Expanding Reach in Rapidly Growing Ketamine Therapy Market

LOS ANGELES, March 22, 2023 (GLOBE NEWSWIRE) — Irwin Naturals Inc. (CSE: IWIN) (OTC: IWINF) (FRA: 97X) (“Irwin” or the “Company”) is thrilled to announce the successful acquisition of Keta Media, LLC, dba Ketamine Media (“Ketamine Media”) as of March 17, 2023. Ketamine Media is the nation’s foremost advertising company dedicated to raising awareness about the clinical use of ketamine. The agreement with Ketamine Media was initially announced on September 29, 2022.

The acquisition, which was completed on March 17, 2023, represents two significant milestones in Irwin’s growth strategy for its Emergence clinics in the mental health industry. Firstly, the acquisition is anticipated to have a positive impact on the company’s annualized EBITDA. Secondly, the addition of this premier marketing agency showcases Irwin’s capacity to attract top-tier talent as it aims to establish the world’s largest network of psychedelic mental health clinics.

This acquisition empowers Irwin Naturals to broaden its presence in the burgeoning ketamine therapy market and offer a diverse array of innovative marketing solutions to support the company’s products and services. Through this acquisition, Irwin plans to expedite the establishment of new potential clinic locations and harness Ketamine Media’s expertise to enhance utilization rates at its existing and future Emergence clinics.

Klee Irwin, founder and CEO of Irwin Naturals, expressed his enthusiasm, stating, “We are delighted to welcome the Ketamine Media team to the Irwin Naturals family. We believe that acquiring Ketamine Media will propel us to new heights in the ketamine therapy market, as we collaborate to deliver cutting-edge marketing solutions for our clients.”

Chris Walden, CEO of Ketamine Media, added, “We are committed to maintaining the high level of service our clients have come to expect. This deal provides us with growth capital, allowing Ketamine Media to rapidly expand our advisory services, significantly benefiting all our clients. We aim to foster greater collaboration within this emerging sector among local market providers. In our discussions with Irwin Naturals, we discovered shared values and goals, including a mutual commitment to helping our existing clients achieve the outcomes that initially led them to partner with Ketamine Media. We have full confidence in Irwin Naturals’ strategic vision to become a leading international brand of psychedelic mental health clinics.”

The total consideration at closing will be paid in cash, including the assumption of certain debts of Ketamine Media.

About Irwin Naturals

Irwin Naturals has been a household name and best-in-class nutraceutical company since 1994. It is now leveraging its brand into both the cannabis and psychedelic sectors. On a mission to heal the world with plant medicine, Irwin has operated profitably for over 27 years¹. The growing portfolio of products is available in more than 100,000 retail doors across North America, where 80% of households know the Irwin Naturals brand². In 2018, the Company first leveraged its brand to expand into the cannabis industry by launching hemp-based CBD products into the mass market. The Company is now leveraging its famous halo of brand trust to become, perhaps, the first household name brand to offer THC-based products. Its rapidly growing national chain of psychedelic mental health clinics is called Irwin Naturals Emergence.

To contact the Company’s Investor Relations department, please call toll-free at (800) 883-4851 or send an email to Investors@IrwinNaturals.com.

“Klee Irwin”
________________________________
Klee Irwin
Chief Executive Officer
T: 310-306-3636
investors@irwinnaturals.com

IR Information

Press Contact

Irwin Naturals Investor Relations
Cassandra Bassanetti-Drumm
T: 310-306-3636
investors@irwinnaturals.com

Regulatory Overview

The following is a brief summary of regulatory matters concerning ketamine in the United States (“US”). Under the Controlled Substances Act (21 U.S.C. § 811) (the “CSA”), ketamine is currently a Schedule III drug as well as being listed under the associated Narcotic Control Regulations, and psilocybin is currently a Schedule I drug.

Most US States have enacted Controlled Substances Acts (“State CSAs”) which regulate the possession, use, sale, distribution, and manufacture of specified drugs or categories of drugs and establish penalties for State CSA violations and form the basis for much state and local drug laws enforcement activity. State CSAs have either adopted drug schedules identical or similar to the federal CSA schedules or, in some instances, have incorporated the federal scheduling mechanism. Among other requirements, some US States have established a prescription drug monitoring or review programs collect information about prescription and dispensing of controlled substances for the purposes of monitoring, analysis and education.

In the United States, facilities holding or administering controlled substances must be registered with the US Drug Enforcement Agency (“DEA“) to perform this activity. As such, medical professionals and/or the clinics in which they operate, as applicable, are also required to have a DEA license to obtain and administer ketamine (a “DEA License“). While ketamine is a controlled substance in the United States, it is approved for general anesthetic induction under the US Food, Drug, and Cosmetic Act. Once a drug is approved for use, physicians may prescribe that drug for uses that are not described in the product’s labelling or that differ from those tested by the manufacturer and approved by the Food and Drug Administration (the “FDA“). Licensed medical practitioners may prescribe ketamine legally in Canada or the United States where they believe it will be an effective treatment in their professional judgment.

Please see Irwin’s filing statement on its SEDAR profile for more information on the regulatory environment and regulations surrounding the US THC industry.

Forward-Looking Information

This news release contains certain forward-looking statements that reflect the current views and/or expectations of management of the Company with respect to performance, business and future events. Forward-looking statements can often be identified by words such as “may”, “will”, “would”, “could”, “should”, “believes”, “estimates”, “projects”, “potential”, “expects”, “plans”, “intends”, “anticipates”, “targeted”, “continues”, “forecasts”, “designed”, “goal”, or the negative of those words or other similar or comparable words. Forward-looking statements are based on the then-current expectations, beliefs, assumptions, estimates and forecasts about the business and the industry and markets in which the Company operates. Forward-looking statements in this news release include statements related to the impact of the acquisition of Ketamine Media on the existing Irwin Naturals Emergence business and the ability to establish new clinic locations, These statements are based on numerous assumptions that are believed by management to be reasonable in the circumstances, and are subject to a number of risks and uncertainties, including without limitation: board and regulatory approval, including the approval of the Canadian Securities Exchange; Irwin being able to acquire and/or enter into business relationships to enter into these new markets; the Company obtaining the required licenses; and changes to regulations and laws regarding cannabis or psychedelics. Forward-looking statements are subject to a number of known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to be materially different from that which are expressed or implied by such forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks, uncertainties, and assumptions which are difficult to predict. Accordingly, readers should not place undue reliance on forward-looking statements and information, which are qualified in their entirety by this cautionary statement. The Company does not undertake any obligation to release publicly any revisions for updating any voluntary forward-looking statements, except as required by applicable securities law.

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

SOURCE: Irwin Naturals Inc.

_______________________________

¹ Under several corporate structures, Klee Irwin has operated the Irwin brand profitably since 1994, as measured by EBITDA adjusted for extraordinary costs.

² Consumer brand recognition information is based on a Company survey with a sample size of 500 randomly selected adults.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

• Strategic transaction assembles an experienced management and scientific team world-renowned in mental health treatment, research and development
• Establishes large footprint of 17 specialized mental health clinics across North America, enhanced by a telehealth platform expected to extend access to critical treatments for millions of people across multiple states in the US
• Combined network of clinics creates a leading international mental health research platform for in-human clinical development of novel therapeutics

Toronto, Ontario–(Newsfile Corp. – January 27, 2023) – Braxia Scientific Corp. (CSE: BRAX) (OTC Pink: BRAXF) (FSE: 4960) (“Braxia “, or the “Company”) a medical research company providing psychiatric, innovative ketamine and psilocybin treatments for mental health disorders, is pleased to announce it has entered into a non-binding amended and restated letter of intent (“LOI”) for a business combination with Irwin Naturals Inc. (CSE: IWIN) (OTCQB: IWINF) (FSE: 97X) (“Irwin”) . Irwin has been one of North America’s leading health and wellness companies for nearly three decades and has recently developed a rapidly growing network of mental health clinics in the US. The LOI sets forth the material terms and conditions upon which Irwin will acquire all of the issued and outstanding common shares (the “Braxia Shares”) of Braxia (the “Proposed Transaction”).

Under the terms of the LOI, Irwin is prepared to offer a purchase price per Braxia Share based upon a valuation of the outstanding Braxia Shares of US$30,000,000 and a deemed value per subordinate voting share (“Irwin Share”) and/or proportionate voting share of Irwin (“Consideration Shares”) equal to the greater of US$3.00 and the volume weighted average trading price of Irwin Shares on the Canadian Securities Exchange (the “CSE”) for the 20 trading days immediately prior to the execution of the Arrangement Agreement. The purchase price would be payable on closing of the Proposed Transaction (the “Closing Date”) by the issuance of Consideration Shares to each holder of Braxia Shares. Based on the closing price of Irwin Shares and Braxia Shares on the CSE on January 25, 2023 of C$3.80 and C$0.05, respectively, the purchase price and exchange ratio imply a 315.72% premium to the price of Braxia Shares. The number of Consideration Shares will also be adjusted upward in the event that the total consideration received by holders of Braxia Shares is less than US$30,000,000, to be determined at a specified period of time after the Closing Date and as set forth in the Arrangement Agreement.

