Core One Labs Archives - Page 3 of 35

January 26, 2022March 9, 2022

PharmaDrug Announces Initiation of Manufacturing of Cepharanthine (PD-001) For Clinical Programs in Rare Cancers And COVID-19

Establishing cGMP supply for IND-enabling and up to Phase 2 clinical studies for PD-001 oral formulation for esophageal cancer and mild to moderate COVID-19

Toronto, Ontario – January 26, 2022 – PharmaDrug Inc. (CSE: PHRX) (OTCQB: LMLLF) (“PharmaDrug” or the “Company“), a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs, is pleased to announce that the Company has initiated the manufacturing of PD-001, a patented enteric-coated oral formulation of cepharanthine, for non-clinical and clinical studies in cancer and infectious diseases. This follows the Company’s recent announcements of the successful completion of its pre-IND meeting with the U.S. Food and Drug Administration (the “FDA“) regarding the proposed development of PD-001 for the treatment of mild to moderate COVID-19 and positive preclinical study results with PD-001 for esophageal cancer and other undisclosed cancers. The current scale of manufacturing activities should fully support development of PD-001 through IND-enabling studies and potential future FDA Phase 1 and 2a clinical studies.

Consistent with FDA requirements, a core battery of drug development activities need to be completed prior to initiation of human testing regardless of the disease indication under development. As such, parallel development of PD-001 for oncology and infectious disease indications will provide valuable time and cost efficiencies to the Company by way of eliminating the need to duplicate multiple standard activities. One such place relates to drug manufacturing control and the need to reproducibly generate a sufficient quantity and quality of drug material to support all non-clinical and clinical testing. To that end, PharmaDrug has purchased a significant quantity of bulk cepharanthine material and has engaged Southwest Research Institute (SwRI) to initiate cGMP manufacturing activities in Q1, 2022. SwRI has a previous track record for producing the Company’s drug substance and drug product according to required specifications. Following receipt of feedback from the FDA in November 2021 on its pre-IND application to treat COVID-19, the Company is confident of its ability to simultaneously execute on both its PD-001 programs (COVID-19 and esophageal cancer) and that the drug product manufactured using existing methodology will yield material that complies with the rigorous standards set forth by the regulator.

Daniel Cohen, CEO and Chairman of PharmaDrug commented, “We are extremely excited to be moving forward with the manufacturing of a cGMP lot of PD-001. We believe cepharanthine has tremendous potential to treat several indications. Following the completion of a successful pre-IND meeting with the FDA and ongoing studies in both rare cancers and COVID-19, we are confident we have a clear path to the clinic on a number of fronts.”

About PD-001 (Enteric-coated Oral Cepharanthine)

Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to successfully treat a variety of acute and chronic diseases. In clinical research, Cepharanthine has been shown to exhibit multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic effects^1,2. However, historically cepharanthine’s low oral bioavailability has represented a major obstacle to realizing its full clinical potential.

The Company is focused on advancing the clinical development of an improved and patented enteric-coated oral formulation of cepharanthine (PD-001) to treat rare cancers and COVID-19. Compared to generic cepharanthine, PD-001 has been shown in rodent and non-rodent models to possess markedly superior bioavailability (more easily absorbed). These findings support the development of an orally administered formulation, and in so doing, removes the undesirable requirement for frequent intravenous dosing.

PD-001 for Cancer

PharmaDrug’s cancer program is based on cepharanthine’s known anti-cancer activities. Cepharanthine has been shown in multiple preclinical efficacy models to inhibit cancer cell proliferation, induce cancer cell apoptosis (death) and restore cancer cell sensitivity to multiple unrelated classes of chemotherapy. Multidrug resistance continues to represent a considerable clinical challenge. As such, preclinical cancer studies aimed at elucidating the mechanisms that underly chemoresistance; including the critical role drug efflux pumps play in this phenomenon by reducing the intracellular concentration of chemotherapeutic drugs, are of particular interest to PharmaDrug. Cepharanthine has been shown in preclinical studies to potently reverse chemoresistance by downregulating expression of ABCB1, the transcript of which codes for multidrug resistance protein 1, (MDR1, aka P- glycoprotein). Importantly, several prior in vitro and in vivo studies have shown that cepharanthine-mediated reductions in ABCB1 expression restores cancer cell sensitivity to a range of chemotherapeutics including taxanes, vinca alkaloids and platinum-based drugs^3-6. Collectively the two studies already completed by the Company, and those currently underway aim to identify and provide focus to novel opportunities in oncology by revealing optimal cancer cell types as a monotherapy and/or drug combinations and situations where PD-001 can prevent, lessen, or reverse chemoresistance, and provide additive or synergistic benefit to existing standard of care treatments (for reference please see previous press releases Nov 18, Oct 15 and July 28, 2021). The Company’s ongoing animal efficacy studies are designed to experimentally examine the role of cepharanthine in restoring chemosensitivity. Based on compelling preclinical data in esophageal cancer and a streamlined path to approval which comes by way of a recently granted FDA Orphan Drug Designation, the Company continues its plans to pursue cepharanthine for this indication.

PD-001 for COVID-19

The global significance of coronavirus infection has been rising following the emergence and identification of the virus that causes severe acute respiratory syndrome (SARS) was first documented in Guandong, China in 2002. Since then, a related virus causing middle east respiratory syndrome (MERS) in 2012 and currently SARS-CoV-2, first identified in 2019, have revealed obvious vulnerabilities related to containing and treating novel coronavirus outbreaks. To date, several third party validated library screens of approved and investigational drugs have identified cepharanthine as a forerunner candidate molecule in the treatment SARS-CoV-2, the virus that causes COVID-19^7-9. In fact, cepharanthine has now been shown to be highly effective at blocking cell death following exposure to multiple different coronaviruses, including COVID-19, lab-attenuated SARS-CoV (original SARS) and the virus that causes Middle East respiratory syndrome (MERS)^7-9. In November 2021 an independent research group examined the potential of cepharanthine to limit the cytopathic effects of the South African COVID-19 variant, B.1.3514. It was found that cepharanthine was at least 6-times more active against the South African variant strain than original SARS-CoV-2, and that cepharanthine was the most effective of all the drugs used in the in vitro screen that was perfomed¹⁰. Although the recent Omicron variant discovered in South African nations shares several features in common with the previous South African variant, B.1.351, it remains to be determined how well cepharanthine will perform at treating this ongoing threat. Despite the promising findings for cepharanthine noted above, translation into clinical application has thus far been hampered by the need for the generic formulation of the drug to be delivered by intravenous due to its intrinsically poor oral bioavailability. As such, it is believed that the Company’s novel oral formulation of cepharanthine, PD-001 would be an ideal candidate to evaluate as a potential treatment for mild to moderate COVID-19. By leveraging its exclusive rights to U.S. Patent: 10,576,077, titled “Pharmaceutical Salt forms of Cepharanthine and Tetrandrine”, PharmaDrug intends to develop and commercialize PD-001 as an oral antiviral treatment for patients with mild to moderate SARS-CoV-2 infection and variants thereof.

