CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this Annual Report, including statements regarding our future results of operations and financial position, business strategy, product candidates, product pipeline, ongoing and planned clinical studies, including those of our collaboration partners, regulatory approvals, research and development ("R&D") costs, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Many of the forward-looking statements contained in this Annual Report are often, but not always, identified by words or phrases such as "would," "seek," "anticipate," "believe," "expect," "plan," "continue," "estimate," "will," "predict," "intend," "forecast," "future," "target," "project," "capacity," "could," "should," "might," "focus," "proposed," "scheduled," "outlook," "potential," "may" or similar expressions and includes suggestions of future outcomes, including, but not limited to statements about:
| ● | discussions concerning the Company's exploration of near-term funding strategies; |
| ● | the Company's plans to advance the R&D of its Product Candidates (as defined herein) to commercialization through studies and clinical trials, including anticipated timing and associated costs; |
| ● | the application and the costs associated with such planned trials, and the Company's ability to obtain required funding and the terms and timing thereof; |
| ● | the expansion of our product offering(s); |
| ● | our business objectives and the expected impacts of previously announced acquisitions and developments; |
| ● | the U.S. Food and Drug Administration ("FDA") and Health Canada, or comparable regulatory authority, application process and any review thereof and its effects on our business objectives; |
| ● | the Company's focus on the research and development of Lucid-MS to prevent and reverse myelin degradation; |
| ● | the Company's Lucid-21-302 clinical development program in multiple sclerosis advancing towards human Phase 2 efficacy trials; |
| ● | the Company's intention to retain 100% of the rights to develop products for pharmaceutical and medical uses; |
| ● | the Company's intention to maintain a portfolio of strategic investments through FSD Strategic Investments Inc.; |
| ● | the Company's belief that its current financial position and recent operational improvements provide a solid foundation for operations and potential growth opportunities; |
| ● | agreements with investor relations companies will play a key role in assisting the Company to enhance its market awareness and foster productive, continuing dialogues with shareholders and other market participants; |
| ● | overall market growth rates and the Company's growth rates; |
| ● | the Company's business plans and strategies, including acquisition opportunities; |
| ● | intentions with respect to, and the ability to execute, the Company's growth strategies; |
| ● | future sales of the Company's products; |
| ● | future regulatory approval and sales of drugs and devices; |
| ● | securing additional licenses from third parties and the entry into license agreements for future product acquisitions; |
| ● | assessments of suppliers' manufacturing capacity and downstream supply of raw materials; |
| ● | relationships with pharmaceutical licensors; |
| ● | relationships with employees and directors; |
| ● | the Company's competitive position in the industry; |
| ● | anticipated trends and challenges in the Company's business and the markets in which it operates; |
| ● | protection of the Company's intellectual property rights; |
| ● | the effects of any non-compliance with government regulations; |
| ● | the exercise of certain shareholder rights; |
| ● | statements with respect to future prospects for Company products; |
| ● | the Company's pursuits of additional product and pipeline opportunities in certain therapeutic markets; |
| ● | future milestone payments; |
| ● | the issuance of Class B Subordinate Voting Shares (as defined herein) pursuant to the ATM Offering (as defined below); |
| ● | the Company's anticipated cash needs and its needs for additional financing; |
| ● | amendment to any laws, rules or regulations, and the impact and timing thereof, including with respect to approval, pricing or reimbursement of drug products; |
| ● | the Company's use of cryptocurrencies as financial assets and as a potential medium of exchange for future transactions; and |
| ● | the Company's ability to conduct future financings and other transactions in cryptocurrency. |
Readers are cautioned not to place undue reliance on forward-looking statements as the Company's actual results may differ materially and adversely 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; |
| ● | the general economic, financial market, regulatory and political conditions in which the Company operates; |
| ● | the interest of potential purchasers in the Product Candidates; |
| ● | anticipated and unanticipated costs; |
| ● | the government regulation of the Corporation's activities and Product Candidates; |
| ● | the timely receipt of any required regulatory approvals; |
| ● | our ability to obtain qualified staff, equipment and services in a timely and cost-efficient manner; |
| ● | our ability to conduct operations in a safe, efficient and effective manner; |
| ● | our expansion plans and timeframe for completion of such plans; |
| ● | our revenue growth and operating efficiencies; |
| ● | customer demand for the Company's products; |
| ● | the Company will have ongoing patent protection; |
| ● | the sufficiency of budgeted capital expenditures in carrying out planned activities; |
| ● | the availability and cost of labour and services; |
| ● | trends in the bio-pharmaceutical industry; |
| ● | there being no significant changes in regulatory, tax and healthcare laws and regulations; |
| ● | the absence of a material change in competition; |
| ● | our ability to maintain our current strategic relationships with Unbuzzd and Celly U.S Nutrition Corp, a Delaware corporation ("Celly U.S."), pursuant to the Unbuzzd License Agreement (as defined herein); |
| ● | our ability to protect and maintain our, and not infringe on third parties', intellectual property rights throughout the world; |
| ● | our ability to raise capital when needed in order to continue our product development programs and commercialization efforts; |
| ● | our ability to attract and retain qualified employees and key personnel; |
| ● | the Company's ability to successfully develop new commercialized products or find a market for their sale; |
| ● | the impact of any future recall of the Company's products; |
| ● | the Company's ability to promote and sustain its products, including any restrictions or constraints on marketing practices under the regulatory framework in which the Company operates; |
| ● | our ability to issue Class B Subordinate Voting Shares pursuant to the ATM Offering; |
| ● | there being generally stable economic and financial conditions in Canada, the United States, Australia, and globally; |
| ● | cryptocurrencies continuing to function as financial assets capable of being held and transferred; and |
| ● | the Company having the ability to conduct future financings and other transactions in cryptocurrency. |
Although the Corporation 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 such statements will prove to be correct.
