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PsyBio Therapeutics Sponsors 16 Collaborative Research Abstract Presentations at Two Scientific Conferences

PsyBio Therapeutics Sponsors 16 Collaborative Research Abstract Presentations at Two Scientific Conferences

OXFORD, Ohio and COCONUT CREEK, Fla. , Dec. 2, 2021 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (” PsyBio ” or the ” Company “), an intellectual property driven biotechnology company focused on discovery and development of novel, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health, today announced, as a result of its sponsored research agreements, sixteen abstracts were submitted for review, accepted through a peer-reviewed process and presented at two scientific conferences as part of its ongoing commitment to share relevant scientific progress and intellectual property portfolio development.

“These recent scientific presentations serve to further expand our contribution to improve mental and neurological health and demonstrates PsyBio’s commitment to being a leader in developing psycho-targeted therapeutic candidates,” stated Evan Levine , PsyBio’s Chief Executive Officer. “Our approach towards collaborative research remains a critical part of our goal.”

These sixteen abstracts cover a wide variety of topics including: biosynthetic pathway and transcriptional methodologic development; evaluation; screening and optimization of systems and organisms; increasing bioproduction yields of natural and non-natural products, as well as the evaluation of impulsivity, motivational, psychiatric, and psychoactive effects of PsyBio’s portfolio of compounds.

“PsyBio remains committed to advancing scientific knowledge and dissemination of results while ensuring intellectual property protection,” stated Michael Spigarelli , MD, PhD, MBA, PsyBio’s Chief Medical Officer. “We are proud of the joint efforts between PsyBio and our sponsored research collaborators that made the sixteen presentations from process development, through biosynthesis and to neurobehavioral testing possible. We will continue to collect data and advance the clinical and scientific knowledge base to be able to help improve mental and neurological health.”

About PsyBio Therapeutics Corp.

PsyBio is an intellectual property driven biotechnology company focusing on discovering and developing new, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psychoactive compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (” forward-looking information “) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the ability of PsyBio to launch clinical trials; the ability of PsyBio to build and protect its intellectual property portfolio of novel drug candidates; the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application; the ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will file one or more IND Applications with the United States Food and Drug Administration (” FDA “); PsyBio will be successful in obtaining all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favourable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The FDA or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSX Venture Exchange (the ” TSXV “) has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

Cision View original content: http://www.newswire.ca/en/releases/archive/December2021/02/c4851.html

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Bright Minds Biosciences Provides Scientific Update on its Novel 5-HT2A Psychedelic Program for the Treatment of Mental Diseases

Bright Minds Biosciences Provides Scientific Update on its Novel 5-HT2A Psychedelic Program for the Treatment of Mental Diseases

Bright Minds Biosciences (DRUG) announced that its drug discovery program has synthesized hundreds of patentable psychedelic compounds. Researchers are optimizing the most encouraging molecules and aim to announce the lead molecule early next year.

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Revitalist Signs its 8th Clinic Lease in Bethesda, Maryland

Revitalist Signs its 8th Clinic Lease in Bethesda, Maryland

VANCOUVER, British Columbia–(BUSINESS WIRE)–REVITALIST LIFESTYLE AND WELLNESS LTD. (“Revitalist” or the “Company”) (CSE: CALM) (OTC: RVLWF) (FSE: 4DO) is pleased to formally announce it has signed a lease for its 8th psychedelic assisted psychotherapy (“PAP”) clinic located at 4833 Rugby Avenue, Suite 600, Bethesda, Maryland, 20814.

Located in the same state as prestigious Johns Hopkins University, the Bethesda location will offer 6,092 square feet of space and 10 infusion rooms. The Bethesda clinic is expected to open by December 31, 2021 and offer Revitalist’s full suite of treatments including IV ketamine infusions, vitamin infusions, medication infusions, intensive outpatient programs, ketamine assisted psychotherapy, Spravato, telemedicine therapy sessions and transcranial magnetic stimulation. With 10 treatment rooms, the clinic can provide over 10,400 ketamine infusions to patients annually.

The addition of the Bethesda lease marks the eighth clinic which will increase the total capacity at Revitalist to 53,792 square feet and 109 treatment rooms as detailed below.

LocationOpening DateSize (Sq Ft)Clinic Capacity for Treatment Rooms (1)
Knoxville, TennesseeFeb-185,38012
Johnson City, TennesseeMay-2111,00022
Chattanooga, TennesseeMay-219,99520
Louisville, KentuckyJun-217,52014
Raleigh, North CarolinaSep-216,54014
Knoxville, Tennessee (2nd location)Nov-213,5007
Novi, MichiganNov-213,76510
Bethesda, MarylandQ4 20216,09210
Total53,792109

1 Estimated based on square footage available in each clinic

Kathryn Walker, CEO, commented, “Maryland is home to a number of important medical, military and research institutions, so gaining a presence in this jurisdiction was an important step in our expansion plan. We look forward to opening the Bethesda location soon and growing our offering of clinics to prospective patients in the United States. Mental health continues to be a national health crisis as rates of anxiety, depression and PTSD keep climbing. Revitalist’s treatments provide important relief and offer hope to those struggling with these illnesses.”

ABOUT REVITALIST LIFESTYLE AND WELLNESS LTD.

Revitalist Lifestyle and Wellness Ltd. (CSE: CALM) (OTC: RVLWF) (FSE: 4DO) is a publicly traded company, headquartered in Knoxville, Tennessee, with seven clinics operating across the United States and expanding. Revitalist is dedicated to empowering individuals toward an improved quality of well-being through a combination of comprehensive care and future-centric treatments provided by medical professionals, mental health experts, and chronic pain specialists. Since opening their first clinic in 2018, Revitalist has provided thousands of infusions for patients suffering from treatment-resistant conditions. Additionally, Revitalist offers a number of lifestyle optimization services and vitamin infusions that can bring anyone closer to total wellness. For additional information and to be added to the Company’s mailing list, please click here.

Twitter: @RevitalistCorp
Facebook: @RevitalistLifestyleandWellnessLtd.
Instagram: @RevitalistCorp
LinkedIn: @RevitalistLifestyleAndWellnessLtd

Forward Looking Statements

This news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “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” or “will” be taken, occur or be achieved. Forward looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Revitalist to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release.

Risks, uncertainties, and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Contacts

On Behalf of the Board
Kathryn Walker
Chief Executive Officer

For further information please contact:
Revitalist Lifestyle and Wellness Ltd.
Email: IR@revitalist.com
Tel: (865) 585-8414

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Braxia Scientific Reports Second Quarter 2022 Financial Results and Provides Corporate Update

Braxia Scientific Reports Second Quarter 2022 Financial Results and Provides Corporate Update

  • Expanded clinical infrastructure to support a growing portfolio of clinical trials of novel interventions and for drug discovery; 14 registered clinical trials in depression, led by Company CEO and Chief Medical and Scientific Officer, completed or in process
  • Excellent progress on only psilocybin trial in Canada actively recruiting study participants to receive psilocybin-assisted therapy
  • Clinical footprint in Canada has administered ~4,900 ketamine treatments to date; focus on expansion opportunities in the U.S. and Europe

 

TORONTO, ONTARIO Nov. 29, 2021 – Braxia Scientific Corp. (“Braxia Scientific”, or the “Company”), (CSE: BRAX) (OTC: BRAXF) (FWB: 496), a medical research company with clinics providing innovative ketamine treatments for persons with depression and related disorders, today announced the filing of its fiscal second-quarter results for the three-month period ending September 30, 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.

“We have made tremendous progress on our strategic priorities, including increasing access to novel treatments for patients with depression through our clinics. We have also established a clinical research infrastructure required to execute on our growing pipeline of registered clinical trials alongside third-party sponsors, with 14 trials registered to date in the area of depression, including Canada’s first and only psilocybin trial actively recruiting study participants to receive psilocybin-assisted therapy,” said Dr. Roger McIntyre, CEO, Braxia Scientific.

“Looking ahead to our clinical research and development, our psilocybin trial is underway with newly trained therapists. These therapists have the required skills to execute a successful psilocybin-assisted therapy trial while ensuring patients receive treatments according to approved protocols and best practices – critical milestones that will create near-term value for Braxia Scientific in terms of patient access, drug development and implementation. While our product development pipeline is at an early stage, we have made progress in our goal to develop new ketamine derivatives and delivery formats underpinned by our large proprietary health database from administering ~4,900 ketamine treatments to date at our clinics.” 

“We continue to prioritize the expansion of our clinical footprint in Canada. We remain disciplined in our growth efforts and continue to actively assess a strong pipeline of opportunities to scale access to ketamine treatments for patients in North America.”

Recent Operational Highlights and Corporate Update

Established Clinical Infrastructure to Advance Research and Drug Development and Provide Patient Access to Ketamine, Psilocybin and other Potential Psychedelics in Future

 

Building on management’s extensive clinical expertise, the Company has expanded the necessary infrastructure to provide novel interventions that include ketamine, psilocybin and other potential future psychedelics that become available.

More specifically, the Company infrastructure has:

  • Established access to a high-quality source of psilocybin that meets all regulatory requirements for human use in clinical research
  • Received over 100 referrals for psilocybin-assisted therapy at our clinic in the first six weeks of opening patient recruitment approved protocols to collect treatment outcome data to allow for further optimization of treatment protocols and development of best practice guidelines
  • Established well-trained medical and research staff to assess patients for psilocybin suitability. This includes twenty (20) therapists licensed to practice in Ontario with specialized training in psilocybin-assisted therapy
  • Built physical space to safely provide psilocybin treatment with a comfortable living room-like environment with appropriate medical and psychological monitoring and evidence-based protocols

 

This infrastructure enables Braxia Scientific to provide psilocybin-assisted therapy as part of the current clinical trial, and importantly, if psilocybin is approved in the future, Braxia Scientific is positioned to provide access to psilocybin-assisted therapy treatment for eligible patients immediately.

Fourteen (14) Clinical Trials Including Landmark Multi-Dose Psilocybin Study: Dr. Joshua Rosenblat, Chief Medical and Scientific Officer for Braxia Scientific, recently commenced a landmark clinical trial to conduct Canada’s first multiple-dose controlled psilocybin study for treatment-resistant depression (TRD). Through this trial, patients will be able to receive immediate access to psilocybin and be monitored by therapists with specialized training in psilocybin-assisted therapy. Whereas most other TRD studies limit participation to patients that have not found relief from a maximum of five other potential remedies, this trial does not impose an upper limit, and allows for patients that have endured dozens of unsuccessful medical treatments, including with ketamine and electroconvulsive therapy.

Developing the Next Generation of Clinicians: The Braxia Institute, the Company’s training centre focused on advancing psychiatric clinical practice and health services of ketamine and psychedelic treatment therapy, is set to graduate the first cohort of medical professionals from its psilocybin-assisted therapy training program. This multidisciplinary group of 20 therapists from diverse psychiatry and psychotherapy backgrounds experienced and learned, through pre-readings, didactic teaching, peer teaching, group discussion and simulations, which provided important background on the use of psilocybin for treating depression and practical considerations for providing psilocybin-assisted psychotherapy. All the enrolled therapists are also required to complete a practicum component, in which medical professionals gain experience in administering psilocybin-assisted therapy for participants with depression as part of an upcoming Health Canada-approved clinical trial.

The Company anticipates that, subject to the regulatory approval of psilocybin, therapists would also be trained to implement psychedelics in clinical practice.

Growing Proprietary Ketamine Research Database: As the Company continues to focus on developing novel ketamine derivatives, Braxia Scientific’s team of researchers also continue to carry out multiple research trials adding to the Company’s large database of proprietary data critical to future drug development efforts.

The Canadian Rapid Treatment Centre of Excellence (CRTCE), a wholly owned Braxia subsidiary, has comprehensive health data from administering approximately 4,900 ketamine treatments at CRTCE clinics. Braxia Scientific’s researchers have published 39 ketamine-related manuscripts in peer-reviewed biomedical journals.

During the quarter, the Company reported encouraging preliminary findings of an important ketamine clinical study that suggest ketamine may be as effective as a standalone antidepressant, versus as an adjunctive therapy. The study, which was conducted at the CRTCE, showed comparable clinical benefits (e.g., antidepressant effects and reduction in suicidal thoughts) in a sample of 220 patients with treatment-resistant depression (TRD) who received intravenous (IV) ketamine infusions as a monotherapy, as compared with those receiving IV ketamine in addition to oral antidepressants.

Following the study protocols, participants in the ketamine monotherapy group achieved response and remission rates of 39.1% and 17.4%, respectively. Meanwhile, those receiving ketamine treatment adjunct to antidepressants, saw corresponding rates of 21.9% and 6.7%.

These initial findings support ketamine’s effectiveness as a rapid-acting antidepressant treatment approach as evidenced by its ability to improve depression as a monotherapy, and the data is particularly important, because it shows that the benefits of ketamine may not be dependent on the co-prescription of other medications.

Publishing timely studies: Braxia Scientific was pleased to announce the publication of a new analysis led by the Company’s CEO, Dr. Roger McIntyre, in the Journal of the Royal Society of Medicine. The study, which showed a decrease in the Canadian suicide mortality rate during the first year of the COVID-19 pandemic, was initiated to evaluate the impact on national suicide rates in Canada of federal, public health and social support programs that were put in place to mitigate the coinciding abrupt changes to social and financial provisions. The findings also underscore Braxia Scientific’s core objective to develop derivatives of ketamine and other psychedelics as additional measures to further reduce suicidality.

Growing Canadian Patient Treatments: To accommodate increasing demand for ketamine treatments, the Company expects to commence expansion of its existing clinics in Toronto and Ottawa in the coming months, as well as ramp up personnel at its existing clinics. Through its four multidisciplinary, community-based Canadian clinics, the Company continues to see increased patient referrals and treatments which led to a year-over-year increase in revenue of nearly 55% in the second quarter of fiscal 2022.

North American Clinic Expansion: Following the publication by the American Journal of Psychiatry of the international guidelines and best practices for clinicians on the use of IV ketamine, which is based on research conducted by the Company’s research team, including CEO Dr. Roger McIntyre and Chief Medical and Scientific Officer Dr. Joshua Rosenblat, at CRTCE, the Company remains focused on expanding its clinical footprint beyond Canada into the U.S. and Europe.  The Company continues to be disciplined in deploying capital towards acquisition initiatives.

Cultivating Name Recognition: Braxia Scientific was featured in recent national and local news coverage, discussing access and promoting the use of ketamine to treat brain-based illnesses, bolstering the Company’s brand awareness. Braxia Scientific CEO Dr. Roger McIntyre was featured on CTV’s W5, Canada’s most-watched current affairs and documentary program. The episode, entitled “Psychedelic Healing,” aired on October 23, 2021.

Braxia Scientific and the CRTCE were also highlighted in a recent article by Toronto Life, a monthly magazine. In the piece, Dr. McIntyre and Dr. Rosenblat discussed the benefits of ketamine therapy to rapidly treat mental disorders like treatment-resistant depression (TRD) and the access to the treatments Braxia Scientific provides through its clinics.

 

Second Quarter Financial Summary

The Company’s cash and cash equivalents as of September 30, 2021, was $9,614,977, compared with $10,257,750 at June 30, 2021.

The Company recorded revenue of $385,525 for the second quarter fiscal 2022, ended September 30, 2021 compared with revenue of $249,049 in the second quarter ended September 30, 2020, reflecting 54.8% increase year-over-year. Second quarter 2022 gross margin was $57,140, compared with $3,603 in the prior year period. Revenues consisted primarily of sales from the administering of ketamine infusion treatments at the CRTCE clinics in Ontario.

Net loss for the quarter decreased 16%, to $1,709,942 including a non-cash share-based compensation expense of $821,748, compared to a net loss of $2,052,580 in the second quarter of the prior year period.

 

Looking Ahead

“Braxia Scientific’s value proposition rests in our superior human capital, well established clinical infrastructure and large proprietary health database,” said Dr. McIntyre. “Our team includes three researchers ranked among the world’s top 25 in depression, as well as mood disorders research. Having conducted or registered 14 clinical trials for depression, we believe Braxia Scientific has a distinct competitive advantage among the leading groups endeavouring to research and develop new psychedelic treatments. With this expertise and data, we will work to enhance our intellectual property, including and developing new chemical entities, while providing patients with access to new pathways to treat their mental health disorders.”

 

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 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 seeks to develop ketamine and 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. Ketamine and psilocybin are currently Schedule I and Schedule III controlled substances, respectively, under the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (the “CDSA”) and it is a criminal offence to possess such substances under the CDSA without a prescription or a legal exemption. Health Canada has not approved psilocybin as a drug for any indication, however ketamine is a legally permissible medication for the treatment of certain psychological conditions. It is illegal to possess such substances in Canada without a prescription.

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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Hollister Biosciences Announces Third Quarter Fiscal 2021 Financial Results Including Revenue of USD $14.5M and Adjusted Ebitda of USD $1.2M

Hollister Biosciences Announces Third Quarter Fiscal 2021 Financial Results Including Revenue of USD $14.5M and Adjusted Ebitda of USD $1.2M

Revenue of $14.5 million increased 53% from prior year period

Gross profit income of $3.5 million increased 151% from prior year period

Net income was $0.4 million versus a loss of $0.6 million in prior year period

Adjusted EBITDA was $1.2 million, versus a loss of $0.6 million in prior year period 

Maintained a strong liquidity position, including a cash & cash equivalents balance of $7.6 million, an increase of 300% from prior year quarter

VANCOUVER, BC, Nov. 29, 2021 /CNW/ – Hollister Biosciences Inc. (CSE: HOLL) (OTC: HSTRF) (FRANKFURT: HOB) (the “Company” or “Hollister“) today announced its financial results for the third quarter fiscal 2021 ended September 30, 2021. All financial information is presented in U.S. dollars unless otherwise indicated.

Hollister Biosciences Inc. Logo (CNW Group/Hollister Biosciences Inc.)
Hollister Biosciences Inc. Logo (CNW Group/Hollister Biosciences Inc.)

