will provide regulatory guidance and support as the Company prepares for its Proof-of-Concept study.

Related to the reorganization, the Company’s Chief Psychedelics Officer, Trevor Millar, is transitioning to an advisory capacity. Mr. Millar has resigned as Chief Psychedelics Officer and has been engaged by the Company as an advisor, effective August 6, 2021. Additionally, as NeonMind’s focus shifts to navigating the regulatory process, the Company has terminated its consulting agreement with Translational Life Sciences and Dr. William Panenka is leaving the Scientific Advisory Board.

In May 2021, the Company established its Specialty Clinics Advisory Board to guide the planning and operation of NeonMind branded clinics across Canada. To support this endeavor, in July 2021 NeonMind appointed Dr. Sagar Parikh, MD to its Specialty Clinics Advisory Board. In this role, Dr. Parikh will leverage his vast expertise in clinical treatment and interventional psychiatry including effectively treating patients with psychedelics such as ketamine, esketamine, and neurostimulation for mood and anxiety disorders to guide NeonMind as it develops specialty clinic services for communities in need. Dr. Parikh also brings pivotal experience in planning and successfully launching new mental health treatments.

NEO-001, the Company’ lead drug candidate targeting obesity, is a high-dose psilocybin treatment coupled with behavior therapy and lifestyle intervention, which aims to improve the efficacy of chronic weight management in adults. The Company has identified a regulatory strategy, including a target indication and product profile, which it believes will best position NeonMind as it advances its first lead candidate through development.

About NeonMind Biosciences Inc.

NeonMind is engaged in preclinical research to develop potential clinical treatments and wellness products to address obesity and weight management conditions and to promote health and wellness. The Company operates three divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings; and (iii) a consumer products division that currently sells mushroom-infused products to promote health and wellness.

In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind’s lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company’s second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.

NeonMind established a medical services division with the goal of launching NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs.

NeonMind’s consumer division currently sells NeonMind-branded coffee products in the United States and Canada through NeonMind’s direct to consumer e-commerce platform.

For more information on NeonMind, go to www.NeonMindBiosciences.com.

Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.

rob@neonmind.com

Tel: 416-750-3101

 

Investor Relations:

KCSA Strategic Communications

Scott Eckstein/Tim Regan

neonmind@kcsa.com

Tel: 212-896-1210

 

Media Inquiries:

KCSA Strategic Communications
Annie Graf

neonmind@kcsa.com

Tel: 786-390-2644

 

The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind’s future performance. The use of any of the words “could”, “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 NeonMind’s current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind’s drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.

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GREENBROOK TMS REPORTS SECOND QUARTER OPERATIONAL AND FINANCIAL RESULTS

August 5, 2021 – Toronto, Ontario – Greenbrook TMS Inc. (TSX: GTMS, NASDAQ: GBNH) (“Greenbrook” or the “Company”), today announced its second quarter 2021 (“Q2 2021”) operational and financial results. All values in this news release are in United States dollars, unless otherwise stated.

 

SECOND QUARTER 2021 OPERATIONAL AND FINANCIAL HIGHLIGHTS

  • Quarterly revenue increased by 40% to a record high of $13.7 million as compared to the second quarter of 2020 (“Q2 2020”) and by 21% compared to the first quarter of 2021 (“Q1 2021”). Revenue for the six-month period ended June 30, 2021 (“YTD 2021”) increased by 18% to $25.0 million, as compared to the six-month period ended June 30, 2020 (“YTD 2020”).
  • Quarterly treatment volumes increased by 37% to a record high of 58,219 as compared to Q2 2020 and 12% as compared to Q1 2021. New patient starts increased by 36% to a record high of 1,659 as compared to Q2 2020 and by 27% to 3,242 in YTD 2021 as compared to YTD 2020, which points to encouraging growth prospects.
  • A return to entity-wide regional operating profitability with operating income of $0.9 million in Q2 2021 as compared to a loss of $0.2 million in Q2 2020 and a loss of $1.5 million in Q1 2021.
  • Loss for the period and comprehensive loss decreased by 31% in Q2 2021 to $6.7 million as compared to Q2 2020, and increased by 4% to $14.6 million during YTD 2021 as compared to YTD
  • On June 14, 2021, the Company completed a non-brokered private placement of 2,353,347 common shares (“Common Shares”) at an offering price of $10.00 per Common Share for aggregate gross proceeds of approximately $23.5
  • Added three newly active TMS centers (“TMS Centers”) during Q2 2021, with an additional seven TMS Centers in development, bringing the total Company TMS Center network to 129 TMS Centers as at June 30, 2021. We believe our development pipeline remains robust and primed for further
  • Based on the promising findings from the Spravato® (esketamine nasal spray) pilot program, we intend to expand offering Spravato® at an additional 8 TMS Centers, for a total of 13 TMS

