Cartesian Therapeutics (RNAC) risk factors, FY2024 10-K

Risks Related to the Development of our Product Candidates

1. 01Our failure to successfully execute on of any of the foregoing for any reason would effectively prevent or delay approval of our lead and other product candidates
2. 02If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented
3. 03We may conduct clinical trials for product candidates at sites outside the United States, and the FDA may not accept data from trials conducted in such locations or the complexity of regulatory burdens may otherwise adversely impact us
4. 04Interim, 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
5. 05Interim, top-line or preliminary data may not be representative of final data. If final data is not as positive as earlier interim, top-line or preliminary we have released, our business prospects would be significantly harmed
6. 06Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any
7. 07trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of our product candidates for any or all targeted indications
8. 08Any of these events could prevent us from achieving or maintaining market acceptance of a particular product candidate, if approved, and could significantly harm our business, results of operations and prospects
9. 09and stop critical activities. If funding for the FDA is reduced, FDA priorities change or a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions which could have a material adverse effect on our business

Risks Related to Manufacturing and our Dependence on Third-Parties

1. 10We expect to continue to grow our manufacturing capabilities and resources and we must incur significant costs to develop this expertise and/or rely on third-parties to manufacture our products
2. 11We have growing manufacturing capabilities, and in order to continue to develop our current product candidates, apply for regulatory approvals and, if approved, commercialize future products, we will need to continue to develop, contract for, or otherwise arrange for any necessary external manufacturing capabilities
3. 12We rely on one or more third-party laboratories to perform certain quality control tests. These laboratories could become unavailable, or provision of their services could be delayed
4. 13We rely, and expect to continue to rely, on third-parties to conduct our clinical trials, and those third-parties may not perform satisfactorily, including by failing to meet deadlines for the completion of such trials

Risks Related to Commercialization of our Product Candidates and Legal Compliance Matters

1. 14Even if any of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success
2. 15We currently have no sales organization. If 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 our product candidates if and when they are approved
3. 16We face substantial competition, including from biosimilars, which may result in others discovering, developing or commercializing competing products before or more successfully than we do
4. 17These 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
5. 18We expect the product candidates we develop will be regulated as biological products, or biologics, and therefore they may be subject to competition sooner than anticipated
6. 19Even if we are able to commercialize any of our product candidates, the products may become subject to unfavorable pricing regulations or third-party coverage or reimbursement policies, any of which would have a material adverse effect on our business
7. 20Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop
8. 21Recently 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
9. 22Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA. We cannot predict the ultimate content, timing or effect of any healthcare reform legislation or the impact of potential legislation on us
10. 23If we or third-parties we rely upon 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

Risks Related to our Financial Position and Need for Additional Capital

1. 24We are a development-stage company, and we expect to incur losses for the foreseeable future and may never achieve or maintain profitability
2. 25We may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to remain profitable would depress our value and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or continue our operations
3. 26needed or on attractive terms, we could be forced to delay, reduce or eliminate our clinical trials, our other research and development programs or any future commercialization efforts
4. 27Our ability to use our net operating loss and research and development tax credit carryforwards to offset future taxable income may be subject to certain limitations
5. 28utilization due to previous ownership changes, or if we undergo an ownership change, our ability to use our NOLs could be limited by Section 382 of the Code. Future changes in our stock ownership, some of which are outside of our control, could result in an ownership change under Sections 382 and 383 of the Code
6. 29We have recorded a material amount of goodwill and indefinite-lived intangible assets in connection with the Merger. We may record impairment charges, which would adversely impact our financial position and results of operations
7. 30In addition, the determination as to whether our indefinite-lived intangible assets related to Descartes-08 are impaired is heavily dependent on the results of our ongoing clinical trials, as well as other factors, such as the potential market for Descartes-08, if approved
8. 31We have incurred substantial expenses related to the integration of Old Cartesian

Risks Related to our Intellectual Property

1. 32If we or our licensors are unable to adequately protect our proprietary technology, or obtain and maintain issued patents that are sufficient to protect our product candidates, others could compete against us more directly, which would negatively impact our business
2. 33Further, it is possible that a patent claim may provide coverage for some but not all parts of a product candidate or third-party product. These and other factors may provide opportunities for our competitors to design around our patents
3. 34If we are unable to protect the confidentiality of our trade secrets and know-how, our business and competitive position would be harmed
4. 35Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
5. 36Third-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
6. 37Claims that we have misappropriated the confidential information or trade secrets of third-parties could have a similar negative impact on our business
7. 38We may become involved in lawsuits to protect or enforce our patents or other intellectual property, and our issued patents covering our product candidates could be found invalid or unenforceable or could be interpreted narrowly if challenged in court
8. 39The lives of our patents may not be sufficient to effectively protect our products and business
9. 40Obtaining 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. 41We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses
11. 42We 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
12. 43We 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
13. 44outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions
14. 45If we do not obtain additional protection under the Hatch-Waxman Act and similar foreign legislation extending the terms of our patents for our product candidates, our business may be harmed

Risks Related to our Operations

1. 46Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel
2. 47We have incurred increased costs as a result of operating as a public company, and our management will be required to devote substantial time to compliance initiatives and corporate governance practices
3. 48A variety of risks associated with maintaining our subsidiary in Russia or expanding operations internationally could adversely affect our business
4. 49Our business and operations, including our development programs, could be materially disrupted in the event of system failures, security breaches, violations of data protection laws or data loss or damage by us or third-parties on which we rely, including our CROs or other contractors or consultants
5. 50Acquisitions or joint ventures could disrupt our business, cause dilution to our stockholders and otherwise harm our business
6. 51Foreign 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

Risks Related to our Common Stock

1. 52The market price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock
2. 53Our executive officers, directors, and principal stockholders, if they choose to act together, will continue to have the ability to control or significantly influence all matters submitted to stockholders for approval
3. 54Anti-takeover provisions in our charter documents and under Delaware law and the terms of some of our contracts could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our management
4. 55We have been in the past and may in the future be subject to stockholder litigation