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Enveric Biosciences CEO, David Johnson, Issues Letter to Shareholders

Enveric Biosciences CEO, David Johnson, Issues Letter to Shareholders

Company has also released its second quarter and first half financial results for the period ended June 30, 2021

NAPLES, Fla., Aug. 18, 2021 — Enveric Biosciences(NASDAQ: ENVB) (“Enveric” or the “Company”), a patient-first biotechnology company developing novel therapeutic drugs to improve the quality of life for cancer patients, Chief Executive Officer, David Johnson, today is issuing an open letter to shareholders.

Dear Fellow Shareholders:

As we approach our annual stockholder meeting on September 14, 2021 and the expected closing of the transaction with MagicMed Industries Inc. (“MagicMed”), we believe we are well-positioned to emerge as a next-generation neuroscience platform. We expect the pending transaction to complement our existing product development activities, which are focused on physical symptoms, with a platform of novel, psychedelics that addresses the large mental health challenges related to CNS indications such as PTSD, anxiety, depression and pain.

We filed our second quarter and first half of 2021 financials last Friday with the SEC, which demonstrates our strong balance sheet of approximately $20 million in cash, no debt and an efficient capital table, affording us the flexibility to be opportunistic about further M&A possibilities and in executing on our current business plan.

We also increased R&D spend during the first half of 2021 and, after the proposed transaction with MagicMed, plan on further investments in mental health initiatives with potential for true disruption in this patient care segment, solidifying our unique position as one of the few NASDAQ-listed mental health companies.

We recognize that the public markets have been difficult for microcap companies in this space for the past several months, and remain committed to executing on our business plan to maximize shareholder value moving forward.

Acquisition of MagicMed

To date, Enveric’s focus has been in the discovery and development of cannabinoid-based therapeutic drugs for patients who suffer from the side effects of cancer therapy. Indications such as Radiation Induced Dermatitis and Chemotherapy Induced Peripheral Neuropathy represent a very large market opportunity and the current standard of care has seen minimal clinical innovation.

Our development activities, however, revealed an even larger opportunity related to a side effect in cancer therapy known as ‘Cancer Related Distress’ (CRD) derived from anxiety, depression and PTSD arising from the diagnosis, treatment protocol or a patient’s concerns about the future. While working to address the physical issues associated with cancer therapy, as a patient-centric company, it became evident that patients also had significant struggles with the mental aspect of their diagnosis. Scientific evidence published by leading academic institutions such as John Hopkins and Yale show the promise of psychedelic molecules as an effective and exciting approach in treating mental health. The FDA’s approval of Janssen’s SPRAVATO® (eskatamine) and its designation of “Breakthrough Therapy” for a Psilocybin and MDMA, further bolsters this published research.

It was with this lens that we started looking for the right partner to enter this space. We have been excited about MagicMed since we first met them. Their library of Intellectual Property for Generation 3molecules, together with their use of Artificial Intelligence, we believe will allow the combined company to address many of the issues not only within our desired cancer indications, but well beyond in this extensive arena of societal mental health problems. In fact, we now believe there is a potential to disrupt the entire market through our IP strategy, which is a very exciting proposition for patients and our shareholders alike.

Dr. Joseph Tucker, current CEO of MagicMed and incoming CEO of Enveric upon the expected closing, and I agree, quite passionately, that mental health is a major global crisis with inadequate current therapies. With a market estimated at more than $250 billion in North America alone, the combined company will be uniquely positioned to bring significant value in the form of efficacious, reliable, life-changing therapies for the patients we seek to serve.

The proposed transaction with MagicMed has now cleared the regulatory approvals and is currently awaiting a shareholder vote of both Enveric and MagicMed shareholders on matters related to the proposed transaction. We expect the proposed transaction to close late in the third quarter or very early in the fourth quarter.

Other key points of progress

Building a World Class Team
To support our growing business, Enveric and MagicMed plan to come together with a very deep and experienced leadership team, while continuously looking for further enhancements. In the second quarter, we announced that Carter Ward had joined the company as our CFO. Carter comes to Enveric with years of Public Company experience in the Life Sciences space, as well as a KPMG pedigree.

