Nuvation Bio (NUVB) risk factors, FY2025 10-K

Risks Related to Commercialization of IBTROZI

1. 01Our near-term prospects are significantly dependent on the commercialization of IBTROZI. If we are unable to successfully commercialize IBTROZI, our ability to generate meaningful revenue or achieve profitability will be materially and adversely affectedNew
2. 02we may not be able to maintain adequate commercial supplies of IBTROZI to meet demandNew
3. 03We have limited experience as a commercial company and our sales, marketing, and distribution of IBTROZI may be unsuccessful or less successful than anticipatedNew
4. 04If the market opportunities for IBTROZI are smaller than we believe, our revenue may be adversely affected, and our business may sufferNew
5. 05IBTROZI may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success70% rewritten
6. 06the willingness of patients to pay out-of-pocket in the absence of coverage by third-party payors, including governmental authoritiesNew
7. 07candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenueNew
8. 08the amount of taxes that we are required to pay
9. 09We rely on a select network of third-party distributors, specialty pharmacies and other vendors to distribute IBTROZI in the U.S., and any failure by such distributors, specialty pharmacies and vendors could adversely affect our revenues, financial condition, or results of operationsNew
10. 10If we are unable to maintain our agreements with third parties to sell and market taletrectinib in jurisdictions outside of the U.S. or our partnered territories, we will be unable to successfully commercialize taletrectinib if and when it is approved in such jurisdictionsNew
11. 11unforeseen costs and expenses associated with creating an independent sales and marketing organization58% rewritten
12. 12regulatory acceptance and continued compliance with regulatory requirements, which vary in each countryNew

Risks Related to the Regulatory Approval of IBTROZI

1. 13We may be unable to maintain regulatory approval for IBTROZI in the U.S. or other jurisdictions, which would severely and adversely affect our business and business prospectsNew
2. 14If any of these events occur, our ability to sell our approved products may be impaired, and we may incur substantial additional expense to comply with regulatory requirements, which could harm our business, financial condition, results of operations and prospects100% rewritten
3. 15Our regulatory approval for taletrectinib in China (sold under the brand name DOVBLERON) in advanced ROS1+ NSCLC is subject to a post-marketing requirement to establish the clinical benefit of the drug in a confirmatory clinical trialNew
4. 16If we or others later discover that IBTROZI or any of our future approved product candidates is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market such approved drug could be compromised26% rewritten
5. 17harm to our reputation and resulting harm to physician or patient acceptance of our productsNew

Risks Related to Our Financial Position and Need for Additional Capital

1. 18We are unable to predict if or when we will generate significant revenue or profitsNew
2. 19the extent to which we acquire or in-license other product candidates and technologies and associated intellectual property, and payments required under such acquisitions or in-licenses
3. 20Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish proprietary rights68% rewritten
4. 21Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations59% rewritten
5. 22Our ability to use our net operating loss carryforwards and certain other tax attributes to offset taxable income or taxes may be limited

Risks Related to our Indebtedness

1. 23Our level of indebtedness and debt service obligations could adversely affect our financial condition and may make it more difficult for us to fund our operations22% rewritten
2. 24increase, which would further increase our risk of being unable to pay off or refinance our outstanding debt obligations at maturity
3. 25The terms of the Loan Agreement and the RIF Agreement place restrictions on our operating and financial flexibility
4. 26We may not have cash available in an amount sufficient to enable us to make interest, principal or other payments on our indebtedness when due
5. 27In the event of default, the lenders could accelerate all of the amounts due under the Loan Agreement or the RIF Agreement, as applicable. Sagard could also exercise its rights to take possession and dispose of certain of our assets that are collateral
6. 28The RIF Agreement place certain restrictions on our operational flexibility

