PART II – OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. See “Part I – Financial Information—Item 1. Unaudited Interim Condensed Consolidated Financial Statements—Note. 18. Provisions,” which updates and supplements the information regarding the Legal Matters in Part I, Item 8. of our Annual Report. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. See “Note 18. Provisions”
Item 1A. Risk Factors
Other than the supplemental risk factors provided below, there have been no material changes to the risk factors described in Item 3.D. of Cellectis’ Annual Report on Form 20-F for the year ended December 31, 2025.
Risks associated with our planned investigator-initiated trials in China for .HEAL-101 and .HEAL-201 could adversely affect the development of our product candidates.
Cellectis intends to initiate Phase 1 investigator-initiated trials (IITs) in China as part of the development strategy for .HEAL-101 and .HEAL-201. IITs are clinical studies that are initiated, sponsored and conducted by independent investigators and/or institutions generally responsible for the conduct of the study and compliance with applicable requirements. IITs are governed under the oversight of the National Health Commission in China and implemented within accredited medical institutions. Approvals by local ethics committees and compliance with China Good Clinical Practice are mandatory requirements for IITs. Because these IITs are an important component of our early clinical development strategy for .HEAL-101 and .HEAL-201, delays, operational challenges, regulatory issues, or an inability to obtain or utilize data from the IIT could delay development, affect our ability to advance these programs into later-stage clinical development, or otherwise adversely affect our business.
Given the nature of IITs, we may have less control over trial conduct, protocol implementation, regulatory interactions, data collection, and analysis, reporting practices and compliance activities than we would in a traditional company-sponsored clinical trial. We may also have less firsthand knowledge regarding the conduct of the IITs and the generation, collection and analysis of data from the IITs. If data generated from the IITs are incomplete, inaccurate, unreliable or otherwise inadequate, or if we are unable to obtain such data on a timely basis, our ability to use the results of the IITs to advance the development of our .HEAL-101 and .HEAL-201 development programs could be adversely affected.
Clinical research conducted in China is subject to local laws, regulations, ethics committee approvals and governmental oversight, which may differ from those in the United States, Europe or other jurisdictions. The laws and regulations in China on therapies that are eligible for IITs in China are subject to differing interpretations by investigators, institutions, ethics committees, and regulators, and we may face delays in receiving, and may not receive, regulatory approval necessary to conduct the IITs in China, which may further delay and adversely affect our .HEAL-101 and .HEAL-201 development programs. Regulatory requirements, interpretations and enforcement practices may change, and we may experience delays in obtaining approvals, enrolling patients, collecting or transferring data, or completing the study. In addition, geopolitical tensions, trade restrictions, obligations related to data privacy and security, cross-border data transfer regulations or other governmental actions could adversely affect our ability to oversee the trials, access trial data or use resulting data to support future regulatory submissions.
If the IITs are delayed, suspended or terminated, conducted inconsistently with applicable requirements, generate incomplete, inaccurate, unreliable or otherwise inadequate data, produce data that regulatory authorities do not accept, raise safety concerns, or if the IITs do not generate clinical proof-of-concept data sufficient to support the continued development of our .HEAL-101 and .HEAL-201 development programs, our business, financial condition, results of operations and prospects could be materially adversely affected.
Regulatory authorities may not accept data from clinical trials conducted in China, which could require us to conduct additional clinical trials and delay the development or approval of our product candidates.
Although data from the IITs may support our .HEAL-101 and .HEAL-201 development programs, including by providing initial clinical proof-of-concept data and informing future clinical development planning, there can be no assurance that the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) or any other regulatory authorities will accept such data to support future regulatory submissions.
The acceptance of data from IITs conducted in China by FDA, EMA or other regulatory authorities may be subject to certain conditions or may not be accepted at all. There can be no assurance that such regulatory authorities will accept data from IITs conducted in China. If regulatory authorities do not accept such data, we may be required to conduct additional clinical trials, which could be costly and time-consuming and could delay or prevent the development, regulatory approval or commercialization of our