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Institutional Review Board Grants Approval for Cybin-Sponsored Feasibility Study Using Kernel Flow Technology to Measure Psychedelic Effects on the Brain

Institutional Review Board Grants Approval for Cybin-Sponsored Feasibility Study Using Kernel Flow Technology to Measure 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 Therapeutics™”, today announced that an Institutional Review Board (“IRB”) has approved a Company-sponsored feasibility study using Kernel’s quantitative neuroimaging technology, Kernel Flow, to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics.

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.

“By leveraging the Kernel Flow technology, we may have the ability to measure longitudinal brain activity before, during and after a psychedelic experience, and collect quantitative data as opposed to subjective patient reporting,” said Doug Drysdale, Cybin’s Chief Executive Officer. “We believe the results of this study will lead to future studies that will test the effectiveness of psychedelic treatments and will further support our mission to develop psychedelics into therapeutics.”

The study received U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) authorization in October 2021 and is expected to begin enrollment in early 2022.

About Kernel Flow

Kernel Flow uses pulsed light instead of continuous wave light to increase measured brain information. In contrast with electroencephalography (“EEG”) electrodes that usually require gel on the head or functional magnetic resonance imaging (“fMRI”) studies that require a participant to lie in a scanner, Kernel Flow is easily wearable. 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 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 September 30, 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:
Leah Gibson
Vice President, Investor Relations
Cybin Inc.
leah@cybin.comSource: Cybin Inc.

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Awakn Life Sciences Expands World’s First Ketamine Study Beyond Gambling Disorder To Include Additional Behavioral Addictions

Awakn Life Sciences Expands World’s First Ketamine Study Beyond Gambling Disorder To Include Additional Behavioral Addictions

GROUNDBREAKING PSYCHEDLIC STUDY WILL INVESTIGATE BINGE EATING DISORDER, COMPULSIVE SEXUAL BEHAVIOR, AND INTERNET GAMING DISORDER

TORONTO, CANADA, 05 January 2022 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE:954) (Awakn), a biotechnology company developing and delivering psychedelic medicines to better treat addiction, announced today that it has received ethical committee approval to expand its existing ketamine study beyond Gambling Disorder to include three other behavioral addictions including Binge Eating Disorder, Compulsive Sexual Behaviour and Internet Gaming Disorder.

The basket study, which will be another world’s first, is led by Prof. Celia Morgan, Awakn’s Head of Ketamine-Assisted Therapy for Addiction, Professor of Psychopharmacology at the University of Exeter, U.K., and an internationally respected expert in the therapeutic use of ketamine. Professor Morgan’s work will investigate a new treatment approach for these behavioral addictions, trying to harness a window in which the brain is able to make new connections. The study will explore and monitor whether the ketamine can increase neuroplasticity using EEG (Electroencephalogram).

Professor Morgan commented, “We are delighted to expand this research and to make further inroads into a treatment area that has had no material pharmacological advancements in far too long, all the while the number of people suffering has steadily increased. We hope this will give us valuable insights to push our ketamine program forward and help these people as quickly as possible.”

There are currently no licensed pharmacological treatments for behavioral addictions or disorders available, and the need to find new and effective treatment options has never been more important. Behavioural addictions have devastating consequences for individuals and their families, affecting physical and mental health, and increasing mortality from suicide. The global populations affected by behavioural addictions are massive with Binge Eating Disorder affecting up to 110 million people; Internet Gaming Disorder affecting 238 million; Sexual Compulsive Behaviour affecting up to 350 million; and Gambling Disorder up to 450 million people.

About Awakn Life Sciences Corp.

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

www.awaknlifesciences.com  |  Twitter  |  LinkedIn  |  Facebook

Notice Regarding Forward Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating to the proposed NEO listing, and 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: whether conditions to the listing on NEO will be satisfied; the business plans and strategies of the Company, the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

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

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

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

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

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

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PharmaTher Announces Publication of Research Data for KETABET™

PharmaTher Announces Publication of Research Data for KETABET™

Second published study to demonstrate the potential therapeutic utility and mechanism of action of KETABET™ (patented combination of ketamine and betaine) in models of depression
​​
Repeated use of KETABET™ exhibits potential protective and reversing effects on ketamine-elicited psychotomimetic behaviors and cognitive impairments

Supports clinical initiatives as a potential next generation ketamine treatment for mental health and pain disorders with patent protection into 2036TORONTO, January 4, 2022 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a life sciences company focused on the development and commercialization of specialty ketamine prescription-based products, today announced the publication of a scientific article demonstrating the potential of KETABET™, a patented combination formulation of FDA-approved ketamine and betaine anhydrous, 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 article titled, “Betaine prevents and reverses the behavioral deficits and synaptic dysfunction induced by repeated ketamine exposure in mice”, is published in Biomedicine & Pharmacotherapy and can be found here.