To support our growing R&D capabilities and team, we have leased a new discovery facility at the University of Calgary, increasing the efficiency and focus of our R&D activities. In addition, we have just agreed to double our team in Calgary to allow them to accelerate our ability to synthesize and screen more drug candidates.

Finally, we have brought in other new skill sets in Project Management, Clinical Research and a new Scientific Advisory Board Member, Dr. Arash from Cedar Sinai Hospital in Los Angeles

Progressing our Pipeline

  • EV101 has now been given approval for a Phase 1/2 trial in Tel Aviv. We will continue to look at the best pathway forward for this initiative.
  • EV102 continues to make progress in our development program and still shows signs that this could be in the clinic in the first half of 2022.
  • EV104 is a discovery stage program for Pain, creating a Proof of Principal on the Diverse Bio Assets we licensed in Q1 of 2021.

Expansion of Intellectual Property

Enveric Biosciences was granted US patent number 11,090,275 on August 17th. This US patent is the first of three pending patent portfolios directed to cancer treatment using cannabidiol (CBD) owned by Enveric. This patent is part of a larger strategy to build a large and strong Patent portfolio. It is an exciting milestone for the company.

Outlook of Combined Company

The combination of Enveric and MagicMed is expected to uniquely and immediately propel us to emerge as a powerful drug discovery and clinical stage mental health biotechnology company, bringing forward novel therapies to improve the standard of care and unmet medical needs globally.

Our focus is very clear:

  • Continue to progress our pipeline into and through the clinic
  • Close the MagicMed Industries transaction and start to utilize their Psybrary to protect, expand and develop new psychedelic drug candidates, starting with PTSD for cancer
  • Opportunistically look for external development ways to add value to Enveric

I want to thank our shareholders for their support as we approach our September 14th stockholder meeting. As always, we look forward to hearing from you. Please email our investor relations department for more information – EnvericBio@KCSA.com.

Sincerely,

David Johnson,
Chairman and CEO
Enveric Biosciences

About Enveric Biosciences
Enveric Biosciences is a patient-first biotechnology company developing rigorously tested, novel cannabinoid medicines to improve quality of life for cancer patients. Initial indications include radiodermatitis, a common and often severe side effect of radiation therapy, and chemotherapy-induced neuropathy. For more information, please visit https://www.enveric.com/.

Additional Information About the Amalgamation and Where to Find It

This communication may be deemed to be solicitation material in respect of the proposed transaction between the Company and MagicMed. In connection with the proposed transaction, the Company has filed relevant materials with the Securities and Exchange Commission (the “SEC”), including a registration statement on Form S-4, as amended (File No. 333-257272), that includes a proxy statement and prospectus. The registration statement was declared effective by the SEC on July 9, 2021, and the proxy statement/prospectus was mailed or otherwise disseminated to stockholders of the Company. Enveric has also filed and may file other relevant documents with the SEC regarding the proposed transaction. THE COMPANY URGES INVESTORS AND STOCKHOLDERS TO READ THE PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY, THE PROPOSED TRANSACTION AND RELATED MATTERS. Investors and stockholders can obtain free copies of the proxy statement/prospectus and other documents filed by the Company with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov. In addition, investors and stockholders can obtain free copies of the proxy statement/prospectus and other documents filed by the Company with the SEC by contacting Investor Relations by mail at Enveric Biosciences, Inc., Attn: Investor Relations, 4851 Tamiami Trail N, Suite 200, Naples, FL 34103. Stockholders are urged to read the proxy statement/prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction.

Participants in the Solicitation

The Company and MagicMed, and each of their respective directors and executive officers and certain of their other members of management and employees, may be deemed to be participants in the solicitation of proxies in connection with the proposed transaction. Additional information regarding these persons and their interests in the proposed transaction is included in the proxy statement/prospectus relating to the proposed transaction that was filed with the SEC. These documents can be obtained free of charge from the sources indicated above.

