This new partnership will see the distribution of the Company’s standardized, naturally derived, psilocybin containing mushrooms for therapeutic use at Healing Escapes Foundation retreats in Jamaica
Vancouver, BC – Havn Life Sciences Inc. (CSE: HAVN) (OTC: HAVLF) (FSE: 5NP) (the “Company” or “HAVN Life”) a biotechnology company pursuing standardized extraction of psychoactive compounds and the development of natural health products, is pleased to announce it has entered into a supply partnership with MPB Group Inc. (the “Supply Agreement”), a comprehensive outpatient mental health clinic with locations in Columbia and Laurel, Maryland that is helping adults, children, adolescents, couples, and families navigate the path to healing. MPB Group Inc. is partnered with Healing Escapes Foundation retreats, a non-profit organization focused on creating immersive, holistic mental health retreats for couples and adults in Jamaica.
HAVN Life will supply naturally derived psilocybin for use during Healing Escapes Foundation retreat programs, which operate in compliance with local and international protocols. The Supply Agreement will provide MPB Group Inc. with product from HAVN Life’s facility in Jamaica, where mushrooms are cultivated under GACP and processed in a GMP facility, ensuring greater consistency and more accurate dosing, as well as higher bioavailability compared to alternative local sources.
“We are thrilled to enter into a partnership with MPB Group Inc.,” says HAVN Life CEO Tim Moore. “For the past year, our Research and Development team has been working diligently in Jamaica, laying the foundation for our global supply of psilocybin mushrooms and related products. Because of the standardized, high quality of our naturally derived psilocybin, we are now attracting partners like MPB Group Inc., who are operating within the therapeutic retreat space and are happy to be able to meet this demand,” he adds.
“Together with the Healing Escapes Foundation, MPB Group Inc. is very excited about this collaboration with HAVN Life, due to the quality of their naturally derived psilocybin which will be offered at our psychedelic-assisted retreats – facilitated by licensed mental health clinicians in pristine Jamaica,” says Mika Uematsu, LCSW-C, Director of Trauma Recovery Program and Chief Psychedelic Officer.
Havn Life’s operations in Jamaica are facilitated by strategic partnerships with Hypha Wellness and P.A. Benjamin Manufacturing Company to provide cultivation and processing facilities for psilocybin containing mushrooms, solidifying relationships with local partners.
### On Behalf of The Board of Directors Tim Moore Chief Executive Officer
About HAVN Life Sciences Inc. HAVN Life Sciences is a biotechnology company pursuing standardized extraction of psychedelic compounds for the creation of APIs, the development of natural health products, and innovative therapies to support brain health and enhance the capabilities of the mind.
Through its research division, HAVN Labs, the company has developed an end-to-end supply chain of GMP naturally derived psychedelic compounds for research that will define the future of modern medicine. With its new line of natural health products, HAVN Life offers a full range of high-quality mushroom and plant extracts that help boost immune function, reduce inflammation and support a healthy lifestyle.
About MPB Group Inc. Founded in 2003, MPB Group Inc. is a comprehensive outpatient mental health clinic with a mission to provide comprehensive, accessible and culturally competent mental health services to adults, children, adolescents, couples, and families to heal from dysfunctional patterns of behaviour. MPB Group Inc. is partnered with Healing Escapes Foundation retreats in Jamaica – luxury, holistic mental health retreats that tap into the five senses to help escape, surrender and restore balance. For more information, please visit www.mpbhealth.com.
Forward-Looking Information: This news release contains “forward-looking information” within the meaning of applicable securities laws relating to statements regarding the Supply Agreement, the Company’s business, products and future of the Company’s business. Although the Company believes that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking information. Such forward-looking statements are subject to risks and uncertainties that may cause actual results, performance and developments to differ materially from those contemplated by these statements depending on, among other things, the risk that the supply of product pursuant to the Supply Agreement will not be completed as contemplated, or at all, risk that the anticipated benefits from the Supply Agreement will not be realized as contemplated, or at all, risks that the Company’s products and plan will vary from those stated in this news release and the Company may not be able to carry out its business plans as expected. Except as required by law, the Company expressly disclaims any obligation and does not intend to update any forward-looking statements or forward-looking information in this news release. Although the Company believes that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. The statements in this news release are made as of the date of this release.
