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NeonMind To Improve Patient Care and Data Management by Adopting Digital Platform for Ketamine Treatments in Preparation of Opening Its Inaugural Specialty Mental Health Clinic

NeonMind To Improve Patient Care and Data Management by Adopting Digital Platform for Ketamine Treatments in Preparation of Opening Its Inaugural Specialty Mental Health Clinic

Engages Thrive Health, a Leading Digital Patient Care Platform to Streamline Care Programs and Data Collection

OAKVILLE, ON / ACCESSWIRE / April 21, 2022 / NeonMind Biosciences Inc. (CSE:NEON)(OTCQB:NMDBD)(FRA:6UF) (“NeonMind” or the “Company“), announced today it has advanced its strategy to streamline access to treatments at its specialty mental health clinics with Thrive Health in preparation of opening its inaugural clinic located in Mississauga, Ontario.

The recent inclusion of intravenous ketamine for mood and anxiety disorders (IV-Ket) in the Canadian guidelines as a recommended treatment is a testament to the value of this treatment, and a growing number of institutions are providing coverage for IV-Ket treatment, setting the precedent for further coverage. Using Thrive Health’s robust care management platform to collect patient profiles, manage care programs, and measure treatment outcomes allows us to improve payment coverage for our treatments and better serve our patients.

“We are seeing greater institutional coverage for IV-Ket treatment which is a testament to the treatment’s value to the health system,” said Rob Tessarolo, President & CEO of NeonMind. “Institutional reimbursement validates the treatment in Canada, and we are primed for increased demand for this treatment”.

Rob Tessarolo also added, “NeonMind is focused on improving treatment outcomes and being able to collect and analyze treatment data throughout our network of clinics will provide a more robust value story for adoption of our treatments and establishing payment coverage for our patients. Working with leading digital healthcare platforms such as Thrive Health enables us to deploy our strategies with scale.”

NeonMind will be working with Thrive Health, a trusted digital care platform used by many hospitals and clinics and selected as the official partner by Health Canada in the development of the Canada COVID-19 app.

NeonMind’s inaugural specialty mental health clinic is located at 89 Queensway West, Suite 604, Mississauga, Ontario, L5B 2V2. For more information related to NeonMind’s specialty clinics, please email medicalinformation@neonmind.com.

About Thrive Health Inc.

Thrive Health was founded in 2016 by a diverse group of patients, clinicians, researchers, parents, and students who came together to help patients going through complex health journeys, working to put people at the center of their care. Thrive’s platform powers health, wellness and care solutions for organizations by empowering individuals with compelling digital experiences. Thrive operates across North America, headquartered in Vancouver BC, and is on a mission to make healthcare work better for everyone.

For more information about Thrive Health, visit https://welcome.thrive.health/

About NeonMind Biosciences Inc.

NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.

In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind’s lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company’s second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.

NeonMind and its strategic partners are building NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs. For more information on NeonMind, visit www.NeonMindBiosciences.com.

CONTACT:
Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.
rob@neonmind.com
Tel: 416-750-3101

The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind’s future performance. The use of any of the words “could”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on NeonMind’s current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind’s drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.

SOURCE: NeonMind Biosciences Inc.

View source version on accesswire.com:
https://www.accesswire.com/698255/NeonMind-To-Improve-Patient-Care-and-Data-Management-by-Adopting-Digital-Platform-for-Ketamine-Treatments-in-Preparation-of-Opening-Its-Inaugural-Specialty-Mental-Health-Clinic

Released April 21, 2022

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Wellbeing Digital Sciences Signs MOU with Pathway Health Regarding the Potential Sale of Certain Assets

Wellbeing Digital Sciences Signs MOU with Pathway Health Regarding the Potential Sale of Certain Assets

The Company is Working to Crystalize the MOU into a Set of Definitive Agreements in the Near Future, with Closings Expected to Occur within the Next 75 Days

Vancouver, British Columbia, April 21, 2022 / Globe Newswire / – Wellbeing Digital Sciences Inc. (“Wellbeing” or the “Company”) (NEO: MEDI) (OTC: KONEF) (FRA: SQ2), an evidence-based mental healthcare company focused on the development and implementation of innovative clinical solutions, such as psychedelic medicine and digital therapeutics supported by clinical research, is pleased to announce that it has signed a memorandum of understanding (“MOU”) with Pathway Health Corp. (“Pathway”) (TSXV: PHC) pursuant to which Pathway would acquire certain Canadian assets of Wellbeing. The contemplated transaction is expected to be completed in two stages, all concluding on or before June 30, 2022, and the consideration for the assets is yet to be determined. Pathway is one of the major providers of out-patient pain management services in Canada that owns and operates eleven community-based clinics across four provinces. Health professionals at Pathway work together to help patients by using a variety of evidence-based approaches.

Pursuant to the terms and conditions of the MOU, Pathway would acquire a license for the pain management program of the Company’s wholly owned subsidiary, IRP Health Ltd. (“IRP”), and the intellectual property (“IP”) associated with the provision of intravenous ketamine services (“IVK”) to treat mental health conditions, among other assets. The MOU also outlines a fractional franchise model for IRP and related fee structure. The first closing is contemplated to include IRP and IVK on or before April 30, 2022, while the second closing is contemplated to include the remaining assets documented in the MOU on or before June 30, 2022.

IRP provides multi-disciplinary rehabilitation services to military veterans, RCMP and first responders. Under the contemplated transaction, IRP would provide IP and support services related to staff training, branding, licensing, and program development including verification of Pathway locations with Veterans Affairs Canada to serve more patients. CGM provides medical cannabis services for patients across Canada via telemedicine and in-person clinics. The completion of the completed transaction is subject to terms and conditions which include but are not limited to the execution of a set of definitive agreements, completion of satisfactory due diligence, the delivery and satisfactory review of the financial statements and the approval of the transaction by the boards of directors of all applicable entities.

Management Commentary

“We are excited to have executed this MOU and are working hard with Pathway to crystalize it into a set of definitive agreements. The contemplated transaction would enable Wellbeing to continue on the path of evolving its competitive strategy focused on evidence-based mental healthcare through contract research and digital therapeutics,” said Najla Guthrie, Chief Executive Officer of Wellbeing.

“This is a significant step in rapidly expanding the accessibility for military veterans, RCMP and first responders of IRP’s Veterans Affairs Canada-approved interdisciplinary pain management program. Path and Wellbeing share the same passion and value to help provide needed services for these heroes. We look forward to solidifying this agreement,” added Steven Inglefield, Chief Operating Officer of Wellbeing and Chief Executive Officer of IRP.

“We’re very pleased to be entering into this agreement with Wellbeing and IRP as we expand our pain and mental health services to our military veterans, RCMP and other first responders,” said Ken Yoon, CEO at Pathway Health. According to a 2021 research paper published by the Journal of Military, Veteran, and Family Health1, veterans appear to be particularly vulnerable to experiencing chronic pain, with rates that are two to three times higher than in the general population. More specifically, recent studies of Canadian Air Force Veterans have noted prevalence between 41% and 64%. “With our experience in chronic pain management and our aim in growing presence in mental health services, we believe Pathway Health is ideally suited to provide valuable clinical services to this most deserving group of Canadians. We feel very honoured to be taking on this role,” added Mr. Yoon.

ABOUT PATHWAY HEALTH

Pathway Health is an integrated healthcare company that provides products and services to patients suffering from chronic pain and related conditions. The Company owns and operates eleven community based clinics across four provinces where its team of health professionals work together to help patients through a variety of evidence-based approaches and products, including medical cannabis. Pathway Health’s patient care programs utilize an interdisciplinary approach that is guided by trained pain specialists, physical and occupational therapists, psychologists, nurses, and other healthcare providers. Pathway is also the leading provider of medical cannabis services in Canada and has established itself as the leading partner with national and regional pharmacy companies for the delivery of medical cannabis services to their customers. The Company is working with several pharmacy companies on the development of Cannabis Health Products (CHPs) for OTC product distribution through retail pharmacy locations across the country following anticipated changes to the Cannabis Act.

For more information, visit Pathway Health’s website: www.pathwayhealth.ca

ABOUT WELLBEING DIGITAL SCIENCES

Wellbeing Digital Sciences Inc. is an evidence-based mental healthcare company focused on the development and implementation of innovative clinical solutions, including psychedelic medicine and digital therapeutics, as supported by clinical research. Its mission is supported by a network of North American clinics that provide forward-thinking therapies and other types of treatment to patients as well as through a contract research organization that offers clinical trials services to clients pursuing drug development. In essence, the Company exists to make breakthrough treatments more accessible and to offer patients transformational experiences.

On behalf of:

WELLBEING DIGITAL SCIENCES INC.

“Najla Guthrie”

Najla Guthrie, CEO

For further information, please contact:

Nick Kuzyk, Investor Relations

Tel: 1-844-746-6351

Email: ir@wellbeingdigital.co

Web: www.wellbeingdigital.co

Twitter: @Wellbeing_IR

Notice Regarding Forward-Looking Information:

This news release contains forward-looking statements including but not limited to statements regarding the Company’s business, assets or investments, as well other statements that are not historical facts. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other forward

looking statements will not occur, which may cause actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. These assumptions, risks and uncertainties include, among other things, the state of the economy in general and capital markets in particular, investor interest in the business and prospects of the Company.

The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. Additionally, the Company undertakes no obligation to comment on the expectations of, or statements made, by third parties in respect of the matters discussed above.

ENDNOTES

  1. “Chronic pain: The Canadian Armed Forces members and Veterans mental health follow-up survey”, Journal of Military, Veteran and Family Health, accessed on April 19, 2022, https://jmvfh.utpjournals.press/doi/full/10.3138/jmvfh-2021-

0051#:~:text=Veterans%20appear%20to%20be%20particularly,than%20in%20the%20general% 20population.&text=Specifically%2C%20recent%20studies%20of%20CAF,between%2041%25 %20and%2064%25.

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NeonMind Engages Leading Digital Platform for Medical Education and Adoption of Ketamine Treatments in Preparation of Opening its Inaugural Specialty Mental Health Clinic

NeonMind Engages Leading Digital Platform for Medical Education and Adoption of Ketamine Treatments in Preparation of Opening its Inaugural Specialty Mental Health Clinic

Initiates Medical Adoption Program with Impetus Digital, a Leading Healthcare Platform for Virtual Medical Education

OAKVILLE, ON / ACCESSWIRE / April 19, 2022 / NeonMind Biosciences Inc. (CSE:NEON)(OTCQB:NMDBD)(FRA:6UF) (“NeonMind” or the “Company“), an integrated drug development and wellness company focused on bringing innovative psychedelic-based treatments to people suffering from obesity and mental health disorders, announced today it has advanced its strategy to enhance access to treatments at its specialty mental health clinics with Impetus Digital in preparation of opening its inaugural clinic located in Mississauga, Ontario.

Intravenous ketamine for mood and anxiety disorders (IV-Ket) was recently included in the Canadian guidelines as a recommended treatment. As a testament to the value of IV-Ket treatments, a growing number of prescribers and their patients are seeking access to this treatment with further opportunities to expand the prescriber base through medical education.

“This is an exciting time for this ground-breaking treatment in Canada as success in adopting novel treatments is vastly enhanced by strong clinical evidence,” said Rob Tessarolo, President & CEO of NeonMind. “Guideline inclusion means that Canadian medical leadership has reviewed the evidence and recommend the use of IV-Ket for treatment”.

Rob Tessarolo also added “NeonMind is now focused on improving availability of access points for IV-Ket treatments with its setup of a network of clinic locations throughout Canada in partnership with leading specialty treatment companies with hundreds of clinic locations already established. We are also focusing on improving education and adoption of our treatments using proven commercial strategies. Working with a leading digital platform provider such as Impetus Digital will help disseminate medical education and enhance adoption of this important treatment”.

NeonMind will be working with Impetus Digital’s InSite Platform®, a trusted platform for virtual medical education to enhance adoption of IV-Ket treatments. This platform will enable us to establish prescriber confidence to include IV-Ket in their treatment toolset and how to refer patients to NeonMind clinics. Impetus Digital has been integral in successful pharmaceutical and healthcare treatment launches in Canada.

NeonMind’s inaugural specialty mental health clinic is located at 89 Queensway West, Suite 604, Mississauga, Ontario, L5B 2V2. For more information related to NeonMind’s specialty clinics, please email medicalinformation@neonmind.com.

About Impetus Digital

Headquartered in Toronto, Ontario, Impetus Digital helps life science organizations across the globe virtualize their in-person meetings, events, and programs, including medical education and product launches. They do this through their best-in-class InSite Touchpoints™ and InSite Events™ offerings, delivered with White-Glove™ service and 360° coverage and care. Leveraging their large portfolio of cutting-edge, life science-specific online collaboration tools, clients can seamlessly gather insights from, and collaborate with, internal and external stakeholders. To find out more about Impetus Digital, visit www.impetusdigital.com or book a demo at www.meetwithimpetus.com

About NeonMind Biosciences Inc.

NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.

In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind’s lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company’s second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.

NeonMind and its strategic partners are building NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs. For more information on NeonMind, go to www.NeonMindBiosciences.com.

CONTACT:
Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.
rob@neonmind.com
Tel: 416-750-3101

The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind’s future performance. The use of any of the words “could”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on NeonMind’s current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind’s drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.

SOURCE: NeonMind Biosciences Inc.

View source version on accesswire.com:

https://www.accesswire.com/697889/NeonMind-Engages-Leading-Digital-Platform-for-Medical-Education-and-Adoption-of-Ketamine-Treatments-in-Preparation-of-Opening-its-Inaugural-Specialty-Mental-Health-Clinic

Released April 19, 2022

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First household name enters psychedelic sector

Irwin Naturals strikes deal to acquire chain of ketamine treatment clinics in Florida and Mexico

Irwin Naturals (IWIN), a major supplement company established in 1994, is acquiring a chain of ketamine clinics in Florida and Mexico, becoming the “world’s first household name to enter the psychedelic mental health treatment sector.” This acquisition is part of a plan to create the world’s largest chain of psychedelic clinics.

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Awakn Provides Shareholders With A Business Update On Its Three Ketamine-Assisted Therapy Clinics In The UK And Norway

Awakn Provides Shareholders With A Business Update On Its Three Ketamine-Assisted Therapy Clinics In The UK And Norway

TORONTO, CANADA, April 13, 2022 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a biotechnology company, researching, developing, and delivering revolutionary therapeutics to treat addiction, today is providing shareholders with a business update on its three fully-operational ketamine-assisted therapy clinics, two in the UK and one in Norway.

Awakn’s clinics team consists of some of the world’s leading authorities in the ketamine/psychedelic-assisted therapy industry, including Dr. Ben Sessa, Awakn’s Chief Medical Officer; Dr. Laurie Higbed, Awakn’s Lead Psychologist, Prof. Celia Morgan, Awakn’s Head of Ketamine-Assisted Therapy, Dr. Lowan Stewart, Managing Director – Nordics and James Collins, Managing Director, Awakn Clinics and Chief Operating Officer of Awakn.

Awakn Clinics Bristol was Awakn’s and the UK’s first medical psychedelic-assisted therapy clinic. The clinic opened during the fourth quarter of 2021 and is now moving into its sixth month of ongoing operations with strong demand for both its evidence backed ‘KARE’ protocol for the treatment of Alcohol Use Disorder (AUD), and its ketamine-assisted therapy for treating depression, anxiety, PTSD and eating disorders.

Awakn Clinics Oslo (formerly Axonklinikken) is one of the Nordics leading ketamine-assisted therapy clinics and was acquired by Awakn in late 2021. The first quarter of 2022 saw Awakn complete the integration of Axonklinikken into its clinics network and in March 2022 officially rebranded the clinic as Awakn Clinics Oslo. Awakn Clinics Oslo is now also providing both Awakn’s evidence backed ‘KARE’ and ketamine-assisted therapy to clients from all over Norway.

Awakn Clinics London is Awakn’s flagship clinic and is now open and treating clients after receiving regulatory approval to begin operations in March 2022. Like Awakn’s other clinics, it is offering their evidence backed treatments for a range of mental health illnesses and addictions.

The KARE protocol for the treatment of AUD was developed in Awakn’s Phase II a/b clinical trial, of which the results were published in January 2022 in the American Journal of Psychiatry. Awakn is the only company in the world now delivering evidence backed ketamine-assisted therapy for the treatments of AUD, a chronic and poorly treated disease affecting 400 million people globally.

Dr. Ben Sessa commented, “To have three clinics operational and delivering ketamine-assisted therapy in such a short space of time is hugely gratifying. The clinics provide an excellent opportunity for Awakn’s development, but most importantly it’s the fact that we are able to help such a such a large cohort of people who have struggled to find an effective treatment for them and their illness.”

