Karyopharm Therapeutics (KPTI) risk factors, FY2025 10-K

Risks Related to Our Financial Position and Capital Requirements

1. 01Our financial condition raises substantial doubt as to our ability to continue as a going concern76% rewritten
2. 02We have incurred significant losses since inception, expect to continue to incur significant losses, and may never achieve or maintain profitability23% rewritten
3. 03navigating the negative impacts to healthcare systems, the ability of our clinical trial sites to conduct current or future trials and the regulatory review process
4. 04evaluate strategic opportunities, such as the acquisition or in-license of other products, product candidates, technologies or companiesNew
5. 05our ability to continue as a going concern61% rewritten
6. 06Our indebtedness could limit cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition and results of operations and impair our ability to satisfy our obligations under the Amended Term Loan, the Convertible Notes or the Amended Revenue Interest Agreement69% rewritten
7. 07placing us at a possible competitive disadvantage with competitors that are less leveraged than we are or have better access to capital64% rewritten
8. 08Note holders may require us to repurchase their Convertible Notes following a fundamental change at a cash repurchase price generally equal to the principal amount of the Convertible Notes to be repurchased, plus accrued and unpaid interestNew
9. 09The accounting method for convertible debt securities such as the Convertible Notes could have a material effect on our reported financial results50% rewritten
10. 10Raising additional capital and other equity issuances by us may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates63% rewritten
11. 11Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price94% rewritten

Risks Related to Commercialization and Product Development

1. 12adverse publicity about our products or favorable publicity about competitive products; and
2. 13our ability to maintain compliance with existing and new health care laws and regulations, including government pricing, price reporting and other disclosure requirements related to such laws and regulations, and the potential impact of such laws and regulations on physician prescribing practices and payor coverage
3. 14We face substantial competition for XPOVIO in multiple myeloma and will face competition for XPOVIO in any additional indications for which it may be approvedNew
4. 15If we are not able to compete effectively against current or potential competitors, our business will not grow and our financial condition and operations will suffer87% rewritten
5. 16failure of any product candidates to demonstrate safety and effectiveness in any clinical trial could negatively impact the perception of selinexor or our other product candidates and/or cause the FDA or other regulatory authorities to require additional testing before any of our product candidates are approvedNew
6. 17negative impacts resulting from a pandemic or other public health emergency, including impacts to healthcare systems and our trial sites’ ability to conduct trial
7. 18have the product removed from the market after obtaining marketing approval70% rewritten
8. 19products, which would harm our business and results of operations. In addition, many of the factors that cause, or lead to, clinical trial delays may ultimately lead to the denial of regulatory approval of our product candidatesNew
9. 20our reputation may suffer
10. 21The results of previous clinical trials may not be predictive of future trial results, and interim or top-line data may be subject to change or qualification based on the complete analyses of data and, therefore, may not be predictive of the final results of a trial
11. 22We may not be successful in our efforts to identify or discover additional potential product candidates, or our decisions to prioritize the development of certain product candidates over others may later prove wrong
12. 23potential product candidates may not be effective in treating their targeted diseases
13. 24If we are unable to maintain or expand our sales, marketing and distribution capabilities, we may not be successful in commercializing XPOVIO or any of our products or product candidates, if approved, that we may acquire or develop
14. 25our ability to supply sufficient inventory of our products for commercial sale
15. 26Product liability lawsuits against us could divert our resources, cause us to incur substantial liabilities and limit commercialization of XPOVIO or any other products that we may develop or acquire
16. 27the inability to successfully commercialize XPOVIO and any other products that we may develop or acquire
17. 28The business that we or our collaborators conduct outside of the U.S. may be adversely affected by international risks and uncertainties30% rewritten

Risks Related to Regulatory Matters

1. 29a product may not be approved for the indications that we, or our collaborators, request or may be limited or subject to restrictions or post-approval commitments that render the approved drug not commercially viable
2. 30injunctions or the imposition of civil or criminal penalties
3. 31We, or our collaborators, may not be able to obtain orphan drug exclusivity for any product candidates we, or they, may develop, and even if we do, that exclusivity may not prevent the FDA or the EMA from approving other competing products54% rewritten
4. 32Current and future legislation may increase the difficulty and cost for us, or any collaborators, to obtain marketing approval and commercialize our or their product candidates, if approved, and affect the prices we, or they, may obtain48% rewritten
5. 33The prices of prescription pharmaceuticals in the U.S. and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our products, if and when licensed96% rewritten
6. 34a new discounting program. The IRA permits the Secretary of the HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial yearsNew
7. 35Our reporting and payment obligations under the Medicaid Drug Rebate Program and other governmental drug pricing programs are complex and may involve subjective decisions. Any failure to comply with those obligations could subject us to penalties and sanctions53% rewritten
8. 36transfer of sensitive US data to countries such as China. These data transfer restrictions (and others that may pass in the future) may create operational challenges and legal risks for our businessNew
9. 37Our employees, independent contractors, consultants, collaborators and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and/or requirements and insider trading, which could cause significant liability for us and harm our reputation
10. 38If 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 have a material adverse effect on our business
11. 39Laws and regulations governing international operations we may have in the future may preclude us from developing, manufacturing and selling certain products outside of the U.S. and require us to develop and implement costly compliance programs
12. 40With the passage of the CREATES Act, we are exposed to possible litigation and damages by competitors who may claim that we are not providing sufficient quantities of our approved products on commercially reasonable, market-based terms for testing in support of their ANDAs and 505(b)(2) applications
13. 41We are subject to governmental export and import controls that could impair our or our collaborators’ ability to compete in international markets due to licensing requirements and subject us or them to liability if we or they are not in compliance with applicable laws
14. 42Changes in and uncertainty surrounding U.S. trade policy could have a material adverse impact on our business, financial condition and results of operationsNew
15. 43Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results69% rewritten
16. 44The biopharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to change, including due to judicial challenges, election cycles, and resulting regulatory updates and changes in policy prioritiesNew

Risks Related to Our Dependence on Third Parties

1. 45If we are unable to establish and maintain our agreements with third parties to distribute XPOVIO to patients, our results of operations and business could be adversely affected
2. 46We rely on third parties as we conduct our clinical trials and some aspects of our research and preclinical studies, and those third parties may not perform satisfactorily, including not meeting local regulatory submission requirements or failing to meet deadlines for the completion of such trials, research or testing
3. 47We do not own or operate, and currently have no plans to establish, any manufacturing facilities for our products or product candidates. We currently rely, and expect to continue to rely, on third-party contract manufacturers to manufacture our products and product candidates for our commercial and clinical use
4. 48the possible misappropriation or disclosure by the third party or others of our proprietary information, including our trade secrets and know-how

Risks Related to Our Intellectual Property

1. 49We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time-consuming and unsuccessful
2. 50Third 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 material adverse effect on the success of our business
3. 51We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
4. 52Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities
5. 53Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, 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
6. 54If our product candidates or any of our future product candidates obtain regulatory approval, additional competitors could enter the market with generic versions of such products, which may result in a material decline in sales of our competing products
7. 55If we do not successfully extend the term of patents covering our product candidates under the Hatch-Waxman Amendments and similar foreign legislation, our business may be materially harmed
8. 56If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
9. 57Not all of our trademarks are registered. Failure to secure those registrations could adversely affect our business
10. 58We use artificial intelligence in our business processes, which could adversely impact our business and operations, including by posing security and other risks to our confidential or proprietary information, including personal information, and, as a result, we may be exposed to reputational harm and liabilityNew

Risks Related to Our Operations and Employee Matters

1. 59Our future success depends on our ability to retain key members of our management team and to attract, retain and motivate qualified personnel45% rewritten
2. 60Our business and operations may be materially adversely affected in the event of information technology system failures or security breaches, and the costs and consequences of implementing data protection measures could be significant

Risks Related to Our Common Stock

1. 61If we fail to maintain compliance with the continued listing requirements of Nasdaq, our common stock could be delisted from trading, which would adversely affect the liquidity of our common stock and our ability to raise additional capitalNew
2. 62We have a substantial number of warrants to purchase common stock outstanding and may in the future issue additional warrants. The exercise of our outstanding warrants will dilute existing stockholders and could adversely affect the trading price of our common stockNew
3. 63Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management
4. 64require the approval of the holders of at least 75% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws
5. 65The price of our common stock has been and may continue to be volatile and your investment in our stock could decline in value or fluctuate significantly, including as a result of analysts’ activities34% rewritten
6. 66the other risks and uncertainties described in this “Risk Factors” section50% rewritten
7. 67Securities or other litigation could result in substantial costs and may divert management’s time and attention from our business73% rewritten
8. 68XPOVIO, or if we cannot obtain regulatory approvals for, or if we otherwise fail to successfully commercialize and launch, our product candidatesNew
9. 69We have broad discretion in the use of our cash, cash equivalents and investments and may not use them effectively
10. 70We are a “smaller reporting company”, and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors
11. 71If we identify a material weakness in our internal control over financial reporting, it could have an adverse effect on our business and financial results and our ability to meet our reporting obligations could be negatively affected, each of which could negatively affect the trading price of our common stock43% rewritten
12. 72If the estimates we make, or the assumptions on which we rely, in preparing our consolidated financial statements, our projected guidance and/or our projected market opportunities prove inaccurate, our actual results may vary from those reflected in our projections and accruals
13. 73Our ability to use our net operating loss carryforwards and tax credit carryforwards to offset future taxable income may be subject to certain limitations
14. 74Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition