Full Press Release Details
Cara Therapeutics Reports Fourth Quarter
and Full Year 2020 Financial Results
- U.S. FDA Accepts NDA Filing for
KORSUVA Injection in CKD-aP -
- Conference call today at 4:30
STAMFORD, Conn., February 25, 2021
- Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing
new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors (KORs), today announced
financial results and operational highlights for the fourth quarter and full year ended December 31, 2020.
"During 2020, we made significant
advances in our late-stage clinical pruritus programs, culminating in the acceptance by the U.S. Food and Drug Administration (FDA)
of our first New Drug Application (NDA) filing for our lead product candidate, KORSUVA (CR845/difelikefalin) Injection for
the treatment of moderate-to-severe pruritus in hemodialysis patients," said Derek Chalmers, Ph.D., D.Sc., President and
Chief Executive Officer of Cara Therapeutics. "In addition, we executed a strategic commercial licensing agreement with Vifor
(International) Ltd. (Vifor) that we believe will provide significant momentum for the launch and adoption of KORSUVA Injection
in the United States, if approved. Looking forward, we also expect 2021 to be a very exciting year for our Oral KORSUVA pruritus
programs as we report top-line data for the KARE Phase 2 dose-ranging trial in atopic dermatitis in the first half of 2021 and
initiate our Phase 3 registration trials in stage III-V CKD patients in the second half of the year."
Fourth Quarter and Recent Developments:
KORSUVA Injection: Chronic Kidney Disease-Associated
Pruritus (CKD-aP): Hemodialysis
In February 2021, the FDA
accepted the filing of the NDA for KORSUVA Injection for the treatment of moderate-to-severe pruritus in hemodialysis
patients. If approved, KORSUVA Injection would be the first treatment for CKD-aP in dialysis patients. If granted priority
review, potential approval and commercial launch of KORSUVA Injection could take place in the second half of 2021.
In October 2020, the Company
entered into a license agreement with Vifor under which it granted Vifor an exclusive license to commercialize KORSUVA Injection
for the treatment of pruritus in hemodialysis patients in the United States under a Cara 60%, Vifor 40% profit-sharing
arrangement. Under the terms of the agreement, the Company received an upfront payment of $100.0 million from Vifor and
an additional payment of $50.0 million for the purchase of the Company's common stock at a price of $17.0094 per
Upon U.S. regulatory approval
of KORSUVA Injection, the Company will also be eligible to receive an additional $50.0 million common stock investment
at a 20% premium to the 30-day trailing average price of the Company's common stock as of such date. In addition, the Company
is eligible to receive payments of up to $240.0 million upon the achievement of certain sales-based milestones.
Oral KORSUVA: CKD-aP: Non-Hemodialysis
In December 2019, the Company announced
positive top-line results from its Phase 2 dose-ranging trial of Oral KORSUVA for the treatment of pruritus in patients with stage
III-V (moderate-to-severe) CKD. The Company expects to conduct an End of Phase 2 Meeting with the FDA regarding this indication
in the second quarter of 2021. Following the meeting, the Company intends to initiate the Phase 3 program in patients with stage
III-V CKD in the second half of 2021.
Oral KORSUVA: Atopic Dermatitis (AD)
In December 2020, the Company announced
that it has completed full enrollment in the ongoing KARE Phase 2 dose-ranging trial of Oral KORSUVA for the treatment of moderate-to-severe
pruritus in approximately 400 adult AD patients. The study is evaluating the safety and efficacy of three tablet strengths (0.25
mg, 0.5 mg and 1.0 mg, twice daily) of Oral KORSUVA versus placebo for 12 weeks, followed by a four-week active extension phase.
KARE's primary efficacy endpoint
is change from baseline in the weekly mean of the daily 24-hour Worst Itch - Numeric Rating Scale (WI-NRS) score at week
12 of the treatment period. The key secondary endpoint for KARE is the assessment of the proportion of patients achieving an improvement
from baseline of 4 points with respect to the weekly mean of the daily 24-hour WI-NRS score at week 12. Itch-related quality
of life scores at the end of week 12 are assessed by the total Skindex-10 and 5-D itch scales.
The Company aims to report top-line results
from this trial in the first half of 2021, subject to any delays related to the ongoing COVID-19 pandemic.
Oral KORSUVA: Chronic Liver Disease-Associated
Pruritus (CLD-aP): Primary Biliary Cholangitis (PBC)
The Company is currently conducting a Phase
2 trial of Oral KORSUVA for the treatment of pruritus in patients with hepatic impairment due to PBC. The trial is evaluating the
safety and efficacy of Oral KORSUVA (1.0 mg tablet, twice daily) versus placebo for 16 weeks. The Company aims to have top-line
data in the second half of 2021, due in part to delays related to the ongoing COVID-19 pandemic.
Oral KORSUVA: Notalgia Paresthetica
In January 2021, the Company initiated
a Phase 2 trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in patients suffering from NP, a nerve disorder
characterized by chronic pruritus of the upper to middle back.
The Phase 2 multicenter, randomized, double-blind,
placebo-controlled 8-week study is designed to evaluate the efficacy and safety of Oral KORSUVA for moderate-to-severe pruritus
in approximately 120 subjects with NP. Subjects will be randomized to receive Oral KORSUVA 2.0 mg twice daily versus placebo for
8 weeks, followed by a four-week active extension period. The primary efficacy endpoint is the change from baseline in the weekly
mean of the daily 24-hour WI-NRS score at Week 8 of the treatment period. Secondary endpoints include change from baseline in itch-related
quality of life scores and a change from baseline in itch-related sleep disturbance subscale at the end of Week 8.
COVID-19 Impacts and Business Operations
Due to the ongoing COVID-19 pandemic and
in accordance with the FDA's updated guidance for conducting clinical trials, the Company has implemented numerous clinical
and operational measures to prioritize the health and safety of patients, employees and study investigators and minimize potential
disruptions to its ongoing clinical studies. Cara is working closely with its clinical and commercial manufacturing partners to
continue to ensure sufficient supply of KORSUVA is available for its ongoing and planned clinical trials.
Based on guidelines from the Centers
for Disease Control and Prevention and the State of Connecticut, all Cara employees continue to work remotely, and business
travel has been restricted.
Expected 2021 Milestones
Upcoming Meeting Activities
The Company expects to make presentations
at the following upcoming conferences:
Fourth Quarter and Full Year 2020 Financial
Cash, cash equivalents and marketable securities
at December 31, 2020 totaled $251.5 million compared to $218.2 million at December 31, 2019. The increase in the balance
primarily resulted from $38.4 million from the sale of common stock in a license agreement with Vifor, partially offset by $5.5
million of cash used in operating activities, which includes $111.6 million of cash received from the Vifor Agreement which was
included as license and milestone fees revenue.
For the fourth quarter of 2020, net income
was $78.9 million, or $1.60 per basic share and $1.59 per diluted share, compared to a net loss of $28.6 million, or $0.61 per
basic and diluted share, for the same period in 2019.
Revenues: Total revenue was $112.1
million for the fourth quarter of 2020, compared to $4.5 million during the same period of 2019. Total revenue primarily consisted
Research and Development (R&D)
Expenses: R&D expenses were $27.1 million in the fourth quarter of 2020 compared to $29.9 million in the same period
of 2019. The lower R&D expenses in 2020 were principally due to a net decrease in costs associated with clinical trials
and travel and related costs, partially offset by a $2.5 million milestone payment made in connection with the license
agreement with Enteris Biopharma, Inc. (Enteris), increases in payroll and related costs, and increases in stock
compensation expense.
General and Administrative (G&A)
Expenses: G&A expenses were $6.7 million in the fourth quarter of 2020 compared to $4.6 million in the same period of 2019. The