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PharmaTher Applies for FDA Orphan Drug Designation for Ketamine to Treat Rare Neurological Disorder Status Epilepticus

PharmaTher Applies for FDA Orphan Drug Designation for Ketamine to Treat Rare Neurological Disorder Status Epilepticus

  • Adds to PharmaTher’s existing FDA orphan drug portfolio with amyotrophic lateral sclerosis and complex regional pain syndrome
  • Strengthens commitment to treat rare disorders and life-threatening conditions with ketamine
TORONTO, November 24, 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 applied with the U.S. Food and Drug Administration (“FDA”) to receive Orphan Drug Designation (“ODD”) for ketamine to treat Status Epilepticus (“SE”), a rare neurological disorder requiring emergency treatment for a seizure.  The Company has received FDA ODD for ketamine to treat amyotrophic lateral sclerosis (“ALS”) and complex regional pain syndrome (“CRPS”).  The addition of SE strengthens the Company’s pharmaceutical strategy in developing novel uses and delivery methods (i.e. microneedle patch) for ketamine to treat rare disorders and life-threatening conditions.

SE is a life-threatening occurrence of a prolonged seizure or recurrent seizures without recovery of consciousness between seizures (Lowenstein 1999) lasting more than five minutes. Epidemiological studies found an annual incidence of SE ranging from 41/100,000-61/100,000 (DeLorenzo 1996). Based on these studies, there are approximately 120,000-180,000 episodes of convulsive SE each year in the U.S. SE affects individuals of all ages and it complicates various neurological and systemic illnesses. If SE is not treated immediately, permanent neuronal damage may occur, contributing to high morbidity and mortality rates. The mortality associated with SE is estimated at 17% and may lead to morbidity, including cognitive defects and neurological injury. SE is initially treated with benzodiazepines, which approximately 35-45% of patients are refractory to benzodiazepines.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “Ketamine has the potential to treat various mental health, neurological and pain disorders, and we are focused on expanding ketamine’s therapeutic utility in rare disorders and life-threatening conditions including, but not limited to, Parkinson’s disease, amyotrophic lateral sclerosis, complex regional pain syndrome, and now status epilepticus.  The FDA orphan drug application for ketamine to treat status epilepticus builds on our belief in the potential of ketamine to improve quality of life and to save lives.”

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 ketamine 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 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” 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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Pure Extracts 1-gram Vape Carts Continue Strong Retail Sell-through

Pure Extracts 1-gram Vape Carts Continue Strong Retail Sell-through

Vancouver, B.C., November 24, 2021 – Pure Extracts Technologies Corp. (CSE: PULL) (OTC: PRXTF) (XFRA: A2QJAJ) (“Pure Extracts” or the “Company”), a plant-based extraction company focused on cannabis, hemp, functional mushrooms and the rapidly emerging psychedelic sector, is pleased to announce that its wholly owned subsidiary, Pure Extracts Manufacturing Corp.’s branded 1 gram vape carts are continuing their strong growth with licensed retailers.

Of the Company’s 24 SKUs listed across 4 provinces (British Columbia, Alberta, Saskatchewan and Ontario) in the recreational cannabis space and 9 SKUs in the medical cannabis space, the 1-gram Pure Pulls branded line of full spectrum oil (FSO) THC vapes is clearly the best seller. Product re-orders are occurring with increasing frequency with shipments usually selling-through within 3 to 5 weeks from delivery to the provinces and the Company believes that this key SKU will help it access the provincial markets in Eastern Canada.

The Company is also building on the success of Pure Chews THC and CBD edible gummies, sold in their unique blister package format, and has submitted multiple Notices of New Cannabis Products (NNCPs) to Health Canada for approval. These products are expected to be in-market in H1 2022.

Pure Extracts’ CEO, Ben Nikolaevsky, commented, “We are pleased to have several key SKUs that are receiving widespread consumer recognition and repeat buying. Our products are of the highest quality, and we have priced them to be within reach of all of consumers.”

ON BEHALF OF THE BOARD

“Ben Nikolaevsky”
Ben Nikolaevsky
CEO and Director

About Pure Extracts (CSE: PULL) (OTC: PRXTF) (XFRA: A2QJAJ)

Pure Extracts Technology Corp. features an all-new, state-of-the-art processing facility located just 20 minutes north of world-famous Whistler, British Columbia. The bespoke facility has been constructed to European Union GMP standards aiming towards export sales of products and formulations, including those currently restricted in Canada, into European jurisdictions where they are legally available. Pure Extracts was granted its Standard Processing License by Health Canada under the Cannabis Act on September 25, 2020, and its Sales Amendment on July 19, 2021. The Company’s stock began trading on the Canadian Securities Exchange (CSE) on November 5, 2020.