 

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

 

“We are proud to announce our highest quarterly consolidated revenue results to date, driven by record quarterly treatment volumes. We also achieved a strong return to entity-wide regional operating profitability and we experienced a record quarterly high in new patient starts, which we anticipate will be a catalyst for future growth. We intend to continue the roll-out of the Spravato® Pilot Program, building on our long- term business strategy of utilizing our network of TMS Centers and affiliated physicians as a service delivery platform for the delivery of innovative treatments to patients suffering from Major Depressive Disorder and other mental health disorders.”

 

SELECTED SECOND QUARTER FINANCIAL AND OPERATING RESULTS (1)

Selected Financial Results

 

 

 

(US$) (unaudited) Q2 2021   Q2 2020   YTD 2021   YTD 2020
Total revenue 13,707,212   9,788,555   25,020,387   21,209,057
Regional operating income (loss) 921,339   (225,198)   (570,779)   514,598
Loss before income taxes (6,738,489)   (9,734,642)   (14,574,655)   (13,975,438)
Loss for the year and comprehensive loss (6,738,489)   (9,734,642)   (14,574,655)   (13,975,438)
Loss attributable to the common shareholders of Greenbrook (6,775,825)   (9,477,505)   (14,402,379)   (13,635,778)
Net loss per share (basic and diluted)(2) (0.48)   (0.76)   (1.04)   (1.13)

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 on the basis of one (1) post- consolidation Common Share for every five (5) pre-consolidation Common Shares. The Share Consolidation was completed on February 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.

 

Selected Operating Results

 

  As at June 30,   As at June 30,   As at December 31,
(unaudited)          
  2021   2020   2020
Number of active TMS Centers(1) 122   113   116
Number of TMS Centers-in-development(2) 7   12   9
Total TMS Centers 129   125   125
Number of management regions 13   13   13
Number of TMS Devices installed 209   189   198
Number of regional personnel 343   275   305
Number of shared-services / corporate personnel(3) 51   44   49
Number of TMS providers(4) 124   112   117
Number of consultations performed(5) 7,124   4,435   11,305
Number of patient starts(5) 3,242   2,544   5,445
Number of treatments performed(5) 110,345   90,551   195,992
Average revenue per treatment(5) $227   $234   $220

Notes:

  • Active TMS Centers represent TMS Centers that have performed billable TMS services during the applicable
  • 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 and six months ended June 30, 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

 

Second 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 August 6, 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: 6948083

The conference call replay will be available beginning at 1:00 p.m. ET on August 6, 2021.

 

About Greenbrook TMS Inc.

 

Operating through 129 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 675,000 TMS treatments to over 19,000 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 September 30, 2020 and

September 30, 2019, and March 31, 2021 and March 31, 2020, 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$) Q2 2021

(unaudited)

   Q2 2020

(unaudited)

   YTD 2021

(unaudited)

   YTD 2020

(unaudited)
Total revenue 13,707,212   9,788,555   25,020,387   21,209,057

 

 

 

 

Direct center and patient care costs 6,854,000   5,166,153   13,214,023   11,047,442
Regional employee compensation 3,068,947   2,323,340   6,055,262   4,849,530
Regional marketing expenses 1,401,295   1,087,698   3,385,916   1,954,800
Depreciation 1,461,631   1,436,562   2,935,965   2,842,687
Total direct center and regional costs 12,785,873   10,013,753   25,591,166   20,694,459
Regional operating income (loss) 921,339   (225,198)   (570,779)   514,598
Center development costs 182,974   140,861   463,407   370,368
Corporate employee compensation 3,670,679   2,398,594   6,557,263   5,022,025
Corporate marketing expenses 181,799   298,237   342,833   603,685
Other corporate, general and administrative expenses  

1,971,005

    

