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CUREVAC, PSYBIO, EVOTEC – REVOLUTION IN THE BILLION-DOLLAR MARKET!

PSYBIO THERAPEUTICS – IN POLE POSITION

The topic of magic mushrooms is new only to the stock market. The history of “magic mushrooms” containing psychedelic substances goes back to the Aztec era. But it was not until the late 1950s that psilocybin and psilocin were isolated as the effective substances of the mushroom by the scientist Albert Hofmann, who also discovered LSD. The pharmaceutical Company Sandoz marketed synthetically produced psilocybin under the name Indocybin® for experimental and psychotherapeutic purposes. However, due to its abuse as a narcotic drug, LSD and other psychedelics were banned by the Reagan administration in the early 1970s.

In recent years, more studies have again been conducted to prove the positive therapeutic effects of drugs such as psilocybin, LSD and other hallucinogens to treat several otherwise untreatable mental disorders such as chronic depression, post-traumatic stress disorder and drug addiction. In this regard, PsyBio Therapeutics is one step ahead of the competition in bringing a revolutionary drug to market.

In collaboration with the University of Miami’s Department of Psychology, the Canadians work with other related compounds, studying their interactions and researching substances that work even better than pure psilocybin. The successful partnership with Miami University, which has already yielded several patents, was expanded last week. The neuropsychiatric drug discovery platform will be expanded to expedite the submission for approval of an investigational new drug, IND, to the FDA.

Overall, the Canadians see themselves as having a significant advantage over other competitors in research and patent prosecution. The unique selling point that favors PsyBio Therapeutics is a process that can produce psilocybin using bacteria significantly cheaper, faster and more environmentally friendly than any other published method. The Canadians are already a big player in the mental health space and this is demonstrated by recently announced personnel appointments. Bob Oliver, who has more than 25 years of experience in the pharmaceutical industry and has held various senior positions at Otsuka, Wyeth and Johnson & Johnson, is joining the Company, as is Dr. Michael Spigarelli, who has been appointed Chief Medical Officer.

PsyBio currently has a market capitalization of EUR 14.98 million. The industry is going strong right now. Companies in the same segment already have unicorn status. With its strong patents and successful collaborations, PsyBio Therapeutics could become a significant player in the fight against depression in the long term.

EVOTEC – COOPERATION EXPANDED

Good news from Evotec. The collaboration with Bristol Myers Squibb, which started in 2018, has now been extended by the Americans via option. As a result, Evotec will receive a payment of an unknown amount through the early extension. The partnership is ongoing in the field of targeted protein degradation. In addition, the screening is to be expanded and with it, the drug pipeline resulting from the collaboration.

Evotec Chief Scientific Officer Cord Dohrmann said, “Targeted protein degradation is an emerging new therapeutic modality with high potential to reach not only already validated targets, but also traditionally hard-to-reach targets, through a novel mechanism of action. This will allow first-in-class disease-modifying therapeutics to be explored and developed.”

CUREVAC – THE PROFITEER FROM THE CHAOS?

Missing vaccines in Germany, plus the confusion surrounding AstraZeneca’s vaccine. Now comes the next bad news. Since last weekend, the vaccine from BioNTech has also come under criticism. The Israeli Ministry of Health is investigating heart muscle inflammation cases that could be linked to the vaccine administration. The preliminary research mentions “dozens of cases” in which myocarditis has occurred. Myocarditis is an inflammation of the heart muscle, which can have various causes. The disease occurred mainly after the second dose, according to the Israeli coordinator for pandemic control, Nachman Ash.

The second German vaccine manufacturer, CureVac, is taking a little longer with its research. Now, however, the Tübingen-based Company is in the home stretch. The trial with CureVac’s Corona vaccine is nearing completion. Almost all of the 40,000 subjects have been vaccinated twice and the safety and tolerability data look very good, said study leader Peter Kremsner. He expects the vaccine to be licensed and vaccinated soon, he said. “It can happen very quickly now. It should work in June unless something else comes up.” It could always happen that the EMA still demands improvements, he said. If there is a vaccine to be added to the portfolio, it’s CureVac!

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CUREVAC, BIONTECH, PSYBIO: YESTERDAY’S GAME CHANGERS – AND TOMORROW’S?

CUREVAC: FROM SLOW-MOVING COMPANY TO BEACON OF HOPE

The Tübingen-based vaccine manufacturer CureVac was long overshadowed by BioNTech, its competitor from Mainz. The reason: the Mainz-based Company was quicker to market and was one of the first vaccines to be used worldwide. But the image problem surrounding AstraZeneca and the difficulties with the similarly designed vector vaccine from Johnson & Johnson are now giving CureVac’s Tübingen-based Company a boost. Even in regulation-loyal Germany, calls are being heard for special approval.

Even if this step does not succeed, CureVac has been on the home stretch since the cooperation with Bayer, which concluded in December. The Company set its sights on perfection early on, putting the goal of being among the first on the back burner. While the vaccine business is already largely over in countries such as the UK, Israel and the US, CureVac’s advanced mRNA vaccine could come at the right time for Europe. The share is already preparing to regain past performance highs. In addition to the EU, other countries that had increasingly hoped for Johnson & Johnson could also switch to CureVac. It is already certain that demand for the Tübingen-based vaccine exceeds supply. The share could still become a winner on the final stretch of the pandemic.

BIONTECH: WHAT IS STILL TO COME?

BioNTech is already a winner – the share is currently trading at an all-time high around EUR 127. The fact that the Company is promising was also evident after the approval in the USA, Europe and many other countries. Some market participants had expected BioNTech to run out of steam after the successful market launch, but it is now clear that, firstly, further booster vaccinations are needed and, secondly, that BioNTech is a leader in mRNA technology. In the future, the focus will also shift to preparations that help against diseases such as cancer. The Company and the share remain promising. However, investors should bear in mind that BioNTech has already priced in a lot of fantasy.

PSYBIO THERAPEUTICS: A PARADIGM SHIFT IN THE FIGHT AGAINST DEPRESSION

The US company PsyBio Therapeutics is at the very beginning of their journey. The Company is using research widely conducted in the US around the active ingredient psilocybin to develop drugs to combat depression. Psilocybin is found, among other things, in so-called magic mushrooms and is known as a hallucinogen. More and more scientists believe that the active ingredient, in precise doses and supported by therapeutic measures, can be very effective against depression. Even when the active ingredient is no longer detected in humans, the psychological effects remain. Since people often have overwhelming metaphysical experiences under the influence of these agents, drugs based on them are a potential game-changer.

PsyBio works closely with the University of Miami and enjoys several advantages thanks to its close relationship with the scientific community, such as working with and combining multiple compounds. PsyBio CEO Evan Levine points out in an interview, “We have a unique relationship with a major research university that gives us access to services and talent that many other companies do not have. Our collaboration with both the engineering and psychology departments at the University of Miami provides us with an unprecedented opportunity to explore novel combinations that competitors would have to queue up commercial service providers for.”

LOW VALUATION MEETS POTENTIAL BILLION-DOLLAR MARKET

While competitors, such as Compass Pathways, are already valued at more than USD 1 billion, PsyBio Therapeutics is currently worth only about USD 33 million on the stock market. Further, the Company has tens of millions in cash on hand. PsyBio Therapeutics, along with anchor shareholders who hold about 40% of the Company, sees itself on a long-term mission to continue researching psychoactive compounds to treat depression. “Psilocybin and related research offer a paradigm shift in the way mental illness and other disorders are treated by ‘rewiring’ the brain and changing the mind. Moreover, this new class of compounds is neither addictive nor lethal and has no negative side effect profile,” Levine said optimistically. With the stock trending sideways for weeks, the current level could be a good time for far-sighted investors – it is still early days for PsyBio.

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BIONTECH, FORMYCON, PSYBIO THERAPEUTICS: A CHANCE FOR NORMALITY?

