Seres Therapeutics (MCRB) risk factors, FY2024 10-K

Risks Related to Our Financial Position and Need for Additional Capital

1. 01the extent to which we acquire or invest in businesses, products and technologies, including entering into licensing or collaboration arrangements for product candidates
2. 02We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern
3. 03We are a clinical-stage company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability
4. 04experience any delays or encounter any issues with any of the above, including but not limited to failed studies, complex results, safety issues or other regulatory challenges
5. 05Because of the numerous risks and uncertainties associated with pharmaceutical product and biological development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability
6. 06Our limited operating history may make it difficult to evaluate the success of our business to date and to assess our future viability
7. 07The total amount of the Second Installment Payment and Milestone Payments we may receive from the Transaction, and the amounts payable or due under the Profit Sharing Payments, are subject to various risks and uncertainties
8. 08We may not be able to realize the anticipated benefits of the Transaction, and we may face new challenges as a smaller, less diversified company
9. 09We have broad discretion as to the use of the proceeds from the Transaction, and may not use the proceeds effectively

Risks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates

1. 10We are early in our development efforts of certain of our product candidates and may not be successful in our efforts to use our reverse translational platform to build a pipeline of product candidates and develop additional marketable drugs
2. 11maintaining and growing an organization of scientists and business people who can develop and commercialize our product candidates and technology
3. 12Our product candidates are based on live biotherapeutics, which is a novel approach to therapeutic intervention
4. 13Clinical drug development involves a risky, lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and potential future commercialization of our product candidates
5. 14regarding trials managed by any current or future collaborators, our collaborators may face any of the above issues, and may conduct clinical trials in ways they view as advantageous to them but potentially suboptimal for us
6. 15have the product removed from the market after obtaining marketing approval
7. 16Delays or difficulties in the enrollment of patients in clinical trials, could result in our receipt of necessary regulatory approvals being delayed or prevented
8. 17Interim “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
9. 18If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we or any collaborators will not be able to commercialize our product candidates or will not be able to do so as soon as anticipated, and our ability to generate revenue will be materially impaired
10. 19The development of therapeutic products targeting the underlying biology of the human microbiome is an emerging field, and it is possible that the FDA and other regulatory authorities could issue regulations or new policies in the future that could adversely affect our live biotherapeutic candidates
11. 20A Fast Track designation by the FDA may not actually lead to a faster development or regulatory review or approval process
12. 21A Breakthrough Therapy, or other similar designations by the FDA for our product candidates may not lead to a faster development, regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval
13. 22Product developers that benefit from PRIME designation may be eligible for accelerated assessment (in 150 days instead of 210 days), which may be granted for medicinal products of major interest from a public health perspective or that target an unmet medical need, but this is not guaranteed
14. 23We may seek orphan drug designation for some of our product candidates but may not be able to obtain it

Risks Related to our Dependence on Third Parties and Manufacturing

1. 24We expect to continue to rely on third parties, such as CROs, clinical data management organizations, medical institutions and clinical investigators, to conduct and manage our clinical trials
2. 25termination or nonrenewal of agreements by third-party manufacturers at times that are costly or inconvenient for us
3. 26We have limited experience manufacturing our product candidates commercially, and we cannot assure you that we can manufacture our product candidates in compliance with regulations at a cost or in quantities necessary to make them commercially viable

Risks Related to Our Product Candidates and Other Legal Matters

1. 27Our product candidates may fail to achieve the degree of market acceptance by physicians, patients, hospitals, third-party payors and others in the medical community necessary for commercial success
2. 28If we are unable to establish effective sales, marketing and distribution capabilities or enter into agreements with third parties with such capabilities, we may not be successful in commercializing any of our product candidates if and when they are approved
3. 29inability to obtain sufficient coverage and reimbursement from third-party payors and governmental agencies
4. 30We face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do
5. 31These third parties compete with us in recruiting and retaining qualified scientific, sales and marketing and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs
6. 32Even if we are able to commercialize any of our product candidates, if approved, the products may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, any of which would harm our business
7. 33Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop
8. 34the inability to commercialize products that we develop, if any
9. 35We may face competition from biosimilars, which may have a material adverse impact on the future commercial prospects of our product candidates
10. 36Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad
11. 37Any product candidate for which we obtain marketing approval will remain subject to significant post-marketing regulatory requirements and oversight
12. 38imposition of civil or criminal penalties
13. 39Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity
14. 40The FDA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses
15. 41Recently 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 obtain
16. 42a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative clinical effectiveness research, along with funding for such research
17. 43Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any

Risks Related to Our Intellectual Property

1. 44our commercial activities or products will not infringe upon the patents or proprietary rights of others
2. 45If we are unable to protect the confidentiality of our trade secrets and know-how, our business and competitive position may be harmed
3. 46Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
4. 47Third 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
5. 48Issued patents covering our product candidates could be found invalid or unenforceable or could be interpreted narrowly if challenged in court
6. 49Obtaining and maintaining our 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 noncompliance with these requirements
7. 50We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
8. 51We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property
9. 52If 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
10. 53We will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection

Risks Related to Our Operations

1. 54Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel
2. 55A variety of risks associated with operating internationally could materially adversely affect our business
3. 56certain expenses including, among others, expenses for travel, translation and insurance; and
4. 57Our business and operations may suffer in the event of information technology system failures, cyberattacks or deficiencies in our cybersecurity
5. 58Actual 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
6. 59Acquisitions, dispositions, or joint ventures could disrupt our business, cause dilution to our stockholders and otherwise harm our business
7. 60Foreign acquisitions 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. 61We have in the past been subject to securities class action litigation and may be subject to similar or other litigation in the future, which may harm our business
9. 62We are subject to complex and changing laws and regulations, which exposes us to potential liabilities, increased costs and other adverse effects on our business
10. 63If 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 harm our business
11. 64Our ability to use our net operating loss carryforwards and research and development credits to offset future taxable income or income tax liabilities may be subject to certain limitations

Risks Related to Our Common Stock

1. 65We have received a notice of the failure to satisfy a continued listing rule from Nasdaq
2. 66Our executive officers, directors and principal stockholders, if they choose to act together, have the ability to significantly influence all matters submitted to stockholders for approval
3. 67A significant portion of our total outstanding shares are eligible to be sold into the market, which could cause the market price of our common stock to drop significantly, even if our business is doing well
4. 68We are a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors
5. 69Provisions in our restated certificate of incorporation and amended and restated bylaws 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
6. 70Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be the sole source of gain for our stockholders
7. 71The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock
8. 72If securities or industry analysts issue an adverse or misleading opinion regarding our business, our common stock price and trading volume could decline
9. 73We will continue to incur costs as a result of being a public company, and our management will continue to devote substantial time to compliance initiatives and corporate governance practices
10. 74Failure to keep up with evolving and conflicting laws, regulations, trends and stakeholder expectations relating to environmental, social and governance, or ESG, practices or reporting could adversely impact our reputation, share price and access to and cost of capital or otherwise adversely impact our business