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Awakn Receives UK State Funding to Identify Optimal Pathway to Market In UK & US For Its Lead Clinical Development Program – Ketamine-Assisted Therapy For Alcohol Use Disorder

Awakn Receives UK State Funding to Identify Optimal Pathway to Market In UK & US For Its Lead Clinical Development Program – Ketamine-Assisted Therapy For Alcohol Use Disorder

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

TORONTO, CANADA, July 05, 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
anthony.tennyson@awaknlifesciences.com

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

Rest of World: ROAD Communications
Paul Jarman / Nora Popova
Awakn@roadcommunications.co.uk

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Ketamine Wellness Centers (KWC) Launches Ketamine Wellness Integrative Therapist Directory

Ketamine Wellness Centers (KWC) Launches Ketamine Wellness Integrative Therapist Directory

Nation’s Largest Ketamine Therapy Provider Offers Complimentary Patient Resource Supporting Holistic Mental Health Treatment

GILBERT, AZ, June 30, 2022 – Ketamine Wellness Centers (KWC), the largest ketamine therapy provider in the U.S. and a subsidiary of Delic Holdings Corp (“Delic” or the “Company”) (CSE: DELC) (OTCQB: DELCF) (FRA: 6X0), today officially launched the Ketamine Wellness Integrative Therapist Directory. The comprehensive resource will connect KWC patients with qualified mental health practitioners who can help them process and integrate the benefits of ketamine therapy into their everyday life.  

The Ketamine Wellness Integrative Therapist Directory is available to anyone visiting KWC’s website. Cognitive therapists practicing in KWC’s operating states will also have the opportunity to join the network at no cost and more therapists will be added in the future. Patients utilizing KWC’s latest resource can reach out to local mental healthcare providers qualified to help individuals integrate ketamine therapy into their treatment plans. All providers or organizations listed included in the referral network align with KWC’s standards and philosophies of care. 

KWC continues to establish itself as a leading mental health treatment provider by offering various methods of accessible care, including ketamine therapy, cognitive therapy and NAD+ infusion therapy. Through its efforts, the company is approaching 100,000 treatments to clinically eligible patients across Arizona, Colorado, Florida, Illinois, Minnesota, Nevada, Texas, Utah and Washington.

“Ketamine therapy is a rapidly growing medical field demonstrating promising results, but many patients overlook the importance of continuous cognitive therapy after their ketamine treatments to maximize the outcomes,” said Kevin Nicholson, CEO of KWC and COO of Delic. “A therapist from the network can work with patients to bridge the outcomes from their completed ketamine therapy into positive, long-term changes in attitudes and behavior. By putting together a comprehensive list of like-minded, qualified mental health professionals and organizations, KWC is continuing to focus on a holistic approach to healing patients suffering from various mental health conditions.”

For more information about Ketamine Wellness Centers’ locations, services and hours of operation, please visit https://www.ketaminewellnesscenters.com/locations/.

About Ketamine Wellness Centers

Ketamine Wellness Centers (KWC) is the largest ketamine therapy provider in the United States with 13 clinic locations serving communities across nine states. Since 2011 KWC has been a trusted leader in bringing IV ketamine therapy into mainstream health care. KWC is approaching 100,000 treatments to clinically eligible patients, from young adults to seniors, in addition to developing specialized programs for veterans and first responders. The KWC team, including a core group of physicians, psychologists, clinicians, and executives, is dedicated to providing value-based, personalized, clinically controlled ketamine infusion care for people suffering from treatment-resistant depression, anxiety, PTSD, OCD and chronic pain. KWC’s scalable business and treatment model is designed for further rapid expansion along with breakthrough innovations in effective therapies and services.

About Ketamine Wellness Integrative Therapist Directory

Ketamine Wellness Centers has met with the providers listed to ensure aligned standards and philosophies of care. However, this list is provided for informational purposes only and should not be construed as a referral by KWC to any specific provider. KWC does not make any express or implied warranties, representations, or endorsements of this list and has not had the credentials or representations within any providers’ listing independently verified. This list includes licensed individuals who identify as being knowledgeable proponents of ketamine integrative care. The practitioners listed represent a variety of modalities, please use your discretion to find a practitioner who meets your specific needs.   Additionally, Ketamine Wellness Centers shall have no responsibility or liability for any damage or loss caused or alleged to be caused by or in connection with use of or reliance on any services available on or through the Integrative Therapy List.

About Delic Corp

Delic is a leader in new medicines and treatments for a modern world, improving access to health benefits across the country and reframing the conversation on psychedelics. The company owns and operates an umbrella of related businesses, including the largest chain of psychedelic wellness clinics in the country, Ketamine Wellness Centers; the only licensed entity by Health Canada to exclusively focus on research and development of psilocybin vaporization technology, Delic Labs; the premier psychedelic wellness event, Meet Delic; and trusted media and e-commerce platforms Reality Sandwich and Delic Radio. 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 effective treatment options to the masses.

Investor Relations Contact
Rich Rodriguez 
rich@deliccorp.com

Media Contact
MATTIO Communications
Clare Redlick 
delic@mattio.com

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PharmaTher Announces Positive Results from Study For Ketamine Microneedle Patch

PharmaTher Announces Positive Results from Study For Ketamine Microneedle Patch

Successfully delivered ketamine and KETABET™ (ketamine and betaine) via microneedle patch, unlocking the potential for desired dosage forms and pharmacokinetic profiles

Pursuing Phase 2 clinical studies in treatment-resistant depression and pain indications in Q4-2022

TORONTO, June 29, 2022 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce that it has successfully completed its research study evaluating the Company’s patented hydrogel-forming microneedle patch, PHARMAPATCH™, to deliver ketamine and KETABET™ (ketamine and betaine anhydrous), which aims to prevent the potential side effects of repeated ketamine treatment for depression and other indications, including suicidal ideation, substance abuse, post-traumatic stress disorder, neurological disorders, and chronic pain.

PHARMAPATCH™ has been shown to successfully deliver esketamine, the S(+) enantiomer of ketamine, which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format. Research results were published in a paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery”1.

The aim of the research program led by Prof Ryan Donnelly at Queens University Belfast (“QUB”) was to develop and characterize PHARMAPATCH™ for the transdermal delivery of ketamine and KETABET™ in a sustained manner and finalize production scale-up processes for clinical studies. Characterization of drug recovery and stability before drug permeation from films via hydrogel-forming microneedle array patches (“MAP”) was assessed in vitro using the Franz cell apparatus. Based on the findings from in vitro permeation investigations, lead candidate MAP formulations were selected and brought forward for in vivo testing using Sprague-Dawley rats to assess the ability to achieve sustained plasma concentrations of ketamine and betaine within the therapeutic range for potential antidepressant therapy over the course of 48 hours.

PHARMAPATCH™ is an alternative platform that allows ketamine to be delivered transdermally in a sustained and de-risked manner. The results from this study represent the first time that multiple formulations of PHARMAPATCH™ for the delivery of ketamine and betaine have been developed, characterized and tested in an animal model. Extensive characterisation of each drug-containing polymeric film and hydrogel-forming MAP combination in terms of swelling capacity, insertion capabilities, drug recovery, stability, and ultimately in vitro drug permeation using the Franz cell apparatus allowed the selection of the most promising candidate formulations for in vivo testing. Hydrogel-forming MAP-mediated delivery of ketamine and betaine were compared with intramuscular injection and orally administered solution, respectively. At regular time intervals during the 48-hour rat study, blood sample results demonstrated that PHARMAPATCH™ was able to deliver plasma levels of ketamine (between 70-200 ng/mL) in a controlled manner throughout the study.

The findings of this work support PHARMAPATCH™ as a promising drug delivery platform through which effective, de-risked, and safe ketamine therapies can be delivered. Considering the high degree of flexibility possessed by this delivery system in terms of formulation, the potential for effective treatment regimens extending beyond 48 hours could be developed through further alterations in surface area, application time, and drug loading of these polymeric patches. 

The Company is preparing for a planned Phase 2 clinical study to allow for ketamine and KETABET™ microneedle patch evaluation in treatment-resistant depression and chronic pain under the FDA 505(b)(2) regulatory pathway. The Company is manufacturing its ketamine microneedle patches at LTS LOHMANN Therapie-Systeme AG for upcoming GLP pre-clinical pig studies to demonstrate the delivery, dosing and safety profile of ketamine in a comparable animal model to support regulatory filings to conduct human clinical studies in Q4-2022. In addition, scale up of the manufacturing process to support GMP and commercial production is currently underway.

About PHARMAPATCH™    

Microneedle-enhanced intradermal delivery is an elegant, efficient and painless method for increasing the skin permeation of many drugs, including ketamine. Transdermal delivery systems offer several advantages over inhalation and intravenous administration. PharmaTher‘s approach with ketamine consists of a 2-part system comprised of a drug-loaded reservoir placed on top of the hydrogel microneedle array. After administration into the skin (i.e. intradermal delivery), the microneedles become hydrated and swell, creating pores for the reservoir to release the drug content into the tissue over the treatment course. Upon removal, the needles are intact, yet rounded, and do not need to be disposed of as sharps. The drug enters the systemic circulation circumventing absorption and first-pass barriers typical for oral delivery. Studies have shown that systemic drug concentrations are reached minutes after administration and maintained over multiple days with transdermal delivery. This system addresses a major unmet need by offering greater ease of administration and including patients with pre-existing conditions that exempt them from oral or inhalation dosing. In addition, it avoids syringe needles, eliminating pain and patient visits to a clinician.

Potential of the Ketamine Microneedle Patch

The Company’s patented hydrogel-forming microneedle (“MN”) patch aims to deliver ketamine for intradermal administration to treat various mental health, neurological and pain disorders. The MN patch consists of hydrogel-forming microneedle arrays and an accompanying reservoir that will overcome limitations by the quantity of drug loaded into the needles or onto the needle surfaces. As such, the MN patch can significantly increase the amount of drug that can permeate through the microneedle array and into the skin.2 The MN patch is tailored for ketamine due to the required drug volume to maximize their therapeutic utility and increase potential market opportunities.

The ketamine MN patch aims to empower patients to dose their medication remotely, safely and conveniently rather than being supervised by a healthcare provider at a certified medical office. The ketamine MN patch has the potential for enabling continuous delivery of ketamine (without pain) with minimal formulation manipulation into systemic circulation while maintaining constant plasma levels for more than 24 hours, which will improve efficacy and compliance for patients.1-2 Also, the ketamine MN patch will incorporate anti-tampering and anti-abuse features that parallel the approach used by commercially available tamper-resistant transdermal fentanyl patches.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of specialty ketamine pharmaceuticals for mental health, neurological, and pain disorders. Learn more at PharmaTher.com.

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”, “may” 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 three and nine month periods ended February 28, 2022 and 2021 (“MD&A”), dated April 25, 2022, 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.

Sources:
1.Courtenay, et al. Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery, Journal of Controlled Release, Volume 322, 2020, Pages 177-186.

2.     Donnelly R.F. Hydrogel-forming microneedles prepared from “super swelling” polymers combined with lyophilised wafers for transdermal drug delivery. PLoSONE. 2014 doi: 10.1371/journal.pone.0111547.

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Ketamine for corporate wellness

Numinus Pilots Mental Health Program for Corporate Clients in Utah

With companies investing more and more money in their employees’ mental health, psychedelic therapy could soon be included in your benefits package.

In 2019, the CBD company HempLucid partnered with Numinus Wellness (NUMI) to offer ketamine-assisted therapy to its staff members. The results were so positive that Numinus is planning to expand the corporate ketamine services to all of its 13 clinics in North America.

“It’s been revolutionary to how we operate as a business,” says HempLucid’s Founder and CEO Chase Hudson. “Offering ketamine treatments to our employees has shown incredible benefits for healing, positivity, and productivity in the work environment.

If anyone manages to negotiate ketamine therapy into their benefits package, please let us know

PDF of article

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First Patient Dosed in Second Phase 2 Add-on Ketamine Trial in Treatment-resistant Depression (TRD)

First Patient Dosed in Second Phase 2 Add-on Ketamine Trial in Treatment-resistant Depression (TRD)

Dosing has commenced in HMNC Brain Health and Develco Pharma’s Phase 2 oral prolonged-release Ketamine (KET01) Study

The trial will assess the efficacy, safety, and tolerability of add-on treatment with KET01 in 117 patients suffering from Treatment-Resistant Depression (TRD)

Munich, June 8, 2022 – HMNC Brain Health (“HMNC” or the “company”), together with Develco pharma, today announced the dosing of the first patient in their second Phase 2 trial with oral prolonged-release Ketamine (KET01) for Treatment-Resistant Depression.

HMNC is a global precision psychiatry biopharma company, pioneering the development of personalized therapies powered by its nascent AI platform and predictive companion diagnostics suite, leading to far shorter treatment durations, higher remission rates, and low side effects has partnered with Develco pharma, a company specializing in the development and manufacture of orally administered modified, prolonged & chrono release drugs, in this trial.

The trial will assess the efficacy, safety, and tolerability of add-on treatment with Ketamine hydrochloride prolonged-release tablets (KET01) in patients suffering from Treatment-Resistant depression (TRD). It will enroll 117 TRD patients at approximately 38 clinical sites. The study’s selection criteria for patients to be included was defined by non-response to a minimum of two standard antidepressants in their current major depressive episode. The trial is expected to confirm the results of the previous trial, with early-onset of efficacy, showing placebo-level dissociative side effects, and excellent tolerability, furthering the take-at-home potential of this novel treatment.