The final purchase price per Braxia Share and the exchange ratio will be set forth and determined at the time the Arrangement Agreement is executed. The LOI further provides that the Consideration Shares would be subject to a lock-up period (the “Lock-Up”) and would be restricted from transfer or sale for a period of 6 months after the Closing Date. Insiders of Braxia would be subject to a Lock-Up period of 12 months from the Closing Date.

Additionally, under the terms of the LOI and in connection with the Proposed Transaction, it is expected that the convertible securities of Braxia would, pursuant to the Arrangement Agreement, either remain outstanding in accordance with their terms or be exchanged for substantially similar securities of Irwin.

The LOI is non-binding and there is no assurance that the Proposed Transaction will be completed as proposed. The completion of the Proposed Transaction is subject to, among other things (i) completion of satisfactory due diligence by each of Braxia and Irwin; (ii) negotiation of and the entering into of a binding definitive Arrangement Agreement in connection with the Proposed Transaction; (iii) receipt of all required corporate approvals from the board of directors of Braxia and Irwin, respectively, and all regulatory and shareholder approvals, including the approval of the CSE and any required third-party consents: and (iv) Braxia having at least C$575,000 in working capital immediately before closing on the Closing Date.

Creating a New Market Leader in US and North American Mental Health

The combined business creates a new market leader with operations in multiple markets in the US (~40+ markets) and in Canada across three important business verticals;

• Clinics: A large and rapidly growing network of clinics providing much needed mental health services. The network of clinics will act as highly specialized hubs of excellence with several deployed in larger population centers, while others will be deployed more regionally to greatly improve and expand access to mental health services throughout the North American market;

• International Clinical Research Services: A leading mental health clinical research organization (CRO) providing in-human clinical study services to a growing pipeline of strategic pharmaceutical sponsors and partners looking to develop innovative therapeutic and diagnostic products to secure marketing authorization from FDA and other health regulators;

• Telehealth: A telehealth platform (KetaMD) designed to expand access to patients virtually in ~40+ US state, extending the operational reach of the clinics within the network, providing services to patients directly in their own home, and multiplying the supply of mental health services available in the market today.

Dr. Roger McIntyre, CEO, Braxia Scientific commented, “With a proven track record of execution in the wellness sector spanning nearly three decades, Irwin has established a strong foothold in mental health. Its growing network of US based clinics combined with its experienced team and access to capital, makes Irwin an excellent partner for Braxia. More importantly, we will be able to quickly and better address the unmet need for treatment of millions of people living with mental health disorders across North America.”

Klee Irwin, CEO, Irwin Naturals, “We are excited to be building North America’s leading mental health and depression network under the medical expertise of Braxia’s scientific management team, including Dr. McIntyre, the world’s foremost expert in depression and ketamine research. This combination is a major accelerator and differentiator for Irwin’s network of Emergence^TM clinics across the US as we launch clinical research services for large pharma and emerging biotechnology companies and enhance our capacity with telemedicine capabilities. Additionally, we are pleased to continue support Braxia’s growth and access to more attractive financing making this an attractive potential business combination for Braxia shareholders.”

Adam Berk, President, Irwin Naturals added, “This combination will optimize the drive for growth of mental health services, creating a first mover advantage in many important markets in North America, while also expanding innovative drug development research to benefit from economies of scale across the businesses.”

None of the securities to be issued pursuant to the Arrangement Agreement have been or will be registered under the United State Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state securities laws, and any securities issued in the Proposed Transaction are anticipated to be issued in reliance upon available exemptions from such registration requirements pursuant to Section 3(a)(10) of the U.S. Securities Act and applicable exemptions under state securities laws. This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities.

About Irwin Naturals Inc.

Irwin Naturals has been a household name and best-in-class herbal supplement formulator since 1994. It is now leveraging its brand to enter into both the cannabis and psychedelic industries. On a mission to heal the world with plant medicine, Irwin has operated profitably for over 27 years.1 Irwin’s growing portfolio of products is available in more than 100,000 retail doors across North America, where nearly 100 million people know the Irwin Naturals brand.2 In 2018, the Company first leveraged its brand to expand into the cannabis industry by launching hemp-based CBD products into the mass market. The Company is now leveraging its famous halo of brand trust with an objective to become one of the first household name brands to offer THC-based products and psychedelic mental health treatment. Irwin Naturals became a publicly traded company on the Canadian Securities Exchange (CSE) in August 2021. The Company’s shares began to be traded on the OTCQB Venture Market in November 2021. More information on the Company’s stock can be found via Bloomberg as well as the Wall Street Journal.

About Braxia Scientific Corp.

Braxia Scientific is a medical research and telemedicine company with clinics that provide innovative ketamine treatments for persons with depression and related disorders. Braxia also launched its U.S. based end-to-end telemedicine platform KetaMD, that utilizes leading technology to provide access to safe, affordable, and potentially life-changing at-home ketamine treatments for people living with depression and related mental health conditions. 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 treatments in-person and virtually 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, Braxia Health (formerly the Canadian Rapid Treatment Center of Excellence Inc.), operates multidisciplinary community-based clinics offering rapid-acting treatments for depression located in Mississauga, Toronto, Kitchener-Waterloo, Ottawa, and Montreal.

ON BEHALF OF THE BOARD

“Dr. Roger S. McIntyre”
Dr. Roger S. McIntyre

Chairman & CEO

– 30 –

FOR FURTHER INFORMATION PLEASE CONTACT:

Braxia Scientific Corp.
Tel: 416-762-2138
Email: [email protected]
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, the potential for ketamine or other psychedelics to treat other mental health conditions, the ability of telemedicine and the Proposed Transaction to address the unmet need for mental health disorders or expand or accelerate the growth of Braxia or Irwin, the potential business or strategic advantages to either Irwin or Braxia in connection with the Proposed Transaction, the negotiation and execution of a definitive Arrangement Agreement, the completion and proposed terms of the Proposed Transaction and the acquisition of all of the issued and outstanding Braxia Shares, required conditions precedent to the Proposed Transaction, including regulatory, court, and securityholder approvals for the Proposed Transaction, and the anticipated benefits of the Proposed Transaction. 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 and its most recent MD&A, 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.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

Company continues to expand its national network of psychedelic mental-healthcare clinics

LOS ANGELES, Dec. 09, 2022 (GLOBE NEWSWIRE) — Irwin Naturals Inc. (CSE: IWIN) (OTC: IWINF) (FRA: 97X) (“Irwin” or the “Company”) completed the acquisition of the assets of Clare Clinic, Inc., d/b/a Florida Mind Health Center.

The Company entered into an acquisition agreement (the “Agreement”) dated October 30, 2022 with Clare Clinic, Inc., d/b/a Florida Mind Health Center, which serves clients out of three healthcare clinics in located in Gainesville, Tallahassee and Panama City, Florida.

The clinics join Irwin Naturals Emergence, a fast-growing national chain offering psychedelic mental healthcare that now includes 8 clinics in Florida.

Klee Irwin, CEO of Irwin Naturals, said “Our roll-up is quickly gathering momentum. This is the eighth ketamine clinic we are adding to our growing portfolio in Florida and is part of our 17 clinics which we have either acquired or have a definitive agreement to acquire in the near future, in over ten states. Our mission is to make this amazingly effective treatment available and accessible throughout the country and beyond. We continue to add to our bottom line through these highly accretive transactions as we focus on acquiring profitable operations.”

Zohar Levites, CRNA, ARNP, MS, founder of Florida Mind Health Center, said “We are very excited to be merging with Irwin Naturals and to be a part of something bigger in a field that could transform the way disorders are treated in Florida and nationwide. As a partner of Irwin Naturals Emergence, we will be able to offer cutting-edge services and compassionate care under the name of a household brand with decades of trust among customers.”

Building a national chain will create some efficiencies and the cost-benefits that come from economies of scale. The incorporation of Irwin Naturals best practices over time will also help drive down operating costs, savings that can be passed on to customers by providing sliding-scale discounts.

Transaction terms

As consideration for the asset purchase, Irwin Naturals will provide sellers cash payments as well as 1,500,000 subordinate voting shares upon closing. Furthermore, the transaction includes an additional contingent consideration based on future milestones related to operational and profitability targets to be satisfied in shares.

About Irwin Naturals

Irwin Naturals has been a household name and best-in-class herbal supplement formulator since 1994. It is now leveraging its brand to enter into both the cannabis and psychedelic industries. On a mission to heal the world with plant medicine, Irwin has operated profitably for over 27 years.¹ Irwin’s growing portfolio of products is available in more than 100,000 retail doors across North America, where nearly 100 million people know the Irwin Naturals brand.² In 2018, the Company first leveraged its brand to expand into the cannabis industry by launching hemp-based CBD products into the mass market. The Company is now leveraging its famous halo of brand trust with an objective to become one of the first household name brands to offer THC-based products and psychedelic mental health treatment. Irwin Naturals became a publicly traded company on the Canadian Securities Exchange (CSE) in August 2021. The Company’s shares began to be traded on the OTCQB Venture Market in November 2021. More information on the Company’s stock can be found via Bloomberg as well as the Wall Street Journal.