How Cepharanthine May Work to Block Coronavirus Entry

In a recent peer reviewed manuscript cepharanthine was shown to display greater antiviral potency against SARS-CoV-2 than existing clinical development candidates remdesivir, lopinavir, favipiravir, nelfinavir and chloroquine⁷. Researchers identified a putative binding site on the surface of SARS-CoV-2 spike protein known to facilitate viral docking with the human ACE2 receptor. Consistent with this mechanism of action, application of cepharanthine to cells exposed to SARS-CoV-2 fully blocked viral internalization and subsequent production of viral particles 24 hours post infection⁷.

Ongoing Need for a Deep Arsenal of Oral Antiviral Medications

The magnitude of the current pandemic has brought into sharp focus how susceptible the world remains to known and novel coronaviruses and has underlined the extreme and urgent need for additional research aimed at pre-emptively developing broad classes of oral antiviral agents that can be stockpiled for rapid distribution. With increasing population density, shifts in agricultural practice, international trade and expanded travel all contributing to elevated health and financial burden related to infectious disease, continued focus on development of oral antivirals to treat existing and emerging viral strains is expected to remain a worldwide priority for the foreseeable future.

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus) at this time.

About PharmaDrug Inc.
PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs. PharmaDrug owns 100% of Pharmadrug Production GmbH (“Pharmadrug Production”), a German medical cannabis distributor, with a Schedule I European Union narcotics license and German EuGMP certification allowing for the importation and distribution of medical cannabis to pharmacies in Germany and throughout the European Union. PharmaDrug owns 100% Sairiyo Therapeutics (“Sairiyo”), a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through clinical trials and the associated regulatory approval process in the US and Europe. Sairiyo is currently developing its patented reformulation of cepharanthine, a drug that has shown substantial third party validated potential for the treatment of COVID-19 and rare cancers. Sairiyo is also conducting R&D in the psychedelics space for the treatment of non-neuropsychiatric conditions. The Company also owns 100% of Super Smart, a company building a vertically integrated retail business with the goal to elevate the use of functional mushrooms, and psilocybin mushrooms where federally legal, as natural based medicines.

For further information, please contact:

Daniel Cohen, Chairman and CEO
dcohen@pharmadrug.co
(647) 202-1824

Caution Regarding Forward-Looking Information:

THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

This press release contains “forward-looking information” within the meaning of applicable securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. Generally, forward-looking information may be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “proposed”, “is expected”, “budgets”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. In particular, this press release contains forward-looking information in relation to: the development and commercialization of cepharanthine, the results of the Company’s research and development in the psychedelics space and the development of the Supersmart business . This forward-looking information reflects the Company’s current beliefs and is based on information currently available to the Company and on assumptions the Company believes are reasonable. These assumptions include, but are not limited to the ability of the Company to successfully execute on its plans for the Company and its affiliated entities; the ability to obtain required regulatory approvals and the Company’s continued response and ability to navigate the COVID-19 pandemic being consistent with, or better than, its ability and response to date.

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 to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; the actual results of the Company’s future operations; competition; changes in legislation affecting the Company; the ability to obtain and maintain required permits and approvals, the timing and availability of external financing on acceptable terms; lack of qualified, skilled labour or loss of key individuals; risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures, service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, economic activity, financing, supply chains and sales channels, and a deterioration of general economic conditions; and a deterioration of financial markets that could limit the Company’s ability to obtain external financing.

A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in the Company’s disclosure documents on the SEDAR website at www.sedar.com. 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. Accordingly, readers should not place undue reliance on forward-looking information. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. 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.

The Company’s securities have not been registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or “U.S. Persons”, as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. 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 the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful.

Forward-looking information contained in this press release is expressly qualified by this cautionary statement. The forward-looking information contained in this press release represents the expectations of the Company as of the date of this press release and, accordingly, are subject to change after such date. However, the Company expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.

References:

Bailly C. Cepharanthine: An update of its mode of action, pharmacological properties and medical applications. Phytomedicine. 2019 Sep;62:152956. doi: 10.1016/j.phymed.2019.152956. Epub 2019 May 10. PMID: 31132753; PMCID: PMC7126782.
Rogosnitzky M, Danks R. Therapeutic potential of the biscoclaurine alkaloid, cepharanthine, for a range of clinical conditions. Pharmacol Rep. 2011;63(2):337-47. doi: 10.1016/s1734-1140(11)70500-x. PMID: 21602589.
Saito T, Hikita M, Kohno K, Tanimura H, Miyahara M, Kobayashi M. Enhanced expression of the multidrug resistance gene in vindesine-resistant human esophageal cancer cells. Oncology. 1994 Sep-Oct;51(5):440-5. doi: 10.1159/000227380. PMID: 8052486.
Zhou P, Zhang R, Wang Y, Xu D, Zhang L, Qin J, Su G, Feng Y, Chen H, You S, Rui W, Liu H, Chen S, Chen H, Wang Y. Cepharanthine hydrochloride reverses the mdr1 (P-glycoprotein)-mediated esophageal squamous cell carcinoma cell cisplatin resistance through JNK and p53 signals. Oncotarget. 2017 Nov 27;8(67):111144-111160. doi: 10.18632/oncotarget.22676. Erratum in: Oncotarget. 2021 Jan 05;12(1):61-62. PMID: 29340044; PMCID: PMC5762312.
Huang CZ, Wang YF, Zhang Y, Peng YM, Liu YX, Ma F, Jiang JH, Wang QD. Cepharanthine hydrochloride reverses P glycoprotein-mediated multidrug resistance in human ovarian carcinoma A2780/Taxol cells by inhibiting the PI3K/Akt signaling pathway. Oncol Rep. 2017 Oct;38(4):2558-2564. doi: 10.3892/or.2017.5879. Epub 2017 Aug 4. PMID: 28791369.
Zahedi P, De Souza R, Huynh L, Piquette-Miller M, Allen C. Combination drug delivery strategy for the treatment of multidrug resistant ovarian cancer. Mol Pharm. 2011 Feb 7;8(1):260-9. doi: 10.1021/mp100323z. Epub 2010 Dec 17. PMID: 21166459.
Ohashi H, Watashi K, Saso W, Shionoya K, Iwanami S, Hirokawa T, Shirai T, Kanaya S, Ito Y, Kim KS, Nomura T, Suzuki T, Nishioka K, Ando S, Ejima K, Koizumi Y, Tanaka T, Aoki S, Kuramochi K, Suzuki T, Hashiguchi T, Maenaka K, Matano T, Muramatsu M, Saijo M, Aihara K, Iwami S, Takeda M, McKeating JA, Wakita T. Potential anti-COVID-19 agents, cepharanthine and nelfinavir, and their usage for combination treatment. iScience. 2021 Apr 23;24(4):102367. doi: 10.1016/j.isci.2021.102367. Epub 2021 Mar 26. PMID: 33817567; PMCID: PMC7997640.
Chen CZ, Xu M, Pradhan M, Gorshkov K, Petersen JD, Straus MR, Zhu W, Shinn P, Guo H, Shen M, Klumpp-Thomas C, Michael SG, Zimmerberg J, Zheng W, Whittaker GR. Identifying SARS-CoV-2 Entry Inhibitors through Drug Repurposing Screens of SARS-S and MERS-S Pseudotyped Particles. ACS Pharmacol Transl Sci. 2020 Oct 19;3(6):1165-1175. doi: 10.1021/acsptsci.0c00112. PMID: 33330839; PMCID: PMC7586456.
Fan HH, Wang LQ, Liu WL, An XP, Liu ZD, He XQ, Song LH, Tong YG. Repurposing of clinically approved drugs for treatment of coronavirus disease 2019 in a 2019-novel coronavirus-related coronavirus model. Chin Med J (Engl). 2020 May 5;133(9):1051-1056. doi: 10.1097/CM9.0000000000000797. PMID: 32149769; PMCID: PMC7147283.
Zhang S, Huang W, Ren L, Ju X, Gong M, Rao J, Sun L, Li P, Ding Q, Wang J, Zhang QC. Comparison of viral RNA-host protein interactomes across pathogenic RNA viruses informs rapid antiviral drug discovery for SARS-CoV-2. Cell Res. 2021 Nov 4:1-15. doi: 10.1038/s41422-021-00581-y. Epub ahead of print. PMID: 34737357; PMCID: PMC8566969.

