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Cybin Announces Initiation of Kernel Flow® Feasibility Study Measuring Psychedelic Effects on the Brain

Cybin Announces Initiation of Kernel Flow® Feasibility Study Measuring Psychedelic Effects on the Brain

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, today announced that the first study visit has been conducted in a Cybin-sponsored feasibility study evaluating Kernel’s quantitative neuroimaging technology, Flow, to measure ketamine’s psychedelic effects on cerebral cortex hemodynamics.

“The commencement of the Kernel feasibility study marks a truly exciting moment, not only for Cybin and Kernel, but also for the entire field of psychedelic drug development. To this point, studies have had to rely on subjective patient reporting. By deploying the innovative Flow technology, this is the first time any company has had the ability to collect and quantify longitudinal brain activity before, during and after a psychedelic experience. We are specifically encouraged by this scientific advancement as it has the potential for Cybin to collect real-time quantitative data for our promising psychedelic-based therapies. These data will support the Company’s leading research position as we move our important treatment options through regulatory discussions and late-stage clinical development,” said Doug Drysdale, Chief Executive Officer of Cybin.

“Kernel Flow is a groundbreaking neuroimaging technology that enables rigorous characterization and quantification of physiological processes in the human brain. Our collaboration with Cybin has the potential to significantly enhance the research evaluating the potential positive effects of psychedelic therapies on the brain to improve mental wellness,” said Bryan Johnson, Founder and Chief Executive Officer of Kernel.

About the Feasibility Study:

The main objective of the Company-sponsored feasibility study is to evaluate a participant’s experience wearing Kernel Flow while in an altered state of consciousness following the administration of ketamine. Participants will receive either a low dose of ketamine or placebo while wearing the Flow headset, which is equipped with hi-tech sensors to record brain activity and will report their experience using structured questionnaires and validated assessments during study visits and at follow-up. The four-week study will also evaluate brain activity before and after administrating the study agents – low-dose ketamine or placebo.

The feasibility study received U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) authorization in October 2021 and Institutional Review Board (“IRB”) approval in January 2022.

As part of Cybin’s sponsorship of the feasibility study, the Company will retain an exclusive interest in any innovations that are discovered or developed through its independent analysis of the study findings.

About Kernel Flow

Kernel Flow is a wearable headset that measures brain activity by recording local changes in blood oxygenation. It is adjustable, can accommodate nearly anyone and is safe. Kernel Flow is groundbreaking neurotechnology because it reduces loud, expensive, and room-sized equipment to a head-worn apparatus while providing neural activity data of the highest possible optical quality. This combination has never existed in such a commercial and scalable device, all factors for why brain interfaces and neuroimaging technology has largely remained in academic labs or hospital basements and why mental health diagnosis and treatment have behavioral, instead of biomarker, endpoints. The entire system is the size and look of a bicycle helmet and could, in the future, be more broadly used for neuroscientific or physiological studies of brain activity during psychedelic use.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Cautionary Notes and Forward-Looking Statements

Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens, including the anticipated results of using Kernel Flow technology, to potentially treat psychiatric disorders.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the period ended December 31, 2021 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

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

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Investor & Media Contacts:
Leah Gibson
Vice President, Investor Relations
Cybin Inc.
leah@cybin.comSource: Cybin Inc.

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Delic Expansion Accelerating into 2022 with New Clinic Openings

Delic Expansion Accelerating into 2022 with New Clinic Openings

Ketamine Wellness Centers (KWC) Opens Locations in Salt Lake City and Reno with More on the Way, Adds FDA-Approved SPRAVATO® to Treatment Options

Survey by The Harris Poll for Delic Finds Majority of Affected Americans Approve of Psychedelics as an Alternative Treatment to Address Anxiety, Depression and PTSD

Vancouver, British Columbia – March 31, 2022 – Delic Holdings Corp (“DELIC” or the “Company”) (CSE: DELC) (OTCQB: DELCF) (FRA: 6X0), a leader in new medicines and treatments for a modern world, is pleased to share the following corporate update:

Delic currently has 13 clinics operational today with more state-of-the-art clinics opening in the next 18 months. The most recent clinic openings include KWC Salt Lake City on January 10 and KWC Reno on March 7.