For investor-related information about the Company, please visit ir.irwinnaturals.com/

To contact the Company’s Investor Relations department, please call toll-free at (800) 883-4851 or send an email to [email protected].

“Klee Irwin”
________________________________
Klee Irwin
Chief Executive Officer
T: 310-306-3636
[email protected]

IR Information

Press Contact

Irwin Naturals Investor Relations
Cassandra Bassanetti-Drumm
T: 310-306-3636
[email protected]

Regulatory Overview

The following is a brief summary of regulatory matters concerning ketamine in the United States (“US”). Under the Controlled Substances Act (21 U.S.C. § 811) (the “CSA”), ketamine is currently a Schedule III drug as well as being listed under the associated Narcotic Control Regulations and psilocybin is currently a Schedule I drug.
Most US States have enacted Controlled Substances Acts (“State CSAs”) which regulate the possession, use, sale, distribution, and manufacture of specified drugs or categories of drugs and establish penalties for State CSA violations and form the basis for many state and local drug laws enforcement activity. State CSAs have either adopted drug schedules identical or similar to the federal CSA schedules or, in some instances, have incorporated the federal scheduling mechanism. Among other requirements, some US States have established a prescription drug monitoring or review programs collect information about prescription and dispensing of controlled substances for the purposes of monitoring, analysis and education.

In the United States, facilities holding or administering controlled substances must be registered with the US Drug Enforcement Agency (“DEA”) to perform this activity. As such, medical professionals and/or the clinics in which they operate, as applicable, are also required to have a DEA license to obtain and administer ketamine (a “DEA License”). While ketamine is a controlled substance in the United States, it is approved for general anesthetic induction under the US Food, Drug, and Cosmetic Act. Once a drug is approved for use, physicians may prescribe that drug for uses that are not described in the product’s labeling or that differ from those tested by the manufacturer and approved by the Food and Drug Administration (the “FDA”). Licensed medical practitioners may prescribe ketamine legally in Canada or the United States where they believe it will be an effective treatment in their professional judgment.

Please see Irwin’s filing statement on its SEDAR profile for more information on the regulatory environment and regulations surrounding the US ketamine industry.

Forward-Looking Information

This news release contains certain forward-looking statements that reflect the current views and/or expectations of management of the Company with respect to performance, business and future events. Forward-looking statements can often be identified by words such as “may”, “will”, “would”, “could”, “should”, “believes”, “estimates”, “projects”, “potential”, “expects”, “plans”, “intends”, “anticipates”, “targeted”, “continues”, “forecasts”, “designed”, “goal”, “objective,” or the negative of those words or other similar or comparable words. Forward-looking statements are based on the then-current expectations, beliefs, assumptions, estimates and forecasts about the business and the industry and markets in which the Company operates. Forward-looking statements in this news release include statements related to information concerning the ability of the Company to perform the terms of the transaction referenced herein; the receipt of all necessary approvals, including regulatory approvals; expectations for other economic, market, business and competitive factors; and the Company actually entering into and doing business in the U.S. cannabis and psychedelics markets. The potential entrance by the Company into these new business segments are in their preliminary stages and may be subject to approval from the board of directors of the Company as well as any regulatory approval, including that of the Canadian Securities Exchange. These statements are based on numerous assumptions that are believed by management to be reasonable in the circumstances, and are subject to a number of risks and uncertainties, including without limitation: board and regulatory approval, including the approval of the Canadian Securities Exchange; Irwin being able to acquire and/or enter into business relationships to enter into these new markets; the Company obtaining the required licenses; and changes to regulations and laws regarding cannabis or psychedelics. Further information on the regulatory environment and risks will be contained in future disclosures. Forward-looking statements are subject to a number of known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to be materially different from that which are expressed or implied by such forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks, uncertainties, and assumptions which are difficult to predict. Accordingly, readers should not place undue reliance on forward-looking statements and information, which are qualified in their entirety by this cautionary statement. The Company does not undertake any obligation to release publicly any revisions for updating any voluntary forward-looking statements, except as required by applicable securities law.

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

SOURCE: Irwin Naturals Inc.

__________________________________

¹ Under several corporate structures, Klee Irwin has operated the Irwin brand profitably since 1994, as measured by EBITDA adjusted for extraordinary costs.
² Consumer brand recognition information is based on a Company survey with a sample size of 500 randomly selected adults.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

MIAMI, Dec. 07, 2022 (GLOBE NEWSWIRE) — Ehave, Inc., (OTC Pink: EHVVF) (the “Company”), a Healthcare Analytics provider with interests in the psychedelic and mental health sectors, today issued a letter to shareholders from its Chief Executive Officer, Ben Kaplan.

Dear Fellow Shareholders

As 2022 draws to a close, many of us will reflect on a year that saw global economic activity experiencing a broad-based and sharper-than-expected slowdown, increased inflation higher than we have seen in several decades, and higher interest rates. Despite these challenges and many others, I am very proud of our Ehave team’s accomplishments in advancing our business plan. Our team executed several vital acquisitions, expanded our research capabilities, and realized many more achievements in our effort to continue to build on our strong foundation.

At the outset, I would like to provide an update on the triangular merger between our publicly traded Mycotopia Therapies (OTC: TPIA) subsidiary, Ei.Ventures, and PSLY.com. The $380 million transaction is structured to close when PSLY.com receives approval for trading on NASDAQ. We are following the procedures for this process as set forth by NASDAQ and the SEC. All parties involved are committed to completing the transaction. This transaction is important to Ehave shareholders because Ehave owns approximately 9,793,754 shares of Mycotopia Therapies. I expect to provide additional updates on this transaction and how it will affect our Ehave shareholders in the near future.

KetaDASH

I want to highlight several significant milestones our Ehave team has achieved in 2022. In February, Ehave purchased 100% of Rejuv IV, a mobile IV therapy provider in the San Francisco Bay Area. Rejuv IV became KetaDASH, a wholly owned subsidiary of Ehave, Inc. KetaDASH provides mobile Ketamine treatments for treatment-resistant depression, anxiety, PTSD, and other conditions, as well as IV infusions with fluids, essential vitamins, minerals, and electrolytes to enhance the health and wellness of its patients. After an initial telemedicine visit, a team of experienced physicians, therapists, and nurses administer every KetaDASH treatment in the patient’s home, office, or mobile location. This innovative service departs from in-clinic intravenous, treatment, or unsupervised telehealth models to an at-home ketamine administration with telehealth and in-person medical supervision.

A typical KetaDASH experience incorporates a prescribing doctor, a nurse for administration and monitoring, and psychotherapists for integration, all from the comfort of the patient’s home. Our KetaDASH team is pioneering efforts in precision medicine through Ehave’s partnership with Entheon Biomedical Corp.’s (CSE: ENBI) (OTCQB: ENTBF) HaluGen Life Sciences division. Our KetaDASH subsidiary is one of the first psychedelic companies to test patients with HaluGen’s expanded psychedelics genetic testing panel. This panel analyzes a series of relevant DNA biomarkers and utilizes pre-screening mental health surveys in order to provide insights into an individual’s risk and potential for adverse reactions with the use of ketamine. Ehave’s KetaDASH subsidiary is fully operational in Sacramento and San Francisco.

KetaDASH Miami

In June, Ehave took delivery of its first mobile KetaDASH unit, a custom high-end medical van utilizing KetaDASH’s software platform. The KetaDASH Mobile Unit was specifically designed to focus on the efficacy of the treatment in a relaxed setting with the patient’s safety and comfort in mind. At the present time, KetaDASH is focusing on health, wellness, and mental health in the Miami area. KetaDASH currently does not offer ketamine treatments in Miami, but plans to start offering them in the first half of 2023.

KetaDASH Miami currently offers IV infusions with fluids, essential vitamins, minerals, and electrolytes to enhance the health and wellness of its patients. These infusions include IV Drip Detox and Hangover Cures, IV Vitamin Therapy for Pain Management, IV Hydration Therapy for Health & Wellness, and IV Therapy for Athletic Advantage and Fitness Recovery. Every infusion is administered by a qualified health care professional to ensure the safety of our patients.

Follow KetaDASH on Instagram at www.instagram.com/ketadash.usa.

MetaHealthU

MetaHealthU provides patients with a way to integrate providers, create troves of usable data for researchers, and clinicians to improve the care our nation’s health system provides to its patients, providing a platform for precision health and giving patients ownership of their data. MetaHealthU focuses on interoperability, population health, and data ownership, and it has created a system that will work by providing patients the opportunity to own their health data.

We reached a milestone of 600 new users on our MetaHealthU platform during the last half of the year. The new users have found tremendous success with the platform and have compiled usable data on specific medical conditions like erectile dysfunction and fatigue. Many of these users have also used our mobile services in KetaDASH Miami.

