Relay Therapeutics (RLAY) risk factors, FY2025 10-K

Risks Related to Clinical Development

1. 01We have never successfully completed any large-scale, pivotal clinical trials, and we may be unable to do so for any product candidates we develop
2. 02Clinical product development involves a lengthy and expensive process, with an uncertain outcome43% rewritten
3. 03We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates
4. 04If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented
5. 05factors we may not be able to control that may limit patients, principal investigators or staff or clinical site availability, such as uncertain geopolitical conditions or current or future pandemics30% rewritten
6. 06never approved as products and there can be no assurance that any of our current or future clinical trials will ultimately be successful or support further clinical development of any of our product candidatesNew
7. 07it may take greater human and financial resources than we will possess to identify additional therapeutic opportunities for our product candidates or to develop suitable potential product candidates through internal research programs, thereby limiting our ability to develop, diversify and expand our product portfolio
8. 08We intend to develop our lead product candidate, may develop other current product candidates and potentially future product candidates, in combination with other therapies, which exposes us to additional risks
9. 09Our product candidates utilize a novel mechanism of action and novel binding locations, which may result in greater research and development expenses, regulatory issues that could delay or prevent approval, or discovery of unknown or unanticipated adverse effects
10. 10We are conducting, or have filed clinical trial applications to conduct, clinical trials for our product candidates outside the United States, and the FDA and similar foreign regulatory authorities may not accept data from such trials

Risks Related to Obtaining Regulatory Approvals

1. 11If we are not able to obtain, or if delays occur in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired65% rewritten
2. 12the approval policies or regulations of the FDA or similar foreign regulatory authorities may significantly change such that our clinical data are insufficient for approval53% rewritten
3. 13not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidatesNew

Risks Related to Commercialization

1. 14Our projections of both the number of people who have the diseases our product candidates are targeting, as well as the subset of people with such disease who have the potential to benefit from treatment with any of our product candidates, are based on estimates31% rewritten
2. 15We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do
3. 16The insurance coverage and reimbursement status of newly-approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for any of our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue
4. 17Factors payors consider in determining reimbursement are based on whether the product is (i) a covered benefit under its health plan; (ii) safe, effective and medically necessary; (iii) appropriate for the specific patient; (iv) cost-effective; and (v) neither experimental nor investigational

Risks Related to Our Reliance on Third Parties

1. 18form relationships with other entities, some of which may be our competitors65% rewritten
2. 19product candidates in the subject indication would be harmed, our costs could increase and our ability to generate revenue could be delayedNew
3. 20the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us
4. 21Our current and anticipated future dependence upon others for the manufacture of our product candidates or products may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basisNew
5. 22The third parties upon whom we rely for the supply of the active pharmaceutical ingredients, drug product and starting materials used in our product candidates are our sole source of supply, and the loss of any of these suppliers could significantly harm our business
6. 23We have and may enter into other licenses or collaborations with third parties for the research, development, manufacture and commercialization of one or more of our programs or product candidates. If these licenses or collaborations are not successful, our business could be adversely affected
7. 24We may seek to establish additional licenses and/or collaborations, and, if we are not able to establish them on commercially reasonable terms, or at all, we may have to alter our development and commercialization plans68% rewritten

Risks Related to Our Operating History

1. 25We are a biopharmaceutical company with a limited operating history28% rewritten
2. 26We have incurred significant operating losses since our inception and anticipate that we will incur continued losses for the foreseeable future22% rewritten
3. 27future accounting pronouncements or changes in our accounting policies
4. 28We have no products approved for commercial sale and we have not generated any revenue from product sales
5. 29maintain a continued acceptable safety profile of the product candidates following approval

Risks Related to Raising Additional Capital

1. 30We will need to raise substantial additional funding. If we are unable to raise capital when needed, we would be forced to delay, reduce or eliminate some of our product development programs or commercialization efforts
2. 31the costs of operating as a public company24% rewritten
3. 32we may be required to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospectsNew
4. 33Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates

Risks Related to Public Health Matters and the Global Economy

1. 34Any future pandemic, epidemic, or outbreak of an infectious disease similar to the COVID-19 pandemic could affect our business and our financial results and could cause disruption to the development of our product candidates77% rewritten
2. 35Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations35% rewritten

Risks Related to Protecting Our Intellectual Property

1. 36following work product assigned to us: the composition of matter, method of use, and method of manufacture of certain compounds directed to a Category 1 Target, as set forth in the DESRES AgreementNew
2. 37After any work product is assigned to us, we will have the right to prepare, file, prosecute and maintain patents that cover such assigned work product. We also have the implicit right to defend patents that cover work product owned by us38% rewritten
3. 38The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation39% rewritten
4. 39derivation, reexamination, inter parties review, post-grant review or interference proceedings challenging our patent rights or the patent rights of others from whom we have obtained licenses to such rightsNew
5. 40Obtaining 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 for non-compliance with these requirements
6. 41Our failure to secure trademark registrations could adversely affect our business and our ability to market our products and product candidates
7. 42If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed

Risks Related to Intellectual Property Litigation

1. 43Third 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
2. 44We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors
3. 45We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time consuming and unsuccessful
4. 46Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities

Risks Related to Enforcement of Our Intellectual Property Rights

1. 47We may not be able to effectively enforce our intellectual property rights throughout the world
2. 48If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed

Risks Related to Third Party Intellectual Property

1. 49We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms
2. 50If we fail to comply with our obligations in the agreements under which we collaborate with or license intellectual property rights from third parties, or otherwise experience disruptions to our business relationships with our collaborators or licensors, we could lose rights that are important to our business
3. 51the priority of invention of patented technology33% rewritten

Risks Related to Intellectual Property Laws

1. 52Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
2. 53Intellectual property rights do not necessarily address all potential threats

Risks Related to Regulatory Approval

1. 54injunctions or the imposition of civil or criminal penalties
2. 55The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses23% rewritten
3. 56Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions70% rewritten
4. 57product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we may intend to charge for our products will also be subject to approvalNew
5. 58Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates

Risks Related to Anti-bribery, Anti-corruption and Other Government Regulations

1. 59Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain products outside of the United States and require us to develop and implement costly compliance programs

Risks Related to Regulatory Review of Certain Drug Development Designations

1. 60We may seek priority review designation for one or more of our product candidates, but we might not receive such designation, and even if we do, such designation may not lead to a faster regulatory review or approval process
2. 61We may seek orphan drug designation for certain of our product candidates and we may be unsuccessful or may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity
3. 62changes might affect our business. Depending on what changes the FDA may make to its orphan drug regulations and policies, our business could be adversely impacted
4. 63We may seek approval of one or more of our product candidates into real-time oncology review, or RTOR. This program may not lead to a faster regulatory review or approval process and does not increase the likelihood that our product candidate(s) will receive marketing approvalNew

Risks Related to Healthcare Legislative Reform

1. 64The FDA, the EMA and other regulatory authorities may implement additional regulations or restrictions on the development and commercialization of our product candidates, and such changes can be difficult to predict
2. 65Healthcare legislative reform measures may have a material adverse effect on our business and results of operations48% rewritten
3. 66Recent federal legislation and actions by federal, state and local governments may permit reimportation of drugs from foreign countries into the United States, including foreign countries where the drugs are sold at lower prices than in the United States, which could materially adversely affect our operating results

Risks Related to Employee Matters

1. 67Our future success depends on our ability to retain key executives and experienced scientific and clinical personnel to attract, retain and motivate qualified personnel77% rewritten
2. 68Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading
3. 69The increasing use of social media platforms presents risks and challenges
4. 70Environmental, social, and governance matters may impact our business and reputation

Risks Related to Growth and Acquisitions

1. 71We expect to expand our development and regulatory capabilities in the future and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
2. 72Our acquisitions expose us to risks that could adversely affect our business, and we may not achieve the anticipated benefits of acquisitions of businesses or technologies
3. 73risks associated with acquiring intellectual property, including potential disputes regarding acquired companies’ intellectual property

Risks Related to Business Disruptions

1. 74lead to opportunities for bad actors to launch cyber-attacks or for employees to cause inadvertent or intentional security risks or incidents. The prevalent use of mobile devices also increases the risk of data security incidentsNew
2. 75If we fail to comply with applicable 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 Trading Our Common Stock

1. 76the other factors described in this "Risk Factors" section
2. 77An active trading market for our common stock may not be sustained

Risks Related to Dividends

1. 78Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain

Risks Related to Insider Control

1. 79Our executive officers, directors, principal stockholders and their affiliates exercise significant control over our company, which will limit your ability to influence corporate matters and could delay or prevent a change in corporate control

Risks Related to Tax

1. 80Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited
2. 81Tax reform legislation could adversely affect our business and financial condition

Risks Related to Operating as a Public Company

1. 82We have incurred and will continue to incur significant costs as a result of operating as a public company, and our management has devoted and will continue to devote substantial time to compliance initiatives
2. 83Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud

Risks Related to Our Charter and Bylaws

1. 84Anti-takeover provisions in our 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
2. 85the authority of the board of directors to issue preferred stock on terms determined by the board of directors without stockholder approval, which preferred stock may include rights superior to the rights of the holders of common stock
3. 86Our Bylaws designate specific courts as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us

Risks Related to Securities Analysts

1. 87If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline