Shattuck Labs (STTK) risk factors, FY2024 10-K

Other

1. 01Summary of Key Risk Factors
2. 02changing industries, which may result in others discovering, developing, or commercializing competing products before or more successfully than we do

Risks Related to Our Business, Our Financial Condition and Capital Requirements

1. 03We are a preclinical-stage biotechnology company and have incurred significant losses since our inception, and we expect to incur losses for the foreseeable future. We have no products approved for commercial sale, have never generated revenue from product sales, and may never achieve or maintain profitability
2. 04We are a preclinical-stage biotechnology company and will need to raise substantial additional capital to continue to fund our operations in the future. We have based our estimates on assumptions that may prove to be wrong, and could exhaust our available financial resources sooner than we currently anticipate
3. 05Raising additional capital may cause dilution to our existing stockholders, restrict our operations, or require us to relinquish rights to our technologies or product candidate(s)
4. 06Our ability to compete depends on retaining our key personnel and recruiting additional qualified personnel
5. 07Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability

Risks Related to the Development and Clinical Testing of Our Product Candidates

1. 08We are substantially dependent on the success of our lead product candidate, SL-325, and our anticipated clinical trials of such product candidate(s) may not be successful
2. 09Our product candidate(s) are in preclinical stages of development and may fail in development or suffer delays. We depend on the successful initiation and completion of clinical trials for our product candidate(s) to advance our product development plans
3. 10Our clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of our product candidates or any future product candidates, which would prevent, delay or limit both the scope of regulatory approval and our ability to successfully commercialize
4. 11We may not be successful in our efforts to identify or discover additional product candidates
5. 12We face competition from entities that have developed or may develop programs for the diseases addressed by product candidate(s) developed by us
6. 13Certain of our programs may compete with our other programs, which could negatively impact our business and reduce our future revenue
7. 14Our product candidates may have serious adverse, undesirable, or unacceptable side effects or other properties that may delay or prevent marketing approval and our ability to market and derive revenue from our product candidate(s) could be compromised
8. 15If we experience delays or difficulties initiating clinical trial sites or enrolling patients in our planned clinical trials, our research and development efforts, business, financial condition, and results of operations could be materially and adversely affected
9. 16with head-to-head clinical trials, in which patients may prefer to participate, which may further reduce the number of patients available to us
10. 17We may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates that may be more profitable or for which there is a greater likelihood of success

Risks Related to Our Regulatory Environment

1. 18Our product candidates for which we intend to seek approval as biologics may face competition sooner than anticipated
2. 19We may not be able to meet requirements for the chemistry, manufacturing and control of our programs
3. 20Disruptions at the FDA and other government agencies could negatively affect the review of our regulatory submissions, which could negatively impact our business
4. 21Current and future laws and regulations may increase the difficulty and cost for us, and any collaborators, to obtain marketing approval of and commercialize our drug candidates and affect the prices we, or they, may obtain
5. 22Our business operations and current and future relationships with healthcare professionals, principal investigators, consultants, vendors, customers, and third-party payors are subject to applicable healthcare laws, which could expose us to penalties
6. 23Our employees, independent contractors, principal investigators, contract research organizations (“CROs”), consultants, commercial partners, suppliers, and vendors acting for us or on our behalf may engage in misconduct or other improper activities, including noncompliance with applicable laws and regulations
7. 24If 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 Our Dependence on Third Parties

1. 25or meet expected deadlines, we may not be able to obtain regulatory authorizations or approvals required to develop or commercialize our product candidate(s) and our business could be materially and adversely affected
2. 26We may not realize the benefits of any future collaboration or licensing arrangement, and if we fail to enter into new strategic relationships our business, financial condition, commercialization prospects, and results of operations may be materially and adversely affected
3. 27If we are unable to obtain sufficient raw and intermediate materials on a timely basis or if we experience other supply difficulties, our business may be materially and adversely affected

Risks Related to Intellectual Property and Information Technology

1. 28Our success depends upon our ability to obtain and maintain patents and other intellectual property rights to protect our technology, including SL-325, methods used to manufacture those product candidate(s), formulations thereof, and the methods for treating patients using those product candidate(s)
2. 29Others may challenge our patents or other intellectual property as invalid or unenforceable
3. 30Our commercial success depends, in part, on our ability to develop, manufacture, market, and sell our product candidate(s) without infringing or otherwise violating the intellectual property and other proprietary rights of third parties
4. 31We may enjoy only limited geographical protection with respect to certain patents and may not be able to protect our intellectual property rights throughout the world
5. 32Changes in patent laws in the United States and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products
6. 33We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property
7. 34Intellectual property rights do not necessarily address all potential threats to our competitive advantage
8. 35We 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
9. 36Obtaining 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
10. 37Our information technology systems, or those used by our CROs or other contractors or consultants, may fail or suffer security breaches, which could materially and adversely affect our business

Risks Related to Ownership of Our Common Stock

1. 38Our stock price may be volatile or may decline regardless of our operating performance, resulting in substantial losses for investors
2. 39Our principal stockholders and management own a significant percentage of our stock and are able to exert significant control over matters subject to stockholder approval
3. 40A sale of a substantial number of shares of our common stock may cause the price of our common stock to decline
4. 41Because we do not anticipate paying any dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain
5. 42Adverse developments affecting the financial services industry, including events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our business, financial condition or results of operations
6. 43If securities or industry analysts either do not publish research about us or publish inaccurate or unfavorable research about us, our business or our market, or if they change their recommendations regarding our common stock adversely, the trading price or trading volume of our common stock could decline
7. 44The requirements of being a public company may strain our resources, result in litigation, and divert management’s attention
8. 45Litigation filed against us could harm our business, and insurance coverage may not be sufficient to cover all related costs and damages
9. 46We may become exposed to costly and damaging liability claims, either when testing a product candidate(s) in the clinic or at the commercial stage, and our product liability insurance may not cover all damages from such claims
10. 47If we fail to maintain proper and effective internal controls over financial reporting our ability to produce accurate and timely financial statements could be impaired
11. 48Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
12. 49Provisions in our amended and restated certificate of incorporation and our amended and restated 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 common stock
13. 50Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes
14. 51Our ability to use our net operating loss carryforwards and other tax attributes may be limited