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Mycrodose Therapeutics Receives DEA License to Research Four Psychedelics

Mycrodose Therapeutics Receives DEA License to Research Four Psychedelics

Mycrodose Therapeutics is pleased to announce that the company has been approved by the United States Drug Enforcement Agency (DEA), State of California Attorney General’s Research Advisory Board, and The US Food & Drug Administration (FDA) to research four (4) psychedelic compounds at their San Diego, California laboratory.

The company’s Schedule I DEA License was granted final approval after the DEA conducted an extensive in-person audit of Mycrodose Therapeutics’ facilities and after the FDA conducted an extensive review of the company’s in-depth research protocols for using Psilocybin, LSD, MDMA, and DMT in the development of their IP protected drug delivery technologies.

Mycrodose Therapeutics is one of a few private companies that has been granted a Schedule I License to research four (4) psychedelic compounds by the United States Drug Enforcement Agency (DEA).

“With the approval to research four Schedule I active pharmaceutics ingredients in our laboratory, we are extremely excited to marry those substances with our proprietary advanced drug delivery technologies. We are confident that our non-conventional drug delivery platforms will not only make the use of psychedelic drugs much safer but also increase the number of patients that can be treated with these powerful APIs. I’m thinking here in particular about children and the elderly. Due to the projected tight dosage control and the convenience of use, we are poised to elevate the status quo of psychedelic drug use in many medical conditions”, says Dr. Kochinke, Mycrodose Therapeutics, Chief Science Officer.

Dr. Frank Kochinke has over 30 years of experience inventing advanced drug delivery technologies and working with Schedule I compounds within the pharmaceutical-biotech industry. Having this in-house core expertise allowed Mycrodose Therapeutics to apply directly to the DEA, whereas many companies in the Psychedelic sector rely on the experience of third-party research institutions or Universities to carry out their research protocols.

Mycrodose Therapeutics laboratory in San Diego is currently in development of two (2) of their four (4) core technologies; the transdermal patch and transmucosal lozenge. The company’s IP Protected technology delivers a sustained and controlled dose of medicine into the body over time, which is believed to be safer and more effective than conventional drug delivery methods.

“We are excited to have a team with the expertise to obtain our Schedule I DEA license without needing to partner with a research institution or University. This milestone continues to validate the depth of our team, our research protocols, and our technologies,” says Chad Conner, Chief Executive Officer.

About Mycrodose Therapeutics:
Mycrodose Therapeutics (http://www.MycrodoseThera.com) is a US-Based pharmaceutical company headquartered in San Diego, California specializing in the development of advanced drug delivery systems utilizing psychedelic compounds to treat mental health and cognitive degenerative diseases. Mycrodose is one of only a few private companies that has been granted a Schedule I License to research four (4) psychedelic compounds: Psilocybin, MDMA, DMT & LSD by the United States Drug Enforcement Agency (DEA).

For more information about Mycrodose Therapeutics, please contact:

Patrick Eckstrom
Chief Operating Officer
Mycrodose Therapeutics
Email: mailto:Patrick@MycrodoseThera.com [Patrick@MycrodoseThera.com __title__ null]
Phone: 1-619-494-1367
Website: http://www.MycrodoseThera.com

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Take this test before your first ayahuasca retreat

Entheon Biomedical Announces Expanded Psychedelics Genetic Test Panel

HaluGen Life Sciences expanded its psychedelic DNA test – it can now assess how your body metabolizes LSD, MDMA and ayahuasca. 

The kit tests for a CYP2D6 gene mutation, which can cause metabolism of the drugs to take up to twice as long. This could lead to longer, more intense trips and adverse reactions. 

Thankfully, the mutation is only present in 5-10% of people!

Entheon Biomedical

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MindMed Provides Status Update on IND for Phase 2b Trial of LSD for the Treatment of Generalized Anxiety Disorder

MindMed Provides Status Update on IND for Phase 2b Trial of LSD for the Treatment of Generalized Anxiety Disorder

FDA has issued a clinical hold on initial IND submission required to initiate Phase 2b trial of LSD for the treatment of generalized anxiety disorder

NEW YORK, Dec. 21, 2021 /PRNewswire/ — Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the “Company”), a leading biotech company developing psychedelic-inspired therapies, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its IND submission intended to support the initiation of a Phase 2b trial of lysergic acid diethylamide (LSD) for the treatment of generalized anxiety disorder (GAD). Additional detail regarding the FDA’s decision is expected within 30 days.

“Our team has a tremendous sense of urgency to bring new treatments, such as LSD, to the many patients in need, particularly given the growing mental health epidemic,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “We remain highly confident in the therapeutic potential of LSD to usher in a new treatment paradigm for these disorders and we look forward to working closely with FDA to satisfy all outstanding concerns as rapidly as possible.”

