Full Press Release Details
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
As used in this management's discussion and analysis of financial condition and results of operations ("MD&A"), unless the context indicates or requires otherwise, all references to the "Company", "FSD", "we", "us" or "our" refer to FSD Pharma Inc., together with our subsidiaries, on a consolidated basis as constituted on June 30, 2021.
This MD&A for the three and six months ended June 30, 2021 and 2020 should be read in conjunction with the Company's unaudited consolidated interim financial statements, the accompanying notes for the three and six months ended June 30, 2021 and 2020 and the audited consolidated financial statements and the accompanying notes for fiscal years ended December 31, 2020, and 2019. The financial information presented in this MD&A is derived from the Company's unaudited consolidated interim financial statements for the three and six months ended June 30, 2021 and 2020 which have been prepared in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board ("IASB"). All amounts are in United States dollar except where otherwise indicated.
This MD&A is dated as of August 12, 2021.
FORWARD-LOOKING INFORMATION
The information provided in this MD&A, including information incorporated by reference, may contain certain forward-looking statements and forward-looking information (collectively referred to as "forward-looking statements") within the meaning of applicable Canadian and U.S. securities legislation about our current expectations, estimates and projections about the future, based on certain assumptions made by us in light of the Company's experience and perception of historical trends. Although we believe that the expectations represented by such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct.
This forward-looking information is identified by words such as "anticipate", "believe", "expect", "plan", "forecast", "future", "target", "project", "capacity", "could", "should", "focus", "proposed", "scheduled", "outlook", "potential", "may" or similar expressions and includes suggestions of future outcomes; the Company's proposed partnership and joint ventures with, and investments in, other entities; the estimated costs of the Company's proposed capital projects and future investments; potential proceeds from the exercise of the Company's outstanding share purchase warrants; actions taken by the Company, or that the Company may take in the future, to adjust its capital structure; the undertaking of clinical research to study the effects of the Company's products on client health; the outcome of clinical trials related to ultra micro-palmitoylethanolamide ("ultramicronized-PEA" or "FSD-201"). Readers are cautioned not to place undue reliance on forward-looking information as the Company's actual results may differ materially from those expressed or implied.
The Company has made certain assumptions with respect to the forward-looking statements regarding, among other things: the Company's ability to generate sufficient cash flow from operations and obtain financing, if needed, on acceptable terms or at all; general economic, financial market, regulatory and political conditions in which the Company operates; purchaser interest in the Company's products; anticipated and unanticipated costs; government regulation of the Company's activities and products; the timely receipt of any required regulatory approvals; the Company's ability to obtain qualified staff, equipment and services in a timely and cost efficient manner; the Company's ability to conduct operations in a safe, efficient and effective manner; and the Company's expansion plans and timeframe for completion of such plans.
Although the Company believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because no assurance can be given that they will prove to be correct. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. These include, but are not limited to: the limited operating history of the Company and history of losses; the Company's ability to continue as a going concern; the highly speculative nature of drug development; the Company's ability to generate sufficient revenue to be profitable; the Company's ability to raise the capital necessary for it to execute its strategy; impact of any future recall of the Company's products; the impact of any negative scientific studies on the effects of micro-PEA; the Company's inability to complete clinical trials and attain the regulatory approvals it needs to commercialize its pharmaceutical products; the Company's product candidates being in the preclinical development stage; the Company's ability to obtain regulatory approval in jurisdictions for any product candidates; delays in clinical trials; failure of clinical trials to demonstrate substantial evidence of the safety and/or effectiveness of product candidates; results of earlier studies or clinical trials not being predictive of future clinical trials; difficulties enrolling patients in clinical trials; potential side effects, adverse events or other properties or safety risks of pharmaceutical product candidates; regulatory regimes of locations for clinical trials outside of the United States; failure to obtain approval to commercialize product candidates outside of the United States; published clinical trial data may change in future trials; manufacturing problems resulting in delays in development or commercialization programs; inability to successfully validate, develop and obtain regulatory approval for companion diagnostic tests for drug candidates; changes in funding for the U.S. Food and Drug Administration ("FDA") and other government agencies; risks associated with development and commercialization of pharmaceutical products, including the inability to accurately predict timing or amounts of expenses, requirements of regulatory authorities, and completion of clinical studies; risks inherent in an agricultural business; rising energy costs; the Company's reliance on key persons; the Company's compliance with environmental, health and safety laws and regulations; insurance risks; interruptions in the supply chain for key inputs; demand for skilled labour, specialized knowledge, equipment, parts and components; the Company's ability to manage its growth; the Company's ability to successfully implement and maintain adequate internal controls over financial reporting or disclosure controls and procedures; the Company not having been required to certify that it maintains effective internal control over financial reporting or effective disclosure