Entera Bio Ltd. Ordinary Shares

ITEM 1A. RISK FACTORS

Except as set forth below in this Item 1A, there have been no material changes with respect to the risk factors disclosed in Part I, Item 1A. of our 2023 Annual Report.

Security, political and economic instability in the Middle East may harm our business.

Our principal research and development facilities are located in Israel. In addition, some of our key employees, officers and directors are residents of Israel. Accordingly, political, economic and military conditions in the Middle East may affect our business directly. Since the establishment of the State of Israel in 1948, a number of armed conflicts have occurred between Israel and its neighboring countries, Hamas (an Islamist militia and political group in the Gaza Strip) and Hezbollah (an Islamist militia and political group in Lebanon).

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I and Iran.

On October7, 2023, thousands of Hamas terrorists infiltrated Israels southern border from the Gaza Strip and conducted a series of alethal attacks onIsraeli civilians and msome military targets. Hamas also launched extensive rocket attacks on the Israeli civilian population and industrial centers located along Israels border with the Gaza Strip and in other areas within thacross the State of Israel. These attacks resulted in thousands of deaths and injuries, and Hamas additionally kidnapped many over 250 Israeli civilians and soldiers. Following the attack, Israels security cabinet declared war agacommenced a counter-offense military campaign against Hamas and commenced ain Gaza.

Since the onset of these events, hostilities have persisted along Israel's northern border with Lebanon, primarily involving the Hezbollah terror organization, as well as other extremist groups in the region, including the Houthis in Yemen and various military campaign ia groups in Syria and Iraq. Israel has conducted multiple targeted strikes against Hamathese terror organizations.

In addition, since April 2024, Israel has experienced a direct attacks from Iran, involving hundreds of drones and ballistic missiles launched towards various parts of themostly densely populated civilian towns across Israel and somemilitary bases, threatening country, mostly targetingntinued aggression while also exerting considerable influence over regional military basesia groups encouraging them to launch attacks against Israel. The Israeli defense systems, aided by international allies, successfully intercepted the majority of thes ballistic missile attacks, minimizing physical damage and casualties. Additionally, since October 2023, the Houthis, a military organization based in Yemen, have launched a series of attacks on global shipping routes in the Red Sea, as well as direct attacks on various parts of Israel. Such incidents contribute to regional instability and could potentially escalate into broader conflicts with Iran and its proxies in the mMiddle eEast, affecting Israel's political and trade relations, especially with neighboring countries and global allies. The situation remains fluid, and the potential for further escalation exists. In October 2024, Israel initiated both air and ground operations against Hezbollah in Lebanon.

While we have a few employees who are in active military service, the ongoing war with Hamas a, the escalation of Hezbollah's attacks on Northern Israeland the conflidirect with offensives from Iran and its proxies have not, to date, materially impacted our business or operations. Furthermore, we do not expect any delays to any of our programs as a result of such conflicts. While RDresearch and msome management are located in Israel, other core activities including clinical, regulatory and our supply chain are not. However, we cannot currently predict the intensity or duration of Israelsthe war against Hamas and/or the conflict with , Hezbollah and Iran, and its proxies, nor can we predict how such conflicts will ultimately affect our business and operations or Israels economy in general.

Additionally, political uprisings, social unrest and violence in various other countries in the Middle East, including Israels neighboring countries Syria, Lebanon, Egypt and Jordan, are affecting the political stability of those countries. This instability may lead to deterioration of the political relationships that exist between Israel and certain countries and have raised concerns regarding security in the region and the potential for armed conflict. Iran is also believed to have a strong influence over various proxy militias across the Middle East, and among the Syrian government, Hamas and Hezbollah, in addition to its readiness to engage in conflict with Israel directly. These situations may potentially escalate in the future into more violent events which may affect Israel and us. These situations, including conflicts which involved missile strikes against civilian and military targets in various parts of Israel, have, in the past, negatively affected business conditions in Israel.

Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners could have a material adverse effect on our business. Although such hostilities did not have a material adverse impact on our business in the past, we cannot guarantee that hostilities will not be renewed and have such an effect in the future. The political and security situation in Israel may result in parties with whom we have contracts claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions. These or other se or other Israeli political or economic factors could harm our operations and product development. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners could adversely affect our operations. In addition, due tolight of the intensity of the ongoing war with Hamas, tIsrael-Hamas War, the escalation of Hezbollah's and Irans attack of Israeli civilian and military sites, in September 2024, the international rating agency Moody's has downgraded Israel's credit rating from A12 to A2 andBaa1, revised its outlook from stable to negative, indicating the possibiflecting heightened geopolity of further downgrades in the futureical risks. This lowered credit rating, as well as the ongoing war with Hamasand conflicts described above, could make it more difficult for us to raise capital, if needed. We could experience disruptions if acts associated with such co, and negatively inflicts result in any serious damage to our facilities. Furuence thermore, several countries, as well as certain companies and organizations, continue to restrict business with Israel and Israeli companies, which c market price of our Ordinary Shares. We could have an adverse effect on our business and financial condition in the future. Our business interrexperience disruption insurance may not adequately compensate us for losses, s if at all, that may occur acts a result of an event assssociated with a security situation in the Middle East, andsuch conflicts result in any losses or damages incurred by us could have a material adverse effect onserious damage to our businessfacilities.

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