Awakn’s business model consists of three different business arms, 1) Research & Development, 2) Clinics and 3) Therapeutics Commercialization. The clinical network enables Awakn to deliver ground-breaking and evidence-backed therapeutics developed by the company’s R&D business through its research and clinical trials. Implementing these patient-centered protocols and therapies have quickly proved critical in providing a new hope to so many people suffering from addiction and mental health issues.

The structure of the business model also allows Awakn to hone and fine tune the delivery model for their therapeutics while amassing real world data and evidence to support its regulatory approval applications. The Therapeutics Commercialization business then takes these protocols and licenses them to partners outside of the environments where Awakn has a physical footprint, starting with the US and Canada in Q3 of this year, equipping them with novel treatments to deliver more effective care for their clients.

About Awakn Life Sciences Corp.

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

www.awaknlifesciences.com | Twitter | LinkedIn | Facebook

Notice Regarding Forward Looking Information

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

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PharmaTher Signs Exclusive Worldwide License Agreement for Patented Formulation and Production Process of Ketamine and Ketamine Analogs

PharmaTher Signs Exclusive Worldwide License Agreement for Patented Formulation and Production Process of Ketamine and Ketamine Analogs

PharmaTher to file ANDA and 505(b)(2) regulatory submissions with the FDA for novel uses, delivery forms and formulations of ketamine for mental health, neurological and pain disordersTORONTO, April 12, 2022 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce that PharmaTher has entered into an exclusive worldwide license agreement with Gesval S.A., a public limited company incorporated by the University of Liège, Belgium, for the development and commercialization of a patented continuous-flow process technology for the preparation of ketamine and ketamine analogs (the “Ketamine Technology”). The Ketamine Technology strengthens the Company’s patent portfolio of ketamine and it will complement the Company’s expanding ketamine pharmaceutical pipeline for use in hospitals, clinics and homes.

PharmaTher is developing and commercializing novel uses, delivery forms and formulations of ketamine and ketamine analogs. As part of its short-term product strategy, the Company is developing its own Ketamine Injection and Infusion product to support the Company’s expected pivotal clinical studies for Parkinson’s disease and Amyotrophic Lateral Sclerosis (Lou Gehrig’s disease), future FDA 505(b)(2) regulatory submissions in mental health, neurological and pain disorders, and its commercialization plans in the U.S. via an FDA Abbreviated New Drug Application (“ANDA”) for anesthesia and procedural sedation. The Company expects to file the ANDA in Q4-2022 for commercialization in the U.S. In addition, the Company’s long-term product strategy is to develop novel ketamine formulations and drug delivery systems, including its patented microneedle patch and proposed wearable pump device for the intradermal and subcutaneous delivery of ketamine, respectively.

Ketamine was approved by the FDA in 1970 and is clinically used for analgesia, sedation, and anesthetic induction.  Ketamine is also emerging as a viable treatment option for various mental health, neurological and pain disorders. However, the methods generally used for the production of ketamine are time-consuming and typically based on stepwise macroscopic batch processes resulting in low productivity, reproducibility and flexibility due to poor mixing and heat transfer.

The Ketamine Technology, developed at the Center for Integrated Technology and Organic Synthesis (CiTOS, ULiège) headed by Professor Jean-Christophe Monbaliu, relates to a scalable, safe and efficient continuous-flow process in micro/mesofluidic reactors for the production of ketamine and ketamine analogs, thereby addressing the shortcomings of the ketamine batch processes to improve yield production, reproducibility, purity profile, and requiring smaller footprint for production. In addition to improving the production process of racemic ketamine, the Ketamine Technology provides various methods for synthesizing ketamine analogs (i.e. arylcycloalkylamine derivatives) by using continuous-flow conditions with a drastically improved efficiency relative to batch procedures, which is of paramount importance for developing next-generation ketamines.

“We are excited to advance patented technology for the novel development and production process of ketamine and ketamine analogs from the University of Liège,” said Fabio Chianelli, CEO of PharmaTher. “We remain committed to our goal of becoming a leader in the development and commercialization of novel ketamine pharmaceuticals and this license not only strengthens our global patent portfolio for ketamine, but also complements our strategy in commercializing novel uses, delivery forms and formulations of ketamine and ketamine analogs to serve the unmet medical needs for mental health, neurological and pain disorders.”

In addition, 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 dosage forms for multiple existing indications; developing novel ketamine analogs; and requiring support to develop and eventually commercialize specific ketamine products for new indications.

