Utilizing their proprietary extraction method, Psyched will launch a line of products with AME-1, their Amanita Muscaria extract for sale in the United States
Toronto, Ontario–(Newsfile Corp. – June 29th, 2022) – Psyched Wellness Ltd. (CSE: PSYC) (OTCQB: PSYCF) (FSE: 5U9) (the “Company” or “Psyched“), a life sciences company focused on the production and distribution of health and wellness products derived from the Amanita Muscaria mushroom, is excited to announce the initial pilot production run of their first-to-market AME-1 product, Calm is scheduled for July 7th. Calm is presented as an extract which harnesses the mushroom’s ability to de-stress and facilitate restful sleep. The inaugural production of Calm signals the company is on track to transition from an R&D organization to a full-scale commercial consumer packaged goods (CPG) entity, generating revenue. All Amanita Muscaria products produced by Psyched Wellness will be available over-the-counter and without a prescription. This means the retail landscape is uncapped, maximizing distribution and listing potential. Calm will be the first legal Amanita Muscaria mushroom product sold in North America.
Chief Commercial Officer, Matthew Singh, commented: “The final formulation for Calm underwent many calibrations over the last few months. We feel an inherent responsibility to bring the absolute best product to market. Each calibration that improved our offering motivated the R&D, Operations, and Production teams to continue reformulating and optimizing until Calm reached its current form. It was important for our team to stay focused and not rush what is arguably the most integral part of product development. Our entire company is excited to share this version of Calm with the world (starting with a release in the United States).”
Assuming a successful pilot production, this will be a “first-ever” on multiple fronts. The team at Psyched plans on producing a craft number of units that will be used to test all flavor profiles and share them with opinion leaders. Updates on the pilot run can be expected 24 to 48 hours after production.
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Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
About Psyched Wellness Ltd.:
Psyched Wellness Ltd. is a Canadian-based health supplements company dedicated to the distribution of mushroom-derived products and associated consumer packaged goods. The Company’s objective is to create premium mushroom-derived products that have the potential to become a leading North American brand in the emerging functional food category. The Company is in the process of developing a line of Amanita muscaria-derived water-based extracts, teas and capsules designed to help with three health objectives: promote stress relief, relaxation and assist with restful sleeping.
Cautionary Statement Regarding Forward Looking Information
This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company’s current belief or assumptions as to the outcome and timing of such future events. The forward-looking information and forward- looking statements contained herein include, but are not limited to, statements regarding: the ability of the Company to develop Amanita Muscaria-derived products; the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; and (ii) the uses and potential benefits of Amanita Muscaria.
Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company’s ability to continue as a going concern; the Company’s ability to continue to develop its mushroom-derived products and associated consumer packaged goods; continued approval of the Company’s activities by the relevant governmental and/or regulatory authorities; and the continued growth of the Company.
These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the potential inability of the Company to continue as a going concern; risks associated with potential governmental and/or regulatory action with respect to the Company’s operations; competition within the psychedelics market; risks with respect to the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; and the risk that there is no potential benefit of Amanita Muscaria consumption.
Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.
Biotech Company Strengthens Strategic Intellectual Property Protection of Targeted Indication
San Diego, California — (June 29, 2022) – Tryp Therapeutics, Inc. (CSE: TRYP) (OTCQB: TRYPF) (“Tryp” or the “Company”), a clinical-stage biotechnology company focused on developing psilocybin-based compounds for diseases with unmet medical needs, announced today the filing of a new provisional patent for the use of psilocybin for the treatment of patients with Binge Eating disorder (BED).
The new patent application is part of Tryp’s corporate strategy to expand the clinical utility of psilocybin-assisted therapy in patients with BED who are awaiting transformative medicines. Tryp’s Phase II S.T.O.P. (Study of the Treatment of Overeating utilizing Psilocybin) trial in collaboration with the University of Florida, represents the first use of psilocybin in conjunction with psychotherapy as a therapeutic intervention in patients with BED. The initial data readout for the first patient dosed in the STOP trial showed potential benefit for patients with BED, further supporting the Company’s commitment to developing psilocybin based therapies for patients with eating disorders. Once issued, the new patent will provide Tryp with an Intellectual Property Protection for BED utilizing its psilocybin-based candidates TRP-8802 and TRP-8803.
“We have elected to pursue indications that are distinct from other industry players, thereby distinguishing our research and development pipeline among our peers,” said Jim Gilligan, Interim CEO and Chief Scientific Officer, Tryp Therapeutics. “TRP-8802, our clinical candidate, has shown promising early data endpoints. The expansion of our patent portfolio enables us to develop a psychedelic treatment in conjunction with psychotherapy for BED patients while also strengthening Tryp’s position as an industry leader with an expanding Intellectual Property Estate.”
Tryp is utilizing TRP-8802 to evaluate the use of psilocybin-related compounds in certain neuropsychiatric disorders in early-stage trials. In disorders where efficacy is indicated, Tryp’s lead drug candidate TRP-8803 which is being developed concurrently, will be studied in subsequent trials. TRP-8803 includes a unique formulation and delivery system and is designed to enhance the positive effects of psilocybin and psilocybin-related compounds, while markedly reducing the limitations of psilocybin dosed through other routes of administration, including oral, nasal and sublingual.
About Binge Eating Disorder (BED)
BED is characterized by recurring episodes of eating large quantities of food and feeling unable to stop.
Nearly 30% of people seeking weight loss treatments show signs of BED.
Up to 3.5% of females and 2.0% of males will develop BED at some point in their lives – nearly 4 million women and 2 million men in the United States; treatments to date have not been effective.