Core One Labs Announces Successful Proof of Concept and Files Patent for Protection of its Recombinant Production System for Optimized Biosynthesis of Psilocybin

Vancouver, British Columbia, Canada – January 21, 2022 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (“Core One” or the “Company”) is pleased to announce that its wholly owned subsidiary, Vocan Biotechnologies Inc. of Victoria, British Columbia, has optimized its recombinant production system (the “System”), successfully testing its proof of concept for the biosynthesis of psilocybin suitable for use in future scale-up and has filed a patent application with the United States Patent and Trademark Office (“USPTO”) titled “Production of Psychedelic Compounds” for protection of its novel psilocybin production system. Psilocybin is a psychedelic compound that is showing enormous promise in treating addiction and depression.

The Company’s team of scientists at Vocan have constructed optimized DNA sequences that can produce enzymes replicating the biosynthetic pathway used by Psilocybe mushrooms. This allows bacteria to become factories for psilocybin production. Under the leadership of Dr. Jan Burian, Chief Scientist, and Dr. Robert EW Hancock, Vocan CEO, Vocan scientists have used DNA modeling to improve and optimize design and produce unique DNA sequences that improve the efficiency and expression of these enzymes, allowing for rapid and cost-effective psilocybin production.
Currently, most companies use chemically synthesized psilocybin as the only available cGMP compliant product that is available in large volumes. The chemical process carries significant costs and is less efficient when compared to a biologically derived psilocybin. Vocan’s biosynthetic process retains the stereochemistry of the natural psilocybin molecules found in hallucinogenic mushrooms, which are known to have a more positive effect than the chemically synthetized counterpart. However, these tiny mushrooms are not an efficient source of psilocybin since the amount produced is quite small and variable.
Vocan’s successful production system engineers bacteria incorporating optimized biosynthetic genes from the Psilocybe mushroom and other species and enables the bacteria to act as a biological factory and synthesize psilocybin.

Additionally, the Company’s team of scientists hypothesise that by using a gene mimicry process and simple chemical modifications to enable the creation of bioidentical compounds, there is potential to produce other known and novel analogs of psilocybin and related psychedelics. The analog compounds may potentially be more effective, targeted, and safer than the natural compounds.

The patent application entitled “Production of Psychedelic Compounds” includes claims that Vocan’s technology will enable the production of cGMP API grade psilocybin, which can be used by pharmaceutical companies, API manufacturers and organizations conducting clinical trials and, where permitted by law, consumers, and patients. Vocan’s method of psilocybin production will provide more affordable access to organizations looking to acquire cGMP API grade psilocybin. Vocan’s psilocybin production method utilizes the well-established industrial process of fermentation and thus can be scaled up while consistently producing a high-quality cGMP product.

“I am very pleased to say that we are fulfilling our promise to our shareholders and to the medical and research sectors, in general, that we have successfully produced biosynthesized psilocybin. Our team of scientists continue to achieve significant and astounding scientific milestones. Our goal is to play a significant role in furthering mental health research and the benefits of psychedelic medicines, and our cost-effective psychedelic compounds will go a long way towards allowing otherwise cost prohibitive medicines to be widely used,” Stated Dr. Hancock, Chairman of the Company, and CEO of Vocan. “This successful proof of concept for development and production of cost effective and stereochemically sound psilocybin puts Core One in a very unique position. It not only potentially positions the Company as first to market with a biosynthetic psychedelic, it positions us to become market-leaders with regards to cost efficiency, as well.

ABOUT CORE ONE LABS INC.

Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

CORE ONE LABS INC.
Joel Shacker
Chief Executive Officer

FOR FURTHER INFORMATION:
Email: info@core1labs.com
Telephone: 1-866-347-5058

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CAUTIONARY DISCLAIMER STATEMENT

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

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

January 24, 2022March 9, 2022

Ketamine One Changes Name To Wellbeing Digital Sciences

The Company’s Common Shares Will Continue to Trade Under the Stock Symbol “MEDI” on the NEO Exchange, “KONEF” on the OTCQB Venture Market and “MY0” on the Frankfurt Stock Exchange

Vancouver, British Columbia, January 24, 2022 / Globe Newswire / – KetamineOne Capital Limited (“Ketamine One” or the “Company”) (NEO: MEDI) (OTC: KONEF) (Frankfurt: MY0), an evidence-based healthcare company focused on innovative clinical solutions, artificial intelligence-powered digital therapeutics and contract research, is pleased to announce that effective January 24, 2022 the Company will change its name to Wellbeing Digital Sciences Inc. (“Wellbeing”) from KetamineOne Capital Limited (collectively, the “Name Change”). Wellbeing will continue to trade under the stock symbol “MEDI” on the NEO Exchange (“NEO”), under the stock symbol “KONEF” on the OTCQB Venture Market and under the symbol “MY0” on the Frankfurt Stock Exchange.

“We are excited to announce our new name and reveal our updated branding that is better aligned with our multidisciplinary approach, which encompasses mental and physical health through the pursuit of a variety of traditional and novel digital therapeutics. Wellbeing Digital Sciences is a name that acknowledges each one of our three core pillars: clinic-based treatments, contract research and health technology,” said Adam Deffett, Interim CEO of WellBeing. “Our mission continues to be the implementation of an innovative and bespoke healthcare offering to underserved populations, such as military veterans and first responders. The stage is set for this year to be a pivotal one for the Company, as many of our technology partnerships, clinical trials and network growth initiatives are expected to come to fruition,” added Mr. Deffett.

