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Tryp Therapeutics To Present At 15th Annual Pain Therapeutics Summit

Tryp Therapeutics To Present At 15th Annual Pain Therapeutics Summit

SAN DIEGO – Oct. 26, 2021 – Tryp Therapeutics (CSE:TRYP; OTCQB:TRYPF) (“Tryp” or the “Company”), a pharmaceutical company focused on developing psilocybin-based compounds for diseases with unmet medical needs, today announced that the Company will present at the 15th Annual Pain Therapeutics Summit on November 1, 2021 at 12:15 p.m. EDT.

The virtual conference will take place on November 1-3, 2021. Greg McKee, Chairman and CEO, will provide an overview of the Company followed by a live Q&A session with emphasis on the chronic pain indications that Tryp is pursuing including fibromyalgia, phantom limb pain, and complex regional pain syndrome (CRPS).

PRESENTATION DETAILS FOR TRYP THERAPEUTICS

Date: November 1, 2021
Time: 12:15 p.m. EDT
Registration: Available here

About Tryp Therapeutics

Tryp Therapeutics is a pharmaceutical company focused on developing psilocybin-based compounds for the treatment of diseases with unmet medical needs through accelerated regulatory pathways. Tryp’s Psilocybin-For-Neuropsychiatric Disorders (PFN™) program is focused on the development of synthetic psilocybin as a new class of drug for the treatment of chronic pain and other indications. The Company has announced upcoming Phase 2a clinical trials with the University of Michigan and the University of Florida to evaluate its drug products for fibromyalgia and overeating disorders, respectively. Tryp is also developing a proprietary psilocybin-based product, TRP-8803, that uses a novel formulation and route of administration to improve the patient experience. For more information, please visit www.tryptherapeutics.com.

Investor Inquiries:
Joseph Green
Edison Group
investors@tryptherapeutics.com

Media Inquiries:
Joy Willis
Tryp Therapeutics
media@tryptherapeutics.com
1-833-811-8797

Forward-Looking Information

Certain information in this news release constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans,” “targets,” “expects” or “does not expect,” “is expected,” “an opportunity exists,” “is positioned,” “estimates,” “intends,” “assumes,” “anticipates” or “does not anticipate” or “believes,” or variations of such words and phrases or state that certain actions, events or results “may,” “could,” “would,” “might,” “will” or “will be taken,” “occur” or “be achieved.” In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of Tryp’s final prospectus available at www.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

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PharmaTher Granted FDA Orphan Drug Designation For Ketamine To Treat Complex Regional Pain Syndrome

PharmaTher Granted FDA Orphan Drug Designation For Ketamine To Treat Complex Regional Pain Syndrome

  • Achieving its second FDA orphan drug designation with ketamine.
  • Building a proprietary ketamine-based product pipeline for rare and near-rare disorders in pain and inflammation.
  • Seeking to enter Phase 2 clinical trial in 2022.

TORONTO, October 13, 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 complex regional pain syndrome (CRPS), a rare chronic pain and inflammatory condition following an injury to a limb (arm, leg, hand or foot).  This follows the FDA ODD grant of ketamine for the treatment of Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease, announced by the Company on August 4, 2021.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “Receiving our second FDA orphan drug designation with ketamine for CRPS continues our momentum in building a specialty ketamine-based product pipeline for not only mental health disorders, but also for rare and near-rare conditions present in neurological (Parkinson’s disease, ALS), pain and inflammatory disorders.  We expect to pursue a Phase 2 clinical study using our proprietary cGMP ketamine product in 2022 for CRPS.”

CRPS is a debilitating condition characterized by severe, continuous, burning or throbbing pain in a limb.  CRPS is known as one of the most painful disorders and the risk of suicide is significantly higher in patients with CRPS with one study demonstrating that 75% of patients had a high risk for suicide (Lee et al., Psychiatry Investig 2014;11(1):32-8).  CRPS has acute (recent, short-term) and chronic (lasting greater than six months) forms of excessive pain accompanied by changes in skin color, temperature and/or swelling, which results in loss of physical function and can lead to significant and sometimes permanent disability.  CRPS can occur after surgery or trauma, including brain or spinal cord injury.  There is currently no medication approved for the treatment of CRPS.

Ketamine acts as a noncompetitive, NMDA channel blocker that can prevent the induction of synaptic potentiation.  NMDA receptors play a central role in the processes of induction and maintenance of pain sensitization, accounting for the analgesic efficacy of ketamine.  Although ketamine has actions at other relevant sites, including nicotinic and opioid receptors, as well as, via monoamine reuptake transporters, it is likely that both the anesthetic and the analgesic actions of ketamine are largely mediated by NMDA receptor antagonism.  Likewise, the psychotropic and sympatho-excitatory side effects of ketamine are also predominantly mediated through NMDA receptor blockade.

