Clairvoyant Initiates First Site for Phase 2 Psilocybin Therapy Clinical Trial for Alcohol Use Disorder

Clairvoyant Initiates First Site for Phase 2 Psilocybin Therapy Clinical Trial for Alcohol Use Disorder

VANCOUVER, BC / ACCESSWIRE / July 6, 2022 / Clairvoyant Therapeutics, a Canadian biotech company, is pleased to announce it has initiated the first of 15 planned sites for CLARITY, the company’s Phase 2 clinical trial investigating psilocybin in the treatment of alcohol use disorder (AUD) (formerly called alcoholism).

CLARITY is a randomized, placebo-controlled clinical trial designed to evaluate the safety and efficacy of 25 mg synthetic psilocybin in conjunction with Motivational Enhancement Therapy (MET). CLARITY has been approved in Canada and has been submitted for regulatory approval in the EU countries selected for its Phase 2 clinical trial.

“We are delighted to initiate our Phase 2 clinical trial,” said Damian Kettlewell, co-founder and CEO of Clairvoyant. “At Clairvoyant, it is our hope that the results of this clinical trial will support the company’s novel psychedelic treatment model for addressing the significant unmet medical need for AUD patients.”

The remainder of the 15 sites are each in an advanced stage of negotiation. These sites are located in major centres in Canada and Europe. The large number of sites for a psychedelic trial reflects Clairvoyant’s objective to be the first company globally to register psilocybin as a therapeutic product to treat AUD patients.

About Alcohol Use Disorder

According to the World Health Organization, 283 million people aged 15 years and older are at risk of alcohol use disorder.[i] Globally, mortality from alcohol consumption is higher than from diseases such as tuberculosis, HIV/AIDS and diabetes.[i]

About Psilocybin Therapy and CLARITY

Psilocybin is the pharmaceutical agent in certain mushrooms which is known to induce a temporary psychedelic state. It was first purified in the 1950s. After thousands of recorded administrations, no addiction or abuse potential has been identified for psilocybin. In the CLARITY trial, subjects are accompanied on their psychedelic treatment journey by two highly trained therapists who have been certified under Clairvoyant’s professional and ethical certification program.

About Clairvoyant

Clairvoyant Therapeutics is a Canadian biotechnology company changing the face of psychedelic therapy with a speed-to-market clinical strategy designed to enable psilocybin therapy in the EU, UK & Canada to treat patients living with Alcohol Use Disorder (AUD) beginning in 2026.

The company’s exceptional team, with a proven clinical track record and deep drug development experience, has made Clairvoyant the most advanced company globally developing psilocybin therapy for the treatment of AUD.

Clairvoyant is committed to meeting the highest standards of verified social and environmental performance, public transparency and legal accountability to balance profit and purpose and is a pending B Corporation Certification. Clairvoyant is a member of Life Science BC and Biotechnology Innovation Organization (BIO).

Learn more at www.clairvoyantrx.com and follow the Company on LinkedIn and Twitter.

For more information:

Media requests:
Marlo Taylor
mtaylor@gagecommunications.ca

Corporate contact:
Damian Kettlewell
damian@clairvoyantrx.com

[i] World Health Organization. Global alcohol action plan 2022-2030 to strengthen implementation of the Global Strategy to Reduce the Harmful Use of Alcohol First draft. June 2021

SOURCE: Clairvoyant Therapeutics

BetterLife Secures Additional Mitacs Funding in Collaboration with Carleton University Research Team for BETR-001 Preclinical Depression Studies

BetterLife Secures Additional Mitacs Funding in Collaboration with Carleton University Research Team for BETR-001 Preclinical Depression Studies

VANCOUVER, British Columbia, July 06, 2022 (GLOBE NEWSWIRE) — BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU), an emerging biotech company focused on the development and commercialization of cutting-edge treatments for mental disorders, is pleased to announce that a joint application to the Mitacs Accelerate program, in collaboration with Dr. Argel Aguilar-Valles at Carleton University (Carleton) Department of Neuroscience, was successfully funded for research into the anti-depressant effects and mechanism of action (“MOA”) of BETR-001 in preclinical models of depression.

BETR-001 is a second-generation Lysergic Acid Diethylamide (“LSD”) derivative molecule that BetterLife believes will mimic the therapeutic potential of LSD without causing psychedelic effects, such as hallucinations.