BIONTECH – VACCINE ALSO FOR ADOLESCENTS

BioNTech SE from Mainz was in the right place at the right time. The German biotechnology company has been listed on the stock exchange since the end of 2019. It has focused on developing and producing active immunotherapies for the treatment of cancer and other serious diseases. BioNTech’s main focus today is research into mRNA-based drugs. These are considered for use as individualized cancer immunotherapies, vaccines against infectious diseases and protein replacement therapies for rare diseases.

The Company caused a sensation when the Federal Republic of Germany became involved in researching a Covid vaccine very quickly. Then came the cooperation with the pharmaceutical giant Pfizer from the USA, known to everyone through the sexual enhancer Viagra. At the beginning of 2021, a Covid-19 vaccine was finally ready to be used worldwide with an efficacy of over 90%. A tremendous German success story, even if in the USA, people often only talk about Pfizer.

Now comes more good news from the USA. The manufacturers Pfizer and BioNTech want to use their Corona vaccine in the USA in adolescents aged 12 and older. An application to expand the existing emergency approval for the vaccine has already been submitted to the Food and Drug Administration (FDA). The use of the vaccine in the US has only been approved for ages 16 and older. If the approval of the authority comes, this would once again boost the all-important vaccination rate worldwide. With the news, the BioNTech share easily surpasses EUR 100 again and is heading for its old high of EUR 109.5. As a result, a new upward cycle could be initiated.

FORMYCON – NO LONGER FAR AWAY

There have been several announcements at Formycon in recent weeks. From a pandemic control perspective, the most important of these is that FYB207, the compound under development, is even more effective against newer, more infectious mutations of SARS-CoV-2, such as the UK variant B.1.1.7, than against earlier less infectious variants. A study published in December 2020 already showed that the efficacy of FYB207 is not affected by so-called spike protein mutations. Spike protein mutations threaten the effectiveness of both vaccines and the majority of antibodies against SARS-CoV-2.

Since we can continue to assume that governments worldwide will not implement mandatory vaccination, the combination of the lack of compulsory vaccination and the non-rare immunodeficiencies can conclude that new SARS-CoV-2 infections will persist indefinitely. Looking only at the Western Hemisphere, Europe and North America, we can continue to expect about 300,000 SARS-CoV-2-related hospitalizations per year. So there is an urgent need for drugs that both mitigate the course and reduce the rate of new infections. Formycon will make a significant contribution here.

We expect Formycon to initiate a Phase I/II study with FYB207 as early as the end of 2021. Assuming that this study’s result is positive, we will very quickly apply for emergency approval for FYB207. As a result, the drug could be on the market as early as 2022. The share is currently consolidating in the EUR 58 to EUR 66 band. More news is likely to be needed for the next share price surge.

PSYBIO THERAPEUTICS CORP. – MOVING FORWARD WITH INNOVATIONS

Florida-based PsyBio Therapeutics Corp. is moving forward. PsyBio is a biotechnology company developing novel formulations of psychoactive drugs produced by genetically engineered bacteria to treat mental and other disorders. The research team has several years of drug development experience based on synthetic biology and its clinical applications.

They have just begun collaboration with the Advanced Biofuels and Bioproducts Process Development Unit, a national laboratory of the US Department of Energy, for the process development of a proprietary biosynthetic formulation of norbaeocystin. Norbaeocystin is an analog of psilocybin and is not a controlled substance. The Company has begun Phase 1 of this process, including technical transfer of analytical chemistry. The goal here is to identify capture methods for fermentation products as well as key raw materials. Work on this is fully underway.

By continuing its efforts in this research field, PsyBio expects to begin scaling up the production of its own biosynthetic norbaeocystin in preparation for use in clinical trials in the near future. An important point here is to develop more nature-inspired psychedelic therapeutics with improved properties over psilocybin monotherapy. Potential efficacy against depression, anxiety, PTSD, and substance abuse is hypothesized and will be clinically demonstrated through the trials. For PsyBio, this would clear the way for exponential growth.

PsyBio’s stock is currently trading between CAD 0.37 and CAD 0.45 in Canada. The corresponding market capitalization is about CAD 22 million. This is undoubtedly only the beginning of a longer story.

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PsyBio Therapeutics Retains KCSA Strategic Communications for Investor Relations Services

TORONTO, April 9, 2021 /PRNewswire/ — PsyBio Therapeutics Corp. (TSXV: PSYB) (“PsyBio” or the “Company“), a biotechnology company pioneering the next generation of targeted psychoactive medications, announces that it has entered into an investor relations agreement (the “Agreement“) with Kanan Corbin Schupak & Aronow, Inc. d/b/a KCSA Strategic Communications (“KCSA“) to provide investor relations services (the “Services“).

PsyBio has selected KCSA to enhance its visibility and profile in the financial community, as the Company continues to execute on its strategies. Pursuant to the engagement, and subject to the overall direction of the Company, KCSA will provide assistance in better engaging with current and potential investors of PsyBio and will work closely with the Company to develop and deploy a comprehensive capital markets strategy. Activities will include providing an investor relations program catering to the financial community, shareholders, and investors.

The provision of the Services are expected to commence on April 9, 2021 for an initial term of six months. The Agreement can be terminated at any time thereafter by the Company or KCSA by providing 30 days’ written notice to the other party of such termination.

Pursuant to the Agreement, KCSA will be paid a monthly fee of US$8,500 as consideration for the provision of the Services. KCSA will not receive any securities as compensation. The Company and KCSA act at arm’s length and KCSA does not currently own any securities of PsyBio, however, KCSA and its clients may acquire a direct interest in the securities of the Company.

The engagement of KCSA remains subject to the approval of the TSX Venture Exchange.

About PsyBio Therapeutics Corp.

PsyBio is a biotechnology company developing novel formulations of psychoactive medications produced by genetically modified bacteria for the treatment of mental health and other disorders. The team has experience in drug discovery based on synthetic biology as well as clinical and regulatory experience moving drugs through human studies and regulatory protocols. Research and development is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of halucinogenic 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 the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forwardlooking 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. 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 and filing new patent applications within the next year; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in obtaining Investigation New Drug Applications and will be able to obtain all necessary approvals for clinical trials; PsyBio’s technology will be safe and effective; 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 forwardlooking 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 forwardlooking 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 U.S. Food and Drug Administration (the “FDA“) or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products have 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 (the “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.

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Bioprocessing Psilocybin for Mental Health

Psilocybin mushrooms make tryptamines, which are responsible for their hallucinogenic effects, but also can be used to treat various mental-health conditions, from anxiety to PTSD.

At the Miami University in Ohio, J. Andrew Jones, PhD, assistant professor in the department of chemical, paper, and biomedical engineering, and his students have developed a new way to make these chemicals. PsyBio Therapeutics, where Jones is chairman of the scientific advisory board, is commercializing the process.

Jones and his team invented a one-pot method of bioprocessing with E. coli to make tryptamines. Starting with 4-hydroxyindole, the process developed by Jones produces psilocybin. He says that this technique provides three key advantages—cheaper, faster, and greener than other methods.

J. Andrew Jones, PhD [PsyBio Therapeutics]

Compared to chemical synthesis, for example, Jones points out that his method “does not require a lot of expensive reagents or multiple purification steps and produces much higher yields—about three times higher.” Plus, it only takes about four days of fermentation, which is twice as fast as synthesizing the compounds with yeast.

And lastly, the method created by Jones does not require the toxic reagents, such as palladium catalysts and hydride reducing agents required by other methods, making it overall a greener process.

Beyond these features, the technique that Jones created offers flexibility, making it easier to modify products. “We can quickly develop an optimized host using the right balance of genetic elements,” Jones explains. “So, our platform is fast in bioprocessing and also in strain development.”

