Immuneering (IMRX) risk factors, FY2024 10-K

Risks Related to Our Financial Condition and Capital Requirements

1. 01We are a clinical-stage oncology company with a limited operating history in developing pharmaceutical products, have not completed any clinical trials and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success and viability
2. 02We have incurred significant net losses for the past several years and we expect to continue to incur significant net losses for the foreseeable future and may never obtain profitability
3. 03We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern
4. 04We will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts
5. 05Advancing the development of our product candidates will require a significant amount of capital. Our existing cash and cash equivalents will not be sufficient to fund all of the activities that are necessary to complete the development of our product candidates
6. 06Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our product candidates on unfavorable terms to us
7. 07Our ability to use our net operating losses and other tax attributes may be limited

Risks Related to Development, Regulatory Approval and Commercialization

1. 08We are a clinical-stage oncology company, and we may not be able to submit additional INDs or IND amendments or comparable documents in foreign jurisdictions to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed
2. 09We are a clinical-stage oncology company, and our company has limited experience in designing clinical trials and may experience delays or unexpected difficulties in obtaining regulatory approval for our current and future product candidates
3. 10We may encounter substantial delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates
4. 11product candidate development and approval process and jeopardize our ability to commence product sales and generate revenues
5. 12The outcome of preclinical studies and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA or other comparable foreign regulatory authorities
6. 13Interim, “top-line” 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
7. 14If we experience delays or difficulties in the enrollment and/or maintenance of patients in clinical trials, our clinical development activities could be delayed or otherwise adversely affected
8. 15Even if approved, our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success
9. 16We may be unable to obtain U.S. or foreign regulatory approvals and, as a result, may be unable to commercialize our product candidates
10. 17Our approach to the discovery and development of product candidates is unproven, and we may not be successful in our efforts to use and expand our DCT platform and capabilities to build a pipeline of product candidates with commercial value
11. 18in clinical trials, and we may not be able to develop any other product candidates. Our DCT platform is evolving and may not reach a state at which building a pipeline of product candidates is possible
12. 19We intend to develop certain of our current product candidates in combination with other therapies, and may develop our future product candidates in combination with other therapies, which exposes us to additional risks
13. 20We 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
14. 21Third parties with product candidates or products targeting the MAPK pathway may produce negative preclinical or clinical data which may adversely affect public perception of our product candidates, and may negatively impact regulatory approval of, or demand for, our potential products

Risks Related to Our Business

1. 22We are substantially dependent on our platform, including our proprietary technologies, which are supported by our information technology systems. Any failure of these or other elements of our platform will materially harm our business
2. 23Our long-term prospects depend in part upon discovering, developing and commercializing product candidates, which may fail in development or suffer delays that adversely affect their commercial viability
3. 24We have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators
4. 25We face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer or less expensive than the product candidates we develop, our commercial opportunities will be negatively impacted
5. 26If the market opportunity for any product candidate that we develop is smaller than we believe, our revenue may be adversely affected and our business may suffer
6. 27We have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any product candidate
7. 28Unfavorable global and regional economic, political and health conditions could adversely affect our business, financial condition or results of operations
8. 29Ongoing and potential future pandemics could adversely impact our business, including our current and future clinical trials, supply chain and business development activities

Risks Relating to Our Dependence on Third Parties

1. 30If we decide to establish new collaborations in the future, but are not able to establish those collaborations on a timely basis, on commercially reasonable terms, or at all, we may have to alter our development and commercialization plans
2. 31We may enter into collaborations in the future with third parties for the development and commercialization of product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates
3. 32Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements

Risks Related to Manufacturing

1. 33Manufacturing drugs, especially in large quantities, is complex and may require the use of innovative technologies. Each lot of an approved drug product must undergo thorough testing for identity, strength, quality, purity and potency
2. 34Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay

Risks Related to Legal and Regulatory Compliance Matters

1. 35Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition
2. 36Our business entails a significant risk of product liability and if we are unable to obtain sufficient insurance coverage such inability could have an adverse effect on our business and financial condition
3. 37Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations
4. 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
5. 39The FDA or other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction
6. 40Obtaining 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 jurisdictions
7. 41Even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight
8. 42The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity
9. 43The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses
10. 44We may face difficulties from changes to current regulations and future legislation
11. 45We may be subject to the UK Bribery Act 2010 (the "Bribery Act"), the U.S. Foreign Corrupt Practices Act of 1977, as amended (the "FCPA"), and other anti-corruption laws, as well as export control laws, import and customs laws, trade and economic sanctions laws and other laws governing our operations

