Posted on

PharmaTher Retains Former FDA Psychiatry Division Director Dr. Thomas Laughren as Regulatory Affairs Advisor

PharmaTher Retains Former FDA Psychiatry Division Director Dr. Thomas Laughren as Regulatory Affairs Advisor

TORONTO, September 29, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today announced that Dr. Thomas Laughren has been retained by PharmaTher as a Regulatory Affairs Advisor.  Dr. Laughren will advise on regulatory matters as it pertains to KETABET™, the Company’s patented combination formulation of FDA-approved ketamine and betaine, as a potential next-generation treatment for neuropsychiatric disorders.
Dr. Thomas Laughren formerly served as the Director for the Division of Psychiatry Products, Center for Drug Evaluation and Research at the FDA where he served for 29 years.  During his tenure as Director for the Division of Psychiatry Products, Dr. Laughren managed the review of all psychiatric drug development activities conducted under INDs and the review of all New Drug Applications and supplements for new psychiatric drug claims.
Dr. Laughren will work with Dr. Maurizio Fava, MD, the Company’s Scientific and Clinical Advisor, and Psychiatrist-in-Chief at Massachusetts General Hospital, to complete the Investigational New Drug (“IND”) application for submission to the FDA for evaluating KETABET™ in a Phase 2 clinical study as a potential treatment for depression.
Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “We are pleased to have Dr. Laughren as a regulatory advisor to support our clinical and commercial initiatives with KETABET™ in depression and other neuropsychiatric disorders.”

KETABET™ is being developed by the Company as a potential novel treatment option for neuropsychiatric disorders, including for the more than 300 million people who suffer from major depressive disorder and 100 million people who are resistant to available treatments worldwide.   KETABET™ has shown in a research study to enhance the antidepressant effect while having the potential to significantly reduce the known negative side effects of ketamine.1  Side effects such as hallucinations, confusion, memory loss and abuse liability compromise the compliance and potential therapeutic value of ketamine.

About PharmaTher Holdings Ltd.

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

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

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

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

References:

  1. J.-C. Lin, M.-Y. Lee, M.-H. Chan, Y.-C. Chen, H.-H. Chen, Betaine enhances antidepressant-like, but blocks psychotomimetic effects of ketamine in mice, Psychopharmacology (Berl). 233 (2016) 3223–32.
Posted on

PharmaTher Announces Closing of CAD$10 Million Private Placement with Institutional Investors

PharmaTher Announces Closing of CAD$10 Million Private Placement with Institutional Investors

TORONTO, Sept. 28, 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (CSE: PHRM)(OTCQB: PHRRF), a clinical-stage psychedelics biotech company, is pleased to announce that it has closed its previously announced private placement with institutional investors of its common shares (“Common Shares”) and warrants to purchase common shares (“Warrants”) for gross proceeds of CAD$10 million (the “Private Placement”). Pursuant to the Private Placement, the Company issued 15,625,000 Common Shares and Warrants to purchase 15,625,000 Common Shares at a purchase price of CAD$0.64 per Common Share and associated Warrant. Each Warrant will entitle the holder to purchase one Common Share at an exercise price of CAD$0.80 per Common Share for a period of five years following the closing date of the Private PlacementH.C. Wainwright & Co. acted as the exclusive placement agent for the Private Placement.

The Company expects to use the net proceeds of the Private Placement for the advancement of its microneedle patch program, its proprietary ketamine product, and for general corporate purposes.

H.C. Wainwright & Co., LLC received (i) a cash commission equal to 8% of the gross proceeds of the Private Placement and (ii) 1,250,000 placement agent warrants (the “Agent Warrants”). Each Agent Warrant entitles the holder to purchase one Common Share at an exercise price of CAD$0.80 per Common Share for a period of five years following the closing date of the Private Placement.

No securities were offered or sold to Canadian residents in connection with the Private Placement. The securities issued under the Private Placement are subject to resale restrictions in the United States under applicable U.S. federal and state securities laws with no resale restrictions in Canada.

The securities offered 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. Accordingly, the securities may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons unless registered under the U.S. Securities Act and applicable state securities laws or pursuant to an exemption from the registration requirements of the U.S. Securities Act and applicable state securities laws. This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

About PharmaTher Holdings Ltd.