KWC added SPRAVATO® (esketamine), the first FDA-approved nasal spray, as a treatment option at the Houston, Las Vegas and Seattle locations for adults with treatment-resistant depression (TRD) and depressive symptoms in adults with major depressive disorder (MDD).

Delic Labs received Health Canada 56 exemptions to perform research and develop IP for MDMA, LSD, DMT, mescaline, 2C-B, and to acquire 60 grams of psilocybin mushrooms from Nectar Health Sciences Laboratory Division Inc., a wholly-owned subsidiary of Psilobrain Therapeutics Inc.

Delic Corp released the findings of its first-ever survey on U.S. attitudes towards psychedelics conducted by The Harris Poll and found a majority of Americans who suffer from anxiety/depression/PTSD (65%) believe that psychedelic medicine (i.e., ketamine, psilocybin and MDMA) should be made available to patients with treatment-resistant anxiety, depression or PTSD. Almost two-thirds (63%) of Americans who have used prescription medications to treat anxiety/depression/PTSD say that while the medication helped, they still experienced residual feelings of anxiety, depression or PTSD; while 83% of Americans experiencing anxiety, depression or PTSD would be open to pursuing alternative treatments proven to be more effective than prescription medication with fewer side effects. *

Delic continued to accelerate its expansion plans through the opening of two new Ketamine Wellness Centers (KWC) in the first quarter of 2022. KWC Salt Lake City officially opened its doors on January 10 making it the first KWC clinic in Utah. The 2,500 square foot KWC Reno clinic opened on March 7 and became the Company’s second clinic in Nevada (the other location is in Las Vegas) and serves local patients and patients in larger California markets who do not have access to affordable in-state providers. The launch of these two new locations brings the total number of clinics for the Company to 13 with more state-of-the-art clinics opening in the next 18 months.

KWC also increased its offering by adding SPRAVATO® (esketamine) nasal spray as a treatment option. Taken with an oral antidepressant, SPRAVATO is the first FDA-approved esketamine nasal spray for adults with treatment-resistant depression (TRD) or to treat depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions. The KWC clinics located in Houston, Las Vegas and Seattle will begin offering SPRAVATO as a treatment option beginning April 1.

Delic Labs continued to expand on their ability to research novel compounds and develop IP for future commercialization with the addition of a Health Canada 56 exemptions for MDMA, LSD, DMT, mescaline, 2C-B, and to acquire 60 grams of psilocybin mushrooms from Nectar Health Sciences Laboratory Division Inc., a wholly-owned subsidiary of Psilobrain Therapeutics Inc. These 56 exemptions are in addition to the one they hold for chemistry analytics on psilocybin mushrooms. Last October, Delic Labs also applied for a Dealer’s License to commercialize its psilocybin research and associated IP for medical and research purposes.

Matt Stang, Co-founder and CEO of Delic, commented: “Based on our survey results, the majority of affected Americans believe that psychedelic medicine should be made available to patients with treatment-resistant anxiety, depression or PTSD. Our mission to make these new, science-backed medicines accessible and affordable to a greater number of people suffering from these conditions is more urgent than ever. The opening of the KWC Salt Lake City and Reno locations and the addition of FDA-approved SPRAVATO as a treatment option means we can serve more patients than any other ketamine provider in the U.S. With its latest Health Canada 56 exemptions, Delic Labs continues to lead the industry on the research of these novel psychedelic compounds and development of IP for future commercialization. Delic is opening doors to a future with more effective medicines for a variety of mental health conditions with longer lasting benefits and less side effects.”

About Delic

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.

*This survey was conducted online within the United States by The Harris Poll on behalf of Delic from December 6 – 8, 2021 among 2,037 adults ages 18 and older, among whom 953 suffer from anxiety/depression/PTSD.

