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.

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.

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.

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.

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.

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