The CSE has not reviewed, approved or disapproved the content of this press release.
VANCOUVER, BC — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), a homegrown, Canadian company producing natural, scalable, and accessible psychedelic and functional mushrooms, as well as synthetic formulations for transformational human experiences, is pleased to announce that it has entered into a supply agreement with SABI Mind, a Calgary-based clinic group providing psychedelic-assisted therapies.
The Company has signed an agreement which will provide SABI Mind’s trained clinical staff with supplies of GMP psilocybin and 3,4-Methylenedioxymethamphetamine (“MDMA”), pending the anticipated approval of its previously announced licensing amendment, for use by practitioners in psychedelic-assisted therapeutic protocols with approved patients via Health Canada’s Special Access Program, clinical trials, and academic studies.
“This agreement is an important step forward for both parties,” said Optimi Health CEO Bill Ciprick. “SABI Mind’s initiation of this agreement demonstrates a commitment to safe supply for the development and implementation of therapeutic modalities using psilocybin and MDMA.”
Clinical distribution is a major milestone in the growth of Canada’s psychedelics sector from the standpoints both of business operations, and as a medical option for those in need.
“There’s growing evidence that MDMA and psilocybin assisted therapies can help treat PTSD, depression and other chronic mental health conditions,” said Philippe Lucas PhD, SABI Mind President. “We’re very pleased to be working with Optimi to ensure a safe, consistent supply of psilocybin and MDMA to SABI patients qualifying under Health Canada’s Special Access Program.”
“As we continue to establish the logistical channels of our new industry, Optimi is extremely gratified to receive requests such as this,” added Ciprick. “The knowledge that the substances we produce, natural or synthetic, will be used by patients in a safe environment to further psychedelic science is a vindication of the principles on which this company was established.”
Optimi Health recently requested an amendment to its Controlled Substance Dealer’s Licence from Health Canada which would enable it to utilize its state-of-the-art analytical laboratory for the production of synthetic MDMA, among other substances.
SABI Mind currently operates a best-in-class clinic in the Sunalta area of Calgary, with expansions planned into Edmonton, Alberta and Victoria, British Columbia.
Authorized parties interested in purchasing Optimi psilocybin and functional mushroom products, MDMA, or other synthetic psychedelics are invited to contact sales@optimihealth.ca where a member of the sales team will respond within 24 hours.
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
Optimi Health Corp. is a homegrown, Canadian success story producing and supplying natural, EU-GMP grade psilocybin and functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable, natural mushroom formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe, natural EU-GMP psilocybin throughout the world. With a vertically integrated approach, Optimi is engaged in the cultivation, extracting, processing and distribution of high quality functional and psychedelic mushroom products at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.
About SABI Mind
Located in Calgary, SABI Mind supports the careful and necessary mending of mental health and chronic pain through psychedelic-assisted therapies. Founded by a group of Calgary-based entrepreneurs brought face-to-face with the challenges of those suffering from mental health conditions, SABI Mind empowers those discouraged by the conventional medical methods with a patient-centered treatment model supported by experienced psychiatrists, anesthesiologists, therapists, client experience specialists, and other clinic staff specially trained in ketamine-assisted psychotherapy and other psychedelic therapies.
FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:
This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, “forward‐looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to activities proposed to be conducted under the Company’s dealer’s license and associated business related to Psilocybin and Psilocin and Optimi’s plans, focus and objectives.
Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under “Forward‐Looking Statements” and “Risk Factors” in the Company’s Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi’s profile at www.sedar.com. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement.
Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
NEW YORK, June 28, 2022 /PRNewswire/ — AIkido Pharma Inc. (Nasdaq: AIKI) (“AIkido” or the “Company”) today announced that on June 23, 2022, the Company received a letter from the Listing Qualifications Department of The NASDAQ Stock Market indicating that it has regained compliance with the $1.00 minimum bid price requirement for continued listing on The NASDAQ Capital Market under Listing Rule 5550(a)(2). The Company regained compliance with the NASDAQ’s requirements when the closing bid price for the Company’s common stock was at or above $1.00 for 10 consecutive business days and the matter is now closed.
About AIkido Pharma Inc.
AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics. The Company’s platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV (coronavirus), MERS-CoV, Ebolavirus and Marburg virus.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the SEC, not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
Vancouver, British Columbia, June 28, 2022 – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical‐stage natural psychedelic drug development company, is pleased to announce that shareholders overwhelmingly approved all proposed resolutions at its Annual General Meeting (”AGM”) of shareholders held virtually this morning.
At the AGM, there were 28 holders of the common shares of Filament (the “Common Shares”) represented in person or by proxy, holding 68,830,831 Common Shares and representing 41.7% of Filament’s 165,126,713 issued and outstanding Common Shares.
All nominees in the management information circular dated May 20, 2022 were elected as directors of the Company. Detailed results of the vote for the election of Filament’s directors were as follows:
Class
Nominee
Votes in Favour
%
Votes Withheld
% Proxy
Common Shares
Ben Lightburn
68,443,081
100.00%
–
–
Chris Wagner
67,590,248
98.75%
852,833
1.25%
Greg Mills
68,309,748
99.81%
133,333
0.19%
Jon Conlin
67,589,848
98.75%
853,233
1.25%
Maureen O’Connell
68,443,081
100.00%
–
–
At the AGM, shareholders also approved: (i) the setting of the number of directors at five (5) and the appointment of the auditor of the Company and the authorization of the directors to fix the auditor’s remuneration. Detailed voting results for the meeting will be available on SEDAR.
ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)
Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.
Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. The forward-looking statements discussed in this press release may include, but are not limited to, information concerning the impact of the patent on the Company’s business and the ability of the Company to secure future patents. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including status of patent applications and the ability to secure patents. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.
GREENWICH, Conn., June 27, 2022 /PRNewswire/ — Ceruvia Lifesciences, a leading neurotransformational medicine biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug application for a Phase 2 clinical trial to determine the efficacy and safety of synthetic psilocybin (SYNP-101) in treating obsessive-compulsive disorder (OCD).
“With positive preliminary results from a Ceruvia funded pilot Phase 2 study taking place at Yale School of Medicine, we are excited to have received FDA approval to begin our Phase 2 clinical trial to examine the efficacy and safety of psilocybin in treating OCD,” said Carey Turnbull, Founder and CEO of Ceruvia Lifesciences. “With few effective treatment options available for the almost 4 million Americans who suffer from OCD, our Phase 2 clinical trial is an important step in helping these patients dramatically improve the quality of their lives.”
Ceruvia’s Phase 2, multicenter, randomized, double blind, active placebo controlled clinical trial will examine the safety and efficacy of synthetic psilocybin (SYNP-101) in treating OCD symptoms. The trial plans to enroll a total of 105 participants who will receive 25mg of SYNP-101 or the active placebo, niaicin. The primary endpoint of the trial is to determine the reduction in OCD symptoms for up to 12 weeks after a single administration of SYNP-101. Efficacy of treatment will be measured using the Yale-Brown Obsessive Compulsive Scale, the most used and validated tool for assessing the clinical severity of OCD symptoms. The trial will commence in the second half of 2022 and will be led by Principal Investigators Dr. Benjamin Kelmedi and Dr. Christopher Pittenger of Yale University School of Medicine.
About Ceruvia Lifesciences
Founded in 2017, Ceruvia Lifesciences is a clinical-stage biopharmaceutical company with a mission to improve the lives of underserved patients suffering from neurological and psychiatric disorders. Founded by Carey Turnbull, Ceruvia is relentlessly focused on the development and commercialization of neurotransformational medicines to deliver meaningful relief to patients suffering from hard-to-treat headache disorders, OCD and substance abuse disorder. For too long, these communities have been poorly understood and under-served. At Ceruvia, we believe they no longer have to live this way. Based on a long history of partnership with leading researchers at Yale University School of Medicine, NYU School of Medicine and Harvard Medical School, Ceruvia is undertaking clinical research in order to help them return to living their lives to the fullest. For more information, please visit www.ceruvialifesciences.com.
