FIELD TRIP HEALTH LTD.
MANAGEMENT’S DISCUSSION AND ANALYSIS
FOR THE THREE MONTHS ENDED JUNE 30, 2021 AND 2020
(Expressed in Canadian dollars, unless otherwise noted)
Management's Discussion and Analysis
For the three months ENDED JUNE 30, 2021 AND 2020
DATED: august 16, 2021
This Management’s Discussion and Analysis ("MD&A") for the three months ended June 30, 2021 and 2020, provides detailed information on the operating activities, performance and financial position of Field Trip Health Ltd. on a consolidated basis ("We", the "Company" or "Field Trip"). This discussion should be read in conjunction with the Company’s annual audited consolidated financial statements and accompanying notes for the fiscal year ended March 31, 2021 and for the period from April 2, 2019 (date of incorporation) to March 31, 2020 (“audited consolidated financial statements”). The financial statements have been prepared in accordance with International Financial Reporting Standards ("IFRS"), as issued by the International Accounting Standards Board (“IASB”), and are reported in Canadian dollars, unless otherwise noted.
The Company’s fiscal year commences April 1st of each year and ends on March 31st of the following year. The Company’s current fiscal year, which ends on March 31, 2022, is referred to as the "current fiscal year", "fiscal 2022", or using similar words. The Company’s current three months ended June 30, 2021, is referred to as the "current fiscal quarter, "first quarter of fiscal 2022", or using similar words.
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CAUTIONARY STATEMENT ABOUT FORWARD-LOOKING STATEMENTS
This document includes "forward-looking information" and "forward-looking statements" within the meaning of Canadian securities laws and within the meaning of the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, made by Field Trip that address activities, events or developments that Field Trip expects or anticipates will or may occur in the future are forward-looking statements, including statements preceded by, followed by or that include words such as "may", "will", "would", "could", "should", "believes", "estimates", "projects", "potential", "expects", "plans", "intends", "anticipates", "targeted", "continues", "forecasts", "designed", "goal", or the negative of those words or other similar or comparable words. Forward-looking statements may relate to future financial conditions, results of operations, plans, objectives, performance or business developments. These statements speak only as at the date they are made and are based on information currently available and on management’s current expectations and assumptions concerning Field Trip’s future events, financial conditions, results of operations, plans, objectives, performance, business developments, objectives or milestones. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking statements in this document include statements related to, the business and future activities of Field Trip, and developments related to, Field Trip after the date of this document, including but not limited to, statements relating to future business strategy, competitive strengths, goals, expansion and growth of Field Trip's business, operations and plans, including potential new revenue streams, the completion of contemplated expansion by Field Trip, changes in laws or regulatory requirements, the market for Field Trip's services, the impact of the COVID-19 pandemic, the business objectives of Field Trip and its research and development activities, the acceptance in the medical community of ketamine and other psychedelic substances as effective treatment for depression, post-traumatic stress disorder, addiction and other mental health conditions, the funds available to Field Trip and the use of such funds, the healthcare industry in Canada and the United States, the ability of Field Trip to operate the clinics, the development, patentability and viability of FT Discovery molecule FT-104, the ability of Field Trip to complete an investigational new drug application and obtain regulatory approvals, as required, prior to initiating any additional clinical trials for FT-104, 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. Forward-looking statements are subject to a number of known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from that which are expressed or implied by such forward-looking statements. These risks and uncertainties include those related to: the ability of Field Trip to secure additional financing for current and future operations and capital projects, as needed; risks associated with the application to list its securities, if at all, on the NASDAQ; future issuances or actual or potential sales of securities; negative operating cash flow and going concern; discretion over the use of proceeds; unpredictability and volatility of the listed securities of Field Trip; speculative nature of an investment in the securities of Field Trip; limited operating history as a public company; a significant number of common shares of Field Trip (the "Common Shares") are owned by a limited number of existing shareholders; the expected future losses of Field Trip and profitability; significant risks inherent in the nature of the health clinic industry; risks associated with failure to achieve its publicly announced milestones according to schedule, or at all; risks related to potential operations in Oregon and other jurisdictions that have passed or are considering measures to legalize psychedelics; risks associated with the regulation of psilocybin containing truffles and mushrooms in The Netherlands, Jamaica and elsewhere; reliance on drug developers; reliance on contract manufacturers; violations of laws and regulations; reliance on the capabilities and experience of its key executives and scientists; the possible engagement in misconduct or other improper activities by employees; the expansion of Field Trip's business through acquisitions or collaborations; risk of product liability claims; risks related to third-party licenses; changes in patent law; litigation regarding patents, patent applications, and other proprietary rights; reliance on third parties; no assurance of an active or liquid market; public markets and share prices; additional issuances and dilution; the ability of Field Trip to secure additional financing for current and future operations and capital projects, as needed, which may not be available on acceptable terms, or at all; Field Trip’s dependence on management and key personnel; general economic, market and business conditions, early-stage industry growth rates, the risks associated with competition from other companies directly or indirectly engaged in Field Trip’s industry; negative results from clinical trials; foreign currency exchange rate fluctuations and its effects on Field Trip’s operations; the risks and costs associated with being a publicly traded company, the market demand for the Common Shares; the impact of the COVID-19 pandemic; non-compliance with laws; medical personnel operating out of Field Trip's clinics; unfavourable publicity or consumer perception; patient acquisitions; drug development risks; substantial risks of regulatory or political change; the ability to obtain necessary government permits and licences; ketamine as a pharmaceutical; non-referral of patients; negative cash flow from operating activities; management of growth; intellectual property; litigation; insurance coverage; Field Trip being a holding company; the industry being difficult to forecast; conflicts of interest; enforcement of legal rights; emerging market risks; enforcement of legal rights in foreign jurisdictions; inadequate internal controls over financial reporting; agriculture risks; violations of laws and regulations related to drug development; reliance on third parties for drug development; ability to produce commercial grade pharmaceuticals; clinical testing; regulatory approval process; cyber-attacks; reliance upon insurers and governments; and difficulty in enforcing judgments and effecting service of process on directors and officers. . Other risks and uncertainties not presently known to the Company or that the Company presently believe are not material could also cause actual results or events to differ materially from those expressed in the forward-looking statements contained herein.
For a more detailed discussion of risks and other factors, see Field Trip's Annual Information Form (“AIF”) dated June 24, 2021 under the heading "Risk Factors", or otherwise disclosed in the public filings made with applicable securities regulatory authorities and available under Field Trip's SEDAR and EDGAR profiles.
There can be no assurance 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. Accordingly, readers should not place undue reliance on forward-looking information and statements. The forward-looking information and statements contained herein are presented for the purposes of assisting readers in understanding Field Trip's expected financial and operating performance and Field Trip's plans and objectives and may not be appropriate for other purposes.
The forward-looking information and statements contained in this document represent Field Trip's views as of the date of this document and forward-looking information and statements contained in the documents incorporated by reference herein represent Field Trip's views as of the date of such documents, unless otherwise indicated in such documents. Field Trip anticipates that subsequent events and developments may cause its views to change. However, while Field Trip may elect to update such forward-looking information and statements at a future time, it has no current intention of doing so except to the extent required by applicable law.
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The Company was formed on September 30, 2008, pursuant to an amalgamation under the Business Corporations Act (Alberta) and adopted the name "Newton Energy Corporation". On September 30, 2020, in connection with the Transaction (as defined below), the Company filed articles of amendment to: (i) consolidated its outstanding Common Shares on an eight (8) old for one (1) new basis; and (ii) change its name from Newton Energy Corporation to "Field Trip Health Ltd."
On October 1, 2020: (i) the Company and Field Trip Psychedelics Inc. ("FTP") completed a series of transactions resulting in a reorganization of FTP and the Company and pursuant to which the Company became the direct parent and sole shareholder of FTP; (ii) the Company changed its year end from December 31 to March 31; and (iii) the Company was continued under the Canada Business Corporations Act (the "Continuance") by Certificate and Articles of Continuance ((i) – (iii) collectively referred to as the "Transaction").
The Transaction constituted a Reverse Takeover of the Company by FTP under applicable securities laws.
The Common Shares were listed on the NEX board of the TSX Venture Exchange (the “TSXV”) until September 30, 2020, when they were delisted from the TSXV in connection with the completion of the Transaction. The Common Shares commenced trading on the Canadian Securities Exchange (the "CSE") on October 6, 2020, under the symbol "FTRP". The Common Shares were subsequently delisted from the CSE and listed on the Toronto Stock Exchange (“TSX”) on June 7, 2021 under the ticker symbols “FTRP” and “FTRP.WT”.
On July 29, 2021, the Common Shares commenced trading on the NASDAQ Global Select Market (“NASDAQ”) under the ticker symbol “FTRP”. Concurrent with the NASDAQ listing, Field Trip’s Common Shares ceased to be quoted on the OTCQX. The Company previously completed the process to ensure its shares are eligible for electronic clearing and settlement through the Depository Trust Company (DTC).
The Company's registered office and head office is located at 30 Duncan Street, Suite 401, Toronto, ON M5V 2C3. The following diagram describes the subsidiaries of the Field Trip, their place of incorporation, continuance or formation, and the percentage of the outstanding voting securities of each subsidiary that are beneficially owned, controlled or directed by the Field Trip.
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The Company operates through several subsidiaries. Please see “Business of the Company”.
|(1)||The above organizational chart excludes non-operating holding companies, which are immaterial to Field Trip’s operations.|
Business of the Company
Field Trip is a global leader in the development and delivery of psychedelic-assisted psychotherapy (“PAP”). PAP is gaining traction in response to clinical research and academic studies showing compelling evidence of its safety and profound efficacy in the treatment of mood disorders, such as severe depression, anxiety and PTSD, which are part of a growing, global mental health crisis.
Field Trip’s primary focus is to develop proprietary, competitive and differentiated psychedelic-assisted therapies (both through novel psychedelic molecules and innovation in therapeutic protocols), which achieve the best patient outcomes in the treatment of mood disorders. Structurally, the focus of our research and development strategies is established by our Field Trip Discovery (“FT Discovery'') division, which is then executed through contract research and manufacturing organizations for molecule development through Field Trip Psychedelics Inc. (“FTP”) and our botanical research arm through Field Trip Natural Products Inc. (“FTNP”), as well as our Field Trip Health (“FT Health”) division, which operates clinics across North America and Europe, for therapeutic protocol research and innovation. In addition to the research and innovation focus, the clinics operated by FT Health operate as patient treatment centers where our medical teams can develop hands-on knowledge and experience to i) further improve on the existing therapeutic protocols to optimize and customize the safe and effective delivery of PAP; ii) identify new indications with existing and novel psychedelic medicines, such as FT-104 and future pipeline drugs under well-controlled conditions, and iii) evaluate the safe and effective use of digital tools developed by our Field Trip Digital (“FT Digital”) division to support and enhance the patient outcomes and experience.
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We believe an integrated approach, combining novel psychedelic drug development, optimized therapeutic protocols and digital tools will significantly increase the likelihood of success of Field Trip’s ultimate goals of successfully commercializing novel PAP therapeutics and therapies. Our clinic infrastructure also allows us to interface and develop relationships with all the critical stakeholders, including patients, therapists, referring physicians, regulators, payers and providers, so as to fully understand the regulatory and commercial landscape for the delivery of KAP and PAP and to define the pathways for market success of our medicines and therapies.
FT Discovery - Advanced Research and Drug Development
FT Discovery is leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics. Through FT Discovery, the Company performs research on botanical psychedelics and psychedelic-based molecules for future therapeutic application of select mental health indications. FT Discovery has two independent activities: (i) developing custom synthetic molecules targeting serotonin 5HT2A receptors, which are, in part, implicated in mood disorders; and (ii) conducting research and development related to the cultivation, as well as the identification and isolation of new substances contained in psilocybin mushrooms and other related fungi (the "Psilocybin Research"), in collaboration with the University of West Indies ("UWI"). Pursuant to a research agreement with UWI (the "UWI Agreement"), the Company has built a 2,072 sq. ft. custom-built research and cultivation facility on the UWI campus (the "Jamaica Facility") to conduct the Psilocybin Research. Further, Field Trip anticipates that insights relating to the administration of psychedelics and psychedelic-assisted psychotherapy within the Clinics can be integrated in the Company's approach to novel drug development.
