Full Press Release Details
Announces Fourth Quarter and Full Year 2023 Financial Results
prioritization of clinical programs to focus on late-stage development of oral difelikefalin for notalgia paresthetica (NP)-
enrollment of KOURAGE 1 Part A portion of NP pivotal program ahead of schedule; topline efficacy and safety results now expected
cash runway into 2026 with clinical prioritization strategy and reduction in force-
call today at 4:30 p.m. EST-
March 4, 2024 - Cara Therapeutics, Inc. (Nasdaq: CARA), a development-stage biopharmaceutical company leading
a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced financial results and operational
highlights for the fourth quarter and full year ended December 31, 2023.
this year, we announced the decision to focus all our resources on our late-stage notalgia paresthetica (NP) clinical program, which
we believe puts us on the path to significant near-term value creation," said Christopher Posner, President and Chief Executive
Officer of Cara Therapeutics. "We completed enrollment in KOURAGE 1 Part A, the dose-finding portion of our pivotal program,
earlier than anticipated and now expect to report topline efficacy and safety results in the third quarter of 2024. With a sizeable patient
population and no approved or effective therapies on the market, we are excited about the commercial potential for oral difelikefalin
in NP. Importantly, our cash runway into 2026 gives us the resources necessary to reach all potential key value-inflection milestones
in our NP clinical program."
In the first quarter
of 2024, the Company completed enrollment in KOURAGE 1 Part A, the dose-finding portion of the Phase 2/3 clinical program evaluating
oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with NP.
The Company enrolled
214 patients and expects topline efficacy and safety results from KOURAGE 1 Part A in the third quarter of 2024. Part A is
not powered for statistical significance. This readout will provide key information, specifically the dose and sample size to initiate
the Phase 3 pivotal portion of the program - Part B of KOURAGE 1 and the second study KOURAGE 2. Final topline results from
the first pivotal study are expected by the end of 2025 with the second pivotal study results in early 2026.
2024, the Company will host a virtual event featuring a panel of leading dermatologists and key opinion leaders to discuss the unmet
need in NP and the potential of oral difelikefalin. The Company will issue an announcement with more details.
Injection U.S. Update
In the fourth quarter
of 2023, KORSUVA (difelikefalin) injection generated net sales of $5.0 million and the Company recorded collaborative
revenue of $2.3 million, which represented the Company's share of the profit from sales of KORSUVA injection.
110,700 vials to dialysis centers during the fourth quarter of 2023 (an increase of 22% vs. the third quarter of 2023), the majority
of which were vials reallocated within the Fresenius network of clinics.
2024, the Transitional Drug Add-On Payment Adjustment (TDAPA) period for KORSUVA injection will expire. After March 31, 2024, KORSUVA
injection will be reimbursed through the ESRD PPS bundle.
to participate in the following upcoming events:
and Full Year 2023 Financial Results
and Sale Agreement: During the three months ended December 31, 2023, the Company entered into a Purchase and Sale Agreement,
or the HCR Agreement, with HCRX Investments Holdco, L.P. and Healthcare Royalty Partners IV, L.P., or collectively HCR, where HCR will
receive future royalty and milestone payments for Kapruvia/KORSUVA (ex U.S. only) up to certain capped amounts in exchange for up to
$40.0 million to the Company. The Company received proceeds of $37.5 million, less $1.0 million of transaction and advisory costs, both
of which were recorded as a long-term liability as of December 31, 2023. This long-term debt balance will increase as imputed interest
is calculated on the outstanding debt balance and will decrease as future royalty and milestone payments are paid to HCR over the period
defined in the HCR Agreement.
Cash, cash equivalents
and marketable securities at December 31, 2023 totaled $100.8 million compared to $156.7 million at December 31, 2022. The
decrease in the balance primarily resulted from $92.1 million of cash used in operating activities, partially offset by $36.5 million
of net proceeds received from the HCR Agreement.
quarter of 2023, net loss was $32.3 million, or $(0.59) per basic and diluted share, compared to net loss of $30.3 million, or $(0.56)
per basic and diluted share, for the same period in 2022.
Total revenue was $3.0 million and $3.3 million for the three months ended December 31, 2023 and 2022, respectively. Revenue primarily
Sold: Cost of goods sold of $0.6 million primarily related to inventory adjustments during the three months ended December 31,
2023. Cost of goods sold of $2.1 million related to commercial supply revenue for KORSUVA injection sales to CSL Vifor during the three
months ended December 31, 2022.