The Company also reaffirms that its pursuits continue to be centred around the following mission and vision statements:

To bring a technology-first approach to psychedelic therapies and drug development;
To operate a network of clinics that support treatments, future research, clinical trials and the integration of digital therapeutics; and
To advance the integration wearable technology and artificial intelligence-powered technology partnerships into each patient’s experience.

In accordance with the Name Change, the Company has launched a new website at www.wellbeingdigital.co. The new website prominently features the strength and clarity of the new Wellbeing brand, with content that includes more information about the Company, the market potential, mental health, a patient portal, investor materials and news. Further, the contact information for investors and other interested parties contained on the website as well as within this news release has been updated to reflect the Name Change. Employee email addresses have also been updated, while Wellbeing’s new social media profiles have been secured and will be launched in due course.

ABOUT WELLBEING

Wellbeing Digital Sciences Inc. (formerly KetamineOne Capital Limited) is an evidence-based healthcare company focused on innovative clinical solutions, artificial intelligence-powered digital therapeutics and contract research. Its mission is supported by a network of North American clinics that provide ketamine-assisted therapies and other types of treatment to patients as well as through a contract research organization that offer clinical trials services to clients pursuing drug development. In essence, the company exists to make breakthrough treatments more accessible and to offer patients transformational experiences.

On behalf of:

WELLBEING DIGITAL SCIENCES INC.

“Adam Deffett“

Adam Deffett, Interim CEO

For further information, please contact:

Nick Kuzyk, Investor Relations

Tel: 1-844-746-6351

Email: ir@wellbeingdigital.co

Web: www.wellbeingdigital.co

Twitter: @Wellbeing_IR

Notice Regarding Forward-Looking Information:

This news release contains forward-looking statements including but not limited to statements regarding the Company’s business, assets or investments, as well other statements that are not historical facts. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. These assumptions, risks and uncertainties include, among other things, the state of the economy in general and capital markets in particular, investor interest in the business and prospects of the Company.

The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. Additionally, the Company undertakes no obligation to comment on the expectations of, or statements made, by third parties in respect of the matters discussed above.

January 24, 2022March 9, 2022

Algernon Pharmaceuticals Discloses Novel Salt Patent Strategy as Part of its Psychedelic Drug DMT Intellectual Property

VANCOUVER, British Columbia, Jan. 24, 2022 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGWO) (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 novel salt forms of DMT. 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.

Many drug compounds’ core structures can often be paired with a salt. Different salts can improve the core drug in several ways, including improved efficacy, safety/tolerability, and stability.

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

The Company recently announced on January 18, 2022, that it has filed a combined Clinical Trials of Investigational Medicinal Products and Ethics Approval application, with the United Kingdom Medicines and Healthcare Products Regulatory Agency for its planned Phase 1 DMT clinical human stroke study.

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.

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.

January 21, 2022March 10, 2022

Numinus Wellness Inc. Reports Q1 2022 Results

Ended quarter with strong cash position of $53.9 million
Revenues grew 245% year-over-year to $0.8 million for the quarter
Generated gross profit of $50,965 during the quarter, representing a 6.5% gross margin
Well-positioned to offer psychedelic-assisted psychotherapy services through Canada’s newly expanded Special Access Program
Clinical trial application made to Health Canada to begin Phase 1 study for proprietary psilocybe extract
MAPS-sponsored MDMA-Assisted Therapy for PTSD study to begin shortly; approvals received from Health Canada and the Institutional Review Board

All financial results are reported in Canadian dollars unless otherwise stated.

VANCOUVER, BC, Jan. 20, 2022 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSX: NUMI) (OTC: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its fiscal first quarter results for the three months ended November 30, 2021.

“We have made significant advancements in all areas of our business over the last several months, with many exciting opportunities on the horizon,” said Payton Nyquvest, Founder and CEO. “Of note, the partnership across our lab and clinical teams has been instrumental in passing key milestones on two major clinical trials: one for a proprietary Psilocybe formulation and the other a MAPS-sponsored MDMA study. In addition, we’re continuing to make discoveries in our Bioscience lab and recently begun genetic testing on several newly-acquired psychedelic mushroom species.”

Mr. Nyquvest continued, “The recent amendments by Health Canada to the Special Access Programme further underscore the importance and growth potential of Numinus’ wellness clinic network. With facilities purpose-designed for a wide range of psychedelic-assisted psychotherapies, therapists already trained on providing Psilocybin-assisted and MDMA-assisted therapies, and a Health Canada distribution license that allows us to import, possess, produce, and distribute psychedelic compounds – Numinus is well positioned as a national leader to provide these important treatments to those who qualify. I’m encouraged by the recent changes by Health Canada and proud of everyone at Numinus for the ongoing leadership, drive and commitment to our mission over the past quarter.”

First Quarter Financial Highlights:

Cash balance of $53.9 million as of November 30, 2021
Revenues grew 244.5% year-over-year to $0.8 million in Q1 2021, due primarily to the acquisition of Mindspace. Sequentially, revenues grew 60.9% compared to Q4 2021.
Gross profit of $50,965 in Q1 2022, compared to gross loss of $38,135 in Q1 2021
Gross margin was 6.5%, compared to -16.6% in Q1 2021
Loss was $5.4 million for Q1 2022, compared to a loss of $1.9 million in Q1 2021

Operational Highlights During and Subsequent to Fiscal First Quarter 2022:

Numinus Bioscience – Laboratory Operations

Q1 2022 revenue of $141,702, a 56.4% sequential increase from Q4 2021, but a 27.7% decrease from $196,090 in Q1 2021. This year-over-year decline is primarily due to the Company ceasing cannabis related activities during 2021 to dedicate resources towards advancing psychedelic-centered service offerings – including psychedelic analytical testing and contract laboratory services, to align with the Company’s strategy and overall objectives.
On November 29, 2021, the Company announced that Numinus Bioscience developed proprietary psychedelic drug tests with new toxicity and potency scans. These new analytical tests will accelerate Numinus’ research and development capabilities and generate new revenue streams through third-party client product testing.

Phase 1 clinical trial on NBIO-01:

On October 24, 2021, Numinus announced it finalized the study design and protocol for a Phase 1 clinical trial on a naturally derived psilocybin extract (“NBIO-01”), advancing Numinus’ investigation of its first proprietary psychedelic product, which was developed using a patent-pending technology.
On January 14, 2022, the Company submitted its clinical trial application to Health Canada for its Phase 1 trial of NBIO-01. The clinical trial, named HOPE, is a two-phase study that will take place at a Vancouver based clinic. Upon approval, Numinus will begin testing the extract for bioavailability and tolerability on 20 healthy volunteers, followed by testing against a psilocybin comparator on a further 28 healthy volunteers.

MAPS-sponsored MDMA-assisted therapy for PTSD clinical trial study (“MAPPUSX”):

On November 10, 2021, the Company announced it will host the Montreal and Vancouver sites of the MAPPUSX study, which will continue to evaluate the safety of MDMA in treating severe PTSD, titled “A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD.”
On January 19, 2022, Numinus announced that it had received approvals from Health Canada and the Institutional Review Board to proceed with its clinical trial study for MAPPUSX. Enrollment for the trial is expected to begin shortly and will be open to eligible participants who were previously enrolled in the placebo arm of the parent study (“MAPP1”) or who were not able to receive treatment due to COVID-19 restrictions.

Subsequent to the quarter:

Numinus Bioscience secured several additional strains of psychedelic mushroom species and has already begun genomic analysis of these spore prints for research purposes.

Numinus Health – Numinus Wellness Clinic Network

Q1 2022 revenue of $647,915, a 61.9% sequential increase from Q4 2021, and a 1,857.6% increase compared to $33,098 during the same period last year when Numinus had only one clinic, which was impacted by COVID-19 during the quarter.
On September 23, 2021, Numinus completed the acquisition of the Neurology Centre of Toronto (“NCT”) for less than $1.0 million, allowing for the planned expansion of NCT into a comprehensive neurologic care center specialized in psychedelic neurology.
During Q1 2022, clients received a total of 6,217 appointments through Numinus clinics (including one-on-one and group therapy sessions, neurology-related appointments and Ketamine-assisted psychotherapy), representing a 91.9% increase in clinic appointments compared to the prior quarter (Q4 2021), due in part to the acquisition of NCT. On a same-store basis, excluding NCT, client appointments increased 42.0% compared to the prior quarter.
On November 10, 2021, the Company announced that it had secured two additional clinic locations in Vancouver and Montreal that will primarily be used for clinical research studies in the near-term.

Subsequent to the quarter:

Numinus has finalized a formal Ketamine-Assisted Psychotherapy (“KAP”) training program for therapists, with virtual training sessions occurring over the next two months. This training program will expand the number of Numinus therapists qualified to provide KAP sessions to clients.
As of January 20, 2022, Numinus has five wellness clinics offering services to clients (one in Vancouver, one in Toronto, and three in Montreal) that have a total of 21 treatment rooms. In addition, the Company has two dedicated research clinics where psychedelic studies are being conducted (one in Vancouver and one in Montreal).

Corporate Updates

On November 22, 2021, the Company changed its OTC ticker symbol to “NUMIF” (from “LKYSF”) to better align with its Canadian ticker symbol.
Subsequent to the quarter:
On December 16, 2021, Numinus graduated to the TSX (from the TSX-Venture), trading under the symbol “NUMI”.

Industry Updates

On January 5, 2022, Health Canada implemented amendments to the Special Access Programme (“SAP”). These amendments now enable:
- Doctors and practitioners to apply for psychedelic medicines that have shown promise through Phase 2 or Phase 3 trials, on behalf of their patients, when other traditional medicines and therapies have not proven effective.
- Doctors and patients to hear, within 48 hours of the application being submitted, if access to psychedelic medicines are approved for their case. If approved, doctors can refer patients to clinics – such as Numinus’ wellness clinics, to receive psychedelic-assisted psychotherapy.
- Companies holding a Health Canada dealers license, including Numinus Bioscience, to act as a licensed distributor of certain psychedelic medicines for SAP approved cases.

Q1 2022 Key Performance Metrics:

		*For the quarter ended November 30:*
	2022	2021	% change
Numinus Bioscience¹ revenue	141,702	196,090	-27.7%
Numinus Health²revenue	647,915	33,098	1,857.6%
Total Revenue	$789,617	$229,188	244.5%
Cost of revenue	(738,652)	(267,323)	176.3%
Gross Profit (Loss)	$50,965	$(38,135)	n.m.
Gross profit margin	6.5%	-16.6%	n.m.
General and administrative expenses	(3,736,890)	(1,285,448)	190.7%
Share-based compensation	(400,568)	(174,250)	129.9%
Sales and marketing expenses	(760,519)	(269,243)	182.5%
Depreciation	(51,829)	(91,261)	-43.2%
Research and development expenses	(330,626)	(89,727)	268.5%
Transaction costs	(45,092)	—	100.0%
Loss before other items	$(5,274,559)	$(1,948,064)	170.8%
Other items	(79,530)	19,327	n.m.
Loss and comprehensive loss	$(5,354,089)	$(1,928,737)	177.6%
Loss per share, basic and diluted	$(0.03)	$(0.02)	50.0%
Average number of shares outstanding, basic and diluted	203,409,202	112,364,998	81.0%

¹ Numinus Bioscience consists of revenues generated through Numinus’ Laboratory Operations.

²Numinus Health consists of revenues generated through Numinus’ clinic network.

Numinus’ condensed consolidated financial statements for the three months ended November 30, 2021 and related management’s discussion and analysis are available on Numinus’ Investor Relations website at www.investors.numinus.com and under the Company’s profile on SEDAR at www.sedar.com. These documents were prepared in accordance with IFRS and with TSX-Venture disclosure timeline requirements, as the company was listed on the TSX-Venture at quarter end.

Conference Call and Webcast Details

Interested parties are invited to participate in the Company’s Q1 2022 results conference call and webcast. On the call Numinus executives will review the Company’s performance and recent initiatives, and answer questions from analysts.

Date:	Thursday, January 20, 2022
Time:	5:30 p.m. (EST)
Dial-In:	1 (833) 989-2968 (Toll-free North America), 1 (236) 714-4028 (International)
Code:	2670376
Webcast:	https://event.on24.com/wcc/r/3574506/6105A28282486D6F95F7834E9C5632E2

The webcast will also be archived on the Events and Presentations page of Numinus’ Investor Relations website: https://www.investors.numinus.com/events-and-presentations

About Numinus
Numinus Wellness (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

Learn more at www.numinus.com and follow us on LinkedIn, Facebook, Twitter, and Instagram.

Forward-looking statements
This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are “forward-looking statements”. Forward-looking statements can be identified by the use of words such as “expects”, “does not expect”, “is expected”, “believes”, “intends”, “anticipates”, “does not anticipate”, “believes” or variations of these words, expressions or statements, that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company’s facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company’s limited operating and profitability track record; dependence on management; the Company’s need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company’s efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws.

SOURCE Numinus Wellness Inc.

For further information: Investor Contact, Jamie Kokoska, Vice President, Investor Relations, jamie.kokoska@numinus.com, +1 833-686-4687; Media Contact, May Lee, Communications Manager, may.lee@numinus.com

January 19, 2022March 9, 2022

Wuhan General Group Launches Mental Illness Drug Discovery Company Neurai Life Sciences

CAPE TOWN, SA / ACCESSWIRE / January 19, 2022 / WUHAN GENERAL GROUP, INC. (OTC PINK:WUHN) (“WGG” or the “Company”), a bioceutical company focused on alternative plant-based cannabinoids and mental health therapeutic research is pleased to share the following update:

Wuhan General Group, Inc./M2Bio Sciences, Inc. is excited to announce the launch of Neurai Life Sciences.

Neurai Life Sciences is a pre- and clinical-stage biotechnology company focusing on the drug discovery and development of next generation therapies treating mental health disorders. The company will lead the industry in artificial intelligence-driven target discovery, innovative and sustainable small molecule chemistry, and inclusive clinical development in the pursuit of novel therapeutics for major depressive disorder, anxiety disorders, and addiction. Neurai Life Sciences is primed to realize the infinite potential of targeted therapeutics within the brain serotonin receptor-mediated signaling pathways.

With the goal of hiring the best international talent, Neurai Life Sciences has recruited Riyad Domingo Ph.D. as Chief Executive Officer. Dr. Domingo is the current Harvard South Africa Fellow for 2021-2022 and holds a doctorate in Medical Biochemistry with a focus on drug discovery and development from the Institute of Infectious Diseases and Molecular Medicine at the University of Cape Town.

“The consequences of the COVID-19 pandemic have underscored the need for the advancement of neuropsychiatric medicine. Mental illness affects everyone, so we at Neurai believe that our targeted drug development process should consider and include all individuals, independent of age, race, or gender. We leverage emerging technologies including machine learning and novel formulation methods, accompanied by well-established industry approaches, thereby driving the evolution of the mental health industry and how therapeutics are developed in the future. This is absolutely vital for the future of our mental health.” said Dr. Domingo.

Jeff Robinson, Wuhan General Inc, CEO added: “Neurai Life Sciences will pioneer a new field of neuropsychiatric medicine. The company will revolutionize and challenge conventional approaches to developing and treating mental health conditions with new medicines and therapies. With Dr. Domingo at the helm, we know that these new technologies will change the lives of millions globally. Neurai is recruiting the brightest minds in the fields of AI and pharma to further complement the ground-breaking technologies and portfolio of molecular assets that are currently in development under Neurai Life Sciences. Never has there been a greater need to combine technology and medicine to address the global mental illness pandemic.”

At this time, Neurai Life Sciences is a private company and 100% owned by Wuhan General Inc. Neurai Life Sciences will be conducting a capital raise to fund initial preclinical research, development, and validation of select drug candidates.

All Wuhan General Inc. shareholders interested in investing in the capital raise for Neurai Life Sciences or for further information, contact Jeff Robinson, Chief Executive Officer, at jeff@m2bio.co or our web site found here. It is anticipated Neurai Life Sciences will seek a liquidity event for its shareholders at a later date. More details to follow.

About Wuhan General Group, Inc./ M₂Bio Sciences, Inc

Wuhan General Group, Inc. (DBA M2bio Sciences), through its wholly-owned subsidiary MJ MedTech is a nutraceutical biotechnology company focused on alternative plant-based cannabinoids and psilocybin medical research that develops and commercializes a range of CBD and mushrooms-based products under Dr. AnnaRx™, Medspresso™, and Liviana™ brands. In addition, our research and clinical trials with psilocybin are aimed at new therapies that will help patients who suffer from alcohol addiction, mental illness, and cardiovascular diseases. Our mission is to advance botanical-based medicine to the forefront by deploying best-practice science and medicine, clinical research, and emerging technologies. The Company is traded on the Over-the-Counter Bulletin Board of NASDAQ under the trading symbol “WUHN”.

Publicly traded company (OTC Pink: WUHN)

Website: www.neurai.life
E-mail: info@neurai.life
Follow us on LinkedIn: Neurai Life Sciences
Website: www.m2bio.co
E-mail: info@m2bio.co

Follow us on Twitter: https://twitter.com/m2bio
Follow us on Facebook: http://www.facebook.com/m2bio
Follow us on YouTube: https://www.youtube.com/channel/M2BioSciences
Follow us on Instagram: https://www.instagram.com/m2bio.sciences

Forward-Looking Statements:

Safe Harbour Statement – In addition to historical information, this press release may contain statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include the intent, belief, or expectations of the Company and members of its management team with respect to the Company’s future business operations and the assumptions upon which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance, and involve risks and uncertainties and that actual results may differ materially from those contemplated by such forward-looking statements. Factors that could cause these differences include, but are not limited to, failure to complete anticipated sales under negotiations, lack of revenue growth, client discontinuances, failure to realize improvements in performance, efficiency and profitability, and adverse developments with respect to litigation or increased litigation costs, the operation or performance of the Company’s business units or the market price of its common stock. Additional factors that could cause actual results to differ materially from those contemplated within this press release can also be found on the Company’s website. The Company disclaims any responsibility to update any forward-looking statements.

SOURCE: Wuhan General Group, Inc./ M₂Bio Sciences, Inc.

View source version on accesswire.com:
https://www.accesswire.com/684558/Wuhan-General-Group-Launches-Mental-Illness-Drug-Discovery-Company-Neurai-Life-Sciences

January 18, 2022March 9, 2022

Psyched Wellness Announces Vantage Hemp Co. as Contract Manufacturing Organization Partner to Bring AME-1-derived Products to Market

Canadian brand leading the emerging functional food category partners with industry-leading extraction and manufacturing partner based in Greeley, Colorado

Toronto, Ontario – January 18, 2022 – 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 Vantage Hemp Co. as the Company’s contract manufacturing organization (“CMO“) partner, facilitating the path to market for Psyched’s AME-1-derived consumer products.

The agreement includes extraction, commercial production and bottling of the products, with the Companies working together to finalize the good manufacturing practices (“GMP“) compliance process and final product formulation through Vantage’s established production capabilities. Psyched has shipped samples of raw material and the desired extract to Vantage’s facilities which will follow the Company’s unique protocols (as outlined in provisional patents submitted last year) to have the first commercial production of AME-1 units ready for sale during the second quarter of 2022. In addition, The Companies plan to develop future products and delivery systems with AME-1 as the base and core ingredient.

“Psyched Wellness is very pleased to partner with Vantage, an established extract manufacturer that meets our high standards of pharmaceutical quality and shares our vision for the future,” said David Shisel, Chief Operating Officer of Psyched Wellness. “Together, we plan to produce and supply the highest quality products to global markets, starting with the United States before scaling distribution internationally. The AME-1-derived supplements that Psyched has been developing for the past two years are natural remedies that will improve the quality of life for many. For the first time in modern history, Psyched Wellness will present a product derived from the Amanita Muscaria mushroom that is safe for human consumption using our proprietary extract, AME-1. Psyched and Vantage both believe in the success of AME-1 as an ingredient and are ensuring that we have the infrastructure and capabilities to scale production to high volumes without sacrificing quality.”

Vantage’s manufacturing facilities and processes are ICH Q7 and WHO GMP-compliant and are managed by an expert team that specializes in medical, pharmaceutical, manufacturing and business operations, creating the highest quality products with precision and scale. In addition, Vantage’s cleanroom for the production of finished products ensures the final products are manufactured in controlled environments that mitigate contamination.

Harvinder Johal, CRO of Vantage, added, “Our partnership with Psyched Wellness ensures that this valuable therapy will be brought to market at an accelerated rate by leveraging Vantage’s science-based and data-driven ethos. We are eager to allow consumers access to this product for the improvement of their health and wellness. Applying our extraction standards to mushroom biomass ensures that the final product meets the same stringent quality standards that we apply to hemp extraction.”

For further information, please contact:

Jeffrey Stevens
Chief Executive Officer
Psyched Wellness Ltd.
Tel: 647-400-8494
Email: jstevens@psyched-wellness.com
Website: http://www.psyched-wellness.com

Christian Santi
Director of Sales
Vantage Hemp Co.
Tel: 720-663-6082
Email: christian@vantagehemp.com
Website: https://vantagehemp.com/

Investor contacts:
Tim Regan/Sophia Bashford
KCSA Strategic Communications
Tel: 347-487-6788
Email: PsychedWellness@kcsa.com

Media contacts:
Brooke Russell
Marigold Marketing & PR
Tel: 877-681-5541
Email: brussell@marigoldpr.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.

About Vantage Hemp Co.:

With large-scale extraction facilities, Colorado-based Vantage Hemp Co. delivers pharmaceutical-grade GMP compliant CBD extracts (including full-spectrum oil, distillate and isolate) that companies can trust. Vantage’s contract manufacturing services offer a broad range of benefits as they operate with integrity and abide by stringent pharmaceutical-production standards to provide quality products to their partners.

Cautionary Statement Regarding Forward-Looking Information

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 the Company’s current belief or assumptions as to the outcome and timing of such future events. The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: the ability of the Company to develop Amanita Muscaria-derived products; the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; the uses and potential benefits of Amanita Muscaria; Vantage Hemp Co,’s relationship with the Company, including them providing CMO and other services to the Company; the parties anticipated timeline and process for meeting production and commercialization; and the Company becoming a leading North American brand in the emerging functional food category.

Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company’s ability to continue as a going concern; the Company’s ability to continue to develop its mushroom-derived products and associated consumer packaged goods; continued approval of the Company’s activities by the relevant governmental and/or regulatory authorities; the continued growth of the Company; Vantage Hemp Co. providing CMO and other services to the Company; the parties meeting their anticipated timeline and process for production and commercialization; and the Company becoming a leading North American brand in the emerging functional food category.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the potential inability of the Company to continue as a going concern; risks associated with potential governmental and/or regulatory action with respect to the Company’s operations; competition within the psychedelics market; risks with respect to the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; the risk that there is no potential benefit of Amanita Muscaria consumption; risk that Vantage Hemp Co.’s will be unable to provide CMO and other services to the Company; risks that the parties will be unable to meet their timeline and/or follow their process for production and commercialization; and risks that the Company will not become a leading North American brand in the emerging functional food category.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. 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 and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

January 18, 2022March 10, 2022

Enveric Biosciences CEO, Dr. Joseph Tucker, Provides 2021 Year in Review and 2022 Outlook in Letter to Shareholders

NAPLES, Fla., Jan. 18, 2022 /CNW/ – Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a patient-centric biotechnology company, today released a letter to shareholders from Dr. Joseph Tucker, Chief Executive Officer of Enveric Biosciences.

Dear Enveric Shareholders and Partners:

Reflecting on 2021, I am both extremely impressed with all the accomplishments and progress made and humbled and energized to tackle the opportunities that lie ahead. 2021 was a foundational year that set the stage for our Company by assembling a talented and expert team to execute our strategy for the future. As we move forward in 2022, we find ourselves strategically positioned with a strengthened balance sheet, a deep bench of experienced industry professionals, a platform for new drug discovery, a robust IP portfolio and a growing pipeline of what we believe to be promising drug candidates. We are energized to engage with what I believe will be yet another transformative year for the company.

2021 Year in Review
Enveric launched as a patient-centric biotechnology company, employing innovation and scientific leadership as core principles. Notable highlights from 2021 include:

Capital Markets: Raised $25 million; added to AdvisorShares Psychedelics ETF (NYSE:PSIL)
M&A and Licensing: Acquired MagicMed Industries Inc.; Exclusively licensed novel molecules from Diverse Biotech
Platform Technology Development: Filed 15 patent applications with claims directed to millions of individual molecules; Launched PsyAI^TM, a proprietary artificial intelligence platform.

As of September 30, 2021, we had $21 million in cash, no debt related to loans payable, and working capital of approximately $20 million, enabling us to continue executing on our business plan.

Looking Forward to 2022
The foundation of Enveric’s growth in 2022 will be built upon three pillars: our Drug Development pipeline, Drug Discovery process, and Intellectual Property strategy.

Drug Development:
- Most importantly, our psychedelic-based drug discovery engine is operating in full force to address many targeted unmet needs, starting with the planned execution of a Phase II clinical trial in Cancer Related Distress (CRD), our lead indication, with a 1^st generation psychedelic asset, EVM-101.
- Our second-generation psychedelic-derived suite of products in our Discovery Research is slated to progress towards nominating our lead Development Candidate, EVM-201, and to proceed towards completing a host of CMC (Chemistry Manufacturing and Controls), Pharmacology, and Toxicology experiments, leading to planned INTERACT and Pre-IND meetings with the FDA.
Drug Discovery:
- Design of hundreds of potential lead drug candidates for enriching our second generation and third generation pipeline programs with the aim of progressing towards several future Development Candidate nominations in target undisclosed indications.
- Focused, enriched and targeted drug discovery engine employing Artificial Intelligence screening to identify top candidates for each program based on drug-like properties, predicted pharmaceutical activity and intellectual property strength.
Intellectual Property:
- Continue to invent new drug candidates and employ internationally filed patent applications to claim the compositions, methods of manufacture, and clinical uses.
- 12 international Patent Cooperation Treaty (PCT) Patent Applications are expected to publish.
- 7 Provisional US Patent Applications are expected to be converted to international PCT Patent Applications.
- 2 additional Provisional US Patent Applications are expected to be filed.

With the new company structure, strengthened by the foundational achievements in 2021 including the assembly of an expert team with the passion and drive for drug development, I am confident in Enveric’s ability to execute on our programs in 2022 and beyond.

On behalf of the Enveric management team and Board of Directors, I thank you for your continued support of the company and I look forward to providing you with further updates as our progress continues.