437,342

   3,639,469   1,384,959
Share-based compensation 203,362   175,447   409,332   284,852
Amortization 115,833   115,833   231,666   231,666
Interest expense 1,334,187   694,208   2,362,099   1,352,042
Interest income (11)   (1,078)   (2,193)   (9,561)
Earn-out consideration –   5,250,000   –   5,250,000
Loss before income taxes (6,738,489)   (9,734,642)   (14,574,655)   (13,975,438)
Income tax expense –   –   –   –
Loss for the period and comprehensive loss (6,738,489)   (9,734,642)   (14,574,655)   (13,975,438)
Loss attributable to non-controlling interest 37,336   (257,137)   (172,276)   (339,660)
Loss attributable to the common shareholders of Greenbrook          (6,775,825)            (9,477,505)   (14,402,379)   (13,635,778)
Net loss per share (basic and diluted) (1) (0.48)   (0.76)   (1.04)   (1.13)

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$) Q2 2021   Q1 2021   Q4 2020   Q3 2020   Q2 2020   Q1 2020   Q4 2019   Q3 2019
(unaudited)                              
Revenue 13,707,212   11,313,175   9,913,552   12,006,570   9,788,555   11,420,502   12,536,671   8,459,103
Regional operating income (loss)(1) 921,339   (1,492,118)   (2,050,168)   967,584   (225,198)   739,796   2,056,836   770,813
Net loss attributable to common shareholders of Greenbrook (6,775,825)   (7,626,554)   (8,391,630)   (7,636,132)   (9,477,505)   (4,158,274)   (7,034,356)   (3,431,009)
Adjusted EBITDA (2,705,666)   (4,013,910)   (4,223,446)   (937,073)   (1,665,672)   (1,648,053)   (1,296,201)   (1,033,876)
Net loss per share – Basic(2) (0.48)   (0.56)   (0.60)   (0.57)   (0.76)   (0.39)   (0.62)   (0.31)
Net loss per share – Diluted(2) (0.48)   (0.56)   (0.60)   (0.57)   (0.76)   (0.39)   (0.62)   (0.31)

 

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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Core One Labs’ Virtual Town Hall Reveals Company is Nearing Production of Biosynthesized Psilocybin: Breakthrough In the Psychedelic Space Expected Upon Successful Completion

Vancouver, British Columbia, Canada – August 4, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABD), (Frankfurt: LD6, WKN: A3CSSU) (the “Company” or “Core One”) is a research and development company focused on bringing psychedelic medicines to market through the development and production of API grade psychedelic compounds, the advancement of psychedelic assisted treatments, and the integration of novel delivery system technology.  The Company is excited to announce information regarding the status and timing of its breakthrough psilocybin technology that was presented by Dr. Robert E.W. Hancock, Executive Chairman during its August 4, 2021, Virtual Town Hal.

Patent is Ready

“We already have a patent written, we could file it today, but we are holding on filing the patent until we have worked through all of the possible tweaks to the technology, that a competitor could use to replicate it…. There is huge value to maintain this technology as proprietary,” stated Dr. Hancock. “At this stage I estimate we will be ready to file the patent within a month or so, and to make deeper announcements about the technology in the month following that.”

With real opportunity for substantial profitability, Core One is doing everything they can to ensure that their technology is well protected.

Potential Profitability

“Currently psilocybin is [very] expensive [when produced chemically or from mushrooms]…. We have estimated we can produce it for considerably less,” stated Dr. Hancock. This takes into account input material, equipment costs, labour and clean up, and it positions Core One Labs to produce the lowest cost psilocybin on the market.

Biosynthetic Production

Core One Labs’ proprietary production method will reshape the way the industry produces psilocybin. “The [general] method we use for production and extraction of psilocybin is tried and true. The production method itself, which is a sub section of production technology called ‘recombinant’ production technology, is utilized for really common substances such as when making insulin, human growth hormones, or amino acids,” stated Dr. Hancock.

Strategic Partnership

Core One has collaborated with one of the world’s top institutions to expedite its research, and further the development of its technology. “The University of British Colombia is one of the top 30 universities in the world … The collaboration with UBC allows us to access all of the tremendous equipment infrastructure and tremendous minds,” stated Dr. Hancock.

Dr Robert E.W. Hancock provided significant updates on Core One’s operations and we encourage you to watch a recording of the Virtual Town Hall presentation on our website at www.core1labs.com, The video recording of the event will be available for viewing within 24hrs from the conclusion of the live event.