Psilocybin, along with other synthetic and natural serotoninergic psychedelics, act to stimulate 5HT2A receptors in the brain resulting in a profound alteration of normal brain signaling and processing, creating what is generally referred to as a "psychedelic experience" or an "altered state of consciousness." Under psychedelics, the brain "escapes” from its usual tightly constrained and predictable patterns of operation, with a global increase in connectivity of brain regions and brain networks. Often, this can allow patients new introspective insights about their past behavior, memories, actions, feelings and beliefs. Psychedelic drug administration combined with psychotherapy can lead to improvements in conditions relating to depression and addiction, which are often a result of dysfunctional brain processing. FT-104 is the first drug candidate in development by FT Discovery. FT-104 is a next generation, synthetic psychedelic molecule whose design is, in part, based on classical serotonin 2A psychedelics. USPTO and PCT patents are pending on FT104’s structure, formulation and use in treating a variety of central nervous system disorders.
Clinics - Field Trip Health Centres
Field Trip believes there is a unique early mover opportunity to build the clinical infrastructure required to meet the anticipated significant demand for psychedelic-assisted therapies. MDMA and psilocybin are expected to receive FDA approval in the next 2 to 5 years. Our Field Trip Health Centres hold significant strategic value in that they enable us to collect large amounts of data from patients on clinical outcomes associated with the set, setting and therapeutic protocols of psychedelic therapies. This data allows us to not only identify areas of unmet need in psychedelic therapies, but also innovate new models and protocols. Our focus with Field Trip Health Centres is to rollout clinics across North America and Europe to position Field Trip as the leading global brand of trusted clinics for psychedelic-assisted therapies, providing ketamine-assisted therapy in North America and psilocybin-assisted therapies in The Netherlands and other jurisdictions, where permitted, for the effective and affordable treatment of depression, anxiety, addiction and other conditions.
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Ketamine is the first, and until opening of the Netherlands location, the only psychedelic administered to patients in conjunction with our custom developed psychotherapy protocol. Beyond its antidepressant effects, ketamine’s ability to promote neural plasticity makes it a powerful tool to pair with Field Trip’s comprehensive psychotherapy program to affect behavioral change. More specifically, Field Trip offers or plans to offer the following types of therapy:
|●||Ketamine-assisted psychotherapy ("KAP") is a clinic-based treatment that combines the administration of ketamine dosing sessions with exploratory and integrative psychology to accelerate the process of discovery, understanding, catharsis and eventually healing. KAP sessions last longer than traditional therapy, are conducted with medical and psychological support and may include therapy-enhancing tools such as music. KAP is available directly through Field Trip or through cooperative agreements with independent psychotherapists who make arrangements for Field Trip to provide ketamine sessions as an adjunct to psychotherapy offered by those independent psychotherapists.|
|●||Psychedelic-assisted psychotherapy combines the use of psychedelic medicines with psychotherapy sessions and other enhancing therapies in a clinical setting. KAP is a type of psychedelic-assisted psychotherapy, that uses ketamine as the psychedelic catalyst.|
|●||Psychedelic-integration psychotherapy consists of one or more psychotherapy sessions to support a patient’s understanding and processing of past psychedelic experiences through reflection and integration of those experiences. Psychedelic-integration psychotherapy can be combined with psychedelic-assisted psychotherapy, including KAP, or may be employed on its own to integrate patient experience outside of a clinical setting. Psychedelic-integration psychotherapy may be offered in a one-on-one or group setting.|
|●||And Beyond Therapy consists of ongoing psychotherapy with the goal of building on the insights gained through KAP and identifying and reinforcing changes to ongoing negative patterns of thought and behaviour. The And Beyond Program is made available through contractor psychotherapists to patients who have had one or more sessions of KAP|
While the use of ketamine in KAP is considered "off-label", such use is legal under medical supervision. As such, ketamine is currently the only legal psychedelic medicine generally available to mental health providers in Canada and the United States. As additional psychedelic medicines become available for use in a therapeutic setting and novel psychedelic medicines become available, Field Trip intends to explore the use of other methods of psychedelic-assisted psychotherapy.
Currently, Field Trip operates and owns clinics in Toronto, Ontario, New York, NY, Santa Monica, CA, Chicago, IL, Atlanta, GA and Houston, TX through physician practices or professional medical corporations ("PCs"), which are owned solely by state-licensed physicians. The PCs’ results are consolidated with Field Trip (see Note 2 Basis of Presentation in our audited annual consolidated financial statements for a detailed discussion of the basis for consolidation). During the current fiscal quarter, the Company commenced construction to build Field Trip Health Centres in San Carlos, CA, Seattle, WA, Austin, TX, Fredericton, NB, Vancouver BC, Stamford, CT and Washington DC. We completed construction of our Amsterdam, The Netherlands location in June 2021 and began accepting patients in July 2021.
FT Digital: Trip and Portal
FT Digital has developed Trip, a mobile application supporting consciousness expansion which is available to users in the Apple and Android app stores, and Portal, a digital health platform to support clients participating in psychedelic therapies at Field Trip Health centers. Our Trip app’s user base grew by 72% from the previous quarter. Portal is a next generation telehealth platform that connects our patients and therapists with individualized patient journeys and content, along with tools such as mood monitoring, journaling, and activity tracking. The feature-sets of both platforms are expected to grow significantly in the coming fiscal year.
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Field Trip operates in a highly regulated industry and in multiple jurisdictions. Below is a summary of key elements of the regulatory environment in which Field Trip operates. Please refer to Field Trip’s AIF for further information.
The Canadian and United States federal governments regulate drugs through the Controlled Drugs and Substances Act (Canada) (the "CDSA") and the Controlled Substances Act (21 U.S.C. § 811) (the "CSA"), respectively, which place controlled substances in a schedule. Under the CDSA, ketamine is currently a Schedule I drug and psilocybin is currently a Schedule III drug. Under the CSA, ketamine is currently a Schedule III drug as well as being listed under the associated Narcotic Control Regulations, and psilocybin is currently a Schedule I drug.
Most US States have enacted Controlled Substances Acts (“State CSAs”), which regulate the possession, use, sale, distribution, and manufacture of specified drugs or categories of drugs and establish penalties for State CSA violations, form the basis for much state and local drug laws enforcement activity. State CSAs have either adopted drug schedules identical or similar to the federal CSA schedules or, in some instances, have incorporated the federal scheduling mechanism. Among other requirements, some States have established a prescription drug monitoring or review programs collect information about prescription and dispensing of controlled substances for the purposes of monitoring, analysis and education. Field Trip complies with all State CSAs in jurisdictions where it operates.
In the United States, facilities holding or administering controlled substances must be registered with the US Drug Enforcement Agency ("DEA") to perform this activity. As such, medical professionals or the clinics in which they operate, as applicable, are also required to have a DEA license to obtain and administer ketamine (a "DEA License"). To the Company’s knowledge, the Clinics in the United States and the required medical professionals hold all required DEA Licenses. Furthermore, the Clinics have in place security, control, recordkeeping, reporting and inventory mechanisms required by the DEA to prevent drug loss and diversion. Staff at Clinics in the United States, including the medical doctors and/or the nurse practitioner(s), advanced practice registered nurse(s) or other medical professionals who report to them, hold the required DEA Licenses and the Corporation has put in place policies designed to adhere to DEA requirements.
The Opium Act (Opiumwe) (the "Opium Act") is the primary drug legislation in the Netherlands which place controlled substances on a list. The controlled substances on those lists and any preparations thereof are prohibited, including psilocybin. However, the Dutch Supreme Court (the highest court in the Netherlands) stated that the plants/fungi in which those substances occur naturally are not prohibited unless specifically listed. Psilocybin-containing truffles or sclerotia are not listed under the Opium Act and, therefore, do not qualify as a controlled substance restricted under the Opium Act. Furthermore, the Dutch Minister of Healthcare confirmed in Parliament that psilocybin-containing truffles are not illegal and can legally be sold, bought and used as a natural product in The Netherlands. Therefore, subject to certain requirements, the Opium Act does not prohibit the cultivation, production and sale of fresh, unprocessed truffles.
Unlike in Canada and the United States, psilocybin mushrooms are not an illegal drug under Jamaica's Dangerous Drugs Act, 1948 (“Jamaica Drug Act”). Therefore, the psilocybin research is not in contravention of the laws of Jamaica and does not require any permit or authorization from the regulatory authorities in Jamaica. In addition, the Minister of Health & Wellness of Jamaica has delivered a letter to the Corporation stating his support for the Corporation's operations in Jamaica.
Field Trip does not deal with controlled substances except in jurisdictions where such activity is legal and then only within (a) laboratory or clinical trial settings, (b) in the case of the Netherlands, within a clinical setting, and (c) in the case of ketamine, as prescribed by a licensed medical practitioner. Field Trip does not have any direct or indirect involvement with illegal selling, production or distribution of any substances in jurisdictions in which it operates.
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On November 3, 2020, the State of Oregon, via Measure 109, became the first state to legalize psychedelic mushrooms for therapeutic use in supervised environments. Measure 109 is expected to allow people in the state who are age 21 or older to access psychedelic mushrooms for personal development upon passing a screening conducted by a qualified therapist. People who use the drug are expected to be able to do so at a psilocybin service centre, with the supervision of a designated service facilitator. Oregon expects to have a two-year planning period in which lawmakers will determine how the drug will be regulated, including qualifications for therapists intending to prescribe psychedelic mushrooms and for psilocybin facilitators. The program is expected to be regulated by the Oregon Health Authority.
On November 4, 2020, the District of Columbia approved an initiative that aims to effectively decriminalize the use of several psychedelic substances. Initiative 81 makes non-commercial possession, distribution, purchase and cultivation of psychedelic and hallucinogenic plants and fungi a lowest law enforcement priority for the Metropolitan Police Department. Similar to state legalization efforts in Oregon, the Company cannot comment on the regulatory framework as it has not been created nor can the Company assess when or if the US federal government will permit such activities.
In addition, since the passage of Measure 109, legislation in respect of psilocybin or psychedelics has been proposed in each of Florida, California, Hawaii and Connecticut drawing on elements of the Oregon ballot measure. In Florida, The Florida Psilocybin Mental Health Care Act, if approved, will create state-sponsored clinics where patients suffering from mental-health disorders could be administered doses of psilocybin by a licensed medical professional. The patient would go through the experience, or "trip," with the professional present and then be offered a post-treatment counseling session. In Hawaii, Senate Bill 738, if approved, will establish treatment centers designated by the Hawaii Department of Health for the monitored, therapeutic administration of psilocybin and psilocin to treat mental illness. In California, Senate Bill 519, if approved, would decriminalize the personal use of psychedelic drugs including psilocybin mushrooms, MDMA1, LSD2, ketamine, DMT3, mescaline and ibogaine for all Californians over the age of 21. In Connecticut, House Bill 6296, if approved, will establish a task force to study the health benefits of psilocybin.
Field Trip expects that legislation of similar natures may be introduced in other jurisdictions in the coming years, as well as additional ballot measures similar to Measure 109. Field Trip cannot comment on the regulatory framework in any such jurisdiction as it has not been created. Field Trip will assess its options to conduct legal business in such jurisdictions when State or Provincial, as applicable, and Federal regulations are established and may seek any required licenses or approvals at that time.
Regulation of Prescription Medications
In Canada, oversight of healthcare is divided between the federal and provincial governments. The federal government is responsible for regulating, among other things, the approval, import, sale, and marketing of drugs such as ketamine. Please see “Regulatory Oversight - Research and Development”.
While Ketamine is a controlled substance in Canada and the United States, it is approved as an anesthetic under the Food and Drugs Act (Canada) and the US Food, Drug, and Cosmetic Act. Once a drug is approved for use, physicians may prescribe that drug for uses that are not described in the product’s labelling or that differ from those tested by the manufacturer and approved by Health Canada or the Food and Drug Administration (the "FDA"), as applicable. This is known as “off-label” use and is a common practice among physicians. Ketamine-based treatment is gaining acceptance for treating depression. Furthermore, a Ketamine nasal spray for the treatment of major depression was approved by the FDA in March 2020 and Health Canada in July 2020.
Health Canada and the FDA have not approved psilocybin as a drug for any indication. However, there are legal routes through which psilocybin may be accessed for medical purposes.
In Canada, Section 56(1) of the CDSA permits the Health Minister to exempt any person or class of persons or any controlled substance or precursor or class thereof from the application of all or any provisions of the Canadian Controlled Substances Act if, in his or her opinion, the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest. In August 2020, Health Minister Patty Hajdu approved such an exemption to allow four (4) Canadians experiencing end of life distress or other intractable mental health conditions incurable cancer to receive psilocybin therapy to treat their end-of-life anxiety. Having the exemption in question permits such individuals to legally obtain and use psilocybin.
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Furthermore, on December 12, 2020, Health Canada announced its intention to remove the current prohibition on access to controlled substances through Health Canada’s Special Access Program (“SAP”). Under the SAP, medical practitioners treating patients with serious or life-threatening conditions can request access to drugs that have not yet been approved for sale in Canada when conventional therapies have failed, are unsuitable, or unavailable. Such amendments would create another means of legally accessing psilocybin through the SAP. 1
In the United States, the FDA has granted psilocybin therapy a breakthrough therapy designation to facilitate drug trials testing its efficacy for treatment resistant depression and major depressive disorder. Similar trials are ongoing in Canada. If approved, these medications would provide a legal route to prescribe psilocybin in the United States.
Although psilocybin-containing truffles or sclerotia are not prohibited by the Opium Act, they are not approved under the Medicines Act. In light of the above and based on advice of counsel in the Netherlands, the Opium Act does not prohibit the presence and/or use of fresh, unprocessed truffles with psilocybin. The truffles with psilocybin may not be subject in any way or form to any further processing (that results in the truffles becoming a preparation prohibited under the Opium Act).
Each province and territory of Canada and each state in the United States mandates the requirements for the Clinics and the conduct of the medical professionals who work in the Clinics. Please refer to the table set out in the Company’s AIF for of even date herewith for details concerning these regulations.
Although it is the Company's intention to administer psilocybin-containing truffles as a food product in The Netherlands, the Company also intends to employ medical professionals in its Amsterdam Centre and has applied for an “alternative care” license under the Dutch Healthcare Quality, Complaints and Disputes Act (WKKGZ).
While the treatments that occur at the Clinics are novel in some respects, the prescription of ketamine and the dispensing of ketamine are not novel and are subject to the same restrictions as would apply to any medical professional who prescribes other controlled substances to his or her patients. There are no special licenses, permits, authorizations or approvals required that are different from any other ordinary course approvals required by applicable governmental authorities for any medical clinic. As such, licensed medical practitioners may prescribe ketamine legally in Canada or the United States where they believe it will be an effective treatment in their professional judgment. It is Field Trip’s policy never to dictate or influence the professional judgement of our physicians, nurses or other clinical staff.
Administration of ketamine as part of the KAP program is performed only following prescription by a licensed physician or by a licensed nurse practitioner or other medical professional, under the supervision of a licensed physician. The Clinics may utilize, in addition to physicians, mid-level practitioners such as physician assistants and nurse practitioners and mental health practitioners such as psychologists and psychotherapists. The exact make-up of staff for each Clinic varies by location and additional professionals and/or administrative staff may also be employed.
In Canada, the provincial/territorial level of government has authority over the delivery of health care services, including regulating health facilities, administering health insurance plans such as OHIP, distributing prescription drugs within the province, and regulating health professionals such as doctors, psychologists, psychotherapists and nurse practitioners. Regulation is generally overseen by various colleges formed for that purpose, such as the College of Physicians and Surgeons of Ontario.
1 See gazette.gc.ca/rp-pr/p1/2020/2020-12-12/html/notice-avis-eng.html
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In the United States, the laws applicable to the Clinics and the conduct of medical professionals therein are at the State level and vary by jurisdiction. Additionally, in the United States, the Clinics or doctors, as applicable, are also required to have a DEA License to prescribe ketamine. In each State, Field Trip plans to offer KAP, psychotherapy and ancillary mental health services.
As of the date hereof, to the best of Field Trip’s knowledge, each of the medical professionals working at the Clinics are in good standing with the applicable regulatory body that governs such medical professional.
Under Field Trip’s business model, there are no state-specific licenses required to (a) operate a mental health clinic prescribing and/or administering ketamine, (b) that apply to the storage and/or administration of ketamine, other than those which mirror the CDSA requirements, and (c) operate or provide management services to the Clinics, other than standard filings with the applicable Secretary of State for out-of-state companies, which Field Trip Health USA Inc. ("Field Trip USA") has obtained in connection with the setup of these locations.
Some states have legislation or policies relating to the "Corporate Practice of Medicine" doctrine ("CPOM") that govern business relationships between licensed medical professionals and unlicensed individuals or companies. The following states have CPOM legislation: New York, California, Illinois, and Texas. The States of Georgia, Washington and Arizona do not have specific CPOM legislation, but case law may have established or invoked CPOM doctrine in those states. In order to comply with CPOM, Clinics in these states are owned solely by State-licensed physicians and are organized as physician practices. In such states, Field Trip USA will provide management services to the physician practices that own such clinics. The relationship between Field Trip USA and the physician practices that it manages are subject to various standards of CPOM, anti-kickback and fee-splitting rules. The District of Columbia does not have a CPOM statutes nor is there clear judicial consideration of CPOM within this jurisdiction. However, Field Trip proposes to organize the Clinics in those jurisdictions as a physician-owned Professional Corporations.
Individuals and entities that conduct business in the US health care industry must comply with applicable state and federal anti-kickback laws that limit activities that may be viewed as incentivization or inducement methods. To the best of the Company's knowledge, no medical professionals at the Clinics receive commissions, incentives or other fees, directly or indirectly.
In The Netherlands, Field Trip’s wellness centre will make psilocybin-containing truffles available to clients in connection with wellness programs. As noted above, psilocybin-containing truffles are neither prohibited under the Opium Act nor are they approved as a medicine. As such, Field Trip is making the psilocybin-containing truffles available to clients as a whole, natural food product. As Field Trip employs medical professionals in its business, we have elected to register as an alternative care provider. In the event that the Dutch authorities take the position that therapy with truffles qualifies as "regular care", or that truffles containing psilocybin qualify as medicinal product, Field Trip would then need to take steps to comply with local laws applicable to a regular care provider. Should this event occur, Field Trip will evaluate its options in the Netherlands to ensure full compliance with all applicable legislation and regulations.
Field Trip’s business is also governed by laws in Canada, the United States and the Netherlands pertaining to handling, use and protection of personal health information, including the Personal Health Information Protection Act (Ontario), The Health Insurance Portability and Accountability Act of 1996, the Netherlands Personal Data Protection Act (Wet Bescherming persoonsgegevens) and similar provincial or state laws. These laws and related regulations grant a number of rights to individuals as to their personal health information and restrict the use and disclosure of such information. Field Trip has in place privacy practices designed to comply with these requirements and ensures that service providers having access to personal health information have entered into agreements that include appropriate protective clauses, including business associate agreements where applicable.
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Natural Products Operations
As psilocybin is not included in the Jamaica Drug Act, it is not a controlled or restricted substance in Jamaica and therefore no other specific controls, permits, licenses or authorizations are required to conduct research on psilocybin. The psilocybin research conducted at the Jamaica Facility is governed by the Jamaica Ministry of Health ("JMH"), Ethics and Medico-Legal Affairs Panel and by the JMH Standards and Regulation Division, as would any other research conducted in a clinical setting. In addition to Good Laboratory Practices ("GLP") and cGMP, research involving human subjects is governed by the JMH Guidelines for the Conduct of Research on Human Subjects. Furthermore, medicines, including natural products, require registration with the JMH prior to importation, distribution and sale in Jamaica, as outlined in the Food and Drugs Act, 1964.
The Psilocybin Research is not in contravention of local laws in Jamaica and the Company has received a legal opinion from local counsel confirming the same with respect to the Psilocybin Research. Through consultation with local resources and personnel with relevant knowledge and experience, as necessary, in Jamaica, the Company is satisfied that all necessary licenses, permits and regulatory approvals have been obtained in order to carry on the business as currently conducted and that such licenses, permits and regulatory approvals that have been obtained are in good standing.
The Company has received legal opinions or advice in each jurisdiction where it currently operates or proposes to operate (other than jurisdictions where the applicable legislation has not yet been created or has not yet been passed), confirming the permissibility of the Company's operations in such jurisdictions.
Research and Development Operations
As the Company's business spans different operational models, the Company relies on a variety of researchers, medical professionals, suppliers, manufacturers and service providers for the conduct of its operations. The Company's research and development activities rely on the following relationships with the following three third parties: (1) the UWI Agreement in respect of the Psilocybin Research; (2) engagement by the Company of a contract research organization ("CRO") regarding FT-104 (the "CRO Engagement") and (3) the service agreement with the Company's contract manufacturing organization ("CMO") in respect of FT-104 (the "CMO Agreement" and together with the CRO Engagement, the "FT-104 Agreements").
UWI is a globally recognized academic institution. The UWI Agreement was negotiated at arm’s length, with legal counsel acting on behalf of the Company both in Canada and Jamaica, and includes appropriate intellectual property and confidentiality provisions. With respect to the FT-104 Agreements, Health Canada and the FDA have indicated that FT-104 is not a controlled substance and therefore does not require licenses, permits or specific approvals. Notwithstanding, the CMO is Health Canada approved, FDA registered and compliant with Good Manufacturing Practices ("cGMP") (a standard applied in the pharmaceutical industry) in synthesis, process optimization and production of drug substances and has been successfully audited by Health Canada and the FDA.
The CRO is Good Laboratory Practices ("GLP") compliant and holds all licenses required for its activities as they relate to the Company. Both the CMO and CRO have controlled substance licenses for other known controlled substances and are qualified for handling FT-104. For certainty, FT-104 is not currently a controlled substance in either the US or Canada (confirmed with both agencies), however since it can produce a psychoactive state, it will likely become a scheduled substance should it be approved for use by a regulatory agency and therefore, the use of a CMO and CRO in compliance with the control substances acts is critical. In addition, the Company has entered into appropriately negotiated services agreements or statements of work with the CMO and CRO that contemplate appropriate intellectual property and confidentiality provisions. In order to develop regulated medicines, including FT-104, the Company’s process must be conducted in strict compliance with the regulations of Health Canada, the FDA and other applicable federal, state, local and regulatory agencies.
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FT-104 is currently in a pre-clinical stage of development, in which the primary activities are: (1) optimization and standardization of Chemistry-Manufacturing and Controls ("CMC"), including additional chemical characterization, synthesis, process optimization, stability, and development of analytical methodology to ensure drug substance quality and (2) non-clinical (same as preclinical) activities ("NCA") that measure performance (pharmacokinetics) and safety (toxicology; pharmacology) using a variety of in-vitro and in-vivo assays. These studies will help to define parameters that would allow the safe testing of the substance in human trials. CMC activities are carried out by the CMO. NCA activities are carried out by the CRO.
The CMO is reliant on suppliers for starting materials to produce FT-104; the CRO is reliant on suppliers to carry out in-vitro and in-vivo assays, such as analytical kits, biological reagents and animal models. The Company, along with the CMO and CRO, only source starting materials from reputable and approved suppliers who hold the proper authorizations and approvals. Weekly or bi-weekly meetings occur to monitor the activities and advancements of CMO and CRO. A third-party regulatory group has been engaged to assist with the development of the regulatory and quality assurance strategies and prepare the regulatory documentation that will be required at each stage of the development.
