Full Press Release Details
Reports Second Quarter 2020 Financial Results
Conference call today at 4:30 p.m. ET -
Conn., August 10, 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
(KORs), today announced financial results and operational highlights for the second quarter ended June 30, 2020.
the second quarter, we continued to advance our clinical development programs for both KORSUVA Injection and Oral KORSUVA.
Following positive top-line data from our KALM -2 pivotal Phase 3 trial of KORSUVA Injection for chronic kidney disease-associated
pruritus (CKD-aP) in hemodialysis patients, we remain on track to submit our first New Drug Application (NDA) to the U.S. Food
and Drug Administration (FDA) in the fourth quarter," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer
of Cara Therapeutics. "We also successfully completed a planned interim statistical analysis of our KARE Phase 2 dose-ranging
trial of Oral KORSUVA for moderate-to-severe pruritus in atopic dermatitis (AD) patients and expect the trial to be fully enrolled
by the fourth quarter."
Quarter and Recent Developments:
Injection: Chronic Kidney Disease-Associated Pruritus (CKD-aP): Hemodialysis
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 from baseline 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) at week 12. KORSUVA Injection was generally well-tolerated through 12 weeks of treatment
with a safety profile consistent with prior clinical trials.
databases are now closed with more than 1,500 total patient exposures achieved, including more than 700 patients completing at
least six months of treatment and more than 400 patients completing one year of treatment.
remains on track to submit an NDA for KORSUVA Injection to the FDA in the fourth quarter of 2020.
KORSUVA: CKD-aP: Non-Hemodialysis
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 plans to conduct an End of Phase 2 Meeting with the
FDA in the first quarter of 2021. In advance of that meeting, the Company intends to initiate the safety portion of the Phase
3 program in the fourth quarter of 2020.
KORSUVA: Atopic Dermatitis (AD)
June 2020, the Company announced the completion of an interim conditional power assessment of its ongoing KARE Phase 2 dose-ranging
trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in AD patients. The 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.
on the recommendation of the Independent Data Monitoring Committee, the size of the trial was increased from an original enrollment
target of 320 patients to 410 patients, to maintain the prespecified statistical power of 80% or greater on the trial's
primary endpoint of change from baseline in the weekly mean of the daily 24-hour Worst Itching Intensity NRS and key secondary
endpoint of the proportion of patients achieving a four point or greater improvement in Worst Itching Intensity NRS score at week
12. The prespecified interim conditional power assessment was conducted after approximately 50% of the originally targeted patient
number had completed the designated 12-week treatment period. The Company expects the trial to be fully enrolled in the fourth
quarter of 2020 and aims to report top-line results in the first half of 2021, subject to any delays related to the ongoing COVID-19
KORSUVA: Chronic Liver Disease-Associated Pruritus (CLD-aP): Primary Biliary Cholangitis (PBC)
Company is 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 continues to screen patients and aims to have top-line data in the first half of 2021, due in part to delays related
to the ongoing COVID-19 pandemic.
Board of Directors Expansion
2020, the Company expanded its Board of Directors by appointing Susan Shiff, Ph.D., M.B.A., as a new Director. Dr. Shiff currently
serves as Senior Vice President and Head of the Center for Observational and Real-World Evidence at Merck, known as MSD outside
the United States and Canada.
Impacts and Business Operations
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 clinical trials.
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.
expects to make presentations at the following upcoming conferences:
Second Quarter 2020 Financial
Net loss was $25.1 million, or $0.54 per basic and diluted share, for the three months ended June 30, 2020, compared to a
net loss of $23.0 million, or $0.58 per basic and diluted share, for the same period of 2019.
Total revenue was $5.6 million for the three months ended June 30, 2020, compared to $5.2 million during the same period of
2019. Total revenue consisted of:
and Development (R&D) Expenses: R&D expenses were $26.1 million for the three months ended June 30, 2020 compared
to $24.4 million for the three months ended June 30, 2019. The higher R&D expenses in 2020 were primarily due to increases
in stock-based compensation expense, payroll and related costs and cost of clinical compound sales, partially offset by a net
decrease in clinical trial costs, conferences, and travel and related costs.
and Administrative (G&A) Expenses: G&A expenses were $5.4 million for the three months ended June 30, 2020 compared
to $5.0 million for the three months ended June 30, 2019. The increase in 2020 was primarily due to increases in consultants'
costs, legal fees, and insurance costs, partially offset by decreases in stock-based compensation expense.
Income, Net: Other income, net was $634,000 for the three months ended June 30, 2020 compared to $947,000 for the three
months ended June 30, 2019. The decrease in 2020 was due to a decrease in accretion and interest income resulting from a
lower yield on our portfolio of investments in the 2020 period.
and Cash Equivalents and Marketable Securities Position: At June 30, 2020, cash and cash equivalents and marketable securities
totaled $153.0 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 cash used in operations of $66.0 million, partially offset by proceeds of $0.3
million from the exercise of stock options.
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 June 30, 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.
will host a conference call today at 4:30 p.m. ET to discuss second quarter 2020 financial results and provide a business update.
in the conference call, please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 7669087.
A live webcast of the call can be accessed under "Events & Presentations" in the News & Investors section of
the Company's website at www.CaraTherapeutics.com.
webcast recording will be available on the Cara website beginning approximately two hours after the call.
About 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. Cara has successfully completed its Phase 2 trial of Oral KORSUVA for
the treatment of pruritus in patients with CKD and is currently conducting Phase 2 trials of Oral KORSUVA in AD and PBC patients
with moderate-to-severe pruritus.
has conditionally accepted KORSUVA as the trade name for difelikefalin injection. CR845/difelikefalin is an investigational drug
product and its safety and efficacy have not been fully evaluated by any regulatory authority.
Forward-looking Statements
Statements contained in this
press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of