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

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

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

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors, including market and other conditions, 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 the 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, including, without limitation, statements relating to the use of proceeds from the Private Placement. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of May 31, 2021 (“MD&A”), dated September 7, 2021, which is available on the Company’s profile at www.sedar.com.
​
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

Posted on

PharmaTher Announces Cad$10 Million Private Placement With Institutional Investors

PharmaTher Announces Cad$10 Million Private Placement With Institutional Investors

NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES
OR FOR DISSEMINATION IN THE UNITED STATE

TORONTO, Ontario, September 24, 2021 – PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has entered into a securities purchase agreement with institutional investors for a private placement of its common shares (“Common Shares”) and warrants to purchase common shares (“Warrants”) for gross proceeds of CAD$10 million (the “Private Placement”).  Pursuant to the Private Placement, the Company will issue 15,625,000 Common Shares and Warrants to purchase up to 15,625,000 Common Shares at a purchase price of CAD$0.64 per Common Share and associated Warrant.  Each Warrant will entitle the holder to purchase one Common Share at an exercise price of CAD$0.80 per Common Share and will be immediately exercisable upon issuance for a period of five years following the issuance date.
​
H.C. Wainwright & Co. is acting as the exclusive placement agent for the Private Placement.

The Company expects to use the net proceeds of the Private Placement for the advancement of its microneedle patch program, its proprietary ketamine product, and for general corporate purposes.

The Private Placement is expected to close on or about September 28, 2021, and is subject to receipt of all applicable approvals and other customary closing conditions, including the approval of the Canadian Securities Exchange.

No securities were offered or sold to Canadian residents in connection with the Private Placement.

The securities being offered 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. Accordingly, the securities may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons unless registered under the U.S. Securities Act and applicable state securities laws or pursuant to an exemption from the registration requirements of the U.S. Securities Act and applicable state securities laws. This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

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

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

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

Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors, including market and other conditions, 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, including, without limitation, statements relating to the closing of the Private Placement, the gross proceeds to the Company from the Private Placement and the use of proceeds from the Private Placement. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of May 31, 2021 (“MD&A”), dated September 7, 2021, which is available on the Company’s profile at www.sedar.com.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

Posted on

Its now safe to vape government funded shrooms on antidepressants: issue 16

Here’s what’s in store for you in today’s issue:

🍄 Combining psilocybin with antidepressants

🍄 Vaping mushrooms?

🍄 The cure for constant hunger

🍄 Government-funded shroom trip

🍄 And more.

You’ll want to stay till the end to learn how someone gained a new skill during their first trip!

(Did a good friend forward this to you? If so be sure to subscribe here)

Be sure to check out this week’s Daily Mushroom podcast!
Psilocybin, is it the next cannabis wave?

In this episode we have Lenny Kerman, a strategic financial consultant who works with various psilocybin and cannabis companies. He talks about how he’s invested in the space and has some valuable information for those looking to invest as well.

Therapeutic banner

Psilocybin or antidepressants? Why not both!

A new study found that combining SSRIs and psilocybin is not only safe, but may be beneficial!

Yesterday, MindMed (MNDM) announced the findings from an ongoing study conducted in collaboration with UHB Liechti Lab.

Psilocybin was found to be safe to administer with an SSRI antidepressant and did not reduce the psychedelic experience. Two weeks prior to the psilocybin dose, volunteers were give a daily pretreatment of the SSRI escitalopram. As a result, the volunteers experienced reduced anxiety and blood pressure increases that can occur with psilocybin administration.

The cure for constant hunger

Can shrooms treat this rare genetic disorder?

Tryp Therapeutics (TRYP) is preparing for a Phase 2a study on overeating disorders including a rare condition called Prader-Willi Syndrome, a genetic disorder that causes intellectual disability, shortness in height, and constant hunger than often leads to obesity and diabetes.

The clinical trial is expected to begin in Q4 of this year and will investigate various other eating disorders such as binge eating and hypothalamic obesity. Ten patients will be given two doses of psilocybin, which in theory will increase neuroplasticity to create healthier neural patterns related to eating habits.

The San Diego company just filed an Investigational New Drug (IND) application with the FDA, for TRP-8802, the psilocybin formulation that will be used in the study.

Say goodbye to extreme anxiety

Mydecine (MYCO) filed a patent for a new anxiety and PTSD drug that provides more immediate relief than pure psilocybin.

The compound, MYCO-003, combines a serotonin agonist with a serotonin releasing agent – two drug classes that increase one’s sense of well-being, safety, and happiness. The formulation has shown positive preclinical data and has potential to relieve extreme anxiety before needing to provide extensive supportive care.

The patent was filed with both the United States Patent and Trademark Office (USPTO) and the World Intellectual Property Organization (WIPO).

Mydecine (MYCO) filed a patent for a new anxiety and PTSD drug that provides more immediate relief than pure psilocybin.

The compound, MYCO-003, combines a serotonin agonist with a serotonin releasing agent – two drug classes that increase one’s sense of well-being, safety, and happiness. The formulation has shown positive preclinical data and has potential to relieve extreme anxiety before needing to provide extensive supportive care.

The patent was filed with both the United States Patent and Trademark Office (USPTO) and the World Intellectual Property Organization (WIPO).

inspirational banner

Government-funded shroom trip

After half a century, the US federal government has started funding psychedelic research again!