“Our first investigator-initiated Phase 2 Proof of concept trial, which we announced the preliminary results for at end of March, suggested a positive trend in efficacy for KET01, which appears to be a safe and well-tolerated antidepressant with substantially limited dissociative side effects,” said Dr. Hans Eriksson, Chief Medical Officer at HMNC Brain Health.

The Ketabon program, which is a joint venture between HMNC Brain Health and Swiss-based Develco Pharma, funded the trial. Patients will be randomized into three treatment groups and will either receive a placebo, KET01 120 mg, or KET01 240 mg once daily (OD), in addition to their ongoing standard antidepressant treatment over a period of three weeks. The primary endpoint is the change on the established Montgomery–Åsberg Depression Rating Scale (MADRS) for depressive severity at day 21 compared to placebo.

HMNC Brain Health CEO Benedikt von Braunmühl added: “We are very pleased to have achieved this important milestone in the development of KET01 for Treatment-Resistant Depression. We believe KET01 has the potential to improve the lives of patients who are not responding to standard antidepressant therapies, and we are looking forward to further develop this potential medication with the insights generated from this trial”.

Topline data from the study is expected to be reported in the second quarter of 2023.

ABOUT HMNC BRAIN HEALTH

HMNC Brain Health (HMNC Holding GmbH) is a global precision psychiatry biopharma company, pioneering the development of personalized therapies, powered by its nascent AI platform and predictive companion diagnostics suite, leading to far shorter treatment durations, higher remission rates, and low side effects. The company develops a unique pipeline for targeting both Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD). The company has operations in both the US and Germany and is backed by a renowned global VC, several family offices, and a strategic healthcare investor. HMNC Brain Health now enters the next stage of its development with a large-scale licensing and fundraising agenda.

ABOUT DEVELCO PHARMA

With headquarters in Pratteln/ Switzerland, Develco Pharma is a Swiss-German pharmaceutical company specializing in the development and manufacture of orally administered modified, prolonged & chrono release drugs containing known active ingredients. Established in 2006, today the company has a workforce of 130 employees. In Germany, a state-of-the-art production facility for analgesics & other indications has been in operation in Schopfheim, in the Baden region, since 2016. Develco identifies and defines pharmaceutical products containing known active ingredients and develops generic, hybrid, value added and innovative formulations backed by clinical data for the delayed or modified release of active ingredients. On the strength of its experience and innovativeness, the company has emerged as an internationally recognized provider of pharmaceuticals for the treatment of several disease areas. The customer base of Develco Pharma includes global pharmaceuticals groups. The company has some 180 market approvals in all (products of different dosages) in Europe, the US, Middle- East, South Africa, Asia,andAustralia.

ABOUT THE KETABON PROGRAM

The Ketabon program, a joint venture between HMNC Brain Health and Develco Pharma in Switzerland, comprises an oral prolonged-release formulation of ketamine for TRD with minimal dissociative side effects. The pharmacokinetic profile of the prolonged-release formulation could significantly improve the risk profile and patient convenience, by minimizing dissociative side effects compared to the currently applied intravenous and intranasal ketamine therapies. TRD patients with insufficient response to standard antidepressants represent 30% of an overall estimated number of 320 million patients worldwide suffering from major depressive disorder. In this group, prolonged-release ketamine has shown high response rates. Clinical development of oral prolonged-release ketamine could also be potentially expanded into other indications, such as anxiety, aggression, PTSD, and panic disorder.

Media contacts

Alexander Schmidt (Europe)
+49 151 22 99 39 765
alexander.schmidt@gaulyadvisors.com

Anne Donohoe (U.S.)
+1 212-896-1265
hmnc@kcsa.com

Investor Contact (U.S.)

Sophia Bashford
+1 929 246 7307
sbashford@kcsa.com

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PharmaTher Announces Positive Results from Study of KETABET™ for Depression

PharmaTher Announces Positive Results from Study of KETABET™ for Depression

KETABET™ (Ketamine and Betaine) shown effectiveness as measured by the Clinician Administered Dissociative States Scale

Study results are adequate to give an effect size in powering a placebo-controlled clinical study

PharmaTher planning a Phase 2 clinical study to incorporate KETABET™ in its proprietary microneedle patch for depressionTORONTO, June 7, 2022 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce positive results from an investigator-led observational study (the “Study”) evaluating the impact of KETABET™, a patented drug combination of FDA-approved ketamine and betaine anhydrous, on the unwanted ketamine side effects seen post ketamine treatment for subjects with depression. KETABET™ aims to prevent the potential adverse psychiatric effects of repeated ketamine treatment for depression and other indications, including suicidal ideation, substance abuse, post-traumatic stress disorder, and chronic pain.