controls and procedures; increased costs as a result of operating as a public company in the United States; risks relating to our status as a foreign private issuer; the Company taking advantage of reduced disclosure requirements applicable to emerging growth companies; the Company's ability to successfully identify and execute future acquisitions or dispositions; expansion of international operations; reliance on the operations of the Company's partners; results of litigation; conflicts of interest between the Company and its directors and officers; payment of dividends; the partial dependence of the Company's operations on the maintenance and protection of its information technology systems; unforeseen tax and accounting requirements; tax risks related to the Company's status as a "passive foreign investment company"; changes in government; changes in government policy; failure of counterparties to perform contractual obligations; the Company's ability to successfully develop new products or find a market for their sale; the Company's ability to promote and sustain its brands; product liability claims or regulatory actions; reputational risks to third parties with whom the Company does business; the Company's ability to produce and sell its medical products outside of Canada; co-investment risks; failure to comply with laws and regulations; the Company's reliance on its own market research and forecasts; competition from synthetic production and new technologies; the Company's ability to transport its products; liability arising from any fraudulent or illegal activity; product liability lawsuits; misconduct or other improper activities by employees, independent contractors, consults, commercial partners and vendors; failure to achieve market acceptance in the medical community; inability to establish sales and marketing capabilities; failure to comply with health and data protection laws; reliance on third parties to conduct clinical trials; loss of single-source suppliers; reliance on contract manufacturing facilities; inability to obtain or maintain sufficient intellectual property protection for the Company's products; third-party claims of intellectual property infringement; patent terms being insufficient to protect competitive position on product candidates; inability to obtain patent term extensions or non-patent exclusivity; inability to protect the confidentiality of trade secrets; inability to protect trademarks and trade names; filing of claims challenging the inventorship of the Company's patents and other intellectual property; invalidity or unenforceability of patents; claims regarding wrongfully use or disclosed confidential information of third parties; inability to protect intellectual property rights around the world; the Company's dual class share structure; that additional issuances of the Company's shares could have a significant dilutive effect; public health crises; and other factors beyond the Company's control.
The Company cautions that the foregoing list of important factors is not exhaustive. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. There is no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. You should carefully consider the matters discussed under "Risks Factors" in our Annual Information Form for the year ended December 31, 2020, Short Form Base Shelf Prospectus dated June 16, 2020 and Prospectus Supplement dated February 11, 2021.
The forward-looking statements contained or incorporated by reference in this MD&A are made as of the date of this MD&A or as otherwise specified. Except as required by applicable securities laws, we undertake no obligation to update publicly or otherwise revise any forward-looking statements or the foregoing list of factors affecting those statements, whether as a result of new information, future events or otherwise or the foregoing lists of factors affecting this information.
All of the forward-looking information contained in this MD&A is expressly qualified by the foregoing cautionary statements.
Additional information relating to FSD can be found on SEDAR at www.sedar.com and on EDGAR at www.sec.gov.
The Company was formed under and is governed by the provisions of the Business Corporations Act (Ontario) (the "OBCA") on November 1, 1998 pursuant to the amalgamation of Olympic ROM World Inc., 1305206 Ontario Company, 1305207 Ontario Inc., Century Financial Capital Group Inc. and Dunberry Graphic Associates Ltd. On May 24, 2018, pursuant to Articles of Amendment, the Company changed its name to "FSD Pharma Inc". The Company's registered office is located at 199 Bay Street, Suite 4000, Toronto, Ontario, M5L 1A9.
FSD Pharma Inc. ("FSD" or the "Company"), through its wholly owned subsidiary, FSD Biosciences, Inc. is a pharmaceutical research and development ("R&D") company focused on developing over time multiple applications of its lead compound, ultra-micro PEA by down-regulating the cytokines to effectuate an anti-inflammatory response.
The Company filed an Investigational New Drug Application ("IND") with the FDA on August 28, 2020 and was approved on September 25, 2020 to initiate a phase 2 clinical trial for the use of FSD201 to treat COVID-19, the disease caused by the SARS-CoV-2 virus. The trial is targeting a total of 352 random patients in a controlled, double-blind multicenter study.
The Company has retained an independent biotechnology and pharma focused firm to evaluate more broadly its principal drug compound, PEA, in order to evaluate its current potential commercial viability.
As of the date hereof, the Company currently has two material subsidiaries: (i) FSD Biosciences Inc. ("FSD Biosciences"), which is wholly owned by the Company and incorporated under the laws of the State of Delaware; and (ii) FV Pharma Inc. ("FV Pharma"), which is wholly owned by the Company and incorporated under the OBCA.
In July 2020, the Company decided to primarily focus its efforts and resources on the pharmaceutical business operated through FSD Biosciences Inc. As of September 30, 2020, the Company, ended all activities of FV Pharma. As a result, the Company is no longer engaged in cannabis-related activities and is in the process of liquidating all of FV Pharma's assets, including the sale of its Facility and/or the adjacent real estate.
Requisitioning Shareholders
On May 16, 2021, the Company announced the results of its annual general and special meeting of the shareholders held on May 14, 2021. The nominees proposed by a group of shareholders led by Anthony Durkacz and Zeeshan Saeed were elected to serve as the Company's directors.