The newly published study further validates the potential of KETABET™ and support the Company’s ongoing investigator-led observational studies evaluating the impact of betaine on the unwanted ketamine side effects seen post ketamine treatment for subjects with either depression or pain. Based on the outcome from the ongoing observational studies, the Company will advance the KETABET™ program with its microneedle patch technology in Phase 2 clinical studies in H2-2022.

Modulation of glutamatergic NMDA receptor by betaine might be the underlying mechanisms accounting for cognitive dysfunction, behavioral deficits, and synaptic neurotransmission induced by chronic ketamine use. The present published study aimed to assess whether repeated co-treatment with betaine and ketamine improved behavioral impairments and hippocampal synaptic plasticity. The experimental results showed that both co-treatment and post-treatment with betaine could exhibit the protective and reversing effects on subchronic ketamine-elicited psychotomimetic behaviors, cognitive impairments, and decreases in synaptic function, LTP, and PSD-95 protein expression. Therefore, betaine may enhance the therapeutic effect when  combined or post-treated with ketamine for treatment-resistant depression or other mood disorders, and benefit substance abuse disorders.1   

A previously published study revealed that betaine could promote the antidepressant-like effects, yet abolish the psychotomimetic action as well as motor- and cognitive-impairing effects of acute ketamine treatment in mice,2 indicating that betaine might potentially enhance the antidepressant efficacy of ketamine and reduce the acute psychotic symptoms in patients when receive ketamine to treat depression. However, it remained unknown if repeated co-treatment with betaine could minimize the adverse psychiatric effects observed after repeated ketamine use, either medically or recreationally.  The present published study supported the repeated use of betaine with ketamine.1

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “The published data demonstrates the potential of KETABET™’s ability to eliminate the unwanted psychomimetic effects and limitations of ketamine, and aims to be a safe and effective at-home treatment option for mental health, neurological and pain disorders.  As such, we remain focused on expanding our clinical programs with KETABET™ for FDA approval.”

PharmaTher has an exclusive license agreement with the National Health Research Institutes to develop and commercialize the intellectual portfolio protecting KETABET™, the patent titled “Method and Composition for Decreasing the Psychotomimetic Side Effect and Addictive Disorder of Ketamine”. Granted patents are issued in Japan (Patent no. 6967532) and Taiwan (Patent no. I648049). In addition, the Company expects to convert the current patent applications in the U.S., Europe, Canada, Israel and China into granted patents.  Patent protection is expected to expire in 2036.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of specialty ketamine prescription-based products such as KETAPATCH™, a  ketamine microneedle patch for mental health and pain disorders, and KETARX™, a ketamine hydrochloride injection USP product for anesthesia, procedural sedation and neurological disorders including Parkinson’s disease and Amyotrophic Lateral Sclerosis. Learn more at PharmaTher.com, Twitter and LinkedIn.

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim”, “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 August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.

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

References:

  1. Chen, Shao-Tsu et al. “Betaine prevents and reverses the behavioral deficits and synaptic dysfunction induced by repeated ketamine exposure in mice.” Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie vol. 144 (2021): 112369. doi:10.1016/j.bio
  2. 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
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PharmaTher Provides Update on Product Pipeline and Expected Milestones for 2022

PharmaTher Provides Update on Product Pipeline and Expected Milestones for 2022

Focused on becoming a leader in the development and commercialization of specialty ketamine prescription-based products
Expected milestones for 2022 include initiating Phase 3 clinical study for ketamine to treat Parkinson’s disease (KETLID); completing Phase 2 clinical study for ketamine to treat ALS (KETALS); completing observational study with ketamine and betaine for depression and pain (KETABET); initiating Phase 2 clinical study for ketamine microneedle patch (KETAPATCH); and seeking FDA approval for Ketamine Hydrochloride Injection USPproduct (KETARX)

​TORONTO, December 21, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a company focused on the development and commercialization of specialty ketamine prescription-based products, is pleased to provide a product pipeline update and expected milestones for 2022.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “2021 proved to be a foundational year for PharmaTher as we achieved a number of milestones which have paved the way for an exciting 2022 in unlocking ketamine’s therapeutic potential for treating Parkinson’s disease and ALS, the development of our ketamine hydrochloride injection USP product and our ketamine microneedle patch as a potential next-generation therapeutic solution for mental health, neurological and pain disorders.  We are now in a position both operationally and financially to seek FDA approval for KETARX, our ketamine prescription product, and to enter clinical studies for KETAPATCH, our ketamine patch product, in 2022.”