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’S DR. ROBERT E.W. HANCOCK TO HOST VIRTUAL TOWNHALL WEBCAST AND PRESENT ON PROPRIETARY BIOSYNTHESIZED PSILOCYBIN WEDNESDAY, AUGUST 4, 2021

Vancouver, British Columbia, Canada – July 30, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABD), (Frankfurt: LD6, WKN: A3CSSU) (“Core One” or the “Company”) is pleased to announce that Dr. Robert E.W. Hancock, the Company’s Chairman, and CEO of its wholly owned subsidiary Vocan Biotechnologies Inc. will be presenting at the Company’s Virtual Town Hall webcast on Wednesday, August 4, 2021 at 1:30 p.m. PST/4:30 p.m. ET/22:30 p.m. CET.

Dr. Hancock will be providing a presentation on the Company’s proprietary biosynthesized psilocybin, its collaboration with the University of British Columbia, and the patenting process of its intellectual property. Dr. Hancock will also be addressing questions received from investors at this live event.

REGISTER FOR THE LIVE EVENT HERE: REGISTER CORE ONE WEBCAST.

CALL INTO THE LIVE EVENT AT:

North America Toll-free: 1-877‑876‑9173,
International Direct Dial Toll Number: +1-785‑424‑1667

A video recording of the webcast presentation will also be posted on the Company’s website approximately 2 hours following the live event.

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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BRAXIA SCIENTIFIC PROVIDES CORPORATE UPDATE AND REPORTS FISCAL FOURTH QUARTER AND FULL-YEAR 2021 FINANCIAL RESULTS

TORONTO, ONTARIO July 30, 2021 – Braxia Scientific Corp. (“Braxia”, or the “Company”), (CSE: BRAX) (OTC: BRAXF) (FWB: 496), today announced the filing of its fiscal fourth-quarter and year-end results for the three- and 12-month periods ending March 31, 2021. Complete financial statements along with related management discussion and analysis can be found in the System for Electronic Document Analysis and Retrieval (SEDAR), the electronic filing system for the disclosure documents of issuers across Canada at www.SEDAR.com.

Through its global leading researchers and experienced implementation team, Braxia Scientific has established its presence in the mental health industry. Braxia Scientific successfully expanded its network of multidisciplinary clinics to four in 2021, with one of very few private clinics approved in Canada to provide innovative intravenous (IV) Ketamine treatments to people with depression and other mental health disorders.

Braxia Scientific is also advancing its research activities related to Ketamine, Esketamine and Psychedelic clinical and real-world evidence trials, and developing novel drugs and IP-capable delivery methods.

“Braxia Scientific has a very strong and very qualified team that is focused on the research, development, and implementation (RD&I) of new treatments and delivery systems to combat depression and other brain-based disorders,” said Dr. McIntyre. “We are prioritizing the expansion of our clinics in North America and the development of ketamine derivatives and IP-capable delivery systems in order to create value for shareholders through this RD&I approach, while building upon a strong foundation with good corporate governance at its core.”

Recent Operational Highlights

Establishing a Clinical and Research and Development Foothold in Ketamine Assisted Therapy

Executing on Clinic Expansion: Braxia Scientific has established a solid foothold in Canada with its owned Ketamine-focused treatment centres. Braxia Scientific operates four multidisciplinary, community-based clinics offering rapid-acting treatments to address the unmet need for accessible, high-quality, advanced mental health services and treatments for depression, suicide, and other mental health disorders.

In conjunction with its joint venture partner, Neurotherapy Montreal, Braxia Scientific opened its latest clinic in Montreal, Quebec, in a state-of-the-art facility, under its wholly owned subsidiary, the Canadian Rapid Treatment Center of Excellence Inc. (“CRTCE”), operating as Braxia Health. Braxia Health is the first to offer novel Ketamine therapy, including intravenous therapy, to patients in a private clinical setting in Quebec.

Securing Patient Payor Funding: In support of its current and future patients, Braxia Scientific successfully established direct billing practices with a health insurance provider for qualifying members of the Canadian military veterans allowing for 100% coverage of oral, nasal spray and IV ketamine treatments, plus travel costs, delivered at the CRTCE. This support will allow Veterans Affairs Canada clients, who numbered 187,100 in 2019-20, to receive fully funded treatment without any concern over out-of-pocket expenses.

Funded Clinical Trials, Leading Research and Development: Supported by its growing network of clinics, Braxia Scientific’s world-leading scientific research team is advancing multiple research and development studies and conducting clinical trials with IV Ketamine, Ketamine derivatives and other psychedelic drugs.

In June 2021, the Company announced that Chief Medical and Scientific Officer Dr. Joshua Rosenblat, will initiate a first-of-its-kind ketamine clinical trial to treat bipolar depression. The fully funded study represents the largest registered trial of its kind in the world, and will investigate the use, safety and efficacy of repeated doses of IV ketamine in patients with bipolar depression. This trial will enable Braxia-led research teams to further advance studies of IV ketamine to support its approval as a safe, effective and rapid-acting alternative treatment for patients with bipolar depression.

Additionally, in July 2021, Dr. McIntyre and Dr. Rosenblat became Principal and Co-Principal Investigators on a grant totalling $918,000 to evaluate the effectiveness of IV ketamine, in combination with internet-based cognitive behavioural therapy (iCBT), to rapidly reduce suicidality in persons with depression, when compared to iCBT alone.

Braxia Scientific Researchers Leading Innovation and Education

The Company was pleased to announce the publication of the International Expert Opinion and Implementation Guidance (the “Guidelines”) for the clinical use of rapid-acting Ketamine and Esketamine for treatment-resistant depression (TRD) in the American Journal of Psychiatry. The Guidelines were developed by Dr. McIntyre and Dr. Rosenblat, along with an international group of 26 medical experts across five continents, establishing Braxia Scientific as an international leader in the rapidly evolving industry of Ketamine, Esketamine and rapid-acting antidepressants.

The Company also launched the Braxia Institute, a training centre focused on advancing psychiatric clinical practice and health services of ketamine and psychedelic treatment therapy for people with treatment-resistant depression and other possible mental health disorders. Through its research-backed training programs, the Braxia Institute is focused on advancing the knowledge base of psychiatrists, physicians and other health-care professionals globally, closing the extraordinary gap between clinical practice groups around the world and the protocols, competencies and best practices identified through peer-reviewed published research.

The Braxia Institute opened enrollment to develop, train, and support a new generation of qualified, independent medical physicians, psychologists, and psychotherapists to implement safe and effective psilocybin-assisted therapy for patients with depression. The therapists will participate in the provision of psychotherapy in upcoming clinical trials at Braxia Health clinics, evaluating the safety and efficacy of psilocybin in treating depression. The Company anticipates that, pending regulatory approval of psilocybin, therapists would also be trained to implement psychedelics in clinical practice.

Strengthened Management, Research and Development Team

Braxia Scientific continued to strengthen its management team. The Company added to its senior leadership team, appointing Stephen R. Brooks as Chief Financial Officer and Peter Rizakos as General Counsel, each bringing extensive business knowledge and expertise.

Additionally, Dr. Rosenblat was appointed Chief Medical and Scientific Officer, overseeing and providing direct clinical patient care. Dr. Rosenblat also oversees several research projects related to the Company’s growing understanding of the optimal use of novel rapid-acting treatments, such as ketamine, esketamine, psilocybin and other novel interventions. He has personally treated hundreds of patients with ketamine and has extensive direct clinical and research experience in this area. Dr. Rosenblat is a staff psychiatrist and clinician-scientist at the Mood Disorders Psychopharmacology Unit at Toronto Western Hospital, an assistant professor at the University of Toronto and a co-founder and research director of 1907 Research. His clinical focus is treatment-resistant unipolar and bipolar depression. He has authored and co-authored more than 130 journal articles and textbook chapters in prestigious journals, such as the New England Journal of Medicine, JAMA Psychiatry, the American Journal of Psychiatry and the Journal of Clinical Psychiatry. He has received numerous local, national and international grants and awards for his research in mood disorders.

The Company strengthened its Board of Directors with the appointment of two new independent directors, Olga Cwiek and Dr. David Greenberg. An experienced and effective practitioner of good governance, Ms. Cwiek served for more than a decade as a board member of Homewood, which included subsidiary Homewood Health Centre, an internationally recognized provider of mental health care.

