Full Press Release Details
Cara Therapeutics Reports First Quarter
2020 Financial Results
- Conference call today at 4:30
STAMFORD, Conn., May 11, 2020 -
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, or KORs, today announced financial results
and operational highlights for the first quarter ended March 31, 2020.
are very excited by the recent success of our KALM -2
pivotal Phase 3 trial of KORSUVA Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated
pruritus. With no approved therapies in the U.S. or Europe for this significant unmet need, we look forward to submitting our
first New Drug Application (NDA) for KORSUVA Injection in the second half of 2020," said Derek Chalmers, Ph.D., D.Sc., President
and Chief Executive Officer of Cara Therapeutics. "Given the challenges of operating under the current COVID-19 environment,
I'd like to commend our entire team for their hard work and dedication in continuing to advance our clinical development
programs and commercial preparations according to plan."
First Quarter and Recent Developments
KORSUVA Injection: Chronic Kidney Disease-Associated
Pruritus (CKD-aP): Hemodialysis
In April 2020, the Company announced positive
top-line results from its KALM-2 global pivotal Phase 3 trial of KORSUVA Injection in hemodialysis patients with moderate-to-severe
CKD-aP. The trial met the primary endpoint, with a statistically significant proportion of patients on KORSUVA Injection achieving
a three-point or greater improvement in the weekly mean Worst Itching Intensity Numeric Rating Scale (NRS) versus placebo (p=0.02)
at week 12. The trial also met the key secondary endpoint, with a statistically significant proportion of patients on KORSUVA Injection
achieving a four-point or greater improvement from baseline in the weekly mean Worst Itching Intensity NRS versus placebo (p=0.01).
KORSUVA Injection was generally well-tolerated through 12 weeks of treatment with a safety profile consistent with prior clinical
More than 1,500 total patient exposures
have now been achieved, including all ongoing safety trials, with more than 600 patients completing at least six months of treatment
and more than 300 patients completing one year of treatment.
The Company remains on track to submit
an NDA to the U.S. Food and Drug Administration (FDA) for KORSUVA Injection in the second half of 2020.
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 remains on track to conduct an End of Phase 2 Meeting with the FDA to enable initiation
of a Phase 3 program in the second half of 2020.
Oral KORSUVA: Atopic Dermatitis (AD)
the Company expanded its ongoing Phase 2 trial of Oral KORSUVA for the treatment of pruritus in patients with AD from 240 adult
patients to approximately 320 adult patients with moderate-to-severe pruritus. The ongoing Phase 2 trial 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 4-week active extension phase. Study sites remain open, although the rate of enrollment has been affected due to the COVID-19
on track to complete an interim statistical analysis in the second quarter of 2020, after approximately 50% of the targeted number
of patients complete the designated 12-week treatment period. The Company expects to report top-line results from this trial in
2020, subject to any delays related to the COVID-19 pandemic.
Chronic Liver Disease-Associated Pruritus (CLD-aP): Primary Biliary Cholangitis (PBC)
The Company continues
to enroll patients in the ongoing 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 expects top-line results from this trial in 2020, subject to any delays related to the COVID-19 pandemic.
COVID-19 Impacts and Business Operations
Due to the 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 ensure sufficient
supply of KORSUVA and the Company currently believes future supply will be uninterrupted.
Based on guidelines from the Centers for
Disease Control and Prevention and the State of Connecticut, all Cara employees are working remotely and business travel has been
The Company expects to make presentations
at the following upcoming virtual conferences:
First Quarter 2020 Financial Results
Net Loss: Net loss was $28.9 million,
or $0.62 per basic and diluted share for the three months ended March 31, 2020, compared to $22.0 million, or $0.56 per basic and
diluted share, for the same period of 2019.
Revenues: Total revenue was $8.1
million for the three months ended March 31, 2020, compared to $4.4 million during the same period of 2019. Total revenue in 2020
Research and Development (R&D) Expenses:
R&D expenses were $33.5 million for the three months ended March 31, 2020 compared to $23.6 million in the same period
of 2019. The higher R&D expenses in 2020 were primarily due to a net increase in clinical trial costs, increases in stock compensation
expense, payroll and related costs, conferences and travel and related costs.
General and Administrative (G&A)
Expenses: G&A expenses were $4.6 million for the three months ended March 31, 2020 compared to $3.9 million in the same
period of 2019. The increase in 2020 was primarily due to increases in legal and accounting fees, stock compensation expense, insurance
costs, franchise taxes, and payroll and related costs. Those increases were partially offset by a decrease in travel and related
Other Income, net: Other income,
net was $1.0 million for the three months ended March 31, 2020 compared to $1.1 million in the same period of 2019. The decrease
in 2020 was primarily due to a decrease in net accretion income partially offset by an increase in interest income resulting from
a higher average balance of the Company's portfolio of investments as compared to the prior year period.
Cash and Cash Equivalents and Marketable
Securities Position: At March 31, 2020, cash and cash equivalents and marketable securities totaled $179.8 million compared
to $218.2 million at December 31, 2019. The decrease in the balance of cash and cash equivalents and marketable securities primarily
resulted from $38.3 million of cash used in operating activities, partially offset by $0.1 million received from the exercise of
Based on timing expectations and projected
costs for current clinical development plans, Cara expects that its existing cash and cash equivalents and available-for-sale marketable
securities as of March 31, 2020 will be sufficient to fund its currently anticipated operating expenses and capital expenditures
into the second half of 2021, without giving effect to any potential milestone payments under existing collaborations.
Cara management will host a conference
call today at 4:30 p.m. ET to discuss first quarter 2020 financial results and provide a business update.
To participate in the conference call,
please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 3875739. A live webcast of
the call can be accessed under "Events & Presentations" in the News & Investors section of the Company's website
An archived webcast recording will be available
on the Cara website beginning approximately two hours after the call.
About Cara Therapeutics
Cara Therapeutics is a clinical-stage biopharmaceutical company
focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral
KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA (CR845/difelikefalin), a first-in-class
KOR agonist that targets KORs located in the peripheral nervous system and on immune cells. In the Company's KALM-1 and KALM-2
Phase 3 trials and two Phase 2 trials, KORSUVA Injection has demonstrated statistically significant reductions in itch intensity
and concomitant improvement in pruritus-related quality of life measures in hemodialysis patients with moderate-to-severe CKD-aP.
Oral KORSUVA is in Phase 2 trials for the treatment of pruritus in patients with CKD, AD and PBC.
The FDA has conditionally accepted KORSUVA as the trade name