A researcher at Johns Hopkins University received a U01 grant from the National Institute on Drug Abuse (NIDA) to fund a multi-site study on psilocybin for tobacco addiction, which will take place at Johns Hopkins, New York University, and the University of Alabama at Birmingham.

The researcher, Dr. Matthew W. Johnson, noted that this is the first time a psychedelic study has received funding since the War on Drugs was declared in the 70s, marking a “new era in legitimacy of psychedelic science”.

Microdosing research expands worldwide!

Yesterday, Wake Network Inc. received a Certificate of Drug Registration from the Jamaican Ministry of Health & Wellness for PSIL428, its microdose formulation made from natural psilocybin.

The certification allows the company to run clinical trials on anxiety and depression and makes PSIL429 available to clinics and academic institutions across the globe. Any country with a special access program can request to import the legal formulation for patient use.

In other microdosing news, MindBio Therapeutics, a subsidiary of Blackhawk Growth Corp. (BLR), is partnering with Trip Pharma’s LeichtMind clinic to launch microdosing clinical trials in Canada!

business banner

Let me hit that vape

Will psychedelic therapy soon involve vaping shrooms?

Delic (DELC) is the first company to receive Health Canada approval to research psilocybin vaporization.

On Monday, Delic entered into an agreement to acquire Ketamine Wellness Clinics, a company that runs 10 ketamine infusion centers across 8 states. The deal increases Delic’s total number of clinics to 12 and adds over 60 medical professionals to the team, making it the largest psychedelic wellness chain in the US. Within the next 18 months, the company hopes to grow this number to 27 clinics!

Once granted FDA-approval, DELIC aims to offer other psychedelic treatments at these locations including MDMA and psilocybin therapy, which could potentially use the vaporization technology!

Optimizing psychedelic therapy…there’s an app for that!

MINDCURE’s (MCUR) digital therapeutics platform could improve the psychedelic healing journey for both patients and clinicians!

The software application, iSTRYM, provides clinicians with a global database of therapy protocols, integration plans, and AI-driven data insights into patient journeys. The application connects to mobile and wearable devices to measure patients’ biological response to the treatment, allowing clinicians to provide personalized care. iSTRYM also offers a Mindfulness Suite that patients can use to explore practices like breathwork and meditation to support their healing. 

This week, MINDCURE signed into an exclusive licensing agreement with ATMA Journey Centers, a private psychedelic therapy clinic in Calgary, which will grant MINDCURE access to anonymous patient data gathered from ATMA’s use of the platform.

legal banner

Half a million Italians want to decriminalize mushrooms!

You may want to postpone your trip to Italy till next year 😉

Italian activists collected 500,000 signatures in favour of a referendum to decriminalize marijuana and psilocybin – enough to qualify for a ballot measure!

The referendum would remove Italy’s prohibition on cultivating psychoactive substances, but the further processing required to produce most narcotics would remain illegal. Fortunately, magic mushrooms are ready to enjoy after cultivation alone! 

A vote is expected to take place in spring of 2022 given that the Court of Cassation and the Constitutional Court sign off on the measure after reviewing the petition. 

Perpetuating the worst research blackout in history

Back in May, UK Prime Minister Boris Johnson approved the rescheduling of psilocybin to make it easier to research its therapeutic effects.

Months have passed, yet the Home Office has failed to act, “perpetuating what can be considered the worst research blackout in scientific history,” according to the Conservative Drug Policy Reform Group (CDPRG). Crispin Blunt MP, chairman of the CDPRG, is urging the Home Office to take action fast to tackle the mental health crisis. 

A Home Office spokesperson said that there are currently no plans to reschedule psilocybin due to the Misuse of Drugs Regulations 2001, but they will consider any recommendations from The Advisory Council on the Misuse of Drugs (ACMD), which is reviewing the barriers to researching controlled drugs.

Industry Quick Hits

Sept 21 – Eversio Wellness Harvests Its First Legally Grown Psychoactive Mushrooms Read more…

Sept 21 – Clearmind Medicine (CMND) Partners with The Hebrew University to Develop Novel Psychedelic Drug Read more…

Sept 21 – FSD Pharma (HUGE) Announces Closing Of Lucid Psycheceuticals Acquisition Read more… 

Sept 23 – Havn Life (HAVN) Announces Supply And Distribution MOU With Mycrodose Therapeutics Read more…

Sept 23 – Numinus (NUMI) Completes Acquisition of Neurology Centre of Toronto Read more…

Sept 23 – Delic (DELC) Announces C$7.0 Million Private Placement With Institutional Investor Read more…

Sept 24 – Novamind (NM) Announces DTC Eligibility for its Common Shares Read more…

Sept 24 – PharmaTher (PHRM) Announces CAD$10 Million Private Placement With Institutional Investors Read more…

Video of the Week

History of Magic Mushrooms

New superpower unlocked

This Reddit user gained a new ability during their first trip.