About Tryp Therapeutics
Tryp Therapeutics is a clinical-stage biotechnology company focused on developing psilocybin-related molecules, including TRP-8803, for the treatment of diseases with unmet medical needs through accelerated regulatory pathways. Tryp’s Psilocybin-For-Neuropsychiatric Disorders (PFN™) program is focused on the development of synthetic psilocybin-related molecules as a new class of drug for the treatment of binge eating, chronic pain, and other indications. The Company has begun enrolling patients in its Phase II trial for the treatment of binge eating disorder at the University of Florida and recently announced an upcoming Phase IIa clinical trial with the University of Michigan to evaluate TRP-8802 for fibromyalgia. TRP-8803 is a proprietary psilocybin-based product that uses a novel formulation and route of administration to potentially improve efficacy, safety and the patient experience. For more information, please visitwww.tryptherapeutics.com.
Media Relations: Francesca DeMauro KCSA Strategic Communications TRYP@KCSA.com
Forward-Looking Information
Certain information in this news release constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans,” “targets,” “expects” or “does not expect,” “is expected,” “an opportunity exists,” “is positioned,” “estimates,” “intends,” “assumes,” “anticipates” or “does not anticipate” or “believes,” or variations of such words and phrases or state that certain actions, events or results “may,” “could,” “would,” “might,” “will” or “will be taken,” “occur” or “be achieved.” In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.
Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp 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 Tryp’s final prospectus available atwww.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; 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 Tryp 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.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
The FDA lifted the clinical hold from a MAPS-sponsored Phase 2 study of MDMA-assisted group therapy for the treatment of posttraumatic stress disorder among veterans at the VA Portland Health Care System
This essential proof-of-principle study tests safety and logistics of group therapy, the first step in fully investigating the treatment for efficacy and broader patient access
The data-driven negotiation strategy included substudies of participants’ no-overnight stay conducted in the first Phase 3 trial of MDMA-assisted therapy for PTSD
After months of negotiations with the U.S. Food and Drug Administration (FDA), the Multidisciplinary Association for Psychedelic Studies (MAPS) has been permitted to initiate the MAPS-sponsored Phase 2 Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder (PTSD) in Veterans (MPG1). Despite its status as the world’s leading research center for PTSD, few Veterans Affairs (VA) facilities have hosted clinical trials of MDMA-assisted therapies for PTSD.
Though the study was approved by the VA Portland Health Care System Institutional Review Board months earlier, the FDA placed a partial clinical hold due to a theoretical safety concern surrounding a perceived need for overnight stays at the trial location, a requirement that was not part of the proposed study protocol. In response to the clinical hold, MAPS submitted safety data from a Phase 3 sub-study; the FDA agreed to lift the clinical hold on June 15, 2022.
In the early Phase 2 studies, we included overnight stays as an opportunity for the participants to rest and integrate what unfolded during their MDMA-assisted therapy session. Though we had no data to suggest there was a concern about safety overnight, these stays became required from the FDA perspective. In the Phase 3 program, we’re collecting safety data from participants with and without overnight stays to gather evidence to whether overnight stays are necessary. From the data we have so far, that doesn’t seem to be the case. We are pleased that the safety data in the Phase 3 substudy without overnight stays could support the FDA in making the data driven decision to permit no overnight stays in this important group study research.
The study is conducted by MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of MAPS, led by Chris Stauffer, M.D., and hosted within the VA Portland Health Care System. Eighteen Veterans in three cohorts of six will undergo the first of two MDMA-assisted therapy sessions individually and the second treatment session in their group cohort, along with individual and group preparation and integration sessions. If MAPS’ appeal was not granted, each cohort of six Veterans would have been obligated to stay overnight in the VA hospital after their MDMA-assisted therapy sessions.
There is so much yet to explore regarding the relational potential of MDMA-assisted therapy, and research on group therapy combined with MDMA sessions is a logical next step. What drives this work for me are the unique therapeutic properties of group cohesion that I’ve witnessed in my previous group therapy trials with oxytocin and psilocybin. If the FDA finds MDMA-assisted therapy to be safe and effective, the benefit of the group model for scalability and access could be an added bonus. My team and I are grateful that the FDA is permitting our innovative MDMA-assisted group therapy protocol, including sending Veterans home after MDMA sessions with a pre-screened and informed support person, to proceed.
The first Phase 3 trial of MDMA-assisted therapy for PTSD achieved encouraging results among participants with severe, chronic PTSD: two months after the final experimental session, 88% of participants experienced a ≥10 point reduction in PTSD symptoms and 67% no longer met the criteria for a diagnosis of PTSD. MDMA may be an effective catalyst for other therapy modalities commonly used in the treatment of PTSD. MAPS PBC is collaborating with experts in these modalities, trained through the MDMA Therapy Training Program, to explore the potential of other treatments through proof-of-principle studies such as MPG1. Group therapy, which can be a highly effective treatment for people with common experiences, may also be highly effective at reducing costs for patients. If this trial indicates the treatment may be safe and effective, further research of group therapy will be pursued as one element of MAPS’ comprehensive patient access and health equity programs.
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 MAPS 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.
ABOUT MAPS PUBLIC BENEFIT CORPORATION 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.
VANCOUVER, BC, CANADA (June 29, 2022) – LOVE Pharma Inc. (“LOVE” and or “the Company”) (CSE:LUV) (FSE: G1Q0), announces it has completed a second closing of its previously announced non-brokered private placement. The Company accepted subscriptions for 50,735,771 units at a price of $0.011 per unit, for gross proceeds of $558,093.50. Each unit consists of one common share and one common share purchase warrant. Each warrant entitles the holder to purchase one additional common share at $0.05 for a period of two years from the date of closing, subject to the option of the Company to accelerate the expiry date in the event that its shares trade at $0.15 or more for 10 consecutive days.
The Company paid $32,655.48 in cash and issued 2,968,680 broker warrants on the same terms as noted above, to qualified finders. Securities issued pursuant to this tranche are subject to trading restrictions until October 30, 2022.
Proceeds will be used for working capital and to review possible acquisitions.
About Love Pharma Inc.
With a focus on the global sexual Health and Wellness markets, Love Pharma Inc. (CSE: LUV) (FSE: G1Q0) was founded in 2020, with a mission to bring to market innovative products that enhance sexual health and wellness while providing an improved quality of life. Love Pharma holds exclusive licenses to produce market, package, sell, and distribute patent-protected therapeutic and pharmaceutical products throughout Europe, the United Kingdom, and North America.