Find out more at https://pureextractscorp.com/

Or contact:

Pure Extracts Investor Relations
Tel: +1 604 493 2052
info@pureextractscorp.com    

This news release contains forward-looking statements relating to the future operations of Pure Extracts,

and the other statements are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of Pure Extracts’, are forward-looking statements and involve risks and uncertainties. A number of factors could cause actual events, performance or results to differ materially from what is projected in forward looking statements. Although we believe that the assumptions underlying these statements are reasonable, they may prove to be incorrect, and we cannot assure that actual results will be consistent with these forward-looking statements. Given these risks, uncertainties and assumptions, investors should not place undue reliance on these forward-looking statements. Whether actual results, performance or achievements will conform to the Company’s expectations and predictions is subject to a number of known and unknown risks, uncertainties, assumptions and other factors, including those listed under “Risk Factors” in the Company’s Annual Information Form. The Company does not undertake to update any forward-looking information, except as, and to the extent required by, applicable securities laws.

This news release contains information about potential sales revenue from supply agreements, which may be considered as disclosure of financial outlook under applicable securities laws. Such information is subject to the same assumptions, risk factors, limitations, and qualifications as set forth in the above paragraph. Specifically, estimated sales revenue which may be derived from supply contracts has been calculated based on current wholesale prices and assume, among other things, that the Company will be able to find buyers for its products. The financial outlook contained in this news release was made by management as of the date of this news release and was provided for the purpose of providing readers with an understanding of the potential revenue which may be derived from any agreements recently entered into by the Company and are not an estimate of profitability or any other measure of financial performance. Readers are cautioned that the financial outlook contained in this document should not be used for purposes other than for which it is disclosed herein.

The CSE has neither approved nor disapproved the contents of this press release.

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Algernon Pharmaceuticals Announces Positive Feedback from U.S. FDA for Phase 1 Ifenprodil Small Cell Lung Cancer Study

Algernon Pharmaceuticals Announces Positive Feedback from U.S. FDA for Phase 1 Ifenprodil Small Cell Lung Cancer Study

VANCOUVER, British Columbia, Nov. 24, 2021 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) a clinical stage pharmaceutical development company, is pleased to announce that it has received positive feedback from the U.S. Food and Drug Administration (U.S. FDA) at its pre-IND (Investigational New Drug) meeting for its investigation of NP-120 (Ifenprodil) for the treatment of small cell lung cancer (SCLC). Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B).

As a result of the feedback, the Company is not planning to conduct any additional pre-clinical research and will immediately move to file an IND application to begin its Phase 1 SCLC study as soon as possible. Based on the feedback from the meeting, the Company plans to use its current Ifenprodil finished product inventory for the study. The U.S. FDA meeting also produced very helpful guidance on the protocol design and endpoints for the planned SCLC study.

The Company is planning to conduct its Phase 1 study in patients with recurrent SCLC and, as a result, preliminary efficacy signals may be observed in the data.

The Company also plans to apply for orphan drug designation for Ifenprodil to treat patients with SCLC. The U.S. Orphan Drug Act grants special status to a drug for the treatment, diagnosis or prevention of a rare disease or condition.

The Company’s decision to investigate Ifenprodil and move it into human trials for SCLC is based on a preclinical study, authored by Dr. William North, and published in January 2019, entitled, “Small-Cell Lung Cancer Growth Inhibition: Synergism Between NMDA Receptor Blockade and Chemotherapy”. In the study, Ifenprodil, in combination with chemotherapeutic agent Topotecan, produced clear additive effects that significantly blocked tumor growth.

In August 2021, Algernon announced that it had signed an exclusive licensing agreement with Dartmouth College to acquire the rights to a method of use patent for treating neuroendocrine cancers, which express functional NMDA receptors. The Company also announced it appointed Dr. William North, professor emeritus at Dartmouth College and cancer research pioneer, as lead consultant.

In addition, based on the positive feedback from this Pre-IND meeting, the Company is also planning to file a Pre-IND meeting request for Ifenprodil and the investigation of pancreatic cancer in a Phase 1 study.

“We are very pleased with the response we received from the U.S. FDA,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals Inc. “Being able to move directly into a SCLC Phase 1 study will save the Company considerable cost and time and will allow us to more quickly begin investigating Ifenprodil as a potential non-toxic cancer treatment option for patients who suffer from this disease.”