OXFORD, Ohio and DENVER, June 27, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), announces that it will be hosting its annual general and special meeting of shareholders (the “Meeting“) virtually at 11:00 am Eastern Time on Thursday, August 11, 2022, as further detailed in proxy materials being distributed to shareholders, which will be available under the Company’s profile on SEDAR at www.sedar.com.
At the Meeting, the Company intends to seek the approval of its shareholders to, among other things, potentially consolidate all of its issued and outstanding subordinate voting shares (“SVS“) and multiple voting shares (“MVS” and, together with the SVS, collectively, the “Shares“) on the basis of a consolidation ratio to be approved by the Company’s board of directors (the “Board“) in accordance with the Company’s articles (the “Consolidation Ratio“), provided that the Consolidation Ratio will be no greater than one post-consolidation Share for every 70 pre-consolidation Shares (the “Consolidation“). The Company is not contemplating any name change in connection with the Consolidation at this time. The Consolidation remains subject to the approval of the Company’s shareholders and acceptance by the TSX Venture Exchange (the “TSXV“).
If the Consolidation Resolution is approved by shareholders at the Meeting, subject to acceptance of the Consolidation by the TSXV, the Board will have discretion to determine when to implement the Consolidation, if at all, and shall determine the Consolidation Ratio at that time. The actual timing for implementation of the Consolidation, if any, will be determined by the Board based upon its evaluation as to when such action would be most advantageous to the Company. If the Board decides to move forward with the Consolidation, provided the Consolidation is approved by shareholders at the Meeting, the Company will disseminate a news release disclosing further details relating to the Consolidation, including the final Consolidation Ratio and the proposed date on which the Consolidation will be effected.
Effect of Consolidation
If the Consolidation is approved and implemented, the principal effect will be to proportionately decrease the numbers of issued and outstanding Shares, based on the Consolidation Ratio selected by the Board and within the range approved by shareholders.
There are currently 61,960,306 SVS and 49,378.706 MVS issued and outstanding. Assuming the maximum Consolidation Ratio of 70 pre-consolidation Shares for every one (1) post-consolidation Share, based on the number of Shares currently outstanding, for illustrative purposes only, the number of Shares issued and outstanding immediately following the completion of the Consolidation would equal approximately 885,147 SVS and 705.411 MVS.
Any fractional post-Consolidation SVS will be will be rounded down to the nearest whole number, and any fractional post-Consolidation MVS will be will be rounded down to the nearest three decimal points. Any such rounded fractional post-Consolidation Shares will be deemed to have been tendered by its registered owner to the Company for cancellation for no additional consideration.
Reasons for Consolidation
The Board is seeking authority to implement the Consolidation in order to reduce the number of Shares issued and outstanding, because the Board believes that: (i) it is desirable for its SVS to trade at a higher price per share, and the Consolidation could potentially result in such an increase; and (ii) an increased trading price could potentially broaden the pool of investors that may consider investing or may be able to invest in the Company, potentially increasing the trading volume and liquidity of the SVS. The Board anticipates that the Consolidation may result in certain additional ancillary benefits as well, which may not be known at this time. There can be no assurance that the Consolidation will result in any increase in the trading price of the SVS or improved trading volume and liquidity, and if such results occur there can be no assurance that this will be sustained.
The Board believes that the proposed range of Consolidation Ratios will provide it with the flexibility to implement the Consolidation in a manner designed to maximize the anticipated benefits to the Company since it is not possible to predict market conditions at the time the Consolidation may be implemented. In setting the Consolidation Ratio within the aforementioned range of ratios to implement, if any, following the receipt of shareholder approval, the Board may consider, among other things, factors such as: (i) the historical trading prices and trading volume of the SVS; (ii) the then prevailing trading price and trading volume of the SVS; (iii) the anticipated impact of the Consolidation on the trading market(s) for the SVS; (iv) the number of SVS that may be issued pursuant to outstanding securities exercisable or exchangeable for, or convertible into, SVS, and pursuant to the exercise of the issued SVS purchase warrants; (v) the overall reduction of the Company’s administrative costs; and (vi) prevailing general market and economic conditions.