Dr. Greenberg is a nationally recognized general medical practitioner with more than 30 years of experience in medicine. He also brings experience in treating mental health and concussions. He has developed and implemented multiple education programs for medical practitioners. Dr. Greenberg is recognized as an expert panel member for the ECHO Concussion Program (ECHO) at the University Health Network, an interactive medical education program with more than 330 hubs in 37 countries, connecting health-care providers with an interprofessional specialist team to advance learning and enhance clinical skills in the area of concussions and related conditions.

Fourth Quarter and 2021 Financial Summary

The Company’s total assets as of March 31, 2021, were $18.5 million, including $11.1 million in cash.

The Company recorded revenues of $1,008,372 and a gross margin of $145,666 for the year ended March 31, 2021. The Company recorded revenues of $346,989 and a gross margin of $60,028 for the three-month period ended March 31, 2021. As a percentage of total revenue, gross margin was approximately 14.4% and 17.3% for the year and three months ended March 31, 2021, respectively. Revenues consisted primarily of sales revenue from the administering of ketamine infusion treatments at the CRTCE clinics.

Net and comprehensive losses for the year and three months ended March 31, 2021 were $88,828,146 and $2,594,726, respectively. The bulk of the annual period loss relates to the previously reported non-cash listing expense of $77,793,883 incurred on the acquisition of Altmed Capital Corp. The main cash components contributing to the annual period loss were advertising and promotion fees of $1,847,510, consulting fees of $1,378,608, office fees of $496,978, and research and development expenses of $1,978,850. The main cash components contributing to the three-month loss were advertising and promotion fees of $623,914, consulting fees of $153,797, office fees of $195,919, research and development expenses of $426,981, and website development fees of $60,879.

Looking Ahead

Braxia Scientific expects to add to its clinic footprint in 2021 and continue carrying out several clinical trials, the majority of which will be funded by third parties. The Company remains steadfastly focused on addressing the public health imperative to identify scalable strategies for reducing depression and other brain-based disorders to improve the health and well-being of Canadians and people around the world.

“Braxia Scientific has achieved significant milestones to date, and we are picking up the pace,” noted CEO Dr. Roger McIntyre. “We will continue to leverage our leading clinical position and our team’s long and successful track record in R&D to engage large pharmaceutical companies and advance the development and eventual distribution of Braxia products.”

About Braxia Scientific Corp.

Braxia Scientific is a medical research company with clinics that provide innovative ketamine treatments for persons with depression and related disorders. Through its medical solutions, Braxia aims to reduce the illness burden of brain-based mental disorders such as major depressive disorder among others. Braxia is primarily focused on (i) owning and operating multidisciplinary clinics, providing treatment for mental health disorders, and (ii) research activities related to discovering and commercializing novel drugs and delivery methods. Braxia develops ketamine and psilocybin derivatives and other psychedelic products from its IP development platform. Through its wholly owned subsidiary, the Canadian Rapid Treatment Center of Excellence Inc., Braxia currently operates multidisciplinary community-based clinics offering rapid-acting treatments for depression located in Mississauga, Toronto, Ottawa, and Montreal.

ON BEHALF OF THE BOARD
“Dr. Roger S. McIntyre”
Dr. Roger S. McIntyre
Chairman & CEO

FOR FURTHER INFORMATION PLEASE CONTACT:
Braxia Scientific Corp.
Tel: 416-762-2138
Email: info@braxiascientific.com
Website: www.braxiascientific.com

The CSE has not reviewed and does not accept responsibility for the accuracy or adequacy of this release.

Forward-looking Information Cautionary Statement

This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations, or beliefs of future performance are “forward-looking statements.”

Forward-looking statements include statements about the intended promise of ketamine-based treatments for depression and the potential for ketamine to treat other emerging psychiatric disorders, such as Bipolar Depression. Such forward- looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events, or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the failure of ketamine, psilocybin and other psychedelics to provide the expected health benefits and unanticipated side effects, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licenses and engaging in activities that could be later determined to be illegal under domestic or international laws. Psilocybin is currently a Schedule III controlled substance under the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (the “CDSA”) and it is a criminal offence to possess such substance under the CDSA without a prescription or a legal exemption. Health Canada has not approved psilocybin as a drug for any indication. These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements.

Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators, including the Amended and Restated Listing Statement dated April 15, 2021, which are available at www.sedar.com. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements.

