Risk Factors Update Summary

• Added atopic dermatitis to clinical program, terminated Phase 3 clinical program for pruritus in hemodialysis patients.
• The company may incur losses in the foreseeable future and may never achieve profitability.
• The company expects its current cash and cash equivalents to fund operations into at least the first half of 2026.
• The company is substantially dependent on oral difelikefalin for the treatment of NP, its only current product. This dependency poses a significant risk.
• The company will need to build marketing, sales, and distribution capabilities in the United States.
• The company incurred net losses of $118.5 million, $85.5 million, and $88.4 million for the years ended December 31, 2023, 2022, and 2021, respectively.
• The establishment of a sales force for oral difelikefalin will be expensive and time-consuming.
• Changed the year from 2022 to 2024 for the completion of the Phase 3 study.
• Increase in federal and state NOL carryforwards from $440 million to $467 million.
• Reduced headcount by approximately 50% in January 2024, impacting institutional knowledge and operations.
• The company may need additional funding to continue development programs and commercialization efforts.
• Strategic prioritization of the pipeline may lead to execution challenges, including cost reduction efforts.
• The company faces significant competition and risks losing revenues if unable to compete effectively.
• Delays or difficulties in enrollment of patients in clinical trials could hinder the receipt of necessary regulatory approvals.
• The company reduced its global workforce by approximately 50% in the first quarter of 2024.
• The company faces significant competition from other pharmaceutical and biotechnology companies.
• Failure to meet demand for oral difelikefalin may result in delays in development and potential revenue loss.
• Transition from "future product candidates" to "potential candidate" may impact demand forecasting accuracy.
• Prioritized late-stage clinical program for oral difelikefalin in chronic pruritus associated with NP.
• Potential delisting from Nasdaq due to stock price below $1.00, affecting market liquidity.
• Challenges in commercializing approved products, KORSUVA injection and Kapruvia, could lead to significant additional expenses.
• Terminated Phase 3 study for pruritus in hemodialysis patients, focusing on chronic pruritus associated with NP.
• Dilution risk highlighted with potential additional funds raised through equity offerings, increasing from $348 million to $473 million.
• Increased competition for top talent due to high turnover, impacting business operations.
• Adjusted commercialization strategy, out-licensing to CSL Vifor and Maruishi, focusing on oral difelikefalin.
• Reduced commitment for KORSUVA injection due to lower-than-expected demand, negotiated to reduce costs.
• Planned workforce reduction of up to 50%, from 106 to 55 employees, to focus on oral difelikefalin.