About PsyBio Therapeutics Corp.
PsyBio is an intellectual property driven biotechnology company developing new, bespoke, fully approved, psycho-targeted therapeutics to potentially improve mental and neurological health. 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 utilizes a bio-medicinal chemistry approach to therapeutic development, in which psychoactive compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring, specifically because they are already known to have an effect within the brain.
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 Meeting; the Consolidation; the Consolidation Ratio; the Company’s expectation that the Company’s name will not be changed; treatment of fractional Shares in connection with the Consolidation; the effect of the Consolidation on the issued and outstanding Shares; the anticipated number of Shares outstanding post-Consolidation; the reasons for and potential anticipated benefits of the Consolidation, including increased trading price, volume and liquidity in respect of the SVS; that an increased trading price for the SVS could potentially broaden the pool of investors that may consider investing or may be able to invest in the Company; anticipated ancillary benefits to the Consolidation; PsyBio’s ability to build its intellectual property portfolio of novel drug candidates; PsyBio’s ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and PsyBio’s ability 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: the Meeting will be held as scheduled; the Consolidation will be approved by shareholders and accepted by the TSXV; the Consolidation will result in certain anticipated benefits to the Company and its shareholders; it is desirable for the SVS to trade at a higher price per share; the Consolidation could potentially result in such an increase which could potentially broaden the pool of investors that may consider investing or may be able to invest in the Company, potentially increasing the trading volume and liquidity of the SVS; and the Consolidation may have certain additional ancillary benefits. 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 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: that the Meeting could be rescheduled, adjourned or otherwise modified; that the post-Consolidation trading price of the SVS may be impacted by several factors in addition to the Consolidation, including the Company’s financial and operational results, its available capital and resources, the state of the market for the Shares at the time, general economic, geopolitical, market and industry conditions, the market perception of the Company’s business and other factors and contingencies which are unrelated to the number of Shares outstanding; that the Consolidation could not be approved by shareholders and/or by the TSXV, or that even if such approvals are obtained, the Board could determine in its discretion not to proceed with the Consolidation as planned, if at all; that the number of Shares outstanding on the record date for the Consolidation, if implemented, will be different than set out in this news release; that the Company may otherwise alter its authorized share structure or share provisions, including as set out in the proxy materials for the Meeting; 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; and 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 Statement 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 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: Evan Levine, CEO, PsyBio Therapeutics Corp., t: 513.449.9585, e: ir@psybiolife.com; Investor Enquiries: Valter Pinto and Tim Regan, KCSA Strategic Communications, t: 212.896.1254, e: valter@kcsa.com
Vancouver, BC — June 27, 2022 — Telescope Innovations Corp. (“Telescope” or the “Company”) (CSE: TELI), a chemical technology company, announces the creation of “Telescope Automation”, a division of the Company that develops automated systems to accelerate chemical and biopharmaceutical research and development. Telescope Automation is pleased to launch its first product, the Direct Inject Liquid Chromatography (“DILC”) platform, an innovative instrument for real-time, immediate analysis of chemical reactions. The DILC platform fuses Telescope’s proprietary hardware, software, and unique integration know-how with proven sampling technology supplied by an internationally renowned manufacturer of lab instrumentation (the “Sampler Manufacturer”). The Sampler Manufacturer is the global leader in enabling hardware and software technology that accelerates the development of chemical and biological processes.
“We have been engaged by several major global pharmaceutical companies to onboard our DILC platform,” said Jason Hein, Telescope CEO. “Telescope has already leveraged this enabling tool across all our operations, and we are now bringing this to market as an unrivaled capability to address an unmet need in process analytics. The versatility and robustness of our platform surpasses other existing solutions for online chemistry analysis.”
This product launch enables Telescope to capture the fast-developing market opportunity for the DILC system, generate revenue, and establish the Company as a partner of choice for process laboratory tool integration. The commercial deployment and insight provided by DILC technology will highlight, at an industrial scale, the unique combination of skills Telescope provides to support chemical, biopharmaceutical, and manufacturing process development.
About Telescope’s Direct Inject (DILC) Platform
The DILC platform enables rapid, robust online analysis of chemical reactions. Specifically, the system samples batch or continuous processes and automatically quenches, dilutes, and injects the samples into a high- or ultra-performance liquid chromatography (“HPLC” or “UPLC”) instrument. When combined with orthogonal techniques such as spectroscopic analysis, this system provides full, comprehensive profiles of chemical reactions in real time (Figure 1).
The DILC system is fully automated and uses the market leading in-situ sampling probe (sold by the Sampler Manufacturer) to deliver reaction samples to HPLC/UPLC instruments in pseudo-real time. The entire process is controlled through Telescope’s intuitive software for workflow management. The DILC system ensures precise and reproducible samples, especially in heterogeneous and multiphase reactions or reactions at sub-ambient or elevated temperatures and pressures. Furthermore the DILC system eliminates delays in quenching that typically lead to variable results and inaccurate analytical information.
Figure 1. Simplified schematic of Telescope’s DILC system in an online chemical analysis setup.
Telescope’s DILC system provides many advantages in chemical process analysis:
Rapid sampling frequency (the time period between sampling is near-HPLC method run times)
No sample aging (sample is delivered directly to analysis with no exposure to the external environment)
Adjustable dilution supporting a wide range of reaction concentrations
Telescope is a chemical technology company developing scalable manufacturing processes and tools for the pharmaceutical and chemical industry. The Company builds and deploys new enabling technologies including flexible robotic platforms and artificial intelligence software that improves experimental throughput, efficiency, and data quality. A key area of application for these tools is the development of scalable manufacturing processes for mental health medicines in the under-utilized tryptamine class of compounds, including psychedelic therapeutics. Telescope also applies these toolsets to resolve inefficiencies in industrial process chemistry and manufacturing. Our aim is to bring modern chemical solutions to meet the most serious challenges in health and sustainability.
Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of the prospectus filed by the Company and available at www.sedar.com.
Forward-looking statements in this document include expectations surrounding the intended operation and use of the DILC platform, the ability of the DILC platform to generate revenue and the commercial viability of marketing the DILC platform to existing pharmaceutical companies, and all other statements that are not statements of historical fact.
Examples of such assumptions, risks and uncertainties include, without limitation, assumptions, risks and uncertainties associated with the global COVID-19 pandemic, including the risk that the Company be deemed a non-essential business and asked to temporarily cease operations; general economic conditions; adverse industry events; the willingness of existing pharmaceutical companies to adopt and utilize the DILC platform; the Company’s ability to access sufficient capital from internal and external sources, and/or inability to access sufficient capital on favorable terms; the ability of the Company to implement its business strategies; competition; and other assumptions, risks and uncertainties.
These factors are not intended to represent a complete list of the factors that could affect the Company; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and the Company expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.
The CSE has neither approved nor disapproved the contents of this news release. Neither the CSE nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.
Vancouver, Canada, and Uttenweiler, Germany (June 27, 2022) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”) is pleased to congratulate Prof. Dr. Raimar Loebenberg as the 2022 recipient of the CSPS Award of Leadership in Canadian Pharmaceutical Sciences. Dr. Loebenberg is a Professor in the Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta (“UoA”), the founder and director of the Drug Development and Innovation Centre (DDIC), UoA, and is a director and founder of XPhyto since 2018.