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PsyBio Therapeutics appoints Dr Michael Spigarelli as chief medical officer to lead ongoing development of its drug discovery platform technology

He will provide PsyBio with decades of clinical product development experience, including clinical trial design and execution, data analytics and presentation, regulatory approval, and quality control

Psybio Therapeutics - PsyBio Therapeutics Corp appoints Dr Michael Spigarelli as chief medical officer to lead the ongoing development its drug discovery platform technology
Before joining PsyBio, Dr Spigarelli served as chief medical officer for Lumen Bioscience

PsyBio Therapeutics Corp (CVE:PSYB) announced Monday the appointment of Dr Michael Spigarelli as chief medical officer to lead the ongoing development of the company’s drug discovery platform technology.

Dr Spigarelli brings his extensive expertise in research and development of biopharmaceuticals including the clinical and regulatory strategy for numerous mental health therapeutics and other conditions, the company said in a statement.

He will provide PsyBio with decades of clinical product development experience, including clinical trial design and execution, data analytics and presentation, regulatory approval, quality control and GXP project management.

READ: PsyBio Therapeutics starts process development of its biosynthetic formulation of norbaeocystin, an analogue of psilocybin

“In this new role, Dr. Spigarelli will provide leadership and insight into clinical operations, research and development, regulatory and quality affairs and program management to lead product development of new psychoactive therapies,” said CEO Evan Levine.

“Mike’s unique combination of skills, from treatment to therapeutic device and diagnostic product development, including numerous US Food and Drug Administration and global regulatory approvals, will be critical for compiling pre-clinical data and clinical trial designs for IND submissions. We are excited to leverage his experience and demonstrate the full potential of our portfolio of psychoactive candidates as we move our products into clinical trials.”

Dr Spigarelli added: “What excites me is the unique position PsyBio is in to potentially develop numerous, novel, and clinically-needed solutions for individuals and their families suffering from a variety of mental health conditions. I am eager to lead the Company’s development and advance its strong pipeline of products through clinical development into human studies and, subject to receipt of all necessary approvals, onto the global markets. Such products will be studied to determine the potential efficacy to positively impact patients lives by better managing their mental health conditions.”

Before joining PsyBio Therapeutics, Dr Spigarelli served as chief medical officer for Lumen Bioscience. Prior to that, he served as vice president of medical affairs for Immucor Inc. During that time, he helped develop strategy and obtain FDA as well as global regulatory approval for numerous assays and reagents.

In connection with the appointment of Dr Spigarelli, the board of directors has agreed to grant him stock options to purchase up to 2 million subordinate voting shares. The options are exercisable at $0.35 each for a period of three years from the date of issuance.

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @PatrickMGraham

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PsyBio Therapeutics Initiates Process Development of Proprietary Biosynthetic Norbaeocystin

OXFORD, Ohio and COCONUT CREEK, Fla., March 23, 2021 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (“PsyBio” or the “Company“), a leader in the field of psychedelic research and drug development, has initiated process development of its proprietary biosynthetic formulation of norbaeocystin in collaboration with the Advanced Biofuels and Bioproducts Process Development Unit, a scale-up facility managed by Lawrence Berkeley National Laboratory, a U.S. Department of Energy national laboratory. Norbaeocystin is an analogue of psilocybin and is not a controlled substance. The Company has commenced Phase I of this process, including analytical chemistry technical transfer to establish detection methods for fermentation products and key feedstocks and metabolites.

“We are pleased to have moved our second product candidate intended to be utilized in conjunction with psilocybin from the laboratories of Dr. J. Andrew Jones at Miami University to a governermental research facility to begin preprarations to scale production of our proprietary biosynthetic norbaeocystin in anticipation for use in clinical trials,” said Evan Levine, Chief Executive Officer of PsyBio. “This is a continuation of our endeavors to develop more nature inspired psychedelic therapeutics with improved characteristics and properties versus monotherapy psilocybin which is currently being studied broadly for potential activity against depression, anxiety, PTSD and substance abuse.”