Through the acquisition of Prismic Pharmaceuticals Inc. ("Prismic"), the Company acquired an exclusive, worldwide license (excluding Italy and Spain) to exploit for certain specified pharmaceutical purposes patents and other intellectual property rights to ultra micro-palmitoylethanolamide ("PEA") owned by Epitech Group SpA ("Epitech"). PEA is a naturally occurring substance that is produced within the body in response to inflammation. FSD Pharma is currently seeking to advance pharmaceutical development programs centered on FSD201 ultra micro-PEA that meet one or more selected criteria. All efforts are intended to be founded on a biological plausibility of an efficacious effect with a high safety profile.
The Company has successfully completed Phase 1 first-in-human safety and tolerability study for FSD201 and has found the compound to be safe with no serious adverse side effects. This study also validated considerable scientific literature already published in the European Union that claims safety and tolerability of micro-PEA. Ultra-micro PEA is currently being dispensed in Italy and Spain as a prescription based medical food supplement since 2004.
The Company received permission from the FDA in June 2020 to submit an IND Application for the use of FSD201 to treat COVID-19, the disease caused by the SARS-CoV-2 virus.
The Company submitted to the FDA an IND Application for the use of FSD201 in August 2020.
Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm and ultimately death. The Company is focused on developing FSD201 for its anti-inflammatory properties to down-regulate the over-expressed immune response and mitigate the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.
In September 2020, the Company received authorization from the FDA to initiate Phase 2 study for the use of FSD201 to treat COVID-19.
The FSD201 COVID-19 trial is currently on hold as the Company evaluates the commercial viability of the Phase 2 study. As was previously stated in the March 17, 2021 Information Circular, the nominees proposed by a group of shareholders led by Anthony Durkacz and Zeeshan Saeed, would audit the Company's current Phase 2 study to determine its current viability and to better understand the risks and costs associated with the Phase 2 study. The Company has retained an independent biotechnology and pharma focused firm to conduct the evaluation and analyses.
Epitech License Agreement
On January 8, 2020, the Company entered into an amended and restated license agreement with Epitech (the "License Agreement"), which amended and restated the license agreement between Prismic and Epitech through which Prismic secured certain intellectual property rights to PEA from Epitech. The License Agreement grants the Company an exclusive, worldwide license (excluding Italy and Spain where the Company is not licensed and Epitech remains entitled to commercialize the Licensed Products (as defined herein), directly or indirectly) (the "Epitech License") to research, manufacture and commercialize products (the "Licensed Products") that are developed using certain proprietary formulations of PEA owned by Epitech and that are to be used to treat chronic kidney disease in humans or, if a prescription drug, any other human condition that is related to pain and chronic pain. The Epitech License also gives FSD the right to use the Licensed IP (as defined in the Epitech License) in the development of a prescription drug for the treatment of the cytokine storm associated with COVID-19. In addition, under the terms of the Epitech License, if Epitech develops or commercializes a prescription drug for the treatment of any other human condition unrelated to pain and chronic pain (a "Different Prescription Drug") in its territory, the Company has a first refusal right to use Epitech's patents to develop and commercialize this Different Prescription Drug in its territory (i.e. worldwide excluding Italy and Spain). Should the Company exercise this right, but then fail to demonstrate commercially reasonable efforts to develop the Different Prescription Drug in the two years following, Epitech would be free to exploit and/or license to third parties the use of the patents for the Different Prescription Drug. The FSD-201 COVID-19 Trials are subject to such requirements. Finally, the Epitech License provides the Company with a nonexclusive license to use Epitech's scientific and technical know-how with respect to ultramicronized-PEA in connection with the development or commercialization of the Licensed Products discussed above.
Under the terms of the License Agreement, the Company is required to make payments to Epitech upon the achievement of specified milestones. Upon first notification by the FDA of approval of a New Drug Application, the non-refundable sum of $700,000 is due and payable to Epitech. Within ten business days of the first notification of approval of a Supplemental New Drug Application by the FDA, the Company is required to pay the non-refundable sum of $1,000,000 to Epitech. None of the specified milestones have been met to date.
The License Agreement also specifies certain royalty payments. Pursuant to the License Agreement, the Company must pay Epitech 25% (in the case of non-prescription drug rights) and 5% (in the case of prescription drug rights) of any one-off lump sum payments it receives as consideration for granting a sub-license to a third-party with respect to a Licensed Product. In addition, the Company is required to pay either: (a) 7% of net sales of the Licensed Products in a product regulatory category other than prescription drugs placed on the market by the Company; (b) 25% of the royalties received by the Company from sub-licensees (such royalties, the "Net Receipts") where Licensed Products in a product regulatory category other than prescription drugs are placed on the market by such sub-licensees; or (c) 5% of net sales or Net Receipts of the Licensed Products that are prescription drugs.
Unless otherwise terminated in accordance with its terms, the Epitech License will remain in force until the Company is no longer obligated to pay royalties under the License Agreement, which obligation will expire on a country-by-country basis when the last valid claim of the Licensed Patents covering the Licensed Products in a given country expires. The approval of a therapeutically equivalent, generic version of the Licensed Product(s) in a country will conclusively demonstrate that a valid claim does not cover the Licensed Products in that country. If there are no patents covering the Licensed Products in a country, royalties are payable for the license of the scientific and technical know-how under the Epitech License until expiration of the last-to expire Epitech patent that relates to PEA.
The above description of the License Agreement is qualified in its entirety by reference to the full text of such agreement, a copy of which is available under the Company's SEDAR and EDGAR profiles.
Innovet License Agreement
On March 9, 2021, the Company entered into the Innovet License Agreement ("License Agreement") with Innovet Italia S.R.L. ("Innovet"). The License Agreement grants the Company an exclusive, worldwide license (excluding Italy, and subject to a first refusal right maintained by Innovet, any other country in Europe) to research, manufacture and commercialize products using certain proprietary formulations of ultra-micro PEA (the "Licensed Products") to treat gastro-intestinal diseases in canines and felines. The License Agreement provides that the Company shall develop the Licensed Products with a view to submitting an Investigational Animal Drug Application with the FDA within thirty-six (36) months of the date of the agreement and shall submit a New Animal Drug Application within sixty (60) months of the effective date of the agreement.
Under the terms of the License Agreement, the Company is required to make payments to Innovet upon the achievement of specified milestones. An initial non-refundable sum of US$500,000 was payable to Innovet on the effective date of the License Agreement and a second non-refundable sum of US$250,000 will be due and payable to Innovet on the first anniversary of the effective date of the License Agreement. Within thirty business days of the first notification of approval of a New Animal Drug Application by the FDA of the first Licensed Product to receive such approval in the United States, the Company is required to pay an additional non-refundable sum of US$750,000 to Innovet. None of the specified milestones have been met to date.
The License Agreement also specifies certain royalty payments. Pursuant to the License Agreement, the Company is required to pay Innovet 14% of any one-off lump sum payments it receives as consideration for granting a sub-license to a third-party with respect to a Licensed Product. In addition, the Company is required to pay 5% of net sales of the Licensed Products.
The above description of the License Agreement is qualified in its entirety by reference to the full text of such agreement, a copy of which is available under the Company's SEDAR and EDGAR profiles.
The Company held three licenses from Health Canada: (i) a Cultivation License (defined below); (ii) a Processing License (defined below); and (iii) a Sale for Medical Purposes Licence (collectively, the "Licenses").
On July 30, 2020, the Company announced that it has notified Health Canada of the Company's decision to forfeit the licenses of FV Pharma and suspend all cannabis-related activities of FV Pharma within 30 days. As of September 30, 2020, the Company ended all activities of FV Pharma and had surrendered its Licenses. The Company is in the process of liquidating all of FV Pharma's assets, including the sale of its Facility and/or the adjacent real estate.
FV Pharma's facility is located at 520 William Street, Cobourg, Ontario, K9A 3A5 (the "Facility"). The Company also owns the 70-acre property on which the Facility is located (the "Facility Property"). FV Pharma acquired the Facility in November 2017. The Facility has 581,538 square feet of building space. The Company is actively exploring a sale of the Facility and/or the Facility Property. See further discussion below under "Discontinued Operations".
The Company has no contractual arrangements and has no commitments for capital expenditures with respect to the Facility or the Facility Property.
The outbreak of the novel strain of coronavirus, specifically identified as "COVID-19," has resulted in governments worldwide enacting emergency measures to combat the spread of the virus. These measures, which include the implementation of travel bans, self-imposed quarantine periods and social distancing, have caused material disruption to businesses globally resulting in an economic slowdown. Governments and central banks have reacted with significant monetary and fiscal interventions designed to stabilize economic conditions. The extent to which COVID-19 and any other pandemic or public health crisis impacts the Company's business, affairs, operations, financial condition, liquidity, availability of credit and results of operations will depend on future developments that are highly uncertain and cannot be predicted with any meaningful precision, including new information which may emerge concerning the severity of the COVID-19 virus and the actions required to contain the COVID-19 virus or remedy its impact, among others. The duration and impact of the COVID-19 outbreak is unknown at this time, as is the efficacy of the government and central bank interventions. It is not possible to reliably estimate the length and severity of these developments and the impact on the financial results and condition of the Company and its operating subsidiaries in future periods.
In order to mitigate the impact of COVID-19, the Company implemented a systematic and orderly scale back of FV Pharma's cultivation operations and a furlough policy for its workforce, except for certain personnel working staggered shifts to ensure continuity of operations and licensure effective March 23, 2020. Following the Company's decision to primarily focus its efforts and resources on the pharmaceutical business operated through FSD Biosciences Inc. in September 2020, FV Pharma surrendered its licenses and ceased all other operational activities. The Company's clinical trials for the use of FSD-201, its lead compound, to treat suspected or confirmed cases of COVID-19 are currently on hold as the Company evaluates the commercial viability of the compound. COVID-19 did not have a material impact on the continuing operations or financial results of the Company for the three and six months ended June 30, 2021.