Our Ehave team developed MetaHealthU as a powerful mobile application platform that empowers individuals to take complete control of their health and their healthcare data. With MetaHealthU, users can securely track all their health data from wearables, Electronic Health Records Systems (EHRs), doctors, and medical labs. The app is available for iOS 11.0 or later and Android. It includes a “digital file cabinet” for medical records. Users can log into their patient portals on various healthcare systems and medical labs and download their medical records in the digital file cabinet. Its features include easy-to-use navigation and search capabilities for users to collect, file, and tag their medical records on a mobile device. More information on MetaHealthU, as well as a free download of the app, can be found at https://apps.apple.com/us/app/metahealthu/id1600512401.

MetaHealthYuru

MetaHealthYuru is a personal mental health monitor that screens for early signs of mental health conditions, such as stress and depression. MetaHealthYuru uses voice analysis to screen for early signs of mental health conditions using a speech-based AI technology. Our MetaHealthYuru platform could potentially predict risk for various types of depression and mood and anxiety-based disorders years before a clinical diagnosis is obtained. This is accomplished by using vocal biomarkers to recognize your real emotional state and mood while tracking your mental health. Our technology can help detect and monitor subtle changes in the mental state by assessing individuals more frequently and objectively than the assessments used today. MetaHealthYuru can track your emotions and mood, analyze your mental state, and suggest potential treatments available for improving your mental well-being.

2023 and Beyond

In 2022 our Ehave team focused its efforts on developing our existing projects. We started the year with a large number and developed suitable metrics to gauge which ones will benefit the most from our resources. Moving forward, we intend to unlock the value created with our Mycotopia Therapies subsidiary and some of the company’s other investments. We also intend to focus our efforts on expanding our KetaDASH and MetaHealthU subsidiaries to propel Ehave into 2023 and beyond.

There is so much more to come.

Sincerely,

Ben Kaplan

Chairman and CEO, Ehave, Inc.

About Ehave, Inc.

Ehave is a leading healthcare services and technology company, focused on progressing psychedelics-to-Therapeutics by engineering novel compounds and new treatment protocols for treating brain health. Together with our network of scientists and mental health professionals, we are on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues, leveraging clinical data to help us achieve optimal patient outcomes. Ehave’s operations span across the entire USA, Canada, Jamaica, and Australia. Additional information on Ehave can be found on the Company’s website at: www.ehave.com.

Forward-Looking Statement Disclaimer

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements: (i) the initiation, timing, progress and results of the Company’s research, manufacturing and other development efforts; (ii) the Company’s ability to advance its products to successfully complete development and commercialization; (iii) the manufacturing, development, commercialization, and market acceptance of the Company’s products; (iv) the lack of sufficient funding to finance the product development and business operations; (v) competitive companies and technologies within the Company’s industry and introduction of competing products; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) loss of key management personnel; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its products and its ability to operate its business without infringing the intellectual property rights of others; (ix) potential failure to comply with applicable health information privacy and security laws and other state and federal privacy and security laws; and (x) the difficulty of predicting actions of the USA FDA and its regulations. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement unless required by law. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is contained under the heading “Risk Factors” in Ehave, Inc.’s Registration Statement on Form F-1 filed with the Securities and Exchange Commission (SEC) on September 24, 2015, as amended, which is available on the SEC’s website, http://www.sec.gov.

For Media and Investor Relations, please contact:

David L. Kugelman

(866) 692-6847 Toll Free – U.S. & Canada

(404) 281-8556 Mobile and WhatsApp

Email: [email protected]

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

ENGLEWOOD CLIFFS, NJ, Dec. 01, 2022 (GLOBE NEWSWIRE) — Silo Pharma, Inc. ( Nasdaq: SILO ) (“the Company”) , a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today issued a letter to shareholders highlighting the Company’s progress and potential for its portfolio of novel, IP-protected technologies and assets developed in collaboration with world-class medical research partners. The letter, in its entirety, is reprinted below.

Dear fellow Silo Pharma shareholders,

The healthcare market continues to build momentum as science and technology lead to new developments for therapeutics. Nowhere is this more evident than in the growing body of scientific research supporting the therapeutic potential of psychedelics. More than ever, alternative new therapies for numerous diseases and mental health disorders are needed to address the health challenges of today.

Our Company, Silo Pharma, Inc. (Nasdaq: SILO) is working diligently to make further advances in the medical and psychedelic space. To date, the research conducted has shown encouraging promise in the delivery, efficacy, and safety of our pipeline therapeutics and technologies.

This has been an exciting year where we have achieved numerous milestones and anticipate upcoming updates as our pipeline progresses. The purpose of this letter is to provide shareholders with an update on our current business. With over $12 million in cash, we are prepared to advance our pipeline, and believe, with our strong balance sheet, no debt, and recent listing on Nasdaq, that we are in a position to further advance the Company and create shareholder value.

Valuable Intellectual Property and Collaboration

We are focused on advancing traditional therapeutics with psychedelic research to treat underserved large markets. We believe that our novel IP-protected technologies and assets, developed in collaboration with world-class medical research partners, offer disruptive market potential.

The unique assets in our portfolio are well protected with issued and numerous provisional patents pending. We obtained these assets through exclusive drug development collaborations, including a joint venture with Zylö Therapeutics, Inc.; a license and option agreement and an investigator-sponsored study agreement with the University of Maryland, Baltimore; a sponsored study agreement and a licensing option agreement with Columbia University; and a sponsored research agreement with the University of California, San Francisco.

Several of our therapeutics may qualify us to pursue the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. This new drug application (NDA) process avoids unnecessary duplication of studies already performed on a previously approved drug, potentially saving clinical time and providing significant cost savings.

Potentially Transformative Assets with Disruptive Market Opportunity

SP-26 — F ibromyalgia

With our joint venture with Zylö Therapeutics, we are developing ketamine for sustained release which utilizes our partner’s Z-pod® technology, a topical drug delivery system developed at the Albert Einstein College of Medicine. Preclinical studies have already shown that the Z-pod can hold and distribute our proprietary ketamine formulation in a time-released manner. Topical administration of ketamine using this technology (designated as SP-26 by Silo Pharma) yielded neuropathic nerve pain reduction in a small animal study — positive results that could be promising for patients suffering from fibromyalgia, our initial indication. A safety evaluation study is currently underway to determine the maximum tolerated dosing data to be utilized in future trials.

We recently began working with our regulatory partner to prepare a pre-Investigational New Drug (IND) package for submission to support getting SP-26 into the clinic.

SPU-16 — M ultiple S clerosis (MS)

Last year, we entered into a license agreement with the University of Maryland, Baltimore (UMB) to examine a patented novel homing peptide for CNS also known as central nervous system (CNS) homing peptides (SPU-16), designed to access through the blood-brain barrier and then home to specific damaged tissue. Animal study results of the homing peptides have shown potential improved delivery of therapeutics and decreased toxicity. Our initial indication is MS.

SPU-21 — R heumatoid A rthritis (RA)

Under a separate commercial evaluation license agreement (CELA) with UMB, we are exploring the use of joint homing peptides (SPU-21) to deliver targeted therapeutics for the treatment of rheumatoid arthritis (RA), an autoimmune disorder. SPU-21 has been shown to inhibit arthritic progression in a preclinical animal model.

SPC-14 — Alzheimer’s Disease (AD)

Last year, we entered a CELA with Columbia University for two therapeutics. The agreement includes an option to license an Alzheimer’s disease therapeutic currently under development.

We recently announced proof-of-concept data supporting the therapeutic potential of this drug candidate (SPC-14) as a treatment for Alzheimer’s disease, as demonstrated in a mouse model. With safety data already available from the FDA-approved therapeutics in the compound, we believe that SPC-14 should be eligible for development under the FDA’s 505(b)(2) regulatory pathway.

SPC-15 — Stress Induced anxiety disorder and PTSD

Our second study with Columbia University examines a targeted prophylactic using ketamine compositions as a method of treatment and prevention for stress-induced affective disorders including post-traumatic stress disorder (PTSD). This treatment (SPC-15) predicts levels of severity or progression of such disorders, and their metabolomic biomarkers response to pharmacological treatments. Based on the research to date, SPC-15 could have an impact on treating stress and anxiety disorders.

Clinical S tudy — E ffects of P silocybin on I nflammatory A ctivity

We have sponsored a clinical study on the effects psilocybin may have on inflammation in the body under a sponsored research agreement with the University of California San Francisco. The study aims to support the implementation of psilocybin as a potential therapeutic for inflammation. The data from this study could provide support for the anti-inflammatory effect of psilocybin.

Therapies Target Underserved Medical Markets

The burgeoning psychedelic drugs market was valued at $2.8 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 17% to $9.8 billion in 2029. ¹ Against this landscape, the disease targets for our drug candidates represent large, underserved medical markets. Following are some facts and figures.