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward Looking Statements
Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties. All statements other than statements of historical fact are forward-looking statements, including, without limitation, statements regarding future financial position, business strategy, use of proceeds, corporate vision, proposed acquisitions, partnerships, joint-ventures and strategic alliances and co-operations, budgets, cost and plans and objectives of or involving the Company. Such forward-looking information reflects management’s current beliefs and is based on information currently available to management. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “predicts”, “intends”, “targets”, “aims”, “anticipates”, “may” or “believes” or variations (including negative variations) of such words and phrases or may be identified by statements to the effect that certain actions “may”, “could”, “should”, “would”, “might” or “will” be taken, occur or be achieved. A number of known and unknown risks, uncertainties and other factors may cause the actual results or performance to materially differ from any future results or performance expressed or implied by the forward-looking information. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of the Company including, but not limited to, the impact of general economic conditions, industry conditions, risks relating to epidemics or pandemics such as COVID–19, including the impact of COVID–19 on the Company’s business, financial condition and results of operations, lack of investor demand for Bitcoin and/or Bitcoin futures exchange traded funds, and dependence upon regulatory approvals. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. The Company does not assume any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by securities laws.
Optimi CEO, Bill Ciprick, recently sat down with Investing News Network’s (INN) Stuart McNish to talk about a host of things all psychedelics and Optimi’s plan to commercialize and supply the next generation of natural psilocybin and synthetic psychedelic medicine.
– Closing of arrangement subject to regulatory approvals, including conditional listing approval by the TSX Venture Exchange. – Closing of the arrangement expected to occur in August. – Also announces closing of subscription receipt offering.
TORONTO, June 29, 2022 (GLOBE NEWSWIRE) — Field Trip Health Ltd. (TSX: FTRP, FTRP.WT, Nasdaq: FTRP) (“Field Trip” or the “Corporation”), a global leader in the development and delivery of psychedelic therapies, today announces that on June 29, 2022, it received final court approval in respect of the previously announced spin-out of its clinics business to Field Trip Health & Wellness Ltd. (“Field Trip H&W”) by way of plan of arrangement (the “Arrangement”).
Closing of the Arrangement remains subject to regulatory approvals, including the conditional listing approval of Field Trip H&W by the TSX Venture Exchange. It is expected that the closing of the Arrangement will occur on or around August 2022. Following the Arrangement, the Corporation will remain listed on the NASDAQ Stock Market and Toronto Stock Exchange, and Field Trip H&W, subject to exchange approval, will list on the TSX Venture Exchange.
Pursuant to the terms of the Arrangement, each share of the Corporation will be exchanged for one common share of the Corporation (to be renamed “Reunion Neuroscience Inc.” on consummation of the Arrangement) and approximately 0.86 of a common shares of Field Trip H&W.
Additionally, the Corporation announces the closing of a fully marketed “commercially reasonable efforts” brokered private placement of subscription receipts of Field Trip H&W led by Bloom Burton Securities Inc., on behalf of itself and a syndicate of agents that included Stifel GMP (collectively, the “Agents”) at an issue price of C$0.50 per Subscription Receipt for aggregate gross proceeds of C$2,100,000 (the “Offering”). The net proceeds of the Offering will be used by Field Trip H&W for clinic operating expenses, working capital, Arrangement expenses, as well as for general corporate purposes. Upon the satisfaction of certain escrow release conditions (the “Escrow Release Conditions”), each subscription receipt shall automatically be exchanged for no additional consideration into one Field Trip H&W common share.
On closing of the Offering, the gross proceeds from the Offering, less 50% of the Agents’ commission and all of the Agents’ expenses (the “Escrowed Proceeds”), were deposited and are held in escrow pending satisfaction of certain escrow release conditions, as agreed to by Field Trip H&W and the Agents, which include the satisfaction of all conditions precedent to the completion of the Arrangement and the receipt of all required regulatory and third party approvals to the Arrangement. Provided the Escrow Release Conditions have been satisfied on or prior to 4:30 p.m. (Eastern Time) on August 31, 2022, the Escrowed Proceeds will be released to Field Trip H&W.
For more details, shareholders are encouraged to read Field Trip’s management information circular dated May 20, 2022 and the supplement related thereto dated June 14, 2022 (collectively, the “Circular”), which is available under the Corporation’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov as well as at: Field Trip Health Ltd. – Governance Documents (https://www.meetfieldtrip.com/governance/governance-documents/default.aspx) must be followed. Please refer to the Circular in its entirety for further information.
About Field Trip Health Ltd.
Field Trip is a global leader in the development and delivery of psychedelic therapies. With our Field Trip Discovery division leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics and our Field Trip Health division building centers for psychedelic therapies opening across North America and Europe along with the digital and technological tools that will enable massive scale, we help people in need with a simple, evidence-based way to heal and heighten engagement with the world.
Follow us on Twitter and Instagram: @fieldtriphealth.
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Cautionary Note Regarding Forward-Looking Information
This release includes forward-looking information (within the meaning of Canadian securities laws and within the meaning of the United States Private Securities Litigation Reform Act of 1995) regarding Field Trip and its business. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such statements are based on the current expectations and views of future events of the management of Field Trip and are based on assumptions and subject to risks and uncertainties. Although the management of Field Trip believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies. Although Field Trip has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Field Trip does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Additional information relating to Field Trip, including its annual information form, can be located on the SEDAR website at www.sedar.com and on the EDGAR section of the SEC’s website at www.sec.gov.
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities.
Neither the Toronto Stock Exchange, nor its Regulation Services Provider, have approved the contents of this release or accept responsibility for the adequacy or accuracy of this release.
Completed strategic review and announced intention to separate the Field Trip Discovery and Field Trip Health divisions into two independent public companies.
