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MINDCURE Signs LOI with Awakn Life Sciences to Distribute Ketamine Protocol for Alcohol Use Disorder into Clinics Across United States and Canada through iSTRYM, MINDCURE’s Digital Therapeutics Platform

MINDCURE Signs LOI with Awakn Life Sciences to Distribute Ketamine Protocol for Alcohol Use Disorder into Clinics Across United States and Canada through iSTRYM, MINDCURE’s Digital Therapeutics Platform

VANCOUVER, BC, October 28, 2021 – Mind Cure Health Inc. (CSE: MCUR) (OTCQX: MCURF) (FRA: 6MH) (“MINDCURE” or the “Company”), a leader in advanced proprietary technology and research for psychedelics, is pleased to announce the signing of a non-binding letter of intent (“LOI”) with Awakn Life Sciences (NEO: AWKN)(OTCQB: AWKNF) (“Awakn”), a biotechnology company with clinical operations researching, developing, and delivering psychedelic medicine to better treat Addiction.

The Company will enter into an agreement with Awakn to be a distributor of its ketamine-assisted psychotherapy for Alcohol Use Disorder (AUD) protocol in the US and Canada. Awakn’s protocol will be distributed through iSTRYM, MINDCURE’s digital therapeutics platform.

MINDCURE released the minimum viable product (MVP) version of iSTRYM into partner clinics across North America in August and will begin full commercial deployment to all partner clinics in Q1 of 2022. The company forecasts 75 partner clinics in Canada and the US deploying iSTRYM upon commercialization. Further deployment anticipates 150 clinics across Canada, the US, the UK, and Europe by Q4 2022.

iSTRYM provides a digital distribution network of science-based protocols developed by MINDCURE’s clinical partners, companies, academic institutions, and other healthcare providers directly to therapists. The Company is already partnering with ketamine-assisted psychotherapy clinics in nine states in the US and two provinces in Canada with plans to expand to the broader mental health market in 2022. The distribution component of iSTRYM unlocks another revenue line for MINDCURE, in addition to clinic and patient level revenues from the platform.

“Awakn’s goal is to fully integrate evidence-backed psychedelic-assisted psychotherapy into mainstream healthcare to better treat addiction. We’re currently building the UK and Europe’s leading chain of medical psychedelic clinics with a focus on treating addiction and other mental health conditions,” said Anthony Tennyson, CEO of Awakn Life Sciences. “We are extremely pleased that we now also have a partnership with MINDCURE to distribute our ketamine-assisted psychotherapy for Alcohol Use Disorder protocol through their iSTRYM platform in the US and Canada.”

Awakn acquired the licensing rights from the University of Exeter for a ketamine-assisted psychotherapy treatment for AUD, which has been validated in a completed Phase II a/b trial. Awakn’s license to use and deliver the ‘Ketamine in the Reduction of Alcoholic Relapse’ (KARE) psychotherapy treatment will be deployed in each of Awakn’s clinics in the UK and Europe and will be led by a consultant psychiatrist. Awakn’s Team includes world leading scientific, research and clinical experts in the treatment addiction, led by Professor David Nutt, who serves as Awakn’s Chief Research Officer and Chair of both the Scientific Advisory Boards (Preclinical and Clinical). The KARE protocol will be distributed by MINDCURE in its digital therapeutic platform across its growing network of clinical partners in the US and Canada.

“Improving mental health is a global challenge and we’re building iSTRYM to be an innovative global solution,” said Kelsey Ramsden, President & CEO, MINDCURE. “This is our first of many overseas partnerships with industry leaders who are developing scientifically rigorous psychedelics protocols and drugs whereby our technology provides a natural distribution partner to support both patients and therapists.”

About Awakn

Awakn Life Sciences (“Awakn”) is a biotechnology company with clinical operations, researching, developing, and delivering psychedelic medicine to better treat Addiction. Awakn’s team consists of world leading chemists, scientists, psychiatrists, and psychologists who are developing and advancing the next generation of psychedelic drugs, therapies, and enabling technologies to treat Addiction. Awakn will also deliver evidence backed psychedelic therapies for Addiction in clinics in the UK and Europe and through licencing partnerships globally. Learn more at awaknlifesciences.com.

About MINDCURE

Mind Cure Health (“MINDCURE”) is a life sciences company focused on innovating and commercializing new ways to promote healing and improve mental health. The company is developing digital therapeutics technology and researching psychedelic compounds to support access to safe, evidence-based psychedelic-assisted therapies globally. Learn more at mindcure.com, and follow us on LinkedIn, Facebook, Twitter, and Instagram.

On Behalf of the Board of Directors

Kelsey Ramsden, President & CEO

Phone: 1-888-593-8995

Forward-Looking Information

Certain information presented in this news release may constitute “forward-looking information” within the meaning of applicable securities laws regarding MINDCURE and its business. Forward-looking information generally can be identified by the use of terms and phrases such as “anticipate”, “believe”, “could”, “estimate”, “expect”, “feel”, “intend”, “may”, “plan”, “predict”, “project”, “subject to”, “will”, “would”, and similar terms and phrases.

Forward-looking information is based on a number of key expectations and assumptions made by management of MINDCURE, including, without limitation: the COVID-19 pandemic impact on the Canadian economy and MINDCURE’s business, and the extent and duration of such impact; no change to laws or regulations that negatively affect MINDCURE’s business; the Company will develop its products as expected and that they will attain the outcomes anticipated; there will be a demand for MINDCURE’s products in the future; no unanticipated expenses or costs arise; MINDCURE will be able to continue to identify products that make them ideal candidates for providing solutions for treating mental health; that strategic partnerships entered by the Company will create the opportunities and outcomes anticipated; that MINDCURE will advance wellness worldwide; that trading on the OTCQX will attract additional investment and provide additional liquidity for shareholders

Forward-looking information is provided for the purpose of presenting information about management’s current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. Forward-looking information inherently entails known and unknown risks and uncertainties about the future and actual results and involves significant risks and

uncertainties and should not be read as a guarantee of future performance or results as actual results may differ materially from those expressed or implied in such forward-looking information. Those risks and uncertainties include, among other things, risks related to: iSTRYM distributing Awakn’s ketamine-assisted psychotherapy for Alcohol Use Disorder protocol in the US and Canada. Although MINDCURE has attempted to identify important factors that could cause actual results, performance or achievements to differ materially from those described in forward-looking information presented, there may be other factors that cause results, performance or achievements to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements as no forward-looking information can be guaranteed.

Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and MINDCURE does not undertake any obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.

The CSE has neither approved nor disapproved the contents of this press release and the CSE does not accept responsibility for the adequacy or accuracy of this release.

For further information:

MINDCURE Investor Relations

investors@mindcure.com

1-888-593-8995

Media Inquiries

Annie Graf / Kristin Cwalinski

KCSA Strategic Communications

mindcure@kcsa.com

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Seelos Therapeutics Presents a Poster on SLS-002 (Intranasal Racemic Ketamine) at the 2021 IASR/AFSP International Summit on Suicide Research

Seelos Therapeutics Presents a Poster on SLS-002 (Intranasal Racemic Ketamine) at the 2021 IASR/AFSP International Summit on Suicide Research

– Data from the Part 1 Open-Label Portion of the Study Demonstrated a Rapid, Robust, and Sustained Improvement on all 4 Scales Utilized Measuring Depression and Suicide

– Data Demonstrated the Group Mean Met the MADRS Responder Criteria at All Times Points Measured from 24 Hours Through Day 29/30 of the Study

– Data Demonstrated the Group Mean Met the MADRS Remission Criteria Initially at Day 6 of the Study

NEW YORK, Oct. 25, 2021 /PRNewswire/ — Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today presented a poster on Part 1, the open-label portion, of the study of SLS-002 (Intranasal Racemic Ketamine) at the IASR/AFSP International Summit on Suicide Research Virtual Conference.

Clinical Improvements in Four Scales over Study Duration in a Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with Major Depressive Disorder at Imminent Risk of Suicide
Clinical Improvements in Four Scales over Study Duration in a Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with Major Depressive Disorder at Imminent Risk of Suicide

The poster titled A Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with Major Depressive Disorder at Imminent Risk of Suicide, demonstrated rapid, robust and sustained reductions on the Montgomery-Åsberg Depression Rating Scale (MADRS), the Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B), the Patient Global Impression of severity for Suicidal Ideation and Behavior (PGIS-SI/B), and the Sheehan-Suicidality Tracking Scale (S-STS).

“SLS-002 demonstrated a rapid onset of action, impressive efficacy and a sustained improvement from the first dose through the end of the study, including the group mean meeting the MADRS remission criteria initially on Day 6 after only 2 doses,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “Meeting these early criteria for response and remission is highly encouraging considering that these patients were not only severely depressed but also acutely suicidal.”

This open-label portion of the study enrolled 17 subjects diagnosed with major depressive disorder (MDD) requiring psychiatric hospitalization due to significant risk of suicide with a baseline score of > 28 points on the MADRS, a score of 5 or 6 on MADRS Item-10, a score of > 15 points on the S-STS total score and a history of previous suicide attempt(s), as confirmed on the Columbia Suicide Severity Rating Scale (C-SSRS) with a history of at least one actual attempt, or if the attempt was interrupted or aborted, is judged to have been serious in intent.

The conference is organized by the International Academy of Suicide Research (IASR) in partnership with the American Foundation for Suicide Prevention (AFSP). 

For additional information: https://suicideresearchsummit.org/

If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, or call the National Suicide Prevention Lifeline at 1-800-273-8255.

About SLS-002

SLS-002 is intranasal racemic ketamine with two investigational new drug applications (“INDs”). The lead program is focused on the treatment of ASIB in MDD. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. SLS-002 looks to address an unmet need for an efficacious drug to treat suicidality in the United States. Traditionally, anti-depressants have been used in this setting but many of the existing treatments are known to contribute to an increased risk of suicidal thoughts in some circumstances, and if and when they are effective, it often takes weeks for the full therapeutic effect to be manifested. We believe there is a large opportunity in the United States and European markets for products in this space. Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were approximately 1,000,000 visits to emergency rooms for suicide attempts in 2013 in the United States alone. Experimental studies suggest ketamine has the potential to be a rapid, effective treatment for refractory depression and suicidality.

About Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company’s robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD) or Post-Traumatic Stress Disorder (PTSD), Amyotrophic lateral sclerosis (ALS), Sanfilippo syndrome, Parkinson’s Disease, other psychiatric and movement disorders plus orphan diseases.

For more information, please visit our website: http://seelostherapeutics.com, the content of which is not incorporated herein by reference.

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding Seelos’ Phase 2 open label study of efficacy, safety, and tolerability of SLS-002 (Intranasal Racemic Ketamine) in adults with major depressive disorder at imminent risk of suicide (the “Study”), statements regarding SLS-002’s prospects and statements regarding the Company’s potential market opportunity. These statements are based on Seelos’ current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos’ business and plans described herein include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, or continuing the Study, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the clinical results from the Study are not replicated), the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos’ current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos’ periodic filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com 
https://seelostherapeutics.com/ 
https://twitter.com/seelostx 
https://www.linkedin.com/company/seelos

SOURCE Seelos Therapeutics, Inc.

Related Links

https://seelostherapeutics.com/
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PharmaTher Engages Alcami for Clinical and Commercial Manufacturing of Novel Ketamine Products

PharmaTher Engages Alcami for Clinical and Commercial Manufacturing of Novel Ketamine Products

  • Leading U.S.-based CDMO to manufacture PharmaTher’s proprietary ketamine products for FDA Phase 3 clinical studies and global commercialization.
  • Expected FDA clinical and commercial supply in H2-2022.
  • Unlocking potential partnership opportunities with research labs, clinics and pharmaceutical companies globally.​

TORONTO, October 19, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, announces it has entered into an agreement with Alcami Corporation (“Alcami”), a global pharmaceutical contract development and manufacturing organization (CDMO) with extensive experience in cGMP sterile fill-finish products and handling of controlled substances, for the clinical and commercial manufacturing of the Company’s proprietary ketamine products.  

PharmaTher is focused on building a specialty ketamine-based product pipeline to support its internal product pipeline, including rare and near-rare neurological disorders such as Parkinson’s disease and ALS (Lou Gehrig’s disease).  The ability to manufacture and supply ketamine products in different dosage forms enables PharmaTher to not only guarantee delivery on its product pipeline but creates opportunity to partner in other value creation opportunities.  The Company expects to form partnerships with research labs, ketamine clinics and pharmaceutical companies that are: seeking a secure supply of cGMP ketamine and ketamine products for current portfolios; exploring alternative dose forms for multiple existing indications; and requiring support to develop and eventually commercialize specific ketamine products for new indications.  It is expected that PharmaTher’s proprietary ketamine drug product(s) will be available for FDA Phase 3 clinical studies and commercial use in H2-2022.

On September 29, 2021, Alcami announced an additional $31 million investment to expand its sterile development and manufacturing operation in Charleston, SC, that will substantially increase its fill-finish and lyophilization capacity.  This expansion will also be able to support PharmaTher’s ketamine product development and commercialization plans globally.

“We are thrilled to work with PharmaTher and offer our expertise in GMP sterile fill-finish manufacturing and controlled-substances to support PharmaTher’s ketamine product programs,” commented Patrick Walsh, Chairman & Chief Executive Officer of Alcami. “The support we have been engaged to provide is a testament to our broad capabilities, technical expertise, and ability to collaborate with customers to consistently deliver high quality results,” added Mr. Walsh.

“PharmaTher is evolving to become a leader in ketamine-based solutions for mental health, neurological and pain disorders, and partnering with Alcami as our exclusive manufacturer for the clinical and commercial supply of ketamine allows us to fulfill our objectives in serving these large markets and future partnering opportunities globally,” said Fabio Chianelli, CEO of PharmaTher.

About Alcami Corporation

Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. Leveraging four US-based scientific campuses, Alcami serves biologics and pharmaceutical companies of all sizes providing customizable and innovative solutions for development, clinical to commercial sterile and oral solid manufacturing, packaging, microbiology, and analytical services. Alcami’s private equity owners include Madison Dearborn Partners and Ampersand Capital Partners. For more information, please visit alcaminow.com, mdcp.com, or ampersandcapital.com. 

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently initiating an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of May 31, 2021 (“MD&A”), dated September 7, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

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The world’s biggest psychedelic therapy provider

Field Trip Health Ltd. Continues Expansion With Psychedelic-Assisted Therapy Centers in Seattle, Vancouver and Fredericton

Field Trip Health (FTRP) just got one step closer to reaching its goal of running 75 psychedelic therapy clinics by 2024.

The company opened three new treatment centers in Seattle, Vancouver and Fredericton. It now administers ketamine-assisted therapy at eight clinics across North America and one in Amsterdam.

The treatment is proving to be effective with clients’ depression scores dropping from an average of 17 (severe) to 6 (mild) and benefits lasting at least 120 days.

PDF of article

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Ketamine Wellness Centers Partners with Veterans Affairs (VA) Community Care Network to Provide Free Ketamine Treatments to Veterans

Ketamine Wellness Centers Partners with Veterans Affairs (VA) Community Care Network to Provide Free Ketamine Treatments to Veterans

Nation’s Largest Clinic Chain’s Partnership with Illinois and Minnesota Chapters to Provide Ketamine Treatments for PTSD, Depression and Pain at No Out-of-Pocket Costs 

VANCOUVER, BC October 15, 2021 – Delic Holdings Corp (“Delic” or the “Company“) (CSE: DELC) (OTCQB: DELCF) (FRA: 6X0) (Original Source) the leading psychedelic wellness platform, today announced two new partnerships between Ketamine Wellness Centers LLC (“KWC“) and the Veterans Administration (VA) Community Care Networks of Illinois and Minnesota. The nation’s largest chain of psychedelic wellness clinics, KWC, will offer ketamine treatments to veterans at no out-of-pocket cost at their locations in Naperville, IL, and Burnsville, MN. The program will cover patients who are experiencing post-traumatic stress disorder (PTSD), major depression and chronic pain, and who have exhausted all traditional medical treatments. KWC also offers a Hero’s Discount at clinics nationwide to cover partial out-of-pocket costs of the treatment for military veterans and first responders.

More than 1.7 million veterans received treatment in a VA mental health specialty program in 2018, according to the U.S. Department of Veterans Affairs. One in ten U.S. adults are diagnosed with PTSD, with higher rates found among military veterans and first responders. The percentage of veterans with PTSD varies by where they served: Operations Iraqi Freedom and Enduring Freedom (11-20%), Gulf War/Desert Storm (12%), and the Vietnam War (30% have had PTSD in their lifetime).

Based on recent research studies, PTSD has been shown to damage synaptic connections in the brain that affect information flow. Ketamine treatments have successfully repaired and improved these connections while also building new, healthy ones. PTSD damage can reappear over time if the treatment is stopped and no other support strategies are put in place.

Matt Stang, co-founder and CEO of Delic commented, “This partnership between KWC and the VA Community Care Network is a true game changer when it comes to the health and wellness of our veterans. They face steep challenges when returning home, especially related to their mental and physical health, including PTSD, depression and pain. Now they can seek the treatment they need without worrying about whether they can afford it. These brave men and women have sacrificed so much to protect this country and we are honored to support them.”