CHANGE IN FUNCTIONAL AND PRESENTATION CURRENCY TO UNITED STATES DOLLAR
The Company changed its functional currency from the Canadian dollar (C$) to the United States dollar (US$) as of October 1, 2020. The change in functional currency was the result of a review of the primary economic environment in which the entity operates and the currency that mainly influences the underlying transactions entered into by the Company.
The Company has elected to change its presentation currency from the C$ to the US$ effective October 1, 2020. The change in presentation currency is a voluntary change which is accounted for retrospectively. The change in presentation currency was made to better reflect the Company's business activities. For comparative reporting purposes, historical financial information has been translated to US$ using the exchange rate as at October 1, 2020, which is the date of the change in the functional and presentation currency.
DISCONTINUED OPERATIONS
As previously noted, in March 2020, the Company decided to focus its efforts and resources on the pharmaceutical business and initiated a process to sell the Facility and Facility Property and exit the medical cannabis industry. The Company is actively marketing the Facility and Facility Property for sale and expects that the sale of the Facility and Facility Property will be completed within the next twelve months.
Assets held for sale consists of the Facility and Facility Property. It is anticipated that no liabilities of the Company will be transferred as part of any proposed transaction. Results of operations related to the Facility are reported as discontinued operations for the three and six months ended June 30, 2021 and 2020.
In accordance with IFRS 5 - Non-current Assets Held for Sale and Discontinued Operations, the assets held for sale were assessed for impairment based on fair value less costs to sell. The fair value was measured using the price at which the Company expects to receive for the disposal of the Facility and Facility Property in its current state less estimates for the costs of disposal. The fair value less costs to sell was higher than the carrying value of the Facility and Facility Property, resulting in recognition of the resulting group at carrying value.
SELECTED FINANCIAL HIGHLIGHTS
The following table presents selected financial information for the three and six months ended June 30, 2021 and 2020:
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||
| $ | $ | $ | $ | |||||||||
| General and administrative | 5,073,691 | 1,909,183 | 8,122,550 | 4,925,055 | ||||||||
| External research and development fees | 3,612,718 | 1,561,518 | 5,582,969 | 1,864,910 | ||||||||
| Share-based payments | 3,020,647 | 364,080 | 6,853,171 | 2,668,322 | ||||||||
| Depreciation and amortization | 982,353 | 994,337 | 1,933,373 | 1,965,668 | ||||||||
| Impairment of right-of-use asset | - | - | - | 89,860 | ||||||||
| Total operating expenses | 12,689,409 | 4,829,118 | 22,492,063 | 11,513,815 | ||||||||
| Net loss from continuing operations | (12,754,390 | ) | (3,925,554 | ) | (22,160,002 | ) | (12,085,461 | ) | ||||
| Net loss from discontinued operations | (452,937 | ) | (566,930 | ) | (986,779 | ) | (1,768,794 | ) | ||||
| Net loss for the period | (13,207,327 | ) | (4,492,484 | ) | (23,146,781 | ) | (13,854,255 | ) |
OVERALL FINANCIAL PERFORMANCE
Three and six months ended June 30, 2021
For the three and six months ended June 30, 2021, general and administrative expenses were $5,073,691 and $8,122,550, respectively, compared to $1,909,183 and $4,925,055 for the comparative periods in the prior year. This represents an increase of $3,164,508 or 166% for the three months ended June 30, 2021, and an increase of $3,197,495 or 65% for the six months ended June 30, 2021, compared to the equivalent periods in the prior year. The increase is primarily related to one-time professional fees incurred during the period due to litigation and the process leading to the Company's contested annual general and special meeting of the shareholders held on May 14, 2021.
For the three and six months ended June 30, 2021, external research and development fees were $3,612,718 and $5,582,969, respectively, compared to $1,561,518 and $1,864,910 for the comparative periods in the prior year. This represents an increase of $2,051,200 or 131% for the three months ended June 30, 2021, and an increase of $3,718,059 or 199% for the six months ended June 30, 2021, compared to the equivalent periods in the prior year. The increase is related to expenses incurred for the research and development of PEA, for Phase 2 Safety and Tolerability testing and COVID-19 study.
For the three and six months ended June 30, 2021, share-based payments expense was $3,020,647 and $6,853,171, respectively, compared to $364,080 and $2,668,332 for the comparative periods in the prior year. This represents an increase of $2,656,567 or 730% for the three months ended June 30, 2021, and an increase of $4,184,849 or 157% for the six months ended June 30, 2021, compared to the equivalent periods in the prior year. The increase in share-based payments is due to share options granted to management and the Board of Directors in the ordinary course following their election at the Company's annual general and special meeting of the shareholders held on May 14, 2021. In addition, in February 2021, the Company's former Board of Directors issued shares to certain individuals who, at that time, were management or members of the Company's Board of Directors.