• Our initial indication for SP-26 is fibromyalgia , a disorder affecting about 4 million American adults, or about 2% of the adult population. It is a chronic condition causing pain to the connective tissues throughout the body including muscles, ligaments, and tendons. Musculoskeletal pain is often accompanied by sleep difficulties, fatigue, mood disorders, and problems with memory and concentration. According to Fortune Business Insights, the fibromyalgia treatment market is projected to grow from $764.1 million in 2020 to $1.4 billion in 2027, at a CAGR of 9.2% in the 2020-2027 period. ²
• SPU-16 targets multiple sclerosis , a debilitating neurological condition that causes the disruption of signal transmitting by the nervous system. Damage to the nerve fibers may cause fatigue, numbness and tingling, weakness, poor coordination, pain, depression, and problems with memory and concentration. As the most widespread disabling neurological condition of young adults, MS affects nearly a million Americans and approximately 2.8 million people worldwide. A report by Fortune Business Insights states that the global multiple sclerosis drugs market is projected to grow from $25.4 billion in 2022 to $33.2 billion by 2029, at a CAGR of 3.9%. ³
• SPU-21 targets rheumatoid arthritis , the most common autoimmune disease in the U.S. affecting around 1.5 million adults. RA is a systemic disease, but most often the immune system will attack the inner lining of the joints bringing pain, swelling, and stiffness that can be debilitating. A 2022 report published by Precedence Research states that the global rheumatoid arthritis drugs market size is expected to reach $70 billion by 2030 with a CAGR of 1.7% in that time period. ⁴
• Targeted by SPC-14, Alzheimer’s disease is an irreversible, progressive brain disorder that is the leading cause of dementia in older adults. AD and related diseases affect more than 6.5 million Americans over the age of 65, or about one in every nine Americans aged 65+. The loss of memory from AD is due to plaque, tangles, or loss of connections within the neural brain cells, which can also affect language, reasoning, visual/spatial skills, and mood. According to Growth+ Reports, the U.S. market for AD drugs is growing at a CAGR of over 7% and is expected to reach $9.7 billion by 2031. ⁵
  
  Targeted by SPC-15, anxiety, PTSD, and other stress-related disorders are becoming more frequent in Americans aged 18+. According to the World Health Organization in 2019, 300+ million people were living with an anxiety disorder, and according to the National Center for PTSD, around 12 million adults in the U.S. alone are reported to have PTSD. ^6 , 7 According to Fortune Business Insights, the global treatment market size for anxiety disorders and depression is projected to reach $13.0 billion in 2027.

Our financial position and balance sheet are strong with zero debt. We own intellectual property and technology rights. We believe our diversified therapeutic candidates have disruptive market potential and offer potentially groundbreaking treatment options for some of the most debilitating diseases and conditions.

We are deeply grateful to our shareholders and appreciate your continued support. We look forward to keeping you informed about the progress of our studies as we advance our programs toward the clinic. This is an exciting and transformative time for our Company.

With best regards,

Eric Weisblum
Chief Executive Officer

About Ketamine
Ketamine is an FDA-approved fast-acting general anesthetic administered through intravenous injection or nasal spray (milder form). Scientific research has shown that ketamine’s interactions with certain brain chemicals may be connected to its pain management, anti-inflammatory, and antidepressant effects. Since 2000, increasing research on ketamine has demonstrated significant results as a treatment for pain conditions including chronic neuro-inflammatory disorders and for mood disorders including depression, PTSD, and anxiety.

About Psilocybin
Considered a serotonergic hallucinogen, this substance is an active ingredient in some species of mushrooms. While classified as a Schedule I controlled substance under the Controlled Substances Act (CSA), there is an accumulating body of evidence that psilocybin may have beneficial effects on depression and other mental health conditions. The U.S. Food and Drug Administration (FDA) and the U.S. Drug Enforcement Agency (DEA) have permitted the use of psilocybin in clinical studies for a range of psychiatric conditions.

About Silo Pharma
Silo Pharma. Inc. is a development-stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as PTSD, Alzheimer’s disease, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the healthcare industry. For more information, visit www.silopharma.com.

Forward-Looking Statements
This communication contains forward-looking statements concerning the Company’s collaborations, business and development plans, and statements regarding the Company’s product candidates, their development, regulatory plans with respect thereto and therapeutic potential thereof, planned interactions with regulatory authorities, and planned clinical development. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations and projections about future events and financial trends that the Company believes may affect its financial condition, results of operations, business strategy, and financial needs. Investors can identify these forward-looking statements by words or phrases such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the Company’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, the Company’s ability to identify additional product candidates for development, the Company’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of our product candidates, competition in the industry in which the Company operates and market conditions. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in our Annual Report on Form 10-K for the year ended December 31, 2021, and other periodic reports filed with the Securities and Exchange Commission available at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof, and we specifically disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact
800-705-0120
[email protected]

¹ Data Bridge Market Research. September 2022
² Fortune Business Insights; Fibromyalgia Treatment Market Size, Share and Trends. September 2022.
³ Fortune Business Insights; Multiple Sclerosis Drugs Market Size, Share… May 2022.
⁴ Precedence Research; Rheumatoid Arthritis Drugs Market, Report 2022-2030. June 2022.
⁵ Growth+ Reports; Alzheimer’s Drugs Market by Drug Type … Global Outlook & Forecast 2021-2031. March 2020.
⁶ World Health Organization; Mental disorders. June 2022.
⁷ U.S. Department of Veterans Affairs, PTSD: National Center for PTSD; How Common Is PTSD in Adults?

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Joe Reda

Founder/Partner

The Special Equities Group “SEG”

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This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

Based on over 20 years of pioneering Yale University research, clinical development currently underway to create and develop viable and efficacious treatment alternatives for patients with major depressive disorder by leveraging the known pharmacology of ketamine and psychedelic-based therapeutics

SAN FRANCISCO, August 23, 2022–(BUSINESS WIRE)–Freedom Biosciences, a clinical-stage biotechnology platform developing next-generation viable and efficacious ketamine and psychedelic therapeutics, today emerged from stealth with $10.5 million in seed financing. MBX Capital led the round and was joined by PsyMed Ventures, Village Global and The Yale Startup, among others. The new financing will help the company advance its current lead ketamine program as well as further multiple additional exploratory programs.

Freedom Biosciences was co-founded in April 2021 by Dr. John Krystal, Chair of the Department of Psychiatry at Yale University, and Dina Burkitbayeva, co-founder of PsyMed Ventures and one of the first investors in the psychedelic therapeutics space. Burkitbayeva now serves as Freedom Bioscience’s CEO, while Dr. Krystal serves as its Chief Scientific Advisor. Dr. Krystal is best known for the discovery of the rapid antidepressant effects of ketamine in patients in the 1990s, which directly led to FDA approval of Janssen’s Spravato Esketamine spray in 2019 for Treatment-Resistant Depression and Major Depressive Disorder with Acute Suicidal Ideation or Behavior.

“With the global mental health crisis on the rise, there’s great curiosity and hope about psychedelics and a recognition that we need new therapeutic tools,” explained CEO Dina Burkitbayeva. “While ketamine has been proven as a successful treatment for depression in patients that do not respond to traditional SSRIs and other prescription medication, current first-generation commercial ketamine treatment options are falling short due to cost, access and burdensome time requirements. John and I founded Freedom Biosciences to help—our mission is simple: to create and develop viable and efficacious treatment alternatives for millions of patients suffering from some of the most debilitating mental health issues. Everyone deserves to lead fulfilling lives, and I’m hopeful that our therapeutics can help make that a reality.”

The leadership team’s extensive experience developing and bringing advanced clinical treatments to market, as well as history of working with and studying antidepressants and novel treatments for psychiatric disorders at Yale University, have helped Freedom Biosciences develop FREE001, its ketamine-specific program. Program FREE001 is a ketamine treatment that’s been demonstrated in clinical trials to have more durable effects than ketamine. A Phase 2 investigational study showed that the combination provided 14 days of antidepressant effects, 2 to 3 times longer than the usual 2-7 days of effects from ketamine alone. This extended efficacy has extremely promising implications for the treatment’s accessibility for patients who are unable to make frequent visits to a clinic.

“We believe Freedom Biosciences’ team is the most knowledgeable group there is when it comes to ketamine’s potent antidepressant potential,” said Gurdane Bhutani, Managing Partner of MBX Capital. “We believe Freedom’s uniquely practical approach to drug development, which leverages a wide body of existing clinical evidence, is the best strategy to get safe, highly effective new medicines to patients as quickly as possible to tackle the enormous burden of depression on our society.”