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: anticipated continued growth in the health and wellness sector (and, in particular, related to psychedelics); the ability of Delic to successfully achieve business ‎objectives, including opening 15 additional clinics over 18 months, ‎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: 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: changes in general economic, ‎business and political conditions, including changes in the financial ‎markets; changes in applicable laws; compliance ‎with extensive government regulation.‎

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.‎

Financial Outlook

This press release contains financial outlook information about revenue run-rate, which is subject to the same assumptions, risk factors, limitations, and qualifications as set out under the heading “Forward-Looking Information and Statements”. The actual financial results of the Company may vary from the amounts set out herein and such variation may be material. The Company and its management believe that the financial outlook has been prepared on a reasonable basis, reflecting management’s best estimates and judgments. However, because this information is subjective and subject to numerous risks, it should not be relied on as necessarily indicative of future results. Except as required by applicable securities laws, the Company undertakes no obligation to update such financial outlook. Financial outlook contained in this press release was made as of the date hereof and was provided for the purpose of providing further information about the Company’s anticipated future business operations on an annual basis. Readers are cautioned that the financial outlook contained in this press release should not be used for purposes other than for which it is disclosed herein.

Non-IFRS Financial Measures‎

This press release refers to certain non-International Financial Reporting Standards ‎‎(“IFRS”) ‎measures. EBITDA refers to net earnings from continuing operations before interest, taxes and tax recoveries, amortization, deferred income tax recovery, unrealized foreign exchange losses, non-cash share-based expenses (Black-Scholes option pricing model) and write-off of assets. EBITDA is not an earnings measure recognized by IFRS and does not have a standardized meaning prescribed by IFRS. Management believes that EBITDA is an alternative measure in evaluating the Company’s business performance. The most directly ‎comparable measure to ‎EBITDA calculated in accordance with IFRS is net income (loss). Readers are cautioned that EBITDA should not be construed as an alternative to net income as determined under IFRS; nor as an indicator of financial performance as determined by IFRS; nor a calculation of cash flow from operating activities as determined under IFRS; nor as a measure of liquidity and cash flow under IFRS. The Company’s method of calculating EBITDA may differ from methods used by other Companies and, accordingly, the Company’s EBITDA may not be comparable to similar measures used by any other company.‎

Investor Relations Contact
Rich Rodriguez
rich@deliccorp.com

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HMNC Brain Health and Develco Pharma Announce Promising Preliminary Results in Treatment-resistant Depression (TRD), Suggesting Antidepressant Efficacy and Showing Placebo-level Dissociative Side Effects in Phase 2 Oral Prolonged-release Ketamine (KET01) Study

HMNC Brain Health and Develco Pharma Announce Promising Preliminary Results in Treatment-resistant Depression (TRD), Suggesting Antidepressant Efficacy and Showing Placebo-level Dissociative Side Effects in Phase 2 Oral Prolonged-release Ketamine (KET01) Study

  • Phase 2 Proof-of-Concept study in TRD patients resistant to standard antidepressants suggests positive trend in efficacy.
  • Potential first-in-class oral prolonged-release formulation of ketamine, KET01, suggests larger improvement in Montgomery–Åsberg Depression Rating Scale (MADRS) scores at 15 days compared to placebo.
  • Improvement in MADRS scores shown at 7 days suggestive of rapid onset of efficacy.
  • Safety: no treatment-related serious adverse events with only placebo-level dissociative side-effects reported.

Munich, March 31, 2022 – HMNC Brain Health (“HMNC” or the “Company”), a global clinical stage biopharmaceutical company pioneering the development of personalized therapies in psychiatry, together with Develco Pharma, a company specializing in the development and manufacture of orally administered modified, prolonged & chrono release drugs today announced promising top- line results from the Phase 2 Proof-of-Concept investigator-initiated trial of its oral prolonged- release formulation of ketamine (KET01) in Treatment-Resistant Depression (TRD).

The trial suggests a positive trend in efficacy, based on the primary endpoint clinical data: After 15 days, the highest dose of 240 mg/day KET01 was associated with a larger improvement on the Montgomery-Åsberg Depression Rating Scale (MADRS) compared with placebo (Δ=-4.99, p=0.1499). In addition, KET01 appears to be a safe and well-tolerated antidepressant, with substantially limited dissociative side effects, and scores on the Clinician-Administered Dissociative States Scale (CADSS) similar to those for placebo.