Sincerely,

Dr. Joseph Tucker,
Chief Executive Officer, Director

About Enveric Biosciences
Enveric Biosciences (NASDAQ: ENVB) is an innovative biotechnology company developing next-generation mental health and oncology treatments and clinical discovery platform, leveraging psychedelic-derived molecules for the mind and synthetic cannabinoids for the body. Enveric’s robust pipeline supports drug discovery efforts and clinical development programs to enable potential commercialization of effective treatments for millions of patients in need around the world. For more information, please visit www.enveric.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans”, ” expects” or “does not expect”, “proposed”, “is expected”, “budgets”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations, or intentions regarding the future. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability to achieve the value creation contemplated by technical developments; the impact of the novel coronavirus (COVID-19) on Enveric’s ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on Enveric’s ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; Enveric’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to Enveric’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

View original content:https://www.prnewswire.com/news-releases/enveric-biosciences-ceo-dr-joseph-tucker-provides-2021-year-in-review-and-2022-outlook-in-letter-to-shareholders-301462479.html

SOURCE Enveric Biosciences

January 17, 2022March 9, 2022

Ketamine One Becomes Exclusive Ketamine Treatment Provider To Victoria Wellness

Utilizing its Previously Announced Partnership with iHealthOX, the Company Will Provide Initial Assessments and Consultations of, Develop Care Plans for and Administer IV or Oral Ketamine Therapy to Victoria Wellness’ Appropriate Clients in Ontario

Vancouver, British Columbia, January 17, 2022 / Globe Newswire / – KetamineOne Capital Limited (“Ketamine One” or the “Company”) (NEO: MEDI) (OTC: KONEF) (Frankfurt: MY0), a company focused on consolidating medical clinics and becoming a North American leader in mental health treatments, is pleased to announce that the Company has entered into a one-year agreement with Victoria Wellness Mental Health Residential and Addition Treatment Centre (“VW” or the “Centre”) for Ketamine One to be the Centre’s exclusive ketamine treatment provider. Located at 5316 Rice Lake Scenic Drive in Gores Landing, Ontario, VW is a residential rehabilitation facility and mental clinic focused on treating anxiety, depression and post-traumatic stress disorder (“PTSD”) by offering personalized therapy treatment programs with a connection to nature to both veterans and the general public.

The Company and the Centre have launched a first class, best practice-based, six-week inpatient Ketamine Integrated Therapy Experience (“KITE”) program. The first three weeks of the KITE program is being structured to offer clients a unique opportunity to benefit from fast acting, evidence based and medically supervised ketamine administration in order to help combat long standing and prescription resistant mental health conditions such as depression and PTSD. Doses of ketamine will be supplemented with specialized and integrated ketamine-assisted psychotherapy (“KAP”). The KITE program will also see VW’s clients embark on a comprehensive, premium, six-week residential recovery experience featuring the best in both data-driven recovery therapies and holistic healing traditions.

VW is looking to become a leader in the mental heath industry by incorporating KAP into its service offering. The Centre already has veterans interested in the KITE program and treatments are expected to begin shortly. Based on Ketamine One’s previously announced partnership, clients will be triaged and psychologically assessed by iHealthOX. Those deemed appropriate for treatment will receive ketamine intravenously at an off-site, third-party pain centre.

“This exclusive agreement with VW is a meaningful opportunity to help even more veterans and other members of the general public who are battling daily with anxiety, depression and PTSD. Ketamine One looks forward to working with the VW team over the next year and beyond,” said Steven Inglefield, Chief

Operating Officer of Ketamine One. “Growing our network of clinics, both directly and indirectly such as through this agreement, is a core part of the Company’s competitive strategy. We are working hard to expand our operations and, ultimately, what that means is working hard to help more people,” added Mr. Inglefield.

“Thank you to Ketamine One for your persistent in the mental health field to allow all Canadians the opportunity to end their mental health struggles with the benefits of ketamine. I am thrilled to form a partnership with Ketamine One to become a leader in the mental health field in Canada. This partnership allows us to provide inpatient residential care with ketamine to the veterans, military and first responders who are suffering from PTSD, depression and other mental health issues. From my own personal experience, you can get better and our KITE program is designed to help you fly,” said Joe Ann Kortman, Executive Director of VW.

Additionally, Ketamine One is please to report that data collection from the first participants in the previously announced single arm, open label study of patients with PTSD who are undergoing the proprietary physical therapy program at the Company’s IRP Health clinics began on January 4, 2022. And lastly, the Company is pleased to announce that the re-branding of IRP Health is now complete. Interested parties can visit www.irphealth.ca to experience the new brand.

ABOUT KETAMINE ONE

KetamineOne Capital Limited (formerly Myconic Capital Corp.) is a company focused on consolidating medical clinics and becoming a North American leader in mental health treatments. It is working to provide the critical infrastructure needed to develop and deliver breakthrough mental health treatments. Currently, Ketamine One has a network of clinics across North America, with plans to further consolidate the highly fragmented industry. KGK Science Inc. is the Company’s wholly owned contract research division, which places it at the forefront of premium clinical research based on the subsidiary’s history and extensive experience in pharmaceuticals, cannabis, and the emerging psychedelic medicine industries. As a collective enterprise, Ketamine One is dedicated to helping solve the growing need for safe and accessible mental health therapy.

On behalf of:

KETAMINE ONE

“Adam Deffett”

Adam Deffett, Interim CEO

For further information, please contact:

Nick Kuzyk, Investor Relations

Tel: 1-844-PHONE-K1 (1-844-746-6351)

Email: IR@ketamine.one

Web: www.ketamine.one

Twitter: @KetamineOne

Notice Regarding Forward-Looking Information:

are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other forward

looking statements will not occur, which may cause actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. These assumptions, risks and uncertainties include, among other things, the state of the economy in general and capital markets in particular, investor interest in the business and prospects of the Company.

INTERESTED IN WORKING WITH KETAMINE ONE?

If you’re interested in being a financial partner, clinic partner, or community advocate, we’d love to talk. partners@ketamine.one

January 15, 2022March 9, 2022

Core One Labs to Host Special Investor Webcast on Tuesday, January 18, 2022

VANCOUVER, British Columbia, Jan. 15, 2022 (GLOBE NEWSWIRE) — Core One Labs Inc. (CSE: COOL), (OTC: CLABD), (Frankfurt: LD6, WKN: A3CSSU) (“Core One” or the “Company”) is pleased to announce, as a follow up to the press release dated January 10, that Dr. Robert E.W. Hancock, the Company’s Chairman, and CEO of its wholly owned subsidiary Vocan Biotechnologies Inc. will host a special investor webcast (the “Webcast”) on Tuesday, January 18, 2022 at 1:30 p.m. PST/4:30 p.m. ET/10:30 p.m. CET.

Participants are invited to submit questions in advance of the webcast, and Dr. Hancock will respond to as many of the questions as possible in the time allowed. To submit your question(s) in advance of the webcast, please email info@core1labs.com.

REGISTER FOR AND WATCH THE LIVE EVENT HERE:

http://www.eventcastpro.com/webcasts/cc/events/27Iq50.cfm

CALL INTO THE LIVE EVENT:

International callers: +1-203-518-9797
US Callers: +1-866-518-6930

Conference ID: COREONELABS

A recording of the webcast presentation will also be posted on the Company’s website approximately 2 hours following the live event.

About Core One Labs Inc.

Core One Labs Inc.

Joel Shacker
Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:
info@core1labs.com
1-866-347-5058

Cautionary Disclaimer Statement:

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

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

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Category: Core One Labs

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Utilizing its Previously Announced Partnership with iHealthOX, the Company Will Provide Initial Assessments and Consultations of, Develop Care Plans for and Administer IV or Oral Ketamine Therapy to Victoria Wellness’ Appropriate Clients in Ontario

INTERESTED IN WORKING WITH KETAMINE ONE?

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