“BETR-001 is a potential novel therapy to treat debilitating psychiatric disorders with high unmet need, such as treatment-resistant severe depression and cluster headaches. BetterLife’s goal is to bring this treatment to Investigational New Drug (“IND”) application and the clinic as soon as possible, and the scientific expertise of Carleton University’s team, headed by Dr. Argel Aguilar-Valles at the Department of Neuroscience, is an ideal partner to help us realize our vision,” said BetterLife’s Chief Executive Officer, Dr. Ahmad Doroudian.

As part of the funded Mitacs Accelerate Program, Dr. Argel Aguilar-Valles (Principal Investigator) and Dr. Vern Lewis (Postdoctoral Fellow) will continue to work with the BetterLife team to assess the efficacy and MOA of BETR-001 in depression models established in their lab.

About BetterLife Pharma

BetterLife Pharma Inc. is an emerging biotechnology company primarily focused on developing and commercializing two compounds, BETR-001 and BETR-002, to treat neuro-psychiatric and neurological disorders.

BETR-001, which is in preclinical and IND-enabling studies, is a non-hallucinogenic and non-controlled LSD derivative in development and it is unique in that it is unregulated and therefore can be self-administered. BetterLife’s synthesis patent for BETR-001 eliminates regulatory hurdles and its pending patent for composition and method of use covers treatment of depression, cluster headaches, post-traumatic stress disorder and other neuro-psychiatric and neurological disorders.

BETR-002, which is in preclinical and IND-enabling studies, is based on honokiol, the active anxiolytic ingredient of magnolia bark. BetterLife’s pending method of use and formulations patent covers treatment of anxiety related disorders including benzodiazepine dependency.

BetterLife also owns a drug candidate for the treatment of viral infections such as COVID-19 and is in the process of seeking strategic alternatives for further development.

For further information, please visit BetterLife Pharma.

About the Department of Neuroscience at Carleton University

Carleton Neuroscience has an international reputation for research on stress and its effects on brain functioning and mental health. The department has an interdisciplinary approach to understanding the emergence, prevention and treatment of mental and physical disorders.

For more information, please visit www.carleton.ca/neuroscience.

About Mitacs

Mitacs is a national, not-for-profit organization that has designed and delivered research and training programs in Canada for 20 years. Working with an extensive network of postsecondary partners, and both federal and provincial governments, we build collaborations that support industrial and social innovation in Canada. Mitacs has worked with thousands of private sector and not-for-profit organizations as well as 78 universities and 77 college, CÉGEP and polytechnic partners to fuel strategic relationships that power Canadian innovation excellence.

To learn more about the organization, please visit https://www.mitacs.ca/en.

Contact Information

David Melles, Investor Relations Manager
Email: David.Melles@blifepharma.com
Phone: 1-778-887-1928

Cautionary Note Regarding Forward-Looking Statements

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.

Doseology Uplists to OTCQB Market in USA

Doseology Uplists to OTCQB Market in USA

Vernon, British Columbia, July 6, 2022 – Doseology Sciences Inc. (CSE: MOOD) (OTCQB: DOSEF) (FSE: VU7) (“Doseology” or the “Company”), a life sciences company focused on mental health and wellness, is pleased to announce the approval of its application for an uplisting to the OTCQB Venture Market (“OTCQB”) in the United States. The Company’s common shares (the “Shares”) will commence trading on the OTCQB today under the symbol “DOSEF”.

“Uplisting is another important milestone towards broadening our market presence across the United States as we engage with our increasingly global investor base,” said Ralph Olson, CEO of the Company. “The OTCQB positions Doseology with increased visibility among the American investment community and improved liquidity for our current and prospective shareholders.”

The Shares will continue trading on the Canadian Securities Exchange under the symbol “MOOD” and on the Frankfurt Stock Exchange under the symbol “VU7”. Investors can find real-time quotes and market information for the Company at: https://www.otcmarkets.com/stock/DOSEF/overview.