Earned patient services revenues of $1.7 million in fiscal fourth quarter, an increase of 26.7% over the prior quarter and 228% year over year. Full year patient services revenue was $4.9 million, up from $0.96 million in the same period of the prior year.
At March 31, 2022, Field Trip had approximately $63.7 million in unrestricted cash and cash equivalents.
On April 5, 2022, granted U.S Patent for the first novel psychedelic molecule in development, molecule FT-104, for exclusive rights for the composition of matter, use and manufacturing of a family of hemi-ester compounds of hydroxytryptamines, including FT-104 until 2040.
In May, 2022, launched Field Trip at Home Powered by Nue Life, an advanced wellness platform for personalized, at-home psychedelic care. The program’s ketamine treatments, interactive companion app, and virtual aftercare programs, provides an alternative to in-clinic care for those seeking treatment, but who are unable to travel to one of Field Trip’s existing locations.
TORONTO, June 29, 2022 (GLOBE NEWSWIRE) — Field Trip Health Ltd. (TSX: FTRP; FTRP.WT; NASDAQ: FTRP) (“FieldTrip“), a leader in the development and delivery of psychedelic therapies, reported fiscal fourth quarter and full year 2022 results for the period ended March 31, 2022 and provided a business update. All results are reported under International Financial Reporting Standards (“IFRS“) and in Canadian dollars, unless otherwise specified.
Corporate Reorganization
Post quarter end, Field Trip announced the completion of its previously announced strategic review and the intention to complete a reorganization that will separate the Field Trip Discovery and Field Trip Health Divisions into two independent public companies (the Spinout Transaction). The reorganization will be completed by way of a Plan of Arrangement (the Arrangement). Field Trip Discovery will be renamed Reunion Neuroscience Inc. (Reunion) and continue to focus on the research and development of novel psychedelic molecules such as FT-104. Field Trip Health will be renamed Field Trip Health & Wellness Ltd. (Field Trip H&W) and will continue its focus on developing proprietary, competitive and differentiated psychedelic-assisted therapies (PAT) through innovation in therapeutic protocols, with a view of achieving the best patient outcomes in the treatment of mental health and mood disorders.
Pursuant to the terms of the Arrangement, each share of the Company will be exchanged for one common share of Reunion and approximately 0.86 common shares of Field Trip H&W. Following the completion of the Arrangement, Reunion will remain listed on the NASDAQ Stock Market and Toronto Stock Exchange, and Field Trip H&W, subject to exchange approval, will list on the TSX Venture Exchange.
Concurrent with closing of the Arrangement, Field Trip H&W is expected to complete a series of private placement financings (the Concurrent Financing) for gross proceeds of $20.0 million, led by Oasis Management Company and Field Trip. Following board approval on June 14, 2022, Field Trip announced that it will increase its initial investment from $5.0 million to $9.8 million for a 21.79% equity interest in Field Trip H&W.
On June 27, 2022, the Company announced its shareholders had approved the Arrangement and Concurrent Financing (thereby approving the Spinout Transaction), at a special meeting of shareholders. In addition, subject to completion of the Arrangement, shareholders approved the Field Trip H&W equity incentive plan and authorized Field Trip H&W to reserve and allot for issuance, and issue, upon the exercise of options, up to 10% of the number of common shares in Field Trip H&W issued and outstanding from time to time, on a non-diluted basis.
On June 29, 2022, the Company received final court approval for the Spinout Transaction by way of the Arrangement. The closing of the Arrangement remains subject to regulatory approvals, including conditional listing approval by the TSX Venture Exchange. It is expected that the closing of the arrangement will occur on or around August 2022.
The Company’s management team and the Board believe that the separation of the two business divisions will establish two independent, leading businesses in their respective areas in the psychedelics sector and ultimately result in maximized long-term value for the Company’s shareholders.
Joseph del Moral, Field Trip’s Co-founder and CEO, said, “Now that the strategic review has concluded, we are focused on the future for the separate drug development and clinics businesses and allowing them to execute on their respective strategic priorities. We are pleased that we were able to secure the financing to execute on our plan in the current challenging market environment, and we are confident that we are setting the companies up for long-term success and increased shareholder value.”
Key Highlights and Recent Developments
During the fiscal fourth quarter, Field Trip continued to advance its drug discovery work which is focused on the research and development of its novel molecule, FT-104, as well as other molecules under development, specifically the FT-200 series. The Field Trip Health clinics business achieved operational efficiencies and increased customer reach as well as announcing innovative strategic partnerships to offer new psychedelic-assisted treatment options.
Field Trip Discovery
FT-104
Field Trip Discovery is leading the development of the next generation of custom synthetic molecules targeting serotonin 5HT2A receptors. FT-104 is the first drug candidate in development by the Company. FT-104, given the name “Isoprocin Gutarate”, is anticipated to produce a psychedelic trip of about 2-3 hours. The structure of FT-104 is based on classical serotonin 2A psychedelics, like psilocybin, which have been reported to be useful in treating a variety of mood disorders, including depression, anxiety and substance abuse.
FT-104 completed Phase 1 enabling studies in early 2022 and is now entering the clinical stage of development in 2022. In late 2021, FT Discovery entered an agreement with an Australian Clinical Research Organization (CRO) to perform a Phase 1 trial with the objective to study the safety, tolerability and pharmacokinetics of single, escalating doses of FT-104 in healthy human volunteer participants. Exploratory objectives include characterization of the intensity, duration and subjective feeling of the psychoactive experience produced by the study drug. The Phase 1 protocol was developed in collaboration with our CRO and our clinical advisory team, was approved by the Human Research Ethics Committee and is being implemented at the clinical trial site where screening and recruitment have begun. Dosing of participants in the study is expected to begin shortly.
On April 5, 2022, the Company was granted a patent for claims related to FT-104. The patent application entitled, “Tryptamine Prodrugs,” grants exclusive rights to Field Trip for the composition of matter, formulations, methods of use and methods of manufacture for a family of hemi-ester compounds of hydroxytryptamines, including Isoprocin. Patent protection will extend to at least mid-2040.
FT-200 Group
During the quarter, Field Trip continued to progress research and development of its FT-200 molecule group. Research so far is showing that candidates in the FT-200 Group are demonstrating interesting pharmacological differences with classical psychedelics that might make them safer serotonin 2A (5HT-2A or “2A”) agonists with a broader use potential in mental healthcare. The aim of the work is to reduce or eliminate the potential for cardiovascular related harm by decreasing the relative activity at the serotonin 2B (5HT-2B or “2B”) receptor. Early stage candidates are under continued investigations.
Dr. Nathan Bryson, Field Trip’s Chief Scientific Officer, said, “Field Trip Discovery has benefited greatly from our association with the clinics division over the past 2 years to better understand the responsible use and enormous potential of psychedelic drug-assisted psychotherapy to produce durable relief for patients. As Reunion Neuroscience, we feel we bring a unique perspective to the development of the next generation, regulated psychedelic medicines, such as FT-104, a proprietary clinical-stage prodrug designed to produce a short duration experience, and FT-200, a family of molecules with potentially reduced cardiovascular risk profiles.”
Field Trip Health Centers
Throughout the fiscal fourth quarter, the Company continued to implement operational improvements to reduce costs and increase throughput at its Field Trip Health Centers. In addition, the clinics saw an improvement in marketing efficiency and revenue growth as a result of improved marketing and digital client acquisition strategies that have increased conversion of new clients to the clinics. Consequently, Field Trip Health Centers achieved fiscal fourth quarter revenue of $1.72 million, representing an increase of 26.7% over the prior quarter and more than three times higher than the same period of the prior year.
During the quarter, the Company announced the opening of its Vancouver, BC and Washington, DC locations. Coming out of the strategic review, and with the increased emphasis on client acquisition through its digital platforms, Trip and Field Trip at Home™, as well as ongoing efficiency improvements of its in-center offerings, Field Trip has deferred the opening of additional new clinics.
Subsequent to quarter end, Field Trip launched its Field Trip at Home™ Powered by Nue Life platform, which provides ketamine treatments from the comfort of a person’s home, providing an alternative to in-clinic care. Through this arrangement, Field Trip offers increased accessibility and convenience for those interested in pursuing the powerful treatment outcomes of ketamine therapy outside of a clinic setting through Nue Life’s at-home and telehealth offerings.
Ronan Levy, Field Trip’s Co-founder and Executive Chairman, commented, “Our Field Trip Health centers have played an important role in enabling access to ketamine and psilocybin assisted treatments that have helped change the lives of those living with depression, anxiety and other mental health conditions. With the future separation of the clinics business, we will be uniquely focused to build upon this strong foundation and direct our efforts into growth in client numbers, while also implementing operational improvements to scale efficiently, continuing the momentum of revenue growth we achieved during the fourth quarter. Furthermore, we will increase our focus on using digital platforms, such as Trip and Field Trip at Home™, to increase our reach. We will work to leverage our existing Field Trip Health Centers to maximize their impact while reducing capital requirements going forward.”
Financial Highlights
For the fiscal fourth quarter ended March 31, 2022, the Company earned patient services revenues of $1,724,102 from its twelve clinics in operation, an increase of $1,197,667 or 228%, over the fourth quarter ended March 31, 2021. The District of Columbia clinic began generating revenues in March 2022. On a year over year comparative basis, revenue of $526,435 in Q4 2021 was generated from the Toronto, New York, Santa Monica, Chicago and Atlanta clinics. The quarter over quarter revenue increase was in part due to the one additional clinic as compared to the prior quarter. Revenue for the fiscal year ended March 31, 2022 was $4,860,129, an increase of $3,899,234 or 406% over the prior fiscal year primarily due to twelve operating clinics compared to five in the prior fiscal year.
Net loss for the fiscal fourth quarter of $14,170,285 was primarily due to total operating costs of $14,323,644 as further detailed below. This compares with a net loss of $7,950,590 in the fiscal fourth quarter of 2021. The increase from the prior year primarily reflects the Company’s focus on growing the clinics business and continued investment in its drug development pipeline. Net loss for fiscal year ended March 31, 2022 of $54,691,130 was primarily due to total operating costs of $57,902,159 and $2,075,004 in interest expense and foreign exchange losses. Net loss for the comparative prior fiscal year was $23,117,607.
Total operating expenses in the fiscal fourth quarter were $14,323,644 and were comprised of the following: general and administration expenses of $7,432,602, patient services expenses of $2,691,335, research and development (R&D) expenses of $2,333,724, depreciation and amortization of $1,124,854, sales and marketing expenses of $434,781 and occupancy costs of $306,798. This compares with total operating costs of $7,752,620 in the fiscal fourth quarter of 2021. The year over year increase in total operating expenses is primarily due to increased general and administrative costs associated with being a public company, higher patient services expense due to larger number of clinics opened as well as higher R&D expenses as the Company progresses on its drug development programs, partially offset by lower sales and marketing and occupancy expenses. Total operating costs for fiscal year 2022 were $57,902,159 compared with $20,055,929 in fiscal year 2021.
Balance Sheet
As of March 31, 2022 Field Trip had unrestricted cash and cash equivalents and restricted cash of $64,496,653.
Selected Consolidated Financial Information
The following table sets forth selected financial information derived from the Company’s unaudited condensed interim financial statements for the fiscal fourth quarter and audited full year 2022 ended March 31, 2022 prepared in accordance with IAS 34 in a manner consistent with the Company’s annual audited financial statements. The following information should be read in conjunction with the financial statements and management’s discussion and analysis, which are available on the Company’s website at www.fieldtriphealth.com and under the Company’s SEDAR profile at www.sedar.com.