About GAD
GAD is a chronic, often debilitating mental health disorder that affects approximately 6% of U.S. adults in their lifetimes. Symptoms of GAD include excessive anxiety and worry that persists for over six months, which can lead to significant impairments in social, occupational and other functioning, according to the National Institute of Mental Health (NIMH). While there is substantial diagnostic overlap between GAD, Major Depressive Disorder and other major mental health disorders, there has been very little innovation focused on the treatment of GAD in the past several decades.

About MindMed
MindMed is a clinical-stage biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address mental health and addiction. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed’s approach to developing the next generation of psychedelic-inspired medicines and therapies.

MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ.

Forward-Looking Statements
Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release include, but are not limited to, statements regarding the therapeutic potential of LSD and the ability to initiate a Phase 2b trial of LSD for the treatment of GAD, the expected timing of additional information regarding the FDA’s decision and working closely with the FDA to satisfy all outstanding concerns as rapidly as possible. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Company. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described under the headings “Risk Factors” in the Company’s filings with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results and future events could differ materially from those anticipated in such information. Although the Company has attempted to identify important risks, uncertainties and factors that could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend and does not assume any obligation to update this forward-looking information.

For Media: media@mindmed.co

For Investors: ir@mindmed.co

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Is LSD the new Adderall?

MindMed Initiates Phase 2a LSD Trial for the Treatment of Adult ADHD

MindMed (MNMD) is collaborating with universities in Switzerland and the Netherlands to study the effects of microdosing LSD on adults with ADHD. Patients will be assessed on symptoms of inattention, impulsivity, and hyperactivity after microdosing twice a week for six weeks. 

“The study builds on the growing evidence demonstrating LSD has the potential to improve mood and selective cognitive processes,” says the company’s new CEO, Robert Barrow, who was appointed this week.

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PharmaTher Announces Positive Research Results for LSD Microneedle Patch

PharmaTher Announces Positive Research Results for LSD Microneedle Patch

  • Delivering LSD via microneedle patch unlocks potential for desired dosage forms and pharmacokinetic profiles for improved safety and effectiveness
  • Pursuing Phase 2 clinical studies in 2022 with LSD and notable psychedelics

TORONTO, December 14, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has successfully completed its first research study evaluating MicroDose-MN™, a proprietary microneedle (“MN”) patch for the intradermal delivery of psychedelics, in delivering lysergic acid diethylamide (“LSD”).  These results provide support to file for an IND application with the FDA to conduct Phase 2 clinical studies in 2022 with LSD for various indications.

The aim of PharmaTher’s research program was to develop a suitable prototype of MicroDose-MN™ patch for transdermal (intradermal) drug delivery to confirm compatibility and suitability to deliver LSD. The research program scope included, full characterization of LSD conjugated on the microneedle patch backbone, establishment and demonstration of the loading capacity for LSD, and release rate evaluations for the LSD conjugated materials using appropriate models that will be used to support the Company’s IND application with the FDA in the future.

The Company’s research program with LSD conjugated microneedles have been successfully fabricated, optimized, and characterized. Both structural aspects and ex-vivo skin insertion assessments of the LSD conjugated microneedles have demonstrated successful fabrication and acceptable performance. The incorporation of LSD into microneedles without issue and the ability to demonstrate complete ex vivo skin model release over several days demonstrates potential for larger doses and modified release profiles. With these results, the Company believes it has an acceptable prototype for completing IND-enabling studies with the aim to conduct clinical studies in 2022.  Details of the research program will be published in a scientific journal.

The Company believes that its MicroDose-MN™ patch for delivering LSD and other psychedelics may enable flexible drug load capacity and combinations, controlled released delivery, and be able to present desired pharmacokinetic and safety profiles. In addition, the MicroDose-MN™ patch for psychedelics aims to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office or hospital.  To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

The Company is completing its evaluation of MicroDose-MN™ with 3,4-methylenedioxy-methamphetamine (“MDMA”) and N, N-dimethyltryptamine (“DMT”) and expects to provide results before the end of this year and pursue clinical studies in 2022.

The Company is actively engaged in partnering discussions for the use of its microneedle patch system to deliver psychedelics including, but not limited to, MDMA, LSD, DMT, ibogaine and mescaline.  As such, PharmaTher offers potential partners a differentiated and validated delivery system for psychedelics, desired pharmacokinetic profiles, intellectual property protection, cGMP microneedle patches for IND-enabling and clinical studies, and a clear clinical pathway towards clinical studies in 2022.

About PharmaTher Holdings Ltd.

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

For more business development opportunities or information about PharmaTher, please contact:

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

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

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim”, “may” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.