In collaboration with Miami University, Oxford Ohio, PsyBio is developing a portfolio of tryptamine derived therapeutic candidates inspired by plants and fungi with psychedelic properties that are intended to be studied in clinical trials to determine efficacy to improve patient outcomes for a variety of mental health and other disorders. Utilizing an efficient patent pending bacterial synthesis process, the Company is endeavoring to deliver a next generation of targeted psychoactive medications. It is expected that PsyBio’s method enabling the rapid generation of a highly stable compound will be cheaper, faster and greener than any other published production method.

“In recent years, psilocybin has been broadly accepted as a therapeutic candidate for a variety of health challenges, however, naturally occuring intermediates in the pathway have not shared similar research attention despite sharing many structural similarities to psilocybin”, stated J. Andrew Jones, Ph.D., Chairman of the Company’s Scientific Advisory Board. “Our research is based on studying these other metabolites from the biosynthetic pathway to potentially develop superior therapeutics with improved medicinal properties. Through our research collaboration with Dr. Matthew McMurray in the psychology department at Miami University and direct access to an in house vivarium, we have been developing and filing intellectual property on tryptamine combinations that have not previously been studied, yet have demonstrated early indications of unique properties that our team is optimizing for intended clinical use.”

About PsyBio Therapeutics Corp.

PsyBio is a biotechnology company developing novel formulations of psychoactive medications produced by genetically modified bacteria for the treatment of mental health and other disorders. The team has experience in drug discovery based on synthetic biology as well as clinical and regulatory experience moving drugs through human studies and regulatory protocols. Research and development are currently ongoing for naturally occurring tryptamines found in different varieties of magic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company is also researching and developing new molecular structures that do not occur in nature 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 the 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. In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including assumptions regarding: PsyBio’s ability to protect its intellectual property within the next year and its ability to file new patent applications within that timeframe; PsyBio’s ability to be successful in discovering new valuable target molecules; PsyBio’s ability to obtain Investigation New Drug Applications and obtain all necessary approvals for clinical trials; PsyBio’s ability to develop more nature inspired psychedelic therapeutics with improved characteristics; the safety and efficacy of PsyBio’s technology; that drug development involves long lead times, is very expensive and involves many variables of uncertainty; and that PsyBio’s technology will be cheaper, faster and greener than other published methods. 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 U.S. Food and Drug Administration (the “FDA“) or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products have 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 (the “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.

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PsyBio Therapeutics Virtually Closes the Market

TORONTO, March 22, 2021 /CNW/ – Evan Levine, Chief Executive Officer, PsyBio Therapeutics Corp. (“PsyBio” or “the Company”) (TSXV: PSYB) and his team joined Dani Lipkin, Director, Global Business Development, TMX Group to celebrate the Company’s new listing on TSX Venture Exchange and close the market.

PsyBio is a US-based biotechnology company developing a new class of drugs intended for the potential treatment of mental health challenges and other disorders. In collaboration with Miami University based in Oxford, Ohio, PsyBio has retained the global exclusive rights to a proprietary platform technology that biologically synthesizes psilocybin and other targeted next generation psychoactive compounds that are produced naturally in fungi and plants. Management of PsyBio expects that the technology will enable the rapid generation of these highly stable psychoactive compounds cheaper, faster and greener than other published methods. https://www.psybiolife.com/

SOURCE TSX Venture Exchange

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Psychedelic Therapeutics Reviewed by NeuroPerspective

SAN DIEGO, March 2, 2021 /PRNewswire/ — NeuroPerspective has released its March/April 2021 issue, featuring its first-ever, comprehensive review of the rapidly-expanding Psychedelic Therapeutics space, where substances formerly relegated to sacramental and/or illegal status are being formally tested as treatments for CNS disorders. Psilocybin, LSD, DMT, 5-MeO-DMT are some of the ‘classic’ psychedelic substances being explored, along with ’empathogens’ like MDMA, dissociative drugs like ketamine, esketamine, arketamine, and a few substances less easily categorized, like ibogaine and its derivatives.

NI Research
NI Research

As NeuroPerspective publisher Harry Tracy PhD notes: “This is not a fallacy or fad, there is already substantial clinical support for the use of psychedelic drugs based on thousands of case-reports and small-scale studies. Now, much more rigorous studies are underway. Already, there is a compelling body of work supporting clinical value in PTSD (where MAPS has had a successful PhIII trial), Treatment-Resistant Depression (Compass Pathways currently is running a PhIIb study), Cancer-related Pain/Anxiety, and Addictions. Other areas, like Eating Disorders, Phantom-Limb Pain, Cancer Pain  and intractable migraines, and even cognitive disorders like ADHD and Alzheimer’s, are being assessed for the potential usefulness of psychedelics.”

 

The Review assesses close to fifty companies involved in psychedelics research: Including MAPS, Compass Pathways, ATAI Life Sciences and its panoply of partnered programs (Viridia, Perception Neuroscience, DeMeRx, Entheogenix, EmpathBio); MindMed,  Beckley Psytech, Field Trip Health, MindCure, Diamond Therapeutics, MYND, Gilgamesh Pharma, Cybin, PsyBio, Small Pharma, Mindset,  Tactogen, Usona Institute, Entheon Biomedical, Eleusis, and many more. These companies cover the gamut of skillsets and viability, from well-founded to ephemeral pipedreams. The rationale for psychedelic mechanisms (e.g. classic 5HT-2a binding, impact on default mode networks) are reviewed, factors governing the path forward for the class are examined in detail.

Despite the numerous books, papers, and conferences that have sprung up in the past two to three years, no publication combines insights into the science, medical, and business underpinnings of the new wave of Psychedelics Therapeutics, and frank assessments of their prospects, like NeuroPerspective provides with this release.

The issue also includes a Company Spotlight appraisal of MindMed; a brief discussion regarding the aducanumab PDUFA extension, and coverage of six Alzheimer’s programs and their clinical news, including Cassava Sciences, Cortexyme, Lilly, and Biohaven.

The report contains 43 pages.

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PsyBio Announces Second Quarter Financial Results of Leo Acquisition Corp.

TORONTO, March 01, 2021 (GLOBE NEWSWIRE) — PsyBio Therapeutics Corp. (formerly Leo Acquisitions Corp.) (TSXV:PSYB) (“PsyBio”), a biotechnology company developing a new class of drugs intended for the treatment of mental health challenges and other disorders, announces the unaudited financial results of Leo Acquisition Corp. (now PsyBio Therapeutics Corp.) for the six month period ended December 31, 2020. A copy of the unaudited consolidated financial statements prepared in accordance with International Financial Reporting Standards and the corresponding management’s discussion and analysis for the three and six months ended December 31, 2020 can be found under PsyBio’s profile at www.sedar.com.

About PsyBio

PsyBio is a US-based biotechnology company developing a new class of drugs intended for the potential treatment of mental health challenges and other disorders. In collaboration with Miami University based in Oxford, Ohio, PsyBio has retained the global exclusive rights to a proprietary platform technology that biologically synthesizes psilocybin and other targeted next generation psychoactive compounds that are produced naturally in fungi and plants. Management of PsyBio expects that the technology will enable the rapid generation of these highly stable psychoactive compounds cheaper, faster and greener than other published methods

Cautionary Notes and Forward-Looking Statements

Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding PsyBio’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. These statements are not historical facts but instead represent only PsyBio’s expectations, estimates and projections regarding future events. These statements are not guaranteeing future performance and involve assumptions, risks and uncertainties that are difficult to predict. Therefore, actual results may differ materially from what is expressed, implied or forecasted in such forward-looking statements. The forward-looking information and forward-looking statements included in this press release are made as of the date of this press release. PsyBio does not undertake an obligation to update such forward-looking information or forward-looking information to reflect new information, subsequent events or otherwise unless required by applicable securities law. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date.

Investor Contacts:
Evan Levine
CEO, PsyBio Therapeutics Corp.
e: evan@psybiolife.com