“This partnership with the Illinois and Minnesota chapters of the VA Community Care Network is vital to the veterans in those communities,” Kevin Nicholson, CEO of KWC stated. “These men and women coming to KWC have exhausted the traditional treatment options and are seeking effective, affordable therapies to help them get their lives back on track. We are continuing to work with the VA Community Care Network to expand this initiative to our other locations so we can ensure veterans everywhere are supported and have the treatments they need. We want to give back to these heroes for all they have done for this country and offer them a sense of hope and optimism about their futures.”

KWC is a limited liability corporation formed under the laws of Arizona, which operates 10 ketamine infusion treatment clinics across Arizona, Colorado, Florida, Illinois, Minnesota, Nevada, Texas, and Washington. KWC is the largest national chain of ketamine infusion clinics in the United States overseeing 60,000 treatments delivered to date.

KWC adds to Delic’s existing portfolio of two clinics operated by Ketamine Infusion Centers in California and Arizona, cementing its position as the leading and largest ketamine wellness provider in the country. Delic expects to open 15 additional clinics across the country over the coming 18 months, further expanding access to millions who can benefit from psychedelic treatment for a variety of mental health conditions.

About Delic Corp, Inc.

Delic is the leading psychedelic wellness platform, committed to addressing the mental health crisis by increasing access to science-backed benefits for all and reframing the psychedelic conversation. The company owns and operates an umbrella of related businesses, including Reality Sandwich and Delic Radio, trusted media and e-commerce platforms; Delic Labs, the only licensed entity by Health Canada to exclusively focus on research and development of psilocybin vaporization technology; Meet Delic, the premier psychedelic wellness event; and the largest chain of psychedelic wellness clinics in the country with Ketamine Infusion Centers and Ketamine Wellness Centers (pending acquisition). Delic is backed by a team of industry and cannabis veterans and a diverse network, whose mission is to provide education, research, high-quality products, and treatment options to the masses. 

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and does not accept responsibility for the adequacy or accuracy of this release.

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 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 unless registered under the U.S. ‎Securities Act and applicable state securities laws or an ‎exemption from such registration is available.‎

Forward-Looking Information and Statements

This press release contains certain “forward-looking information” within the meaning of applicable ‎Canadian securities ‎legislation and may also contain statements that may constitute “forward-looking ‎statements” within the meaning of ‎the safe harbor provisions of the United States Private Securities ‎Litigation Reform Act of 1995. Such forward-looking ‎information and forward-looking statements are not ‎representative of historical facts or information or current ‎condition, but instead represent only the ‎Company’s beliefs regarding future events, plans or objectives, many of ‎which, by their nature, are ‎inherently uncertain and outside of Delic’s control. Generally, such forward-looking ‎information or ‎forward-looking statements can be identified by the use of forward-looking terminology such as ‎‎”plans”, ‎‎”expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, ‎‎‎”anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or may ‎contain ‎statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be ‎taken”, “will continue”, ‎‎”will occur” or “will be achieved”. The forward-looking information and forward-‎looking statements contained herein ‎may include, but are not limited to: information regarding the timing or terms upon which the Transaction will be completed; potential benefits of the Transaction;  anticipated continued growth in the health and wellness sector (and, in particular, related to psychedelics); the ability of Delic to successfully achieve business ‎objectives, ‎and expectations ‎for other economic, ‎business, and/or competitive factors.‎

By identifying such information and statements in this manner, Delic is alerting the reader that ‎such ‎information and statements are subject to known and unknown risks, uncertainties and other factors ‎that may cause ‎the actual results, level of activity, performance or achievements of Delic to be ‎materially different from those ‎expressed or implied by such information and statements. Such risks and other factors may include, but are not limited to: risks and uncertainties relating to the Transaction not closing as planned or at all or on terms and conditions set forth in the Merger Agreement; incorrect assessment of the value and potential benefits of the Transaction; direct and indirect material adverse effects from the COVID-19 pandemic; inability to obtain future financing on suitable terms; failure to obtain required regulatory and other approvals; risks inherent in the psychedelic treatment sector; changes in applicable laws and regulations; and failure to comply with applicable laws and regulations.

In addition, in ‎connection with the forward-looking ‎information and forward-looking statements contained in this press ‎release, Delic has made certain ‎assumptions. These assumptions include, but are not limited to:

assumptions as to the time required to negotiate a definite agreement and complete matters related to the Transaction; the ability to consummate the Transaction; ‎the ability of the parties to ‎obtain, in a timely manner, the requisite regulatory, corporate and other third party approvals and the satisfaction of ‎other conditions to the ‎consummation of the Transaction on the proposed terms; the potential impact of the announcement or consummation of the Transaction on ‎relationships, ‎including with regulatory bodies, employees, suppliers, customers and competitors; ‎changes in general economic, ‎business and political conditions, including changes in the financial ‎markets; changes in applicable laws; compliance ‎with extensive government regulation; and the diversion ‎of management time on the Transaction.‎

Should one or more of these risks, uncertainties or other factors materialize, or should assumptions ‎underlying the ‎forward-looking information or statements prove incorrect, actual results may vary ‎materially from those described ‎herein as intended, planned, anticipated, believed, estimated or ‎expected.‎

Although Delic believes that the assumptions and factors used in preparing, and the expectations ‎contained ‎in, the forward-looking information and statements are reasonable, undue reliance should not ‎be placed on such ‎information and statements, and no assurance or guarantee can be given that such ‎forward-looking information and ‎statements will prove to be accurate, as actual results and future events ‎could differ materially from those anticipated ‎in such information and statements. The forward-looking ‎information and forward-looking statements contained in this ‎press release are made as of the date of ‎this press release, and Delic does not undertake to update any ‎forward-looking information ‎and/or forward-looking statements that are contained or referenced herein, except in ‎accordance with ‎applicable securities laws. All subsequent written and oral forward- looking information and ‎statements ‎attributable to Delic or persons acting on its behalf is expressly qualified in its entirety by this ‎‎notice.‎

Media & Investor Relations Contact

Rich Rodriguez

rich@deliccorp.com 

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PharmaTher Granted FDA Orphan Drug Designation For Ketamine To Treat Complex Regional Pain Syndrome

PharmaTher Granted FDA Orphan Drug Designation For Ketamine To Treat Complex Regional Pain Syndrome

  • Achieving its second FDA orphan drug designation with ketamine.
  • Building a proprietary ketamine-based product pipeline for rare and near-rare disorders in pain and inflammation.
  • Seeking to enter Phase 2 clinical trial in 2022.

TORONTO, October 13, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for ketamine in the treatment of complex regional pain syndrome (CRPS), a rare chronic pain and inflammatory condition following an injury to a limb (arm, leg, hand or foot).  This follows the FDA ODD grant of ketamine for the treatment of Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease, announced by the Company on August 4, 2021.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “Receiving our second FDA orphan drug designation with ketamine for CRPS continues our momentum in building a specialty ketamine-based product pipeline for not only mental health disorders, but also for rare and near-rare conditions present in neurological (Parkinson’s disease, ALS), pain and inflammatory disorders.  We expect to pursue a Phase 2 clinical study using our proprietary cGMP ketamine product in 2022 for CRPS.”

CRPS is a debilitating condition characterized by severe, continuous, burning or throbbing pain in a limb.  CRPS is known as one of the most painful disorders and the risk of suicide is significantly higher in patients with CRPS with one study demonstrating that 75% of patients had a high risk for suicide (Lee et al., Psychiatry Investig 2014;11(1):32-8).  CRPS has acute (recent, short-term) and chronic (lasting greater than six months) forms of excessive pain accompanied by changes in skin color, temperature and/or swelling, which results in loss of physical function and can lead to significant and sometimes permanent disability.  CRPS can occur after surgery or trauma, including brain or spinal cord injury.  There is currently no medication approved for the treatment of CRPS.

Ketamine acts as a noncompetitive, NMDA channel blocker that can prevent the induction of synaptic potentiation.  NMDA receptors play a central role in the processes of induction and maintenance of pain sensitization, accounting for the analgesic efficacy of ketamine.  Although ketamine has actions at other relevant sites, including nicotinic and opioid receptors, as well as, via monoamine reuptake transporters, it is likely that both the anesthetic and the analgesic actions of ketamine are largely mediated by NMDA receptor antagonism.  Likewise, the psychotropic and sympatho-excitatory side effects of ketamine are also predominantly mediated through NMDA receptor blockade.

The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). The FDA grants orphan status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan drug designation would qualify a drug for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately $2.4 million.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently initiating an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of May 31, 2021 (“MD&A”), dated September 7, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

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PharmaTher Initiates Phase 2 Clinical Trial of Ketamine for the Treatment of Parkinson’s Disease

PharmaTher Initiates Phase 2 Clinical Trial of Ketamine for the Treatment of Parkinson’s Disease

“KET-LID” trial to evaluate ketamine’s safety and efficacy in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease

TORONTO, October 6, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, announced today that it has initiated its Phase 2 KET-LID clinical trial of Ketamine for the treatment of Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease. Patient screening and enrollment is expected to begin in October 2021 with data anticipated in late-Q4 2021.The Phase 2 KET-LID clinical trial is a randomized, double-blind, active placebo-controlled study evaluating the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.  The primary and secondary endpoints are the changes in the following: i) total score of the Unified Dyskinesia Rating Scale (UDysRS), ii) total objective score (III, IV) of the UDysRS, iii) total daily OFF times as assessed by subject- completed 24-hour diaries, and iv) Unified Parkinson’s Disease Rating Scale (UPDRS) total score of part III (motor) and sum score of Questions 4.1 and 4.2 (dyskinesia) in part IV.

As previously announced, an IND for the trial has been approved by the FDA.  The Company has completed its clinical trial start-up activities and selection of essential vendors including  project management, central laboratory, clinical supply kits and logistics, data management and biostatistics, and clinical site management and monitoring.  Clinical trial drug product (ketamine) and active placebo (midazolam) have also been obtained.  

For further detail about the KET-LID trial (ClinicalTrials.gov Identifier: NCT04912115), titled “A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Intravenous Infusion of Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease,” please visit https://clinicaltrials.gov/ct2/show/NCT04912115?term=PharmaTher&draw=2&rank=1.

If the Phase 2 clinical study is positive, the Company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study under the 505(b)2 regulatory pathway in the first half of 2022.  

“Initiation of the Phase 2 clinical trial of ketamine to treat Parkinson’s disease, or the KET-LID trial, is a significant milestone for PharmaTher and we are excited about the opportunity to advance a potential new therapeutic solution for Parkinson’s disease patients,” said Fabio Chianelli, CEO of PharmaTher.  
There can be no assurance that the FDA will support any potential request for an expedited path to approval or further development for ketamine in the treatment of Parkinson’s disease.

Ketamine’s Potential In Parkinson’s Disease       

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

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

About Parkinson’s Disease

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

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently initiating an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of May 31, 2021 (“MD&A”), dated September 7, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

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Awakn Life Sciences Announces Closing Of Acquisition Of Leading Ketamine-Assisted Psychotherapy Clinic In Norway

Awakn Life Sciences Announces Closing Of Acquisition Of Leading Ketamine-Assisted Psychotherapy Clinic In Norway

Transaction concludes with the launch of “Awakn Clinics Oslo AS” as part of Awakn Life Sciences Nordic Expansion 

TORONTO, October 05, 2021 – Awakn Life Sciences Corp. (“Awakn” or the “Company”), (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954), a biotechnology company developing and delivering psychedelic therapeutics (medicines and therapies) to treat addiction, is pleased to announce the closing of its acquisition of Axonklinikken AS (“Axon”), a leading ketamine-assisted psychotherapy clinic in Norway, as previously announced on September 16, 2021. Upon the completion of the transaction, Axon will be renamed ‘Awakn Clinics Oslo AS,’ and Dr. Lowan Stewart will be appointed as Regional Director for the Nordics and Managing Director Awakn Clinics Oslo AS.