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

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Blackhawk Growth’s MindBio Therapeutics Advances Microdosing Clinical Trial to 59 Patients

Blackhawk Growth’s MindBio Therapeutics Advances Microdosing Clinical Trial to 59 Patients

Vancouver, British Columbia – TheNewswire – November 15, 2021 – Blackhawk Growth Corp. (CNSX:BLR) (OTC:BLRZF) (Frankfurt:0JJ) (the “Corporation” or “Blackhawk”), is pleased to announce that their wholly-owned subsidiary, MindBio Therapeutics Pty Ltd (“MindBio”), has reached a new milestone for its Phase 1 clinical trial microdosing LSD with 59 participants successfully completing the trial.  The clinical trial is the first and largest safety clinical trial of its kind anywhere in the world.

MindBio is a multi-disciplinary company pioneering new treatments for mental health conditions using psychedelic medicines, technology assisted mental health interventions and psychedelic assisted psychotherapies.

MindBio is on track to have its Phase 1 clinical trial in 80 healthy participants completed by April in 2022.  In this unique study, trial participants are prescribed the drug by a doctor and take it home with them in the same way they would take an anti-depressant medication.  Clinical trial participants are assessed on a comprehensive range of psychometric and biometric markers to determine safety and efficacy of the drug.

LSD is a psychoplastogen, which is a fast-acting class of therapeutics, capable of rapidly promoting structural and functional neural plasticity and shows potential for treating diseases in psychiatry1. Microdosing involves patients taking a small amount of the medicine on a regular basis.  In larger doses, LSD is a hallucinogenic drug that changes cognition and perception, however in much smaller “microdoses”, the medicine is subperceptual, meaning that patients can take the drug without noticing its hallucinogenic effects, but still receive the medicinal benefit and get on with their normal day.

“This is extremely exciting work” says Frederick Pels, CEO of Blackhawk Growth Corp. “Our clinical trial is paving the way forward to create a class of new medicines that propose novel and effective solutions for treating serious mental illness. MindBio continues to demonstrate how its exceptional team of clinicians and engineers are dedicated to building products that can have a significant impact on people’s lives. I look forward to updating shareholders as developments continue to progress.”

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6149016/

About Blackhawk Growth

Blackhawk is an investment holding company looking to create substantial value for its shareholders through the acquisition and development of high growth companies. It has focused its investments in the health, cannabis and cannabidiol industries in both Canada and the United States. Its portfolio of companies includes Sac Pharma, LeichtMind Clinics, Noble Hemp, Spaced Food, NuWave Foods, and MindBio Therapeutics. Blackhawk continues to bring its investments to cash flow and is growing at an exceeding pace.

The Company diligently posts updates through videos from the official company YouTube channel https://www.youtube.com/channel/UCs4f2tt3yAvOGhNLjgNOy-A

Please join the conversation on our Blackhawk group supporter’s telegram group at https://t.me/Blackhawkgrowthcorp and visit us online at https://www.blackhawkgrowth.com.

For further information please contact:

Frederick Pels, Chief Executive Officer

(403)-991-7737

fred@blackhawkgrowth.com

Cautionary Note Regarding Forward-Looking Statement

All statements in this press release, other than statements of historical fact, are “forward-looking information” with respect to the Company within the meaning of applicable securities laws, including with respect to transaction and future operations of MindBio Therapeutics Pty Ltd. The Company provides forward-looking statements for the purpose of conveying information about current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. By its nature, this information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. These risks and uncertainties include but are not limited those identified and reported in the Company’s public filings under the Company’s SEDAR profile at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise unless required by law.

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Blackhawk Growth’s MindBio Therapeutics Completes Safety Milestone In Its Phase 1 Clinical Trials

Blackhawk Growth’s MindBio Therapeutics Completes Safety Milestone In Its Phase 1 Clinical Trials

Vancouver, British Columbia – TheNewswire – November 08, 2021 – Blackhawk Growth Corp. (CNSX:BLR.CN) (OTC:BLRZF) (Frankfurt:0JJ) (the “Corporation” or “Blackhawk”), is pleased to announce that its wholly owned subsidiary, MindBio Therapeutics Pty Ltd (“MindBio”), has received feedback from the trial’s independent Data and Safety Monitoring Committee that the Phase 1 clinical trial is approved to continue after a successful six month safety review.

MindBio is a multi-disciplinary company pioneering new treatments for mental health conditions using psychedelic medicines, technology assisted mental health interventions and psychedelic assisted psychotherapies.

MindBio is currently undertaking the world’s first clinical trial of its kind microdosing LSD to 80 healthy participants who take the drug at home in the same way that they would take any other medication. MindBio is also targeting Major Depressive Disorder and distress in late-stage cancer patients in its Phase 2 trials which are currently in development and will follow next year.

The approval to continue Phase 1 clinical trials microdosing LSD after the independent safety review is a positive milestone achieved with more than 50% of the participants having now completed the trial.