Pharmaceutical Development and Approval Requirements – Canada
Before a prescription drug product candidate may be marketed in Canada, the process required generally involves:
|●||Chemical and Biological Research - Laboratory tests are carried out on tissue cultures and with a variety of small animals to determine the effects of the drug. If the results are promising, the manufacturer will proceed to the next step of development.|
|●||Pre-Clinical Development – A combination of in-vitro and in-vivo studies assess the effects of the drug in varying amounts over differing periods of time. If it can be shown that the drug causes no serious or unexpected harm at the doses required to have an effect, the manufacturer will proceed to clinical trials.|
|●||Clinical Trials — Phase 1 - The first administration in humans is to test if people can tolerate the drug. If this testing is to take place in Canada, the manufacturer must prepare a clinical trial application for the Therapeutic Products Directorate of Health Canada (the "TPD"). This includes the results of the first two steps and a proposal for testing in humans. If the information is sufficient, the Health Products and Food Branch of Health Canada (the "HPFB") grants permission to start testing the drug, generally first on healthy volunteers.|
|●||Clinical Trials — Phase 2 - Phase 2 trials are carried out on people with the target condition (patients), who are usually otherwise healthy, with no other medical condition. Trials carried out in Canada must be approved by the TPD. In Phase 2, the objectives of the trials are to continue to gather information on the safety of the drug and begin to determine its effectiveness.|
|●||Clinical Trials — Phase 3 - If the results from Phase 2 show promise, the manufacturer provides an updated clinical trial application to the TPD for Phase 3 trials. The objectives of Phase 3 include determining whether the drug can be shown to be effective, and have an acceptable side effect profile, in people who better represent the general population. Further information will also be obtained on how the drug should be used, the optimal dosage regimen and the possible side effects.|
|●||New Drug Submission - If the results from Phase 3 continue to be favourable, the drug manufacturer can submit a new drug submission ("NDS") to the TPD. A drug manufacturer can submit an NDS regardless of whether the clinical trials were carried out in Canada. The TPD reviews all the information gathered during the development of the drug and assesses the risks and benefits of the drug. If it is judged that, for a specific patient population and specific conditions of use, the benefits of the drug outweigh the known risks, the HPFB will approve the drug by issuing a notice of compliance.|
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|●||Scheduling - FT-104 is a psychoactive substance with the potential for abuse. If FT-104 is approved as a drug, we will need to hold discussions with Health Canada to determine a risk management plan to protect FT-104 from potential diversion and misuse by patients, as well as to schedule its removal from Category III (no known medical utility) to another category based on data acquired during development and based on the drug’s adverse properties, if any, related to potential abuse and addiction.|
Pharmaceutical Development and Approval Requirements – United States
Before a prescription drug product candidate may be marketed in the United States, the process required generally involves:
|●||completion of extensive nonclinical laboratory tests, animal studies and formulation studies, all performed in accordance with the FDA's Good Laboratory and Manufacturing Practice regulations;|
|●||submission to the FDA of an investigational new drug application, which must become effective before human clinical trials may begin;|
|●||for some products, performance of adequate and well-controlled human clinical trials in accordance with the FDA's regulations, including good clinical practices, to establish the safety and efficacy of the product candidate for each proposed indication;|
|●||submission to the FDA of a new drug application ("NDA"); and|
|●||scheduling in collaboration with the DEA based on the drugs adverse properties, if any, related to potential abuse and addiction.|
|●||FDA review and approval of the NDA prior to any commercial marketing, sale or shipment of the drug.|
The operations of the Company, as currently conducted, do not require and are not dependent on, any licenses to conduct such operations.
The Company oversees and monitors compliance with applicable laws in each jurisdiction in which it operates. In addition to the Company's senior executives and the employees responsible for overseeing compliance, the Company has local regulatory/compliance counsel engaged in every jurisdiction (provincial, state and local) in which it operates. The principal medical professional at each Clinic serves as the liaison to provincial, state and/or local governmental authorities. The Company has developed protocols for use in all of its Clinics with the goal of ensuring that each of the Clinics’ operations and employees strictly comply with applicable laws and regulations and that operations do not endanger the health, safety or welfare of the community. Additionally, the Company has established a team of advisors with cross-functional expertise in business, neuroscience, pharmaceuticals, mental health and psychedelics to advise management.
In conjunction with the Company's human resources and operations departments, the Company oversees and implements training on the Company's protocols. The Company will continue to work closely with external counsel and other compliance experts, and is evaluating the engagement of one or more independent third-party providers to further develop, enhance and improve its compliance and risk management and mitigation processes and procedures in furtherance of continued compliance with the laws of the jurisdictions in which the Company operates. The programs currently in place include continued monitoring by executives of the Company to ensure that all operations conform to and comply with required laws, regulations and operating procedures. The Company further requires that each Clinic and all third parties in which it is engaged with report and disclose all instances of non-compliance, regulatory, administrative, or legal proceedings that may be initiated against them. The Company is currently in compliance with the laws and regulations in all jurisdictions and the related licencing framework applicable to its business activities. Additionally, the Company has established a Professional Corporation (a "PC") Advisory Committee with a mandate to provide strategic advice with respect to the structure of clinics as PCs and the protocols for operations of the PCs.
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The Company has developed and continues to refine a compliance program designed to ensure operational and regulatory requirements continue to be satisfied. Field Trip has also put in place an AML Policy designed to ensure proactive, ongoing steps are taken to create and maintain operations that are conducted in compliance with all applicable AML laws, including in Canada, the United States and other jurisdictions. Through its human resources and operations departments, the Company oversees and implements training for all employees with respect to the Company's protocols.
The Company has received legal opinions or advice in each jurisdiction where it currently operates or proposes to operate (other than jurisdictions where the applicable legislation has not yet been created or has not yet been passed into law), confirming the permissibility of the Company's operations in such jurisdictions.
The Company's operations are conducted in compliance with local laws where such activities are permissible and either (a) do not require any specific legal or regulatory approvals, or (b) the Company has all necessary legal and/or regulatory approvals. See Risk Factors.
KEY HIGHLIGHTS AND RECENT DEVELOPMENTS
First Fiscal Quarter
During the first fiscal quarter, we continued to execute on our FT-104 drug development strategy, the buildout of a globally recognized brand of psychedelic-assisted therapy clinics and the development of our digital tools, “Trip” and “Portal”. With the signing of 5 new clinic leases during the quarter and an additional 3 subsequently, we significantly ramped our operations in order to position us as an early mover in the emerging psychedelics industry, which, according to Canaccord Genuity’s May 21, 2020 research report on Psychedelic-derived medicines and therapies, is estimated to be a $100 billion market. Despite the continuing impact of the COVID-19 pandemic and its variants on operations, we believe that interest in, and demand for, psychedelic therapies will continue to rapidly expand over the coming years. The COVID-19 pandemic has resulted in an estimated three-fold increase in the incidence of depression in the US. We anticipate that we will see an increase in long-term demand for our depression related psychedelic therapies as case counts start to diminish in the future. With 7 existing clinics and 11 locations under construction or about to commence construction, we remain on track to have 20 clinics open or under construction by December 2021.
On May 4, 2021, the Company announced the opening of its fifth location in the United States in the city of Houston, TX. The Houston location is the second Field Trip Health center to open in 2021. Field Trip also announced that it entered into leases and commenced construction to build Field Trip Health centers in San Diego, CA, San Carlos, CA, Seattle, WA, Washington DC and Fredericton, NB. During the current fiscal quarter, the Company also leased locations in Austin, TX, Stamford, CT and Vancouver, BC.
On May 6, 2021, Field Trip announced that its Common Shares are eligible for electronic clearing and settlement through The Depository Trust Company ("DTC") in the United States. DTC is a subsidiary of The Depository Trust & Clearing Corporation, a United States company that manages the electronic clearing and settlement of publicly-traded companies. Securities that are eligible to be electronically cleared and settled through DTC are considered "DTC eligible." This electronic method of clearing securities speeds up the receipt of stock and cash and thus accelerates the settlement process for investors and brokers, enabling the stock to be traded over a wider selection of brokerage firms.
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On May 20, 2021, the Company announced the appointment of former US Senate Majority Leader Tom Daschle as a Special Advisor to the Company. Senator Daschle is one of the longest serving Senate Democratic leaders in history and one of only two to serve twice as both Majority and Minority Leader. In 1978, he was elected to the U.S. House of Representatives, where he served eight years. In 1986, he was elected to the U.S. Senate and was chosen as Senate Democratic Leader in 1994. Senator Daschle is also the Founder and CEO of the Daschle Group, a Public Policy Advisory of Baker Donelson and a legal and government affairs firm that advises clients on a broad array of economic, policy and political issues.
On June 7, 2021 Field Trip’s Common Shares and Warrants commenced trading on the TSX under the ticker symbols “FTRP” and “FTRP.WT” respectively. The Common Shares continued to trade on the OTCQX market under the symbol “FTRPF”. In connection with the TSX listing, Field Trip’s Common Shares and Warrants were delisted from the CSE. In conjunction with its TSX listing, the Company announced that it has bolstered its Board of Directors with the appointments of Barry Fishman as Lead Director and a member of the Audit Committee, and Ellen Lubman as Director. Mr. Fishman is an accomplished business leader and Board Director with proven success in strategy development, performance enhancement and public company governance, with an expansive global network and deep pharmaceutical knowledge. Ms. Lubman brings nearly 20 years of experience in corporate and business development, portfolio strategic planning, financial strategy and investor relations through leadership roles in small biotech and large pharma, starting her career as a Wall Street equity research analyst.
On June 8, 2021, the Company announced that it had applied to list its Common Shares on the NASDAQ Stock Market (“NASDAQ”). In advance of an anticipated listing on NASDAQ, Field Trip filed a registration statement with the United States Securities and Exchange Commission on July 19, 2021. The Company also announced that it anticipates being able to commence Phase 1 human trials for FT-104 and expects to have 20 Field Trip Health centers operating or under construction, including its existing 7 locations in New York, NY, Toronto, ON, Los Angeles, CA, Chicago, IL, Houston, TX, Atlanta, GA and Amsterdam, NL.
During the current fiscal quarter, the Company filed USPTO and PCT patents relating to FT104’s structure, formulation and use in treating a variety of central nervous system disorders.
Subsequent to the current fiscal quarter, the Company entered into lease agreements for locations in Dallas, TX, Miami, FL and Scottsdale, AZ. The Company also signed a lease for additional space at its Toronto headquarters and clinic location to accommodate increased operations personnel. We completed construction of our Amsterdam, The Netherlands clinic and began accepting patients in July 2021.
On July 29, 2021, the Common Shares commenced trading on the NASDAQ Global Select Market (“NASDAQ”) under the ticker symbol “FTRP”. The Company’s Common Shares continue to trade in Canada on the TSX under its current symbol FTRP. Concurrent with the NASDAQ listing, Field Trip’s Common Shares ceased to be quoted on the OTCQX. The Company previously completed the process to ensure its shares are eligible for electronic clearing and settlement through the Depository Trust Company (DTC). In addition, Ronan Levy and Ellen Lubman joined the Compensation Committee and Mujeeb Jafferi and Dr. Ryan Yermus resigned as directors of the Company. Mr. Jafferi and Dr. Yermus will continue to serve as Field Trip’s Chief Operating Officer and Chief Clinical Officer, respectively.
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NON-REVENUE GENERATING PROJECTS
Field Trip currently has four significant projects, which have not yet generated any revenue or significant revenues:
|a.||FT-104 drug development;|
|b.||psilocybin-producing fungi research and cultivation at its Jamaica Facility;|
|c.||the opening of Field Trip Health Centres in North America and Europe; and|
|d.||the development of its digital tools, being the "Trip" app and "Portal".|
Development of the chemistry, manufacturing and controls (“CMC”) of the active ingredient, FT-104, continues to progress. Scale-up batches and engineering batches have been completed and stability studies initiated. In addition, analytical controls have been developed to properly characterize the drug substance and to help define drug specifications. GMP production of the drug substance has been achieved. Finalization of the drug product formulation for use in Phase 1 is in progress.
Pre-clinical activities will continue through 2021. The objectives of preclinical studies include determination of the pharmacokinetics, metabolism and routes of elimination in animal species, as well as, defining potential toxicologies and safety pharmacology. This battery of studies which will enable Phase 1 development is expected to be completed by the end of calendar 2021.
The Company is finalizing a proposal for the Phase 1 study that will assess pharmacokinetics, safety and tolerability of single escalating doses of FT-104 in healthy volunteers. Internal experts, as well as scientific and clinical advisors will be consulted in drafting the formal Phase 1 protocol over the coming months. The purpose of the Phase 1 is to determine the safe and tolerable range of doses of FT-104 that can be used in future Phase 2 development, where the drug’s efficacy can be evaluated. The Company anticipates that FT-104 will enter Phase 1 in calendar Q1 2022 (see Effects of COVID Pandemic section in this MD&A).
The Company’s belief that FT-104 has a product profile that is ideal for treatment of patients with depression was bolstered by recent results demonstrating that the 5HT2A agonist psilocybin, given twice over a period of 3 weeks, is at least as efficacious as 6 weeks of daily administration of escitalopram in a small randomized clinical study (Carhartt-Harris et al. NEJM 2021; 38:1402).
