ARS Pharmaceuticals (SPRY) risk factors, FY2024 10-K

Risks Related to Our Business

1. 01If we are unable to fully develop and maintain our sales, marketing and distribution capabilities on our own or through collaborations with marketing partners, we may not be successful in commercializing neffy
2. 02unforeseen delays, costs and expenses associated with maintaining our sales organization
3. 03The market for neffy and our intranasal epinephrine technology may be smaller than we expect
4. 04If we are unable to achieve and maintain adequate levels of third-party payor coverage and reimbursement for neffy on reasonable pricing terms, its commercial success may be severely hindered
5. 05neffy has only been studied in a limited number of patients. neffy is now available to a much larger number of patients, and we do not know whether the results of neffy’s use in such larger number of patients will be consistent with the results from our clinical studies
6. 06Obtaining regulatory approval of neffy or our current or future intranasal epinephrine technology product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval in other jurisdictions
7. 07enforcing and defending intellectual property rights and claims
8. 08We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, further development and the commercialization of our current and future intranasal epinephrine technology product candidates
9. 09the potential for policies or regulations of the FDA, the EMA, the EU or any other applicable foreign regulatory authorities to significantly change in a manner rendering our clinical data insufficient for approval
10. 10The results of early-stage clinical trials and preclinical studies may not be predictive of future results. Initial data in our clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials
11. 11Interim topline 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. 12Product liability lawsuits against us or any of our current and future licensing and collaboration partners could divert our resources and attention, cause us to incur substantial liabilities and limit commercialization of neffy or our current or future intranasal epinephrine technology product candidates
13. 13the inability to successfully commercialize neffy or our current or future intranasal epinephrine technology product candidates
14. 14A pandemic, epidemic, or outbreak of an infectious disease may materially and adversely affect our business, including our nonclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results
15. 15refusal of the FDA, the EMA or the other regulatory bodies to accept data from clinical trials in affected geographies outside the United States, the EU or other relevant local geographies
16. 16The increasing use of social media platforms presents new risks and challenges

Risks Related to Our Results of Operations and Financial Position

1. 17We expect that our timing of sales and our results of operations will fluctuate for the foreseeable future, which may make it difficult to predict our future performance from period to period
2. 18We have incurred significant losses since our inception
3. 19acquire or in-license other product candidates and technologies
4. 20We may need additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development activities or commercialization efforts
5. 21the ongoing costs of operating as a public company
6. 22Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidate
7. 23Changes in tax law could adversely affect our business and financial condition
8. 24Our ability to use net operating loss carryforwards and certain other tax attributes may be limited

Risks Related to our Legal and Regulatory Environment

1. 25injunctions or the imposition of civil or criminal penalties
2. 26Recently enacted and future legislation may increase the difficulty and cost for us to commercialize neffy or our current or future intranasal epinephrine technology product candidates and affect the prices we may obtain
3. 27Governments outside the United States may impose strict price controls, which may adversely affect our revenues, if any
4. 28We will incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies
5. 29If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business

Risks Related to Our Dependence on Third Parties

1. 30We rely completely on third parties to manufacture and warehouse both our domestic and international supply of neffy and our current and future intranasal epinephrine technology product candidates
2. 31the misappropriation of our proprietary information, including our trade secrets and know-how
3. 32Our reliance on third parties requires us to share our trade secrets, know-how and other proprietary information, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed

Risks Related to Our Intellectual Property

1. 33Our commercial success depends on our ability to obtain and maintain sufficient intellectual property protection for neffy, our current and future intranasal epinephrine technology product candidates and other proprietary technologies
2. 34If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected
3. 35We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business
4. 36Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents
5. 37Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect neffy and our current or future intranasal epinephrine technology product candidates
6. 38Obtaining and maintaining patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
7. 39Patent terms may be inadequate to protect our competitive position for neffy and our current or future intranasal epinephrine technology product candidates for an adequate amount of time and may adversely affect our anticipated future revenues and operating earnings
8. 40We cannot ensure that patent rights relating to inventions described and claimed in our pending patent applications will issue or that patents based on our patent applications will not be challenged and rendered invalid and/or unenforceable
9. 41whether we may experience patent office interruption or delays to our ability to timely secure patent coverage to any potential additional indications or any future product candidates
10. 42We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect our ability to develop and market neffy and our current or future intranasal epinephrine technology product candidates
11. 43If we are sued for infringing on the intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing neffy or our current or future intranasal epinephrine technology product candidates
12. 44We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful and could result in a court or administrative body finding our patents to be invalid or unenforceable
13. 45neffy or our current or future intranasal epinephrine technology product candidates may face competition from generic inhalable epinephrine products sooner than expected, and our patents may be challenged
14. 46Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties
15. 47Intellectual property litigation may lead to unfavorable publicity that harms our reputation
16. 48We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property
17. 49If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected
18. 50Intellectual property rights do not necessarily address all potential threats to our competitive advantage
19. 51If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
20. 52We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties
21. 53In the future, we may need to obtain additional licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms, and which may cause us to operate our business in a more costly or otherwise adverse manner that was not anticipated

Risks Related to Employee Matters and Managing Growth

1. 54Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees
2. 55Our employees, independent contractors, consultants, current and future licensing and collaboration partners and CROs may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation
3. 56laws that require the reporting of financial information or data accurately
4. 57We may encounter difficulties in managing our growth, which could disrupt our operations

Risks Related to the Securities Markets and Ownership of Our Common Stock

1. 58The market price of our common stock could be volatile
2. 59period-to-period fluctuations in our financial results
3. 60In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against those companies
4. 61Delaware law and provisions in our amended and restated certificate of incorporation and amended and restated bylaws could make a merger, tender offer or proxy contest difficult, thereby depressing the trading price of our common stock
5. 62We do not anticipate paying any cash dividends in the foreseeable future
6. 63Future sales of shares by existing stockholders could cause our stock price to decline
7. 64We are an “emerging growth company” and we cannot be certain if the reduced disclosure requirements applicable to “emerging growth companies” will make our common stock less attractive to investors
8. 65If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline
9. 66If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired