Corbus Pharmaceuticals Holdings (CRBP) risk factors, FY2024 10-K

Other

1. 01Summary of Risks Associated with Our Business

Risks Related to Our Business, Financial Position and Need for Capital

1. 02We are a biopharmaceutical company with a limited operating history
2. 03We have incurred operating losses in each year since our inception and expect to continue to incur substantial losses for the foreseeable future. We may never become profitable or, if we achieve profitability, be able to sustain profitability
3. 04We are currently operating at a loss and expect our operating costs will increase significantly as we incur further costs related to pre-clinical development and the clinical trials for our drug candidates. As of December 31, 2024, we held cash, cash equivalents, and investments of approximately $149.1 million

Risks Related to Product Development, Regulatory Approval, Manufacturing and Commercialization

1. 05Our success is dependent upon successful development of our drug candidates in our pipeline or that we may acquire. If we are unable to generate revenues from any product candidates, our ability to create stockholder value will be limited
2. 06We do not generate revenues from any FDA approved drug products. Our current business currently depends on the successful development, regulatory approval, and commercialization of our drug candidates, which may never occur
3. 07Drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results
4. 08the FDA or comparable foreign regulatory authorities may decide that the clinical trial endpoints we have chosen, the statistical analysis plans that we use, or any other parameter that we rely on to show the safety and efficacy of our drugs, are not parameters that can be used to support approval of our products
5. 09Reductions in staffing and funding at FDA and other federal agencies could cause delays in the development and approval of our products
6. 10If we are not able to obtain any required regulatory approvals for our drug candidates, we will not be able to commercialize our product candidates and our ability to generate revenue will be limited
7. 11Changes in product candidate manufacturing or formulation may result in additional costs or delay
8. 12Approval may be delayed or denied because we cannot satisfy FDA’s Chemistry, Manufacturing and Control Requirements
9. 13Even if we receive regulatory approval for our drug candidates, we still may not be able to successfully commercialize any of our products, and the revenue that we generate from sales, if any, may be limited
10. 14the willingness of patients to pay out-of-pocket in the absence of third-party coverage or reimbursement
11. 15Our product candidates may cause undesirable side effects or have other unexpected properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in post-approval regulatory action
12. 16Any of the above events resulting from undesirable side effects or other previously unknown problems could prevent us or our potential partners from achieving or maintaining market acceptance of the affected product candidate and could substantially increase the costs of commercializing our product candidates
13. 17We face competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively
14. 18Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug candidates and affect the prices we may obtain
15. 19Our future growth depends, in part, on our ability to enter into and succeed in markets outside of the U.S., where we may choose to rely on third-party collaborations and will be subject to additional regulatory and commercial burdens, risks and other uncertainties
16. 20the interpretation of contractual provisions governed by foreign laws in the event of a contract dispute
17. 21If we market our drug candidates in a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting laws, we may be subject to civil or criminal penalties
18. 22There are risks associated with scaling up manufacturing to commercial scale. If our contract manufacturers are unable to manufacture our drug candidates on a commercial scale, this could potentially delay regulatory approval and commercialization or materially adversely affect our results of operations
19. 23Any termination or suspension of or delays in the commencement or completion of any necessary studies of our drug candidates for any indications could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects
20. 24delays related to the impacts of pandemics, including slowdowns in enrollment or our ability to complete our clinical trials on our expected timeline
21. 25We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates
22. 26Third-party coverage and reimbursement and health-care cost containment initiatives and treatment guidelines may constrain our future revenues
23. 27Our collaboration partners are conducting and may intend to conduct additional clinical trials for certain of our drug candidates at sites outside the U.S., and the FDA may not accept data from trials conducted in such locations or may require additional U.S.-based trials

Risks Relating to Our Intellectual Property Rights

1. 28It is difficult and costly to protect our intellectual property rights, and we cannot ensure the protection of these rights
2. 29We have in-licensed a portion of our intellectual property, and if we fail to comply with our obligations under these arrangements, we could lose such intellectual property rights or owe damages to the licensor of such intellectual property
3. 30Our product candidates may infringe the intellectual property rights of others, which could increase our costs and delay or prevent our development and commercialization efforts
4. 31require us to enter into royalty or licensing agreements
5. 32We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers
6. 33We are, and may become, subject to claims that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets that, regardless of merit, could result in significant expense and loss of our intellectual property rights
7. 34We may be subject to claims challenging the inventorship of our patents and other intellectual property

General Company-Related Risks

1. 35We will need to grow the size of our organization, and we may experience difficulties in managing this growth
2. 36Future capital raises may dilute our existing stockholders’ ownership and/or have other adverse effects on our operations
3. 37If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our drug candidates
4. 38a decline in the value of our stock
5. 39We may acquire businesses, assets, or products, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions
6. 40Significant disruptions of information technology systems or breaches of data security could materially adversely affect our business, results of operations and financial condition
7. 41Changes in geopolitical conditions, U.S.-China trade relations and other factors beyond our control may adversely impact our business and operating results
8. 42intergovernmental conflicts or actions, such as armed conflict, trade wars, retaliatory tariffs, and acts of terrorism or war
9. 43Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and results of operations
10. 44Global conditions, dislocations in the financial markets, any negative financial impacts affecting U.S. as a result of tax reform or changes to existing trade agreements or tax conventions, may adversely impact our business

Risks Related to our Common Stock

1. 45An active, liquid trading market for our common stock may not be sustained
2. 46a lack of visibility for shares of our common stock may have a depressive effect on the market price for shares of our common stock
3. 47Our common stock is currently listed for trading on The Nasdaq Capital Market. We must satisfy the continued listing requirements of The Nasdaq Stock Market LLC ("Nasdaq") to maintain the listing of our common stock on The Nasdaq Capital Market
4. 48The market price of our common stock may be significantly volatile
5. 49general economic or political conditions in the U.S. or elsewhere
6. 50failure to complete significant transactions or collaborate with vendors in manufacturing a product
7. 51Sales of a substantial number of shares of our common stock in the public market could occur at any time. These sales, or the perception in the market that the holders of a large number of shares of common stock intend to sell shares, could reduce the market price of our common stock
8. 52We do not currently intend to pay dividends on our common stock in the foreseeable future, and consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock
9. 53If we fail to maintain effective internal controls, we may not be able to report financial results accurately or on a timely basis, or to detect fraud, which could have a material adverse effect on our business or share price
10. 54We may be unable to complete our analysis of our internal controls over financial reporting in a timely manner, or these internal controls may not be determined to be effective, which may adversely affect investor confidence in our company and, as a result, the value of our common stock
11. 55Upon dissolution of our company, you may not recoup all or any portion of your investment
12. 56Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited
13. 57Legislation or other changes in U.S. tax law could adversely affect our business and financial condition
14. 58Our certificate of incorporation, as amended, allows for our board to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our common stock