Updated budgets for preclinical, clinical and business development activities related to FT-104 through calendar Q2 2022 are provided in section Milestones and Available Funds.
The Company has also undertaken additional scientific, commercial and business development activities during the quarter to add to the drug development pipeline. This includes prospecting for opportunities for licensing and partnering, as well as synthesis of novel, patentable 5HT2A agonist families of molecules that improve convenience, safety and/or efficacy of psychedelic medicines and therapies. The Company intends to add at least one new molecule to the development pipeline before year end.
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In October 2020, the Company formally opened the “Jamaica Psilocybin research Facility.” Cultivation research initiated in our temporary facility within the UWI complex was moved to the new dedicated facility. Several psilocybe mushroom varieties are in-cultivation. Operations include parametric optimization of different growth medium and growth conditions for different species, development of analytical techniques to characterize active substances (tryptamine alkaloids), and characterization of the development of mycelia and truffle formations as a function of cultivating methods. The goal is to better understand the techniques for production of mushrooms with reproducible yields and quality, create processes for production, storage, packaging and stability, as well as analytical methods needed for complete characterization, including methods to demonstrate “food safety” (i.e., potency, bioburden, absence of pesticides (none are used), other potential environmental toxins). It is emphasized here that the psilocybin-containing mushrooms, truffles in all botanical forms, whether dried or fresh, are strictly for R&D purposes only and are destroyed when no longer useful. None of the botanical substances or extracts are sold, consumed or provided for consumption, nor are they exported to any of these ends.
We expect to spend $1,200,000 over the next 12 months on ongoing psilocybin research (see Milestones and Available Funds). We intend to continue our psilocybin research thereafter in order to further our intellectual property portfolio through the development of optimized cultivation methods, extraction techniques and pursuit of novel molecule discovery.
Our Field Trip Health Centres hold significant strategic value in that they enable us to collect large amounts of data from patients on clinical outcomes associated with the set, setting and therapeutic protocols of psychedelic therapies. This data allows us to not only identify areas of unmet need in psychedelic therapies, but also innovate new models and protocols. In fact, based on the insights derived from our operations, we have launched two new programs that will be offered through our centres: group ketamine sessions, and continuing therapy post-treatment for patients who have completed our therapeutic programs. We will continue to leverage the data collection and insights generated from our expansion to enable us to innovate new treatments, new offerings and increase operational efficiency.
Through our Field Trip Health centres, we are creating real world impact on the lives of our patients. Since launch, we have seen remarkable success with our ketamine-assisted therapies. Most of our patients are experiencing a significant and sustained improvement in depression and anxiety scores — often from severe levels at intake to minimal upon program completion.
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In May 2021, we opened the Houston clinic, our fifth location in the US and second clinic opening in 2021. During the current fiscal quarter, we entered into leases the following locations: San Carlos, Seattle, Washington, Austin, Stamford, Fredericton and Vancouver. Subsequent to quarter end, we entered into lease agreements for Miami, Scottsdale, Dallas and signed a lease for additional space at our Toronto headquarters and clinic location to accommodate increased operations personnel, (see Subsequent Events section of this MD&A). With 11 clinics in the construction pipeline and as COVID-19 and its variants persist, clinic openings have been delayed by 3 months on average. The chart below sets out the status and target opening date of each location:
|Location||Size (Sq Ft)||Status||Target Opening Date|
|San Diego||3,868||Construction in progress||October 2021|
|San Carlos||4,947||Construction in progress||October 2021|
|Seattle||4,292||Construction in progress||September 2021|
|Austin||7,642||Pre-construction in progress||January 2022|
|Fredericton||4,000||Construction in progress||September 2021|
|Vancouver||5,150||Pre-construction in progress||November 2021|
|Washington||3,000||Pre-construction in progress||November 2021|
|Stamford||4,125||Construction in progress||October 2021|
|Miami||7,474||Pre-construction in progress||Q1 2022|
|Scottsdale||3,438||Construction in progress||January 2022|
|Dallas||5,450||Pre-construction in progress||January 2022|
|Toronto HQ||4,674||As-Is||August 1, 2021|
Digital Tools: Trip and Portal
In October 2020, we launched our proprietary digital portal, along with an updated version of our Trip mobile software application. Our "Trip" app’s user base grew by 72% from the previous quarter. During the current fiscal quarter, we continued to develop new functionality for these digital tools and we anticipate a "Trip" premium version will be released in the second half of calendar 2021, along with further enhancements to the digital portal.
Effects of COVID-19 Pandemic on Operations
The COVID-19 pandemic and various government steps to reduce the spread of COVID-19 have had and continue to have a significant impact on the way people live, work and interact and have significantly impacted and will likely continue to impact economic activity around the world.
During the COVID-19 pandemic, many of the regions in which we operate or plan to operate, including in connection with relationships with contract drug manufacturers (“CMO”) have experienced unprecedented “lockdowns” or “stay at home” orders, and other government mandated restrictions to try and reduce the spread of COVID-19. The situation continues to be uncertain and varies by market as infection rates of COVID-19 remain high in many regions throughout the world including Canada, the United States and The Netherlands where we have existing or planned clinic locations and CMOs. Because our clinics have been deemed “essential service”, we have been able to continue operating our clinics, however, the health, safety and well-being of our employees has been our first priority and has informed the rate at which we have been on-boarding new patients to ensure compliance with health and safety measures and social distancing protocols, consistent with government recommendations and requirements.
During the current fiscal quarter, with case counts rising significantly as the result of the Delta variant, we continued and will continue to experience direct and indirect consequences of the COVID-19 pandemic and its variants on our operations over the next 12 months, including construction delays that may impact the timing of our clinic openings, and potential reluctance of people to attend in-person ketamine dosing sessions and group therapy sessions at our clinics, which may cause an extended period for each clinic, on average, to breakeven, which we estimate between 15 to 18 months from the date of first patient dosing. Given the increased uncertainty surrounding COVID-19 as a result of its variants, we will continue to evaluate the timing of our clinic rollouts as appropriate.
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From a drug development perspective, we continue to experience:
|●||delayed deliverables due to temporary quarantining of critical personnel within contract organizations at CMO and CRO. The Company’s contract drug manufacturer (CMO) has moved to shift work to reduce risks of COVID transmission within the company, yet there has been occasional sickness that has delayed the completion of tasks according to original schedules. The CMO and the Company have, as needed adapted to the situations that have presented, but continued future delays could impact downstream non-clinical and clinical activities|
|●||delayed arrival of reagents to the CMO from chemical supplier warehouses, possibly due to shortages. Some critical supplies, such as the key starting material for the synthesis of FT-104 has been stockpiled to hedge against potential future shortages. Some more common reagents have become in short supply recently. The Company monitors these activities to minimize potential impacts to timelines.|
|●||reduced availability of animal services due to increased activity in preclinical activities at selected CRO. The CRO has informed that there has been a very significant increase in requests for preclinical studies since calendar Q3 2020. The Company has reserved scheduled slots for many critical preclinical activities, well in advance of scheduling under normal circumstances. Through the quarter, we have been able to meet all timelines, however, timelines have been increasingly challenging to meet.|
We anticipate that the long-term goals of the Company will require additional capital contributions via debt or equity financings. In the event that the impact of COVID-19 worsens and negatively affects capital markets generally, there is a risk that the Company may not be able to secure funding for these long-term objectives.
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MILESTONES AND AVAILABLE FUNDS
The final short form prospectus of the Company dated March 12, 2021 (the "SF Prospectus"), which is available on SEDAR at www.sedar.com, identified certain business milestones of the Company, which are re-produced below. As of the date hereof, the Company has provided the status of these milestones, the actual or revised estimated costs and the revised date of expected completion thereof, if applicable. The following are "forward-looking statements" and as such, there is no guarantee that such milestones will be achieved on the timelines indicated or at all. Forward-looking statements are based on management's current expectations and are subject to a number of risks, uncertainties, and assumptions. See "Forward-Looking Statements".
|Objective||Milestone Description||March 2021 Prospectus Estimated Cost||Actual/Revised Estimated Cost||Actual/Estimated|
Patenting, Phase 1
completed and Phase 2
|US utility and PCT patent filings||$||100,000||$||90,000||Q2 2021||In Progress|
|CMC development and pre-clinical studies completed||$||2,440,000||$||1,804,330||Q3 2021||In Progress|
|Phase 1 studies completed||$||2,025,000||$||2,025,000||Q2 2022||Not started|
|Phase 2 studies completed||$||9,350,000||$||13,550,000||Q3 2023||Not started|
|75 Operational Clinics||10th clinic operational (i.e. 4 additional clinics)||$||1,500,000||$||1,900,000||Q2 2021||Completed|
|15th clinic operational||$||1,250,000||$||2,000,000||Q3 2021||In Progress|
|20th operational clinic||$||2,000,000||$||2,000,000||Q4 2021||Not started|
|30th operational clinic||$||4,000,000||$||4,000,000||Q4 2022||Not started|
|75th operational clinic||$||15,500,000||$||18,000,000||Q4 2024||Not started|
|Issuer Technology Platforms||Trip App available in app store||$||220,000||$||300,000||Q4 2021||Free app available. Premium version launch Q4 2021.|
|Patient Portal launched||$||220,000||$||500,000||Q4 2021||Portal completed. Further enchancements to launch Q4 2021.|
Operational clinics include opened clinics and clinics under construction.
Our CMC development and pre-clinical studies have been delayed three months to calendar Q4 2021 due to the impact of COVID-19 on our CRO and CMO operations. Although we believe we will still be able to complete our Phase 1 PK study by calendar Q2 2022, we currently maintain a target start date for Phase 2 POC (1st indication) in Q4 2022 with completion in calendar 2023.
Total Funds Available
As of the closing of the March BD Offering, the Company had $107,895,033 in funds available. The table below sets out the anticipated use of the available funds and any variances to such uses from what was described in the SF Prospectus. The use of proceeds represents the anticipated costs for next 12 months from July 1, 2021 to June 30, 2022 and assumes that no additional funds will be raised by the Company.
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The current use of funds represents the sum total of the unspent amount and additional use of funds. The Company notes the below variances do not have a material impact on the Company's ability to achieve its business objectives and milestones.
|Use of Available Funds||March 2021|
of Funds (January 1 to
January 1 to
June 30, 2021
|Current Use of|
Funds (July 1,
2021 to June 30,
|FT-104 Drug Development|
|US utility and PCT patent filings||$||77,000||$||90,000||Nil||Nil|
|CMC development and pre-clinical studies||$||1,522,804||$||1,691,000||Nil||$||113,330|
|Phase 1 studies||$||2,025,000||Nil||$||(358,333||)||$||1,666,667|
|Phase 2 studies||Nil.||Nil||$||1,150,000||$||1,150,000|
|Psilocybin Fungi Research and Cultivation (Jamaica Facility)|
|Research and development||$||1,320,000||$||304,000||$||(564,784||)||$||755,216|
|5 additional clinics (Chicago, Amsterdam, Houston, Atlanta, San Diego)||$||1,270,000||$||820,000||Nil||$||400,000|
|13 additional clinics fiscal 2022||$||4,100,000||$||415,000||$||830,000||$||5,345,000|
|Technology platforms (Trip App and Patient Portal)||$||151,000||$||247,000||$||658,643||$||718,643|
|General & administrative||$||3,854,881||$||4,006,000||$||7,411,176||$||10,575,057|
|Total use of funds||$||20,484,184||$||10,505,000||$||14,539,625||$||31,071,267|
|Unallocated working capital||$||87,410,849||$||76,823,766|
With respect to FT-104 drug development, our total CMC development and pre-clinical studies budget has been reduced to $1,804,000 as per the “Milestones” table above. After current spend of $1,691,000, we anticipate current use of proceeds of $113,330 to complete these milestones.
With respect to the Jamaica Facility, we have revised our estimates based on actual spend.
With respect to Clinic Expansion, we have allocated an additional $1,245,000 in leasehold improvement costs, or an average increase of $95,000 per clinic, based on revised assumptions relating to our most recent lease negotiations, design plans to accommodate group therapy and additional offerings, and actual costs incurred with the opening of our clinics to date.