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 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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Blackhawk Growth Subsidiary, MindBio Therapeutics, Accelerates Phase 1 & Phase 2 Microdosing Clinical Trials

Blackhawk Growth Subsidiary, MindBio Therapeutics, Accelerates Phase 1 & Phase 2 Microdosing Clinical Trials

Vancouver, British Columbia – TheNewswire – September 07, 2021 – Blackhawk Growth Corp. (CNSX:BLR.CN) (OTC:BLRZF) (Frankfurt:0JJ) (the “Company” or “Blackhawk”) is pleased to provide an update on its most recent investment, MindBio Therapeutics Pty Ltd. (“MindBio Therapeutics”), a clinical stage drug development company conducting research into microdosing and medicinal use of psychedelic medicines to treat a range of debilitating mental health conditions.

MindBio Therapeutics reports that in September 2021, 50% of the phase 1 safety trial in healthy patients will be completed and they will have collected complete safety data on the study participants.  Within the next 6 months, MindBio Therapeutics will complete the remainder of phase 1 trials microdosing LSD.

In the first clinical trial of its kind, participants are prescribed microdoses of LSD to take home in much the same way they would take any other over the counter medicine.  This unique clinical trial aims to demonstrate safety and efficacy of use of microdoses of psychedelic drugs for a medicinal purpose in a community setting.  It is expected that these “community” safety features demonstrated during the clinical trials will be used to support the commercial advancement of the medicines as they move through the regulatory and approvals process.

MindBio Therapeutics has numerous additional trials approved or planned.

  • —Phase 2 Clinical Trials have also just been approved with microdosing of LSD in late stage cancer patients.
  • —MindBio Therapeutics has also three phase 2 clinical trials in planning where microdoses of LSD will be tested against depression, chronic pain and mild cognitive impairment.

A recent peer review has shown that MindBio Therapeutics is one of very few publicly reported psychedelic companies involved in both Phase 1 and Phase 2 clinical trials. MindBio Therapeutics is pioneering the development of micro-dose formulations and a range of technology and artificial intelligence applications to ensure the safe dosage, use and administration of psychedelic medicines in the community. Early indications show that LSD is tolerated well in micro-doses and has a lower side effect profile than the currently prescribed anti-depressant drugs.

Blackhawk Grants Incentive Stock Options and Restricted Shares Units

Blackhawk’s board of directors has granted 4,500,000 incentive stock options to purchase common shares of the Company to certain employees and consultants of MindBio Therapeutics as well as 2,000,000 restricted share units. The options vest on the date of issuance and are exercisable until September 7, 2023 at an exercise price of $0.55 per option share.  The restricted share units vest and will convert into common shares on January 8, 2022, provided the holder remains involved with the Company at the time.

About Blackhawk Growth

Blackhawk is an investment holding 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 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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Will shrooms replace opioids?

TRYP THERAPEUTICS ANNOUNCES PLANS FOR PHASE 2A CLINICAL TRIAL FOR FIBROMYALGIA WITH THE UNIVERSITY OF MICHIGAN

Current treatments for fibromyalgia are often ineffective, with less than 10% of patients adhering to treatment for more than a year and 30% resorting to opioids to relieve pain.

Tryp Therapeutics (TRYP), a BC psychedelics company, is working to change this with psilocybin medicine.

This Wednesday, Tryp announced that it will be conducting a Phase 2a clinical trial to evaluate its oral formulation of synthetic psilocybin, TRYP-8802, in treating fibromyalgia, a chronic pain disorder that affects up to 8% of the population.

The trial will take place at the University of Michigan’s Chronic Pain & Fatigue Research Center and will be the world’s first trial of its kind. TRYP-8802 also shows potential to treat eating disorders, phantom limb pain, and complex regional pain syndrome by increasing neuroplasticity.

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Research shows psilocybin’s potential to treat cocaine addiction and chronic pain

Magic mushrooms: UAB studying benefits for addiction and pain

Dr. Peter Hendricks, a researcher at the University of Alabama in Birmingham, found that patients given psilocybin saw significant and lasting reductions in cocaine use compared to patients given a placebo. He plans to continue studying psilocybin’s effect on addiction, as well as on chronic pain conditions like fibromyalgia. Hendricks explains that psilocybin disrupts repetitive thought patterns in the default mode network of the brain, the structures that engage in unfocused activities. “Suddenly your horizons are broadened, and broadened tremendously, and you’re thinking about something other than obtaining or using that drug (or worrying about your pain)”.

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