“I’m in my 40s and have been tone deaf as well as having hearing loss my whole life. I can’t carry a tune or recognize notes/melodies, and have never connected emotionally to music. When I dance, I’m just imitating others. I don’t know how to dance to music.

I tried magic mushrooms for the first time. My friend had music playing and at one point during my trip, I started humming and singing. I became the song and my body knew how to dance and play an instrument. My fingers were making the most intricate, precise movements- strumming an instrument like a professional musician. Dance movements came to me and I could feel it in my nervous system as I danced. Afterwards, I was still ready to believe that I was probably horribly out of tune and stumbling around and making stuff up, but my friend- who was not tripping- confirmed that I was carrying a tune, humming the song that was playing, and danced as if I had been trained and done it all my life.

This is just… unbelievable. And also merely a facet of the whole trip! I’d love to hear if this resonates with others and if there have been similar experiences!”

Playlist of the Week

Trippy playlist for all
mushroom balloon
Posted on

PharmaTher Added to the North American Psychedelics Index and First Psychedelic Exchange Traded Fund

PharmaTher Added to the North American Psychedelics Index and First Psychedelic Exchange Traded Fund

​TORONTO, September 21, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that the Company has been included to the North American Psychedelics Index, (the “Index”), which is the underlying index of the Horizons Psychedelic Stock Index Exchange Traded Fund (the “ETF”) (NEO: PSYK).
The Index is designed to provide exposure to the performance of North American publicly-listed life sciences companies focused on psychedelic medicines, and other companies with business activities in the psychedelics industry. The Index is also designed to provide diversified exposure to the psychedelics industry, at weights that can easily and cost effectively be replicated, while at the same time reflecting the evolution of the industry in a timely fashion.

The ETF invests in, and indirectly derive revenues from, companies in the psychedelics industry engaged in legal activities involving psychedelic drugs and substances.

PharmaTher is one of currently twenty-four companies to have met the requirements of listing within the ETF.  The ETF seeks to replicate the performance of the North American Psychedelics Index, net of expenses. Rebalancing of the North American Psychedelics Index occurs each calendar quarter.  At those points, all stocks eligible for inclusion are generally re-weighted by their respective float market capitalization.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “We are pleased to be included into the first ever Psychedelic ETF as a recognition of our accomplishments in the advancement of prescription-based psychedelic pharmaceuticals.  The inclusion into the Index and ETF not only broadens our investor awareness, but also provides us with greater confidence in our business model that focuses on the research, development and commercialization of novel uses, formulations and delivery forms of ketamine for mental health (i.e. Depression), rare and near-rare neurological (i.e. Parkinson’s disease, Amyotrophic lateral sclerosis), and pain disorders.

The holdings of the Index, the ETF and its current portfolio weights are regularly updated and available at www.HorizonsETFs.com/ETF/PSYK.

The ETF is managed by Horizons ETF Management an innovative financial services company offering one of the largest suites of exchange traded funds in Canada. The Horizons ETFs product family includes a broadly diversified range of solutions for investors of all experience levels to meet their investment objectives in a variety of market conditions. Horizons ETFs has over $19 billion of assets under management and 95 ETFs listed on major Canadian stock exchanges. Horizons also brought the first cannabis ETF to market in 2017 and continues to lead the industry with ETFs in emerging industries.

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, including ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently conducting an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing novel microneedle patches for the intradermal delivery of psychedelics.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

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

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

Posted on

PharmaTher Provides Product Pipeline Updates and Anticipated Milestones for Q4-2021 and 2022

PharmaTher Provides Product Pipeline Updates and Anticipated Milestones for Q4-2021 and 2022

  • 10 clinical sites selected to participate in the FDA Phase 2 clinical study evaluating ketamine for the treatment of Parkinson’s Disease
  • Initiated investigational new drug (IND) application to proceed to a Phase 2 clinical study for KETABET™ to treat depression
  • Completed Phase 2 clinical study protocol for ketamine to treat ALS for IND submission to the FDA
  • Near completion of research programs to advance novel microneedle patches for the delivery of psychedelics
  • Selected U.S.-based CDMO to develop and supply proprietary ketamine products for FDA Phase 3 clinical studies and commercialization
  • Positioned ketamine focused product pipeline for potential Phase 3 clinical studies and commercial supply in 2022

TORONTO, September 13, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to provide a product pipeline update and anticipated milestones for Q4-2021 and 2022 including ongoing FDA Phase 2 clinical study programs, microneedle patch delivery programs for psychedelics, and clinical, commercial manufacturing and supply for its proprietary ketamine and microneedle patch products.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “I am very pleased with the progress of our clinical programs for ketamine as a potential treatment for Parkinson’s disease, ALS and depression.  Our research programs for microneedle patch delivery are nearing completion and preparations for FDA Phase 1 and 2 clinical studies are on track.  To support these and future programs, we are securing manufacturing and supply of our proprietary ketamine products and microneedle patches for planned FDA Phase 2 and 3 clinical studies and commercialization in 2022 and beyond.  We remain focused on achieving our milestones in Q4-2021 and building a solid foundation that will allow us to become a leader in the development and commercialization of novel ketamine-based products. In addition, our intradermal delivery of ketamine and psychedelics via our proprietary microneedle patches position us for potential next-generation therapeutic solutions for mental health, neurological and pain disorders.”