With respect to occupancy costs, rent payments have increased over the period due to a combination of a higher clinic count over the July 1, 2021 to June 30, 2022 period and an increase in rent expense assumptions, as we are now seeking larger spaces to accommodate group therapy and additional offerings.
With respect to marketing costs, these are monies set aside for patient acquisition and are expected to increase with new clinic openings.
With respect to general and administrative expenses, we have allocated an additional $7,411,176 for going public expenses as result of our TSX and NASDAQ uplistings and increased professional and consulting fees.
With respect to our technology platforms, our March 2021 use of proceeds included third party development costs only. We have now included the $280,000 cost of our internal development and product teams in our current use of funds figure, which were previously reported in general & administrative expense.
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The Company has negative cash flow from operating activities and has historically incurred net losses. To the extent that the Company has negative operating cash flows in future periods, it may need to deploy a portion of its existing working capital to fund such negative cash flows. See "Risks and Uncertainties ".
The expected use of funds represents the Company's current intentions based upon its present plans and business condition, which could change in the future as its plans and business conditions evolve. The amounts and timing of the actual use of the net proceeds will depend on multiple factors and there may be circumstances where, for sound business reasons, a reallocation of funds may be necessary in order for the Company to achieve its stated business objectives. The Company may also require additional funds in order to fulfill its expenditure requirements to meet existing and any new business objectives, and the Company expects to either issue additional securities or incur debt to do so. As a result, management will retain broad discretion in the application of the available funds, and shareholders will be relying on management's judgment regarding such application.
See “Results of Operations” section for a discussion of occupancy costs, marketing expenditures and general and administrative expenses.
The material factors or assumptions used to develop the estimated costs disclosed above are included in the "Forward-Looking Statements" section above. The actual amount that the Company spends in connection with each of the intended uses of proceeds will depend on a number of factors, including those listed under "Risks and Uncertainties" or unforeseen events.
- 23 -
SELECTED CONSOLIDATED FINANCIAL DATA
|3 months ended||3 months ended|
|June 30, 2021||June 30, 2020|
|General and administration||7,685,666||1,353,920|
|Sales and marketing||986,705||151,832|
|Research and development||1,359,390||735,002|
|Depreciation and amortization||615,483||209,760|
|Other Income (Expenses)|
|Net Loss per Share - Basic and Diluted||(0.22||)||(0.21||)|
|Cash and cash equivalents||27,630,348||7,041,330|
|Total Non-Current Financial Liabilities||10,815,355||3,219,052|
reverse takeover transaction
On October 1, 2020, FTP completed its going public transaction (the “Transaction”) pursuant to the terms of an agreement entered into on August 21, 2020 between FTP, Newton and Newton Subco. On September 30, 2020, immediately prior to the closing of the Transaction, Newton filed articles of amendment to: (i) consolidate its outstanding common shares on an eight (8) old for one (1) new basis; and (ii) change its name from Newton Energy Corporation to "Field Trip Health Ltd.".
The Transaction constituted a reverse takeover by way of a three-cornered amalgamation under applicable securities law, with FTP as the reverse takeover acquirer and Newton as the reverse takeover acquiree. Pursuant to the terms of the agreement, Newton acquired all the issued and outstanding common shares of FTP. Holders of FTP common shares received one post-consolidation common share of Newton in exchange for each FTP share held. Newton became the direct parent and sole shareholder of FTP, changed its year end from December 31 to March 31 and continued under the Canada Business Corporations Act by Certificate and Articles of Continuance.
- 24 -
In connection with the completion of the Transaction, Newton common shares listed on the NEX board of the TSXV were delisted on September 30, 2020. Field Trip Health Ltd. shares commenced trading on the Canadian Stock Exchange on October 6, 2020, under the stock symbol FTRP. The Common Shares were subsequently delisted from the CSE and listed on the TSX and NASDAQ. See Key Highlights and Recent Developments - First Fiscal Quarter - Operational Highlights.
The Transaction does not constitute a business combination as Newton does not meet the definition of a business under IFRS 3 – Business Combinations. Immediately after the Transaction, shareholders of FTP owned 100% of the voting rights of Newton. As a result, the Transaction has been accounted for as a capital transaction with FTP being identified as the accounting acquirer and the equity consideration being measured at fair value, using the acquisition method of accounting. The Transaction has been accounted for in the consolidated financial statements as a continuation of the financial statements of FTP.
Purchase price consideration
FTP is deemed to have acquired the former Newton as part of the Transaction. The Transaction was accounted for using the acquisition method of accounting whereby the assets acquired, and liabilities assumed were recorded at their estimated fair value at the acquisition date. The acquisition did not meet the criteria for a business combination and is therefore treated as a recapitalization under the scope of IFRS 2 – Share Based Payments. The consideration consisted entirely of shares and options of Field Trip Health Ltd. which were measured at the estimated fair value on the date of acquisition. The fair value of the Common Shares issued to the former Newton shareholders was determined to be $1,590,212 based on the fair value of the shares issued (795,106 shares at $2.00 per share). The fair value of the Newton Options was determined to be $74,982 using a Black Scholes model based on the following assumptions: Stock price volatility - 70%; Risk-free interest rate – 0.29 - 0.33%; Stock price at October 1, 2020 - $2.00 and an expected life of 2.52 – 3.86 years. In connection with the acquisition of Newton, the Company incurred transaction costs of $571,435, of which $375,713 was settled in cash and the remaining $195,722 in Company stock options.
|Consideration: Newton Commons Shares||1,590,212|
|Consideration: Newton Options||74,982|
|Identifiable assets acquired: Newton Cash||66,487|
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RESULTS OF OPERATIONS
For the First Quarter of Fiscal 2022
For our first fiscal quarter ended June 30, 2021, we earned patient services revenues of $867,400 from our Toronto, New York, Santa Monica, Chicago, Atlanta and Houston clinics, a 65% increase over our previous fourth fiscal quarter of $526,435, and a 3,613% increase over our comparative quarter ended June 30, 2020 of $23,359. Our Houston clinic began contributing revenues in May 2021. Our prior year comparative quarter patient services revenues of $23,359 comprised Toronto only. We expect to scale our revenue as the number of patients treated at our locations increases. We will continue our rollout of clinics across North America and Europe, with a total target of 20 clinics by December 2021 (see Non-Revenue Generating Projects – Clinical Operations section of this MD&A).
Net loss for our first fiscal quarter of $12,530,395 was primarily due to general and administration expenses of $7,685,666, research and development expenses of $1,359,390, patient services expenses of $1,287,071, unrealized foreign exchange loss of $1,074,954, sales & marketing expenses of $986,705, depreciation and amortization of $615,483 and occupancy costs of $376,615. Net loss for our prior year comparative quarter of $2,958,904 was primarily due to general and administration expenses of $1,353,920, research and development costs of $735,002, unrealized foreign exchange loss of $394,120, depreciation and amortization of $209,760 and sales and marketing expenses of $151,832
General and Administration
Components of general and administrative expenses for the three months ended June 30, 2021 and 2020 were as follows:
|3 months ended||3 months ended|
|June 30, 2021||June 30, 2020|
|Travel and entertainment||375,856||9,040|
|IT and technology||453,566||54,448|
|Office and general||80,989||4,031|
|Total general and administration||7,685,666||1,353,920|
For our first fiscal quarter ended June 30, 2021, general and administrative expenses totaled $7,685,666 an increase of $6,331,746 compared to general and administrative expenses of $1,353,920 for the comparative quarter ended June 30, 2020. This increase was primarily due to operations and medical office administration (“MOA”) personnel costs of $2,216,000 relating to our 7 existing clinics and the following clinics under construction: San Diego, San Carlos and Austin, external services of $2,043,635 comprised of professional and consulting fees, investor relations and insurance expense, (of which $1,041,657 are non-recurring and primarily related to our TSX and Nasdaq uplistings, and $994,374 are recurring public company costs), share-based payments of $1,229,219, IT and technology costs of $399,118 related to increased personnel and travel and entertainment expenses of $366,816 related to clinic buildouts. General and administrative expenses for the quarter ended June 30, 2020 primarily related to costs incurred at our Toronto headquarters and clinic when Field Trip was still a private company.
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Components of occupancy costs for the three months ended June 30, 2021 and 2020 were as follows:
|3 months ended||3 months ended|
|June 30, 2021||June 30, 2020|
|Operating rent expense||98,350||33,469|
|Taxes, maintenance, insurance||4,754||7,009|
|Minor furniture and fixtures||240,860||1,284|
|Utilities and services||32,651||22,021|
|Total occupancy costs||376,615||63,783|
Occupancy costs relate to our Toronto headquarters, Toronto, New York, Santa Monica, Chicago, Atlanta, Houston and Amsterdam clinics and the Jamaica Facility.
For our first fiscal quarter ended June 30, 2021, occupancy costs totaled $376,615, an increase of $312,832 compared to occupancy costs of $63,783 for the comparative quarter ended June 30, 2020. This increase was primarily due to the purchase of minor furniture and fixtures of $239,576 and increased operating rent expense of $64,881 related to the clinics and Jamaica Facility. Occupancy costs for the quarter June 30, 2020 related mainly to the Toronto lease.
Sales and Marketing
Components of sales and marketing for the three months ended June 30, 2021 and 2020 were as follows:
|3 months ended||3 months ended|
|June 30, 2021||June 30, 2020|
|Brand and public relations||367,564||62,463|
|External marketing services||450,094||37,660|
|Total sales and marketing||986,705||151,832|
For our first fiscal quarter ended June 30, 2021, sales and marketing expenses totaled $986,705, an increase of $834,873 compared to sales and marketing expenses of $151,832 for the comparative quarter ended June 30, 2020. This increase was primarily due to external marketing services of $412,434 relating to paid social and search services and podcasts to drive patient interest, brand and public relations costs of $305,101, and personnel costs of $85,591. During the quarter, the Company continued to build out organic and paid digital acquisition channels across all Clinics, resulting in consistent growth in client enquiries week over week.
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Research and Development
Components of research and development for the three months ended June 30, 2021 and 2020 were as follows:
|3 months ended||3 months ended|
|June 30, 2021||June 30, 2020|
|Supplies and services||270,823||2,067|
|Total research and development||1,359,390||735,002|
External services fees relate primarily to fees paid to third parties to (i) further FT-104 development; and ii) manage the construction and project management of the Jamaica Facility, oversee the operations of the Jamaica Facility, provide legal advice and manage government relations. Construction of the Jamaica Facility was completed in October 2020 and the lab officially opened in February 2021. External services fees also include non-cash share-based payments relating to the Jamaica Facility shares (see Note 18 Share-Based Payments in the audited annual consolidated financial statements for the fiscal year ended March 31, 2021).
For our first fiscal quarter ended June 30, 2021, research and development expenses totaled $1,359,390, an increase of $624,388 compared to research and development expenses of $735,002 for the comparative quarter ended June 30, 2020. This increase was primarily due to external services of $299,413 paid to a third-party CMO and CRO to further FT-104 development, related supplies and services of $268,756 and personnel costs of $56,219. Development of the chemistry, manufacturing and controls (CMC) of the active ingredient, FT-104, continues to progress. See Non-Revenue Generating Projects for a discussion of FT-104 milestones and anticipated costs.
Depreciation and Amortization
Components of depreciation and amortization for the three months ended June 30, 2021 and 2020 were as follows:
|3 months ended||3 months ended|
|June 30, 2021||June 30, 2020|
|Depreciation and Amortization - Leasehold Improvements||77,527||23,221|
|Depreciation and Amortization - Furniture & Fixtures||19,671||2,802|
|Depreciation and Amortization - Computer Equipment & Software||41,492||7,474|
|Depreciation and Amortization - Medical Lab and Equipment||14,293||270|
|Depreciation and Amortization - Right of use asset||428,165||166,567|
|Depreciation and Amortization - Intangible assets||34,335||9,426|
|Total depreciation and amortization||615,483||209,760|
For our first fiscal quarter ended June 30, 2021, depreciation and amortization totaled $615,483, an increase of $405,723 compared to depreciation and amortization of $209,760 for the comparative quarter ended June 30, 2020. This increase was mainly due to the operation and improvement of leasehold properties (right of use assets) for the new clinics and Jamaica Facility. As at June 30, 2021, we had leases in Toronto, New York, Santa Monica, Chicago, Atlanta, Houston and Amsterdam clinics as well as the buildout of the Jamaica Facility.