Risks Related to Our Intellectual Property

1. 46If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our future licensing arrangements on acceptable terms, we may not be able to successfully develop and commercialize the affected product candidates, which would have a material adverse effect on our business
2. 47The patent protection and patent prosecution for some of our product candidates may be dependent on our future licensors and third parties
3. 48patents may be invalid and/or unenforceable, and such applications may never result in valid, enforceable patents. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business
4. 49applications can take many years to issue, there may be currently pending patent applications that may later result in issued patents that our product candidates may infringe
5. 50Accordingly, an adverse determination in a judicial or administrative proceeding, or the failure to obtain necessary licenses, could prevent us from developing and commercializing our product candidates, which could harm our business, financial condition and results of operations
6. 51We may be involved in lawsuits to protect or enforce our patents or the patents of our future licensors, which could be expensive, time-consuming and unsuccessful. Further, our future in-licensed issued patents could be found invalid or unenforceable if challenged in court
7. 52Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline
8. 53Derivation or interference proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us to cease using the related technology or to attempt to license rights from the prevailing party
9. 54Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents
10. 55Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
11. 56We or our future licensors may be subject to claims challenging the inventorship or ownership of our or our future in-licensed patents and other intellectual property
12. 57Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
13. 58We may not be able to protect our intellectual property rights throughout the world
14. 59Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
15. 60If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
16. 61We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information or alleged trade secrets of third parties or competitors or are in breach of non-competition or non-solicitation agreements with our competitors or their former employers
17. 62If 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. 63We use third-party open source software, which could negatively affect our ability to offer our solutions and subject us to litigation or other actions
19. 64Intellectual property rights do not necessarily address all potential threats to our competitive advantage

Risks Related to Employee Matters and Managing our Growth

1. 65If we are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be able to successfully sell or market our product candidates that obtain regulatory approval
2. 66Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees
3. 67In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth
4. 68cannot assure you that we will be able to manage our existing third-party service providers or find other competent outside contractors and consultants on economically reasonable terms, or at all
5. 69A variety of risks associated with operating internationally could materially adversely affect our business
6. 70Acquisitions, joint ventures or other transactions involving third parties could disrupt our business, cause dilution to our stockholders and otherwise harm our business
7. 71Potential foreign transactions involve unique risks in addition to those mentioned above, including those related to integration of operations across different cultures and languages, currency risks and the particular economic, political and regulatory risks associated with specific countries
8. 72We have broad discretion in the use of our cash reserves and may not use them effectively

Risks Related to Ownership of Our Class A Common Stock

1. 73We may be unable to maintain an active, liquid and orderly trading market for our Class A common stock and, as a result, it may be difficult for you to sell your shares of our Class A common stock
2. 74The price of our stock has been and may in the future be volatile, and you could lose all or part of your investment
3. 75If securities or industry analysts do not publish research or reports, or if they publish adverse or misleading research or reports, regarding us, our business or our market, our stock price and trading volume could decline
4. 76Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval
5. 77Sales of a substantial number of shares of our Class A and/or Class B common stock in the public market could cause our stock price to fall
6. 78We do not currently intend to pay dividends on our Class A common stock and, consequently, your ability to achieve a return on your investment will depend on appreciation of the value of our Class A common stock
7. 79Provisions in our certificate of incorporation and bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our Class A common stock

General Risks

1. 80Our operations are vulnerable to interruption by fire, severe weather conditions, power loss, telecommunications failure, terrorist activity, military conflict, future pandemics and other events beyond our control, which could harm our business
2. 81We are an “emerging growth company,” and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our Class A common stock less attractive to investors
3. 82We cannot predict if investors will find our Class A common stock less attractive because we may rely on these exemptions. If some investors find our Class A common stock less attractive as a result, there may be a less active trading market for our Class A common stock and our stock price may be more volatile
4. 83The requirements of being a public company may strain our resources, result in more litigation and divert management’s attention
5. 84We may be subject to securities litigation, which is expensive and could divert management attention
6. 85New tax legislation may impact our results of operations and financial condition