Eloxx Pharmaceuticals, Inc.

RISK FACTOR SUMMARY

The following is a summary of the principal risks of an investment in our common stock. This summary does not list all the risks that we face. Additional discussion of the risks summarized below follow directly under the heading “Risk Factors” and should be carefully considered, together with other information in our 2025 Annual Report and our other filings with the SEC before making an investment decision regarding our common stock.

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We are heavily dependent on the success of our lead product candidate, exaluren. If exaluren does not achieve positive results during development or suffers any material development delays, it may adversely impact the commercial viability of exaluren and our business.

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We are a clinical stage biotechnology company and have incurred significant operating losses since our inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future. We may never achieve or maintain profitability.

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We will need substantial additional funding. If we are unable to raise capital when needed, we would be forced to delay, reduce, or eliminate our product development programs or commercialization efforts.

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Preclinical and clinical drug development is a lengthy and expensive process, with an uncertain outcome. Our preclinical and clinical programs may experience delays or may never advance, which would adversely affect our ability to further advance clinical development, obtain regulatory approvals or commercialize our product candidates on a timely basis or at all, which could have an adverse effect on our business.

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We and our collaborating partners may be subject, directly or indirectly, to federal and state healthcare fraud and abuse and false claims laws and regulations. If we or our collaborating partners are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

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Our product candidates, including exaluren, may cause adverse events or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance.

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Even though we have received orphan drug designation from the FDA for exaluren for the treatment of AS and orphan medicinal product designation from the European Commission for exaluren for the treatment of ADPKD, we may not be able to maintain the benefits of such orphan designations or obtain orphan drug marketing exclusivity for exaluren or any of our other product candidates for AS, ADPKD or other indications.

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We may find it difficult to recruit and enroll patients in our clinical trials, which could cause significant delays in the completion of such trials or may cause us to abandon one or more clinical trials.

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If we are unable to develop and commercialize our product candidates, our business will be adversely affected.

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If we fail to adequately protect or enforce our intellectual property rights or secure rights to third party patents, the value of our intellectual property rights would diminish, and our business, competitive position and results of operations would suffer.

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If we infringe the rights of third parties, we could be prevented from selling products, forced to pay damages and required to defend against litigation which could result in substantial costs and may have a material adverse effect on our business, results of operations and financial condition.

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Our common stock is currently listed on the Nasdaq Stock Market LLC (“Nasdaq”). There are no assurances that we will be able to successfully maintain compliance with Nasdaq’s listing requirements and remain listed on the Nasdaq Capital Market.

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We have been delinquent in our public filing obligations under the Securities Exchange Act of 1934, as amended, and there are no assurances that we will be successful in continuing to meet our public filing obligations.

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Maintaining and improving our financial controls and the requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain qualified board members.

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