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Numinus Wellness Closes Q3 2021 With $63.2 Million Cash Position, Lab and Trial Advances, and Strategic Expansion into Psychedelic Neurology

VANCOUVER, BC, July 29, 2021 – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSXV: NUMI), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its fiscal third quarter results ended May 31, 2021.

In the third quarter, Numinus maintained a healthy cash position, achieved key milestones in its lab and proprietary portfolio, expanded the clinic network, and continued to advance its basic and clinical research.

All financial results are reported in Canadian dollars unless otherwise stated.

Q3 2021 Highlights:

  • Cash balance of $63.2 million as at May 31, 2021.
  • Completed $40.3 million bought deal financing and exercised $1.6 million in warrants and options.
  • Generated revenues of $562,076 and $1,022,771 for the three and nine months, respectively, ended May 31, 2021, compared to $216,244 and $610,148 for the same periods, respectively, ended May 31, 2020, for a total year-over-year increase of 160% and 68%, respectively.
  • Received amendments to the Health Canada licence under Numinus Bioscience, including the addition of Ketamine and LSD to the list of permitted research substances (alongside DMT, MDMA, Mescaline, Psilocin, Psilocybin) and expanded ability to produce finished products for research and supply of other groups. These changes expand the lab’s capabilities and position as an industry manufacturer and supplier.
  • Announced 7,500 square foot expansion of Numinus Bioscience’s research laboratory.
  • Announced a Phase 1 clinical trial to assess the safety and efficacy of a Psilocybe extract developed at Numinus Bioscience.
  • Announced key milestones in the compassionate access trial of psilocybin-assisted psychotherapy for substance use disorders.
  • Made key leadership hires in business development and strategy, clinic operations, communications and marketing, experience design, lab operations and M&A to support growth and innovation.

Highlights Subsequent to Quarter End:

  • Announced acquisition of the Neurology Center of Toronto (NCT) for a total of $1.1 million, allowing for the planned expansion of NCT into a comprehensive neurologic care centre specialized in psychedelic neurology.
  • Filed a provisional patent application with the United States Patent and Trademark Office (USPTO) for a rapid production process containing psychoactive compounds, with the first proprietary extract from Psilocybe cubensis containing psilocybin, other indole alkaloids and additional beneficial compounds.
  • Received Health Canada approval for the compassionate access trial of MDMA-assisted therapy in collaboration with the Multidisciplinary Association for Psychedelic Studies (MAPS).
  • Uplisted to Tier 1 of the TSX Venture Exchange.

Commentary and Outlook

“Q3 underscores that Numinus is well into its next phase of rapid growth. Continuing the strong performance seen in Q2, we’ve maintained a healthy cash balance while making key investments in our human and technical infrastructure that provide a strong foundation for the significant advances seen across our lab and clinics,” said Payton Nyquvest, Numinus Founder and CEO. “Numinus Bioscience is demonstrating its leadership in scientific discovery grounded in accessibility, while Numinus Health continues to advance on robust clinic expansion and service delivery targets.We are prepared to sustain this growth trajectory over the coming quarter, and we are grateful to all of our clients, investors, partners and allies for supporting our mission to bring healing and wellness to all.”

“We are proud of our third quarter results that saw a steady increase in revenue from our clinic operations,” said John Fong, Numinus CFO. “As we expand our clinic network and lab activities, we look forward to seeing further revenue growth and operational efficiency across our business units.”

Selected Consolidated Financial Results

For the three months ended May 31, For the nine months ended May 31,
2021 2020 2021 2020
Revenue $562,076 $216,244 $1,022,771 $610,148
Cost of revenue (577,573) (140,650) (1,136,127) (363,879)
(15,497) 75,594 (113,356) 246,269
Operating expenses (4,779,580) (1,231,210) (10,860,168) (4,323,959)
Loss before other items (4,795,077) (1,155,616) (10,973,524) (4,077,690)
Other items (29,347) (2,179,306) (17,509) (2,230,190)
Loss before income tax (4,824,424) (3,334,922) (10,991,033) (6,307,880)
Income tax – 6,187 – (53)
Loss and comprehensive loss $(4,824,424) $(3,328,735) $(10,991,033) $(6,307,933)

 

Numinus’ condensed consolidated interim financial statements for the period ended May 31, 2021 and related management’s discussion and analysis are available on Numinus’ website at www.numinuswellness.com  and under the Company’s profile on SEDAR at www.sedar.com.