The investigator-led observational study is a randomized crossover study with subjects suffering from unmanageable depression and currently receiving ketamine treatment but experiencing unwanted side effects of ketamine. The study enrolled 10 subjects and aimed to determine if the administered oral betaine anhydrous before ketamine treatment can reduce some or all of the unwanted side effects observed in the first few hours of ketamine therapy as determined by the Clinician Administered Dissociative States Scale (“CADDS”). Alleviation or reduction of side effects support further progression of this product strategy. The CADDS is currently the standard scale used for studies assessing acute psychoactive effects of ketamine. It is used to measure present-state dissociative symptoms and assess treatment-emergent dissociative symptoms. The CADDS is comprised of 23 questions each evaluated on a 5-point scaling system (0 = “not at all”, 1 = “mild”, 2 = “moderate”, 3 = “severe”, and 4 = “extreme”). Assessment is based on three components, including depersonalization, derealization and amnesia, and an overall total score representing the severity of the condition. Depersonalization is a state in which one loses a sense of identity relative to thoughts and feelings. Derealization is a state where one feels detached from their surroundings.

The Study’s data support the benefit of pre-treatment with oral anhydrous betaine prior to ketamine administration for certain side effects measured by CADDS, including depersonalization and derealization. A reduction in mean of 66% at 40 minutes following ketamine infusion initiation was seen for each of these measures in the Study. Ketamine and betaine were well tolerated with no serious adverse events reported. Although the Study was not meant for statistical significance, it supports the Company’s planned placebo-controlled phase 2 clinical study incorporating KETABET™ in the Company’s proprietary microneedle patch and will further evaluate betaine anhydrous dose, timing of pre-treatment, and duration of effect on depersonalization and derealization effects of low-dose ketamine. Reduction in the depersonalization and derealization side effects associated with low-dose ketamine infusion will potentially improve treatment compliance, treatment dose range, and treatment duration associated with ketamine therapy. Additional influence of pre-treatment with betaine prior to low-dose ketamine administration will further define the Company’s KETABET™ product scope for this and potentially other indications. Complete results of the Study are expected to be submitted for presentation at a medical congress by 2H-2022.

Dr. Raul Cruz, MD, Principal Investigator of the Study, commented: “The results of this pilot observational study were very promising as the pre-treatment with betaine prior to ketamine administration demonstrated a better recovery from ketamine effects and higher dose tolerability for patients that typically experience dose limiting side effects. In general, patients that typically experienced nausea during treatment had a notable reduction and improved recovery. We are encouraged by the increase in alertness and decreased dizziness with pre-treatment of betaine and look forward to incorporating this combination into our practice for patients that require ketamine therapy for depression.”      

Fabio Chianelli, CEO of PharmaTher, commented: “We are very pleased with the results from this Study as it provides support for advancing our microneedle patch program in a potential Phase 2 clinical study evaluating KETABET™ for mental health and pain disorders.”

Based on the Study results, the Company is preparing to engage the FDA to establish the next steps for a planned Phase 2 clinical study to allow for KETABET™ evaluation in depression under the 505(b)(2) regulatory pathway. The Company intends to use its proprietary hydrogel-forming microneedle patch for the planned Phase 2 clinical study.

Granted patents of KETABET™ are issued in the U.S. (Patent No. 11,213,495), Japan (Patent no. 6967532) and Taiwan (Patent no. I648049). The Company expects to convert the current patent applications in Europe, Canada, Israel and China into granted patents. Patent protection is expected to expire in 2036.

Potential of KETABET™

KETABET™, a patented drug combination of FDA-approved ketamine and betaine anhydrous, has been shown in research to enhance the antidepressant effect while having the potential to reduce the known negative side effects of ketamine significantly.1 Side effects such as hallucinations, confusion, memory loss and abuse liability compromise the compliance and potential therapeutic value of ketamine.2  The combination of ketamine and betaine anhydrous produced more robust antidepressant-like responses than their individual effects and that the combination blocked the psychotomimetic effects of ketamine.1  This suggests that betaine anhydrous can be considered as an add-on therapy to ketamine or as a fixed-dose combination therapy for treatment-resistant depression, treatment-resistant bipolar disorder, post-traumatic stress disorder, obsessive-compulsive disorder and chronic pain.