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Patient Services Expense
Components of patient services expenses for the three months ended June 30, 2021 and 2020 were as follows:
|3 months ended||3 months ended|
|June 30, 2021||June 30, 2020|
|Supplies and services||52,565||3,493|
|Payment provider fees||19,117||194|
|Total patient services expense||1,287,071||56,975|
Patient services expense is comprised of direct costs incurred by the clinics to generate patient services revenue at the Toronto, New York, Santa Monica, Chicago, Atlanta and Houston clinics. Field Trip opened its first clinic in Toronto in March 2020.
Components of interest income for the three months ended June 30, 2021 and 2020 were as follows:
|3 months ended||3 months ended|
|June 30, 2021||June 30, 2020|
|Interest income on bank balances||126,560||-|
|Interest income on refundable lease deposit||4,402||1,646|
|Interest income on shareholders’ loan||653||621|
|Total interest income||131,615||2,267|
Components of interest expense for the three months ended June 30, 2021 and 2020 were as follows:
|3 months ended||3 months ended|
|June 30, 2021||June 30, 2020|
|Interest expense on leases||(145,611||)||(37,233||)|
|Interest expense on loan||(976||)||-|
|Interest expense on bank balances||-||18|
|Total interest expense||(146,587||)||(37,251||)|
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Other Income (Expense)
Components of other income (expense) for the three months ended June 30, 2021 and 2020 were as follows:
|3 months ended||3 months ended|
|June 30, 2021||June 30, 2020|
|Unrealized foreign exchange loss||(1,074,954||)||(394,120||)|
|Realized foreign exchange gain (loss)||(9,041||)||(127||)|
|Government assistance - wage subsidy||-||18,000|
|Government assistance - CEBA loan||12,102||-|
|Total other income (expense)||(1,071,893||)||(376,247||)|
During the current fiscal quarter and comparative prior year quarter, we recorded unrealized foreign exchange losses of $1,074,954 and $394,722 respectively, which reflected a strengthening of the U.S. dollar against the Canadian dollar on our U.S.-denominated bank balances.
We also applied for, and received, governmental assistance related to the COVID-19 pandemic:
|(i)||The Canada Emergency Business Account (CEBA) program provides an interest-free loan of $40,000, of which and if required conditions are met, only 75% or $ 30,000 of the loan amount is repayable by December 31, 2022. On June 3, 2021, the Company applied for and received a $20,000 CEBA loan expansion. The loan is interest-free and is in addition to the initial $40,000 CEBA loan received on September 17, 2020. With a total loan payable of $60,000, the debt forgiveness is not available unless the initial $40,000 is repaid. The loan forgiveness is calculated as follows: 25% on the initial $40,000; plus 50% on amounts above $40,000 and up to $60,000. The maximum amount of debt forgiven is $20,000. Government assistance is comprised of the fair value of the loan amount forgiven using an 15% effective interest rate (see Note 15 Loan Payable of our audited consolidated financial statements).|
|(ii)||The 10%Temporary Wage Subsidy for Employers (TWS) program provides a subsidy of 10% of wages from March 18, to June 19, 2020 up to $1,375 for each eligible employee. The maximum total is $25,000 for each eligible employer. For the three months ended June 30, 2021, the Company received wage subsidies of $nil (June 30, 2020 - $18,000).|
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SELECTED FINANCIAL INFORMATION – SUMMARY OF QUARTERLY RESULTS
The following table sets out selected quarterly information for the previous 8 quarters of the Company up to June 30, 2021:
|Q1 2022||Q4 2021||Q3 2021||Q2 2021|
|3 Months Ended||3 Months Ended||3 Months Ended||3 Months Ended|
|June 30, 2021||March 31, 2021||December 31, 2020||September 30, 2020|
|Loss per share - basic and diluted||(0.22||)||(0.18||)||(0.22||)||(0.16||)|
|Q1 2021||Q4 2020||Q3 2020||Q2 2020|
|3 Months Ended||Period Ended||3 Months Ended||3 Months Ended|
|June 30, 2020||March 31, 2020||December 31, 2019||September 30, 2019|
|Loss per share - basic and diluted||(0.21||)||(0.05||)||(0.10||)||(0.08||)|
The increase in net loss from our previous quarter ended March 31, 2021 to our current quarter ended June 30, 2021, was due to a corresponding increase in operating expenses of $4,568,310, primarily driven by general and administration expenses of $3,048,997, (of which $934,900 related to non-recurring costs due to our TSX and Nasdaq uplistings and $396,535 related to recurring public company costs), patient services of $700,743 related to the ramp of our clinics, research and development of $487,435 and sales and marketing costs of $311,637 primarily related to paid social media and podcasts to increase brand awareness.
Historically, the Company’s operating results have fluctuated on a quarterly basis and we expect that quarterly financial results will continue to fluctuate. If anticipated patient services revenues in any quarter do not occur when we expect due to unexpected delays in our North American clinic rollout and the economic impact of COVID-19 outbreak, our operating results for that quarter and future quarters may be adversely affected. Furthermore, historical patterns of expenditures cannot be taken as an indication of future expenditures. The amount and timing of expenditures and therefore liquidity and capital resources vary substantially from period to period depending on the number of clinics opened, the number of research and development programs being undertaken at any one time, the stage of the development programs, the timing of significant expenditures for pre-clinical studies and clinical trials and the availability of funding from investors. Because of the historical variations in our operating results, our limited operating history and the rapidly evolving nature of our business, we believe that period-to-period comparisons of our revenue and operating results are not necessarily meaningful and should not be relied upon as indications of our future performance.
LIQUIDITY AND CAPITAL RESOURCES
Cash and Working Capital
Since inception, we have financed our operations primarily from the issuance of equity and, to a lesser degree, from patient revenues from our clinics and interest income on funds available for investment. The Company's primary capital needs are funds to advance its research and development activities, clinic rollout and digital teletherapy tools development and for working capital purposes. These activities include staffing, preclinical studies, clinical trials and administrative costs.
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We have experienced operating losses and cash outflows from operations since incorporation, and will require ongoing financing to continue its research and development, clinic rollout and digital tele-therapy development activities. We have not earned significant revenues from the clinics, nor have we earned any revenue or reached successful commercialization of any products. Our success is dependent upon the ability to finance our cash requirements to continue our activities. We have significant lease obligations related to our current clinics, newly leased property, construction and office locations.
On June 3, 2021, the Company applied for and received a $20,000 CEBA loan expansion. The loan is interest-free and is in addition to the initial $40,000 CEBA loan received on September 17, 2020. With a total loan payable of $60,000, the debt forgiveness is not available unless the initial $40,000 is repaid. The loan forgiveness is calculated as follows: 25% on the initial $40,000; plus 50% on amounts above $40,000 and up to $60,000. The maximum amount of debt forgiven is $20,000.
On June 22, 2021, 144,377 FTP Compensation Warrants were exercised at a price of $2.00 for gross proceeds of $288,755.
During the current fiscal quarter, 70,583 options were exercised for gross proceeds of $68,670.
See "Subsequent Events" for details on issuances after June 30, 2021.
There is no assurance that additional capital or other types of financing will be available if needed or that these financings will be on terms at least as favourable to the Company as those previously obtained, or at all. See "Risks and Uncertainties".
The table below sets out our cash, funds held in trust, restricted cash and working capital as at June 30 and March 31, 2021:
|As at||As at|
|June 30, 2021||March 31, 2021|
|Funds held in trust||-||795,516|
|Working capital calculation:|
Funds held in trust of $795,516 as at March 31, 2021 represent unrestricted funds held at a Canadian chartered bank by the Company’s corporate counsel, representing proceeds from the March Bought Deal Offering which were subsequently released in April 2021.
As at June 30, the Company had $100,501 (March 31, 2021 - $100,501) of restricted cash held as collateral against Field Trip Psychedelics Inc. credit card limit. The funds are invested in two cashable GIC accounts. $35,176 matures on November 4, 2021, and $65,325 matures on January 20, 2022, respectively. The Company also had $361,678 (March 31, 2021 - $487,540) of restricted cash held at the PCs which, under the terms of the MSA, must be used to pay PC personnel and expenses before satisfying prior and current management fees.
Working capital represents the excess of current assets over current liabilities. The decrease in our cash was primarily due to cash used in investing activities of $1,024,045 and cash used in operating activities of $10,899,444, partially offset by cash provided by financing activities of $38,356.
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The following table shows our cash flows from operating, investing and financing activities for the three months ended June 30, 2021 and 2020:
|3 months ended||3 months ended|
|June 30, 2021||June 30, 2020|
|Cash used in operating activities||(10,899,444||)||(1,960,777||)|
|Cash used in investing activities||(1,024,045||)||(501,096||)|
|Cash provided by financing activities||38,356||(133,880||)|
Cash used in operating activities
During the current fiscal quarter, cash used in operating activities of $10,899,444 was primarily due to the net loss of $12,530,395 and net changes in non-cash working capital of $1,508,654, partially offset by the following non-cash items: share-based payments of $1,412,133, unrealized foreign exchange loss of $1,074,954, depreciation and amortization of $615,483, interest expense on lease commitments of $145,611.
During the comparative quarter ended June 30, 2020, cash used in operating activities of $1,960,777 was primarily due to the net loss of $2,958,904, partially offset by non-cash share-based payments of $691,572, depreciation and amortization of $209,760 and net changes in non-cash working capital of $61,828.
Cash used in investing activities
During the current fiscal quarter, cash used in investing activities of $1,024,045 consisted primarily of acquisition of property, plant and equipment of $673,899 for our Atlanta, Houston and Amsterdam clinics, acquisition of intangible assets of $112,412 relating to our digital patient portal ("Patient Portal") and Trip App, and refundable security deposits paid for right-of-use assets of $237,734.
During the comparative quarter ended June 30, 2020, cash used in investing activities of $501,096 consisted primarily of acquisition of property, plant and equipment for our Toronto headquarters and clinic of $327,411, acquisition of intangible assets of $119,173 relating to our digital teletherapy tools Patient Portal and Trip App and refundable security deposits paid for right-of-use assets of $54,512.
Cash provided by financing activities
During the current fiscal quarter, cash provided by financing activities of $38,356 was primarily due to proceeds from the exercise of warrants of $288,755, proceeds from the exercise of stock options of $68,670 and additional CEBA loan received of $20,000, partially offset by repayment of lease obligations of $339,069.
During the comparative quarter ended June 30, 2020, cash used in financing activities of $133,880 was primarily due to repayment of lease obligation of $211,668, partially offset by proceeds on issuance of common shares of $95,617.
See also "Milestones & Available Funds" for additional commentary of the use of funds by the Company.
- 33 -
OFF-BALANCE SHEET ARRANGEMENTS AND CONTRACTUAL OBLIGATIONS
We do not have any off-balance sheet arrangements that have, or are reasonably likely to have, a current or future effect on our financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.