Project KETLID:  Ketamine for Levodopa-Induced Dyskinesia in Parkinson’s Disease

The Company’s Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04912115)  to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia (“LID”) in patients with Parkinson’s disease is currently ongoing and the Company now expects topline results in Q1-2022. Positive Phase 2 clinical results will allow the Company to request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study under the 505(b)2 regulatory pathway by Q3-2022.

PharmaTher has an exclusive license agreement with the University of Arizona for the intellectual property protecting the potential use of ketamine to treat movement disorders.  The possible therapeutic effect of low-dose ketamine on LID was noted in a retrospective analysis of Parkinson’s disease patients who received ketamine for pain relief. During this analysis, it was observed that the patients experienced an improvement in LID lasting several weeks beyond treatment [Sherman et al, 2016]. These results were corroborated in a test of low-dose ketamine in a rodent LID model, and this possible effect has also been examined in a controlled study [Bartlett et al, 2016].

Project KETALS:  Ketamine for Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s Disease)       

An Investigator-initiated IND application has been submitted and it is expected the FDA will accept the IND to proceed to a clinical study for ketamine to treat ALS patients within the next 30 days.  Patient enrollment is targeted for Q1-2022.  On August 3rd, 2021, the Company was granted orphan drug designation by the FDA for ketamine to treat ALS.

PharmaTher has an exclusive license agreement with the University of Kansas for the intellectual property protecting the potential use of ketamine to treat ALS. Ketamine has the potential to effectively increase the life expectancy of those with ALS at any stage and slow the progressive loss of muscle associated with poor outcomes of the disease. The University of Kansas Medical Center researchers and inventors of the potential use of ketamine to treat ALS, Dr. Richard J. Barohn, M.D., John A. Stanford, Ph.D., and Dr. Matthew Macaluso, D.O., have made the promising discovery that ketamine can be administered as an effective treatment for ALS. In addition, unpublished and patent-pending preclinical research has shown that the administration of ketamine preserves muscle function in advancing ALS and increases life expectancy when given in the early stages of muscle decline.

Project KETABET: Ketamine and Betaine Combination Formulation

The Company is supporting an Investigator-lead observational study to evaluate the impact of betaine anhydrous on the unwanted ketamine side effects seen post ketamine treatment for subjects with depression.  The Company now expects results to be reported in early Q1-2022.  Based on the results, the Company will advance the KETABET program with its microneedle patch for clinical studies in the H2-2022.

PharmaTher has an exclusive license agreement with the National Health Research Institutes for the development and commercialization of a patented combination formulation of FDA-approved ketamine and betaine. KETABET has been shown in research to enhance the antidepressant effect while having the potential to reduce the known negative side effects of ketamine significantly.  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 [Lin, Jen-Cheng et al., 2016].

Project KETAPATCH: Ketamine Microneedle Patch

In collaboration with The Queen’s University of Belfast (“QUB”), led by Professor Ryan Donnelly, the Company has successfully completed the evaluation of a patented hydrogel-forming microneedle patch to deliver Ketamine and KETABET as a potential next-generation treatment for neuropsychiatric, neurodegenerative and pain disorders.  This de-risking milestone supports the Company’s expansion in finalizing IND-enabling studies and the clinical manufacturing scale up with LTS Lohmann, a leader in transdermal delivery systems, to support FDA and international regulatory submissions.  Validation and tech transfer activities to support clinical studies are in progress and the Company expects to conduct clinical studies in H2-2022.

PharmaTher has an exclusive license agreement with QUB for the development and commercialization of a patented hydrogel-forming microneedle delivery technology developed by Professor Ryan Donnelly to support PharmaTher’s product and clinical development initiatives with ketamine and psychedelics.  Professor Donnelly’s lab successfully completed research and published a paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery” validating the delivery of esketamine, the S(+) enantiomer of ketamine, in a novel microneedle patch which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format [Courtenay, Aaron J et al., 2020].