Awakn Clinics Oslo AS Clinic will serve as the Nordic hub from which Awakn plans to expand its clinical network across the region. The acquisition is part of Awakn’s larger strategy to open several addiction and mental health clinics across Europe, including two clinics in the U.K., Bristol and London, that Awakn anticipates being operational this year. Awakn Clinics Oslo AS, led by Dr. Stewart, will be focused on delivering ketamine-assisted psychotherapy for patients and eventually will incorporate ketamine in the Reduction of Alcoholic Relapse’ (KARE) psychotherapy intervention, validated in a phase II ab clinical trial led by the University of Exeter and licensed by Awakn on March 2, 2021.

“The close of our acquisition in Norway is a key strategic milestone in making psychedelic therapeutics to treat addiction a mainstream treatment – helping individuals and their families to move past their addictions and live a fuller life,” said Anthony Tennyson, Awakn’s CEO. “This acquisition will enable Awakn to demonstrate the depth of our three-pronged revenue generation strategy: clinics in the U.K. and Europe, licensing partnership beyond the U.K. and Europe, and therapeutics commercialization. We look forward to opening more clinics across the Nordic region and globally as we aim to become the leading authority in the development and delivery of psychedelic therapeutics.”

Pursuant to the terms of the transaction, Awakn has issued to the shareholders of Axon an aggregate of 200,000 common shares of Awakn at a deemed price of CAD$2.50. The initial 200,000 common shares issued are subject to a lock-up resulting in 10% having been released immediately on closing of the acquisition and 15% to be released every three months thereafter. Awakn has also agreed to pay to the shareholders of Axon the following additional consideration (the “Additional Consideration”) of up CAD$1.35m based on Axon meeting certain milestones:

  • Opening a second clinic in Norway.
  • Opening a first clinic in a second Nordic country.
  • Opening a first clinic in a third Nordic country.
  • Achieving agreed revenue and EBIDTA targets.

Awakn shall have the option to pay any amount of the Additional Consideration in cash or common shares at its option. The value to calculate the number of the common shares to be issued shall be the greater of (i) a 10-day volume weighted average price, (ii) the minimum price allowable by the NEO Exchange, and (iii) CAD$2.50.

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company with clinical operations, developing and delivering psychedelic therapeutics (medicines and therapies) to better treat addiction. Awakn’s team consists of world leading chemists, scientists, psychiatrists, and psychologists who are developing and advancing the next generation of psychedelic drugs, therapies, and enabling technologies to treat addiction. Awakn will deliver this evidence backed psychedelic therapies in clinics in the U.K. and Europe and through licensing partnerships globally.

www.awaknlifesciences.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 to , the intended business of the Company, the expansion of the Company’s business, and generation of revenue. 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: 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; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; 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:

KCSA Strategic Communications
Valter Pinto / Tim Regan
Phone: +1 (212) 896-1254
Awakn@KCSA.com

Media Enquiries:

America and Canada: KCSA Strategic Communications
Anne Donohoe
Adonohoe@KCSA.com

Rest of World: ROAD Communications
Paul Jarman / Anna Ramsey
Awakn@roadcommunications.co.uk

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Delic Partnership With Paradigm Healthcare Of Georgia Brings Clinically Relevant Toxicology Testing To Ketamine Treatment For First Time

Delic Partnership With Paradigm Healthcare Of Georgia Brings Clinically Relevant Toxicology Testing To Ketamine Treatment For First Time

Psychedelic Treatment Chain Ketamine Infusion Centers Will Leverage State-of-the-Art Toxicology Testing Solution to Ensure Highest Quality Results Across Locations

Vancouver, British Columbia – September 30, 2021 – Delic Holding Corp Inc. (“DELIC” or the “Company”) (CSE: DELC) (OTCQB: DELCF) (FRA: 6X0) (original source), the leading psychedelic wellness platform, today announced a first of its kind partnership with Paradigm Healthcare, an independent clinical laboratory located in St. Simons, Georgia, United States, with a focus on high complexity, clinical toxicology, to bring state-of-the-art  testing to  Ketamine Infusion Centers LLC (“KIC”). Through the partnership, KIC will have access to ​​Paradigm’s Benchmark UDT™ toxicology solution that uses LC/MS/MS test methods to identify and accurately measure drug compounds in the body, ensuring the highest quality toxicology results and clinically relevant test data to support medical decision-making.

The addition of Paradigm’s innovative Benchmark UDT™ test platform gives KIC the ability to:

  • Identify any type of drug that may already be present in a patient’s system to avoid potential conflicts with ketamine infusion and to ensure patient safety before ketamine treatment is started.
  • Detect very high levels of ketamine and norketamine, thereby enabling KIC clinicians to make patient-specific treatment decisions and to ensure proper ketamine levels are maintained throughout infusion treatment.
  • Compare ketamine and norketamine levels with analytical data captured from Clinifusion EMR, including benchmarks when treatment started and ended, at what point patients began getting better, and the number of times the patient visited the clinics for treatments, to provide the best overview of a patient’s treatment journey.

Matt Stang, founder and CEO of DELIC stated, “Paradigm’s Benchmark testing platform brings state-of-the-art drug testing technology and new reporting tools to clinicians who use psychedelics to treat people with serious behavioral health conditions; We are proud to partner with Paradigm. By integrating their state-of-the-art testing capabilities, KIC will be able to provide patients suffering from depression, anxiety, PTSD and other debilitating conditions the most accurate, personalized ketamine treatment protocol in the industry.”

“We believe this partnership with Paradigm will take patient care to the next level,” said Sonny Diaz, co-founder of KIC. “Their powerful toxicology testing gives us the ability to quickly assess a patient’s system ahead of treatment and develop a custom plan for moving them through the protocol. Paired with data from Clinifusion EMR, we can see exactly when they started to get better and can keep people at the right levels to maintain their wellness. KIC will be the only clinic able to aggregate this type of analytical data and validate the results.”

Catherine Veal, President, Paradigm stated, “We are very excited about this partnership with Delic and KIC. Paradigm is committed to providing the best scientific data available to support KIC and Delic in their efforts to combine laboratory science with the developing science of psychedelic treatments in patient care. Our industry-leading toxicology testing will now be available to help people who struggle with different behavioral health conditions, including PTSD, major depression, anxiety, as they undergo ketamine infusion to find their way back to better health and wellness.”

KIC enables Delic to leverage its central hub of psychedelic education, media, and information sources to patients seeking psychedelic therapy. Delic Corp is uniquely positioned to bring digital awareness to its various holdings under the Delic Corp umbrella, and drive online users to brick and mortar holdings, including KIC’s physical psychedelic clinics.

Over the last 3 years, KIC has expanded from Arizona to California, while overseeing 4,000 treatments delivered to date, and generating over USD$1.5MM in revenue. KIC operates under the Delic Corp umbrella, under the direction and guidance of Diaz, Dr. Christopher Ray, Rogelio Monzon, and Ganesh Acharya.

About Paradigm Healthcare

Paradigm is based in the United States and its laboratory is located in St. Simons, Georgia. Paradigm is accredited through the College of American Pathologists (CAP) and CLIA. Paradigm performs high-complexity toxicology testing. Paradigm’s laboratory personnel are very experienced and understand the challenges clinicians face when using laboratory science to support quality patient care. For more information about Paradigm and its Benchmark UDT™ testing platform and support of KIC, contact Ananda Smith, Sales Director at +1 (602) 689-9102 or anandas@paradigm.healthcare. Paradigm is not affiliated with Paradigm Labs of Arizona.

About Ketamine Infusion Centers

Ketamine Infusion Centers (“KIC”) is the leading ketamine infusion treatment clinic chain and one of the most experienced in the country, operating locations in California and Arizona. KIC’s evidence-based practices, peer-reviewed studies, and superior quality products result in the best standard of care for legal psychedelic treatments to combat chronic diseases and pain disorders. Part of the Delic Corp family, the leading psychedelic wellness platform, KIC is committed to expanding greater treatment access for patients and improving patient outcomes.

About DELIC Corp.

Delic is the leading psychedelic wellness platform, committed to bringing science-backed benefits to all and reframing the psychedelic conversation. The company owns and operates an umbrella of related businesses, including trusted media and e-commerce platforms like Reality Sandwich and Delic Radio, Delic Labs, the only licensed [6] entity by Health Canada to exclusively focus on research and development of psilocybin vaporization technology, Meet Delic the premiere psychedelic wellness event, and Ketamine Infusion Centers one of the largest ketamine clinics in the country. Delic is backed by a team of industry and cannabis veterans and a diverse network, whose mission is to provide education, research, high-quality products, and treatment options to the masses.9

Media and Investor Relations Contact

Rich Rodriguez

rich@deliccorp.com

The Canadian Securities Exchange ‎has neither approved nor disapproved the contents of this news release and does not accept responsibility ‎for the adequacy or accuracy of this release.‎

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 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 unless registered under the U.S. ‎Securities Act and applicable state securities laws or an ‎exemption from such registration is available.‎

Forward-Looking Information and Statements

This press release contains certain “forward-looking information” within the meaning of applicable ‎Canadian securities ‎legislation and may also contain statements that may constitute “forward-looking ‎statements” within the meaning of ‎the safe harbor provisions of the United States Private Securities ‎Litigation Reform Act of 1995. Such forward-looking ‎information and forward-looking statements are not ‎representative of historical facts or information or current ‎condition, but instead represent only the ‎Company’s beliefs regarding future events, plans or objectives, many of ‎which, by their nature, are ‎inherently uncertain and outside of Delic’s control. Generally, such forward-looking ‎information or ‎forward-looking statements can be identified by the use of forward-looking terminology such as ‎‎”plans”, ‎‎”expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, ‎‎‎”anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or may ‎contain ‎statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be ‎taken”, “will continue”, ‎‎”will occur” or “will be achieved”. The forward-looking information and forward-‎looking statements contained herein ‎may include, but are not limited to: information regarding the timing or terms upon which the Transaction will be completed; potential benefits of the Transaction;  anticipated continued growth in the health and wellness sector (and, in particular, related to psychedelics); the ability of Delic to successfully achieve business ‎objectives, ‎and expectations ‎for other economic, ‎business, and/or competitive factors.‎

By identifying such information and statements in this manner, Delic is alerting the reader that ‎such ‎information and statements are subject to known and unknown risks, uncertainties and other factors ‎that may cause ‎the actual results, level of activity, performance or achievements of Delic to be ‎materially different from those ‎expressed or implied by such information and statements. Such risks and other factors may include, but are not limited to: risks and uncertainties relating to the Transaction not closing as planned or at all or on terms and conditions set forth in the Merger Agreement; incorrect assessment of the value and potential benefits of the Transaction; direct and indirect material adverse effects from the COVID-19 pandemic; inability to obtain future financing on suitable terms; failure to obtain required regulatory and other approvals; risks inherent in the psychedelic treatment sector; changes in applicable laws and regulations; and failure to comply with applicable laws and regulations.

