TriSalus Life Sciences (TLSI) risk factors, FY2024 10-K

Risks Related to Our Financial Condition

1. 01We have a limited operating history, have incurred significant losses since our inception and anticipate incurring increasing expenses and continuing losses for the foreseeable future
2. 02Our future capital needs may require us to sell additional equity or debt securities that may dilute our stockholders, adversely affect the market price of our Common Stock or introduce covenants that may restrict our operations
3. 03We have entered into the OrbiMed Credit Agreement, pursuant to which we may borrow up to $50.0 million in senior secured term debt. Our obligations under the OrbiMed Credit Agreement are secured by substantially all of our assets
4. 04We may issue additional Common Stock from time to time under our equity incentive plans. Any such issuances would dilute the interest of our stockholders and likely present other risks
5. 05It may take us longer than expected to fully realize the anticipated benefits and synergies of these transactions and those benefits and synergies may ultimately be smaller than anticipated or may not be realized at all, which could adversely affect our business and operating results
6. 06The Dynavax Agreement, entered into by Legacy TriSalus in connection with its purchase of nelitolimod, requires us to make potentially significant payments to Dynavax before we will have regulatory approval of nelitolimod and be able to generate revenue from sales of nelitolimod

Risks Related to TriNav

1. 07Our revenue is primarily generated from sales of our TriNav device and we are therefore highly dependent on it for our success. Failure to achieve continued market acceptance of TriNav for any reason will harm our business and future prospects
2. 08Our business is dependent upon the continued adoption of TriNav by hospitals and physicians
3. 09Any change to TriNav’s reimbursement status that reduces our level of reimbursement could cause TriNav sales to materially decline and impede market adoption
4. 10We currently have a limited marketing, sales and distribution organization. If we are unable to successfully grow our marketing, sales and distribution capabilities, then our product revenues related to TriNav, our results of operations and financial condition will suffer
5. 11Increases in costs, disruption of supply or shortage of materials could harm our business

Risks Related to Nelitolimod and Product Development

1. 12Clinical trials of our product candidates or potential product candidates may fail to produce results necessary to support regulatory clearance or authorization
2. 13Interim, “topline” and preliminary data from clinical trials of our product candidates may change as more patient data becomes available and are subject to confirmation, audit, and verification procedures that could result in material changes in the final data
3. 14Use of toll-like receptor (TLR) agonist, including nelitolimod, may negatively impact the immune system. Serious adverse event data relating to TLR agonists may require us to reduce the scope of or discontinue certain of our pre-clinical or clinical activities
4. 15Even if we obtain regulatory approval for our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community, which could materially adversely impact our business, results of operations and financial condition
5. 16or licensing of our product candidates, stricter labeling requirements for those product candidates that are licensed, and a decrease in demand for any such product candidates

Risks Related to Our Business and Industry

1. 17Changes in existing third-party coverage or our inability to secure and maintain favorable reimbursement may impact our ability to sell our products, which would materially and adversely impact our business, results of operations, financial condition and prospects
2. 18We generally do not have long-term contractual commitments from our customers, and our customers may choose not to enter into new agreements with us
3. 19We may be unable to effectively manage our growth or achieve anticipated growth
4. 20We depend on our senior management team and the loss of one or more key employees or an inability to attract and retain highly skilled employees could adversely affect our business
5. 21Workforce shortages may continue to negatively impact our operations
6. 22If we fail to promote, protect, and maintain our brand in a cost-effective manner, we may lose market share and our ability to commercialize our products and revenues will suffer
7. 23The medical device and drug development industries are characterized by rapid, continuous innovation, and if we cannot keep pace with rapid innovation in those industries, our products and product candidates will become less competitive and our ability to commercialize our products and revenues will suffer
8. 24We currently rely on, and may in the future rely on, third-party contractors, including certain sole-source suppliers and manufacturers, to supply and manufacture preclinical, clinical and commercial drug supplies for nelitolimod and any future product candidates
9. 25Our risk management processes and procedures may not be effective
10. 26Natural or man-made disasters and other similar events may significantly disrupt our business, and negatively impact our business, financial condition and results of operations
11. 27Further, such damage or disruption to the supply, manufacturing, or trial sites of nelitolimod could impair our ability to complete our clinical trials on a timely basis, if at all

Risks Related to Our Legal and Regulatory Environment

1. 28We are subject to numerous complex regulatory requirements, and failure to comply with these regulations, or the cost of compliance with these regulations, may harm our business
2. 29These authorities may, in certain circumstances, require us to conduct and report the results of certain clinical studies or trials and to commit to voluntarily conducting additional clinical trials. Developments following regulatory approval or clearance may adversely affect sales of our products
3. 30More stringent oversight by the FDA and other agencies in recent years has resulted in increased enforcement activity, which increases our compliance risk
4. 31The complexity of a combination product that includes a drug and a medical device presents additional, unique development and regulatory challenges, which may adversely impact our development plans and our ability to obtain regulatory approval or clearance of our product candidates
5. 32We intend to use the FDA’s expedited drug development programs for nelitolimod but may not be able to achieve expedited development or approval for this product candidate
6. 33Even if we obtain regulatory approval or clearance for any of our product candidates, they will be subject to extensive and ongoing regulatory requirements for manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, sampling and record-keeping
7. 34If any of these events occurs, our ability to sell such product may be impaired, and we may incur substantial additional expense to comply with regulatory requirements, which could harm our business, financial condition, results of operations and prospects
8. 35If any of our product candidates receives marketing approval or clearance and we or others later discover that the product is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market the product could be compromised
9. 36Healthcare reform and other governmental and private payor initiatives may have an adverse effect upon, and could prevent, the commercial success of our products or product candidates
10. 37TriNav and the PRVI device must be manufactured in accordance with federal and foreign regulations, and we or any of our suppliers or third-party manufacturers could be forced to recall the products or terminate production if we fail to comply with these regulations
11. 38If treatment guidelines for the cancer indications that we are targeting change or the standard of care evolves, we may need to redesign our preclinical or clinical trials of, or seek new marketing authorization from, the FDA for any approved products
12. 39We could be subject to litigation that could have an adverse effect on our business and operating results
13. 40Potential product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop
14. 41Trade Commission Act), and other similar laws (e.g., wiretapping laws). For example, HIPAA as amended by HITECH imposes specific requirements relating to the privacy, security, and transmission of individually identifiable health information
15. 42Changes in tax law and differences in interpretation of tax laws and regulations may adversely impact our financial statements
16. 43Our ability to use our net operating loss carryforwards and certain other tax attributes is limited

Risks Related to Our Intellectual Property

1. 44Failure to obtain, adequately protect, maintain or enforce our intellectual property rights could substantially harm our business and results of operations
2. 45not be provided to us. Any of the foregoing could have a material adverse effect on our competitive position, business prospects and financial conditions
3. 46The expiration or loss of patent protection may adversely affect our future revenues
4. 47If we do not obtain protection under the Hatch-Waxman Amendments by extending the patent term, our business may be harmed
5. 48We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business
6. 49We may be subject to claims that we or our employees, consultants, contractors or advisors have infringed, misappropriated or otherwise violated the intellectual property of a third party, or claiming ownership of what we regard as our own intellectual property
7. 50Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner
8. 51We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
9. 52We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products and product candidates
10. 53Certain provisions in our intellectual property agreements may be susceptible to multiple interpretations
11. 54If we fail to comply with our obligations under any agreements, we may be required to pay damages and could lose intellectual property rights that are necessary or useful for developing and protecting our product candidates
12. 55Intellectual property rights do not necessarily address all potential threats to our business
13. 56If we do not obtain protection under the Hatch-Waxman Amendments by obtaining data exclusivity, our business may be harmed
14. 57Obtaining 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 non-compliance with these requirements
15. 58If our trademarks 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

Risks Related to the Ownership of Our Securities

1. 59We have limited experience operating as a United States public company and may not be able to adequately develop and implement the governance, compliance, risk management and control infrastructure and culture required for a public company, including compliance with the Sarbanes Oxley Act
2. 60A material weakness is a deficiency or combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the financial statements would not be prevented or detected on a timely basis
3. 61If we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired
4. 62There is a risk that we will not be able to conclude, within the prescribed time period or at all, that our internal control over financial reporting is effective as required by Section 404 of the Sarbanes-Oxley Act
5. 63The price of our securities has been and may continue to be volatile
6. 64We may be unable to maintain the listing of our securities on Nasdaq in the future
7. 65Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price
8. 66If our operating and financial performance in any given period does not meet the guidance provided to the public or the expectations of investment analysts, the market price of Common Stock may decline
9. 67We could be subject to securities class action litigation
10. 68Reports published by analysts, including projections in those reports that differ from our actual results, could adversely affect the price and trading volume of our securities
11. 69Sales of our securities or the perception of such sales, by us or our equity holders, in the public market or otherwise, could cause the market price for our securities to decline
12. 70Our Warrants are exercisable for Common Stock, the exercise of which would increase the number of shares eligible for future resale in the public market and result in dilution to our stockholders
13. 71Our Warrants may not be exercised at all or may be exercised on a cashless basis and we may not receive any cash proceeds from the exercise of the Warrants
14. 72Anti-takeover provisions contained in our Certificate of Incorporation and Bylaws, as well as provisions of Delaware law, could limit the ability of stockholders to take certain actions and could delay or discourage takeover attempts that stockholders may consider favorable
15. 73These provisions, alone or together, could delay or prevent hostile takeovers and changes in control of us or changes in our Board and our management
16. 74Our Certificate of Incorporation, to the extent permitted by applicable law, contains provisions renouncing our interest and expectation to participate in certain corporate opportunities identified or presented to our non- employee directors or stockholders