The Phase 2 trial evaluated whether KET01 administered in doses of 240 mg/day and 160 mg/day for 15 days to patients with TRD as an adjunct treatment to standard antidepressants can improve depressive symptoms compared to placebo. Recruitment stopped early after inclusion of 27 patients with TRD instead of 99, due to the effects of COVID-19 together with very stringent criteria for definition of treatment resistant depression on recruitment.

The primary endpoint, change in MADRS from baseline to day 15, showed a mean advantage of -4.99 units compared with placebo (95% confidence interval (CI): -11.81, 1.83, p=0.1499) suggesting a positive trend in efficacy for the highest tested dose (240 mg/day) on the established MADRS rating scale for depressive severity.

Additionally, the data suggest KET01 has a rapid onset of action, with a clinically meaningful improvement of -5.67 units (95%CI: -12.57, 1.23, p=0.1062) already after 7 days compared with placebo.

Importantly, safety results from the trial demonstrated that KET01 was well tolerated, with no treatment-related serious adverse events reported. The scores on the Clinician-Administered Dissociative States Scale (CADSS) were similar to those for placebo.

Dr. Hans Eriksson, HMNC Brain Health’s Chief Clinical Development Officer, said, “The encouraging preliminary results we have seen demonstrate the safety of KET01, showing the potential for development of a first-in-class, oral prolonged-release formulation of ketamine treatment for patients suffering from Treatment-Resistant Depression. In addition, our data suggest that KET01 is rapidly acting with a clinically meaningful improvement compared with placebo already after 7 days, which stands in sharp contrast to standard antidepressants which have a delayed onset of action of up to several weeks.”

The study was funded by the Ketabon program, which is a joint venture between HMNC Brain Health and Develco Pharma, sponsored by University of Zürich and conducted under the central leadership of Professor Erich Seifritz, Director of the Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich. Dr. Michael Colla coordinated the medical implementation as head of the clinical trial at the University of Zurich, as successor of Prof. Annette Brühl, after she moved to the University of Basel. The statistical evaluation of the study was carried out by SCOPE, a globally renowned CRO.

Professor Seifritz commented, “We are pleased with the top-level results from this Phase 2 study on Treatment-Resistant Depression with KET01, as they hold significant positive implications for the clinical development of oral prolonged-release ketamine to help those afflicted, making up as many as 30 percent of depression patients. Not only does the data suggest this to be a potentially safer treatment for people suffering from Major Depressive Disorder who have not found currently available antidepressants effective, but it could potentially be expanded to include additional mental-health indications in the future. Ketabon and the University of Zurich will continue to work together in the development of KET01, with future studies being planned.”

HMNC Brain Health, in partnership with Develco Pharma, is about to start a multinational, larger CRO-led Phase 2 randomized, double-blind, placebo-controlled trial in patients with TRD in the second quarter of 2022. First results are expected for mid-2023.

“We are highly encouraged by the findings in this study, showing a clinically meaningful improvement and excellent tolerability in patients treated with 240 mg/day KET01. We will bring our experiences from this study to further trials with KET01 and are looking forward to the next steps in the development of this promising medication”, said Develco Pharma CEO Dr. Martin Renner.

Dr. Eriksson added, “The suggested clinically relevant improvement in efficacy and the good safety and tolerability profile that we saw in the Phase 2 Proof-of-Concept trial support our plans for the larger study which we are preparing to launch. With the capabilities of our team and strong Scientific Advisory Board, we are well placed to undertake the next steps for progressing Ketabon towards more studies and the pathway to approval and commercialization.”

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 predictive companion diagnostics, leading to far shorter treatments and higher remission rates. The Company develops a unique pipeline for targeting both Major Depressive Disorder (MDD) and Treatment- Resistant Depression (TRD). The Company has operations both in the US and Germany and is backed by a renowned global VC, several family offices, and a strategic healthcare investor. The Company 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 and Australia.

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.

ABOUT THE PSYCHIATRIC UNIVERSITY HOSPITAL ZURICH

The Department of Psychiatry, Psychotherapy and Psychosomatics at the Psychiatric University Hospital Zurich is an internationally leading institute of translational research into innovative and novel biological and psychological treatments of psychiatric conditions, with a focus on Major Depression, Schizophrenia and Addiction. The translational approach is based on a comprehensive bio-psycho-social disease model overarching the full spectrum from molecular neuroscience to clinical and social psychiatry and back.