Forward-looking statements appear in a number of places in this Annual Report and include, but are not limited to, statements regarding our intent, belief, or current expectations. Forward-looking statements are based on our management's beliefs and assumptions, and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified under "Item 3. Key information - D. Risk Factors" in this Annual Report. These risks and uncertainties include multiple factors:
| ● | the success of our clinical studies, our ability to obtain and maintain regulatory approval and to commercialize our Product Candidates, which include Lucid-21-302 ("Lucid-MS"), for the treatment of multiple sclerosis ("MS") and our product for alcohol misuse in the healthcare area; |
| ● | failure of our licensing partners, Unbuzzd and Celly U.S. to continue selling and distributing unbuzzd™, a functional beverage product that seeks to provide relief from inebriation and accelerate alcohol metabolism in the consumer market; |
| ● | the ability of our competitors to discover, develop or commercialize competing products to unbuzzd™, Lucid-MS or other product candidates before or more successfully than we do; |
| ● | our plans to research, develop and commercialize our Product Candidates; |
| ● | the occurrence of serious adverse, undesirable, or unacceptable side effects related to our Product Candidates; |
| ● | the acceptance by the FDA and applicable foreign regulatory authorities of data from studies for Lucid-MS or our alcohol misuse products that we and our collaboration partners conduct within and outside the U.S. now and in the future; |
| ● | our foreign private issuer status, the loss of which would require us to comply with the Exchange Act of 1934, as amended (the "Exchange Act") domestic reporting regime, and cause us to incur significant legal, accounting, and other expenses; |
| ● | our incorporation in Ontario, the laws of which govern our corporate affairs and may differ from those applicable to companies incorporated in the U.S.; |
| ● | the limited operating history of the Company and history of losses, and anticipated significant losses for the foreseeable future incurred to pursue commercialization of the Product Candidates; |
| ● | the Company's inability to file investigational new drug applications ("INDs") or clinical trial applications ("CTAs") on timelines it reasonably anticipates, if at all; |
| ● | the current stage of development of our Product Candidates and the inherent uncertainty of clinical development programs; |
| ● | the Company's reliance on its Product Candidates; |
| ● | the Company's ability to identify, license or discover additional product candidates; |
| ● | failure to achieve the degree of market acceptance and demand for our products or Product Candidates by physicians, patients, healthcare payors, and others in the medical community which are necessary for commercial success; |
| ● | 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; |
| ● | potential side effects, adverse events or other properties or safety risks of the Product Candidates; |
| ● | preliminary, interim data obtained from the Company's clinical trials may not be indicative of future scientific observations or conclusions; |
| ● | inability to establish sales and marketing capabilities, or enter into agreements with third parties, to sell and market any Product Candidates that the Company may develop; |
| ● | the ability to provide the capital required for research, product development, operations and marketing; |
| ● | violations of laws and regulations resulting in repercussions; |
| ● | risks inherent in a pharmaceutical business and the development and commercialization of pharmaceutical products; |
| ● | delays in clinical trials; |
| ● | the Company's inability to attain or maintain the regulatory approvals it needs in any jurisdiction; |
| ● | failure of counterparties to perform contractual obligations; |
| ● | changes, whether anticipated or not, in laws, regulations and guidelines that may result in significant compliance costs; |
| ● | uncertainty associated with insurance coverage and reimbursement status for newly-approved pharmaceutical products; |
| ● | the effect that any public health crises, such as pandemics or epidemics may have on the Company's business; |
| ● | the price of our securities may be volatile due to a variety of factors; |
| ● | the inability to obtain required additional financing on terms favourable to the Corporation or at all; |
| ● | the Company's anticipated negative cash flow from operations and non-profitability for the foreseeable future; |
| ● | the issuances of equity securities and the conversion of outstanding securities to Class B Subordinate Voting Shares; |
| ● | the Company's dual class share structure; |
| ● | the market price of the Class B Subordinate Voting Shares possibly being subject to wide price fluctuations; |