The CSPS Award of Leadership in Canadian Pharmaceutical Sciences is bestowed upon an individual who has demonstrated leadership in advancing the cause of pharmaceutical research and development in Canada. Prof. Dr. Loebenberg received a Bachelor of Science degree in Pharmacy from the Johannes Gutenberg-University, Mainz, Germany and a PhD in Pharmaceutics from the Johann Wolfgang Goethe-University, Frankfurt, Germany. He joined the University of Alberta in 2000 where he is the founder and director of the Drug Development and Innovation Centre, Faculty of Pharmacy and Pharmaceutical Sciences. Prof. Dr. Loebenberg’s research interests are in biopharmaceutics to predict the oral performance of drugs and botanicals and inhalable nanoparticles to treat lung diseases such as lung cancer, tuberculosis and leishmanasis. He is a cofounder of RS Therapeutics Inc., a foam-based topical drug delivery company.
Prof. Dr. Loebenberg’s recent notable positions include: president of the Canadian Society for Pharmaceutical Sciences 2014 to 2015; vice chair of the United States Pharmacopeia Dietary Supplement Expert Committee 2016 to 2017; current member of the United States Pharmacopeia Dietary Supplement Expert Committee; current vice chair of the Specialty Committee of Traditional Chinese Medicine in Pharmaceutics of the World Foundation of Chinese Medicine Science; and current member of the Health Canada Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology and the Scientific Advisory Panel on Opioid Analgesic Abuse.
XPhyto is proud to have Prof. Dr. Loebenberg on its board of directors and leading its psychedelic medicine program with a multi-pronged approach including GMP drug synthesis, proprietary drug delivery systems, novel psychedelic analogue engineering, and clinical validation.
On PTSD Awareness Day, MAPS PBC announces plans to develop the New Drug Application for MDMA-assisted therapy in collaboration with MMS Holdings
The second Phase 3 trial of the Breakthrough-Designated Therapy for PTSD will be completed in late 2022, with a targeted NDA submission in 2023 supported by MMS Holdings
MMS Holdings was selected for extensive experience supporting neuroscience-related and first-in-class NDAs
MAPS Public Benefit Corporation (MAPS PBC) announced today that it has selected MMS Holdings (MMS), an award-winning data-focused contract research organization (CRO), as its CRO for the development of a New Drug Application (NDA) for MDMA-assisted therapy for posttraumatic stress disorder (PTSD). This announcement comes on PTSD Awareness Day and follows MAPS PBC’s May milestone: completing enrollment for the MAPP2, the second, confirmatory Phase 3 trials.
MAPP1, the first of two Phase 3 trials conducted by MAPS PBC to evaluate investigational MDMA-assisted therapy for the treatment of PTSD, showed that 88% of participants experienced a clinically significant reduction (≥10 points) in PTSD symptoms two months after the last experimental session, with no serious safety signals emerging. In addition to being granted Breakthrough Therapy designation, MDMA-assisted therapy has the potential to become the first-in-class FDA-approved psychedelic-assisted therapy.
MMS will support the NDA submission by providing regulatory strategy, biostatistics, statistical programming, medical writing, medical review, publishing, and submission project management support.
Part of our mission at MMS is using our decades of experience to bring life-changing therapies to positively improve patient lives worldwide. While PTSD was identified decades ago, we remain woefully behind with therapeutic treatment options. This collaboration with MAPS PBC and their groundbreaking therapy may change the course of PTSD treatment and could greatly impact those with the disorder.
MMS brings decades of experience developing new drug applications, averaging support for 8 to 12 annually and specializing in first-in-class and other challenging submissions with their creative approach. Since inception, MMS sponsors have not received a refusal to file or a complete response letter, giving MAPS PBC the confidence that a successful submission dossier will be submitted to the FDA.
MAPS PBC is excited to work with a Contract Research Organization like MMS that has years of neuroscience and regulatory submission experience.Together, we can work towards gaining FDA approval and bringing this treatment to patients and families who may greatly benefit from it.
Reaching completion of enrollment for the second Phase 3 study is an extraordinary achievement for this program and one step closer to submission of the NDA. I am confident that collaboration with MMS will lay the groundwork for a high quality regulatory submission.