“We are very pleased to report these safety outcomes in our clinical trials,” said Frederick Pels, CEO of Blackhawk Growth Corp. “These results showcase the caliber of work we are doing, targeting more effective medical treatments for mental health conditions. Throughout these trials, MindBio is solidifying its position as a market leader in the psychedelic research sector. We look forward to updating shareholders with further developments in the near future.”

 

About Blackhawk Growth

Blackhawk is an investment holding company looking to create substantial value for its shareholders through the acquisition and development of high growth companies. It has focused its investments in the health, cannabis and cannabidiol industries in both Canada and the United States. Its portfolio of companies includes Sac Pharma, LeichtMind Clinics, Noble Hemp, Spaced Food, NuWave Foods, and MindBio Therapeutics. Blackhawk continues to bring its investments to cash flow and is growing at an exceeding pace.

The Company diligently posts updates through videos from the official company YouTube channel https://www.youtube.com/channel/UCs4f2tt3yAvOGhNLjgNOy-A

Please join the conversation on our Blackhawk group supporter’s telegram group at https://t.me/Blackhawkgrowthcorp and visit us online at https://www.blackhawkgrowth.com.

For further information please contact:

Frederick Pels, Chief Executive Officer

(403)-991-7737

fred@blackhawkgrowth.com

Cautionary Note Regarding Forward-Looking Statement

All statements in this press release, other than statements of historical fact, are “forward-looking information” with respect to the Company within the meaning of applicable securities laws, including with respect to transaction and future operations of MindBio Therapeutics Pty Ltd. The Company provides forward-looking statements for the purpose of conveying information about current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. By its nature, this information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. These risks and uncertainties include but are not limited those identified and reported in the Company’s public filings under the Company’s SEDAR profile at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise unless required by law.

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PharmaTher Provides Research Update on Microneedle Patch Delivery Technologies for Psychedelics

PharmaTher Provides Research Update on Microneedle Patch Delivery Technologies for Psychedelics

  • Completing IND-enabling studies with novel microneedle patch for ketamine, psilocybin, MDMA, LSD, and DMT.
  • Expanding research in evaluating ibogaine and mescaline.
  • Aiming for FDA Phase 1 and 2 clinical studies in Q2-2022.
  • Discussing partnership opportunities for delivering psychedelics with MicroDose-MN™ and MacroDose-MN™ patches.
TORONTO, November 1, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today provides an update on the ongoing research studies with its novel microneedle (“MN”) patch as a next generation delivery technology for psychedelics, including ketamine, psilocybin, 3,4-methylenedioxy-methamphetamine (“MDMA”), lysergic acid diethylamide (“LSD”), and N, N-dimethyltryptamine (“DMT”).

The Company has research collaborations with the Terasaki Institute to evaluate MicoDose-MN™; a patent-pending biocompatible and biodegradable gelatin methacryloyl microneedle patch, to deliver psilocybin, MDMA, LSD and DMT, and with The Queen’s University of Belfast (“QUB”) to evaluate MacroDose-MN™; a patented hydrogel-forming microneedle patch, to deliver ketamine and PharmaTher’s proprietary ketamine combination formulation, ketamine and betaine (“KETABET™”) for mental health, neurological and pain disorders.

Research results with MicroDose-MN™ for psilocybin and LSD will be made available in November 2021, followed by results with MDMA and DMT in December 2021.  Research results with MacroDose-MN™ for ketamine and KETABET™ will be made available in December 2021.  Current research results are very encouraging; therefore, the Company has decided to expand research to include ibogaine and mescaline, prepare IND applications with the FDA for Phase 1 and 2 clinical studies in Q2-2022, and discuss partnership opportunities with specialty pharmaceutical companies seeking a novel and validated delivery system for psychedelics targeting specific indications and desired pharmacokinetic profiles.

PharmaTher is proceeding with its IND-enabling studies and manufacturing scale-up for cGMP microneedle patches for its expected clinical studies in 2022.  The MicroDose-MN™ and MacroDose-MN™ patches can efficiently penetrate the stratum corneum layer (outer layer of the skin), enable flexible drug load capacity and combinations, and control-release delivery, which may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems.  In addition to the potential of maintaining constant plasma levels for more than 24 hours, the MN patches aim to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

“We are nearing completion of our research programs in validating the utility of our microneedle patch delivery technologies for psychedelics, derisking our plans in advancing the completion of our IND-enabling studies to support future clinical studies and partnering opportunities,” said Fabio Chianelli, CEO of PharmaTher.  “As we look forward to announcing our research results, our focus continues to expand our ketamine-based product pipeline and advance our microneedle patch programs to unlock significant value and return on investment for long-term revenue potential through our products and our future partners.”

About PharmaTher Holdings Ltd.

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

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 August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.

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