Arcus Biosciences (RCUS) risk factors, FY2025 10-K

Risks Related to our Limited Operating History, Financial Position and Capital Requirements

1. 01We have a history of operating losses, have never generated any revenue from product sales and anticipate that we will continue to incur significant losses for the foreseeable future
2. 02We may need to obtain additional funding. If we do not receive or are unable to raise additional capital when needed, we may be forced to restrict our operations or delay, reduce or eliminate our product development programs77% rewritten

Risks Related to the Discovery and Development of our Investigational Products

1. 03If we are unable to obtain regulatory approval for our investigational products, or experience significant delays in doing so, our business will be materially harmed
2. 04We may be unable to establish any long-term supply agreements with third-party manufacturers or to do so on acceptable terms, which increases the risk of failing to timely obtain sufficient quantities of our investigational products or such quantities at an acceptable cost
3. 05If we experience delays in obtaining approval or if we fail to obtain approval of our investigational products, the commercial prospects for our investigational products may be harmed and our ability to generate revenues will be materially impaired
4. 06The results of preclinical studies and early clinical trials are not always predictive of future results35% rewritten
5. 07Any difficulties or delays in the commencement or completion, or the termination or suspension, of our current or planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue or adversely affect our commercial prospects
6. 08Preliminary, topline, and interim data from our clinical studies that we announce or publish from time to time are subject to audit and verification procedures that could result in material changes in the final data and may change as more patient data become available
7. 09Most of our clinical trials are open-label studies and may be susceptible to bias
8. 10Adverse findings from clinical trials conducted by third parties investigating the same investigational products as us in different territories or different investigational products directed to the same target as one of our programs could adversely affect our development program57% rewritten
9. 11Development of combination therapies may present more or different challenges than development of single agent therapies79% rewritten
10. 12assess the effects attributable to each drug in the combination product. Moreover, the applicable requirements for approval of a combination therapy may differ from country to countryNew
11. 13The design or our execution of our ongoing and future clinical trials may not support marketing approval
12. 14We have conducted, and continue to conduct, portions of our clinical trials outside the U.S., and the FDA may not accept data from trials conducted in foreign locations21% rewritten

Risks Related to Reliance on Third Parties, Manufacturing and Commercialization

1. 15We expect to depend on our collaboration with Gilead for the research, development, manufacture and commercialization of certain of our investigational products. If this collaboration is not successful, our business could be adversely affected48% rewritten
2. 16Supply by third parties of the investigational products, standard-of-care drugs or comparator agents used in our clinical trials may become limited or interrupted, or more costly, which could delay, prevent or impair our development efforts28% rewritten
3. 17Our manufacturing partners are subject to extensive regulation. In the event any of our manufacturers fail to comply with such regulations or perform its obligations, our business may be adversely affected and we may need to delay or halt the development of our investigational products
4. 18Our employees, clinical trial investigators, CROs, consultants, vendors, collaboration partners and any potential commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading
5. 19Even if we receive regulatory approval for any investigational product, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense
6. 20The occurrence of any event or penalty described above may inhibit our ability to commercialize our investigational products and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity
7. 21Even if we receive marketing approval, we may not be successful in commercializing our investigational products
8. 22We may fail to obtain orphan drug designations from the FDA for our investigational products, and even if we obtain such designations, we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivityNew
9. 23Even if we receive marketing approval for one or more of our investigational products, our commercial success is dependent on obtaining coverage and reimbursement for a product from a government or other third-party payor, which coverage may be delayed or may not be sufficient to cover our costs41% rewritten
10. 24Our ability to obtain coverage and reimbursement approval for any of our investigational products, if approved, could have a material adverse effect on the demand for that investigational product, and on our business and our overall financial condition91% rewritten
11. 25are approved by the FDA, they may never be approved or commercialized outside the U.S., which would limit our ability to realize their full market potentialNew
12. 26Any investigational products for which we intend to seek approval as biologic products may face competition sooner than anticipated

Risks Related to our In-Licenses and Other Strategic Agreements

1. 27We may not realize the benefits of any acquisitions, in-license or other collaborations or strategic alliances that we enter into

Risks Related to Intellectual Property

1. 28We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties
2. 29We may not be able to protect our intellectual property rights outside of the U.S
3. 30Changes in patent law in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our investigational products57% rewritten
4. 31We may rely on trade secret and proprietary know-how which can be difficult to trace and enforce and, if we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
5. 32We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property
6. 33Patent terms may be inadequate to protect our competitive position on our investigational products for an adequate amount of time

Risks Related to our Business Operations

1. 34We expect to expand our business operations and, as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
2. 35Our future success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel
3. 36We are highly dependent on the services of our founders, Terry Rosen, Ph.D., who serves as our Chief Executive Officer, and Juan Jaen, Ph.D., who serves as our President
4. 37We face substantial competition, which may result in others discovering, developing or commercializing products more quickly or marketing them more successfully than us. If their investigational products are shown to be safer or more effective than ours, then our commercial opportunity will be reduced or eliminated21% rewritten
5. 38Unfavorable global economic, political and trade conditions could adversely affect our business, financial condition or results of operations and may exacerbate the effects of the risks described herein94% rewritten
6. 39recent inflation that increased our operating expenses and disruptions in the capital and credit markets that may reduce our ability to raise additional capital when needed on acceptable terms, if at allNew
7. 40Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties
8. 41We or the third parties upon which we depend may be adversely affected by earthquakes, fires or other natural disasters
9. 42Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited
10. 43Changes in tax laws and regulations or exposure to additional tax liabilities could adversely affect our financial results34% rewritten

Risks Related to Our Industry

1. 44Product liability lawsuits against us could cause us to incur substantial liabilities and could limit our commercialization of any investigational products that we may develop
2. 45Failure to comply with data privacy and data protection laws, regulations, or other obligations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business84% rewritten
3. 46receive individually identifiable health information from a HIPAA-covered healthcare provider or research institution that has not satisfied HIPAA’s requirements for disclosure of individually identifiable health informationNew
4. 47misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators or other adverse consequences
5. 48Our business operations expose us to broadly applicable fraud and abuse, transparency, government price reporting, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties
6. 49Changes in healthcare law and implementing regulations, as well as changes in healthcare policy, may impact our business in ways that we cannot currently predict, and may have a significant adverse effect on our business and results of operations62% rewritten
7. 50If 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 the success of our business

Risks Related to Owning our Common Stock

1. 51The stock price of our common stock has been and may continue to be volatile or may decline regardless of our operating performance
2. 52The amount of our future losses is uncertain and our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline
3. 53The concentration of our stock ownership will likely limit our stockholders’ ability to influence corporate matters, including the ability to influence the outcome of director elections and other matters requiring stockholder approval48% rewritten
4. 54Delaware 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. 55Sales of substantial amounts of our shares may cause the price of our common stock to decline
6. 56We are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and the rules and regulations of the New York Stock Exchange. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal controls over financial reporting