FDA Phase 2 Clinical Study Programs     

For the rest of 2021, PharmaTher will focus on advancing three promising developments through FDA Phase 2 clinical studies:

Ketamine for Parkinson’s Disease    

The FDA’s approval to proceed with a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease triggered clinical program execution.  The Company has completed its clinical trial start-up activities and selection of essential vendors including  project management, central laboratory, clinical supply kits and logistics, data management and biostatistics, and clinical site management and monitoring.  Clinical trial drug product (ketamine) and active placebo (midazolam) have also been obtained.  

More importantly, the Company has selected ten (10) clinical sites in the U.S. to participate in the Phase 2 clinical study.  Patient screening has begun and the Company expects patient enrollment to support the delivery of clinical results in Q4-2021.

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

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

KETABET™ for Treatment-Resistant Depression    

The Company has finalized the Phase 2 clinical study protocol to evaluate KETABET™ for treatment-resistant depression.  The Company is working with its scientific and clinical advisor, Dr. Maurizio Fava, MD, with the aim to complete the IND and file it with the FDA in early October.  With the overlap of the clinical operations from the Parkinson’s disease study, the Company has already activated start-up activities and identified potential clinical sites to screen and enroll patients for the proposed Phase 2 clinical study in Q4-2021.  The aim is to share initial clinical results by the end of this year.

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

KETABET™ is the Company’s patented combination formulation of FDA-approved ketamine and betaine as a potential next-generation treatment for neuropsychiatric disorders.  More than 300 million people suffer from major depressive disorder and of those, 100 million are resistant to available treatments worldwide.   KETABET™ research has shown potential enhancement of the antidepressant effect while having the potential to significantly reduce the known negative side effects of ketamine.1  Side effects such as hallucinations, confusion, memory loss and abuse liability compromise the compliance and potential therapeutic value of ketamine.

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

The Company has been granted orphan drug designation by the FDA for ketamine to treat ALS and along with its clinical advisors, has finalized the Phase 2 clinical study protocol. The IND application for this study is in process and will be filed with the FDA in October 2021 with patient enrollment targeting Q1-2022.

PharmaTher has an exclusive license agreement with the University of Kansas for the intellectual property protecting the potential use of ketamine to treat ALS.  Preclinical research has shown that the administration of ketamine preserves muscle function in advancing ALS and could potentially increase life expectancy when given in the early stages of muscle decline.

Proprietary Microneedle Patch Delivery Programs for Psychedelics    

PharmaTher is working with its research and development partners to advance next-generation microneedle patches for the delivery of psychedelics:

Hydrogel-Forming Microneedle Delivery Technology for Ketamine           

PharmaTher has exclusive worldwide development and commercial rights for the delivery of ketamine, esketamine and KETABET™ using a patented hydrogel-forming microneedle patch.  The Company is working with Professor Ryan Donnelly under a research agreement with The Queen’s University of Belfast to develop the microneedle patch for the delivery of ketamine and KETABET™.  Foundational research is almost complete and final research results will become available in December 2021.   To date, initial proof of concept with ketamine and KETABET™ is very encouraging.  The Company is currently preparing for validation and tech transfer activities to support Phase 1 and Phase 2 clinical studies in 2022.  Development progress will be made available as they arise for the remainder of the year.

The Company’s microneedle patch leverages the successful proof of concept achieved in delivering esketamine, the S(+) enantiomer of ketamine, via the microneedle patch, which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format.2  Details of the research can be found in a published paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery.” 

GelMA Microneedle Delivery Technology for Psychedelics

The Company is working with the Terasaki Institute under a research agreement to finalize the development of a proprietary microneedle delivery technology comprised of a biocompatible and biodegradable gelatin methacryloy (GelMA) composite for use with psychedelics such as psilocybin, DMT, MDMA and LSD.  The GelMA patch delivery technology is the driving force of the Company’s psychedelics microdosing program.  The research program is almost complete and successful proof of concept with psilocybin and LSD has been achieved.  Full research results will be made available in November 2021.  The Company is currently preparing for validation and tech transfer activities to support Phase 1 and Phase 2 clinical studies in 2022.