In addition, in ‎connection with the forward-looking ‎information and forward-looking statements contained in this press ‎release, Delic has made certain ‎assumptions. These assumptions include, but are not limited to:

assumptions as to the time required to negotiate a definite agreement and complete matters related to the Transaction; the ability to consummate the Transaction; ‎the ability of the parties to ‎obtain, in a timely manner, the requisite regulatory, corporate and other third party approvals and the satisfaction of ‎other conditions to the ‎consummation of the Transaction on the proposed terms; the potential impact of the announcement or consummation of the Transaction on ‎relationships, ‎including with regulatory bodies, employees, suppliers, customers and competitors; ‎changes in general economic, ‎business and political conditions, including changes in the financial ‎markets; changes in applicable laws; compliance ‎with extensive government regulation; and the diversion ‎of management time on the Transaction.‎

Should one or more of these risks, uncertainties or other factors materialize, or should assumptions ‎underlying the ‎forward-looking information or statements prove incorrect, actual results may vary ‎materially from those described ‎herein as intended, planned, anticipated, believed, estimated or ‎expected.‎

Although Delic believes that the assumptions and factors used in preparing, and the expectations ‎contained ‎in, the forward-looking information and statements are reasonable, undue reliance should not ‎be placed on such ‎information and statements, and no assurance or guarantee can be given that such ‎forward-looking information and ‎statements will prove to be accurate, as actual results and future events ‎could differ materially from those anticipated ‎in such information and statements. The forward-looking ‎information and forward-looking statements contained in this ‎press release are made as of the date of ‎this press release, and Delic does not undertake to update any ‎forward-looking information ‎and/or forward-looking statements that are contained or referenced herein, except in ‎accordance with ‎applicable securities laws. All subsequent written and oral forward- looking information and ‎statements ‎attributable to Delic or persons acting on its behalf is expressly qualified in its entirety by this ‎‎notice.‎

 

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Awakn Life Sciences to Acquire Leading Ketamine-assisted Psychotherapy Clinic in Norway

Awakn Life Sciences to Acquire Leading Ketamine-assisted Psychotherapy Clinic in Norway

Launches Nordics Regional Expansion

Dr. Lowan Stewart, One of Europe’s Preeminent Ketamine Physicians, Appointed as Awakn’s Regional Director for the Nordics

TORONTO, September 16, 2021 – Awakn Life Sciences Corp. (“Awakn” or the “Company”)), (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) a biotechnology company developing and delivering psychedelic medicine to treat addiction, is pleased to announce that it has signed a binding share exchange agreement to acquire a 100% interest in Axonklinikken AS (“Axon”), a leading ketamine-assisted psychotherapy clinic in Norway. As part of the transaction Axon will be renamed ‘Awakn Oslo AS’, and Axon’s majority shareholder Dr. Lowan Stewart will be appointed as Regional Director for the Nordics and Managing Director Awakn Oslo AS.

The acquisition will enable Awakn to accelerate its clinic roll out program, as Awakn  will now parallel path its regional expansion plans in both the Nordics (Norway, Sweden, Denmark, Finland and Iceland) and U.K. & Ireland, territories with a combined 100m population and US$5trn GDP.

Awakn Oslo AS will serve as a regional hub from which Awakn plans to expand across the Nordics and is in addition to the two other clinics Awakn plans to have operational this fiscal year (Bristol and London locations), all of which Awakn expects to begin generating revenue in the near-term.

“This is a key element of our goal for Awakn to become the leading authority in the development and delivery of psychedelic therapeutics to treat addiction,” said Anthony Tennyson, Awakn’s CEO. “Our approach of development and delivery enables Awakn to earn revenue while we also develop a deep IP portfolio with strong commercial potential. This acquisition will enable Awakn to accelerate the first element of our three-pronged revenue generation strategy: clinics in the UK and Europe, licencing partnership beyond the UK and Europe, and therapeutics commercialisation.”

The new Oslo clinic will be led by Dr. Stewart, one of Europe’s preeminent ketamine physicians. Dr. Stewart was previously the founder and medical director of the Santa Fe Ketamine Clinic, the first ketamine treatment center in New Mexico. He has lectured internationally on ketamine for depression and is a member of the American Society of Ketamine Physicians.

“This marks huge progress for psychedelic-assisted therapies in the Nordic region. As a practicing physician, medical adviser and researcher, I am excited at the opportunity to further expand the use of ketamine-assisted therapies for those suffering from addiction to this region of the world,” said Dr. Stewart. “With its robust pipeline of research, Awakn is poised to address a growing need in our communities for new, research-backed treatment options for a variety of mental illnesses that provide significantly better outcomes.”

As consideration for the acquisition, Awakn shall issue to the shareholders of Axon an aggregate of 200,000 common shares of Awakn at a deemed price of $2.50 per share. Awakn has also agreed to pay to the shareholders of Axon the following additional consideration (the “Additional Consideration”) of up CAD1.35m based on Axon meeting certain milestones:

  • Opening a second clinic in Norway.
  • Opening a first clinic in a second Nordic country.
  • Opening a first clinic in a third Nordic country.
  • Achieving agreed revenue and EBIDTA targets.

Awakn shall have the option to pay any amount of the Additional Consideration in cash or common shares at its option. The value to calculate the number of the common shares to be issued shall be the greater of (i) a 10-day volume weighted average price, (ii) the minimum price allowable by the NEO Exchange, and (iii) CAD$2.50. The initial 200,000 common shares issued shall be subject to a lock-up resulting in 10% being released upon completion of the acquisition and 15% every three months thereafter.

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company with clinical operations, developing and delivering psychedelic medicine to better treat addiction. Awakn’s team consists of world leading chemists, scientists, psychiatrists, and psychologists who are developing and advancing the next generation of psychedelic drugs, therapies, and enabling technologies to treat addiction. Awakn will also deliver evidence backed psychedelic therapies for addiction in clinics in the U.K. and Europe and through licencing partnerships globally.

www.awaknlifesciences.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 to the acquisition of Axon, the intended business of the Company, the expansion of the Company’s business, generation of revenue. 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: 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; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; 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:

KCSA Strategic Communications

Valter Pinto / Tim Regan

Phone: +1 (212) 896-1254

Awakn@KCSA.com

Media Enquiries:

America and Canada: KCSA Strategic Communications

Anne Donohoe

Adonohoe@KCSA.com

Rest of World: ROAD Communications

Paul Jarman / Anna Ramsey

Awakn@roadcommunications.co.uk