Project KETARX: Ketamine Prescription (Rx) Product

The Company is developing its own Ketamine Hydrochloride Injection USP product as part of its plans to support the Company’s future Phase 3 clinical studies and its commercialization plans in the U.S. via a supplemental Abbreviated New Drug Application (“sANDA”) with the FDA for use in anesthesia and procedural sedation.  The Company expects to file for its sANDA in Q4-2022 for commercialization in the U.S. and international markets thereafter.

PharmaTher has entered into an agreement with Alcami Corporation, a global pharmaceutical contract development and manufacturing organization with extensive experience in cGMP sterile fill-finish products and handling of controlled substances, for the clinical and commercial manufacturing for the Company’s KETARX project. The Company expects to form partnerships with research labs, ketamine clinics and pharmaceutical companies that are: seeking a secure supply of cGMP ketamine and ketamine products for current portfolios; exploring alternative dose forms for multiple existing indications; and requiring support to develop and eventually commercialize specific ketamine products for new indications.  In addition, the Company will enter the market with KETARX targeting ketamine’s FDA approved label for anesthesia and procedural sedation.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the research, development and commercialization of specialty ketamine prescription-based products including KETAPATCH, a  ketamine microneedle patch for mental health, neurological and pain disorders, and KETARX, a ketamine hydrochloride injection USP product for anesthesia and procedural sedation. Learn more at PharmaTher.com, Twitter and LinkedIn.

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim”, “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 August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.

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

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Pasithea Therapeutics Opens Second Ketamine Therapy Clinic in the United Kingdom

Pasithea Therapeutics Opens Second Ketamine Therapy Clinic in the United Kingdom

— Expanding Pasithea Clinics footprint in London —

MIAMI BEACH, Fla., Dec. 21, 2021 (GLOBE NEWSWIRE) — Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a novel biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders, today announced that its wholly owned subsidiary, Pasithea Clinics, has opened its second London clinic in Marylebone offering intravenous (“IV”) ketamine therapy to patients suffering from treatment-resistant mental health issues. The Company opened its first U.K. clinic in Knightsbridge in October 2021.

“Through our second London clinic, we are pleased to increase access to this important therapy for patients in the U.K. with treatment-resistant mental health disorders,” stated Dr. Tiago Reis Marques, CEO of Pasithea Therapeutics. “More than ever, new treatment therapies are urgently needed for these patients and by broadening our coverage, we can work to close the treatment gap.”

“Two decades of research supports the efficacy of ketamine in improving symptoms experienced in some mental health disorders. With the opening of our Marylebone location, we are expanding our footprint in the U.K. and will continue to work toward bringing this treatment option to patients nationwide,” said Dr. Yassine Bendiabdallah, Managing Director of Pasithea Clinics in the U.K.

Ketamine is a U.S. Food and Drug Administration (“FDA”) approved drug introduced to the medical community as an anesthetic more than 50 years ago. It has recently been repurposed for the treatment of psychiatric disorders using significantly lower doses than in anesthesia and is gaining ground as a promising treatment for mental health disorders. In certain psychiatric conditions, such as treatment-resistant depression (“TRD”) and post-traumatic stress disorder (“PTSD”), it has shown remarkable efficacy and a rapid and sustained effect.

Major Depression is the leading cause of long-term disability worldwide, according to the World Health Organization, with existing treatments having limited success rates, numerous side effects and onset of action delayed by several weeks. Studies have shown that up to 70% of those who receive IV ketamine treatment can eventually show a clinical response. While the number of treatments suggested is done on a case-by-case basis, a typical treatment plan consists of up to six infusions in the interval of two to three weeks.

About Pasithea Therapeutics Corp.

Pasithea Therapeutics Corporation is a U.S. biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders. With an experienced team of experts in the fields of neuroscience and psychopharmacology, Pasithea is developing new molecular entities for the treatment of psychiatric and neurological disorders. Pasithea is also focused on addressing the needs of patients currently suffering with mental illness by providing access to IV ketamine infusions both in clinics and in-home settings.

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the SEC. Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.