About Ifenprodil

Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils and certain types of cancer cells.

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com.

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

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Allied Corp Signs Yearly Supply Contract With Veterans for Healing Using the Allied Inside™ Business Model With Colombian Produced Cannabis Flower

KELOWNA, British Columbia, Nov. 24, 2021 (GLOBE NEWSWIRE) — Allied Corp. (“Allied” or the “Company”) (OTCQB: ALID) is pleased to announce the signing of a supply contract (the “contract”) for the 2022 calendar year and beyond. Allied will be only exporting cannabis flower after the Colombian government allows it and will provide supply only to countries where it is legal to sell into (for example, the United States only allows for THC levels to be less than 0.3%).

On November 18th 2021, a contract was signed between Allied and a globally focused veterans innovative healing organization called Veterans For Healing(“VFH”) for a volume of 4000 kilograms per month of Colombian produced 20%+ high-CBD percentage flower. 2000 kilograms monthly is destined for the United States and 2000 kilograms monthly is destined for the United Kingdom. The intent is that this flower will be processed into high percentage CBD content cigarette packages for sale into the United States and United Kingdom markets. These cigarette packages will be branded with the VFH brand with the Allied Inside™ mark on the package. The Allied Inside™ mark signifies that there is Allied Corp produced flower contained.

About Allied Inside™ Model: Click for more here

The Allied Inside™ value proposition enables national brands and companies to brand, market and sell their retail products into their market with the Allied Inside™ product contained. The Allied product is produced in Colombia and provided as a wholesale product to many international partners to then distribute and sell. The Allied Inside™ model offers qualified clients the ability to import large volumes of Colombian produced flower with a small up front percentage of payment and the remainder due under terms of future payment (ie 60-90days). This enables off-take partners to sell into their market and essentially pay for the remainder of the payment out of their sales revenue.

About Veterans for Healing:

Veterans For Healing (“VFH”) is a globally reputed company that has been gained, through tangible action within several countries around the globe, a strong Veterans following as an advocate for veteran help, health and healing.

VFH has partners in many countries around the globe that serve veterans in every aspect of health and wellness. Within their global network, VFH is committed to ensuring premium quality products, consistent supply and proven genetics, for their client’s medical cannabis needs. VFH helps by guiding Veterans through Veterans Affairs organizations and helping with medical authorizations as needed. VFH also has ready access to psychologists, psychiatrists, physicians, natural health companies and coordinators in many countries.

VFH can offer education on medical cannabis for optimizing results, access to online yoga, peer support and other healing practices and connection into a peer cohort that offers healing events and gatherings for Veterans and their families. For more on VFH please click here: CLICK FOR MORE ON VFH.

“We are excited to bring the Allied Inside™ business model to market. In my opinion, Veterans for Healing is the perfect partner. As Colombia continues to move towards the ability to export cannabis flower to countries where it is legal to do so, these contracts point to the demand that the global cannabis market is asking for. We believe that these supply contracts are just the start of Allied’s production volumes. We harvest on a weekly basis and by nature of this we believe that we will be able to provide rolling supply that is harvested fresh every week. We also continue to build relationships with buyers in many different countries around the globe and, through this, we believe that we are ready to supply the market demand in many international markets where it is legal to do so.” said Mr. Calum Hughes, CEO and Chairman of Allied Corp.

About Allied Corp. – https://allied.health/

Allied Corp. is an international cannabis company with its main production center in Colombia and is one of the few companies that has exported from Colombia internationally. In preparation for the possible legalization of cannabis by the US Federal Government, Allied also has the option to purchase a US cannabis license in the US (Nevada) exercisable if such were to happen. In addition to this, Allied has three CBD-brands to market with products selling in the United States. Lastly, Allied has both Cannabinoid and psilocybin products in the pharmaceutical development track seeking pharma drug indications for depression, anxiety and PTSD.