Media contacts

Alexander Schmidt (Europa)
+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.)

Tim Regan / Sophia Bashford
+1 347-487-6788
tregan@kcsa.com / sbashford@kcsa.com

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Ketamine found to be safe and effective for teen depression

Efficacy of Intravenous Ketamine in Adolescent Treatment-Resistant Depression: A Randomized Midazolam-Controlled Trial

One in four young adults contemplated suicide last year.

Clearly, something needs to change. Could ketamine be the solution?

A study last month found that ketamine was well-tolerated in adolescents aged 13-17 and significantly reduced their depression symptoms.

76% of participants had at least a 50% reduction in depression scores within 3 days of receiving a ketamine infusion, compared to 35% of the placebo group.

The teens had tried between 1 and 7 antidepressants without success prior to the treatment. They all remained on their medications during the trial (SSRIs, non-SSRI antidepressants, mood stabilizers, or lithium) with no serious adverse side effects.

PDF of article

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Ketamine Wellness Centers (KWC) Expands Treatment Options with Introduction of SPRAVATO® Nasal Spray

Ketamine Wellness Centers (KWC) Expands Treatment Options with Introduction of SPRAVATO® Nasal Spray

FDA-Approved Spray Treatment Ensures KWC Will Now Serve More Patients than Any Other Ketamine Provider in the U.S. with the Addition of SPRAVATO, Beginning April 1

GILBERT, AZ, Mar. 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), has expanded its treatment options to include SPRAVATO® nasal spray. The KWC clinics located in Houston, Las Vegas and Seattle will be offering this treatment option beginning April 1. 

Taken with an oral antidepressant, SPRAVATO is the first FDA-approved esketamine nasal spray for adults with treatment-resistant depression (TRD) or to treat depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions. Patients interested in this treatment option will first undergo KWC’s thorough intake and screening process to ensure they are suitable candidates and would gain the most benefit from the treatment. KWC’s clinical protocols ensure SPRAVATO treatments are administered in exactly the right care and patient safety settings. 

The introduction of SPRAVATO underscores KWC’s’ commitment to providing clinically-backed, accessible and affordable treatments to patients nationwide. To achieve this goal, the insurance experts at Ketamine Wellness Centers will help interested patients navigate the complexities of their healthcare coverage and assist them in determining their coverage and potential out-of-pocket costs for the treatment. The company’s dedication to providing the highest quality service available, coupled with its vast network of ketamine clinics, allows it to serve more patients than any other ketamine therapy provider.

“Ketamine Wellness Centers strives to be our patients’ strongest advocate by providing effective and affordable mental health treatment, and SPRAVATO is the next step in maintaining that standard,” said Kevin Nicholson, CEO of KWC and Chief Operating Officer for Delic. “Our team rigorously studied SPRAVATO’s clinical efficacy before offering the treatment to our wider patient community and expanding our care options. We are confident that adding this treatment to our mental wellness centers will greatly benefit our patients.”

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

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.

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
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Media Contact
MATTIO Communications
Phoebe Wilson
delic@mattio.com

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Predict which psychedelics are right for you

Entheon Biomedical Announces Expanded Psychedelics Genetic Test Panel & New Clinical Research Platform

Ketamine therapy for depression seems promising, but how do you know if it’s right for you?

About 30% of people have a genetic variant that impairs the secretion of BDNF, a protein that promotes the growth of neurons.

Since ketamine works by increasing the release of BDNF, people with this gene variant may have a decreased response to the antidepressant effects of ketamine therapy.

HaluGen just expanded its Psychedelics Genetic Test Kit to test for the gene variant! It also tells you how sensitive you’re to classical psychedelics and if you are at risk for schizophrenia, bipolar disorder, or psychosis.

Use code “DAILYMUSHROOM” to get 10% off HaluGen’s Psychedelics Genetic Test!

