Clinical Trial Success Uncertainty: The success of Protara's clinical trials, especially for lead candidate TARA-002, is not guaranteed, and unfavorable results could significantly impact its development and future prospects.

Regulatory Approval Challenges: Even with positive clinical data, obtaining necessary regulatory approvals from agencies like the FDA or EMA is a complex and uncertain process that can be delayed or denied.

Capital Requirements and Funding Dilution: Protara is a development-stage company and will require significant additional funding to continue operations and advance its pipeline, which may lead to further equity dilution for existing shareholders.