No Offer or Solicitation

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You can generally identify forward-looking statements by the use of forward-looking terminology such as “anticipate,” “believe,” “budgets,” “continue,” “could,” “estimate,” “expect,” “explore,” “evaluate,” “forecasts,” “intend,” “scheduled,” “may,” “might,” “plan,” “potential,” “predict,” “project,” ‘proposed,” “seek,” “should,” or “will,” or the negative thereof or other variations thereon or comparable terminology. These forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company’s and MagicMed’s control. Statements in this press release regarding the Company, MagicMed and the combined company that are forward-looking, including projections as to the anticipated benefits of the proposed transaction, the impact of the proposed transaction on the Company’s and MagicMed’s business and future financial and operating results, the amount and timing of synergies from the proposed transaction, expectations regarding capital structure following the closing of the proposed transaction, the combined company’s pipeline, intellectual property protection and R&D spend, and the closing date for the proposed transaction, are based on management’s estimates, assumptions and projections, and are subject to significant uncertainties and other factors, many of which are beyond the Company’s and MagicMed’s control. These factors include, among other things, the combined company’s ability to execute successfully its strategic plans, including its business development strategy, the expiration of patents or data protection on certain products, including assumptions about the combined company’s ability to retain patent exclusivity of certain products, the impact and result of governmental investigations, the combined company’s ability to obtain necessary regulatory approvals or obtaining these without delay, the risk that the combined company’s products prove to be commercially successful or that contractual milestones will be achieved. Similarly, there are uncertainties relating to a number of other important factors, including: results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. FDA and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; the ability to enroll patients in planned clinical trials; unplanned cash requirements and expenditures; the amount of funds the combined company requires for its product candidates; competitive factors; the ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates; the ability to maintain key collaborations; the impact of the ongoing COVID-19 pandemic on the combined company’s results of operations and business plan and the global economy; and general economic and market conditions. Additional information concerning these risks, uncertainties and assumptions can be found in the Company’s filings with the SEC, including the risk factors discussed in the Company’s most recent Annual Report on Form 10-K, as updated by its Quarterly Reports on Form 10-Q and future filings with the SEC.

Investor Contacts
Valter Pinto / Allison Soss
KCSA Strategic Communications
212.896.1254 / 212.896.1267
valter@kcsa.com/ asoss@kcsa.com

Media Contacts
Caitlin Kasunich / Raquel Cona
KCSA Strategic Communications
212.896.1241 / 212.896.1204
ckasunich@kcsa.com/ rcona@kcsa.com

Filed by Enveric Biosciences, Inc.
Pursuant to Rule 425 of the Securities Act of 1933
and deemed filed pursuant to Rule 14a-6
of the Securities Exchange Act of 1934

Commission File No.: 001-38286

Cision View original content:https://www.prnewswire.com/news-releases/enveric-biosciences-ceo-david-johnson-issues-letter-to-shareholders-301357557.html

SOURCE Enveric Biosciences

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The end to nicotine addiction?

Mydecine Innovations strikes five-year research agreement with Johns Hopkins University to study psychedelic therapies

Johns Hopkins University has been at the forefront of psychedelic research since the early 2000’s. Now, its researchers are partnering with Mydecine Innovations (MYCO) to end one of the most difficult addictions to treat.

The Denver-based company just signed into a 5-year research agreement with Johns Hopkins to study psychedelic therapies. Initial research will focus on smoking cession, expanding on previous findings that 80% of smokers were able to quit after one dose of psilocybin.

Mydecine also announced that it has added 4 news lead drug candidates to its portfolio.

 

 

 

PDF of article

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Core One Labs Acquires Frontier Mycology

Core One Labs Acquires Frontier Mycology

Vancouver, British Columbia, Canada – August 17, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (the “Company” or “Core One”) is a research and development company focused on bringing psychedelic medicines to market through the development and production of API grade psychedelic compounds, the advancement of psychedelic assisted treatments, and the integration of novel delivery system technology.  The Company is pleased to announce it has completed the acquisition (the “Transaction”) of all of the outstanding share capital of Frontier Mycology Corp. (“Frontier”).

Frontier, through its website MushroomNews.Org, is a compilation of the globe’s top mushroom news, providing compelling content, such as news and media coverage, financial analysis and relevant research on both functional and psychedelic mushrooms.   Frontier’s objective is to reduce the stigma towards psychedelic medicines by providing information and transparency on all aspects of the psychedelic industry, and to drive the psychedelics industry into the forefront of modern medicine. In addition to being a trusted information source in the psychedelics’ space, Frontier also embodies a  an e-commerce platform, with a growing selection of legal functional mushroom products.