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Ketamine + Parkinson’s meds

PharmaTher Announces Positive Topline Results from Clinical Study of Ketamine for Parkinson’s Disease

The most common Parkinson’s medication, Levodopa, causes involuntary muscle movements in most patients who take it long-term.

PharmaTher (PHRM) found that a low dose of ketamine reduces these muscle spams in 100% of Parkinson’s patients — but it’s unclear by how much or for how long…

However, a separate study from 2016 found that low doses of ketamine reduced this side effect for up to one month and also eased depression.

PharmaTher is confident that the results will pave the way for a Phase 3 trial. 

PDF of article

PDF of article 2

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PharmaTher Announces Positive Topline Results from Clinical Study of Ketamine for Parkinson’s Disease

PharmaTher Announces Positive Topline Results from Clinical Study of Ketamine for Parkinson’s Disease

100% of patients treated with ketamine demonstrated reduction in dyskinesias as measured by the Unified Dyskinesia Rating Scale

Ketamine was well tolerated with no serious adverse events reported

Study results are adequate to give an effect size in powering a Phase 3 clinical study

PharmaTher planning a Phase 3 clinical study to allow for FDA approval of KETARX™ (ketamine) for Parkinson’s disease under the 505(b)(2) regulatory pathwayTORONTO, March 23, 2022 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce positive topline results from the dose-finding and tolerability clinical study (the “Study”) of ketamine for the treatment of levodopa-induced dyskinesia (“LID”) in patients with Parkinson’s disease. The Study results are adequate to give an effect size in powering a Phase 3 clinical study which is expected to bridge the design with increased treatment duration relative to the Company’s Phase 2 clinical study (NCT04912115).

The Study evaluated the safety, tolerability and efficacy of low-dose ketamine infusion for the treatment of LID in patients with Parkinson’s disease. Efficacy data from the Study demonstrated that 100% of patients treated with ketamine demonstrated a reduction in dyskinesias as measured by the Unified Dyskinesia Rating Scale during the Study period compared to the pre-treatment baseline. Safety data from the Study demonstrated that ketamine was well tolerated with no serious adverse events reported. All adverse events were mild or moderate and reflected the expected side-effects of ketamine administration. This Study further supports the previous findings in the observational study publication, titled “Case Reports Showing a Long-Term Effect of Subanesthetic Ketamine Infusion in Reducing l-DOPA-Induced Dyskinesias,” regarding the positive impact of ketamine in reducing LID.  Full results of the Study are expected to be submitted for presentation at a medical congress by June 2022.

Dr. Scott Sherman, MD, PhD, Principal Investigator of the Study, commented: “The results of this clinical study further support that ketamine is well-tolerated even in an older population of patients with advanced Parkinson’s disease. This opens the door to a fast-track development of a novel non-surgical treatment for levodopa-indued dyskinesia, that will fill a major gap in the existing therapeutic arsenal.” Dr. Scott Sherman is the Associate Professor of Neurology and Director of the Movement Disorders Center at the University of Arizona College of Medicine, Medical Director of the Arizona Chapter of American Parkinson’s Disease Association, and Director of the Parkinson’s Disease Program of the HealthSouth Rehabilitation Institute of Tucson.

Fabio Chianelli, CEO of PharmaTher, commented: “We are very pleased with the results from this clinical study as it gives us further confidence that ketamine can safely and effectively reduce levodopa-induced dyskinesia in patients with Parkinson’s disease and it paves the way for a potential Phase 3 clinical study to support FDA approval via the 505(b)(2) regulatory pathway.”

Based on the Study results, the Company is preparing to engage the FDA to establish the next steps for a planned Phase 3 clinical study to allow for ketamine’s approval for Parkinson’s disease under the 505(b)(2) regulatory pathway. The Company plans to use its proprietary ketamine intravenous product, KETARX™, for the planned Phase 3 clinical study.

Ketamine’s Potential In 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. 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.

Ketamine is an FDA-approved N-methyl-D-aspartate receptor-modulating (NDMA) 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 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.

About Parkinson’s Disease   

There is currently no cure for Parkinson’s disease, although some drug combinations are used to treat the disease symptoms. 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.

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.

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 period of November 30, 2021 (“MD&A”), dated January 27, 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.