Risks Related to the Development of our Product Candidates

1. 29If we do not obtain regulatory approval for and successfully commercialize additional product candidates or we experience significant delays in doing so, we may incur significant losses32% rewritten
2. 30obtaining licenses to any third-party intellectual property we deem necessary or desirable
3. 31We are currently conducting, and may in the future conduct, clinical trials for current or future product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such clinical trials
4. 32Our DDC platform-based product candidates are based on a novel technology, which makes it difficult to predict the time and cost of product candidate development
5. 33We may in the future develop product candidates in combination with other therapies and that may expose us to additional risks
6. 34Clinical trials are very expensive, time-consuming and difficult to design and implement, and involve uncertain outcomes. Furthermore, results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies or clinical trials
7. 35Interim, “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
8. 36We may encounter substantial delays in our preclinical studies or clinical trials or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities
9. 37changes in regulatory requirements and guidance that require amending or submitting new clinical protocols
10. 38Our drug 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
11. 39If we encounter continued or new difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
12. 40the risk that patients enrolled in clinical trials will drop out of the trials before completion
13. 41Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our current or planned clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our product candidates51% rewritten
14. 42we may not realize the full commercial potential of these product candidates that receive marketing approval if, among other reasons, we are unable to appropriately identify patients or types of tumors with the specific genetic alterations targeted by these product candidates
15. 43We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success
16. 44We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do74% rewritten
17. 45seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercializationNew
18. 46We may become exposed to costly and damaging liability claims, either when testing our product candidates in the clinic or at the commercial stage, and our product liability insurance may not cover all damages from such claims
19. 47Even if we receive Fast Track designation or granting of other FDA expedited programs, or other comparable foreign expedited programs, for any of our product candidates, there is no guarantee that such product candidates will experience a faster regulatory review or obtain regulatory approval
20. 48Even if we receive Orphan Drug designation for any of our product candidates, we may be unable to maintain the benefits associated with such designation, including the potential for market exclusivity54% rewritten

Risks Related to Our Dependence on Third Parties

1. 49We do not have any laboratory facilities and have relied on CROs to perform most of the medicinal chemistry work associated with our drug discovery activities
2. 50We do not have our own manufacturing capabilities and will rely on third parties to produce clinical and commercial supplies of taletrectinib, safusidenib, and our other current and future product candidates
3. 51failure to deliver our products under specified storage conditions and in a timely manner28% rewritten
4. 52and regulatory approval or commercial launch for any resulting products may be delayed, or there may be a shortage in supply, either of which could significantly harm our business, financial condition, results of operations and prospectsNew
5. 53Potential disputes between us and Daiichi Sankyo, including disagreements regarding the Taletrectinib In-License Agreement and the Safusidenib In-License Agreement
6. 54If we are not able to establish and maintain collaborations, we may have to alter some of our future development and commercialization plans45% rewritten

Risks Related to Regulatory Compliance

1. 55Health reform measures, including enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may charge for such product candidates57% rewritten
2. 56European and other foreign law equivalents of each of the laws, including reporting requirements detailing interactions with and payments to healthcare providers86% rewritten
3. 57arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of revenue or profits; and other adverse business consequencesNew
4. 58Our processing activities subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements and other obligations relating to data privacy and security85% rewritten

Risks Related to Our Intellectual Property

1. 59If we are unable to obtain, maintain, protect and enforce sufficient patent and other intellectual property rights for our product candidates and technology, or if the scope of patent and other intellectual property rights obtained is not sufficiently broad, we may not be able to compete effectively in our market
2. 60The patent protection we obtain for our product candidates and technology may be challenged or not sufficient to provide us with any competitive advantage
3. 61Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed
4. 62We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful, and issued patents covering our technology and product candidates could be found invalid or unenforceable if challenged
5. 63We may not be able to protect our intellectual property rights throughout the world
6. 64We may not identify relevant third-party patents or pending patent applications or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect our ability to develop and market our product candidates
7. 65If we are unable to obtain licenses from third parties on commercially reasonable terms or fail to comply with our obligations under such agreements, our business could be harmed
8. 66Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
9. 67Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
10. 68Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated if we fail to comply with these requirements
11. 69Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could negatively impact the success of our business
12. 70We may be subject to claims by third parties asserting that we or our employees have infringed upon, misappropriated or otherwise violated their intellectual property rights, or claiming ownership of what we regard as our own intellectual property83% rewritten
13. 71disclosed intellectual property, including trade secrets or other proprietary information, of others, such as any such individual’s former employer. Litigation may be necessary to defend against these claimsNew
14. 72Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities
15. 73If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
16. 74We may not be able to protect and enforce our trademarks and trade names, or build name recognition in our markets of interest thereby harming our competitive position
17. 75Intellectual property rights do not necessarily address all potential threats
18. 76the patents or pending patent applications of others may harm our business; and

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

1. 77Disruptions at the FDA and other government agencies caused by layoffs, funding shortages or global health concerns could negatively impact our businessNew
2. 78Our future success depends on our ability to retain Dr. Hung and our other key employees, consultants and advisors and to attract, retain and motivate qualified personnel
3. 79We expect to expand our development, regulatory, sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
4. 80Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements
5. 81times of war and other major conflicts, we and the third parties with whom we work may be vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks, that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our services
6. 82implement and maintain specific security measures or industry-standard or reasonable security measures to protect our information technology systems and sensitive dataNew

Risks Related to Doing Business in China and Our International Operations

1. 83International trade policies, including tariffs, sanctions and trade barriers, including changes in the political and economic policies and relations between the U.S. and China, have adversely impacted and may continue to adversely impact our business, financial condition, results of operations and prospectsNew
2. 84Changes in tariff classifications, country-of-origin requirements, or customs procedures can occur with limited notice. This uncertainty complicates our long-term investment decisions regarding manufacturing facilities, supply chain optimization, and research and development locationsNew
3. 85As a company with operations and business relationships outside of the United States, our business is subject to economic, political, regulatory and other risks associated with international operations
4. 86If we fail to comply with Chinese 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 the success of our business
5. 87Development in the Chinese legal system could materially and adversely affect us
6. 88Regulatory requirements on currency exchange may limit our ability to receive and use effectively financing in foreign currencies
7. 89We and our shareholders face uncertainties in China with respect to indirect transfers of equity interests in China resident enterprises
8. 90Any failure to comply with Chinese regulations regarding the registration requirements for our employee equity incentive plans may subject us to fines and other legal or administrative sanctions, which could adversely affect our business, financial condition and results of operations

Risks Related to Ownership of Our Securities

1. 91The market price of our securities may be volatile and fluctuate substantially, which could result in substantial losses for our investors and may subject us to securities litigation suits
2. 92other events or factors, many of which are beyond our control
3. 93The dual-class structure of our common stock has the effect of concentrating voting power with our Chief Executive Officer, which limits other stockholders’ ability to influence the outcome of important transactions, including a change in control
4. 94We cannot predict the impact our dual-class structure may have on the market price of our Class A common stock
5. 95There can be no assurance that we will be able to comply with the continued listing standards of the NYSE
6. 96Future sales, or the perception of future sales, by us or our stockholders in the public market could cause the market price for our securities to decline
7. 97Because we do not anticipate paying any cash dividends on our Class A common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains and you may never receive a return on your investment
8. 98We may issue additional securities without your approval, which would dilute your ownership interests and may depress the market price of our securities49% rewritten
9. 99things, future acquisitions or repayment of outstanding indebtedness, without stockholder approval, in a number of circumstancesNew
10. 100Anti-takeover provisions in our amended and restated certificate of incorporation and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult, and may prevent attempts by our stockholders to replace or remove our current management
11. 101the ability of the board of directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by the board of directors
12. 102any action asserting a claim against us that is governed by the internal-affairs doctrine or otherwise related to our internal affairs
13. 103We are eligible to report as a “smaller reporting company,” and as a result of the reduced reporting requirements applicable to “smaller reporting companies,” our securities may be less attractive to investors
14. 104If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired56% rewritten
15. 105We will incur costs and demands upon our management as a result of complying with the laws and regulations affecting public companies in the U.S., which may harm our business
16. 106If securities or industry analysts cease publishing research or reports about us, our business or our market, or if they change their recommendations regarding our securities adversely, the price and trading volume of our securities could decline