This announcement comes on PTSD Awareness Day, observed annually to educate people about PTSD and its symptoms, reduce stigma toward people with mental injuries, and bring hope for improved treatments. It is estimated that more than 350 million people, including 12 million Americans, are estimated to experience PTSD from accidents, war, interpersonal violence, or other causes. Yet underdiagnosis is common, particularly among marginalized populations. PTSD may be misdiagnosed as a commonly comorbid condition such as anxiety, depression, or substance use disorder. While some first-line treatments are effective in the treatment of PTSD or its symptoms, dropout rates may be high or the treatments might have limited effectiveness for certain causes of trauma.
NOTE The safety and efficacy of MDMA-assisted therapy is currently under investigation. It has not yet been approved by the FDA or other regulatory authorities, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future regulatory approval or availability of MDMA-assisted therapy.
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ABOUT MMS MMS Holdings (MMS) is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Visit mmsholdings.com to learn more.
ABOUTMAPS Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS is sponsoring the most advanced psychedelic therapy research in the world: Phase 3 clinical trials of MDMA-assisted therapy for PTSD. Since MAPS was founded, philanthropic donors and grantors have given more than $130 million for psychedelic and marijuana research and education. MAPS has earned both the Guidestar Platinum Seal of Transparency and a 4-Star Rating from Charity Navigator.
ABOUTMAPS PUBLIC BENEFIT CORPORATION (MAPS PBC) MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, commercialization, and patient access of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization. MAPS PBC is the parent company of MAPS EU, formed to organize and administer clinical trials of investigational MDMA-assisted therapy for PTSD in the United Kingdom and European Union.
TORONTO–(BUSINESS WIRE)–Greenbrook TMS Inc. (TSX: GTMS, NASDAQ: GBNH) (“Greenbrook” or the “Company”), a leading provider of Transcranial Magnetic Stimulation (“TMS”) therapy in the United States, announced today an update on the status of its previously-announced proposed acquisition (the “Acquisition”) of Check Five LLC, a Delaware limited liability company (doing business as “Success TMS”) (“Success TMS”). Greenbrook and Success TMS continue to work diligently towards closing the Acquisition and now expect to complete the Acquisition in early Q3 2022.
“We are very pleased with the progress we have made in connection with the Acquisition. We believe the Acquisition will demonstrate our ability to deliver on one of the key pillars of our strategy for sustained growth”
As previously announced on May 15, 2022, Greenbrook entered into a membership interest purchase agreement pursuant to which Greenbrook will acquire Success TMS, along with an intention to secure additional debt financing from a third party-lender to fund the Company’s future expansion plans and for general corporate and working capital purposes.
As previously disclosed, on March 30, 2022, the Company received a waiver from Oxford Finance LLC (“Oxford”) with respect to the Company’s obligation under the existing credit agreement to deliver annual audited financial statements with respect to fiscal 2021 that do not contain any “going concern” or similar qualification or exception (the “Waiver”). As consideration for the Waiver, the Company covenanted that it would complete an equity and/or subordinated debt offering for proceeds of at least $12 million by June 30, 2022. In light of the ongoing Acquisition and proposed debt financing processes, Oxford has agreed to extend the Waiver to July 15, 2022.
“We are very pleased with the progress we have made in connection with the Acquisition. We believe the Acquisition will demonstrate our ability to deliver on one of the key pillars of our strategy for sustained growth,” said Bill Leonard, President and Chief Executive Officer. “This Acquisition will allow us to continue to expand our national footprint of TMS centers throughout the United States and accelerate our path to profitability. We are excited to begin working with our new colleagues at Success TMS who share our passion for delivering exceptional patient care to those suffering from depression and other mental disorders.”
About Greenbrook TMS Inc.
Operating through 148 Company-operated treatment centers, Greenbrook is a leading provider of TMS therapy, an FDA-cleared, non-invasive therapy for the treatment of Major Depressive Disorder and other mental health disorders, in the United States. TMS therapy provides local electromagnetic stimulation to specific brain regions known to be directly associated with mood regulation. Greenbrook has provided more than 840,000 TMS treatments to over 24,000 patients struggling with depression.
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