The Company leases real property for its clinical and office locations. Additional (non-lease) rent payments for these locations are variable, and therefore have not been included in the right-of-use asset or lease obligations. The Company is committed for estimated additional variable (non-lease) rent and capital asset payments obligations as follows:
|Payments||< 1 year||1-2 years||2-3 years||3-4 years||4-5 years||5 years|
|Amsterdam Clinic||October 31, 2026||338,858||63,536||63,536||63,536||63,536||63,536||21,178|
|Atlanta Clinic||January 31, 2031||264,453||27,595||27,595||27,595||27,595||27,595||126,478|
|Chicago Clinic||September 30, 2031||584,116||58,412||58,412||58,412||58,412||58,412||292,056|
|Houston Clinic||March 31, 2026||252,279||51,311||51,311||51,311||51,311||47,035||-|
|Santa Monica Clinic|
June 30, 2030
|Toronto Clinic and Headquarters||October 31, 2023||260,237||111,530||111,530||37,177||-||-||-|
|San Carlos Clinic||August 31, 2031||588,603||49,050||58,860||58,860||58,860||58,860||304,113|
November 30, 2021
In addition to variable rent payments, the Company has committed to base rent payments at its Houston, San Diego, Seattle, and Washington DC clinics that have been excluded from right-of-use asset and lease obligation balances, as the leases have been executed but have not yet commenced.
|Payments||< 1 year||1-2 years||2-3 years||3-4 years||4-5 years||5 years|
|San Diego Clinic||January 31, 2032||2,613,826||57,426||234,139||241,042||248,521||255,999||1,576,699|
|Seattle Clinic||December 31, 2028||1,629,100||106,390||216,106||222,754||229,404||236,054||618,392|
|Vancouver Clinic||August 31, 2031||977,128||137,333||58,667||57,426||234,139||241,042||248,521|
|Fredericton Clinic||July 31, 2031||1,095,794||58,667||57,426||234,139||241,042||248,521||255,999|
|Austin Clinic||March 31, 2032||3,040,956||54,333||221,677||265,023||291,302||300,028||1,908,593|
|Connecticut Clinic||May 31, 2032||1,568,397||11,929||143,390||146,257||149,182||152,244||965,395|
(1) See "Non-Revenue Generating Projects – Clinical Operations" for additional details.
|Total||1 year||2-3 years||4-5 years||5 years|
|Jamaica Facility||April 6, 2023||733,665||677,373||56,292||-||-|
In connection with its partnership with UWI, FTNP agreed to lease property from UWI, contribute up to US$1,000,000 of initial capital for the Jamaica Facility and psilocybin research, and a total of US$100,000 to fund student development initiatives at UWI over a 36-month period. $263,121 was transferred from construction in progress to leasehold improvements in the three months ended June 30, 2021 (see Note 10 Property Plant and Equipment to the audited consolidated annual financial statements).
- 34 -
OUTSTANDING SHARE DATA
The Company has an unlimited number of Common Shares and preferred shares authorized for issuance, of which the following Common Shares are issued and outstanding as at June 30, 2021 and 2020 as of the date hereof, on a fully-diluted basis and no preferred shares are issued and outstanding:
|Number of||Number of|
|Common Share||Common Share|
|Equivalents as at||Equivalents as at|
|Class of Securities||June 30, 2021||March 31, 2021|
|FTP Compensation Warrants||198,892||343,269|
|Options to purchase Common Shares||5,896,769||5,150,798|
|Jamaica Facility Shares reserved for issuance||450,000||600,000|
During the current quarter, the Company granted 969,888 options to employees, directors and consultants. The options vest over a period of 1 to 4 years, are exercisable for a period of 2 to 10 years from issuance, and are exercisable at a price of $5.53 to $7.00 per option. The Company also issued 70,583 Common Shares of the Company on the exercise of options with an exercise price of $0.50 to $2.00 per Common Share.
Subsequent to the current quarter, the Company issued 176,648 options to employees and consultants. The options vest over a period of 4 years, are exercisable for a period of 10 years from issuance and are exercisable at a price of $7.74 per option.
See "Liquidity and Capital Resources" and "Subsequent Events" for details on options.
During the current fiscal quarter, the Company issued 144,377 Common Shares of the Company on the exercise of the FTP Compensation Warrants with an exercise price of $2.00 per Common Share (see Note 17 Warrants).
See "Liquidity and Capital Resources" and "Subsequent Events" for details on warrants.
Jamaica Facility Shares
Field Trip Psychedelics Inc. will issue 1,200,000 fully paid-up Common Shares to Darwin Inc. (the “Jamaica Facility Shares”); 600,000 upon commencement of research in the newly renovated research facility, 150,000 one year from the initial closing date (“Cliff”), and 450,000 on a prorated basis quarterly, commencing on the first calendar quarter following the Cliff and ending on the date that is 36 months following the Cliff.
- 35 -
On September 25, 2020 Field Trip issued the first installment of the Jamaica Facility shares, being a total of 600,000 Common Shares at a deemed price per Field Trip Common Share of $2.00. On June 22, 2021 Field Trip issued the second installment of the Jamaica Facility shares of 150,000 Common Shares. As at June 30, 2021, the Company had the remaining 450,000 Common Shares reserved for issuance.
TRANSACTIONS WITH RELATED PARTIES
Field Trip entered into shareholder loan agreements with two of its advisors for a total of $60,000 in July 2019. The notes are non-interest bearing (i.e., not on commercial terms) and are due on demand or five years from the date of note issuance. These loans are expected to be repaid in full at maturity. The Company measured the loans at fair value at initial recognition using an appropriate market interest rate. The below-market element of the loans was determined at initial recognition as the difference between the loan principal amount and fair value. This difference was recognized in equity as distribution to these shareholders. Total distribution arising from the initial fair value measurement of shareholders’ loan was $13,596. The fair values at initial recognition were accounted for as amortized cost financial assets in accordance with IFRS 9. The amortized cost of the loans as at June 30, 2021 was $51,174 (see Note 9 Other Assets) and total interest income accrued at market rate in profit or loss for the three months ended June 30, 2021 was $653 (see Note 26 Interest Income).
Key Management Personnel
Key management personnel are those persons having authority and responsibility for planning, directing and controlling the activities of the Company, including directors. Key management at June 30, 2021 includes twelve directors and executive officers of Field Trip. Key management personnel compensation for the three months ended June 30, 2021 and 2020 was comprised of:
|3 months ended||3 months ended|
|June 30, 2021||June 30, 2020|
|Share-based compensation (Note 18)||406,812||37,356|
Directors and officers of the Company control 35% or 20,210,593 of the outstanding voting shares of the Company.
CRITICAL ACCOUNTING ESTIMATES
The preparation of financial statements in conformity with IFRS requires management to make judgements, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets and liabilities, revenue and expenses and the related disclosures of contingent assets and liabilities and the determination of our ability to continue as a going concern. We regularly evaluate our estimates and assumptions related to share-based transaction expense, property plant and equipment, intangible assets and shareholder loans. We base our estimates and assumptions on current facts, historical experience and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of costs and expenses that are not readily apparent from other sources. Actual results could differ materially from these estimates and assumptions. We review our estimates and underlying assumptions on an ongoing basis. Revisions are recognized in the period in which the estimates are revised and may impact future periods.
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The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the financial statements, have been set out in Note 3 of our audited consolidated financial statements.
With the exception of share-based payments (see Note 18), there have been no material changes in any of critical accounting policies and estimates during the current fiscal quarter.
ACCOUNTING CHANGES AND IMPACT OF RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
Accounting standards or amendments to existing accounting standards that have been issued, but have future effective dates, are either not applicable or are not expected to have a significant impact on our financial statements.
FINANCIAL INSTRUMENTS AND RISK MANAGEMENT
IFRS 13 – Fair Value Measurements provides a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs are those that reflect market data obtained from independent sources, while unobservable inputs reflect the Company’s assumptions with respect to how market participants would price an asset or liability. These two inputs to measure fair value fall into the following three different levels of the fair value hierarchy:
|Level 1 –||Quoted prices in active markets for identical instruments that are observable;|
|Level 2 -||Quoted prices in active markets for similar instruments; inputs other than quoted prices that are observable and derived from or corroborated by observable market data; and|
|Level 3 -||Valuations derived from valuation techniques in which one or more significant inputs are unobservable.|
The hierarchy requires the use of observable market data when available.
Cash, restricted cash, accounts receivable, and accounts payable and accrued liabilities are all short-term in nature and, as such, their carrying values approximate fair values. There have been no transfers between any levels of the fair value hierarchy.
The Company is exposed to credit risk, liquidity risk, interest rate risk and currency risk. The Company’s Board of Directors has overall responsibility for the establishment and oversight of the Company’s risk management framework. The Audit Committee of the Board of Directors is responsible for review the Company’s financial risk management policies.
Credit risk is the risk of an unexpected loss if a counterparty to a financial instrument fails to meet its contractual obligations. The Company is exposed to credit risk on its cash and accounts receivable. The carrying amount of these financial assets represents the maximum credit exposure. The Company’s cash is held on deposit with major banks in Canada, the United States, and Jamaica which we believe lessens the degree of credit risk.
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Field Trip manages its liquidity risk by reviewing on an ongoing basis its capital requirements. The Company typically settles its financial obligations in cash. The ability to settle obligations in cash is dependent on the Company raising financing in a timely manner and by maintaining sufficient cash in excess of anticipated needs. As at June 30, 2021, the Company had $27,630,348 of unrestricted cash and cash equivalents.
Undiscounted contractual obligations as of June 30, 2021 and March 31, 2021 are as follows:
June 30, 2021
|Less than 1||1 year to||3 years to|
|Total||year||3 years||5 years||Over 5 years|
|Accounts payable and accrued liabilities||4,036,835||4,036,835||-||-||-|
|Total financial liabilities||19,540,687||6,007,716||3,541,599||3,472,714||6,518,658|
March 31, 2021
|Less than 1||1 year to||3 years to|
|Total||year||3 years||5 years||Over 5 years|
|Accounts payable and accrued liabilities||5,348,110||5,348,110||-||-||-|
|Total financial liabilities||14,841,615||6,826,052||2,325,745||1,988,112||3,701,706|
Interest Rate Risk
Financial instruments that potentially subject the Company to cash flow interest rate risk are those assets and liabilities with a variable interest rate. Currently, the Company has no assets or liabilities with a variable interest rate. Financial assets and financial liabilities that bear interest at fixed rates are subject to fair value interest rate risk. The Company’s lease obligations are at fixed rates of interest.
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The Group is exposed to currency risk related to the fluctuation of foreign exchange rates and the degree of volatility of those rates. Currency risk is limited to the portion of the Group’s business transactions denominated in currencies other than the Canadian dollar, which are primarily expenses in United States dollars. As at June 30, 2021, the Group held USD dollar denominated cash of $45,645,732 USD (March 31, 2021 - $45,902,622 USD), USD denominated accounts receivable of $344,983 USD (March 31, 2021 - $32,989) and had USD dollar denominated accounts payable and accrued liabilities in the amounts of $632,258 USD (March 31, 2021 - $487,541 USD). Therefore, a 1% change in the foreign exchange rate would have a net impact as at June 30, 2021 of $562,173 (March 31, 2021 - $571,509). USD dollar revenue for the three months ended June 30, 2021 were $477,911 USD (2020 - $ nil USD) and USD dollar expenses for the three months ended June 30, 2021 were $3,712,379 USD (2020 - $814,957 USD). Varying the foreign exchange rate for the three months ended June 30, 2021 to reflect a 1% strengthening of the U.S. dollar would have increased the net loss by approximately $39,725 (2020 - $11,298) assuming that all other variables remained constant.
On July 06, 2021 , the Company executed a lease agreement to build its Dallas, Texas clinic, commencing on December 1, 2022 and ending March 31, 2032. Total commitments under the lease are approximately $1,975,759.
On July 14, 2021, the Company executed a lease agreement to build its Miami, Florida clinic, commencing on the same date and ending July 31, 2031. Total commitments under the lease are approximately $4,098,144.
On July 15, 2021, the Company executed a lease agreement for an additional 4,674 sq. ft. at its Toronto headquarters location, commencing on August 1, 2021 and ending September 30, 2026. Total commitments under the lease are approximately $790,651.
On July 22, 2021, the Group executed a lease agreement to build its Scottsdale, Arizona clinic, commencing on the same date and ending April 30, 2032. Total commitments under the lease are approximately $1,527,948.
On July 27, 2021, the Company received final approval from NASDAQ to list its common shares on the NASDAQ Global Select Market. The Company’s shares began trading at market open on July 29, 2021 with the ticker symbol FTRP.
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The Company’s common stock will continue to trade in Canada on the TSX Exchange under its current symbol FTRP; and concurrent with the listing of Field Trip’s common shares on NASDAQ in the US, the shares will cease to be quoted on the OTCQX. The Company has previously completed the process to ensure its shares are eligible for electronic clearing through the Depository Trust Company (DTC).
RISKS AND UNCERTAINTIES
The Company’s AIF of even date herewith sets forth material risks and uncertainties that may affect our business, including our future financing and operating results and could cause our actual results to differ materially from those contained in forward-looking statements we have made in this MD&A. The risks and uncertainties AIF, which are incorporated in this MD&A by reference) are not the only ones we face. Additional risks and uncertainties not presently known to us or that we believe to be immaterial may also adversely affect our business. Further, if we fail to meet the future expectations of the public market in any given period now that the Company’s shares are listed, the market price of our Common Shares could decline. We operate in a highly competitive environment that involves significant risks and uncertainties, some of which are outside of our control. (See “Risk Factors” in the AIF for details).