For the three and six months ended June 30, 2021, depreciation and amortization was $982,353 and $1,933,373, respectively, compared to $994,337 and $1,965,668 for the comparative periods in the prior year. This represents a decrease of $11,984 or 1% for the three months ended June 30, 2021, and a decrease of $32,295 or 2% for the six months ended June 30, 2021, compared to the equivalent periods in the prior year. Depreciation and amortization is related to the amortization of intellectual property.
For the three and six months ended June 30, 2021, net loss was $13,207,327 and $23,146,781, respectively, compared to $4,492,484 and $13,854,255 for the three and six months ended June 30, 2020. Net loss for the three and six months ended June 30, 2021, is comprised of net loss from continuing operations of $12,754,390 and $22,160,002 and net loss from discontinued operations of $452,937 and $986,779 compared to net loss from continuing operations of $3,925,554 and $12,085,461 and net loss from discontinued operations of $566,930 and $1,768,794 for the three and six months ended June 30, 2020.
| As at June 30, | As at December 31, | |||||||||||
| 2021 | 2020 | Change | ||||||||||
| $ | $ | $ | % | |||||||||
| Cash | 43,196,613 | 17,524,822 | 25,671,791 | 146% | ||||||||
| Total assets | 68,350,918 | 41,967,205 | 26,383,713 | 63% | ||||||||
| Total liabilities | 10,073,855 | 5,658,622 | 4,415,233 | 78% |
The Company concluded the six months ended June 30, 2021 with cash of $43,196,613 (December 31, 2020 - $17,524,822).
Cash used in operating activities for the six months ended June 30, 2021 was $12,068,527 compared to $9,216,704 for the six months ended June 30, 2020.
Cash used in investing activities for the six months ended June 30, 2021 was $500,000 compared to cash provided by investing activities of $6,372,375 for the six months ended June 30, 2020. During the six months ended June 30, 2021, the Company made payments for acquired intellectual property under the Innovet License Agreement of $500,000, compared to proceeds of $6,372,375 from the sale of investments during the six months ended June 30, 2020.
Cash provided by financing activities for the six months ended June 30, 2021 was $38,240,318 compared to cash provided by financing activities of $6,948,400 for the six months ended June 30, 2020. During the six months ended June 30, 2021, the Company issued shares for net proceeds of $38,341,407 offset by the repayment of $71,424 of notes payable and the repayment of $29,665 for lease obligations. During the six months ended June 30, 2020, the Company issued shares for net proceeds of $6,909,994, received $59,548 from the exercise of stock options offset by repayment of $21,142 for lease obligations.
RESULTS OF OPERATIONS
The following table outlines our consolidated statements of loss for three and six months ended June 30, 2021 and 2020:
| For the three months ended June 30, | For the six months ended June 30, | ||||||||||||||||||||||||
| 2021 | 2020 | Change | 2021 | 2020 | Change | ||||||||||||||||||||
| $ | $ | $ | % | $ | $ | $ | % | ||||||||||||||||||
| Expenses | |||||||||||||||||||||||||
| General and administrative | 5,073,691 | 1,909,183 | 3,164,508 | 166% | 8,122,550 | 4,925,055 | 3,197,495 | 65% | |||||||||||||||||
| External research and development fees | 3,612,718 | 1,561,518 | 2,051,200 | 131% | 5,582,969 | 1,864,910 | 3,718,059 | 199% | |||||||||||||||||
| Share-based payments | 3,020,647 | 364,080 | 2,656,567 | 730% | 6,853,171 | 2,668,322 | 4,184,849 | 157% | |||||||||||||||||
| Depreciation and amortization | 982,353 | 994,337 | (11,984 | ) | -1% | 1,933,373 | 1,965,668 | (32,295 | ) | -2% | |||||||||||||||
| Impairment of right-of-use asset | - | - | - | 100% | - | 89,860 | (89,860 | ) | -100% | ||||||||||||||||
| Total operating expenses | 12,689,409 | 4,829,118 | 7,860,291 | 163% | 22,492,063 | 11,513,815 | 10,978,248 | 95% | |||||||||||||||||
| Loss from continuing operations | (12,689,409 | ) | (4,829,118 | ) | (7,860,291 | ) | 163% | (22,492,063 | ) | (11,513,815 | ) | (10,978,248 | ) | 95% | |||||||||||
| Other income | - | (13,251 | ) | 13,251 | -100% | (1,292 | ) | (26,853 | ) | 25,561 | -95% | ||||||||||||||
| Finance expense | 18,917 | 68,474 | (49,557 | ) | -72% | 38,242 | 141,637 | (103,395 | ) | -73% | |||||||||||||||
| Gain on settlement of financial liability | (39,542 | ) | (40,409 | ) | 867 | -2% | (49,792 | ) | (40,409 | ) | (9,383 | ) | 23% | ||||||||||||
| Loss (gain) on change in fair value of warrants and derivative liability | (294,947 | ) | - | (294,947 | ) | 100% | 261,609 | (634,415 | ) | 896,024 | -141% | ||||||||||||||
| Loss (gain) on changes in fair value of investments | 380,553 | (918,378 | ) | 1,298,931 | -141% | (580,828 | ) | 1,131,686 | (1,712,514 | ) | -151% | ||||||||||||||
| Net loss from continuing operations | (12,754,390 | ) | (3,925,554 | ) | (8,828,836 | ) | 225% | (22,160,002 | ) | (12,085,461 | ) | (10,074,541 | ) | 83% | |||||||||||
| Net loss from discontinued operations | (452,937 | ) | (566,930 | ) | 113,993 | -20% | (986,779 | ) | (1,768,794 | ) | 782,015 | -44% | |||||||||||||
| Net loss | (13,207,327 | ) | (4,492,484 | ) | (8,714,843 | ) | 194% | (23,146,781 | ) | (13,854,255 | ) | (9,292,526 | ) | 67% |
REVIEW OF OPERATIONS FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2021 AND 2020
General and administrative
General and administrative expenses for the three and six months ended June 30, 2021 and 2020 are comprised of:
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||||||||||
| 2021 | 2020 | Change | 2021 | 2020 | Change | |||||||||||||||||||
| $ | $ | $ | % | $ | $ | $ | % | |||||||||||||||||
| Professional fees | 2,797,012 | 181,454 | 2,615,558 | 1441% | 3,848,488 | 1,220,251 | 2,628,237 | 215% | ||||||||||||||||
| General office, insurance and administration expenditures | 1,132,494 | 776,979 | 355,515 | 46% | 1,979,776 | 1,771,137 | 208,639 | 12% | ||||||||||||||||
| Consulting fees | 545,586 | 394,209 | 151,377 | 38% | 1,275,426 | 1,033,386 | 242,040 | 23% | ||||||||||||||||
| Salaries, wages and benefits | 973,662 | 479,792 | 493,870 | 103% | 1,668,398 | 964,688 | 703,710 | 73% | ||||||||||||||||
| Investor relations | 36,448 | 116,307 | (79,859 | ) | -69% | 75,249 | 419,588 | (344,339 | ) | -82% | ||||||||||||||
| Building and facility costs | 188,019 | 15,323 | 172,696 | 1127% | 578,382 | 196,660 | 381,722 | 194% | ||||||||||||||||
| Foreign exchange loss (gain) | (129,161 | ) | 91,371 | (220,532 | ) | -241% | (284,345 | ) | 33,855 | (318,200 | ) | -940% | ||||||||||||
| 5,544,060 | 2,055,435 | 3,488,625 | 170% | 9,141,374 | 5,639,565 | 3,501,809 | 62% | |||||||||||||||||
| Allocated to: | ||||||||||||||||||||||||
| Continuing operations | 5,073,691 | 1,909,183 | 3,164,508 | 166% | 8,122,550 | 4,925,055 | 3,197,495 | 65% | ||||||||||||||||
| Discontinued operations | 470,369 | 146,252 | 324,117 | 222% | 1,018,824 | 714,510 | 304,314 | 43% |
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||||||||||
| 2021 | 2020 | Change | 2021 | 2020 | Change | |||||||||||||||||||
| $ | $ | $ | % | $ | $ | $ | % | |||||||||||||||||
| Professional fees | 2,797,012 | 181,454 | 2,615,558 | 1441% | 3,848,488 | 1,220,251 | 2,628,237 | 215% |
Professional fees increased from $181,454 to $2,797,012 or 1441% and increased from $1,220,251 to $3,848,488 or 215% for the three and six months ended June 30, 2021, respectively, compared to the equivalent periods in the prior year. For the three and six months ended June 30, 2021, the increase is due to litigation and the Company's contested annual general and special shareholders meeting held on May 14, 2021.
General office, insurance and administration expenditures
General office, insurance and administration expenditures for the three and six months ended June 30, 2021 and 2020 are comprised of the following:
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||||||||||
| 2021 | 2020 | Change | 2021 | 2020 | Change | |||||||||||||||||||
| $ | $ | $ | % | $ | $ | $ | % | |||||||||||||||||
| Insurance, shareholders and public company costs | 918,955 | 536,209 | 382,746 | 71% | 1,575,709 | 1,022,896 | 552,813 | 54% | ||||||||||||||||
| Travel, meals and entertainment | 14,280 | 22,659 | (8,379 | ) | -37% | 100,076 | 291,614 | (191,538 | ) | -66% | ||||||||||||||
| Office and general administrative | 199,259 | 218,111 | (18,852 | ) | -9% | 303,991 | 456,627 | (152,636 | ) | -33% | ||||||||||||||
| General office, insurance and administration expenditures | 1,132,494 | 776,979 | 355,515 | 46% | 1,979,776 | 1,771,137 | 208,639 | 12% |
Insurance, shareholders and public company costs
Insurance, shareholders and public company costs increased from $536,208 to $918,955 or 71% and increased from $1,022,896 to $1,575,709 or 54% for the three and six months ended June 30, 2021, respectively, compared to the equivalent periods in the prior year. These costs primarily consist of insurance and other related expenditures associated with being a publicly-listed Company on the NASDAQ. The primary reason for the increase for the three and six months ended June 30, 2021, compared to the equivalent periods in the prior year is due an increase in the cost of director and officers insurance.
Travel, meals and entertainment
Travel, meals and entertainment expenses decreased from $22,659 to $14,280 or 37% and decreased from $291,614 to $100,076 or 66% for the three and six months ended June 30, 2021, respectively, compared to the equivalent periods in the prior year. Travel, meals and entertainment expenses fluctuate from period to period based on the nature of the transactions the Company undertakes.
Office and general administrative
Office and general administrative expenses decreased from $218,111 to $199,259 or 9% and decreased from $456,627 to $303,991 or 33% for the three and six months ended June 30, 2021, respectively, compared to the equivalent periods in the prior year. Office and general administrative expenses may vary from period to period based on operational activities.
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||||||||||
| 2021 | 2020 | Change | 2021 | 2020 | Change | |||||||||||||||||||
| $ | $ | $ | % | $ | $ | $ | % | |||||||||||||||||
| Consulting fees | 545,586 | 394,209 | 151,377 | 38% | 1,275,426 | 1,033,386 | 242,040 | 23% |
Consulting fees increased from $394,209 to $545,586 or 38% and increased $1,033,386 to $1,275,426 or 23% for the three and six months ended June 30, 2021, respectively, compared to the equivalent periods in the prior year. Consulting fees include fees paid to individuals and professional firms who provide advisory services to the Company and fluctuate from period to period based on the nature of the transactions the Company undertakes.
Salaries, wages and benefits
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||||||||||
| 2021 | 2020 | Change | 2021 | 2020 | Change | |||||||||||||||||||
| $ | $ | $ | % | $ | $ | $ | % | |||||||||||||||||
| Salaries, wages and benefits | 973,662 | 479,792 | 493,870 | 103% | 1,668,398 | 964,688 | 703,710 | 73% |
Salaries, wages and benefits expenses increased from $479,792 to $973,662 or 103% and increased from $964,688 to $1,668,398 or 73% for the three and six months ended June 30, 2021, respectively, compared to the equivalent periods in the prior year. The increase is primarily due to expenses incurred in connection with the termination of employment of employees during the period and employer health tax.
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||||||||||
| 2021 | 2020 | Change | 2021 | 2020 | Change | |||||||||||||||||||
| $ | $ | $ | % | $ | $ | $ | % | |||||||||||||||||
| Investor relations | 36,448 | 116,307 | (79,859 | ) | -69% | 75,249 | 419,588 | (344,339 | ) | -82% |
Investor relations expenses decreased from $116,307 to $36,448 or 69% and decreased from $419,588 to $75,249 or 82% for the three and six months ended June 30, 2021, respectively, compared to the equivalent periods in the prior year. The decrease is primarily related to lower spending on investor relations and marketing during the three and six months ended June 30, 2021.
Building and facility costs
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||||||||||
| 2021 | 2020 | Change | 2021 | 2020 | Change | |||||||||||||||||||
| $ | $ | $ | % | $ | $ | $ | % | |||||||||||||||||
| Building and facility costs | 188,019 | 15,323 | 172,696 | 1127% | 578,382 | 196,660 | 381,722 | 194% |
Building and facility costs increased from $15,323 to $188,019 or 1127% and increased from $196,660 to a $578,382 or 194% for the three and six months ended June 30, 2021, respectively, compared to the equivalent periods in the prior year. Such costs include property taxes, security services, repairs and maintenance expenditures and utilities. The increase for the three and six months ended June 30, 2021, respectively, compared to the equivalent periods in the prior year is primarily due to repair costs incurred for the Heritage building located on the Facility Property and an environmental land study of the Facility Property.
Foreign exchange loss (gain)
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||||||||||
| 2021 | 2020 | Change | 2021 | 2020 | Change | |||||||||||||||||||
| $ | $ | $ | % | $ | $ | $ | % | |||||||||||||||||
| Foreign exchange loss (gain) | (129,161 | ) | 91,371 | (220,532 | ) | -241% | (284,345 | ) | 33,855 | (318,200 | ) | -940% |
Foreign exchange loss (gain) increased from a loss of $91,371 and $33,855 to a gain of $129,161 and $284,345 for the three and six months ended June 30, 2021, respectively, compared to the equivalent periods in the prior year. The primary reason for the foreign exchange gain was due to the increase in strength of the Canadian dollar relative to the US dollar and its impact on cash balances denominated in the Canadian dollar.
External research and development fees
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||||||||||
| 2021 | 2020 | Change | 2021 | 2020 | Change | |||||||||||||||||||
| $ | $ | $ | % | $ | $ | $ | % | |||||||||||||||||
| External research and development fees | 3,612,718 | 1,909,183 | 1,703,535 | 89% | 5,582,969 | 1,864,910 | 3,718,059 | 199% |