Clinical and Commercial Manufacturing and Supply Initiatives          

Proprietary Ketamine

PharmaTher is focused on building a specialty ketamine-based product pipeline.  The Company has selected a U.S.-based GMP contract development and manufacturing organization (CDMO) with extensive experience in the development, production and supply of clinical and commercial controlled substance sterile products.  PharmaTher will work with the CDMO to develop the Company’s proprietary ketamine drug product(s) to support future clinical studies and global commercial supply.

It is expected that the proprietary ketamine drug products will be available for FDA Phase 3 clinical studies and commercialization in H2-2022.

Proprietary Microneedle Patch

The Company entered into a co-development agreement with TSRL, Inc. to jointly develop the patented hydrogel-forming microneedle patch delivery technology.  This allows the Companies to control the manufacturing and supply of microneedle patches for their respective clinical and commercial drug programs.

PharmaTher is focused on incorporating psychedelics and TSRL is focused on incorporating antiviral medications in a microneedle patch with the potential to improve the safety (i.e. fewer side effects), efficacy (i.e. bioavailability, optimized dosing regimen including continuous system delivery) and compliance (i.e. storage, distribution and self-administration) of these compounds that currently must be taken orally, inhaled, injected and intravenously.

Recent activities included the tech transfer for scale-up and manufacturing of clinical supplies to a GMP contract research lab and a pre-IND meeting with the FDA that achieved agreement with the agency on proposed 505(b)2 product development plans.

The Company aims to validate non-clinical and clinical production of the microneedle patch by October 2021 and begin non-clinical and clinical manufacturing supply at the end of 2021.  The Company expects to enter into Phase 1 and 2 clinical studies in 2022 to evaluate its microneedle patch in delivering ketamine, KETABET™, psilocybin, DMT, MDMA and LSD.

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, including ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently conducting an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing novel microneedle patches for the intradermal delivery of psychedelics.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

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

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

References:

  1. J.-C. Lin, M.-Y. Lee, M.-H. Chan, Y.-C. Chen, H.-H. Chen, Betaine enhances antidepressant-like, but blocks psychotomimetic effects of ketamine in mice, Psychopharmacology (Berl). 233 (2016) 3223–32.
  2. Courtenay, et al. Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery, Journal of Controlled Release, Volume 322, 2020, Pages 177-186.
Posted on

PharmaTher to Present at H.C. Wainwright 23rd Annual Global Investment Conference

PharmaTher to Present at H.C. Wainwright 23rd Annual Global Investment Conference

  • To provide an update on PharmaTher’s product pipeline and upcoming milestones on its FDA Phase 2 clinical studies and microneedle patch programs involving ketamine and psychedelics

​TORONTO, September 9, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce its participation in the H.C. Wainwright 23rd Annual Global Investment Conference (“the Conference”), taking place virtually on September 13-15, 2021.

PharmaTher’s CEO and Chairman, Fabio Chianelli, will discuss the Company’s product pipeline and upcoming milestones, including its FDA Phase 2 clinical study programs with ketamine for Parkinson’s disease, treatment-resistant depression and amyotrophic lateral sclerosis (“ALS” or “Lou Gehrig’s Disease”).  Also, the Company’s microneedle patch programs with ketamine, KETABET™ and psychedelics will be discussed.

The presentation will be available to registered Conference attendees for on-demand viewing beginning at 7:00 AM EST on September 13.

Qualified investors can learn more about the Conference and register to schedule a one-on-one meeting with PharmaTher’s management here.

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 conducting an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing novel microneedle patches for the intradermal delivery of psychedelics.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

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

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

Posted on

PharmaTher Provides Business Highlights and Releases Annual Financials for Fiscal Year Ended May 31, 2021

PharmaTher Provides Business Highlights and Releases Annual Financials for Fiscal Year Ended May 31, 2021

TORONTO, September 7, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today released business highlights and financial results for its fiscal year ended May 31, 2021.  Unless otherwise indicated, all amounts in this press release are in Canadian dollars. 
Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “We had a tremendous year which focused on solidifying exclusive licenses for the development and commercialization of novel ketamine uses and formulations, as well as drug delivery technologies via a microneedle transdermal patch with the aim to change the way how ketamine and psychedelics are used to treat mental health, neurological and pain disorders.  In addition, we have strengthened our intellectual property portfolio and built a formidable clinical and scientific advisory team to support our research collaborations with leading research institutions and our clinical and commercial ambitions.  PharmaTher is now focused on completing its drug delivery research programs and clinical studies for the use of ketamine in Parkinson’s disease, depression, and ALS.  I like to thank the PharmaTher team, our Board of Directors and our shareholders for supporting our objective in unlocking the therapeutic potential of ketamine and psychedelics as next-generation pharmaceuticals for unmet medical needs.”

