Milestone Pharmaceuticals (MIST) risk factors, FY2024 10-K

Risks Related to Our Financial Position and Capital Needs

1. 01We have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability
2. 02incur additional legal, insurance related, accounting and other expenses associated with operating as a public company
3. 03Because of the numerous risks and uncertainties associated with drug development, we are unable to accurately predict the timing or amount of expenses or when, or if, we will be able to achieve profitability
4. 04Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability
5. 05We will require substantial additional funding to finance our operations. If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate our development of etripamil or other operations
6. 06the costs of operating as a public company
7. 07Economic uncertainty may adversely affect our results of operations
8. 08Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our product candidates
9. 09Our ability to use our non-capital loss carryforwards to offset future taxable income may be subject to certain limitations

Risks Related to the Development of Our Product Candidates

1. 10We may not be successful in our efforts to expand our pipeline of product candidates beyond etripamil for PSVT
2. 11The development of additional product candidates is risky and uncertain
3. 12a product candidate may not be accepted as safe and effective by physicians, patients, the medical community or third-party payors
4. 13Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials, and we cannot assure you that any ongoing, planned or future clinical trials will lead to results sufficient for the necessary regulatory approvals
5. 14We may encounter substantial delays or difficulties in our clinical trials
6. 15we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs
7. 16Our product development costs will also increase if we experience delays in testing or obtaining marketing approvals. We do not know whether any of our preclinical studies or clinical trials will begin as planned, need to be restructured or be completed on schedule, if at all
8. 17Clinical trials are very expensive, time consuming and difficult to design and implement
9. 18Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by multiple factors outside our control
10. 19Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial potential or result in significant negative consequences following any potential marketing approval
11. 20Interim, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
12. 21As an organization, we have completed pivotal clinical trials, but we have never submitted a successful NDA. We may be unable to do so for any product candidates we may develop
13. 22We may explore additional strategic collaborations that may never materialize, or we may be required to relinquish important rights to and control over the development of our product candidates to any future collaborators

Risks Related to the Commercialization of Our Product Candidates

1. 23If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell etripamil or any future product candidates, we may not be successful in commercializing etripamil or any future product candidates, if and when they are approved
2. 24Even if etripamil or any future product candidates receive marketing approval, they may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success
3. 25the availability of third-party coverage and adequate reimbursement; any restrictions on the use of the drug together with other medications; and the awareness and support from key opinion leaders in cardiology
4. 26Even if we successfully obtain approval for etripamil, its success will be dependent on its proper use
5. 27If the market opportunities for etripamil and any future product candidates are smaller than we estimate, our business may suffer
6. 28We may face substantial competition, which may result in others developing or commercializing drugs before or more successfully than us
7. 29also have significantly greater research and marketing capabilities than we do. If we are not able to compete effectively against existing and potential competitors, our business and financial condition may be harmed
8. 30If we commercialize etripamil or any future product candidates outside of the United States, a variety of risks associated with international operations could harm our business
9. 31business interruptions resulting from pandemics and public health crisis (such as the COVID-19 pandemic), geopolitical actions, including war (such as the Russia-Ukraine and Israel-Hamas wars) and terrorism or natural disasters including earthquakes, typhoons, floods and fires
10. 32The pharmaceutical industry in China is highly regulated, and such regulations are subject to change, which may negatively affect the commercialization of the Company’s medicines and drug candidates in that country
11. 33Coverage and adequate reimbursement may not be available for etripamil or any future product candidates, which could make it difficult for us to gain market acceptance
12. 34Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidates that we may develop
13. 35injury to our reputation and significant negative media attention

Risks Related to Regulatory Compliance

1. 36Even if we obtain and maintain approval for etripamil or any future product candidates from the FDA, we may never obtain approval of etripamil or any future product candidates outside of the United States, which would limit our market opportunities and could harm our business
2. 37Even if we obtain regulatory approval for etripamil or any future product candidates, they will remain subject to ongoing regulatory oversight
3. 38refuse to allow us to enter into supply contracts, including government contracts
4. 39In addition, we cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad
5. 40Healthcare legislative reform measures may have a negative impact on our business and results of operations
6. 41100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024
7. 42Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business