“We delivered another solid quarter, continuing to drive year-over-year growth. Our performance in this quarter was driven by organic growth of our core business, Venom Extracts. As we approach the end of our final quarter and the beginning of a period of transformation, our strengthened and experienced leadership team is laser focused on creating shareholder value, delivering sustainable profitable growth, keeping operating costs low, and scaling the Company for optimal global success.”
–          Jake Cohen, Chief Executive Officer, Hollister

“Hollister’s third quarter results demonstrate the strength of our business and commitment to executing against our strategy. With its strong balance sheet, we believe the Company is well positioned and prepared for growth as it continues on its strategic transformation.”
–          Eula Adams, Chief Financial Officer, Hollister

Third Quarter 2021 Financial Results

  • Total revenue was $14.5 million, an increase of $5 million or 53% compared to the prior year period.
  • Gross profit was $3.5 million compared to $1.4 million for the prior year period.
  • Net income was $0.4 million versus a loss of $0.6 million in the prior year period.
  • Adjusted EBITDA was $1.2 million compared to a loss of $0.6 million in the prior year period.
  • Cash and cash equivalents was $7.6 million, a 300% increase as compared to $1.9 million at June 30, 2020.

Third Quarter 2021 Business Highlights

  • On July 13th, 2021, the Company announced it was added as an index constituent in the Solactive US Marijuana Companies Index (the “Index“) as part of the Index’s June 2021 quarterly rebalancing and as a result is now a holding in the Horizons US Marijuana Index ETF (NEO: HMUS).
  • On August 25th, 2021, the Company announced ‘Hollister Brand Campus‘ (the “Campus“) a 30-Acre Arizona Brand Campus with planned 700,000 square feet of cultivation area and an existing 28,500-square-foot processing and manufacturing facility.
  • On August 31st, 2021, the Company announced two new board members, Mr. Kevin Harrington, an original “Shark” from the NBC hit TV series “Shark Tank” and Mr. Jakob Ripshtein, the former CFO of Diageo North America and President of Aphria Inc.

Recent Events

  • On October 18th, 2021, the Company announced a series of operational and strategic updates to create shareholder value, enhance governance, operations and market positioning while preparing the Company for the next phase of its growth, including:
    • Appointment of:
      • Jacob Cohen as Chief Executive Officer
      • Eula Adams as Chief Financial Officer
      • Chris Lund as Chief Commercial Officer
      • Jill Karpe as Senior Vice President of Admin and Finance;
    • Refocused business strategy to develop a “house of brands” focused on cannabis consumer packaged goods;
    • Initiated rebranding corporate identity and name of the company; and
    • Reduction of expenses and resource allocation on non-core business activities.
  • On November 2nd, 2021, the Company announced it received an order from the Ontario Securities Commission granting Hollister an exemption from certain provisions governing disclosure and other matters applicable to issuers with outstanding “restricted securities”.
  • On November 23rd, 2021, all matters put forward before the Company’s shareholders for consideration and approval, as listed in the management information circular of the Company dated October 18, 2021 (the “Circular“), were approved by the requisite majority of votes cast at the Company’s Annual General and Special Shareholder Meeting. This includes the election of all six (6) Board of Director nominees listed in the Circular: Jakob Ripshtein, Jacob Cohen, Eula Adams, Lily Dash, Kevin Harrington, and Brett Mecum.

Outlook
The Company believes the outlook is strong and has developed a solid strategy supported by strong operational, financial and leadership capabilities. In January 2021, the state of Arizona enacted sales of adult-use cannabis ahead of industry expectations. The Company recognized a substantial increase in demand for its branded goods and bulk wholesale products, creating a larger volume of sales in the first half of the year as dispensaries and brands readied for inventory for the market change. During Q3 2021 and beyond the Company focused its efforts on improving sales of higher margin products and aligning supply and demand to flow with the seasonality of the Arizona and cannabis markets at large. Management reports that January through November sales are estimated to exceed $64.5 million. Management believes the previously forecasted guidance of $70 million is achievable and driven by sales of finished and bulk products in the company’s core market of Arizona. Historically, fourth quarter sales in Arizona improved versus summer months due to local population increases from seasonal residents returning and holiday visitors. The overall Arizona market demand has seen improvements in the categories that the company operates and is expected to continue.

Sales through the end of November are preliminary and are unaudited and subject to change and adjustment when the Company prepares its audited consolidated financial statements for the year ended December 31, 2021. Accordingly, investors are cautioned not to place undue reliance on the foregoing information. The preliminary results provided in this news release constitute “forward-looking information” within the meaning of applicable Canadian securities laws, are based on several assumptions and are subject to a number of risks and uncertainties. Actual results may differ materially. See “Cautionary Statement Regarding Forward-Looking Information”.

The Company will continue optimizing its platform in Arizona through improved same-store sales, loyalty, and expanding its product portfolio and market penetration. The recently announced Campus project is progressing and once production has commenced it is expected to provide the Company with substantially reduced direct material costs, resulting in improved gross margin. The Campus also has ample space to expand production of higher margin finished products. 

As previously announced, the Company is moving forward, implementing  its “house of brands” cannabis consumer packaged goods strategy which includes manufacturing and distribution of owned and partner branded cannabis products in chosen markets. Additionally, the Company is planning to rationalize its existing brand and product portfolio, dedicating efforts towards new, highly targeted brand partnerships and the acquisition or development of owned brands.

On the corporate development front, the process to rebrand the Company and to align it with its refined strategy has commenced. Campaigns to improve awareness and broaden the shareholder base are being developed.

The Company has placed certain non-core assets including its California operations in a care and maintenance program to reduce expenses and improve overall financial and operational performance.

In addition to operational, financial, governance and strategy improvements, the Company has also been dedicating efforts to enter new markets with its existing brands.

USE OF NON-IFRS FINANCIAL MEASURES
This press release includes certain non-IFRS financial measures. Reconciliations of these non-IFRS financial measures to the most directly comparable financial measure calculated and presented in accordance with IFRS are included below. This information should be considered as supplemental in nature and not as a substitute for, or superior to, any measure of performance prepared in accordance with IFRS. The Company’s management team uses adjusted EBITDA to evaluate operating performance and trends and to make planning decisions. The Company’s management team believes adjusted EBITDA helps identify underlying trends in the business that could otherwise be masked by the effect of the items that are excluded. Accordingly, the Company believes that adjusted EBITDA provides useful information to investors and others in understanding and evaluating the operating results, enhancing the overall understanding of past performance and future prospects, and allowing for greater transparency with respect to key financial metrics used by management in its financial and operational decision-making.

The table below reconciles net income (loss) and comprehensive income (loss) to Adjusted EBITDA (Loss for the three and nine months ended September 30, 2021 and 2020:

Three months ended
September 30,		Nine months ended
September 30,
2021202020212020
$$$$
Net income (loss) and comprehensive income (loss)457,148(649,095)4,040,649(2,584,259)
Add (deduct) impact of:
Accretion–3,150–9,451
Depreciation333,739445,045964,861574,098
Finance costs123,300107,274332,905327,135
Foreign exchange gain(29,665)–(57,961)–
Interest expense34237,75020,35687,750
Transaction costs–––379,684
Acquisition expense–––535,478
Interest income(46,802)–(112,890)–
Gain on sublease––262,015–
Gain on lease extinguishment19,951–19,951–
Lease renegotiation costs(252,036)–(252,036)–
Income tax expense617,000(8,400)2,438,000(8,400)
Deferred income tax recovery(3,000)–(131,000)–
Foreign currency translation adjustment22,8663,9027,05581,642
Adjusted EBITDA (Loss)1,242,843(60,374)7,531,905(597,421)

The live audio earnings conference call may be accessed online and by phone using the link: https://www.renmarkfinancial.com/events/third-quarter-2021-results-cse-holl-2021-11-30-160000. Investors may pre-register for the call by navigating to the same link provided. The conference call will be archived for replay and accessible at https://hollisterbiosciences.co/investors/.

About Hollister
Hollister is a multi-state company with a portfolio of innovative, high-quality cannabis & hemp branded consumer products and white-labeling manufacturing. The Company’s products are sold in 370 dispensaries across Arizona and California. Hollister’s wholly-owned brand, Venom Extracts, is a category-leading brand that sold more than 4 million grams in 2020, accounting for up to 30% of category sales in Arizona.

Products from Hollister include HashBone, the brand’s premier artisanal hash-infused pre-roll, along with concentrates (shatter, budder, crumble), distillates, solvent-free bubble hash, pre-packaged flower, pre-rolls, tinctures, vape products and full-spectrum high CBD pet tinctures. The Company’s wholly-owned California subsidiary Hollister Cannabis Co is the 1st state and locally licensed cannabis company in the city of Hollister, CA, birthplace of the “American Biker”.

Website:  www.hollisterbiosciences.co

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION:

This news release includes certain “forward-looking information” as defined under applicable Canadian securities legislation, including statements regarding the plans, intentions, beliefs, and current expectations of the Company with respect to future business activities and operating performance. To the extent any forward-looking information in this news release constitutes “financial outlooks” within the meaning of applicable Canadian securities laws, such information is being provided as preliminary financial and operational 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 is often identified by the words “may”, “would”, “could”, “should”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” or similar expressions and includes information regarding: the impacts of the Campus; the implementation of the Company’s “house of brands” cannabis consumer packaged goods strategy; the Company’s rebranding; and expectations for other economic, business, and/or competitive factors. Forward-looking information is necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Financial outlooks, as with forward-looking information generally, are, without limitation, based on the assumptions and subject to various risks as set out herein. The Company’s actual financial position and results of operations may differ materially from management’s current expectations and, as a result, the Company’s revenue may differ materially from the estimated revenue provided in this news release.

Investors are cautioned that forward-looking information is not based on historical fact but instead reflects management’s expectations, estimates or projections concerning future results or events based on the opinions, assumptions and estimates of management considered reasonable at the date the statements are made. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance, or achievements of the Company. Among the key factors that could cause actual results to differ materially from those projected in the forward-looking information are the following: the Company’s financial results, including the Company’s revenue for the year to date will be as projected; regulatory and licensing risks; changes in consumer demand and preferences; changes in general economic, business and political conditions, including changes in the financial markets; the global regulatory landscape and enforcement related to cannabis, including political risks and risks relating to regulatory change; compliance with extensive government regulation; public opinion and perception of the cannabis industry; the impact of COVID-19; and the risk factors set out in the Company’s annual information form dated August 28, 2020, filed with Canadian securities regulators and available on the Company’s profile on SEDAR at www.sedar.com.

The Company, through several of its subsidiaries, is indirectly involved in the manufacture, possession, use, sale, and distribution of cannabis in the recreational and medicinal cannabis marketplace in the United States. Local state laws where the Company operates permit such activities however, investors should note that there are significant legal restrictions and regulations that govern the cannabis industry in the United States. Cannabis remains a Schedule I drug under the US Controlled Substances Act, making it illegal under federal law in the United States to, among other things, cultivate, distribute or possess cannabis in the United States. Financial transactions involving proceeds generated by, or intended to promote, cannabis-related business activities in the United States may form the basis for prosecution under applicable United States federal money laundering legislation.

While the approach to enforcement of such laws by the federal government in the United States has trended toward nonenforcement against individuals and businesses that comply with recreational and medicinal cannabis programs in states where such programs are legal, strict compliance with state laws with respect to cannabis will neither absolve the Company of liability under United States federal law, nor will it provide a defense to any federal proceeding which may be brought against the Company. The enforcement of federal laws in the United States is a significant risk to the business of the Company and any proceedings brought against the Company thereunder may adversely affect the Company’s operations and financial performance.

Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated, or expected. Although the Company has attempted to identify important risks, uncertainties and factors that could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking information, which speak only as of the date of this news release. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by law.

SOURCE Hollister Biosciences Inc.

For further information: Company Contact: Joshua Lavers: ir@hollisterbiosciences.co, Tel: (416) 644-2020 or (212) 812-7680

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Clearmind Medicine Launches Study for Binge Eating with The Hebrew University Using its Proprietary MEAI Compound

Clearmind Medicine Launches Study for Binge Eating with The Hebrew University Using its Proprietary MEAI Compound

‍Focus on the discovery and development of novel therapeutic strategies to treat obesity and its related metabolic disorders

TORONTO, Nov. 24, 2021 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (CSE: CMND, FSE: CWY0, OTC Pink: CMNDF), (“Clearmind” or the “Company”), a psychedelic medicine biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and undertreated health problems, is pleased to announce it has signed an agreement to fund a new research and development project with the Hebrew University of Jerusalem’s Obesity and Metabolism Laboratory, to evaluate the Company’s proprietary compound, MEAI’s direct effect on binge eating including food and water intakes as well as activity and metabolic parameters.

The study, which will be overseen by Prof. Joseph (Yossi) Tam, D.M.D., Ph.D., head of the Obesity and Metabolism Laboratory and Associate Professor of Pharmacology at the Hebrew University’s Institute for Drug Research, will focus on testing the potential of MEAI to treat binge eating and related behaviors, and will support the discovery and development of novel therapeutic strategies to safely treat obesity and its associated metabolic disorders.

Increasingly prevalent in developed nations, the conditions of being overweight and obese are a serious health concern as they contribute to so many other conditions, including heart disease, stroke, type 2 diabetes, fatty liver disease, and certain types of cancers, some of the leading causes of preventable, premature death in the US. The Center for Disease Control and Prevention estimates that about 74% of adults in the US are overweight1 and over 40% are considered obese2. According to a recent study published in 2020, this phenomenon is also accompanied with the high and rising costs of obesity to the US Health Care system at an estimated annual medical cost for the full non-institutionalized population of adults, in 2013, equaling $342.2 billion.

Adi Zuloff-Shani, Ph.D., CEO of Clearmind, commented on the announcement, “The medical community has yet to establish an effective therapeutic or preventative treatment for obesity, despite its increasing prevalence and severe negative impacts on the medical and economic health of people around the world. Clearmind has been able to demonstrate the positive influence MEAI has on binge behavior with regard to alcohol use, and our preliminary research indicates it may have a similar effect on metabolic disorders.”

Prof. Tam added, “I have spent my career exploring the biological mechanisms underlying obesity and the metabolic syndrome, intending to develop an effective drug therapy. After viewing the early data on MEAI, I am optimistic that this compound has the potential to be a building block for a real solution and look forward to working with the Clearmind team to advance our shared objective.”

The first phase of the three-stage study will focus on assessing the direct effect of MEAI on food and water intakes as well as its ability to modulate activity and metabolic parameters.

Following the initial screening, the study will evaluate MEAI’s efficacy as a therapeutic metabolic agent on a high-fat diet-induced obese mouse model, by measuring MEAI’s potential to treat obesity, hepatic injury, glycemic and hormonal imbalance. Lastly MEAI’s binge eating and drinking mitigating properties will be determined by comparison of cumulative food and sucrose preference, respectively.

About Clearmind Medicine Inc.

Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.

The Company’s intellectual portfolio currently consists of four patent families. The first, “Binge Behavior Regulators”, has been granted in the U.S., Europe, China and India, with pending divisional applications in Europe and the U.S. The second, “Alcohol Beverage Substitute”, has been approved for a European patent, with pending applications in the U.S., China and India. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on the Canadian Securities Exchange under the symbol “CMND“, the Frankfurt Stock Exchange under the symbol “CWYO” and on the OTC Pink under the symbol “CMNDF“.

For further information, please contact:
Investor Relations,
Email: invest@clearmindmedicine.com
Telephone: (778) 400-5347
General Inquiries,
Info@Clearmindmedicine.com
www.Clearmindmedicine.com

FORWARD-LOOKING STATEMENTS:

This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Such statements include discussion of the new research and development project with the Hebrew University of Jerusalem’s Obesity and Metabolism Laboratory and the benefits of product candidate. There is no certainty that any of these events will occur. Although such statements are based on management’s reasonable assumptions, there can be no assurance that such assumptions will prove to be correct. We assume no responsibility to update or revise them to reflect new events or circumstances.

Investing into early-stage companies inherently carries a high degree of risk, and investment into securities of the Company shall be considered highly speculative.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities in any province in which such offer, solicitation or sale would be unlawful. The securities issued, or to be issued, under the Private Placement have not been, and will not be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Neither the Canadian Securities Exchange (the “CSE”) nor its Regulation Services Provider (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

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Allied Corp Signs Yearly Supply Contract With Veterans for Healing Using the Allied Inside™ Business Model With Colombian Produced Cannabis Flower

KELOWNA, British Columbia, Nov. 24, 2021 (GLOBE NEWSWIRE) — Allied Corp. (“Allied” or the “Company”) (OTCQB: ALID) is pleased to announce the signing of a supply contract (the “contract”) for the 2022 calendar year and beyond. Allied will be only exporting cannabis flower after the Colombian government allows it and will provide supply only to countries where it is legal to sell into (for example, the United States only allows for THC levels to be less than 0.3%).

On November 18th 2021, a contract was signed between Allied and a globally focused veterans innovative healing organization called Veterans For Healing(“VFH”) for a volume of 4000 kilograms per month of Colombian produced 20%+ high-CBD percentage flower. 2000 kilograms monthly is destined for the United States and 2000 kilograms monthly is destined for the United Kingdom. The intent is that this flower will be processed into high percentage CBD content cigarette packages for sale into the United States and United Kingdom markets. These cigarette packages will be branded with the VFH brand with the Allied Inside™ mark on the package. The Allied Inside™ mark signifies that there is Allied Corp produced flower contained.

About Allied Inside™ Model: Click for more here

The Allied Inside™ value proposition enables national brands and companies to brand, market and sell their retail products into their market with the Allied Inside™ product contained. The Allied product is produced in Colombia and provided as a wholesale product to many international partners to then distribute and sell. The Allied Inside™ model offers qualified clients the ability to import large volumes of Colombian produced flower with a small up front percentage of payment and the remainder due under terms of future payment (ie 60-90days). This enables off-take partners to sell into their market and essentially pay for the remainder of the payment out of their sales revenue.

About Veterans for Healing:

Veterans For Healing (“VFH”) is a globally reputed company that has been gained, through tangible action within several countries around the globe, a strong Veterans following as an advocate for veteran help, health and healing.

VFH has partners in many countries around the globe that serve veterans in every aspect of health and wellness. Within their global network, VFH is committed to ensuring premium quality products, consistent supply and proven genetics, for their client’s medical cannabis needs. VFH helps by guiding Veterans through Veterans Affairs organizations and helping with medical authorizations as needed. VFH also has ready access to psychologists, psychiatrists, physicians, natural health companies and coordinators in many countries.

VFH can offer education on medical cannabis for optimizing results, access to online yoga, peer support and other healing practices and connection into a peer cohort that offers healing events and gatherings for Veterans and their families. For more on VFH please click here: CLICK FOR MORE ON VFH.

“We are excited to bring the Allied Inside™ business model to market. In my opinion, Veterans for Healing is the perfect partner. As Colombia continues to move towards the ability to export cannabis flower to countries where it is legal to do so, these contracts point to the demand that the global cannabis market is asking for. We believe that these supply contracts are just the start of Allied’s production volumes. We harvest on a weekly basis and by nature of this we believe that we will be able to provide rolling supply that is harvested fresh every week. We also continue to build relationships with buyers in many different countries around the globe and, through this, we believe that we are ready to supply the market demand in many international markets where it is legal to do so.” said Mr. Calum Hughes, CEO and Chairman of Allied Corp.

About Allied Corp. – https://allied.health/

Allied Corp. is an international cannabis company with its main production center in Colombia and is one of the few companies that has exported from Colombia internationally. In preparation for the possible legalization of cannabis by the US Federal Government, Allied also has the option to purchase a US cannabis license in the US (Nevada) exercisable if such were to happen. In addition to this, Allied has three CBD-brands to market with products selling in the United States. Lastly, Allied has both Cannabinoid and psilocybin products in the pharmaceutical development track seeking pharma drug indications for depression, anxiety and PTSD.

Investor Relations:
ir@allied.health
1-877-255-4337

Forward-Looking Statements:
This press release contains “forward-looking information” within the meaning of applicable securities laws in Canada or “forward-looking statements” made pursuant to the “safe harbour” provisions of the United States Private Securities Litigation Reform Act of 1995 (collectively, “forward-looking information”). Forward-looking information may relate to the Company’s future outlook and anticipated events, plans or results, and may include information regarding the Company’s objectives, goals, strategies, future revenue or performance and capital expenditures, and other information that is not historical information. Forward-looking information can often be identified by the use of terminology such as “believe,” “anticipate,” “plan,” “expect,” “pending,” “in process,” “intend,” “estimate,” “project,” “may,” “will,” “should,” “would,” “could,” “can,” the negatives thereof, variations thereon and similar expressions. The forward-looking information contained in this press release is based on the Company’s opinions, estimates and assumptions in light of management’s experience and perception of historical trends, current conditions and expected future developments, as well as other factors that management currently believes are appropriate and reasonable in the circumstances. Forward looking statements in this press release include the following: that Allied is leveraging the conditions in its Colombia grow operation and future Kelowna location to support its Research and Development efforts; that Allied is making important strides forward to position itself as a leader in the medical cannabis space, that Allied intends to make a series of proposed trademark and other intellectual property protection filings, as part of the Company’s Intellectual Property and Pharma Development (IP&PD) Strategy, statements respecting the joint development, manufacturing, and introduction of TACTICAL RELIEF™ branded products, and the use of proceeds from the offering of convertible notes.

There can be no assurance that the underlying opinions, estimates and assumptions will prove to be correct. Risk factors that could cause actual results to differ materially from forward-looking information in this release include: the Company’s exposure to legal and regulatory risk; the effect of the legalization of adult-use cannabis in Canada and Colombia on the medical cannabis industry is unknown and may significantly and negatively affect the Company’s medical cannabis business; that the medical benefits, viability, safety, efficacy, dosing and social acceptance of cannabis are not as currently expected; that adverse changes or developments affecting the Company’s main or planned facilities may have an adverse effect on the Company; that the medical cannabis industry and market may not continue to exist or develop as anticipated or the Company may not be able to succeed in this market; risks related to completion of the greenhouse construction in Colombia, risks related to market competition; risks related to the proposed adult-use cannabis industry and market in Canada and Colombia including the Company’s ability to enter into or compete in such markets; that the Company has a limited operating history and a history of net losses and that it may not achieve or maintain profitability in the future; risks related to the Company’s current or proposed international operations; risks related to future third party strategic alliances or the expansion of currently existing relationships with third parties; that the Company may not be able to successfully identify and execute future acquisitions or dispositions or successfully manage the impacts of such transactions on its operations; risks inherent to the operation of an agricultural business; that the Company may be unable to attract, develop and retain key personnel; risks resulting from significant interruptions to the Company’s access to certain key inputs such as raw materials, electricity, water and other utilities; that the Company may be unable to transport its cannabis products to patients in a safe and efficient manner; risks related to recalls of the Company’s cannabis products or product liability or regulatory claims or actions involving the Company’s cannabis products; risks related to the Company’s reliance on pharmaceutical distributors; that the Company, or the cannabis industry more generally, may receive unfavourable publicity or become subject to negative consumer or investor perception; that certain events or developments in the cannabis industry more generally may impact the Company’s reputation or its relationships with customers or suppliers; that the Company may not be able to obtain adequate insurance coverage in respect of the risks that it faces, that the premiums for such insurance may not continue to be commercially justifiable or that there may be coverage limitations and other exclusions which may result in such insurance not being sufficient; that the Company may become subject to liability arising from fraudulent or illegal activity by its employees, contractors, consultants and others; that the Company may experience breaches of security at its facilities or losses as a result of the theft of its products; risks related to the Company’s information technology systems; that the Company may be unable to sustain its revenue growth and development; that the Company may be unable to expand its operations quickly enough to meet demand or manage its operations beyond their current scale; that the Company may be unable to secure adequate or reliable sources of necessary funding; risks related to, or associated with, the Company’s exposure to reporting requirements; risks related to conflicts of interest; risks related to fluctuations in foreign currency exchange rates; risks related to the Company’s potential exposure to greater-than-anticipated tax liabilities; risks related to the protection and enforcement of the Company’s intellectual property rights, or the intellectual property that it licenses from others; that the Company may become subject to allegations that it or its licensors are in violation of the intellectual property rights of third parties; that the Company may not realize the full benefit of the clinical trials or studies that it participates in; that the Company may not realize the full benefit of its licenses if the licensed material has less market appeal than expected and the licenses may not be profitable; as well as any other risks that may be further described in and the risk factors discussed in the Company’s continuous disclosure including its Management’s Discussion and Analysis sections in its Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K and Current Reports on Form 8-K filed under the Company’s profile at www.sec.gov.

Although management has attempted to identify important risk factors that could cause actual results to differ materially from those contained in the forward-looking information in this presentation, there may be other risk factors not presently known to the Company or that the Company presently believes are not material that could also cause actual results or future events to differ materially from those expressed in such forward-looking information in this presentation. 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. Accordingly, readers and viewers should not place undue reliance on forward-looking information, which speaks only as of the date made. The forward-looking information contained in this release represents the Company’s expectations as of the date of this release or the date indicated, regardless of the time of delivery of the presentation. The Company disclaims any intention, obligation or undertaking to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required under applicable securities laws.

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Revitalist Reports Sales Growth of 100% for the 10 months ended October 31, 2021 compared to the same period in 2020

Revitalist Reports Sales Growth of 100% for the 10 months ended October 31, 2021 compared to the same period in 2020

VANCOUVER, BC, November 16, 2021 – REVITALIST LIFESTYLE AND WELLNESS LTD. (“Revitalist” or the “Company”) (CSE: CALM) (OTC: RVLWF) (FSE: 4DO) is pleased to announce its clinic operations generated approximately $1.55 million in revenue for the ten months ended October 31, 2021, compared to $789,000 for the same period in 2020. The growth represents an approximate 100% increase over prior year and is attributable to organic growth at its flagship clinic in Knoxville, TN, plus additional revenue from its pipeline of 8 clinics in 5 States.  Estimated gross margin on this level of sales is approximately $1.17 million.

The Company has consistently achieved month over month sales growth as evidenced in the chart below.

 

Mrs. Kathryn Walker, CEO, commented, “We continue to build on our clinic network and mood and pain services which is attributing to the year over year sales growth. Most of our recent new clinics were opened in the second half of 2021 and are starting to see traction with new patient growth. Our marketing team led by our Chief Marketing Officer Larry Heinzlmeir, have developed marketing strategies in the communities that we serve allowing us to attract new patients and optimize revenue growth. We expect to continue this growth trajectory into 2022 given the demand for mental health services.”

 

ABOUT REVITALIST LIFESTYLE AND WELLNESS

Revitalist Lifestyle and Wellness Ltd. (CSE: CALM) (OTC: RVLWF) (FSE: 4DO) is a publicly traded company, headquartered in Knoxville, Tennessee, with five clinics operating across the United States and expanding. Revitalist is dedicated to empowering individuals toward an improved quality of well-being through a combination of comprehensive care and future-centric treatments provided by medical professionals, mental health experts, and chronic pain specialists. Since opening their first clinic in 2018, Revitalist has provided thousands of infusions for patients suffering from treatment-resistant conditions. Additionally, Revitalist offers a number of lifestyle optimization services and vitamin infusions that can bring anyone closer to total wellness. For more information, please visit www.revitalist.com or follow us at:

Twitter:                @RevitalistCorp

Facebook:           @RevitalistLifestyleandWellnessLtd.

Instagram:          @RevitalistCorp

LinkedIn:             @RevitalistLifestyleAndWellnessLtd

Contacts

On Behalf of the Board
Kathryn Walker
Chief Executive Officer

Revitalist Lifestyle and Wellness Ltd.
Email: IR@revitalist.com
Tel: (865) 585-8414

Forward Looking Statements

This news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “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” or “will” be taken, occur or be achieved. Forward looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Revitalist to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release.

Risks, uncertainties, and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

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Field Trip Health Ltd. Reports Second Fiscal Quarter 2022 Financial Results and Provides Business Update

Field Trip Health Ltd. Reports Second Fiscal Quarter 2022 Financial Results and Provides Business Update

  • Announced plans to advance FT-104, its novel psychedelic compound, to clinic for Treatment-Resistant Depression and Postpartum Depression as the lead indications.
  • Initiated a new pipeline research program focused on discovering novel psychedelics with a reduced cardiovascular risk profile compared to classic psychedelics (the “FT-200 Group”) and filed a provisional patent in connection to the composition of matter for the first molecule identified in the FT-200 Group.
  • Continued to invest in best-in-class clinical infrastructure, with nine clinics currently in operation and nine locations under construction or about to commence construction.
  • Commenced trading on the NASDAQ Global Select Market (“NASDAQ”) under the ticker symbol “FTRP”.
  • As at September 30, 2021, Field Trip had approximately $88 million in unrestricted cash and cash equivalents and short-term investments.
  • Commenced a strategic review of the current corporate structure to assess options to maximize the value of the drug development and therapy delivery business units.

TORONTO, Nov. 15, 2021 (GLOBE NEWSWIRE) — Field Trip Health Ltd. (TSX: FTRP; FTRP.WT; NASDAQ: FTRP) (“FieldTrip“), a leader in the development and delivery of psychedelic therapies, reported its second fiscal quarter 2022 results for the three months ended September 30, 2021 and provided a business update. All results are reported under International Financial Reporting Standards (“IFRS“) and in Canadian dollars, unless otherwise specified.

Key Highlights and Recent Developments

During the quarter, Field Trip progressed its strategy of building a leading psychedelic therapy company (Field Trip Health) and continued to invest in its drug development pipeline and program expansion (Field Trip Discovery).

Field Trip Discovery

FT-104

During the quarter, it was announced that the lead indications for FT-104, Field Trip’s lead novel psychedelic compound in development (patent pending), will be Treatment Resistant Depression and Postpartum Depression. FT-104 is a novel, synthetic 5HT2A receptor agonist compound. It is currently advancing through preclinical studies with the in vivo portion completed, and final results from safety pharmacology and GLP toxicology are expected in calendar Q4 2021. To date, GLP toxicology, cardiovascular, pulmonary, and neurological safety pharmacology studies, as well as genotoxicity potential, all continue to be encouraging. In addition, final manufacturing of clinical trial material is scheduled for production to enable FT-104 to move into Phase 1 clinical trials in the first half of calendar 2022. The Company has experienced, and may continue to experience, delays in initiating Phase 1 clinical trials due to the ongoing COVID pandemic and delays at its contract manufacturing organization.

FT-200 Group: Introducing Field Trip’s Second Novel Psychedelic Program

The Company also announced the discovery of a novel molecule that, based on in vivo assay details, has the structure of classical psychedelics and has demonstrated improved selectivity for the target serotonin 2A receptor (5HT2A) relative to FT-104 and psilocybin versus off target serotonin, 5HT1A, 5HT2B and 5HT2C receptors. This is meaningful because off-target 5HT2B activity has been associated with increased risk of cardiovascular toxicity. Based on this discovery, the Company is expanding the scope of its development pipeline to focus on a new group of molecules termed the FT-200 Group, (which includes the molecule mentioned above), that have the structure of classical psychedelics, with similar potency at the 5HT2A receptor as FT-104 and psilocybin, but with reduced or the absence of activity at the off-target 5HT2B receptor. The aim of the work is that by reducing or eliminating 5HT2B activity it may allow molecules like those in the FT-200 Group to be administered more frequently, such as more chronic or chronic intermittent administration or ‘microdosing’ strategies.

“The first molecule identified in the FT-200 Group demonstrates significant promise to maintain 5HT2A activity while reducing off-target serotonin receptor activity. We are continuing to conduct preclinical work on this molecule and will explore structural analogs within the FT-200 Group to better refine and optimize this new family of substances, understand their properties better and work towards identifying a lead candidate”, said Joseph del Moral, Field Trip’s Co-founder and CEO.

On October 29, 2021 the Company filed a provisional patent application in the United States to protect the composition, as well as potential formulations and uses of the first molecule in the FT-200 group.

Field Trip Health Centres

Leveraging the growing awareness of Field Trip’s psychedelic-assisted therapy clinics, Field Trip announced on August 31, 2021 the launch of the KAP Co-operative Program (“KAP Co-op”), a program that enables eligible independent psychedelic therapists to provide ketamine-assisted psychotherapy (and, in the future, other legal, psychedelic-assisted therapies) at its Field Trip Health Centres. Field Trip also announced the launch of training programs designed to provide interested psychotherapists or other qualified mental health professionals and clinicians with access to best-in-class training on KAP.

The Company continues to invest in its clinics and during the quarter, entered into lease agreements for locations in Dallas, TX, Miami, FL and Scottsdale, AZ. Subsequent to the quarter end, the Company announced the opening of the Seattle, WA clinic, its sixth in the United States and ninth overall, along with the recent opening of a location in Fredericton, NB, and the imminent opening of a location in Vancouver, BC.

Hannan Fleiman, Field Trip’s Co-Founder and President, said, “We continue to see strong growth in our clinic business and our team is proud of the outcomes we are helping our patients achieve. We have continued to make significant investments in building out the leading platform for the delivery of psychedelic therapies and to position our clinics to be at the absolute forefront of our industry in establishing the critical infrastructure for the current and emerging psychedelic therapies with 9 clinics now in operation and 9 locations under construction or about to commence construction. Importantly, the clinics enable Field Trip to capture significant amounts of patient data on clinical outcomes which we expect to help inform future clinical development and treatment strategies.”

From a brand perspective, Field Trip continues to be a globally recognized company in the industry. During the quarter, the Company was featured in many top-tier print and broadcast media outlets, including Forbes, Vox Media, Insider, People and others, generating nearly 2 billion total potential media impressions. Field Trip’s brand presence and reach continues to generate strong website traffic and patient interest in the KAP treatments offered by the Company.

NASDAQ Listing

On July 29, 2021, Field Trip’s Common Shares commenced trading on the NASDAQ Global Select Market (“NASDAQ”) under the ticker symbol “FTRP”, providing the Company with greater access to capital. The Common Shares continue to trade in Canada on the TSX under its current symbol FTRP. Concurrent with the NASDAQ listing, Field Trip’s Common Shares ceased to be quoted on the OTCQX. The Company previously completed the process to ensure its shares are eligible for electronic clearing and settlement through the Depository Trust Company (DTC). In addition, Ronan Levy and Ellen Lubman joined the Compensation Committee and Mujeeb Jafferi and Dr. Ryan Yermus resigned as directors of the Company. Mr. Jafferi and Dr. Yermus continue to serve as Field Trip’s Chief Operating Officer and Chief Clinical Officer, respectively.

Mr. del Moral, continued, “The milestone of listing on NASDAQ during the quarter was testament to the rapid progress we have made and increased our visibility in the marketplace, improving trading liquidity and ultimately enhancing long term shareholder value as we further strengthen our leadership position in the psychedelic medicine industry.”

Strategic Review of Corporate Structure

The Company has commenced a strategic review designed to ensure that each operating unit is best positioned, optimally resourced, and focused to provide maximum long-term value to all stakeholders.

Mr. Joseph del Moral, said, “With the FT-104 nearing the clinic, the expansion of discovery efforts around our FT-200 Group, and the growing number of opportunities for Field Trip Health Centers we believe it is the correct time to review all strategic options to ensure we continue to maximize the growth potential and value of each business unit.”

The Company has engaged Bloom Burton Securities Inc. as its financial advisor in connection with the strategic review.

Financial Highlights

For the second fiscal quarter ended September 30, 2021, the Company earned patient services revenues of $907,816 from its Toronto, New York, Santa Monica, Chicago, Atlanta, Houston and Amsterdam clinics, an increase of $813,284 or 860% over the comparative quarter ended September 30, 2020 of $94,532 and an increase of $40,416 or 5% over the prior fiscal first quarter. The Amsterdam clinic began generating revenues in September 2021. Second fiscal quarter 2021 patient services revenues were generated from only two clinics, Toronto and New York. The modest quarter over quarter revenue increase was in part due to the COVID-19 Delta variant and seasonality associated with the slower summer months. Revenues in the first part of the third quarter indicate a clear upward trend as a result of recent process optimizations to accelerate patient on-boarding and increase clinic capacity.

Net loss for the second fiscal quarter of $13,019,280 was primarily due to total operating costs of $15,638,596, of which $2,055,890 was related to non-cash share-based compensation and $848,712 was related to non-cash depreciation and amortization. This was partially offset by a foreign exchange gain of $1,856,088. This compares with a net loss of $3,932,444 in the second fiscal quarter of 2021. The increase from the prior year primarily reflects the Company’s focus on growing the business and continued investment in its drug development pipeline and best-in-class clinic infrastructure. As the Company continues to scale, it is optimizing and streamlining the development of its psychedelic-assisted therapies.

Total operating costs in the second fiscal quarter were $15,638,596 and were comprised of the following: general and administration expenses of $8,917,717, research and development expenses of $2,102,787, patient services expenses of $1,917,451, sales and marketing expenses of $1,315,434, depreciation and amortization of $848,712 and occupancy costs of $536,495. This compares with total operating costs of $3,810,177 in the second fiscal quarter of 2021.

The difference in general and administrative expenses in the second fiscal quarter also included $596,055 in non-recurring expenses primarily related to the NASDAQ uplisting, $1,330,847 in recurring public company costs as well as non-cash share-based payments of $1,380,398.

Balance Sheet

As of September 30, 2021 Field Trip had unrestricted cash and cash equivalents, funds held in trust and short-term investments of $87,526,034.

Selected Consolidated Financial Information

The following table sets forth selected financial information derived from the Company’s unaudited condensed interim financial statements for the three months and six months ended September 30, 2021 prepared in accordance with IAS 34 in a manner consistent with the Company’s annual audited financial statements. The following information should be read in conjunction with the financial statements and management’s discussion and analysis, which are available on the Company’s website at www.fieldtriphealth.com and under the Company’s SEDAR profile at www.sedar.com.

FIELD TRIP HEALTH LTD

STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

3 months ended 3 months ended 6 months ended 6 months ended
September 30,
2021		 September 30,
2020		 September 30,
2021		 September 30,
2020
$ $ $ $
Revenue
Patient services 907,816 94,532 1,775,216 118,131
907,816 94,532 1,775,216 118,131
Operating Expenses
General and administration 8,917,717 2,092,593 16,260,688 3,366,948
Occupancy costs 536,495 111,877 913,110 175,660
Sales and marketing 1,315,434 281,185 2,379,561 435,940
Research and development 2,102,787 806,536 3,555,901 1,601,898
Depreciation and amortization 848,712 269,578 1,464,195 479,338
Patient services 1,917,451 248,408 3,375,272 321,665
Total Operating Expenses 15,638,596 3,810,177 27,948,727 6,381,449
Other Income (Expenses)
Interest income 111,934 2,589 243,549 4,838
Interest expense (256,522 ) (60,962 ) (403,109 ) (98,195 )
Other income (expense) 1,856,088 (158,426 ) 783,396 (534,673 )
Net Loss (13,019,280 ) (3,932,444 ) (25,549,675 ) (6,891,348 )
Net Loss per Share – Basic and Diluted (0.23 ) (0.16 ) (0.44 ) (0.28 )

 

As at
September 30,
2021
$		 As at
March  31,
2021
$
Cash and cash equivalents 22,388,946 38,469,057
Funds held in trust – 795,516
Restricted cash 619,127 588,041
Short-term investments 65,137,088 72,552,870
Accounts receivable 2,464,223 813,761
Total Assets 119,912,854 126,450,005
Total Non-Current Financial Liabilities 18,102,184 6,426,484

Certain comparative figures have been reclassified where necessary to conform with current period presentation.

Conference Call

The Company will conduct a conference call and webcast to discuss its results the following morning, Tuesday, November 16 at 8:30 am ET. To access the call, please dial 1-877-407-9716 (within the U.S.) or 1-201-493-6779 (outside the U.S.) and provide conference ID 13724604. A live webcast of the conference call can be accessed via the Events and Presentations section of the Field Trip Health Investor Relations website here.

For those unable to attend the live call, a telephonic replay will be available until 11:59 pm ET on Tuesday, November 30, 2021. To access the replay of the call dial 1-844-512-2921 (within the U.S.) or 1-412-317-6671 (outside the U.S.) and provide conference ID 13724604. An archived copy of the webcast will be available on the Events and Presentations section of the Field Trip Health Investor Relations website after the conclusion of the call.

About Field Trip Health Ltd.

Field Trip is a global leader in the development and delivery of psychedelic therapies. With our Field Trip Discovery division leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics and our Field Trip Health division building centres for psychedelic therapies opening across North America and Europe along with the digital and technological tools that will enable massive scale, we help people in need with a simple, evidence-based way to heal and heighten engagement with the world.

Learn more at https://www.meetfieldtrip.com, https://www.fieldtriphealth.com and https://www.fieldtriphealth.nl.

Follow us on Twitter and Instagram: @fieldtriphealth.

To receive company updates about Field Trip and to be added to the email distribution list please sign up here.

Cautionary Note Regarding Forward-Looking Information  

This release includes forward-looking information (within the meaning of Canadian securities laws and within the meaning of the United States Private Securities Litigation Reform Act of 1995) regarding Field Trip and its business. 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 statements are based on the current expectations and views of future events of the management of Field Trip and are based on assumptions and subject to risks and uncertainties. Although the management of Field Trip believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including the timing, completion and potential outcomes of the Strategic Review, the funds available to Field Trip and the use of such funds, the ability of Field Trip to operate its clinics, the construction and commencement of construction of additional clinics, the development, patentability and viability of FT-104 and the FT-200 Group, the ability of Field Trip to complete an investigational new drug application and obtain regulatory approvals, as required, prior to initiating clinical trials for FT-104 and molecules within the FT-200 Group, the ability of Field Trip to meet eligibility requirements for clinical testing and through to more complex clinical trials, the ability of Field Trip to obtain regulatory approvals prior to each clinical trial and the ability of Field Trip to generate patient member growth, interest in the training program, interest in the KAP Co-Op Program, uptake of the KAP Co-Op Program by therapists and patients, the ability of management to sustain and continue optimization of its clinical operations, the timing and results of its research and development programs, approval of phase 1 human trials, if any, the risk that future clinical studies may not proceed as expected or may produce unfavorable results, the opening of additional clinics, the COVID-19 epidemic, the medical clinic industry, market conditions, economic factors, management’s ability to manage and to operate the business and the equity markets generally. Although Field Trip has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Field Trip does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Additional information relating to Field Trip, including its Annual Information Form, can be located on the SEDAR website at www.sedar.com and on the EDGAR section of the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities.

Neither the Toronto Stock Exchange, nor its Regulation Services Provider, have approved the contents of this release or accept responsibility for the adequacy or accuracy of this release.

CONTACTS:

Media contacts:
Rachel Moskowitz
Autumn Communications
202-276-7881
press@fieldtriphealth.com

Nick Opich / McKenna Miller
KCSA Strategic Communications
212-896-1206 / 347-487-6197
press@fieldtriphealth.com

Investor contacts:
Kathleen Heaney / Tim Regan
KCSA Strategic Communications
fieldtripIR@kcsa.com

SOURCE Field Trip Health Ltd.

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Red Light Holland Psilocybin Truffles, Sold in The Netherlands, Complete First Evaluation Under a Health Canada Approved cGMP Laboratory

Red Light Holland Psilocybin Truffles, Sold in The Netherlands, Complete First Evaluation Under a Health Canada Approved cGMP Laboratory

  • Red Light Holland is continuing its groundbreaking working synergies with Shaman Pharma Corp. and their cGMP laboratory partner, CCrest Laboratories Inc. who holds a Controlled Drugs and Substances License issued by Health Canada

  • Red Light Holland previously completed two exports, under Health Canada psilocybin import permits, for commercial sale of psilocybe truffles grown in the Company’s farm in Horst, Netherlands to CCrest Laboratories’ cGMP pharmaceutical laboratory in Montreal, Canada

  • Red Light Holland’s psilocybe truffles are being evaluated and tested by CCrest Laboratories for:
    • The suitability of Red Light Holland’s naturally occuring psilocybin as a source of active pharmaceutical ingredients (“API”) for scientific and potentially medical and therapeutic purposes
    • Providing Red Light Holland customers with scientific information regarding relative strength of different truffles strain sold
    • Moving towards dose standardization in anticipation of Oregon measure 109 and potentially other world wide locations.