Under the terms of the Agreement, PharmaTher gained exclusive worldwide development and commercial rights to an intellectual property portfolio consisting of a granted patent (Europe patent: 3700887B1) and patent applications (PCT/EP2018/097033) titled, “Methods for the preparation of arylcycloalkylamine derivatives” in the U.S., China and Canada.

Consistent with industry standards, PharmaTher paid a one-time fee for entering into the Agreement, and all other future payments are based on clinical trial and revenue milestones reached by PharmaTher. 

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.

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Seelos Therapeutics Announces Amendment of SLS-002 Agreement to Repurchase the Remaining Royalties Payable to Phoenixus AG for SLS-002 (Intranasal Racemic Ketamine Program), All Future Success and Commercial Based Milestones and the Change of Control Fee

Seelos Therapeutics Announces Amendment of SLS-002 Agreement to Repurchase the Remaining Royalties Payable to Phoenixus AG for SLS-002 (Intranasal Racemic Ketamine Program), All Future Success and Commercial Based Milestones and the Change of Control Fee

NEW YORK, April 11, 2022 /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, announced today an amendment of the agreement with Phoenixus AG, formerly known as Vyera Pharmaceuticals AG (“Vyera”), for the development of SLS-002 (intranasal racemic ketamine) to repurchase in cash and stock the remaining royalties payable on any future net sales of SLS-002, all future success and commercial based milestones and the change of control fee in the event SLS-002 is acquired.  

On March 6, 2018, Seelos entered into an asset purchase agreement (the “Purchase Agreement”) with Vyera, currently known as Phoenixus AG, to acquire the assets and liabilities of Vyera’s intranasal racemic ketamine program, which Seelos now calls SLS-002. As additional consideration to certain upfront cash and equity payments and success-based milestone payments contemplated under the prior agreement, Seelos agreed to pay a mid-teens percentage royalty on any future net sales of SLS-002. In February 2021, Seelos amended the asset purchase agreement, for three additional cash payments, agreeing to repurchase 9% of the future royalties and reduce its royalty obligations to a mid-single digit percentage on any future net sales of SLS-002. Seelos completed those payments in February, June, and September of 2021. Under the amendment entered into on April 8, 2022, for additional cash and stock payments due by April 2022, July 2022 and January 2023, the parties have agreed to terminate in full all contingent payment obligations to Vyera and its related entities under the Purchase Agreement, effective upon the payment and issuance of all cash and stock payments.

“We believe this repurchase of the remaining financial obligations owed or that may become payable on SLS-002 has the potential to return meaningful future value to Seelos’ stockholders, assuming we are successful in the clinical development, regulatory approval processes, and commercialization of the intranasal ketamine program,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos.

“This amendment removes all future royalties due to Vyera, nearly $100 million of potential future milestones and a change of control fee in the event this program were to be acquired as a standalone transaction or as part of a larger transaction,” said Michael Golembiewski, CFO of Seelos.

About SLS-002

SLS-002 is intranasal racemic ketamine with two investigational new drug applications for the treatment of Acute Suicidal Ideation and Behavior in Major Depressive Disorder or Post-Traumatic Stress Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. SLS-002 looks to address an unmet need for a therapy to treat suicidality in the U.S. Traditionally, anti-depressants have been used in this setting but many of the existing treatments are known to contribute to an increased risk of suicidal thoughts in some circumstances, and if they are effective, it often takes weeks for the full therapeutic effect to be manifested. The clinical development program for SLS-002 included two parallel healthy volunteer studies (Phase I) and is being followed by pivotal registration studies after meeting with the FDA. Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were more than 1,000,000 visits to emergency rooms for suicide attempts in 2019 in the U.S. alone. Experimental studies suggest ketamine has the potential to be a rapid, effective treatment for depression and suicidality.

About Seelos Therapeutics

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

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

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the ability of the royalty repurchase to return meaningful future value to Seelos stockholders, and Seelos’ ability to succeed in the clinical development, regulatory approval processes and commercialization of its intranasal ketamine program (SLS-002). These statements are based on Seelos’ current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated to Seelos’ business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials, the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos’ current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos’ periodic filings with the U.S. Securities and Exchange Commission, including its 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 
www.seelostherapeutics.com
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos 

Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York, NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

SOURCE Seelos Therapeutics, Inc.