More than 300 million people suffer from major depressive disorder and 100 million people are resistant to available treatments worldwide.  Ketamine is emerging as a viable treatment option for depression. Recent clinical studies have shown that low dose ketamine produces a rapid-acting and sustained antidepressant effect in major depressive disorder,3 bipolar depression,4 depression with suicidal ideation5 and post-traumatic stress disorder.6 Despite this, the potential for abuse and misuse of ketamine and the adverse mental effects of ketamine leads to its limited clinical use and discontinuation.

Betaine anhydrous (CYSTADANE®) was approved by the FDA in 1996 to treat homocystinuria to decrease elevated homocysteine blood concentrations. There is growing evidence that betaine plays a critical role in regulating brain functions and has an antidepressant-like effect.7 Betaine has been reported to prevent seizures in rodents,8 to improve symptoms of Rett syndrome,9 and to delay the onset of neurologic impairment due to vitamin B12 deficiency10 clinically.  Furthermore, betaine attenuates memory deficits induced by homocysteine.11

Potential of the Hydrogel-forming Microneedle Patch

The Company’s patented hydrogel-forming microneedle (“MN”) patch aims to deliver ketamine and KETABET™ for intradermal administration to treat various mental health, neurological and pain disorders. The MN patch consists of hydrogel-forming microneedle arrays and an accompanying reservoir that will overcome limitations by the quantity of drug loaded into the needles or onto the needle surfaces. As such, the MN patch can significantly increase the amount of drug that can permeate through the microneedle array and into the skin.12 The MN patch is specifically tailored for ketamine and KETABET™ due to the volume of drug that is required to maximize their therapeutic utility and increase potential market opportunities.

The KETABET™ MN patch aims to empower patients to dose their medication remotely, safely and conveniently rather than being supervised by a healthcare provider at a certified medical office. KETABET™ MN patch has the potential for enabling continuous delivery of KETABET™ (without pain) with minimal formulation manipulation into systemic circulation while maintaining constant plasma levels for more than 24 hours that will improve efficacy and compliance for patients.12-13 Also, PharmaTher’s KETABET™ MN patch will incorporate anti-tampering and anti-abuse features that parallel the approach used by commercially available tamper-resistant transdermal fentanyl patches.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of specialty ketamine pharmaceuticals for mental health, neurological, and pain disorders. Learn more at PharmaTher.com.

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”, “may” 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 three and nine month periods ended February 28, 2022 and 2021 (“MD&A”), dated April 25, 2022, 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.

Sources:

  1. J.-C. Lin, M.-Y. Lee, M.-H. Chan, Y.-C. Chen, H.-H. Chen, Betaine enhances antidepressant-like, but blocks psychotomimetic effects of ketamine in mice, Psychopharmacology (Berl). 233 (2016) 3223–32
  2. Krystal et al. 1994; Perry et al. 2007
  3. Murrough et al. 2013; Wan et al. 2014
  4. Ionescu et al. 2015; Nugent et al. 2014; Rybakowski et al. 2013
  5. Aligeti et al. 2014; Thakurta et al. 2012; Zigman and Blier 2013
  6. Feder et al. 2020
  7. ​Freed 1984; 1985
  8. Kim et al. 2013; Di Pierro et al. 2015
  9. Percy and Lane 2005
  10. van der Westhuyzen and Metz 1984
  11. ​Chai et al. 2013
  12. Donnelly R.F. Hydrogel-forming microneedles prepared from “super swelling” polymers combined with lyophilised wafers for transdermal drug delivery. PLoSONE. 2014 doi: 10.1371/journal.pone.0111547.
  13. Courtenay, et al. Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery, Journal of Controlled Release, Volume 322, 2020, Pages 177-186.
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Ehave, Inc. Announces its KetaDASH Mobile Unit will be Delivered to Miami Beach on June 10, 2022

Ehave, Inc. Announces its KetaDASH Mobile Unit will be Delivered to Miami Beach on June 10, 2022

MIAMI, June 03, 2022 (GLOBE NEWSWIRE) — Ehave, Inc. (OTC Pink: EHVVF) (the “Company”), a leading healthcare services and technology company, announced today its KetaDASH subsidiary will accept delivery of its KetaDASH Mobile Unit in Miami Beach Florida on June 10, 2022. The KetaDASH Mobile Unit is a custom high-end medical van utilizing KetaDASH’s software platform. By bringing exclusive Ketamine IV treatments directly to the patient, KetaDASH will empower doctors and patients with real-time health data for better clinical decisions and health outcomes.

