Cellectis SA
For the period ended Dec 31, 2023. Filed Apr 29, 2024.
View on SEC.govAbout this filing
The yearly report of a company based outside the US. It covers much of what a 10-K does, and may follow accounting rules other than US ones.
FY2023 · Filed Apr 29, 2024
Contents
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report contains “forward-looking statements” within the meaning of applicable federal securities laws, including the Private Securities Litigation Reform Act of 1995. All statements other than present and historical facts and conditions contained in this Annual Report, including statements regarding our future results of operations and financial position, business strategy, plans and our objectives for future operations, are forward-looking statements. These forward-looking statements are subject to numerous risks and uncertainties and are made in light of information currently available to us. Many important factors, in addition to the factors described in this Annual Report, may adversely affect such forward-looking statements. When used in this Annual Report, the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions identify forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
the implementation of our strategic plans for our business, product candidates and technology;
the initiation, timing, progress and results of our research and development programs and our pre-clinical and clinical studies;
our ability to advance product candidates into, and successfully complete, clinical studies;
our manufacturing capabilities and operations at our in-house manufacturing facilities;
the timing of regulatory filings and the likelihood of favorable regulatory outcomes and approvals;
our ability to contract on commercially reasonable terms with contract research organizations, or CROs, third-party suppliers of biological raw or starting materials and manufacturers;
the ability of third parties with whom we contract to successfully conduct, supervise and monitor clinical studies for our therapeutic product candidates;
our ability to obtain additional funding for operations;
the potential benefits of our licensing agreements and our ability to enter into future arrangements;
the ability and willingness of licensees or partners to actively pursue development activities under our licensing agreements;
our receipt of milestone or royalty payments pursuant to our licensing agreements with Allogene Therapeutics, Inc. (“Allogene”), Les Laboratoires Servier and Institut de Recherches Internationales Servier (together “Servier”) and AstraZeneca Ireland Limited (“AZ Ireland”);
our ability to maintain and establish collaborations or obtain additional grant funding;
future sales of our ordinary shares by AstraZeneca Holdings B.V. ("AZ Holdings") and the market price of our ordinary shares and ADSs;
significant influence over us by the group of companies including AZ Holdings, AZ Ireland and their respective affiliates (referred to as "AstraZeneca" in this Annual Report) and the continuing involvement of certain of our directors with AstraZeneca and its affiliates;
the rate and degree of market acceptance of, and demand for, our product candidates;
our status as a passive foreign investment company, or PFIC, for U.S. federal income tax purposes;
the financial performance and cash runway for our Therapeutics business;
our expectations regarding the period during which we qualify as a foreign private issuer, or FPI;
developments relating to our competitors and our industry, including competing therapies and technologies.
You should refer to the section of this Annual Report titled “Risk Factors” for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward- looking statements in this Annual Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. We qualify all of our forward-looking statements by these cautionary statements.
Market Data
This Annual Report contains market data and industry forecasts that were obtained from various industry publications. In presenting this information, we have also made assumptions based on such data and other similar sources, and on our knowledge of, and our experience to date in, the biotechnology industry. Market data and industry forecasts involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. While we believe the market position, market opportunity and market size information included in this Annual Report is generally reliable, such information is inherently imprecise. Various risks, including those described in the section of this Annual Report entitled “Risk Factors,” could cause results to differ materially from those expressed in the estimates made by us and independent parties.
Website Disclosure
We use our website (www.cellectis.com) and our corporate Twitter account (@cellectis) and our corporate LinkedIn account (https://www.linkedin.com/company/cellectis) as routine channels of distribution of company information, including press releases, analyst presentations, and supplemental financial information, as a means of disclosing otherwise material non-public information and for complying with our disclosure obligations. Accordingly, investors should monitor these corporate websites and corporate Twitter and LinkedIn accounts in addition to following press releases, filings with the SEC, and public conference calls and webcasts. Additionally, we provide notifications of announcements as part of our website. Investors and others can receive notifications of new press releases posted on our website by signing up for email alerts.
None of the information provided on these websites, in our press releases or public conference calls and webcasts or through social media is incorporated into, or deemed to be a part of, this Annual Report or in any other report or document we file with the SEC, and any references to such websites or corporate Twitter accounts are intended to be inactive textual references only.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.