Pasithea Therapeutics Corp. Company Contact
Dr. Tiago Reis Marques
Chief Executive Officer
E: tiago@pasithea.com

Pasithea Therapeutics Corp. Investor Relations
Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Primary Logo

Source: Pasithea

Released December 21, 2021

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PharmaTher Enters Into Process Development Agreement With LTS Lohmann for Ketamine Microneedle Patch

PharmaTher Enters Into Process Development Agreement With LTS Lohmann for Ketamine Microneedle Patch

​TORONTO/ANDERNACH, December 20, 2021 — PharmaTher Holdings Ltd. (“PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a company focused on the development and commercialization of specialty ketamine products, and LTS LOHMANN Therapie-Systeme AG (“LTS”), a leading pharmaceutical technology company, today announced they have entered into a process development agreement for the clinical trial scale up of PharmaTher’s proprietary Ketamine microneedle patch product.
In cooperation with the Queen’s University of Belfast, PharmaTher successfully completed the evaluation of a patented hydrogel-forming microneedle patch to deliver Ketamine, a potential next-generation treatment for neuropsychiatric, neurodegenerative and pain disorders.  Under the agreement, PharmaTher will cooperate with LTS in the process development and scale up of PharmaTher’s Ketamine microneedle patch product. LTS will be responsible for development and non-commercial manufacturing activities and support PharmaTher’s Investigational New Drug (IND) submission to the FDA in the U.S. and the Investigational Medicinal Product Dossier (IMPD) submission to EMA in the EU.  PharmaTher will be responsible for the planning and execution of clinical studies with the Ketamine microneedle patch product.

“We are excited to work with LTS, a leader in transdermal delivery systems, to complete the clinical development of our ketamine microneedle patch product for clinical studies and scale up for future commercial use,” said Fabio Chianelli, CEO of PharmaTher. “With our success in our proof of concept studies in delivering ketamine in our proprietary microneedle patch invivo, we now have a clear development path to unlock the value for ketamine in various unmet medical needs and we are focused on working closely with LTS to produce cGMP ketamine microneedle patches for PharmaTher’s upcoming Phase 1/ 2 clinical studies in 2022.”

Dr. Hanshermann Franke, SVP R&D and Member of the Global Leadership Team commented “LTS is a leading company in microneedle technology and we utilize our expertise, experience and innovation to create drug delivery solutions to improve patient outcomes. The effective treatment of mental illness and neurological disorders are core focus areas for us, and we are pleased to announce this partnership with PharmaTher in the expectation that we can lead the way in this unmet patient need.”

About PharmaTher’s Microneedle Patch

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 a number of advantages over inhalation and IV administration. PharmaTher‘s approach consists of a 2-part system comprised of a drug-loaded reservoir that is 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 directly enters the systemic circulation, circumventing absorption and first-pass barriers typical for oral delivery.  Studies have shown that systemic drug concentrations are reached within minutes after administration and are maintained over multiple days with transdermal delivery. This system addresses a major unmet need by offering greater ease of administration, inclusion of 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.

About PharmaTher Holdings Ltd.

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

About LTS LOHMANN Therapie-Systeme AG

LTS LOHMANN Therapie-Systeme AG is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems such as Transdermal Patches (“TTS”) and Oral Thin Films (“OTF”) for the pharmaceutical industry. LTS´ commercial offering encompasses more than 20 marketed products and a diverse pipeline of more than 30 development projects targeting multiple disease indications. LTS’s innovation pipeline contains both partner-funded as well as proprietary, LTS-funded projects. LTS maintains its leading position through the continuous refinement of its core TTS and OTF technologies and by advancing emerging drug delivery technologies, including Micro Array Patches (MAP) for the transdermal delivery of large molecule, biological actives. Founded in 1984, LTS operates today from two sites in Andernach, Germany and West Caldwell, NJ, USA and a representative office in Shanghai, China.