FIELD TRIP HEALTH LTD
STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
3 months ended
3 months ended
Fiscal Year Ended
Fiscal Year Ended
March 31, 2022
March 31, 2021
March 31, 2022
March 31, 2021
$
$
$
$
Revenue
Patient services
1,724,102
526,435
4,860,129
960,895
1,724,102
526,435
4,860,129
960,895
Operating Expenses
General and administration
7,432,602
4,130,894
32,276,757
10,514,029
Occupancy costs
306,798
433,279
1,667,985
897,391
Sales and marketing
434,781
714,223
3,893,426
1,686,941
Research and development
2,333,274
922,894
7,310,688
3,514,258
Depreciation and amortization
1,124,854
539,321
3,603,067
1,394,404
Patient services
2,691,335
1,012,009
9,150,236
2,048,906
14,323,644
7,752,620
57,902,159
20,055,929
Other Income (Expenses)
Interest income
84,349
38,714
425,904
51,037
Interest expense
(372,290
)
(112,928
)
(1,096,343
)
(303,296
)
Other income (expense)
(1,282,802
)
(611,158
)
(978,661
)
(1,600,172
)
Reverse takeover listing expense
–
(39,033
)
–
(2,170,142
)
Net Loss
(14,170,285
)
(7,950,590
)
(54,691,130
)
(23,117,607
)
Net Loss per Share – Basic and Diluted
(0.25
)
(0.18
)
(0.95
)
(0.70
)
Conference Call
The Company will conduct a conference call and webcast to discuss these results on Thursday, June 30, 2022 at 8:30 a.m. ET. To access the call, please dial 1-877-407-9716 (within the U.S.) or 1-201-493-6779 (outside the U.S.) and provide conference ID 13730739. A live webcast of the conference call can be accessed via the Events and Presentations section of the Field Trip Health Investor Relations website here.
For those unable to attend the live call, a telephonic replay will be available until 11:59 p.m. ET on Thursday, July 7, 2022. To access the replay dial 1-844-512-2921 (within the U.S.) or 1-412-317-6671 (outside the U.S.) and provide conference ID 13730739. The webcast will be archived and available in the Events and Presentations section of the Field Trip Health Investor Relations website approximately one hour after the conclusion of the live call.
About Field Trip Health Ltd.
Field Trip is a global leader in the development and delivery of psychedelic therapies. With our Field Trip Discovery division leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics and our Field Trip Health division building centers for psychedelic therapies opening across North America and Europe along with the digital and technological tools that will enable massive scale, we seek to help people in need with a simple, evidence-based way to heal and heighten engagement with the world.
Follow us on Twitter and Instagram: @fieldtriphealth.
To receive company updates about Field Trip and to be added to the email distribution list please sign up here.
Cautionary Note Regarding Forward-Looking Information
This release includes forward-looking information (within the meaning of Canadian securities laws and within the meaning of the United States Private Securities Litigation Reform Act of 1995) regarding Field Trip and its business. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such statements are based on the current expectations and views of future events of the management of Field Trip and are based on assumptions and subject to risks and uncertainties. Although the management of Field Trip believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including the timing, completion and potential outcomes of the Spinout Transaction, the funds available to Field Trip and the use of such funds, the ability of Field Trip to operate its clinics, the construction and commencement of construction of additional clinics, the development, patentability and viability of FT-104 and the FT-200 Group, the ability of Field Trip to complete an investigational new drug application and obtain regulatory approvals, as required, prior to initiating clinical trials for FT-104 and molecules within the FT-200 Group, the ability of Field Trip to meet eligibility requirements for clinical testing and through to more complex clinical trials, the ability of Field Trip to obtain regulatory approvals prior to each clinical trial and the ability of Field Trip to generate patient member growth, interest in the training program, interest in the various treatment programs by therapists and patients, the ability of management to sustain and continue optimization of its clinical operations, the timing and results of its research and development programs, approval of phase 1 human trials, if any, the risk that future clinical studies may not proceed as expected or may produce unfavorable results, the opening of additional clinics, the COVID-19 epidemic, the medical clinic industry, market conditions, economic factors, management’s ability to manage and to operate the business and the equity markets generally. Although Field Trip has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Field Trip does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Additional information relating to Field Trip, including its Annual Information Form, can be located on the SEDAR website at www.sedar.com and on the EDGAR section of the SEC’s website at www.sec.gov.
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities.
Neither the Toronto Stock Exchange, nor its Regulation Services Provider, have approved the contents of this release or accept responsibility for the adequacy or accuracy of this release.
Vancouver, B.C., June 28, 2022 – Pure Extracts Technologies Corp. (CSE: PULL) (OTC: PRXTF) (XFRA: A2QJAJ) (“Pure Extracts” or the “Company”), a plant-based extraction company focused on cannabis, hemp, functional mushrooms and the rapidly emerging psychedelic sector, is pleased to announce that its wholly-owned subsidiary, Pure Extracts Manufacturing Corp., has received a purchase order (PO) from the Ontario Cannabis Store (OCS) for its new, high potency, 1g vape carts. This Pure PullsTM branded product called 9 lb Hammer will be available in August for purchase through licensed, private retailers throughout the province of Ontario, and through the OCS’ online store.
This new distillate vape listing with its up to 90% THC potency and botanical terpenes has been created by Pure Extracts from its intellectual property consisting of 30+ proprietary formulations and will compliment the Company’s 1g full spectrum oil (FSO) CBD Blend vapes and 1g FSO THC GSC vapes that were previously listed by the OCS. Pure Extracts’ other OCS listings are Pure Chews edible Fire Burst THC gummies and Pure Chews edible CBD 100mg gummies.
With a trend towards higher potency cartridges as consumer preferences mature, demand for Pure Pulls 9 lb Hammer is strong across Canada as this refined THC distillate offers a strong, smooth and enjoyable experience to the consumer while generating high margins for the Company.
Pure Extracts’ CEO, Ben Nikolaevsky, remarked, “We are excited about receiving our largest ever PO by both dollar amount and unit count. And it’s especially gratifying to have received this PO from the OCS, in the largest and most competitive provincial cannabis market in Canada. This marks another successful milestone in the expansion of our line of branded products.”
About Pure Extracts Technologies Corp. (CSE: PULL) (OTC: PRXTF) (XFRA: A2QJAJ)
Pure Extracts features an all-new, state-of-the-art processing facility located just 20 minutes north of world-famous Whistler, British Columbia. The bespoke facility has been constructed to European Union GMP standards aiming towards export sales of products and formulations, including those currently restricted in Canada, into European jurisdictions where they are legally available. Pure Extracts was granted its Standard Processing License by Health Canada under the Cannabis Act on September 25, 2020, and its Sales Amendment on July 19, 2021. The Company’s stock began trading on the Canadian Securities Exchange (CSE) on November 5, 2020.
“Ben Nikolaevsky” Ben Nikolaevsky CEO and Director
This news release contains forward-looking statements relating to the future operations of Pure Extracts,
and the other statements are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of Pure Extracts’, are forward-looking statements and involve risks and uncertainties. A number of factors could cause actual events, performance or results to differ materially from what is projected in forward looking statements. Although we believe that the assumptions underlying these statements are reasonable, they may prove to be incorrect, and we cannot assure that actual results will be consistent with these forward-looking statements. Given these risks, uncertainties and assumptions, investors should not place undue reliance on these forward-looking statements. Whether actual results, performance or achievements will conform to the Company’s expectations and predictions is subject to a number of known and unknown risks, uncertainties, assumptions and other factors, including those listed under “Risk Factors” in the Company’s Annual Information Form. The Company does not undertake to update any forward-looking information, except as, and to the extent required by, applicable securities laws.
This news release contains information about potential sales revenue from supply agreements, which may be considered as disclosure of financial outlook under applicable securities laws. Such information is subject to the same assumptions, risk factors, limitations, and qualifications as set forth in the above paragraph. Specifically, estimated sales revenue which may be derived from supply contracts has been calculated based on current wholesale prices and assume, among other things, that the Company will be able to find buyers for its products. Financial outlook contained in this news release was made by management as of the date of this news release and was provided for the purpose of providing readers with an understanding of the potential revenue which may be derived from supply agreement recently entered into by the Company and are not an estimate of profitability or any other measure of financial performance. Readers are cautioned that the financial outlook contained in this document should not be used for purposes other than for which it is disclosed herein.
The CSE has neither approved nor disapproved the contents of this press release.
● Red Light Holland launches: ‘Red Light. Set. Go!’ program to work with exceptional local Oregonians from diverse backgrounds who wish to enter the legal psilocybin service market.
● Shunji Smith, Japanese American avid mushroom grower, teacher, and small business owner from Eugene, Oregon joins the program.
● Red Light Holland and Halo Collective mutually dissolve Red Light Oregon, Inc.
Toronto, Ontario–(Newsfile Corp. – June 28, 2022) – Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTC Pink: TRUFF) (“Red Light Holland” or the “Company“), an Ontario-based corporation engaged in the production, growth, and sale of a premium brand of magic truffles, is pleased to announce its updated plan regarding aiming to enter the legal psilocybin service market that will be created by the adoption of Measure 109 in the state of Oregon (“Measure 109“).
While some of the regulations in Oregon are still unclear at this time, Measure 109 intends to promote diversity and provide a head start to local Oregonians, which prompted Red Light to create the ‘Red Light. Set. Go!’ program (the “Program“) – a unique program aimed at working with exceptional Oregonians from diverse backgrounds who wish to enter the legal psilocybin service market. The Program will provide selected candidates with expert advice and funding to help them attempt to enter the legal psilocybin service market.
Shunji Smith, a Japanese American avid mushroom grower, teacher, and small business owner from Eugene, Oregon, is the first to team up with the Company under the Program.
“I’ve been a big believer in Red Light’s mission since I first heard of them and I’m very grateful to join this Program,” exclaimed Mr. Smith. “It’s a big dream of mine to enter the Oregon Psilocybin services market on the manufacturing side and with Red Light’s support, I believe together we can make a big impact,” added Mr. Smith.
“We noticed a big gap between Measure 109’s intentions and what we are seeing on the ground when it comes to promoting diversity and equity as the regulations are complex and entering the market requires initial capital that most individuals wishing to enter do not have access to” said Todd Shapiro, Chief Executive Officer and a Director of Red Light Holland. “Therefore, we established this Program to further align our vision with the intention of Measure 109 while seeking to provide value to our shareholders. With this Program, we will continue to grow our Mycelium network. Shunji has a combination of unique expertise and a deep passion for the promise of psilocybin services so we are very excited to work with him,” added Mr. Shapiro.
Measure 109 will make psilocybin services available to Oregonians 21 years and older without a need for medical diagnosis. The service must include a required prep-session, psilocybin session in a licensed facility supervised by a licensed facilitator and a possibility of an integration session. On December 31, 2022, the Oregon Health Authority will prescribe forms and regulations necessary for the exact implementation. To follow the current state of regulations in Oregon check out OHA website: https://www.oregon.gov/oha/PH/PREVENTIONWELLNESS/Pages/Oregon-Psilocybin-Services.aspx
Dissolution of Red Light Oregon, Inc.
Further to the Company’s joint press with Halo Collective Inc. (“Halo“) released date April 27, 2021, the Company wishes to announce that Halo and the Company have agreed to mutually dissolve Red Light Oregon, Inc.
“We wish Halo well, but after monitoring Oregon’s developments of Measure 109 very closely and having conversations with an Oregonian Senator, Measure 109 committee members, legal counsel and our direct Red Light team on the ground – we genuinely believe that our true alignment and best step forward is with our newly formed ‘Red Light. Set. Go!’ initiative. We are excited to work with Shunji and look forward to more advancements in Oregon,” said Sarah Hashkes, Red Light Holland Chief Technology and Innovation officer.
About Red Light Holland
Red Light Holland is an Ontario-based corporation engaged in the production, growth and sale (through existing Smart Shops operators and an advanced e-commerce platform) of a premium brand of magic truffles.
Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This press release contains certain “forward-looking information” within the meaning of applicable Canadian securities legislation. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current condition, but instead represent only the Company’s beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of the Company’s control. Often, but not always, forward-looking statements and information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company or its respective subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained in this news release. Examples of such information include statements with respect to: the future plans and goals of the Company; the success of the Program; future participants and guidelines of the Program; Red Light Oregon, Inc. being dissolved; the adoption of Measure 109 and future regulations surrounding psilocybin and the Company; the Company providing funding and expertise to Program participants; the continued growth of the Mycelium network; and future changes in legislation, including Measure 109 and the regulations surrounding psilocybin.
Forward-looking information in this news release are based on certain assumptions and expected future events, namely: continued approval of the Company’s activities by the relevant governmental and/or regulatory authorities; the continued growth of the Company; the Company meeting their anticipated timeline and process for growth, sales, production and commercialization; the Company’s products being safe and providing their anticipated benefits; continued demand for the Company’s microdosing products; the success of the Program, including the Company adding future participants to the Program; Red Light Oregon, Inc. being dissolved; the adoption of Measure 109 and future regulations surrounding psilocybin and the Company not changing such that the Program will be unable to continue; the Company providing funding and expertise to Program participants; the continued growth of the Mycelium network; and future changes in legislation, including Measure 109 and the regulations surrounding psilocybin not impacting the Company’s ability to fulfil its plans and goals.
Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, expectations regarding future growth and expansion of the operations of the business; regulatory and licensing risks; changes in general economic, business and political conditions, including changes in the financial and stock markets; risks related to infectious diseases, including the impacts of the COVID-19 pandemic; legal and regulatory risks inherent in the psychedelics industry, including the global regulatory landscape and enforcement related to psychedelics; political risks and risks relating to regulatory change; risks relating to anti-money laundering laws; compliance with extensive government regulation and the interpretation of various laws regulations and policies; public opinion and perception of the psychedelics industry; risks surrounding the success of the Program and the ability of the Company to gain future Program participants; risk that Red Light Oregon, Inc. will not be dissolved; risk that Measure 109 with not be adopted and/or future changes to regulations surrounding psilocybin and/or the Company’s business may hinder the ability of the Company to attain its goals and/or pursue its plans; risk that the Company will be unable to fund and/or provide expertise to Program participants; risks that the Company’s Mycelium network will no longer grow and/or plateau; and such other risks contained in the public filings of the Company filed with Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com.
Although the Company believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements. The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws.
Melbourne, Australia, June 28, 2022 – Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, wishes to advise that Dr Sud Agarwal has resigned as non-executive director.
Dr Agarwal’s key contribution to the Company was his strategic vision and foresight to originate Incannex’s proprietary cannabinoid combination drugs, IHL-42X, IHL-216A and IHL-675A (Combination Compounds). All pre-clinical and clinical studies undertaken to assess the Combination Compounds have been positive and the Company’s understanding of their medical and commercial potential has advanced significantly during Dr Agarwal’s tenure.
The clinical development activities associated with the Combination Compounds have been, and will continue to be managed by Chief Scientific Officer,Dr Mark Bleackley, who has been the Company’s lead contact with the U.S. Food and Drug Administration (‘FDA’) and all relevant regulatory bodies, with input from the medical and scientific advisory team and contracted clinical research organisations. All psychedelic research and development activities are managed and led by Dr Paul Liknaitzky and his team at Monash University, there will be no disruptions to the current operational structure of the development of the Company’s assets.
Appointments of Dr George Anastassov and Mr Lekhram Changoer With effect from the closing of Incannex’s acquisition of 100% of APIRx Pharmaceuticals, Dr George Anastassov, founding managing director of APIRx Pharmaceuticals, will replace Dr Agarwal on the board of directors. Co-founder of APIRx, Mr Lekhram Changoer (MSc) will join the Incannex management team as chief technology officer (CTO), responsible for the development and implementation of science and technical strategies for clinical and GMP-grade commercial manufacturing of pharmacotherapies.
Dr Anastassov and Mr Changoer will be employed by Incannex on a full-time basis. They will continue to drive the development of APIRx projects, whilst also being key members of the medical and scientific advisory team, assisting with the development of the Combination Compounds. Importantly for the progression of the Combination Compounds, Dr Anastassov and Mr Changoer are experienced with liaising and negotiating with FDA and the European Medicines Agency (EMA), having presented numerous regulatory submissions, including pre- investigational new drug (‘IND’) meeting packages and IND applications, to regulatory agencies over many years.
Furthermore, APIRx has strong relationships with international academic institutions and research hospitals including Mount Sinai School of Medicine, New York (USA), University of St. Andrews (UK), Free University of Amsterdam (NL), University of Wageningen (NL), and Mauritsclinics (NL). These relationships, among others, will be important to Incannex as all clinical research programs escalate.
Strategic rationale for collegial management adjustments Following research success in the Combination Compounds and the acquisition of APIRx pharmaceuticals, which has 22 distinct research and development projects, the board of directors recognise that the Company’s core strategic imperative to develop a diversified base of high-quality proprietary assets has been firmly established. The key imperative for Incannex now is the development of the Company’s proprietary drug candidates over which proof of concept has been established.
Further to the appointments of Dr Anastassov and Mr Changoer, a recruitment process is currently taking place for several full-time candidates with medical development and pharmaceutical commercialisation experience. Candidates from the United States are being sought.
Dr Agarwal’s resignation will also alleviate potential future conflict of interest issues pertaining to work undertaken by Cannvalate Pty Ltd, Dr Agarwal’s medicinal cannabis advisory firm. Dr Agarwal explained, “It is with some sadness that I move on from IHL and I wish the company success in it’s future drug development plans.”
Inncanex’s Managing Director and CEO, Mr Joel Latham said: “The Board of Incannex wishes to thank Dr Agarwal for his work on behalf of the Company and wishes him well for his future endeavours.”
This announcement has been approved for release to ASX by the Incannex board of directors.
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