Joel Shacker, CEO of the Company stated, “This acquisition further expands our presence in the psychedelic space, by allowing us access to potential investors who utilize this website as a tool for keeping up to date on this growing industry. The direct-to-consumer ecommerce platform for functional mushrooms, also allows the company to generate sales to consumers, who can then be converted to different products as the legalization of psychedelics progresses.”

Transaction Structure

The Transaction was completed pursuant to a share purchase agreement among the Company, Frontier and the shareholders of Frontier (the “Definitive Agreement”) dated effective August 16, 2021.  Pursuant to the Definitive Agreement, and in consideration for the acquisition of Frontier, the Company has issued 666,666 common shares and 634,920 share purchase warrants entitling the holders to acquire a further 634,920 common shares of the Company at a price of $6.50 per share until August 17, 2023.

The Company is at arms-length from Frontier and its shareholders.  The Transaction neither constitutes a fundamental change nor a change of business for the Company, nor has it resulted in a change of control of the Company within the meaning applicable securities laws and the policies of the Canadian Securities Exchange.  In connection with completion of the Transaction, the Company has issued 17,964 common shares to certain third-parties who provided administrative services necessary to complete the Transaction.

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

FOLLOW US:

Website: https://core1labs.com/

Twitter: https://twitter.com/Coreonelabs

Facebook: https://www.facebook.com/Core-One-Labs-Inc-100969251278277/

LinkedIn: https://www.linkedin.com/company/core-one-labs

Instagram: https://www.instagram.com/coreonelabsinc/

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.

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Clearmind Medicine Commences Trading On The Frankfurt Stock Exchange

Clearmind Medicine Commences Trading On The Frankfurt Stock Exchange

Shares To Be Dually Listed On Canadian Securities Exchange

TORONTO,Aug. 17, 2021– Clearmind Medicine Inc. (CSE: CMND) (“Clearmind”or the “Company“), a psychedelic medicine biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and undertreated health problems, is pleased to announce the listing of its common shares for trading on the Frankfurt Stock Exchange (“FSE”) under the symbol CWY0.

The FSE is the world’s third largest trading exchange, ranking only behind the New York Stock Exchange and NASDAQ. Home to public companies from more than 80 different countries, the FSE represents over 1.4 million securities and generates more than €1 trillion trading volume annually.

“We are very pleased to have Clearmind shares dually -listed on the Frankfurt Stock Exchange. The increased visibility will help strengthen trading liquidity and facilitate investment in the Company by institutional and retail investors across Europe. The psychedelic drug market is expected to surpass $10 billion by 2027, and we believe Clearmind shares provide an excellent opportunity to participate in that growth,“ commented Adi Zuloff-Shani, Ph.D., CEO of Clearmind.

About Clearmind Medicine Inc.

Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.

The Company’s intellectual portfolio currently consists of two patent families. The first, “Binge Behavior Regulators”, has been granted in the U.S., Europe, China and India, with pending divisional applications in Europe and the U.S. The second, “Alcohol Beverage Substitute”, has been approved for a European patent, with pending applications in the U.S., China and India. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on the Canadian Securities Exchange under the symbol “CMND” and the Frankfurt Stock Exchange under the symbol “CWY0.”

For further information, please contact:

Investor Relations,

Email: invest@clearmindmedicine.com

Telephone: (778) 400-5347

General Inquiries,

Info@Clearmindmedicine.com

www.Clearmindmedicine.com

FORWARD-LOOKING STATEMENTS:

This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Such statements include submission of the relevant documentation within the required timeframe to the satisfaction of the relevant regulators and raising sufficient financing to complete the Company’s business strategy. There is no certainty that any of these events will occur. Although such statements are based on management’s reasonable assumptions, there can be no assurance that such assumptions will prove to be correct. We assume no responsibility to update or revise them to reflect new events or circumstances. 

Investing into early-stage companies inherently carries a high degree of risk, and investment into securities of the Company shall be considered highly speculative.

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 any province in which such offer, solicitation or sale would be unlawful. The securities issued, or to be issued, under the Private Placement have not been, and will not be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Neither the Canadian Securities Exchange (the “CSE”) nor its Regulation ServicesProvider (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

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Diamond Therapeutics Announces Health Canada Approval of Clinical Trial with Low-Dose Psilocybin

TORONTO, Aug. 17, 2021 /CNW/ – Diamond Therapeutics Inc. (“Diamond”), a drug development company focused on low-dose psychedelic therapies for use in the treatment of mental health, is pleased to announce that it has received a No Objection Letter from Health Canada, allowing Diamond to proceed with a human clinical trial to evaluate low doses of psilocybin in healthy volunteers.

The trial is a Phase 1 randomized, placebo-controlled, double-blind study to evaluate the safety and pharmacokinetics of low doses of psilocybin in as many as 80 study participants.

According to Health Canada’s clinical trials database, to date, there are only two other Canadian clinical trials involving psilocybin.

“We are grateful to Health Canada for their support of this groundbreaking study,” says Judy Blumstock, CEO of Diamond. 

The study will build on the results of previous animal research conducted by Diamond that demonstrated for the first time that certain, low, non-hallucinogenic doses of psilocybin hold potential for therapeutic use. Diamond believes these findings may help unlock the use of low-dose psilocybin to treat psychiatric disorders, including anxiety and depression. 

“This upcoming clinical trial will enable Diamond to gain critical clinical information that will help inform future human trials with psilocybin and other pipeline compounds,” says Dr. Edward Sellers, chair of Diamond’s scientific advisory board.

Diamond is also planning to launch a Phase 2 trial to investigate low-dose psilocybin’s efficacy in treating anxiety, which is the most common mental health disorder in the U.S., causing moderate to severe disability in over 50% of sufferers. This Phase 2 study will be conducted in both Canada and the U.S.

As well, Diamond plans to support an investigator-led study of low-dose psilocybin in the U.S. to explore its effects on patients with moderate depression.

“We’re very excited to commence our clinical program. It brings us one step closer to creating therapeutics that can help more people access effective and safe treatments for mental health conditions,” says Ms. Blumstock.

“It’s because of the hard work of our team, partners and advisors that we’ve been able to achieve this significant milestone,” she says.

Note:
The safety and efficacy of psilocybin for any indication has not yet been established.

About Diamond Therapeutics
Diamond Therapeutics is a psychedelic drug development company based in Toronto. Our mission is to develop new and better therapies for mental health conditions by unlocking the promise of psychedelic compounds. Diamond is focused on sub-perceptual, non-hallucinogenic treatments that hold potential for use across a broad patient cohort —maximizing the positive impact better drugs can have on the global mental health crisis. To learn more about Diamond, visit www.diamondthera.com.

Cautionary Statements Regarding Forward-Looking Information
This news release includes certain “forward-looking information” under applicable Canadian securities legislation. Forward-looking information includes statements other than statements of historical fact that can be identified by phrases such as “expects”, “anticipates”, “intends”, “aims”, “plans” and “believes”, and are based on expectations, estimates and projections as at the date of this news release. Forward-looking statements in this news release include, but are not limited to, the potential effects of low dose psilocybin and other psychedelic treatments, the potential use in treating mental health conditions and the timing and completion of Diamond’s clinical programs and trials. Forward-looking information is necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; delay or failure to receive applicable regulatory approvals; that factors may occur which impede Diamond’s future business plans; the results of continued development, marketing and sales; and other factors beyond the control of Diamond. 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 information. Diamond disclaims any intention or obligation to update or revise any forward-looking information in this news release, whether as a result of new information, future events or otherwise, except as required by law.

SOURCE Diamond Therapeutics Inc.

For further information: Rebecca Brown, rebecca@diamondthera.com

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PsyBio Therapeutics Files Patent Application with USPTO for Production Methods of Methylated Trypatamines and Associated Analogs

PsyBio Therapeutics Files Patent Application with USPTO for Production Methods of Methylated Trypatamines and Associated Analogs

PsyBio’s intellectual property portfolio now includes seven pending provisionals and one pending non-provisional patent application

Company has also initiated preclinical studies aimed at treating psychologic and neurologic conditions

OXFORD, Ohio and COCONUT CREEK, Fla., Aug. 16, 2021 /CNW/ — PsyBio Therapeutics Corp. (TSXV: PSYB, OTCQB:PSYBF) (“PsyBio” or the “Company“), an intellectual property driven biotechnology company developing novel formulations of psychoactive medications produced by genetically modified bacteria and other innovative mediums for the potential treatment of mental health challenges and other neurological disorders, has filed a new provisional patent application with the United States Patent and Trademark Office (USPTO) entitled Methods for the Production of a Methylated Tryptamines and Intermediates or Side Products, adding additional methylated tryptamines including compounds such as N,N-Dimethyltryptamine (“DMT”) and associated analogs for development of potential treatments for a variety of human health conditions. PsyBio’s intellectual property portfolio now includes seven pending provisionals and one pending non-provisional patent application.

The addition of methylated tryptamines with pending patent protection is focused on the potential improvement of treatments for mental health conditions including depression, anxiety and addiction, as well as other psychological and neurologic conditions.

DMT, as an example of a methylated tryptamine, is a tryptophan-derived alkaloid naturally present in certain plants and animals. DMT has an extensive history of being ingested as a mixture called Ayahuasca among several indigenous groups from the Northwestern Amazon for therapeutic purposes. Ayahuasca is a combination of DMT, made from the leaves of the shrub Psychotria viridis, and monoamine oxidase inhibitors required for DMT work, from the vine Banisteriopsis caapi. As a structural analog of serotonin, DMT binds a subset of serotonin receptors in the brain which is believed to be the basis for its purported therapeutic effect.

“This innovative technology adds a wide range of new potential drug candidates to PsyBio’s portfolio of microbially derived small molecules,” said Dr. J. Andrew Jones, Chairman of the PsyBio Scientific Advisory Board and Co-Inventor on the provisional patent application. “Leveraging the scalability and speed of a bacterial biosynthetic approach for these compounds is expected to lead to a cost competive synthesis with reduced environmental impact over current production methods.”

PsyBio has leveraged its expertise in synthetic biology, metabolic engineering, biomedicinal chemistry, clinical pharmacology and drug development using genetically modified organisms and, when appropriate, targeted synthesis to produce DMT and other relevant target analogs for potential therapeutic treatment of mental health challenges and other neurological disorders. PsyBio has filed intellectual property on a method for the production of a methylated tryptamine or an intermediate thereof utilizing a prokaryotic host. PsyBio intends to continue utilizing its resources to rapidly develop and test new drug candidates within this and other psychedelic categories in anticipation of launching future clinical trials.

“PsyBio continues to build a highly talented in-house team of world class scientists, engineers, medicinal chemists and pharmacology experts enabling the Company to build its intellectual property portfolio of novel drug candidates,” stated Evan Levine, PsyBio’s Chief Executive Officer. “The Company by design has high quality internal resourses to discover and actively screen compounds that could possibly have a positive impact on human health across a variety of medical indications. The Company is conducting scientifically designed experiments to leverage these new innovations and plans to move target candidates into scaled commercial manufacturing and regulatory application upon rigorous preclinical safety and efficacy testing, identifying a confirmed signal in one of our selected indications and receipt of all necessary regulatory approvals.”

“PsyBio’s strategy is to continually expand its drug discovery portfolio by adding additional classes of molecular targets, including methylated tryptamines such as DMT and related compounds,” said Michael Spigarelli, PsyBio’s Chief Medical Officer. “This concept allows PsyBio to prioritize selection and indication matching, moving the safest and most active single agent and combination therapeutic candidates forward into clinical trials.”

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is an intellectual property driven biotechnology company developing novel formulations of psychoactive medications produced by genetically modified bacteria for the potential treatment of mental health challenges and other disorders. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company is also researching and developing new non-naturally occurring molecular structures which may have unique therapeutics properties.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information“) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the ability of PsyBio to launch clinical trials; the ability of PsyBio to build its intellectual property portfolio of novel drug candidates; the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application; the ability to achieve cost competive synthesis with reduced environmental impact over current production methods; and the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will file its initial pre-Investigational New Drug (“IND“)  Application request and IND Application within anticipated timeframes; PsyBio will be successful in obtaining IND Applications and will be able to obtain all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favourable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The United States Food and Drug Administration (“FDA“) or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSX Venture Exchange (“TSXV“) has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release. 

SOURCE PsyBio Therapeutics Corp.

For further information: For further information contact: Evan Levine, CEO, PsyBio Therapeutics Corp., t: 513.449.9585, e: ir@psybiolife.com; Investor Enquiries: Valter Pinto / Tim Regan, KCSA Strategic Communications, t: 212.896.1254, e: valter@kcsa.com, https://www.psybiolife.com/

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Mindset Pharma Announces Publication of Three PCT Patent Applications for Its Next Generation Psychedelic Drug Candidates

Mindset Pharma Announces Publication of Three PCT Patent Applications for Its Next Generation Psychedelic Drug Candidates

TORONTO, Aug. 16, 2021 (GLOBE NEWSWIRE) — Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) (“Mindset” or the “Company”), a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs, today announced that the Patent Cooperation Treaty (“PCT”) has published three patent applications, covering a range of Mindset’s Family 1 and Family 2 compounds, under the publication numbers: WO/2021/155467, WO/2021/155468, and WO/2021/155470.

With a priority date of more than 18 months ago, the patent applications cover a comprehensive range of novel diverse proprietary compounds designed to deliver superior therapeutic benefits to psilocybin with lower overall metabolic and safety liability and more predictable duration of action, along with their related synthetic process methods, potential compositions, formulation methods and therapeutic uses. The applications include novel prodrug, conjugates, deuterated and non-deuterated derivatives of psilocin, as well as its side-chain restricted analogs.

“The publication of our PCT patent applications reaffirms the novelty of our approach and first-to-file advantage,” said James Lanthier, CEO of Mindset. “We continue to run in vitro and in vivo tests on these patent-pending compounds to further validate their superior efficacy and safety profile.”

Mindset’s Family 1 compounds leverage state-of-the art modern drug design using conjugated and deuterated psilocybin and psilocin design strategies to improve on psilocybin’s potential toxicity and pharmacokinetics profile. Mindset’s Family 2 compounds are next-generation psilocybin and psilocin drug candidates optimized for in-clinic settings. The Company has run a battery of highly specialized in-vitro and in-vivo tests on its patent-pending novel compounds to select the optimal psychedelic drug candidates for progressing towards human clinical trials.

To watch a video of Mindset’s CEO discuss the announcement in greater detail, please visit: https://youtu.be/SPx3KQB27Fw.

For more information, please contact:

Investor Contact:
Allison Soss/Tim Regan
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 212-896-1267/ 347-487-6788

Company Contact:
James Lanthier, CEO
Email: jlanthier@mindsetpharma.com

Jason Atkinson, VP, Corporate Development
Email: jatkinson@mindsetpharma.com
Phone: 416-479-4094

About Mindset Pharma Inc.
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds.

For further information on Mindset, please visit our website at www.mindsetpharma.com.

Forward-Looking Information

This news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “would”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. Additional information regarding risks and uncertainties relating to the Company’s business are contained under the heading “Risk Factors” in the Company’s annual information form for the financial year ended June 30, 2020 dated March 5, 2021. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law.

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

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Can psilocybin repair the brain?

Wesana Health Commences Functional Animal Study for Treatment of Traumatic Brain Injury

Recent research suggests that psilocybin promotes the growth of neurons in the brain, but is it enough to repair extreme brain damage? Some claim it can, and we’ll have more insights soon!

Wesana Health (WESA) began conducting functional animal studies to test a psilocybin-based regimen on traumatic brain injury (TBI) and is expecting to have results by the end of the year. The studies will examine the effect of different combinations of doses on locomotor activity, as well as on anxiety and depression, which are common side effects of brain injuries.

The company recently completed a preliminary study on TBI, anxiety and depression related to TBI, and migraines unrelated to TBI, and will complete a pivotal study based on the findings by the end of September.

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Treating meth addiction and brain damage

Revive Therapeutics Provides Update on Psychedelics Clinical Product Pipeline

Revive Therapeutics (RVV) is partnering with the University of Wisconsin-Madison to conduct two exciting new psilocybin studies.

One study will research the effect of psilocybin on traumatic brain injury (TBI) and strokes, expanding on preclinical findings that psilocybin improved cognitive function in mice with TBI.

Revive will also conduct a Phase 1/2 clinical study to determine psilocybin’s impact on adults with methamphetamine use disorder. Both studies will begin patient enrollment by the end of the year.

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