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

For more information about LTS, please contact:

Dr. Iris Schnitzler
Head of Marketing and Market Services
LTS LOHMANN Therapie-Systeme AG
Email: iris.schnitzler@ltslohmann.com
Website: www.ltslohmann.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 August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.
​
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

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Ketamine Wellness Centers Opening Salt Lake City & Reno Locations

Ketamine Wellness Centers Opening Salt Lake City & Reno Locations

KWC Expands to Include 12 Locations by Q1 2022, Further Establishing its Position as the Nation’s Largest Chain of Wellness Clinics, Adds to Delic’s Network of Locations 

VANCOUVER, BC, Dec. 2, 2021 /PRNewswire/ – Delic Holdings Corp (“Delic” or the “Company”) (CSE: DELC) (OTCQB: DELCF) (FRA: 6X0) (Original Source), a leader in new medicines and treatments for a modern world, today announced its subsidiary Ketamine Wellness Centers (KWC) plans to open two new clinics in Salt Lake City, Utah, and Reno, Nevada, by February 2022. KWC was acquired by Delic in September 2021 and currently operates 10 ketamine infusion treatment clinics across eight states, delivering more than 60,000 treatments to date across Arizona, Colorado, Florida, Illinois, Minnesota, Nevada, Texas and Washington.

KWC Salt Lake City, located in the suburb of Taylorsville at 6087 South Redwood Road, Suite B, is the first of the company’s clinics in Utah and is expected to open on January 10, 2022. The facility, which allows for up to seven treatment rooms, will become one of KWC’s largest clinics in the U.S. 

KWC Reno, opening in February 2022, will be KWC’s second clinic in Nevada and is strategically positioned to not only serve local residents but also patients in larger California markets who do not have access to affordable in-state providers. 

“Offering accessible, personalized and high-quality care is integral to Ketamine Wellness Centers’ mission, and we look forward to supporting the emotional wellness of new patients in Utah and Nevada,” said Kevin Nicholson, CEO of KWC and Chief Operating Officer for Delic. “As the nation grapples with the ongoing silent mental health crisis, we are committed to helping patients struggling with various conditions get back control over their lives again and find relief through these powerful treatments.”

Through these latest openings, Delic continues to execute its strategy of expanding ketamine treatment centers to secondary cities in order to reach the greatest number of patients and provide reasonably priced treatments. 

Matt Stang, co-founder and CEO of Delic, commented, “Demand for mental health services continues to climb year over year, with one in five U.S. adults experiencing a mental health condition. However, patients around the country still lack access to affordable and effective options. Through the largest chain of wellness clinics offering ketamine treatments in the U.S., Delic aims to directly address this critical issue by focusing our efforts on expanding access to these best-in-class treatments to more people every day. We believe affordable, effective treatments with minimal side effects should be available to anyone who needs them.”

In addition to the 12 KWC clinics, Delic’s existing portfolio also includes two clinics operated by Ketamine Infusion Centers LLC (“KIC”) in California and Arizona, cementing its position as the leading and largest psychedelic wellness provider in the country. Delic expects to open 13 additional clinics across the country over the coming 18 months, further expanding access to millions who can benefit from new medicines and treatments for a variety of mental health conditions and adds to their position as a central hub of education, media, and cultural conversations around these new medicines and treatments.

Delic is committed to addressing the mental health crisis by increasing access to science-backed benefits for all and reframing the psychedelic conversation. The company does this through an umbrella of related owned and operated businesses to support scaling the impact and reach of treatment, including 1) the largest and most accessible network of physical clinics to administer effective treatments, 2) a licensed lab to develop IP, R&D and innovative high quality and safe product lines, and 3) trusted media and e-commerce platforms and in-person events to market the services directly to patients and consumers and gain data.

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 12 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, 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.

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

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

Forward-Looking Information and Statements

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

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

In addition, in connection with the forward-looking ‎information and forward-looking statements contained in this press ‎release, Delic has made certain ‎assumptions. These assumptions include, but are not limited to: assumptions as to the time required to negotiate a definite agreement and complete matters related to the Transaction; the ability to consummate the Transaction; ‎the ability of the parties to ‎obtain, in a timely manner, the requisite regulatory, corporate and other third party approvals and the satisfaction of ‎other conditions to the ‎consummation of the Transaction on the proposed terms; the potential impact of the announcement or consummation of the Transaction on ‎relationships, ‎including with regulatory bodies, employees, suppliers, customers and competitors; ‎changes in general economic, ‎business and political conditions, including changes in the financial ‎markets; changes in applicable laws; compliance ‎with extensive government regulation; and the diversion ‎of management time on the Transaction.‎

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

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

SOURCE Delic Holdings Corp

Investor Contact

Rich Rodriguez

rich@deliccorp.com

Media Contact

MATTIO Communications

Noah Bethke

delic@mattio.com

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Pasithea Therapeutics Expands its Mobile Clinics into Florida and Nevada

