Company: ENTXW
Filing Date: 2025-01-10
Form Type: 424B5
Source: 0001178913-25-000079
Chunk: 11

Company: Entera Bio Ltd.
Filing Date: 2025-01-10
Form: 424B5
Chunk 11
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 our current and future 
 product candidates;                                                                                                                                                                                                                          |

| • | The regulatory approval processes of the U.S. Food and Drug Administration (“FDA”) and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval 
 for our product candidates, our business will be materially harmed;                                                                                                                                                                           |

| • | Preclinical development is uncertain. Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a 
 timely basis or at all;                                                                                                                                                                                                                    |

| • | Positive results from preclinical studies and early-stage clinical trials may not be predictive of future results. Initial positive results in any of our clinical trials may not be indicative of results obtained when the trial is completed 
 or in later stage trials;                                                                                                                                                                                                                       |

| • | The scope, progress and costs of developing our product candidates such as EB613 for Osteoporosis and EB612 or other oral peptides for Hypoparathyroidism may alter over time based on various factors such as regulatory requirements, 
 collaboration agreements, the competitive environment and new data from pre-clinical and clinical studies;                                                                                                                              |

| • | the accuracy of our estimates regarding expenses, capital requirements, the sufficiency of our cash resources and the need for additional financing; |

| • | our ability to continue as a going concern absent access to sources of liquidity; |

| • | Our ability to raise additional funds or consummate strategic partnerships to offset additional required capital to pursue our business objectives, which may not be available on acceptable terms or at all. A failure to obtain this 
 additional capital when needed, or failure to consummate strategic partnerships, could delay, limit or reduce our product development, and other operations;                                                                           |

| • | Even if a current or future product candidate 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;                                                                                                                                                                                                                                   |

S - 7

| • | The successful commercialization of our product candidates, if approved, will depend in part on the extent to which governmental authorities and third-party payors establish adequate coverage and reimbursement levels and pricing policies; |

| • | Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue; |

| • | If we are unable to obtain and maintain