Risks Related to Our Dependence on Third Parties

1. 43We will rely on third parties to produce clinical and commercial supplies of etripamil and any future product candidates
2. 44the possibility that, to the extent we need to complete technology transfers to a backup CMO or alternative CMO, we may be subject to additional costs associated with the technology transfer or dependent on the cooperation of our current CMOs
3. 45We rely on third parties to conduct, supervise and monitor our preclinical studies and clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business
4. 46undergo changes in priorities or become financially distressed
5. 47Etripamil is intended to be used with a nasal-spray device, which may result in additional regulatory and supply risks

Risks Related to Our Intellectual Property

1. 48compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights
2. 49Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
3. 50Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
4. 51Intellectual property rights do not necessarily address all potential threats to our business
5. 52We may become involved in lawsuits to protect or enforce our patents or other intellectual property rights, which could be expensive, time consuming and unsuccessful
6. 53Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a negative impact on the success of our business
7. 54We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms
8. 55We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property
9. 56Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect etripamil and any future product candidates
10. 57We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business
11. 58Reliance on third parties requires us to share our proprietary information, which increases the possibility that such information will be misappropriated or disclosed
12. 59Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business
13. 60If we are unable to protect the confidentiality of our proprietary information, our business and competitive position would be harmed

Risks Related to Our Business Operations, Employee Matters and Managing Growth

1. 61Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel
2. 62We may expand our organization in the future, and we may experience difficulties in managing this growth, which could disrupt our operations
3. 63third parties with whom we work to detect, investigate, mitigate, contain, and remediate a security incident could result in outages, data losses, and disruptions of our business
4. 64Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading
5. 65Our current or future acquisitions or strategic collaborations could increase our capital requirements, dilute our shareholders, cause us to incur debt or assume contingent liabilities and subject us to other risks
6. 66our inability to generate revenue from acquired technology and/or drugs sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs

Risks Related to Ownership of Our Common Shares

1. 67The market price of our common shares has been and may continue to be volatile and fluctuate substantially, and you could lose all or part of your investment
2. 68investors’ general perception of us and our business
3. 69Unstable market and economic conditions, including as a result of recent bank closures, public health crises or geopolitical tensions such as the Russia-Ukraine and/or the Israel-Hamas war, may have serious adverse consequences on our business, financial condition and share price
4. 70Our common shares are thinly traded, and our shareholders may be unable to sell their shares quickly or at market price
5. 71Concentration of ownership of our common shares among our existing executive officers, directors and principal shareholders may prevent new investors from influencing significant corporate decisions
6. 72If research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our share price and trading volume could decline
7. 73Because we do not anticipate paying any cash dividends on our share capital in the foreseeable future, capital appreciation, if any, will be your sole source of gain
8. 74We have broad discretion in the use of our cash and cash equivalents and may use them in ways in which you do not agree or in ways that do not increase the value of your investment
9. 75Future changes to tax laws could materially adversely affect our Company and reduce net returns to our shareholders
10. 76Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits
11. 77We are a “smaller reporting company” under the SEC’s disclosure rules, meaning that we have either: (i) a public float of less than $250 million; or (ii) annual revenues of less than $100 million during the most recently completed fiscal year; and no public float; or a public float of less than $700 million
12. 78We are incurring, and expect to continue to incur additional costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives
13. 79As a non-accelerated filer and smaller reporting company, we are exempt from Section 404(b) of the Sarbanes-Oxley Act, which requires auditor attestation to the effectiveness of internal control over financial reporting. We are, however, subject to Section 404(a) of the Sarbanes-Oxley Act
14. 80Because we are a Canadian company, it may be difficult to serve legal process or enforce judgments against us
15. 81We are governed by the corporate laws of Québec, Canada which in some cases have a different effect on shareholders than the corporate laws of Delaware
16. 82Certain provisions of our bylaws and certain Canadian legislation, together or separately, could discourage or delay certain change in control transactions or shareholder proposals