Pasithea Therapeutics Expands its Mobile Clinics into Florida and Nevada

— Pasithea Clinics commences in-home IV ketamine infusion therapy in Florida and Nevada —

— Treatments conducted by board-certified medical professionals —

— Expansion to additional U.S. cities in coming months —

MIAMI BEACH, Fla., Dec. 01, 2021 (GLOBE NEWSWIRE) — Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a novel biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders, today announced that Pasithea Clinics, its wholly owned subsidiary, has expanded the availability of its intravenous (“IV”) ketamine therapy to patients in Florida and Nevada. Ketamine was introduced to the medical community as an anesthetic more than 50 years ago and in sub-anesthetic doses has shown remarkable efficacy in the treatment of certain psychiatric conditions, such as treatment-resistant depression (“TRD”) and post-traumatic stress disorder (“PTSD”).

“In November, we opened our first U.S. mobile clinics in New York and California, and we’re pleased to announce that our in-home IV ketamine infusion therapy is now available in Nevada and Florida,” said Dr. Tiago Reis Marques, CEO of Pasithea Therapeutics. “The pandemic has exacerbated the mental health crisis and the number of patients suffering from depression increased by approximately 25% in the past year. Today, up to three million Americans are known to have a diagnosis of treatment-resistant depression. These patients often struggle to complete day-to-day activities, and the effort required to visit a physical clinic can feel overwhelming. By expanding access to in-home treatment, we aim to close the treatment gap. Initially, the treatment will be offered in Miami and Las Vegas and will expand to other cities in these states in the coming weeks. Pasithea mobile clinics are already available in New York City, Los Angeles, San Diego, and San Francisco.”

“The efficacy of ketamine in improving symptoms of some mental health disorders is well documented, and our mobile clinics enable patients to receive therapy in the privacy and comfort of their own homes while still under the care of an experienced medical team. This type of program can be crucial for people who struggle with treatment-resistant depression and is an important step in expanding access to IV ketamine treatment. We look forward to continuing our U.S. expansion in the coming months,” concluded Dr. Adam Nadelson, Managing Director of Pasithea Clinics in the United States.

Studies have shown that up to 70% of those who receive IV ketamine treatment will eventually show a clinical response. While the number of treatments suggested is done on a case-by-case basis, a typical treatment plan consists of up to six infusions over a period of two to three weeks.

About Pasithea Therapeutics Corp.

Pasithea Therapeutics Corporation is a U.S. biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders. With an experienced team of experts in the fields of neuroscience and psychopharmacology, Pasithea is developing new molecular entities for the treatment of psychiatric and neurological disorders. Pasithea is also focused on addressing the needs of patients currently suffering with mental illness by providing access to IV ketamine infusions both in clinics and in-home settings.

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the SEC. Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.

Pasithea Therapeutics Corp. Company Contact
Dr. Tiago Reis Marques
Chief Executive Officer
E: tiago@pasithea.com

Pasithea Therapeutics Corp. Investor Relations
Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Primary Logo

Source: Pasithea

Released December 1, 2021

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PharmaTher Granted New Japanese Patent for KETABET™ (Ketamine Combination Formulation), Strengthening Global Patent Portfolio

PharmaTher Granted New Japanese Patent for KETABET™  (Ketamine Combination Formulation), Strengthening Global Patent Portfolio

PharmaTher (PHRM) was granted a Japanese patent for KETBET, a combination of ketamine and betaine anhydrous that can be used for various mental health and pain disorders. Betaine anhydrous enhances the antidepressant effect of ketamine while reducing the side effects.
PharmaTher Inc.
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Seelos Therapeutics Announces Acquisition of an Exclusive License of iX Biopharma’s Proprietary Wafer-Based Delivery Platform for Sublingual Ketamine

Seelos Therapeutics Announces Acquisition of an Exclusive License of iX Biopharma’s Proprietary Wafer-Based Delivery Platform for Sublingual Ketamine

– New SLS-003 Program Extends Seelos’ Ketamine Franchise into Additional Indications Including Chronic Neuropathic Pain and Additional Psychiatric Disorders

– Program has been Granted Orphan Drug Designation in the US for the Treatment of Complex Regional Pain Syndrome

NEW YORK, Nov. 24, 2021 /PRNewswire/ — Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced it has entered into an exclusive license agreement (License Agreement), whereby it acquired a worldwide license (excluding China, Taiwan, Macau and Hong Kong) from iX Biopharma Ltd (iX Biopharma) for Wafermine™, a sublingual racemic ketamine wafer, and a worldwide license for other sublingual ketamine wafers, delivered using a proprietary fast-dissolving wafer-based drug delivery platform technology known as WaferiX™.