On Behalf of the Board of Directors

Ralph Olson
Chief Executive Officer
Doseology Sciences Inc.About OTCQB

The OTCQB, operated by OTC Markets Group Inc., is designed for developing and entrepreneurial companies in the United States and abroad. Companies must be current in their financial reporting and undergo an annual verification and management certification process, including meeting a minimum bid price and other financial conditions. With compliance and quality standards, the OTCQB provides investors improved visibility to enhance trading decisions. The OTCQB is recognized by the United States Securities and Exchange Commission as an established public market providing public information for analysis and valuation of securities.About Doseology Sciences (CSE: MOOD) (OTCQB: DOSEF) (FSE: VU7)

Doseology Sciences Inc. is building a progressive brand focused on mental health and wellness through cultivation, extraction and innovative nutraceutical and pharmaceutical products. Doseology aims to make a meaningful impact on the mental health pandemic by utilizing and developing functional fungi and plant-derived drugs. With a vertically integrated approach, Doseology intends to process and distribute products at its facilities in Vernon, British Columbia, in accordance with applicable laws to ensure safe and high-quality production. Doseology’s medicinal mushroom products, including tinctures, powders and supplements, are available on doseology.com.For further information contact:

Investor Relations: investor@doseology.com
General Inquiries: hello@doseology.com 
Telephone: 236-349-0064
Website: doseology.com

Forward-Looking Statements
This press release contains statements that constitute “forward‐looking information” within the meaning of applicable securities laws. Forward‐looking information is often identified by the words “may,” “would,” “could,” “should,” “will,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “expect” or similar expressions. Readers are cautioned that forward‐looking information is not based on historical facts but instead reflects the Company’s management’s expectations, estimates or projections concerning the business of the Company’s future results or events based on the opinions, assumptions and estimates of management considered reasonable at the date the statements are made. 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. Among the key factors that could cause actual results to differ materially from those projected in the forward‐looking information are the following: changes in general economic, business and political conditions, including changes in the financial markets; decreases in the prevailing prices for products in the markets that the Company operates in; adverse changes in applicable laws or adverse changes in the application or enforcement of current laws; regulations and enforcement priorities of governmental authorities; compliance with government regulation and related costs; and other risks described in the Company’s prospectus. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward‐looking information prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated, or expected. Although the Company has attempted to identify important risks, uncertainties and factors which could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. The Company does not intend, and does not assume any obligation, to update this forward‐looking information except as otherwise required by applicable law. For more information, investors should review the Company’s filings which are available on SEDAR.

No securities regulatory authority has either approved or disapproved of the contents of this press release. The Company’s securities have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, or any state securities laws, and may not be offered or sold in the United States, or to or for the account or benefit of any person in the United States, absent registration, or an applicable exemption from the registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities in the United States, or in any other jurisdiction in which such offer, solicitation or sale would be unlawful.

The CSE does not accept responsibility for the adequacy or accuracy of this release.

Filament Health Announces Sixth Patent Issuance

Filament Health Announces Sixth Patent Issuance

The patent describes the extraction and standardization of stable doses of psychedelic compounds

Vancouver, British Columbia, July 6, 2022  – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical-stage natural psychedelic drug development company, today announced that it has been issued a sixth patent for the extraction and standardization of natural psilocybin and associated psychedelic compounds. Filament’s latest patent was issued by the Canadian Intellectual Property Office (CIPO) and describes essential technology for transforming variable psychedelic raw materials into pharmaceutical-grade, standardized drug candidates.

“The continued growth of our patent portfolio validates Filament’s strong intellectual property strategy and drug development platform,” said Ryan Moss, Chief Science Officer at Filament Health. “Our ability to transform valuable natural substances into IP-protected pharmaceutical-grade drug candidates sets us apart as industry leaders.”

Filament has developed innovative technology to extract and standardize stable doses of natural compounds from magic mushrooms. On August 3, 2021, Filament was issued the first-ever patent for the extraction and standardization of natural psilocybin. In under a year, the Company has been issued a total of four patents by CIPO and two by the United States Patent and Trademark Office.

“Since Filament’s founding, we have endeavoured to identify the most efficient means to extract naturally sourced fungal APIs,” said Taran Grey, Director of Intellectual Property. “We are proud to add yet another functional patent to our portfolio that describes more of the ways we produce novel drug candidates each and every day.”

ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on TwitterInstagram and LinkedIn

FILAMENT HEALTH

Anna Cordon, Director of Communications
778.245.9067
anna@filament.health

INVESTOR RELATIONS

ir@filament.health

FORWARD LOOKING STATEMENTS

Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. The forward-looking statements discussed in this press release may include, but are not limited to, information concerning the impact of the patent on the Company’s business and the ability of the Company to secure future patents. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including status of patent applications and the ability to secure patents. There can be no assurance that such statements 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 statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.306

IntelGenx Announces Completion of Share Issuance in Payment of Principal and Interest on Debentures

IntelGenx Announces Completion of Share Issuance in Payment of Principal and Interest on Debentures

SAINT LAURENT, Quebec, July 05, 2022 (GLOBE NEWSWIRE) — IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) announces that, as previously disclosed on June 1, 2022 and in accordance with the terms of the trust indenture governing the Debentures (as defined below), as supplemented, it has issued (i) 19,381,223 shares of common stock of the Company (“Shares”) at a deemed price of C$0.2812 in payment of the outstanding C$5,450,000 aggregate principal amount of the Company’s convertible unsecured subordinated debentures due June 30, 2022 (the “Debentures”) and (ii) 573,684 Shares at a deemed price of C$0.38 per Share in payment of an aggregate of C$218,000 interest due on the Debentures as of June 30, 2022.

The Convertible Debentures, listed on the Toronto Stock Exchange under the symbol IGX.DB, have been delisted from trading as of the close of business on June 30, 2022.

About IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm™ and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.

IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.

Source: IntelGenx Technologies Corp.

For more information, please contact:

Stephen Kilmer
Investor Relations
(647) 872-4849
stephen@kilmerlucas.com

Or

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com

Algernon Pharmaceuticals Discloses Novel DMT Salt Patent Strategy Includes Bioactive Nicotinate and Pamoate

Algernon Pharmaceuticals Discloses Novel DMT Salt Patent Strategy Includes Bioactive Nicotinate and Pamoate

VANCOUVER, British Columbia, July 05, 2022 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF) a clinical stage pharmaceutical development company is pleased to disclose that as part of its intellectual property patent applications filed in early 2021 for AP-188 (“N,N-dimethyltryptamine” or “DMT”), the Company included nicotinate and pamoate as novel salt forms of DMT. Nicotinate and pamoate are commonly used counterions when producing salts.

A novel salt form of a drug is a new and separate structure from the original compound and is considered a new composition of matter, anchoring the Company’s novel patent filings. Many drug compounds’ core structures can be paired with another compound to form a salt. Different salts can improve the core drug in several ways, including improved efficacy, safety/tolerability, and stability.

The Company also announces that in its own binding study of nicotinate and pamoate, the salts showed, when compared to fumarate, the most studied form of DMT, that they had similar binding to the 5-HT2A and sigma-1 receptors; key receptors in the brain that are activated by DMT.

In addition to improved physicochemical properties, nicotinate and pamoate are not inert, but in fact have shown neuronal activity independent of DMT and may assist with the efficacy of DMT as a potential treatment for stroke.

In a mouse model of ischemic stroke, pamoate (in the form of pamoic acid) alone displayed neuroprotective effects including reduced infarct volume, oxidative stress and iron deposition, as well as improved motor function compared to vehicle controls. Benefits were seen even when treatment was delayed by one hour.1 STUDY 1

Nicotinate (in the form of nicotinic acid or niacin) is a form of vitamin B3 and is an essential nutrient. In a rat stroke model, nicotinic acid alone significantly increased markers of neuroplasticity, and complementary in vitro studies showed an increase in BDNF/Trk-B expression.2 STUDY 2

Furthermore, in another rat stoke study, niacin alone was able to improve functional recovery even when treatment is started 24 hours after the occurrence of the occlusion and there is no significant difference in lesion volume.3 STUDY 3

The Company believes that it has maximized its intellectual property position around DMT, which includes filing patent applications for new novel bioactive salt forms, as outlined herein, as well as dosing, formulation, and method of use patent applications for stroke rehabilitation.

“Shortly after filing our PCT application, we received a Written Opinion from the International Searching Authority that DMT nicotinate and DMT pamoate are novel and non-obvious, and appear to be patentable,” said Christopher J. Moreau, CEO of Algernon. “Since DMT on its own is naturally occurring and is therefore unpatentable as a new chemical entity, Algernon’s strategy is to ensure that along with trying to achieve good clinical data, the Company has a correspondingly strong intellectual property position that is unique and protectable.”

