Full Press Release Details
Reports Fourth Quarter and Full Year 2019 Financial Results
- Conference call today at 4:30
STAMFORD, Conn., February 27, 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 fourth quarter and full year ended December 31, 2019.
"During 2019, we reported
significant advancements in both our KORSUVA Injection and Oral KORSUVA late-stage clinical pruritus programs,
including positive results from our first pivotal Phase 3 efficacy trial (KALM -1) of KORSUVA Injection for the
treatment of chronic kidney disease-associated pruritus in patients undergoing hemodialysis and our Phase 2 trial of Oral
KORSUVA in pre-dialysis patients. Additionally, we broadened our clinical pruritus program for Oral KORSUVA with the
initiation of Phase 2 trials in both atopic dermatitis and liver disease patients," said Derek Chalmers, Ph.D., D.Sc.,
President and Chief Executive Officer of Cara Therapeutics. "We expect 2020 to be an exciting year as our KALM-2
pivotal Phase 3 trial advances to top-line data in the second quarter and we aim to file our first NDA for KORSUVA Injection
in the second half of the year."
Fourth Quarter and Recent Developments:
KORSUVA Injection: Chronic Kidney Disease-Associated
Pruritus (CKD-aP): Hemodialysis
The Company expects top-line data for its
pivotal KALM-2 Phase 3 global trial of KORSUVA Injection in the second quarter of 2020 and remains on track to file a New Drug
Application, or NDA, to the U.S. Food and Drug Administration, or FDA, for KORSUVA Injection in the second half of 2020.
In October 2019, the Company announced
the completion of an interim statistical assessment for its pivotal KALM-2 Phase 3 global trial of KORSUVA Injection. Based on
the recommendation of the Independent Data Monitoring Committee, the size of the trial was increased from an original enrollment
target of 350 patients to 430 patients.
Currently, more than 1,500 total patient
exposures have 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.
In November 2019, the Company announced
a publication in the New England Journal of Medicine of full results from the KALM-1 Phase 3 trial of KORSUVA Injection
in patients undergoing hemodialysis with moderate-to-severe CKD-aP.
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. Oral KORSUVA met the primary endpoint with a statistically significant reduction in the weekly
mean of the daily 24-hour worst itching intensity Numeric Rating Scale with the 1.0 mg tablet strength versus placebo after the
12-week treatment period (p=0.018). Oral KORSUVA was generally well-tolerated with a safety profile consistent with that seen in
previous KORSUVA clinical trials. The Company aims to complete an End of Phase 2 Meeting with the FDA to enable initiation of a
Phase 3 program of Oral KORSUVA in non-hemodialysis CKD-aP patients in the second half of 2020.
Oral KORSUVA: Atopic Dermatitis (AD)
In January 2020, 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 AD patients with moderate-to-severe pruritus. The 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. An interim statistical analysis will be conducted after approximately 50% of the targeted number of patients complete the
designated 12-week treatment period, which is expected in the second quarter of 2020. The Company aims to report top-line data
from this trial in 2020.
Oral KORSUVA: 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 KOSRUVA (1.0 mg tablet, twice daily) versus placebo for 16 weeks. The Company
aims to report top-line data from this trial in 2020.
Expected 2020 Milestones
Upcoming Meeting Activities
The Company expects to make presentations
at the following upcoming conferences:
Fourth Quarter and Full Year 2019 Financial
Cash, cash equivalents and marketable securities
at December 31, 2019 totaled $218.2 million compared to $182.8 million at December 31, 2018. The increase in the balance resulted
primarily from $136.5 million of cash raised in a follow-on offering of the Company's common stock in July 2019 and $6.1
million received from the exercise of stock options, partially offset by $109.2 million of cash used in operating activities.
For the fourth quarter of 2019, net loss
was $28.6 million, or $0.61 per basic and diluted share, compared to a net loss of $20.7 million, or $0.52 per basic and diluted
share, for the same period in 2018.
For the full year ended December 31, 2019,
net loss was $106.4 million, or $2.49 per basic and diluted share compared to a net loss of $74.0 million, or $2.06 per basic and
diluted share, for the full year ended December 31, 2018.
(1) License and milestone fees
revenue of $19.7 million and $13.4 million for the full year ended December 31, 2019 and 2018, respectively, was recognized by
the Company related to its license agreement with VFMCRP.
(2) There was no collaborative
revenue recognized for the full year ended December 31, 2019 or 2018.
(3) The Company recognized $140,000
and $33,000 of revenue from the sales of clinical compound during the full year ended December 31, 2019 and 2018, respectively,
in connection with the sale of clinical compound to Maruishi Pharmaceuticals Co. Ltd.
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 December 31, 2019 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 fourth quarter and full year 2019 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 9907568. A live webcast of
the call can be accessed under "Events and 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 Phase 3 trial and two Phase 2 trials, KORSUVA (CR845/difelikefalin) 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 and is currently being investigated in Phase 3
trials in hemodialysis patients with CKD-aP. Oral KORSUVA is in Phase 2 trials for the treatment of pruritus in patients with
The FDA 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.