  • Red Light Holland and CCrest Laboratories continue to demonstrate their strong commitment to the highest regulatory compliance standards

Toronto, Ontario–(Newsfile Corp. – November 15, 2021) – Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTC Pink: TRUFF) (“Red Light Holland” or the “Company“), an Ontario-based corporation engaged in the production, growth and sale of a premium brand of magic truffles, is pleased to announce that it has received the first reports, produced by Shaman Pharma Corp. and CCrest Laboratories Inc. under Health Canada approval, evaluating the suitability of Red Light Holland’s natural psilocybin as a source of active pharmaceutical ingredients (“API”) for scientific and potentially medical and therapeutic purposes.

“This report is a step forward both for the recreational market, as well as the pharmaceutical market interested in naturally occurring psilocybin. We’re excited to share some of the scientific findings from the report on the three different truffles strains that we grow in The Netherlands, for our newly launched variety of products such as the iMicrodose Triniti pack, featuring all three strains that were tested,” said Todd Shapiro, CEO and Director of Red Light Holland. “Red Light Holland and Shaman Pharma are once again pushing the limits, having a true ally and partner with cutting-edge scientific expertise to evaluate our truffles. This is certainly a major milestone in Red Light Holland’s mandate of pursuing research and development, product advancements, technology and applied science which bolsters our Scarlette Lillie Science and Innovation division.”

Red Light Holland initially supplied its truffles in March 2021, with a second shipment in August 2021, to CCrest Laboratories, a cGMP pharmaceutical laboratory in Montreal enabled with a Health Canada Controlled Drugs and Substances license, specializing in highly regulated narcotics, including psychedelics. The raw materials proved to be suitable to complete the first phase of the scientific research, which included the development of proprietary analytical methods and protocols, such as assays to determine the presence and concentration of psilocybin and performing extraction to isolate psilocybin, from both fresh and dried sclerotia.

These cGMP compliant scientific methods and protocols of Quality Control, Analysis and Extraction are aimed at developing intellectual property for achieving the industrial-scale commercialization of medical purpose psychedelic substances in this emerging pharmaceutical sector. Exceeding the exacting regulatory requirements opens a new realm of possibilities for disruptive healthcare innovation using natural psychedelic mushroom derivatives.

Given the prohibited status of psilocybin, listed along Schedule I drugs under the United Nations 1971 Convention on Psychotropic Substances, science on the subject has remained limited, mostly manifested in the literature and methods produced in academic settings. Some of the known compounds in magic mushrooms – psilocybin, psilocin, norpsilocin, baeocystin, norbaeocystin, and aeruginascin – present similarities in their molecular structure, yet these chemicals can react with significant variation in the laboratory, and their little-known differences in behavior once inside the body could prove complimentary or synergistic, possibly creating a so-called entourage effect.

The report demonstrates that different solvents, such as water and methanol in various ratios, render extraction at different speed and quantity and can transform the compounds in the process. Using the same materials with various process modifications, the individual effect on an organism (e.g., human) could yield a significant difference in cognitive experience. In human metabolism, psilocybin is primarily a pro-drug that is dephosphorylated to active metabolite psilocin. One variation in the extraction method has yielded exclusively psilocin, indicating it could bypass dephosphorylation in the metabolism. These variations can lead to discovering innovative delivery mechanisms, which could provide better control between the onset speed and effective duration.

As one of the involved scientists explains, they have positively answered the hypothesis “what if?…” Red Light’s truffles are a viable source of active compounds, the next objective is using the compounds in the development process of pharma-grade ingredients or creating standardised doses for legal markets. With the first phase considered a success, the companies are wrapping up this work and moving to the next phases.

The scientists are now focusing on optimizing the extraction yield, as well as generating comparative data between the raw material attributes: genetic, size and weight, water content, and so on, as factors that can establish the proportions and total content of the various compounds, in a newly developed proprietary protocol identified as SP1-173-L – Qualitative and Quantitative Determination of Psilocybin & Psilocin truffles and mushrooms by Liquid Chromatography.

The objective of the SP1-173-L protocol is to assess the content of compounds in three species of truffles: Galindoi, Mexicana & Tampanensis, using the Liquid Chromatography method developed at CCrest Laboratories. The study will address the suitability of the analytical procedure, the assay of compounds in the three varieties of truffles and the variability of contents within the species and truffles size. Water content will be determined for all specified and sized samples. The tests will be performed by trained analysts at CCrest Laboratories, ensuring that the facilities and instrumentation are properly calibrated and qualified as needed. The laboratory systems will be in compliance with applicable regulations and in-house general laboratory procedures.

This protocol defines the experimental design and the data to be collected for the comparison of compounds contained in truffles of different size and species. The assay is conducted on three species of truffles, supplied by Red Light Farm. The data evaluation consists of:

  • Evaluation of the suitability of the analytical procedure SP1-173-L (precision and repeatability of injection).
  • The comparison of content of compounds will be obtained from three different samples from each species: small truffles, big truffles and a mix of small and big truffles, for a total of nine samples.
  • Determination of water content in the three different species of fresh truffles: Galindoi, Mexicana and Tampanensis.

In previous assays detailed in the reports, the Mexicana species appeared to be the most potent by a few percentage points, measuring at just under 1mg/gram of combined psilocybin and psilocin. The Tampanensis showed the highest proportion of psilocybin, the psilocin composing less than 10% of the total. The Galindoi, while the least potent overall, demonstrated the most balanced mix, with the psilocin equal to slightly more than 50% of the psilocybin content. While these three species are currently sold legally in the Netherlands, due to regulatory restrictions it has not been possible before now to achieve this level of comparison in a formal cGMP setting.

“We are advancing in uncharted territory where we are discovering a promising horizon, so we are definitely motivated to keep moving forward. This scientific work barely scratches the surface of possibilities, we are excited to increasingly deploy our proven pharma abilities in deepening the qualification of Red Light Holland`s truffles as a source of novel therapeutic ingredients,” commented Alex Grenier, CEO of Shaman Pharma and President of CCrest Laboratories. “While synthetic psychedelics are dominating the field, it makes sense to look at the original natural source, because something like an entourage effect would not be reproduced by synthesis. Just as much-hyped artificial cannabinoid analogues were not successful in displacing phytocannabinoids (marijuana), we anticipate the development of a tremendous share of demand for natural psychedelic mushroom derivatives, initially to supply research before cascading downstream to larger markets. Our approach, which is scientific, rigorous, and calculated, is also tailored to the real-world movement out there, the active audience for psychedelics, including many scientists, who are demanding natural origins.”

Red Light Holland continues to establish itself as a leader in the recreational sector and push for legal, responsible and safe access to natural psychedelic truffles/mushrooms while Scarlette Lillie Science and Innovation pursues research and development, technology, and applied science.

About Red Light Holland

Red Light Holland is an Ontario-based corporation engaged in the production, growth and sale (through existing Smart Shops operators and an advanced e-commerce platform) of a premium brand of magic truffles.

For additional information on the Company:
Todd Shapiro
Chief Executive Officer & Director
Tel: 647-643-TRIP (8747)
Email: todd@redlighttruffles.com
Website: https://redlighttruffles.com/

Forward-Looking Statements

About Shaman Pharma Corp.

Shaman Pharma is a federally registered Canadian corporation with the mission to power outstanding psychedelic life science innovation. Accelerating time-to-market through its portfolio of assets, Shaman launches and consolidates revenue-driven pharma-biotech life sciences ventures focused on supplying psychedelic drugs & novel active ingredients.

Forward-Looking Statements

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties, certain of which are beyond the control of Red Light Holland. Forward-looking statements are frequently characterized by words such as “plan”, “continue”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. Forward looking statements include, but are not limited to: statements with respect to the evaluation and testing of the Company’s naturally occurring psilocybe truffles by CCrest Laboratories for scientific and medical purposes; the potential of the Company’s products being used for scientific and medical purposes; statements with respect to the Company’s expansion into the mental wellness pharmaceutical sector; the future sharing of the test results with the Company’s customers and shareholders; and the Company’s ability to establish itself as the leader in the recreational psychedelics sector.

Forward-looking information is based on a number of key expectations and assumptions made by Red Light Holland, including without limitation: the COVID-19 pandemic impact on the Canadian economy and Red Light Holland’s business, and the extent and duration of such impact; no change to laws or regulations that negatively affect Red Light Holland’s business; there will be a demand for Red Light Holland’s products in the future; no unanticipated expenses or costs arise; the Company will be able to continue to develop products that are allowed to be imported and sold under Health Canada’s import permit; and the partnership with Shaman Pharma Corp. will help Red Light Holland to achieve its business goals. Although the forward-looking information contained in this news release is based upon what the Company believes to be reasonable assumptions, it cannot assure investors that actual results will be consistent with such information.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the inability of the Company to continue as a going concern; the inability of the Company to obtain all necessary governmental and/or other regulatory approvals, licenses, and permits necessary to operate and expand the Company’s facilities; the effect of regulatory and/or political change and its effect on the legislation and regulations surrounding the psychedelics industry; p negative perception of the medical-use and adult-use psilocybin industry; the inability of CCrest to complete the planned testing of the Company’s products; the potential unviability of psilocybin for medical and/or scientific purposes; the inability of the Company to continue its growth; the Company’s limited operating history; reliance on management; the Company’s requirements for additional financing; and competition for mental health and wellness investments.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.