| ● | whether an active trading market for the Class B Subordinate Voting Shares is sustained; |
| ● | the Company's ability to maintain compliance with Nasdaq Stock Market LLC's ("Nasdaq") rules for continued listing on the Nasdaq; |
| ● | the Company's ability to identify and execute future acquisitions or dispositions effectively; |
| ● | lack of dividends, and reinvestment of retained earnings, if any, into the Company's business; |
| ● | the Company's reliance on management, key persons and skilled personnel; |
| ● | reliance on contract manufacturing facilities; |
| ● | manufacturing problems that could result in delay of the Company's development or commercialization programs; |
| ● | insurance and uninsured risks; claims from suppliers; conflicts of interest between the Company and its directors and officers; |
| ● | the Company's ability to manage its growth effectively; |
| ● | supply chain interruptions and the ability to maintain required supplies of equipment, parts and components; |
| ● | the Company's ability to successfully implement and maintain adequate internal controls over financial reporting or disclosure controls and procedures; |
| ● | the dependence of the Company's operations, in part, on the maintenance and protection of its information technology systems and those of its third-party collaborators, CROs or other contractors or consultants, which could face cyber-attacks; |
| ● | failure to execute definitive agreements with entities in which the Company has entered into letters of intent or memoranda of understanding; |
| ● | unfavorable publicity or consumer perception towards the Product Candidates; |
| ● | reputational risks to third parties with whom the Company does business; failure to comply with laws and regulations; |
| ● | the Company's reliance on its own market research and forecasts; |
| ● | competition from other technologies and pharmaceutical products; |
| ● | the Company's ability to safely, securely, efficiently and cost-effectively transport our products to consumers; |
| ● | liability arising from any fraudulent or illegal activity or misconduct by the Company's directors, officers, employees, contractors, consultants, commercial partners or vendors; |
| ● | unforeseen claims made against the Company, including product liability claims or regulatory actions; |
| ● | reliance on single-source suppliers for the acquisition of the drug substance and drug product for any of the Product Candidates; |
| ● | inability to obtain or maintain sufficient intellectual property protection for the Product Candidates; |
| ● | 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 used or disclosed confidential information of third parties; |
| ● | risks related to the Company's investment in Unbuzzd, including the ability of Unbuzzd and Celly U.S. to commercialize the exclusive rights to the recreational applications for the Company's alcohol misuse technology; |
| ● | risks related to the Company's status as a foreign private issuer; |
| ● | the Company taking advantage of reduced disclosure requirements applicable to emerging growth companies; |
| ● | the Company's classification as a "passive foreign investment company"; |
| ● | that the Company's international business operations could expose it to regulatory risks or factors beyond our control; |
| ● | risks related to expansion of international operations; |
| ● | the Company's ability to produce and sell products in, and export products to, other jurisdictions; |
| ● | regulatory regimes of locations for clinical trials outside of Canada and the United States; |
| ● | failure to obtain approval to commercialize Product Candidates outside of Canada and the United States; |
| ● | if clinical trials are conducted outside of Canada and the United States, FDA and Health Canada may not accept data from such trials; |
| ● | other factors beyond the Company's control; |
| ● | the Company will not issue Class B Subordinate Voting Shares pursuant to the ATM Offering; |
| ● | risks related to the value, liquidity and regulatory treatment of cryptocurrencies held as treasury assets; |
| ● | our inability to conduct future financing and other transactions in cryptocurrency; |
| ● | the Company being subject to counterparty risks, including particular risks relating to its custodians with regards to the holding of digital assets in custodial accounts; |
| ● | national phase filing risk; and |
| ● | the other risk factors discussed under "Item 3. Key information - D. Risk Factors." |
These forward-looking statements are applicable only as of the date of this Annual Report, and are subject to a number of risks, uncertainties and assumptions described under the sections in this Annual Report entitled "Item 3. Key information - D. Risk Factors" and "Item 5. Operating and Financial Review and Prospects" and elsewhere in this Annual Report. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.