###

About Numinus

Numinus Wellness (TSX-V: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

Learn more at www.numinuswellness.com and follow us on LinkedIn, Facebook, Twitter, and Instagram.

Forward-looking statements

This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are “forward-looking statements”. Forward-looking statements can be identified by the use of words such as “expects”, “does not expect”, “is expected”, “believes”, “intends”, “anticipates”, “does not anticipate”, “believes” or variations of these words, expressions or statements, that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company’s facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company’s limited operating and profitability track record; dependence on management; the Company’s need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company’s efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws. 

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.

For further information:

John Fong

Chief Financial Officer and Corporate Secretary

Numinus

invest@numinus.ca

May Lee

Communications Manager

Numinus

may@numinus.ca

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Mydecine to Participate in Upcoming Investor Events in August 2021

DENVER, July 28, 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 two upcoming investor events in August 2021:

  • BTIG Biotechnology Conference to be held virtually on August 9-10, 2021. Mr. Bartch will present on Tuesday, August 10th at 3:00 p.m. ET.
  • Canaccord Genuity’s 41st Annual Growth Conference to be held virtually on August 10-12, 2021. Mr. Bartch will present on Tuesday, August 10th at 10:00 a.m. ET.

For more information about the conferences, or to schedule a one-on-one meeting with Mydecine management, please contact your appropriate BTIG or Canaccord representative directly, or send an email to 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.

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

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

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’ AKOME SEEKS TO REVOLUTIONIZE TREATMENT OF PARKINSON’S DISEASE AND SUBMITS APPLICATION TO PROTECT IP

Vancouver, British Columbia, Canada – July 26, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABD), (Frankfurt: LD6, WKN: A3CSSU) (the “Company”) is pleased to announce that its wholly owned subsidiary Akome Biotech Ltd. (“Akome”) has commenced the development of another breakthrough psychedelic drug formulation, and confirms the filing of another provisional patent application with the United States Patent and Trademark Office (USPTO) under application number 63147338, for the protection of its intellectual property designed to address Parkinson’s Disease, also known as AKO004.

Akome’s AKO004 psychedelic drug formulation, for use in the treatment of Parkinson’s disease, is a composition comprising the psychedelic compound N,N-dimethyltryptamine (DMT) and, a specifically chosen, naturally occurring plant bioactive.  Initial data analysis indicates that the AKO004 composition is safe and efficacious for use, and presents many positive properties which may counter or mitigate neurodegeneration including, anti-oxidant activity (through downregulation of adhesion molecules), oxidative stress suppression (through direct free radical scavenging), and upregulation of intracellular antioxidant defenses (e.g. enhancing glutathione levels).  Additionally initial data mapping also suggests that the compound may play a neuroprotective role in the brain, generally.

Parkinson’s disease is a progressive neurodegenerative disorder that is caused by degeneration of the nerve cells in the part of the brain called the substantia nigra, which controls movement.  Neurodegeneration occurs when nerve cells in the brain or peripheral nervous system lose function over time and ultimately die.  [1]It is estimated that over 10 million people worldwide are living with Parkinson’s disease.  Within the United States it is further estimated that over 930,000 people live with Parkinson’s disease and approximately 60,000 more are diagnosed each year. An even more staggering statistic is that this number is predicted to rise to 1.2 million by 2030.

Although treatments may help relieve some of the physical or mental symptoms associated with neurodegenerative diseases, there is currently no way to slow disease progression and no know cures.

“Cellular reprogramming has been very progressive over the last decade.  Akome’s AKO0004 drug formulation presents strong indication as a viable candidate for the treatment of Parkinson’s disease,” 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.

ON BEHALF OF THE BOARD OF DIRECTORS OF CORE ONE LABS INC.

Joel Shacker

Chief Executive Officer

FOR FURTHER INFORMATION:

Email: info@core1labs.com

Telephone: 1-866-347-5058

FOLLOW US:

Website: https://core1labs.com/

Twitter: https://twitter.com/Coreonelabs

Facebook: https://www.facebook.com/Core-One-Labs-Inc-100969251278277/

LinkedIn: https://www.linkedin.com/company/core-one-labs

Instagram: https://www.instagram.com/coreonelabsinc/

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.

[1] https://www.parkinson.org/Understanding-Parkinsons/Statistics