About DMT

N,N-Dimethyltryptamine, or DMT, is a hallucinogenic tryptamine drug producing effects similar to those of other psychedelics like LSD, ketamine, psilocybin and psilocin. DMT occurs naturally in many plant species and animals and has been used in religious ceremonies as a traditional spiritual medicine by indigenous people in the Amazonian basin. DMT can also be synthesised in a laboratory.

Several preclinical studies have demonstrated that DMT helps mitigate tissue damage and promote neurogenesis as well as structural and functional neural plasticity, with significance. These are key factors involved in the brain’s ability to form and reorganize synaptic connections, which are needed for healing following a brain injury.

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.

1. Sharmin O, Haque Abir A, Potol A, Alam M, Banik J, Towheedur Rahman AFM, Tarannum N, Wadud R, Farhad Habib Z, Rahman M. Scientific Reports 10, 9400 (2020).

2. Cui, X, Chopp M, Zacharek A, Roberts C, Buller B, Ion M, Chen J. Stroke 41(9), 2044 (2010).

3. Chen J, Cui X, Zacharek A, Jiang H, Roberts C, Zhang C, Lu M, Kapke A, Feldkamp CS, Chopp M. Annals of Neurology 62(1), 49 (2007).

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.

Awakn Receives UK State Funding to Identify Optimal Pathway to Market In UK & US For Its Lead Clinical Development Program – Ketamine-Assisted Therapy For Alcohol Use Disorder

Awakn Receives UK State Funding to Identify Optimal Pathway to Market In UK & US For Its Lead Clinical Development Program – Ketamine-Assisted Therapy For Alcohol Use Disorder

Awakn Provides Business Update on Progressing its Lead Program from Phase II b to Phase III

TORONTO, CANADA, July 05, 2022 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954), a revenue-generating biotechnology company researching, developing and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), is pleased to announce it has secured funding from Innovate UK to identify the quickest and most cost-effective route to market in both the UK and the US for Awakn’s lead program – proprietary ketamine-assisted therapy for treating AUD. Innovate UK is the UK’s national innovation agency which provided the funding in an initiative delivered jointly by CPI and ABHI.

Awakn’s activities will be delivered in collaboration with Veristat, a global Clinical Research Organization (CRO) that specialises in accelerating client therapies through the clinical development process into regulatory approval and commercialization. Veristat supported marketing applications for 12% of all US Food and Drug Administration (FDA) Novel Drug Approvals in 2021.  

Awakn’s Chief Scientific Officer, Shaun McNulty commented: “Our Phase II a/b ‘KARE’ study, led by Professor Celia Morgan, showed that ketamine-assisted therapy has the potential to revolutionize the treatment of AUD.  This funding enables Awakn, working closely with Veristat, to bring a much-needed effective treatment approach to the market as soon as possible.  Delivering this innovative therapeutic approach as rapidly as possible to patients in the UK and the US is critical to address this major unmet medical need.”

Anthony Tennyson Awakn’s CEO added: “Securing these funds from Innovate UK is a major endorsement of our efforts and approach to developing new and effective treatments for addictions.  Our Lead program has all the right components to make a lasting difference for the very significant number of people who are suffering from AUD.   We are also delighted to be working with a partner of the calibre of Veristat and to have the ability to benefit from their significant expertise. The addiction treatment market opportunity is, unfortunately, large and growing, and Awakn is uniquely positioned to offer proven therapeutics supported by data to sufferers for whom the current standard of care is inadequate and relapse rates are unacceptably high.

Project Kestrel

Awakn is also providing a business update on its lead program. Awakn has renamed its lead program to Project Kestrel. Project Kestrel will aim to deliver marketing authorization/regulatory approval for ketamine-assisted therapy to treat AUD in both the UK and the US with clear Intellectual Property (IP) surrounding the treatment.  Project Kestrel builds on Awakn’s successful Phase II a/b ‘KARE’ clinical trial and efficacy data released in January 2022, which demonstrated safety and efficacy as a new treatment option for AUD patients.

Awakn has started planning and intends to initiate a Phase III trial in the UK in 2022 as a prelude to initiating a further Phase III trial in the US thereafter.  Both are designed to provide the key data necessary to bring Project Kestrel to the market as soon as possible.  Awakn has also applied for a grant to the National Institute for Health and Care Research (NIHR) in the UK to cover two-thirds of the cost of the planned UK Phase III trial and a decision on this application is anticipated shortly.

The outputs from Project Kestrel will benefit all of Awakn’s Research and Development project portfolio by defining a clear regulatory pathway for drug-assisted therapies to treat not only AUD but also a broad range of other behavioral addictions which Awakn is developing therapies for.

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a revenue-generating biotechnology company researching, developing, and commercialising therapeutics to treat substance and behavioral addictions.  Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 400m people globally for which the current standard of care is inadequate. Our goal is to provide effective therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels. 

www.awaknlifesciences.com  |  Twitter  |  LinkedIn  |  Facebook

About Project Kestrel

Project Kestrel is the lead clinical development program of Awakn Life Sciences.  Project Kestrel is supported by Awakn’s Phase II a/b ‘KARE’ clinical trial which examined ketamine-assisted therapy for the treatment of Alcohol Use Disorder (AUD).  The trial resulted in patients experiencing on average 86% abstinence at 6 months post treatment versus 2% before the trial which means that study participants went from being sober on average 7 days a year to being sober on average 314 days a year.  Awakn is planning to initiate a Phase III trial in the UK in 2022 and plans to seek regulatory approval in the UK and the US in due course.

About Veristat

Veristat, a scientific-minded global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 27 years of experience in clinical trial planning and execution, Veristat is equipped to support any development program. The company has prepared nearly 100 marketing applications for approval with global regulatory authorities in the last 10 years. 

https://www.veristat.com        Twitter             LinkedIn          Facebook

Notice Regarding Forward-Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, ”would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to:COVID-19; fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. 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, other than as required by law.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Investor Enquiries:
Anthony Tennyson, CEO, Awakn Life Sciences
anthony.tennyson@awaknlifesciences.com

Media Enquiries:
America and Canada: KCSA Strategic Communications 
Anne Donohoe
Adonohoe@KCSA.com

Rest of World: ROAD Communications
Paul Jarman / Nora Popova
Awakn@roadcommunications.co.uk

PharmAla Biotech appoints Kevin Roy to its Board of Directors

PharmAla Biotech appoints Kevin Roy to its Board of Directors

Mr. Roy will bring exceptional financial expertise to PharmAla’s Board and improve the company’s corporate governance

VANCOUVER, BC, July 4, 2022 /CNW/ – PharmAla Biotech Holdings Inc. (CNSX: MDMA) is pleased to announce that it has appointed Mr. Kevin Roy to its board of directors. An exceptionally qualified former CFO, Mr. Roy will lend his financial expertise to the company.

“I’m so pleased to welcome Kevin to the PharmAla Board. He brings exactly the kind of experience we need to our team,” said Jodi Butts, PharmAla’s Board Chair. “His strong accountancy and fiduciary experience will increase the company’s corporate governance and allow us to continue growing the business of supporting clinical trial practitioners globally.”

Mr. Roy is a former executive team member at FirstService Corporation (FSV: TSX, NASDAQ), having served as CFO of FirstService Brands division, and is a Chartered Professional Accountant. He lives in Toronto with his family. Mr. Roy will serve as chair of the Company’s Audit Committee.

“I’m excited to join PharmAla’s board and contribute to the company’s growth,” said Kevin Roy. “The company’s development over the past year has been impressive, and I am fully committed to the company’s mission of developing MDMA as a treatment for a number of mental health conditions.”

PharmAla Biotech also announces, with gratitude and regret, the resignation of former Director Solomon Elimimian.
For more information, please visit www.PharmAla.ca, where you can sign up to receive regular news updates.

ABOUT PHARMALA

PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.

Lexston closes previously announced Non-Brokered Unit Private Placement

Lexston closes previously announced Non-Brokered Unit Private Placement

Vancouver, British Columbia TheNewswire –  July 4, 2022. Lexston Life Sciences Corp. (the “Company”) (CSE:LEXT) (OTC:LEXTF) announces that further to its news releases dated June 1, 2022 and June 27, 2022, the Company has issued 18,562,440 units (“Units”) at a purchase price of $0.05 per Unit for gross proceeds of $928,122 (the “Private Placement”).  Each Unit consists of one common share in the capital of the Company (“Share”) and one share purchase warrant (“Warrant”).  Each full Warrant entitles the holder to purchase one Share for a period of five years, at a purchase price of $0.075 per Share.  

The Company has paid $4,480 cash to Haywood Securities Inc and $15,400 to Raymond James Ltd. and issued 89,600 broker’s warrants to Haywood Securities Inc. and 308,000 broker’s warrants to Raymond James Ltd. as finders’ fees.  The finders’ warrants are subject to the same terms and conditions as the Warrants issued pursuant to the Private Placement.

All securities issued pursuant to the Private Placement are subject to a statutory hold period of four months plus a day from the date of issuance in accordance with applicable securities legislation.

The net proceeds from the Private Placement will be used by the Company for general working capital.

On Behalf of the Board of Directors

LEXSTON LIFE SCIENCES CORP.

Jagdip Bal Chief Executive Officer

Telephone: (604) 928-8913

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Algernon Pharmaceuticals Announces Closing of Public Offering of Units

Algernon Pharmaceuticals Announces Closing of Public Offering of Units

July 04, 2022 11:14 ET | Source: Algernon Pharmaceuticals

VANCOUVER, British Columbia, July 04, 2022 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF) is pleased to announce the closing of its previously announced marketed public offering of units of the Company (the “Units” or the “Offered Securities”) with Research Capital Corporation as the sole agent and sole bookrunner (the “Agent”). Pursuant to the offering, the Company issued 309,117 Units at a price of $3.75 per Unit for gross proceeds of $1,159,188.75 (the “Offering”).

Each Unit consists of one Class A common share of the Company (a “Common Share“) and one Common Share purchase warrant of the Company (a “Warrant“).

Each Warrant entitles the holder thereof, subject to adjustment in certain circumstances, to purchase one Common Share (a “Warrant Share”) at an exercise price equal to $4.70 per Warrant Share (the “Warrant Exercise Price”) for a period of 5 years following the date of issuance (the “Expiry Date”), subject to acceleration of the Expiry Date as described below.

In the event of a down-round financing during the period of 5 years following closing of the Offering (a “Dilutive Issuance”), the Warrants contain an anti-dilution protection feature, to adjust the Warrant Exercise Price and increase the number of Warrant Shares issuable thereunder if Common Shares are sold or issued for a consideration per share less than the Warrant Exercise Price (subject to certain exemptions), provided, that the exercise price will not be less than $1.875 (the “Floor Price”).

Provided that if, at any time prior to the expiry date of the Warrants, the volume weighted average trading price of the Common Shares on the CSE, or other principal exchange on which the Common Shares are listed, is greater than $14.10 for 20 consecutive trading days, the Company may, within 10 business days of the occurrence of such event, deliver a notice to the holders of Warrants accelerating the Expiry Date of the Warrants to the date that is not less than 30 days following the date of such notice and the issuance of a press release by the Company announcing the acceleration notice (the “Accelerated Exercise Period”). Any unexercised Warrants shall automatically expire at the end of the Accelerated Exercise Period.

The net proceeds from the Offering of the Units will be used to fund research and development programs, general and administrative expenses and for working capital purposes.

The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), and such securities may not be offered or sold within the United States or to, or for the account or benefit of, “U.S. persons” (as defined in Regulation S under the U.S. Securities Act) absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

About Algernon Pharmaceuticals Inc.

Algernon is a drug re-purposing company that investigates safe, already approved drugs 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.

Algernon has filed intellectual property rights globally for Ifenprodil for the treatment of respiratory diseases.

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.

The Canadian Securities Exchange has not in any way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this press release.

Forward-looking statements
This news release contains certain statements which constitute forward-looking statements or information under applicable Canadian securities laws, including statements relating to the expected use of proceeds from the Offering. Such forward-looking statements are subject to numerous known and unknown risks, uncertainties and other factors, some of which are beyond the Company’s control, which could cause actual results or events to differ materially from those stated, anticipated or implied in the forward-looking statements. Although the Company believes that the forward-looking statements in this news release are reasonable, they are based on factors and assumptions, based on currently available information, concerning future events, which may prove to be inaccurate. As such, readers are cautioned not to place undue reliance on the forward-looking statements, as no assurance can be provided as to future plans, operations, results, levels of activity or achievements. The forward-looking statements contained in this news release are made as of the date of this news release and, except as required by applicable law, the Company does not undertake any obligation to publicly update or to revise any of the forward-looking statements, whether as a result of new information, future events or otherwise.