Investor Relations:
ir@allied.health
1-877-255-4337

Forward-Looking Statements:
This press release contains “forward-looking information” within the meaning of applicable securities laws in Canada or “forward-looking statements” made pursuant to the “safe harbour” provisions of the United States Private Securities Litigation Reform Act of 1995 (collectively, “forward-looking information”). Forward-looking information may relate to the Company’s future outlook and anticipated events, plans or results, and may include information regarding the Company’s objectives, goals, strategies, future revenue or performance and capital expenditures, and other information that is not historical information. Forward-looking information can often be identified by the use of terminology such as “believe,” “anticipate,” “plan,” “expect,” “pending,” “in process,” “intend,” “estimate,” “project,” “may,” “will,” “should,” “would,” “could,” “can,” the negatives thereof, variations thereon and similar expressions. The forward-looking information contained in this press release is based on the Company’s opinions, estimates and assumptions in light of management’s experience and perception of historical trends, current conditions and expected future developments, as well as other factors that management currently believes are appropriate and reasonable in the circumstances. Forward looking statements in this press release include the following: that Allied is leveraging the conditions in its Colombia grow operation and future Kelowna location to support its Research and Development efforts; that Allied is making important strides forward to position itself as a leader in the medical cannabis space, that Allied intends to make a series of proposed trademark and other intellectual property protection filings, as part of the Company’s Intellectual Property and Pharma Development (IP&PD) Strategy, statements respecting the joint development, manufacturing, and introduction of TACTICAL RELIEF™ branded products, and the use of proceeds from the offering of convertible notes.

There can be no assurance that the underlying opinions, estimates and assumptions will prove to be correct. Risk factors that could cause actual results to differ materially from forward-looking information in this release include: the Company’s exposure to legal and regulatory risk; the effect of the legalization of adult-use cannabis in Canada and Colombia on the medical cannabis industry is unknown and may significantly and negatively affect the Company’s medical cannabis business; that the medical benefits, viability, safety, efficacy, dosing and social acceptance of cannabis are not as currently expected; that adverse changes or developments affecting the Company’s main or planned facilities may have an adverse effect on the Company; that the medical cannabis industry and market may not continue to exist or develop as anticipated or the Company may not be able to succeed in this market; risks related to completion of the greenhouse construction in Colombia, risks related to market competition; risks related to the proposed adult-use cannabis industry and market in Canada and Colombia including the Company’s ability to enter into or compete in such markets; that the Company has a limited operating history and a history of net losses and that it may not achieve or maintain profitability in the future; risks related to the Company’s current or proposed international operations; risks related to future third party strategic alliances or the expansion of currently existing relationships with third parties; that the Company may not be able to successfully identify and execute future acquisitions or dispositions or successfully manage the impacts of such transactions on its operations; risks inherent to the operation of an agricultural business; that the Company may be unable to attract, develop and retain key personnel; risks resulting from significant interruptions to the Company’s access to certain key inputs such as raw materials, electricity, water and other utilities; that the Company may be unable to transport its cannabis products to patients in a safe and efficient manner; risks related to recalls of the Company’s cannabis products or product liability or regulatory claims or actions involving the Company’s cannabis products; risks related to the Company’s reliance on pharmaceutical distributors; that the Company, or the cannabis industry more generally, may receive unfavourable publicity or become subject to negative consumer or investor perception; that certain events or developments in the cannabis industry more generally may impact the Company’s reputation or its relationships with customers or suppliers; that the Company may not be able to obtain adequate insurance coverage in respect of the risks that it faces, that the premiums for such insurance may not continue to be commercially justifiable or that there may be coverage limitations and other exclusions which may result in such insurance not being sufficient; that the Company may become subject to liability arising from fraudulent or illegal activity by its employees, contractors, consultants and others; that the Company may experience breaches of security at its facilities or losses as a result of the theft of its products; risks related to the Company’s information technology systems; that the Company may be unable to sustain its revenue growth and development; that the Company may be unable to expand its operations quickly enough to meet demand or manage its operations beyond their current scale; that the Company may be unable to secure adequate or reliable sources of necessary funding; risks related to, or associated with, the Company’s exposure to reporting requirements; risks related to conflicts of interest; risks related to fluctuations in foreign currency exchange rates; risks related to the Company’s potential exposure to greater-than-anticipated tax liabilities; risks related to the protection and enforcement of the Company’s intellectual property rights, or the intellectual property that it licenses from others; that the Company may become subject to allegations that it or its licensors are in violation of the intellectual property rights of third parties; that the Company may not realize the full benefit of the clinical trials or studies that it participates in; that the Company may not realize the full benefit of its licenses if the licensed material has less market appeal than expected and the licenses may not be profitable; as well as any other risks that may be further described in and the risk factors discussed in the Company’s continuous disclosure including its Management’s Discussion and Analysis sections in its Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K and Current Reports on Form 8-K filed under the Company’s profile at www.sec.gov.

Although management has attempted to identify important risk factors that could cause actual results to differ materially from those contained in the forward-looking information in this presentation, there may be other risk factors not presently known to the Company or that the Company presently believes are not material that could also cause actual results or future events to differ materially from those expressed in such forward-looking information in this presentation. 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 information. Accordingly, readers and viewers should not place undue reliance on forward-looking information, which speaks only as of the date made. The forward-looking information contained in this release represents the Company’s expectations as of the date of this release or the date indicated, regardless of the time of delivery of the presentation. The Company disclaims any intention, obligation or undertaking to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required under applicable securities laws.

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Pasithea Therapeutics Corp. Announces Pricing of a $30.4 Million Private Placement Priced at a Premium to the Market Under Nasdaq Rules

Pasithea Therapeutics Corp. Announces Pricing of a $30.4 Million Private Placement Priced at a Premium to the Market Under Nasdaq Rules

MIAMI BEACH, Fla., Nov. 24, 2021 (GLOBE NEWSWIRE) — Pasithea Therapeutics Corp. (Nasdaq: KTTA; KTTAW) (“Pasithea” or the “Company”), a biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders, today announced that it has entered into securities purchase agreements with certain institutional investors to purchase 8.68 million shares of its common stock and warrants to purchase 8.68 million shares of its common stock, at a purchase price of $3.50 per share and accompanying warrant in a private placement priced at a premium to the market under Nasdaq rules. The gross proceeds to the Company from the private placement are expected to be approximately $30.4 million before deducting the placement agent’s fees and other estimated offering expenses.

The warrants will be immediately exercisable from the date of issuance and have an exercise price of $3.50 per share. The warrants will expire five years from the date of issuance. The offering is expected to close on or about November 29, 2021, subject to the satisfaction of customary closing conditions.

EF Hutton, division of Benchmark Investments, LLC, is acting as exclusive placement agent for the offering.

The Company currently intends to use the net proceeds from the private placement to fund pre-clinical research and development work for future product candidates, invest in developing its U.S. and UK clinic businesses, and for working capital and general corporate purposes.

The securities were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and have not been registered under the Act, or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

Under an agreement with the investors, the Company is required to file an initial registration statement with the Securities and Exchange Commission (“SEC”) covering the resale of the securities to be issued to the investors in the private placement no later than 15 days from the date of the securities purchase agreements and to use best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 90 days after the date of the securities purchase agreements in the event of a “full review” by the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state 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 or jurisdiction.

About Pasithea Therapeutics Corp.

Pasithea Therapeutics Corp. is a U.S. biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders. With an experienced team of experts in the fields of neuroscience and psychopharmacology, Pasithea is developing new molecular entities for the treatment of psychiatric and neurological disorders. Pasithea is also focused on addressing the needs of patients currently suffering with mental illness by providing access to IV ketamine infusions both in clinics and in-home settings.

Forward-Looking Statements

This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this press release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the SEC. Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.

Pasithea Therapeutics Corp. Company Contact

Dr. Tiago Reis Marques
Chief Executive Officer
E: tiago@pasithea.com

Pasithea Therapeutics Corp. Investor Relations

Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Source: Pasithea

Released November 24, 2021

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LOVE Pharma (LUV) To Acquire Microdoz Therapy Inc. To Expedite Study Of Psilocybin Assisted Treatment Of Cannabis Use Disorder

LOVE Pharma (LUV) To Acquire Microdoz Therapy Inc. To Expedite Study Of Psilocybin Assisted Treatment Of Cannabis Use Disorder

LOVE Pharma (LUV) signed a letter of intent to acquire Microdoz Therapy Inc. to accelerate a psilocybin trial for cannabis use disorder. Seems ironic considering that the company also sells THC and CBD oral strips!

 

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Psyched Wellness Appoints Chief Commercial Officer to Lead Sales and Marketing of AME-1 and Launch CPG Products

Psyched Wellness Appoints Chief Commercial Officer to Lead Sales and Marketing of AME-1 and Launch CPG Products

Toronto, Ontario – November 23, 2021 – Psyched Wellness Ltd. (CSE: PSYC) (OTCQB: PSYCF) (FSE: 5U9) (the “Company” or “Psyched“) a life sciences company focused on the production and distribution of artisanal functional and psychedelic mushrooms, is pleased to announce that it has appointed Matthew Singh as Chief Commercial Officer. Mr. Singh will drive the Company’s development into a full-scale packaged goods provider as it prepares to launch its Amanita Muscaria (AME-1)-derived consumer products in 2022.

“I’m thrilled at the opportunity to level-up our executive team and organization as we transition from an R&D-focused start-up to a world-class CPG company,” said Jeffrey Stevens, CEO of the Company. “Matt joining Psyched at this time demonstrates his confidence in the market opportunity of our proprietary extract of the Amanita Muscaria mushroom as a new entrant into the health and wellness category. Matt has already developed a strong sales and branding strategy since he started consulting with Psyched in June and joining us full-time in a leadership role shows the concentration we are putting into bringing our products to market next year.”

Mr. Singh has an extensive track record of success launching brands, products, and corporate strategy within the multibillion-dollar beverage and pharmaceutical industries in Canada and internationally. Accustomed to driving revenue into the hundreds of millions, he was previously the head of VPX Pharmaceuticals’ numerous CPG properties, in Canada and East Asia securing immediate profitability with each Sports Nutrition, Energy Drink, Cannabis, and Alcoholic good VPX added to their portfolio. Prior to VPX, Mr. Singh spent almost a decade at Red Bull Canada, where he ran the company’s Business Development department, and over seven years with Coca Cola. In addition, he is an integral contributor to multiple start-up endeavors as a consultant, board member, and advisor within the health, wellness, and digital intelligence verticals.

Mr. Singh commented, “It was an easy decision to join the team at Psyched full-time. We have developed a truly phenomenal product and look forward to multiple big announcements leading up to a market launch, in 2022. I have been fortunate to work with industry leaders and market disruptors in the extremely competitive beverage and pharmaceutical landscapes throughout my career, and the CPG potential already developed by the team at Psyched has me more excited than anything I have witnessed thus far. We believe this product will have a sustainable commercial and societal impact, starting in North America and then scaling throughout the globe, and I am proud to be a part of the journey with Psyched Wellness. My thanks go to Jeff, David, and the Board for adding me to an already stellar team.”

For further information, please contact:

Jeffrey Stevens
Chief Executive Officer
Psyched Wellness Ltd.
t: 647-400-8494
e: jstevens@psyched-wellness.com
w: http://www.psyched-wellness.com

Investor Contacts:
Tim Regan/Sophia Bashford
KCSA Strategic Communications
t: (978) 505-2478
e: PsychedWellness@kcsa.com

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

About Psyched Wellness Ltd.:

Psyched Wellness Ltd. is a Canadian-based health supplements company dedicated to the distribution of mushroom-derived products and associated consumer packaged goods. The Company’s objective is to create premium mushroom-derived products that have the potential to become a leading North American brand in the emerging functional food category. The Company is in the process of developing a line of Amanita muscaria-derived water-based extracts, teas and capsules designed to help with three health objectives: promote stress relief, relaxation and assist with restful sleeping.

Cautionary Note Regarding Forward-looking Information

This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. Forward-looking information includes, but is not limited to, statements with respect to Mr. Singh’s beliefs that the product will have a sustainable commercial and societal impact in North America and the world, Mr. Singh’s beliefs that Amanita will change the world and have the effects it is expected to have on stress relief, relaxation, and sleeping, and the Company’s operational plans including timelines relating to its application with the FDA for a New Dietary Ingredient (NDI) and Health Canada for a Natural Health Product Number (NHPN) in December 2021, and the completion of the pre-clinical trials, and marketing products in the first half of 2022. Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “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” or “will be taken”, “occur” or “be achieved”. Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance, or achievements of the Company, as the case may be, to be materially different from those expressed or implied by such forward-looking information. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended, including the Company’s ability to receive the necessary raw materials needed to complete the research and market the products which further depends on the Company receiving Amanita muscaria mushrooms of the necessary quality and potency, the Company having the resources to complete the research and prepare and file the applications for the NDI and NHPN, and the Company receiving an NDI and NHPN by December, 2021, and the products having the expected impact on stress relief, relaxation, and sleeping.

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. Accordingly, readers should not place undue reliance on forward-looking information. The Company does not undertake to update any forward-looking information, except in accordance with applicable securities laws.

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Revive Therapeutics Files for FDA Orphan Drug Designation for Bucillamine in the Prevention of Ischemia-Reperfusion Injury During Liver Transplantation

Revive Therapeutics Files for FDA Orphan Drug Designation for Bucillamine in the Prevention of Ischemia-Reperfusion Injury During Liver Transplantation

TORONTO, Nov. 23, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has filed an application with the U.S. Food and Drug Administration (“FDA”) to receive Orphan Drug Designation (“ODD”) for Bucillamine for the prevention of ischemia–reperfusion injury (IRI) during liver transplantation.