Business Highlights:

  • Solidified four exclusive license agreements, including the University of Arizona for the development and commercialization of ketamine in the treatment of Parkinson’s disease; BioRAE, Inc. for the development and commercialization of a novel biocompatible and biodegradable gelatin methacryloyl microneedle delivery technology developed at the University of California, Los Angeles (UCLA) for use with psychedelic pharmaceuticals (i.e. psilocybin, MDMA, LSD, DMT); National Health Research Institutes for the development and commercialization of a patented combination formulation of ketamine and betaine (KETABET™); The Queen’s University of Belfast for the development and commercialization of a patented hydrogel-forming microneedle delivery technology developed by Professor Ryan Donnelly to deliver ketamine and KETABET™; and The University of Kansas for the development and commercialization of ketamine in the treatment amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease.
  • Formed essential research and development collaborations, including a sponsored research agreement with the Terasaki Institute to develop a novel microneedle patch that aims to deliver psilocybin, MDMA, LSD and DMT; a sponsored research agreement with The Queen’s University of Belfast for the development of a patented hydrogel-forming microneedle patch to deliver ketamine and PharmaTher’s proprietary ketamine formulation, KETABET™; a collaboration agreement with MediSynergics, LLC. to develop patented ketamine derivatives and to investigate drug discovery and development of next-generation psychedelic derivatives; and a co-development agreement with TSRL, Inc. to jointly develop a microneedle array patch with the aim to control the manufacturing and supply of microneedle patches for the Company’s clinical and commercial drug programs.
  • Closed the sale of PharmaTher’s intellectual property pertaining to psilocybin, via an asset purchase agreement with Revive Therapeutics Ltd. (CSE: RVV, USA: RVVTF), for consideration of up to $10 million satisfied as follows: (i) $3 million in cash (ii) $4 million through the issuance of securities in the capital of Revive and (iii) up to $3 million, in either cash or securities in the capital of Revive for future milestones.
  • Strengthened the Company’s clinical and scientific advisory team with the addition of Maurizio Fava, MD, Psychiatrist-in-Chief in the Department of Psychiatry at Massachusetts General Hospital; Dr. Robert A. Hauser, MD, MBA, Professor of Neurology and Director of the University of South Florida Parkinson’s Disease and Movement Disorders Center; Dr. Alberto J. Espay, MD, MSc, FAAN, Professor and Endowed Chair of the University of Cincinnati James J. and Joan A. Gardner Family Center for Parkinson’s Disease and Movement Disorders; and Professor Matthew Macaluso, D.O., Bee McWane Reid Professor for the Department of Psychiatry and Behavioral Neurobiology in the School of Medicine at The University of Alabama at Birmingham (UAB) and Clinical Director of the UAB Depression and Suicide Center.
  • Announced the FDA approved the Company’s Investigational New Drug application to proceed with a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.

Financial Highlights
·      Cash and cash equivalents ($2,778,081) and Investment ($3,100,000) for a total of $5,878,081 as of May 31, 2021.
·      Net loss was $2,664,196 for the financial year ended May 31, 2021.
For further information, please refer to the Company’s audited annual financial statements prepared in accordance with International Financial Reporting Standards and the related management’s discussion and analysis for the financial year ended May 31, 2021, which are available under the Company’s profile on SEDAR at www.sedar.com.

About PharmaTher Holdings Ltd.

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

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

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

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

Posted on

Revive Therapeutics Provides Update on Psychedelics Clinical Product Pipeline

  • Focusing on novel uses, production and delivery forms of psilocybin as a next generation solution for mental illness, substance abuse and neurological disorders
  • Advancing to FDA clinical studies for methamphetamine use disorder and stroke

TORONTO, Aug. 10, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on the Company’s psychedelics development and clinical programs with a focus on psilocybin.

Michael Frank, CEO of the Company, commented, “We are advancing a robust psychedelics-based product pipeline that includes product development, preclinical and clinical studies that aim to unlock the potential therapeutic value of psilocybin in various uses, formulations and delivery methods to treat mental health, substance abuse and neurological disorders.   Revive is embarking on the next stage of growth of its psychedelics strategy by focusing on building key partnerships with US academic institutions and other leading organizations, as well as developing intellectual property and entering into FDA clinical studies with psilocybin.”

Psilocybin in the Treatment of Methamphetamine Use Disorder

The Company is working with the Board of Regents of the University of Wisconsin System under a clinical trial agreement to conduct a Phase I/II clinical study to evaluate the safety and feasibility of psilocybin in adults with methamphetamine use disorder. Study start-up activities have taken place and enrollment activities are to continue throughout the remainder of the year. As a result of the study, clinical data will provide proprietary and valuable information on the safety, efficacy and dosing of psilocybin to support future pivotal FDA clinical studies in oral forms of delivery including oral thin film strips. The clinical study will be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy, which holds a Wisconsin special authorization and DEA license to perform clinical research with psilocybin. In addition, the Company will have exclusive access to key intellectual property from this study to support development, regulatory and commercial initiatives.