Key members of the Freedom Biosciences team also include Robert Berman, M.D., who serves as the Head of the Scientific Advisory Board and Senior Medical Advisor. Dr. Berman first discovered the rapid antidepressant effects of ketamine in humans alongside Dr. Krystal at Yale University. He was the co-founder and inaugural Chief Medical Officer for Biohaven Pharmaceuticals (NYSE:BHVN), now a commercial-stage biopharmaceutical company focused on treating neurological diseases, which was acquired by Pfizer. Inaugural members of Freedom Biosciences Scientific and Strategic Advisory Board also include:

• Dr. Zubin Bhagwagar, Global Program Lead at RallyBio with 25+ years of academic and industry experience in biopharma
• Dr. Robin Carhart-Harris, founder of the Center for Psychedelic Research at Imperial College London, has designed human brain imaging studies with LSD, psilocybin, MDMA and DMT, and clinical trials of psilocybin therapy for severe mental illnesses
• Dr. Victoria Hale, former Chair of the Board of Directors at Multidisciplinary Association for Psychedelic Studies (MAPS) and co-founder and former CEO of Medicines360
• Dr. Alex Kwan, Associate Professor in the Meinig School of Biomedical Engineering at Cornell University
• Dr. Tom Laughren, former Division Director for the Division of Psychiatry Products, Center for Drug Evaluation and Research at FDA
• Dr. Kurt Rasmussen, Chief Scientific Officer at Delix Therapeutics and former Head of Division of Therapeutics & Medical Consequences at National Institute on Drug Abuse (NIDA)
• Dr. Gerard Sanacora, Director of Yale Depression Research Program and Co-Director of Yale New Haven Hospital Intervention Psychiatry Service

For more information, visit: www.freedombio.co

About Freedom Biosciences

Freedom Biosciences is a clinical-stage biotechnology platform developing next-generation viable and efficacious ketamine and psychedelic therapeutics. The company was co-founded by Dr. John Krystal, Chair of the Department of Psychiatry at Yale University, and Dina Burkitbayeva, founder of PsyMed Ventures, alongside Hunter Bouchard and Morgan Springer. Freedom Biosciences launched from stealth in 2022 and is backed by MBX Capital, Village Global and PsyMed Ventures, among others. To learn more, visit: www.freedombio.co

View source version on businesswire.com: https://www.businesswire.com/news/home/20220823005203/en/

Contacts

Media:
Freedom Biosciences
Cathy Corwin/Quarter Horse PR
[email protected]

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

Springfield, Oregon–(Newsfile Corp. – August 23, 2022) – Silo Wellness Inc. (CSE: SILO) (OTCQB: SILFF) (FSE: 3K7A) (“Silo Wellness” or the “Company”), a leading global psychedelics company, is pleased to announce that it has opened its first ecotourism microdosing psilocybin resort and retreat center at Go Natural Jamaica in Long Bay, Portland, Jamaica. “We have been bombarded by cost-conscious client inquiries wanting to explore nature with the help of psilocybin,” explained Mike Arnold, an Oregon attorney and the founder of Silo Wellness. “They are what we consider ‘psychedelic curious.’ These are not looking to experiment with psychedelics for recreational purposes at a club or party. They are very intentional and mindful individuals looking to better understand themselves and their place in the universe. They aren’t looking for mental health therapy or a deep dive ego death. They are wanting to learn about psilocybin while learning about themselves. This is an unmet need in the psychedelic space, and Silo Wellness is well positioned to assist.

One of Silo Wellness’s most valuable assets is its data. From what the Company has learned from thousands of client inquiries and consumer comments on retreats is that not everyone is looking for the ‘deep dive’ or to treat mental illnesses. Many want to self-titrate on to mushrooms through serial microdosing. “Our Silonauts often want to be at a rustic seaside resort looking at shooting stars on a gram of mushrooms,” stated Arnold. “Or they want to go for a snorkel on a 0.1 gram microdose. They crave an increased connection to nature.”

Jamaica Luxury Psychedelic Retreats vs. Psilocybin Microdosing Retreats

Silo’s “luxury” retreats have been featured in Bloomberg, Fodor’s Travel, The Evening Standard, Men’s Health and The Washington Post, among others. However, Silo Wellness never intended to enter the luxury retreats space. “That wasn’t my vision,” continued Arnold. “Our mission is to put psychedelic healing into the hands of those suffering as quickly and inexpensively as possible. Nonetheless, the luxury model was necessary during COVID and has been very good to us and for our clients. However, it is not available to everyone due to the price point, which is a shame and also contrary to our mission.”

“The vision at our Go Natural Jamaica microdosing resort is to offer a lower price point with a seafront ‘luxury view’ but with more rustic accommodations,” Arnold continued. “We can significantly lower the cost by making air conditioning optional, for example, or provide a dorm room with bunk beds right alongside a luxury villa on the same site. I myself prefer to suffer in nature while primitive camping, rafting, or waterfall exploring with or without psychedelics. I don’t want to hear the buzz of the A/C at night. I want to hear the buzz of consciousness to the soundtrack of nature. I want to hear a tropical storm. I want to hear the whistling Jamaican tree frogs. I want to sleep under the stars while microdosing. And I want Silo’s clients to enjoy this God-given luxury that experienced psychedelic users can do on their own, but in the safety and comfort of secure accommodations under the cover our of risk mitigation protocols.”

Spiritual Ecotourism and Psychedelic Retreats in Oregon and Jamaica

Silo Wellness sees nature immersion as essential for human growth. Human consciousness is the most complicated and impressive thing to evolve out of nature – more complicated and inexplicable than a black hole. Silo sees it as incumbent on individuals to explore consciousness while exploring nature to get that reset along with a new purpose-driven download to be the best version of themselves.

In 2022, Silo’s Oregon nature-immersion psychedelic retreat was featured in Outside Magazine‘s article, “The Future of Nature Therapy is Psychedelic.” Its colorful narrative begins with an emotional play-by-play account of a ketamine deep-dive trip report by a brave participant with PTSD from sexual assault and depression: “[She] sees the blue pool, shimmering like a winter oasis. It sparkles below a snowy trail and rocky gray cliffs, the iridescent turquoise water rippling under the rushing downpour of Tamolitch Falls…[Her] otherworldly trip didn’t happen in the flesh. It took place in her mind, after she’d taken ketamine…”

Beyond what Silo’s cliffside beachfront resort has to offer, participants will have optional microdosing nature excursions that can include a waterfall swim, harvesting supper at a permaculture jungle farm, a bamboo raft river float, Caribbean boat tour and island picnic, etc.

Set, Setting, and Dosing: Perceptible Sub-psychedelic Microdosing in Nature

“This retreat isn’t necessarily imperceptible microdoses,” stated Arnold, “although clients are welcome to experience psychedelics for the first time in this way. Silo’s self-titrating psilocybin protocols allow people to work their way up dosing in a controlled way to experience the sub-psychedelic effects.

“We want people to be able to commune with nature at sub-psychedelic but perceptible doses. We know that most of our clients are uncomfortable taking a 0.3 gram ‘social dose’ or a 0.7 to one gram ‘hiker’s dose’ or ‘museum dose’ for the first time. Instead, we will provide the framework for them to slowly walk themselves up over time to these more advanced dosages. This prevents the ‘cannabis edibles dilemma’ of stacking doses with greater than expected effects.”

Jamaica Psilocybin Microdosing Retreat Pricing and Shareholder/Owner Discounts

Silo’s Labor Day retreat (September 3-6) has lodging and meals starting at $240/night for dorm lodging to $499.99/night for single occupancy with a three-night minimum. Double occupancy is also available. More information can be found at www.SiloWellness.com/jamaica-microdosing.

Farm-/field-/sea-/bush-to-table traditional natural Jamaican cuisine is included. Locally sourced psilocybin mushroom microdosing capsules are available on site for a nominal cash purchase. Applicants receive a one-on-one meeting with our experienced client journey planning team and an evaluation for appropriateness for retreat, contraindications, etc. by our Ph.D. pharmacologist and co-inventor of the world’s first psilocybin nasal spray. Qualified participants will also be provided with recommended reading materials, journaling prompts, videos regarding retreat location, logistics, and how to make the most of the process to help them put in the work to reset and reprogram their minds. Additional services can be found on the website, including transportation to retreat, additional add-on lodging before or after retreat, air conditioning, healthful smoothies and natural snacks, yoga, and food upgrade of menu choices (although this is discouraged as we recommend a full emersion into a new lifestyle closer to the land in an authentic local Jamaican fashion).

For a limited time, Silo’s shareholders may receive up to 20% off a retreat or priority booking for a private curated retreat for the owner and his or her guests. Owners may also request a special discount code to share on social media for up to 20% off for anyone in their network. Inquire for details and applicability.

Additional Corporate Updates

Since the May 2022 shareholder meeting, the Silo team has been working diligently to secure additional property partnerships in Jamaica to scale up retreats in order to reduce costs and to provide additional revenue through increased inventory. This strategy would provide the opportunity for the Company to negotiate longer-term staffing contracts at a lower price per retreat. In July, the Company successfully conducted a luxury retreat in Trelawny, Jamaica, with positive feedback from participants. The Company has also been working to best position itself for Oregon psilocybin by visiting rural retreat properties for potential purchase or joint venture and intends to purchase an urban retreat center.

The Company’s May 2022 letter of intent with Dyscovry Science is still active and that transaction is still expected to close with documents being finalized by the respective attorneys. Additionally, following the 20-1 share consolidation that occurred at the May shareholders meeting, the Company has seen its total shares issued increase due to debt conversions from the first two funding tranches received from the financing announced in April. The Company is in active discussions with other potential finance groups regarding debt restructuring and a potential private placement which would be contingent on renegotiating the April debt financing terms. The company has retained three f The Company may also spinout retreat assets into a separate wholly-owned subsidiary for an Oregon-specific capital raise. Use of proceeds for that would be include closing on a psilocybin service center property, BM 109 licenses fees and expenses, property improvements necessary for licensing, legal fees, marketing, and other administrative and operations costs.

Additionally, the Company entered into an advertising and investor awareness campaign with Dig Media Inc. dba Investing News Network (INN). INN is a private company headquartered in Vancouver, Canada, dedicated to providing independent news and education to investors since 2007 at www.investingnews.com. Beginning today for a 12-month term of the agreement, INN will provide advertising on its website to increase awareness of the issuer. INN does not provide Investor Relations or Market Making services. The cost of the campaign is $9,165/month. INN can be reached at 604-688-8231 or [email protected]. One purpose of the campaign is to drive awareness to the Company’s psychedelic vacations that are offered at a discount to shareholders/owners. Given the activist nature of plant medicine consumers, the Company’s goal is to one day have all participants at retreats being shareholders. More information regarding investor discounts can be found at https://www.silowellness.com/benefits/.

ABOUT SILO WELLNESS

Silo Wellness is a growth-oriented holding company focused on functional mushroom and psychedelic opportunities that benefit from a unified ecosystem and exceptional leadership. Founded in 2018 and headquartered in Toronto, Silo Wellness has a presence in both Jamaica and Oregon. Silo Wellness is a publicly traded company on the Canadian (CSE: SILO) and Frankfurt (FSE: 3K7A) exchanges and trading on the OTCQB Venture Market (OTCQB: SILFF).

For more information about Silo Wellness or to book a Jamaican psilocybin retreat, please visit www.silowellness.com.

Silo Wellness Company Contact:

Mike Arnold, President

541-900-5871

IR at silo wellness dot com

CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION: This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates, and projections as at the date of this news release. Any statement that involves discussions with respect to 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 statements. Forward-looking information may relate to anticipated events or results including, but not limited to the Company successfully launching Jamaica microdosing operations, possibly retreat spinout, alternative financing and other statements made in the Corporate Update, and the Company’s future business plans. Forward-looking statements are 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 statements. Such factors include, but are not limited to: general business, economic, competitive, regulatory, political and social uncertainties and the potential impact of COVID-19. Such risks and uncertainties include, among others, the risk factors included in Silo Wellness’s continuous disclosure documents available on www.sedar.com. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.

Readers should not place undue reliance on the forward-looking statements and information contained in this news release. Silo Wellness assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

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

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

The national chain of psychedelic mental-healthcare clinics growing rapidly

LOS ANGELES, Aug. 08, 2022 (GLOBE NEWSWIRE) — Irwin Naturals Inc. (CSE: IWIN) (OTC: IWINF) (FRA: 97X) (“Irwin” or the “Company”) completed the acquisition of two ketamine clinics in Georgia through an asset purchase of Invictus Clinics, LLC, which will be brought into the fast-growing national chain of psychedelic mental-health facilities.

The clinics are located in Atlanta and Woodstock, Ga., operated under the name of the Invictus Clinic. They offer ketamine-assisted therapy, hydration via IV infusion as well as NAD+. They join Irwin Naturals Emergence, a national chain of mental-health facilities providing cutting-edge care behind a truly household brand name that is recognized in 80 percent of U.S. homes.¹

Klee Irwin, CEO of Irwin Naturals, said, “The vision we laid out for Irwin Naturals Emergence is becoming a reality with each acquisition we announce and execute. We wanted to be a first mover in this new and revolutionary area of healthcare, and adding these two clinics is further proof that we are a first mover in this space.”

Wesley Karcher, MSN, CRNA, Co-Founder of Invictus, added, “This is a huge opportunity for us to build upon our goals of creating a business capable of providing these life-changing treatments to those in need and making people aware of the effectiveness of our programs. A central mission at Irwin Naturals Emergence is to expand access and even serve as a bridge, in those instances, where we wait for the insurance industry to catch up to the power of ketamine and other psychedelics in mental healthcare. With this partnership, we are aligning our goals and hope to expand our footprint quickly throughout the Southeast and beyond.”

Brandon Grinage, MD, Co-founder, and Medical Director at Invictus, added, “I am delighted at the opportunity for Wesley and myself to partner with Irwin Naturals. From the very first conversation, it was apparent that our values and visions are aligned. Furthermore, this deal makes apparent our ambitions to raise mental health awareness and bring treatment to millions of Americans in dire need. I am humbled to be joining an organization that is rapidly becoming the tip of the arrow in the ketamine and psychedelic space.  Irwin Naturals Emergence will no doubt be a leader of mental health in this country.”

Over the past several months, Irwin Naturals Emergence has vetted the more than 600 independent ketamine clinics currently operating in the United States, seeking to identify profitable clinics that practice the standard of customer care consistent with the Irwin Naturals brand. The company has then invited those clinics into the family so to speak by joining Irwin Naturals Emergence in the national rollup that is now underway.

The acquisition of the two Georgia clinics completes the sale agreement that was announced June 21. When the month of July began, Irwin Naturals Emergence had binding agreements or had completed the acquisitions of a total of 10 different ketamine clinics across five different states.

Building a national chain will offer some efficiencies and the cost-benefits that come from economies of scale. It can also help drive down operating costs, a savings that can be passed on to customers by providing sliding-scale discounts and even pro bono treatment for those in need.

The Irwin Naturals brand will be like a beacon in this new area of mental-health treatment, bringing a level of not just familiarity but loyalty. Irwin Naturals has been in business since 1994, providing best-in-class nutraceuticals and earning the customer trust and popular recognition that have made it a household name. Irwin Naturals products are stocked on the shelves of more than 100,000 storefronts in North America.

Klee Irwin, Irwin Naturals CEO, “We’ve safely cared for your health needs for 28 years and that provides a level of assurance to those for whom this may feel new or maybe even controversial. We can sort of hold the hands of those looking into these new life-changing treatments. It’s safe. It’s effective. We send a message simply by being in the space.”

Transaction terms

As consideration for the acquisition, Irwin Naturals will provide sellers cash payments, as well as at least 333,333 Subordinate Voting Shares to be issued no later than January 10, 2023. Furthermore, the transaction includes an additional contingent consideration based on future milestones related to operational and profitability targets, to be satisfied in shares.

About Irwin Naturals

Irwin Naturals has been a household name and best-in-class herbal supplement formulator since 1994. It is now leveraging its brand to enter into both the cannabis and psychedelic industries. On a mission to heal the world with plant medicine, Irwin has operated profitably for over 27 years². Irwin’s growing portfolio of products is available in more than 100,000 retail doors across North America, where nearly 100 million people know the Irwin Naturals brand.³ In 2018, the Company first leveraged its brand to expand into the cannabis industry by launching hemp-based CBD products across the United States. The Company is now leveraging its famous halo of brand trust with an objective to become one of the first household name brands to offer THC-based products and psychedelic mental health treatment. Irwin Naturals became a publicly traded company on the Canadian Securities Exchange (CSE) in August 2021. The Company’s shares began to be traded on the OTCQB Venture Market in November 2021. More information on the Company’s stock can be found via Bloomberg as well as the Wall Street Journal.

For investor-related information about the Company, please visit ir.irwinnaturals.com/

To contact the Company’s Investor Relations department, please call toll-free at (800) 883-4851 or send an email to [email protected].

“Klee Irwin”
________________________________
Klee Irwin
Chief Executive Officer
T:310-306-3636
[email protected]

IR Information

For investor-related information, please visit ir.irwinnaturals.com/, call (800) 883-4851, or email [email protected].

Press Contact

Irwin Naturals Investor Relations
Cassandra Bassanetti-Drumm
T: 310-306-3636
[email protected]

Forward-Looking Information

This news release contains certain forward-looking statements that reflect the current views and/or expectations of management of the Company with respect to performance, business and future events. Forward-looking statements can often be identified by words such as “may”, “will”, “would”, “could”, “should”, “believes”, “estimates”, “projects”, “potential”, “expects”, “plans”, “intends”, “anticipates”, “targeted”, “continues”, “forecasts”, “designed”, “goal”, “objective,” or the negative of those words or other similar or comparable words. Forward-looking statements are based on the then-current expectations, beliefs, assumptions, estimates and forecasts about the business and the industry and markets in which the Company operates. Forward-looking statements in this news release include statements related to information concerning the ability of the Company to perform the terms of the transaction referenced herein; the receipt of all necessary approvals, including regulatory approvals; expectations for other economic, market, business and competitive factors; and the Company actually entering into and doing business in the U.S. cannabis and psychedelics markets. The entrance by the Company into these new business segments are in their preliminary stages and may be subject to approval from the board of directors of the Company as well as any regulatory approval, including that of the Canadian Securities Exchange. These statements are based on numerous assumptions that are believed by management to be reasonable in the circumstances, and are subject to a number of risks and uncertainties, including without limitation: board and regulatory approval, including the approval of the Canadian Securities Exchange; Irwin being able to acquire and/or enter into business relationships to enter into these new markets; the Company obtaining the required licenses; and changes to regulations and laws regarding cannabis or psychedelics. Further information on the regulatory environment and risks will be contained in future disclosures. Forward-looking statements are subject to a number of known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to be materially different from that which are expressed or implied by such forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks, uncertainties, and assumptions which are difficult to predict. Accordingly, readers should not place undue reliance on forward-looking statements and information, which are qualified in their entirety by this cautionary statement. The Company does not undertake any obligation to release publicly any revisions for updating any voluntary forward-looking statements, except as required by applicable securities law.