Seelos plans to evaluate sublingual ketamine, now named SLS-003, in pain indications such as chronic neuropathic pain and Complex Regional Pain Syndrome (CRPS) and in additional psychiatric disorders, including post-traumatic stress disorder (PTSD).

The US Food and Drug Administration (FDA) has granted Wafermine™ Orphan Drug designation for the treatment of CRPS.

“Our licensing of this new program broadens Seelos’ ketamine franchise with a formulation that we believe will be more suitable for chronic dosing in indications like CRPS and PTSD, which are both very difficult indications to treat effectively,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “The pharmacokinetic, pharmacodynamic and safety profiles of SLS-003 that have been demonstrated to date suggest a formulation with the potential of being prescribed with less restrictions than current formulations. Our team is very excited to be developing both acute, in SLS-002, and a potentially chronic, in SLS-003, ketamine-based therapy programs. We look forward to initiating studies with SLS-003 in 2022 and our recent capital raises have accounted for the expected development costs for initiating studies.”

“We are delighted to collaborate with Seelos Therapeutics, whose deep insights in ketamine drug development make them an ideal partner to further the development of Wafermine™ and the other sublingual ketamine products,” said Eddy Lee, Chairman and CEO of iX Biopharma. “Licensing our WaferiX™-based pharmaceutical drugs to suitable third parties for development and commercialization is a core strategy to unlock the value of our assets. We are therefore excited that this commercially significant agreement with Seelos is a validation of our ability to deliver on this strategy.”

Pursuant to the License Agreement, Seelos will pay iX Biopharma  a one-time, upfront fee of $9,000,000, comprised of $3,500,000 in cash and $5,500,000 in restricted shares of Seelos’ common stock for the worldwide license for Wafermine™ (excluding China, Taiwan, Macau and Hong Kong), the worldwide license for WaferiX™ in other ketamine formulations, and clinical supplies. Seelos will also pay iX Biopharma certain milestone payments contingent on achievement by Seelos of certain development, regulatory and commercial milestones and a low double-digit royalty on future net sales of certain licensed products.

About iX Biopharma LTD

iX Biopharma is a specialty pharmaceutical and nutraceutical company listed on the Catalist board of the Singapore Exchange Securities Trading Limited (SGX-ST), operating a fully integrated business model from drug development to manufacturing and supply, with facilities in Australia. The Group is focused on the development and commercialization of therapies for diseases of the central nervous system using novel, patent-protected formulations for sublingual delivery.

For more information about iX Biopharma LTD, please visit their website: https://www.ixbiopharma.com/.

About WaferiX™

The licensed products utilize iX Biopharma’s patented sublingual wafer technology, known as WaferiX™, to disintegrate under the tongue rapidly for faster therapeutic action and predictable dosing. In pharmacokinetic studies, sublingual delivery using WaferiX™ increased bioavailability of active compounds when compared to oral administration, while avoiding excessively high peak plasma concentrations typical of IV bolus dosing.

About Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare disorders. The Company’s robust portfolio includes several late-stage clinical assets targeting psychiatric and movement disorders, including orphan diseases. Seelos is based in New York, New York.

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

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those related to the efficacy and potential applications for the Licensed Products and associated Wafermine technology; the satisfaction of the conditions related to any contingent milestone or royalty payments; and the funding of all future development, manufacturing and commercialization of the Licensed Products. These statements are based on Seelos’ current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos’ business and plans described herein include, but are not limited to, the risks that Seelos will not realize the expected benefits from the license with iX Biopharma, risks associated with the implementation of Seelos’ business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos’ current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos’ periodic filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information: 
Anthony Marciano 
Chief Communications Officer  
Seelos Therapeutics, Inc. (Nasdaq: SEEL) 
300 Park Avenue, 2nd Floor 
New York, NY 10022 
(646) 293-2136 
anthony.marciano@seelostx.com 
https://seelostherapeutics.com/   
https://twitter.com/seelostx   
https://www.linkedin.com/company/seelos

SOURCE Seelos Therapeutics, Inc.

Related Links

https://seelostherapeutics.com/