Company: IPHYF
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001598599-25-000042
Chunk: 7

Company: Innate Pharma SA
Filing Date: 2025-04-30
Form: 20-F
Item: Item 3
Chunk 7
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 the Company expects.

Clinical testing is expensive, time consuming and subject to uncertainty. The Company cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical studies can occur at any stage of testing, and its future clinical studies may not be successful. Events that may prevent successful or timely completion of clinical development include:

• inability to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support the initiation of clinical trials;

• delays or failure in reaching a consensus with regulatory agencies on clinical study design;

• delays in reaching agreement on acceptable terms with prospective Contract Research Organisations (CROs) and investigational sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and investigational sites;

• imposition of a temporary or permanent clinical hold by regulatory agencies, including as a result of a new safety finding that presents unreasonable risk to clinical study participants, a negative finding from an inspection of its clinical trial operations or investigational sites, developments in trials conducted by competitors for related technology that raise regulators’ concerns about risk to patients of the technology broadly or if a regulatory body finds that the investigational protocol or plan is clearly deficient to meet its stated objectives. For example, in October 2023, the lacutamab IND was put on partial hold by the FDA following the death of one patient from hemophagocytic lymphohistiocytosis (HLH). The FDA then lifted this partial hold based on their review of the fatal case which Innate, together with a steering committee of independent experts, determined to be related to aggressive disease progression and lacutamab unrelated;

• delays in recruiting suitable patients to participate in its clinical studies;

• difficulty collaborating with patient groups and investigators;

• failure by the Company, its CROs or other third parties, including its collaborators, to adhere to clinical study requirements;

• delays in having patients complete participation in a clinical study or return for post-treatment follow-up;

• patients withdrawing from a clinical study;

• occurrence of adverse events associated with a product candidate that are viewed to outweigh its potential benefits;

• changes in regulatory requirements and guidance that require amending or submitting new clinical trial protocols;

• regulatory feedback requiring the Company to amend the protocols of ongoing clinical studies in response to safety considerations, as the Company has previously been required to;

• changes in the standard of care on which a clinical development plan was based, which may require new or additional clinical trials