Ehave’s KetaDASH subsidiary began operations in the Sacramento and San Francisco area earlier this year. KetaDASH is a managed service organization focused on the psychedelic sector with the mission of helping physicians streamline their practice operations, create new revenue opportunities, and achieve better patient outcomes. KetaDASH treatments are conducted by a team of experienced physicians, therapists and nurses who will come to your home, office, or mobile location and provide a complete ketamine treatment experience, after an initial telemedicine visit. The KetaDASH Mobile Unit is specifically designed to focus on safety, setting, comfort and efficacy of treatments. 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. Follow KetaDASH on Instagram at www.instagram.com/ketadash.usa.

Ben Kaplan, CEO of Ehave, said, “Ketamine is an FDA approved drug that has been used for over 50 years as a safe dissociative anesthetic that is now being studied as a treatment for major depression. In certain psychiatric conditions, such as treatment-resistant depression, anxiety, post-traumatic stress disorder and alcohol abuse, ketamine has shown very encouraging results.”

Mr. Kaplan continued, “I am honored to include pictures of our KetaDASH Mobile Unit, which we created together. As we make plans to go live this summer in Miami Beach, one very important message is that I would like to say ‘Thank You’ to all of the team members and license partners. Most importantly, I would like to say ‘Thank you’ to our shareholders, who have helped us make all of this happen.”

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: Ir@Ehave.com

Skype: kugsusa

LinkedIn: https://www.linkedin.com/in/davidkugelman

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Awakn Life Sciences Initiates Follow-on Behavioral Study to Focus on Gambling Disorder

Awakn Life Sciences Initiates Follow-on Behavioral Study to Focus on Gambling Disorder

Study Initiated Following Recent Successful Pilot Study and Patent Filing

TORONTO, CANADA, June 2, 2022 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) (‘Awakn’), a biotechnology company, researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announced today that they have initiated a larger behavioral addiction study investigating ketamine as a treatment for Gambling Disorder. Awakn announced on May 19, 2022, that the Company had completed a successful pilot study for a range of behavioral addictions. On May 26, 2022, Awakn announced the filing of a Patent Cooperation Treaty (PCT) for the treatment of behavioral addictions with ketamine and ketamine-assisted psychotherapy.

The larger study announced today will include 42 patients who are suffering from Gambling Disorder and will see participants undergo a memory reactivation procedure, which is designed to weaken the link between reward and addiction memories. The larger placebo-controlled study will be the first investigation globally to explore this technique to treat Gambling Disorder.

The study will use advanced brain imaging technology EEG (Electro Encephalography) and will index the synaptic plasticity post-ketamine administration with the aim of identifying the window of greatest neuroplastic change. This would potentially allow Awakn to predict when therapy will be at its most effective due to the neuroplasticity. The study will also collect detailed pharmacokinetic (PK) data and analyze metabolites as well as examining neurological biomarkers. 

Awakn CEO Anthony Tennyson commented, “Awakn is dedicated to helping people who are suffering from addiction, and we are greatly enthused by the significant research & development milestones we have passed in recent weeks.  None of this would be possible without the dedication of the Awakn team and I would like to formally thank them, and everyone involved, including patients, physicians, and carers.”

Gambling Disorder affects up to 450 million[1] people globally. In the US alone, it is estimated that more than 2.5% of the population suffer from Gambling Disorder, that is over 8 million people2. With no pharmacological treatments currently available, the need to find an effective treatment has never been more acute.

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company, researching, developing and commercializing combined therapeutics to treat addiction, with a focus on Alcohol Use Disorder.  Awakn’s team consists of renowned research experts, world leading chemists, scientists, psychiatrists, and psychologists. Addiction is one of the biggest unmet medical needs of our time, affecting over 20% of the global population and is an industry valued at over $100bn per annum. Awakn is working to disrupt this underperforming industry by advancing the next generation of drugs and therapies to be used in combination, through preclinical research and clinical-stage trials.

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 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
anthony.tennyson@awaknlifesciences.com

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

Rest of World: ROAD Communications
Paul Jarman / Nora Popova
Awakn@roadcommunications.co.uk

[1]: Problem gambling worldwide: An update and systematic review of empirical research (2000–2015):

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5370365

2: North American Foundation for Gambling Addiction Help:

https://nafgah.org/statistics-gambling-addiction-2016/

Posted on

Ketamine Wellness Centers (KWC) Launches SPRAVATO® Nasal Spray Therapy in Minneapolis, Salt Lake City and Dallas

Ketamine Wellness Centers (KWC) Launches SPRAVATO® Nasal Spray Therapy in Minneapolis, Salt Lake City and Dallas

Largest Ketamine Provider in the U.S. Now Offering FDA-Approved Esketamine Nasal Spray Offering for Adults in Six Cities

GILBERT, AZ, June 1, 2022 – Ketamine Wellness Centers (KWC), the largest ketamine therapy provider in the U.S. and a subsidiary of Delic Holdings Corp (“Delic” or the “Company”) (CSE: DELC) (OTCQB: DELCF) (FRA: 6X0), has expanded the availability of SPRAVATO® to three new cities and increased the total number of clinics offering the FDA-approved esketamine nasal spray to six. Starting June 1, the KWC clinics in Minneapolis, Salt Lake City and Dallas will join the Houston, Las Vegas and Seattle locations in offering SPRAVATO to their patient base.

