Tvardi Therapeutics, Inc. Q4 FY2023 earnings call

• In January 2023, Cara prioritized oral difelikefalin for notalgia paresthetica (NP), extending cash runway into 2026. NP is a highly underserved neuropathic condition with no approved therapies. - Oral difelikefalin showed positive results in a Phase 2 proof-of-concept study for NP. - Completed enrollment ahead of schedule in COURAGE I Part A (dose-finding portion of Phase 2/3 study) and expects top-line efficacy and safety results in Q3 2023. - Unfavorable reimbursement changes for KORSUVA led to no meaningful future revenue contribution. - Financed with HCR agreement, recording net proceeds as a long-term liability with non-cash revenue and imputed interest.

In the fourth quarter of 2023, KORSUVA injection generated net sales of $5 million. Revenue was $3 million, consisting of $2.3 million collaborative revenue from CSL Vifor’s sales of KORSUVA injection and $0.7 million from royalties and milestone payments related to the HCR agreement. Demand for KORSUVA had a 22% quarter-to-quarter increase in wholesaler shipments to clinics, but most was reallocated inventory, not translating to incremental revenue. Cost of goods sold for the quarter was $0.6 million, lower than the prior year's $2.1 million.

• Cash runway extended into 2026 due to prioritization of the NP program. - Anticipates reporting top-line efficacy and safety results from COURAGE I Part A in Q3 2023. - Current unrestricted cash expected to fund operating plan into 2026.

• Unfavorable reimbursement changes for KORSUVA could restrict access and revenue. - Risks associated with clinical trial outcomes and regulatory approvals for the NP program.

Q: How large a clinical program do you think NP could be in Phase 3?

A: The size of the Phase 3 program (Part B) will be based on results from Part A, with the aim to select one dose.

Q: Given rapid enrollment and community interest, would you consider partnering in late-stage development?

A: The asset is unencumbered, and Cara intends to continue developing NP.

Q: Expectations for Part A readout, replication of data?

A: Anticipate placebo response slightly higher due to study design differences, but expect separation from placebo and aim to select favorable dose.

Q: Placebo effect changes in Part A, quality of life measurement?

A: Placebo response higher due to 3:1 randomization, larger study, and awareness; quality of life endpoints still being navigated.

Q: Disclosure of safety details in Part A readout, safety expectations for highest dose?

A: Will disclose top-line efficacy and safety, expect similar safety profile to KOMFORT study.

Q: Other potential settings for oral difelikefalin, business development beyond NP?

A: Focused on NP, but may explore assets leveraging value inflection points in NP program.