Cara Therapeutics Q1 2024 Financial Results

Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on transforming the treatment of pruritus, has released its financial results and operational updates for the first quarter ending March 31, 2024. The company is making significant strides in its notalgia paresthetica (NP) pivotal clinical program, with topline efficacy and safety results from KOURAGE 1 Part A now anticipated by the end of the second quarter of 2024.

Cara's President and CEO, Christopher Posner, emphasized the rapid progress of the NP clinical program and the medical dermatology community's strong interest in finding an effective anti-pruritic treatment for NP patients. Posner expressed optimism about advancing the Phase 2/3 program of oral difelikefalin, a differentiated asset for treating this commonly under-researched sensory neuropathy.

The KOURAGE 1 Part A study is part of the dose-finding phase of the Phase 2/3 clinical program aimed at assessing oral difelikefalin for moderate-to-severe pruritus in NP patients. The study has enrolled 214 participants, and the upcoming results will inform the appropriate dose and sample size for the Phase 3 pivotal segment of the program, including Part B of KOURAGE 1 and the subsequent KOURAGE 2 study. Final topline results from the initial pivotal study are expected by late 2025, with the second pivotal study's results anticipated in early 2026.

In March 2024, Cara Therapeutics organized a virtual event titled "Meet the NP Experts," featuring leading dermatologists and key opinion leaders. The event focused on discussing the unmet needs in NP and the potential benefits of oral difelikefalin. A webcast replay of this event can be accessed in the Investors section of the company's website.

For the first quarter of 2024, KORSUVA® (difelikefalin) injection achieved net sales of approximately $1.8 million, and the company recorded collaborative revenue of around $800,000 from its share of the profit from KORSUVA injection sales. Wholesalers distributed 111,720 vials to dialysis centers during this period. However, the Transitional Drug Add-On Payment Adjustment (TDAPA) period for KORSUVA injection ended on March 31, 2024, and the injection will now be reimbursed through the ESRD PPS bundle.

Financially, Cara Therapeutics reported a decrease in cash, cash equivalents, and marketable securities, totaling $69.8 million as of March 31, 2024, compared to $100.8 million at the end of 2023. This reduction primarily resulted from $30.5 million used in operating activities. The net loss for the first quarter of 2024 was $30.7 million, or $(0.56) per basic and diluted share, compared to a net loss of $26.7 million, or $(0.49) per basic and diluted share, during the same period in 2023.

Total revenue for the quarter was $2.1 million, a significant drop from $6.2 million in the same quarter of the previous year. This revenue primarily included $0.8 million from collaborative revenue related to the profit share from CSL Vifor's sales of KORSUVA injection, $0.6 million from commercial supply revenue related to sales of KORSUVA injection to CSL Vifor, and $0.6 million from other revenue related to royalty payments earned from ex-U.S. sales of KORSUVA/Kapruvia.

The cost of goods sold was $0.6 million, reflecting commercial supply revenue for KORSUVA injection sales. Research and development (R&D) expenses were $22.0 million for the first quarter, down from $24.3 million in the previous year. This decrease was mainly due to lower costs associated with discontinued programs and reduced stock-based compensation, payroll, and travel expenses, partially offset by increased costs related to the oral difelikefalin NP program. General and administrative expenses remained steady at $6.8 million. Restructuring expenses were $2.4 million, related to the strategic focus on NP and the resulting workforce reduction.

Cara Therapeutics anticipates that its current cash and equivalents will sufficiently support its operating plan into 2026, covering planned pivotal trials in NP.

The KOURAGE Phase 2/3 clinical program is evaluating oral difelikefalin for treating moderate-to-severe pruritus in NP patients. The program comprises two studies, KOURAGE 1 and KOURAGE 2, which will likely be double-blind, placebo-controlled, 8-week studies, with patients having the option to continue in open-label 52-week extensions.

Cara Therapeutics continues to be a leader in developing new treatment paradigms for pruritus, aiming to improve the lives of patients with conditions like NP for which there are currently no FDA-approved therapies.