Development (R&D) Expenses: R&D expenses were $28.4 million for the three months ended December 31, 2023 compared to
$26.0 million in the same period of 2022. The higher R&D expenses in 2023 were primarily due to increases in clinical trial costs
related to the Company's three late-stage development programs partially offset by a decrease in stock-based compensation expense.
R&D expenses in the three months ended December 31, 2023 included a $1.7 million expense related to an agreement for manufacturing
commitments that are no longer needed due to the reduced demand expectations of KORSUVA in the U.S.
Administrative (G&A) Expenses: G&A expenses were $6.6 million for the three months ended December 31, 2023 which were
relatively flat compared to $6.4 million in the same period of 2022.
net: Other income, net was $0.9 million for the three months ended December 31, 2023 compared to $1.0 million in the same period
expense on liability related to sales of future royalties and milestones: Non-cash interest expense was $0.6 million which represented
imputed interest on the carrying value of the liability associated with the HCR Agreement and the amortization of the related issuance
costs associated with the purchase and sale agreement for the three months ended December 31, 2023. There was no non-cash interest
expense for the three months ended December 31, 2022.
ended December 31, 2023, net loss was $118.5 million, or $(2.19) per basic and diluted share, compared to net loss of $85.5 million,
or $(1.59) per basic and diluted share for the full year ended December 31, 2022.
Total revenue was $21.0 million and $41.9 million for the full years ended December 31, 2023 and 2022, respectively. Revenue primarily
Sold: Cost of goods sold of $6.2 million and $7.3 million for the years ended December 31, 2023 and 2022, respectively, related
to commercial supply revenue for KORSUVA injection sales to CSL Vifor.
Development (R&D) Expenses: R&D expenses were $108.5 million for the full year ended December 31, 2023 compared to $91.9
million for the full year ended December 31, 2022. The higher R&D expenses in 2023 were primarily due to increases in clinical
trial costs related to the Company's three late-stage development programs and increased payroll-related costs, partially offset
by a decrease in stock-based compensation expense. R&D expenses in 2023 also included a $1.7 million expense related to an agreement
for forecasted manufacturing commitments that are no longer needed due to the reduced demand expectations of KORSUVA in the United States,
while R&D expenses in 2022 included the recognition of the $5.0 million milestone payment due to Enteris BioPharma, Inc.
Administrative (G&A) Expenses: G&A expenses were $27.8 million for the full year ended December 31, 2023 compared to
$30.3 million for the full year ended December 31, 2022. The decrease in 2023 was primarily related to a decrease in stock-based
compensation expense.
net: Other income, net was $3.6 million for the full year ended December 31, 2023 compared to $2.1 million for the full year
ended December 31, 2022. The increase in other income, net was primarily due to an increase in interest income resulting from a
higher yield on our portfolio of investments during the year ended December 31, 2023.
expense on liability related to sales of future royalties and milestones: Non-cash interest expense was $0.6 million which represented
imputed interest on the carrying value of the liability associated with the HCR Agreement and the amortization of the related issuance
costs associated with the HCR Agreement for the year ended December 31, 2023. There was no non-cash interest expense for the year
ended December 31, 2022.
our current unrestricted cash and cash equivalents and available-for-sale marketable securities will be sufficient to fund our currently
anticipated operating plan into 2026. Our current operating plan reflects the impact of our prioritization announcement in January 2024
which includes costs related to our pivotal program in NP.
Phase 2/3 Clinical Program in Notalgia Paresthetica
2/3 clinical program evaluating oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica
(NP). The program is comprised of two studies - KOURAGE 1 and KOURAGE 2 - which are double-blind, placebo-controlled, 8-week
studies with patients allowed to roll-over into open-label 52-week extensions.
KOURAGE 1 is composed
of two parts. The dose-finding portion of KOURAGE 1 (Part A) includes 214 patients who are randomized equally to four arms (0.25
mg BID, 1.0 mg BID, 2.0 mg BID, placebo BID). Part A is not powered for statistical significance.
KOURAGE 2 will likely be double-blind, placebo-controlled, 8-week studies with patients randomized 1:1 to either difelikefalin or matching
placebo. The primary endpoint for both the dose-finding portion of KOURAGE 1 (Part A) and the two pivotal studies Part B and
KOURAGE 2 will likely be the proportion of patients with a 4-point improvement at Week 8 from baseline in the worst itch numeric
About Cara Therapeutics
Cara Therapeutics is