Currently, there is no approved treatments available for IRI. Liver ischemia-reperfusion injury is a major complication of liver transplantation and is one of the leading causes for post-surgery hepatic dysfunction leading to an increased risk of post-operative morbidity and mortality. According to the United Network for Organ Sharing (“UNOS”) there were 8,906 liver transplants in 2020 and at the time of the ODD submission there were 11,664 on the waiting list for a liver transplant. Although many therapeutic strategies have been shown to be effective in controlled experimental models, most have yielded equivocal results in clinical practice or have yet to reach human clinical trials.

Revive believes the use of Bucillamine during liver transplantation has the potential to be a safe and effective approach to address the unmet medical need for a novel strategy to limit or prevent IRI. Bucillamine, a cysteine derivative that contains two donatable thiol groups, in the context of IRI is capable of replenishing the thiol group in glutathione, thereby reactivating this endogenous defense against oxidant injury. In addition, Bucillamine appears to have anti-inflammatory effects unrelated to its antioxidant effect. Bucillamine has the potential to address the shortage of quality organs by reducing the susceptibility to IRI of steatotic livers thereby making these livers available for transplants. Bucillamine also has the potential to improve graft function and patient outcome by preventing or lessening IRI.

Michael Frank, CEO of Revive commented: “We are continuing to advance novel uses of Bucillamine not only as a treatment for infectious diseases, but also for rare conditions that have no treatment options such as IRI. The FDA orphan drug application for Bucillamine as a potential solution in preventing IRI during liver transplantation and subsequently to other organ transplants complements our overall strategy of developing Bucillamine as a strong platform for other conditions.”

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 ODD 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. ODD would qualify bucillamine 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 USD $2,400,000.

About Revive Therapeutics Ltd.

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

For more information, please contact:

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

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

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics, and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

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Blackhawk Growth Enters Into Credit Facility For Up To $10 Million

Blackhawk Growth Enters Into Credit Facility For Up To $10 Million

Vancouver, British Columbia – TheNewswire – November 23, 2021 – Blackhawk Growth Corp. (CSE:BLR) (CNSX:BLR.CN) (Frankfurt:0JJ) (the “Corporation” or “Blackhawk”), is pleased to announce that it has entered into a financing agreement (the “Credit Facility”) for up to $10-million. The loan facility was arranged by RiverFort Global Capital Ltd. (a United Kingdom London-based firm regulated by the Financial Conduct Authority) (“RiverFort”) and funded by a regulated institutional investor (the “Investor”). The Corporation intends to utilize the proceeds from the Credit Facility to support the Corporation’s research undertaken in Trip Pharma as well as for operational and working capital purposes of Blackhawk.

Frederick Pels, Chief Executive Officer of Blackhawk, commented: “this new Credit Facility serves as a proactive step towards continuing to strengthen Blackhawk’s balance sheet, improving our long-term financial liquidity and lowering our overall cost of capital. Teaming with RiverFort will allow us to continue growing our investment portfolio while driving returns for our stakeholders with a partner who demonstrates an understanding of the opportunity of lending to venture backed companies.”

Pursuant to the terms of the Credit Facility, Blackhawk has agreed to draw down an initial tranche of $2.5-million, with this debt maturing on November 22, 2023, with interest payable by Blackhawk in an amount equal to 10 per cent per annum on the tranche. Any subsequent advances under the loan, will be subject to interest payable at an equivalent rate, to be applied to the term between the date of the relevant advance date and the maturity date. Drawdowns of each subsequent tranche of the Credit Facility will be subject to the satisfaction of customary closing conditions involving Blackhawk and the Investor, including any required regulatory approvals.

The loan provides for 40-per-cent warrant coverage for each advance or drawdown, determined as being 40 per cent of the principal amount of the tranche divided by the Corporation’s share price at the time of the advance. The exercise price of the warrants will be set at 140 per cent of the Corporation’s share price at the time of the advance and the warrants will expire three years after the date they are granted. In connection with the initial tranche, Blackhawk has issued 1,538,461 warrants to the Investor whereby each warrant will entitle the Investor to purchase one common share of the Corporation at a price of $0.91 per share until November 22, 2024.

As part of the Credit Facility, the Investor will have the option to convert up to 100 per cent of the principal amount of the loan into shares at a fixed conversion price equal to 120 per cent of the market price of the shares at the time of the applicable drawdown. The fixed conversion price for the initial tranche is $0.78 per share. In addition, the Investor may at its option, once every 30 days, request and require that the debt represented by the interest that has been deemed to accrue on the loan be converted into shares at a price equal to 90 per cent of the last closing price of the shares on the day prior to the notice of such conversion.

Gytis Martinkus, chief executive officer of RiverFort, stated:

“The team here at RiverFort has been very impressed with the work being undertaken for Trip Pharma and the operations of LeichtMind Clinics, as well as the professionalism of the Blackhawk group as a whole. The research in the microdosing is market-leading and the team at Blackhawk have demonstrated its advanced applications to us in detail. We look forward to seeing the news regarding the progression of this research and development with its associated clinical trials.”

Blackhawk, the Investor and RiverFort are independent and operate at arm’s length from one another. The loan agreement and any warrants issued to the Investor pursuant to the loan agreement will be issued pursuant to prospectus exemptions set out in National Instrument 45-106 – Prospectus Exemptions and any shares issued upon conversion of the loan or upon exercise of the warrants will, if issued, also be issued pursuant to prospectus exemptions set out in NI 45-106 and will be subject to applicable statutory hold periods under National Instrument 45-102 – Resale of Securities.

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 Corporation 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 Corporation within the meaning of applicable securities laws, including with respect to use of the proceeds from the Credit Facility. The Corporation 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 Corporation ’s public filings under the Corporation’s SEDAR profile at www.sedar.com. Although the Corporation 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 Corporation 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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Cannabis Global Expands into Solventless Cannabis Extracts at Lynwood Facility

Cannabis Global Expands into Solventless Cannabis Extracts at Lynwood Facility

LOS ANGELES, CA / ACCESSWIRE / November 23, 2021 / Cannabis Global, Inc. (OTC PINK:CBGL), an innovation-oriented company investing in disruptive cannabis technologies, today announces an important enhancement to its cannabis product manufacturing capabilities at its Natural Plant Extract of California facility in Lynwood, a suburb of Los Angeles. The facility is now producing solventless cannabis concentrates for use in its own cannabis products, including edibles, beverages and prerolls.

Most of the cannabis extract products on the market are prepared using solvents such as butane, propane, and carbon dioxide to extract the oils and cannabinoids from the plant. These products ultimately have most of the solvents removed, but the taste profile of the original plant material is altered in the overall process. The solvent-less extraction methods used by the Company instead rely 100% on water, ice, heat and pressure to extract the desirable components from the cannabis plant.

“Consumers are increasingly turning to solvent-less products for three reasons: purity, taste and experience,” commented Arman Tabatabaei, CEO of the Company. “We do not have to remove the chemical solvents from these products as none are ever added. It’s just water, heat and pressure. Many consumers prefer the natural taste of solvent-less produced extracts and believe such products offer a superior user experience. We expect continued growth in the marketplace as consumers increasingly gravitate toward these high quality products.”

Solvent-less operations at the Company’s Natural Plant Extract of California facility include both ice water hash production, which uses water and ice to separate the valuable trichomes from the plant materials, and rosin production, which uses heat and pressure to produce an ultra-premium concentrate. The Company plans to utilize these solventless concentrates to enhance cannabis products, such as premium pre-rolls, edibles and beverages, which are in various stages of availability and pre-production.

About Cannabis Global, Inc.
Cannabis Global, Inc. is a Los Angeles-based, fully audited and reporting Company with the U.S. Securities & Exchange Commission, trading under the stock symbol CBGL. We are an emerging force in the cannabis marketplace with a growing product and proprietary intellectual property portfolio. We are marketing and producing Comply Bag™, an innovative solution for cannabis storage, transport and tracking. Our subsidiary, Natural Plant Extract (NPE), is a Southern California licensed cannabis manufacturer and distributor which licenses our technologies to produce edibles for the cannabis marketplace. Cannabis Global has filed three non-provisional and multiple provisional patents for cannabis infusion and nanoparticle technologies and continues an active research & development program.

Forward-Looking Statements
This news release contains “forward-looking statements” which are not purely historical and may include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, the development, costs and results of new business opportunities and words such as “anticipate,” “seek,” intend,” “believe,” “estimate,” “expect,” “project,” “plan,” or similar phrases may be deemed “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new projects, the future U.S. and global economies, the impact of competition, and the Company’s reliance on existing regulations regarding the use and development of cannabis-based products. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission. For more information, please visit www.sec.gov.

CONTACT:
Arman Tabatabaei
IR@CannabisGlobalInc.com
+1 (310) 986-4929

IR Contact:
John Grosso
http://www.iconiconsulting.com/
+1 (424) 239-9521

SOURCE: Cannabis Global, Inc.

View source version on accesswire.com:
https://www.accesswire.com/674248/Cannabis-Global-Expands-into-Solventless-Cannabis-Extracts-at-Lynwood-Facility