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

SOURCE: Irwin Naturals Inc.

__________________________
¹ Based on a formal Company survey with a sample size of 500 randomly selected adults.
² Under several corporate structures, Klee Irwin has operated the Irwin brand profitably since 1994, as measured by EBITDA adjusted for extraordinary costs.
³ Consumer brand recognition information is based on a formal Company survey with a sample size of 500 randomly selected adults.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

VANCOUVER, BC, July 6, 2022 /CNW/ – Nirvana Life Sciences Inc. (Nirvana or the “Company”) (CSE: NIRV), a western Canadian based life sciences company aimed at developing psychedelic therapeutic medicines, including non-addictive chronic pain and relapse preventing products is pleased to announce it has acquired an exclusive license for the psychedelics sector for a novel delivery system for its psychedelic based therapies currently in development.

Nirvana Life Sciences Inc. has recently added a novel delivery system for active pharmaceutical ingredients (APIs) with high bioavailability and rapid onset to its portfolio. This novel delivery system, invented by the Company’s Head of Innovation, Robert August for the licensor Hai Beverages Inc. will be used as a formulating agent for both water soluble and non-water-soluble APIs, whose onset when taken orally would be a standard twenty to forty-five minutes. This delivery system will allow the compound to bypass first pass liver metabolism and directly enter the bloodstream, resulting in a rapid onset of 5 minutes or less. This delivery system also functions as a solubilizing agent for non-water-soluble materials.

With the growing interest in psychedelic assisted therapy, improved ways of efficiently delivering the APIs are in demand for a range of psychedelics. This formulating delivery system can take a psychedelic psychoactive like MDMA, which has a high rate of come up anxiety with patients and eliminate that anxiety by drastically shortening the time of onset. Also, with dissociative drugs like Ketamine, a dose could be rendered orally, but effectively come on as if injected intramuscularly, an advancement that could be revolutionary to the field of medicine.

Mr. Robert August, Nirvana’s Head of Innovation and Chief Chemist stated: “This water-soluble formulation has served us well in other areas of medicine by increasing efficacy and shortening length of onset considerably. We are very excited to see what new and interesting formulations we can develop with this system in the therapeutic psychedelic sector. I am very happy to be working with Dr. Nabissi and the ITD Labs team in formulating so that we can utilize the latest in vivo, in vitro and PK/PD study data on psychedelics to continue to expand our portfolio of formulations for use in psychedelic therapeutic medicine.”

This license is a non-arms length transaction as defined in MI 61-101 and references exemptions outlined in sections 5.7 (1)(a) and 5.5 (a).

About Nirvana Life Sciences Inc.

Nirvana Life Sciences Inc. has been founded with a simple objective of researching and developing non-addictive pain management and relapse prevention products that can provide healthier outcomes for patients who live with chronic pain and/or have battled with addiction. Nirvana believes that using naturally sourced psychedelics in novel formulations holds the promise of delivering non-addictive solutions that are effective in managing pain and addiction. Nirvana’s team, consisting of leading researchers from around the globe, will develop therapies that have the potential of freeing millions from addiction and saving society billions of dollars annually.

 Forward Looking Statements

This news release contains certain forward-looking statements and forward-looking information (collectively referred to herein as “forward- looking statements”) within the meaning of Canadian securities laws including, without limitation, statements with respect to the future investments by the Company. All statements other than statements of historical fact are forward-looking statements. Undue reliance should not be placed on forward-looking statements, which are inherently uncertain, are based on estimates and assumptions, and are subject to known and unknown risks and uncertainties (both general and specific) that contribute to the possibility that the future events or circumstances contemplated by the forward-looking statements will not occur. Although the Company believes that the expectations reflected in the forward-looking statements contained in this press release, and the assumptions on which such forward-looking statements are made, are reasonable, there can be no assurance that such expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking statements included in this document, as there can be no assurance that the plans, intentions, or expectations upon which the forward-looking statements are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause the Company’s actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. The forward-looking statements contained in this news release are made as of the date hereof and the Company does not undertake any obligation to update publicly or to revise any of the included forward-looking statements, except as required by applicable law. The forward-looking statements contained herein are expressly qualified by this cautionary statement.

SOURCE Nirvana Life Sciences Inc.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

Awakn Provides Business Update on Progressing its Lead Program from Phase II b to Phase III

Toronto, Ontario–(Newsfile Corp. – July 5, 2022) – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954), a revenue-generating biotechnology company researching, developing and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), is pleased to announce it has secured funding from Innovate UK to identify the quickest and most cost-effective route to market in both the UK and the US for Awakn’s lead program – proprietary ketamine-assisted therapy for treating AUD. Innovate UK is the UK’s national innovation agency which provided the funding in an initiative delivered jointly by CPI and ABHI.

Awakn’s activities will be delivered in collaboration with Veristat, a global Clinical Research Organization (CRO) that specialises in accelerating client therapies through the clinical development process into regulatory approval and commercialization. Veristat supported marketing applications for 12% of all US Food and Drug Administration (FDA) Novel Drug Approvals in 2021.

Awakn’s Chief Scientific Officer, Shaun McNulty commented: “Our Phase II a/b ‘KARE’ study, led by Professor Celia Morgan, showed that ketamine-assisted therapy has the potential to revolutionize the treatment of AUD. This funding enables Awakn, working closely with Veristat, to bring a much-needed effective treatment approach to the market as soon as possible. Delivering this innovative therapeutic approach as rapidly as possible to patients in the UK and the US is critical to address this major unmet medical need.”

Anthony Tennyson Awakn’s CEO added: “Securing these funds from Innovate UK is a major endorsement of our efforts and approach to developing new and effective treatments for addictions. Our Lead program has all the right components to make a lasting difference for the very significant number of people who are suffering from AUD. We are also delighted to be working with a partner of the calibre of Veristat and to have the ability to benefit from their significant expertise. The addiction treatment market opportunity is, unfortunately, large and growing, and Awakn is uniquely positioned to offer proven therapeutics supported by data to sufferers for whom the current standard of care is inadequate and relapse rates are unacceptably high.

Project Kestrel

Awakn is also providing a business update on its lead program. Awakn has renamed its lead program to Project Kestrel. Project Kestrel will aim to deliver marketing authorization/regulatory approval for ketamine-assisted therapy to treat AUD in both the UK and the US with clear Intellectual Property (IP) surrounding the treatment. Project Kestrel builds on Awakn’s successful Phase II a/b ‘KARE’ clinical trial and efficacy data released in January 2022, which demonstrated safety and efficacy as a new treatment option for AUD patients.

Awakn has started planning and intends to initiate a Phase III trial in the UK in 2022 as a prelude to initiating a further Phase III trial in the US thereafter. Both are designed to provide the key data necessary to bring Project Kestrel to the market as soon as possible. Awakn has also applied for a grant to the National Institute for Health and Care Research (NIHR) in the UK to cover two-thirds of the cost of the planned UK Phase III trial and a decision on this application is anticipated shortly.

The outputs from Project Kestrel will benefit all of Awakn’s Research and Development project portfolio by defining a clear regulatory pathway for drug-assisted therapies to treat not only AUD but also a broad range of other behavioral addictions which Awakn is developing therapies for.

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a revenue-generating biotechnology company researching, developing, and commercialising therapeutics to treat substance and behavioral addictions. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 400m people globally for which the current standard of care is inadequate. Our goal is to provide effective therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels.

www.awaknlifesciences.com | Twitter | LinkedIn | Facebook

About Project Kestrel

Project Kestrel is the lead clinical development program of Awakn Life Sciences. Project Kestrel is supported by Awakn’s Phase II a/b ‘KARE’ clinical trial which examined ketamine-assisted therapy for the treatment of Alcohol Use Disorder (AUD). The trial resulted in patients experiencing on average 86% abstinence at 6 months post treatment versus 2% before the trial which means that study participants went from being sober on average 7 days a year to being sober on average 314 days a year. Awakn is planning to initiate a Phase III trial in the UK in 2022 and plans to seek regulatory approval in the UK and the US in due course.

About Veristat

Veristat, a scientific-minded global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 27 years of experience in clinical trial planning and execution, Veristat is equipped to support any development program. The company has prepared nearly 100 marketing applications for approval with global regulatory authorities in the last 10 years.

https://www.veristat.com Twitter LinkedIn Facebook

Notice Regarding Forward-Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to:COVID-19; fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. 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, other than as required by law.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act“) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Investor Enquiries:
Anthony Tennyson, CEO, Awakn Life Sciences
[email protected]

Media Enquiries:
America and Canada: KCSA Strategic Communications
Anne Donohoe
[email protected]

Rest of World: ROAD Communications
Paul Jarman / Nora Popova
[email protected]

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.