Psilocybin in the Treatment of Traumatic Brain Injury (TBI) and Stroke

The Company is advancing the research and intellectual property acquired from PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) on psilocybin as a potential solution to managing TBI and stroke. Preclinical studies demonstrated that psilocybin, given after injury, improved cognitive function in TBI mice. The Company is proceeding to an FDA clinical study to be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy. Start-up activities have already begun and patient enrollment is expected to commence in Q4-2021.

Psilocybin Oral Thin Film Strip Development

The Company has initiated the product development program under a feasibility agreement with LTS Lohmann Therapie-Systeme AG, a leader in pharmaceutical oral thin films, to develop and manufacture a proprietary psilocybin oral thin film strip for mental illness, substance abuse and neurological disorders.   Research grade prototypes will be available to evaluate dosing and delivery rates in various dosage forms with the expectation to conduct clinical studies in 2022.

Psilocybin Biosynthesis Program

Under its research collaboration with North Carolina State University (NC State), the Company is developing a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform developed by Dr. Gavin Williams, Professor and Researcher at NC State. The biosynthetic platform developed by Dr. Gavin Williams provides a potentially simple and efficient method for rapidly producing natural products, such as psilocybin, using an engineered enzymatic pathway in E. coli. Certain technical milestones have been achieved to date, offering a clear path towards completing validation methods to demonstrate a novel yet simple production process of biosynthetic psilocybin that can be used at a critical scale for clinical and commercial use.

Psilocybin International Research and Commercialization

The Company recently entered into an agreement with the University of Health Sciences Antigua to utilize Revive’s novel psychedelic-assisted therapies including its tannin-chitosan delivery system and to pioneer the clinical research and development of psychedelics in Antigua and Barbuda. Clinical research will be conducted at the University in Q4-2021 with the aim for commercialization in 2022 in Antigua and Barbuda. Once approved for sale, the Company will seek commercial partnerships with specialty pharmaceutical companies in the Caribbean and Latin America.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. Through its subsidiary Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts 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” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive 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 Revive 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. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

Posted on

PharmaTher Granted FDA Orphan Drug Designation For Ketamine To Treat Amyotrophic Lateral Sclerosis

  • Focusing on becoming a global leader in prescription-based ketamine products
  • Advancing to a Phase 2 clinical study in the U.S.​

​TORONTO, August 4, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for ketamine in the treatment of Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “Receiving FDA orphan drug designation is a massive validation for ketamine as a potential treatment for ALS, and it allows us to confidently proceed in evaluating ketamine in a phase 2 clinical study in patients suffering from this life-threatening disease.  This designation not only expedites our regulatory, clinical and product development plans, but also validates our belief in the potential of ketamine as a therapeutic solution for neurological disorders.”

PharmaTher has an exclusive license agreement with The University of Kansas (KU) for the development and commercialization of the intellectual property of ketamine in the treatment of ALS.  The FDA evaluated the research data licensed from KU in the ODD application that ultimately served as the foundation to allow the FDA to grant the designation.  The Company is also working with clinicians in finalizing a phase 2 study protocol to evaluate ketamine for ALS in the U.S.

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.

Ketamine works by blocking the action of the ionotropic glutamate receptor, the NMDA receptor.  Thus, unlike other inhibitors of NMDA receptor function, such as riluzole, ketamine indirectly dampens NMDA receptor-related glutamate excitotoxicity.  Further, ketamine can lower D-serine concentrations intracellularly and also partially activates dopamine receptors.  Collectively, these mechanisms of ketamine contribute in part to the drug’s neuroprotective effects, which may extend to the motor neurons targeted in ALS.

ALS is a progressive neuromuscular disease with a life expectancy of only two to six years after diagnosis.  Currently, there is no known cure for ALS.  ALS affects approximately 50,000 people in the U.S. and Europe, with over 5,000 new cases diagnosed annually.  As ALS advances, upper and lower motor neurons die, causing the brain to lose its ability to control muscle movement.  As a result, ALS patients experience progressive loss of voluntary muscle action as an effect of the disease, resulting in the inability to speak, eat, move and, eventually, breathe.  The FDA approved only three pharmaceuticals for the treatment of ALS: riluzole, edaravone, and Nuedexta (dextromethorphan HBr and quinidine sulfate).  These drugs are effective against disease mechanisms of ALS but fail to have measurable effects on attenuating disease progression or improve survival.  Therefore, there is an imperative need for new pharmacological therapies that can stop or slow the muscle decline associated with ALS progression and extend the life expectancy of the ALS patient.

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

About PharmaTher Holdings Ltd.

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

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of February 28, 2021 (“MD&A”), dated April 28, 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.