Taken with an oral supplement, SPRAVATO is an FDA-approved treatment for adults experiencing treatment-resistant depression (TRD) or depressive symptoms associated with major depressive disorder (MDD). Patients interested in pursuing this treatment option will work with the company’s experienced intake and screening teams to ensure that SPRAVATO is the most positive choice for them. KWC providers are trained to administer SPRAVATO treatments in the right care and patient safety settings.

Many of the nation’s largest insurers have included SPRAVATO in their coverage. Insurance experts at KWC are available to help patients navigate the complexities of healthcare coverage and assist in determining coverage and potential out-of-pocket costs.

“KWC aims to provide a diverse range of accessible and clinically-supported mental healthcare options to our national patient community,” said Kevin Nicholson, CEO of KWC and Chief Operating Officer of Delic. “We’re excited to continue growing the availability of SPRAVATO, the first treatment of its kind, and we look forward to helping more patients across our network of clinics understand how it can benefit their mental health as we expand into new states.” 

For more information about Ketamine Wellness Centers’ locations, services and hours of operation, please visit https://www.ketaminewellnesscenters.com/locations/.

About Ketamine Wellness Centers

Ketamine Wellness Centers (KWC) is the largest ketamine therapy provider in the United States with 13 clinic locations serving communities across nine states. Since 2011 KWC has been a trusted leader in bringing IV ketamine therapy into mainstream health care. KWC has provided over 60,000 treatments to clinically eligible patients, from young adults to seniors, in addition to developing specialized programs for veterans and first responders. The KWC team, including a core group of physicians, psychologists, clinicians, and executives, is dedicated to providing value-based, personalized, clinically controlled ketamine infusion care for people suffering from treatment-resistant depression, anxiety, PTSD, OCD and chronic pain. KWC’s scalable business and treatment model is designed for further rapid expansion along with breakthrough innovations in effective therapies and services.

About Delic Corp, Inc.

Delic is a leader in new medicines and treatments for a modern world, improving access to health benefits across the country and reframing the conversation on psychedelics. The Company owns and operates an umbrella of related businesses, including the largest chain of psychedelic wellness clinics in the country, including Ketamine Infusion Centers and Ketamine Wellness Centers; the only licensed entity by Health Canada to exclusively focus on research and development of psilocybin vaporization technology, Delic Labs; the premier psychedelic wellness event, Meet Delic; and trusted media and e-commerce platforms Reality Sandwich and Delic Radio. 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 effective treatment options to the masses.

About SPRAVATO®

SPRAVATO® (esketamine) CIII nasal spray is a nonselective, noncompetitive antagonist of the N-methyl-D-aspartate (NMDA) receptor – an ionotropic glutamate receptor. It is a first-of-its kind medicine approved by the FDA in two major depressive disorder (MDD) subpopulations with high unmet need.1

SPRAVATO® is approved in the United States, in conjunction with an oral antidepressant, to treat adults with treatment-resistant depression (TRD) and to treat depressive symptoms in adults with MDD with acute suicidal ideation or behavior.

Reference

1. Duman RS. F1000Research. 2018;7:F1000.

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 Statesunless 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.‎

Investor Relations Contact
Rich Rodriguez
rich@deliccorp.com

Media Relations Contact
Clare Redlick
MATTIO Communications clare@mattio.com

Posted on

Why ketamine reduces depression so quickly

Why ketamine is a speedster antidepressant

Several studies have found that ketamine produces a rapid antidepressant effect, reducing suicidal ideation in just hours.

A new study from Northwestern University sheds light on why the benefits are so instantaneous.

Traditional antidepressants work by increasing the number of neurons in the brain, which can take several weeks.

Ketamine, on the other hand, was found to increase activity in newborn neurons, which then activates other cells in the hippocampus.

“This small population of cells acts like a match, starting a fire that ignites a bunch of activity in a lot of other cells that produce the behavioral effects,” says lead study author Dr. John Kessler.

“That’s important because when you give ketamine to patients now, it affects multiple regions of the brain and causes a lot of adverse side effects. But since we now know exactly which cells we want to target, we can design drugs to focus only on those cells.”

PDF of article

PDF of study