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 first quarter ended March 31,
2021.
“During the first quarter of the year, we were
very pleased with the FDA acceptance, with Priority Review, of our
first NDA filing for our lead product candidate, KORSUVA™
Injection, for the treatment of moderate-to-severe pruritus in
hemodialysis patients. With an expected Prescription Drug User Fee
Act (PDUFA) target action date of August 23, 2021, we remain
focused, along with our commercial partner, Vifor Pharma, on
preparation for the U.S. launch of KORSUVA Injection in the second
half of 2021, if approved,” said Derek Chalmers, Ph.D., D.Sc.,
President and Chief Executive Officer of Cara Therapeutics. “In
addition, we continue to progress our Oral KORSUVA programs across
a number of late-stage trials in patient populations where
effective treatment of pruritus remains a significant unmet need.
Having now generated Phase 2 data in pre-dialysis CKD patients and,
more recently in mild-to-moderate atopic dermatitis patients in our
KARE Phase 2 trial, we hope to initiate Phase 3 programs in both
clinical indications by year-end.”
First 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. Shortly after
this decision, the FDA granted Priority Review for the NDA filing
of KORSUVA Injection in March 2021 with an expected PDUFA target
action date of August 23, 2021. Following these decisions, the
potential approval and U.S. commercial launch of KORSUVA Injection
could take place in the second half of 2021. If approved, KORSUVA
Injection would be the first treatment for CKD-aP in hemodialysis
patients.
In October 2020, the Company entered into a
license agreement with Vifor (International) Ltd. (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,
upon U.S. regulatory approval of KORSUVA Injection, the
Company will be eligible to receive a $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.
In March 2021, the Company and Vifor Fresenius
Medical Care Renal Pharma Ltd. (VFMCRP) announced that the European
Medicines Agency (EMA) accepted to review the Marketing
Authorization Application (MAA) for difelikefalin injection for the
treatment of pruritus associated with chronic kidney disease in
hemodialysis patients. The EMA will review the application under
the centralized marketing authorization procedure. If approved,
difelikefalin would receive marketing authorization in all member
states of the European Union (EU), as well as in Iceland,
Liechtenstein, and Norway. The EMA is expected to render a decision
on the EU MAA in the second quarter of 2022.
Oral KORSUVA: Non-Dialysis Dependent
(NDD) CKD-aP
In April 2021, the Company held an End of Phase
2 Meeting with the FDA to discuss the results of the Phase 2 trial
of Oral KORSUVA in NDD CKD-aP and the potential Phase 3 program.
The FDA indicated the acceptability of Stage 5 pre-dialysis CKD
patients as a viable patient population for a Phase 3 trial. The
FDA also indicated the potential to use data from Cara’s previous
trials of KORSUVA Injection in dialysis patients to support an
approval based on a single Phase 3 clinical trial of Oral KORSUVA
in the Stage 5 pre-dialysis population. The Company currently plans
to initiate its Phase 3 program by year-end 2021. The Company also
intends to continue discussions with the FDA on the potential
inclusion of earlier stage CKD patients in the Phase 3 program.
Oral KORSUVA: Atopic Dermatitis
(AD)
In April 2021, the Company announced top-line
results from its Phase 2 KARE dose-ranging clinical trial of Oral
KORSUVA for the treatment of moderate-to-severe pruritus in
mild-to-severe atopic dermatitis patients. The study did not meet
its primary endpoint of Worst Itch – Numeric Rating Scale (WI-NRS)
change from baseline at week 12 or secondary endpoint of 4-point
responder analysis in the intent to treat (ITT) patient population.
However, in a pre-specified analysis of mild-to-moderate (BSA
<10%) AD patients (64% of ITT patient population), the study met
its primary endpoint of WI-NRS change and secondary endpoint of
4-point responder analysis in this patient population.
Additionally, a statistically significant improvement was
demonstrated in the 4-point responder analysis, which we expect
will be the Phase 3 registrational endpoint, in mild-to-moderate AD
patients, with 32% of KORSUVA-treated patients achieving a greater
than 4-point reduction vs. 19% in placebo group (p=0.03). Oral
KORSUVA was generally well-tolerated across all doses.
The Company intends to request an End of Phase 2
Meeting with the FDA to be held in the second half of 2021 and,
subject to discussions with the FDA, aims to initiate a Phase 3
program by the end of the year.
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 continues to screen
patients in this ongoing Phase 2 trial and aims to have top-line
data in the second half of 2021.
Oral KORSUVA: Notalgia Paresthetica
(NP)
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 back. The Company is
actively enrolling patients in this trial.
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 4-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. The Company 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.
Upcoming Meeting Activities
The Company expects to make presentations at the
following upcoming conferences:
- Bank of America Merrill Lynch
Healthcare Conference, May 10-13, 2021
- Jefferies Healthcare Conference,
June 1-4, 2021
First Quarter 2021 Financial
Results
Cash, cash equivalents and marketable securities
at March 31, 2021 totaled $228.3 million compared to $251.5 million
at December 31, 2020. The decrease in the balance primarily
resulted from cash used in operating activities of $23.7 million,
partially offset by proceeds of $0.7 million from the exercise of
stock options.
For the three months ended March 31, 2021, net
loss was $23.3 million, or $0.47 per basic and diluted share,
compared to a net loss of $28.9 million, or $0.62 per basic and
diluted share, for the same period in 2020.
Revenues: Total revenue was $1.9 million for the
three months ended March 31, 2021, compared to $8.1 million during
the same period of 2020. Total revenue primarily consisted of $1.9
million of license and milestone fees, and collaborative revenue
during the three months ended March 31, 2021, which related to the
milestone payment the Company earned from Maruishi Pharmaceutical
Co. Ltd.’s (Maruishi) first initiation of a Phase 3 trial for
uremic pruritus in Japan under the agreement with Maruishi. The
Company recognized $8.0 million of license and milestone fees
revenue during the three months ended March 31, 2020, which related
to the license fees earned in connection with the agreement with
VFMCRP.
Research and Development (R&D) Expenses:
R&D expenses were $19.1 million for the three months ended
March 31, 2021 compared to $33.5 million in the same period of
2020. The lower R&D expenses in 2021 were principally due to a
net decrease in costs associated with clinical trials and travel
and related costs, partially offset by increases in payroll and
related costs, and increases in stock compensation expense.
General and Administrative (G&A) Expenses:
G&A expenses were $6.4 million for the three months ended March
31, 2021 compared to $4.6 million in the same period of
2020. The higher G&A expenses in 2021 were principally due
to increases in stock compensation expense, payroll and related
costs, commercial costs, insurance costs and information technology
related costs, partially offset by a decrease in consultants’
costs.
Other Income, net: Other income, net was $0.3
million for the three months ended March 31, 2021 compared to $1.0
million in the same period of 2020. The decrease in other income,
net was primarily due to a decrease in interest income resulting
from a lower yield on the Company’s portfolio of investments in the
2021 period.
Financial Guidance
Based on timing expectations and projected costs
for current clinical development plans, Cara expects that its
existing unrestricted cash and cash equivalents and
available-for-sale marketable securities as of March 31, 2021 will
be sufficient to fund its currently anticipated operating expenses
and capital expenditures into 2023, without giving effect to any
potential milestone payments or potential product revenue under
existing collaborations.
Conference Call
Cara management will host a conference call
today at 4:30 p.m. ET to discuss first quarter 2021 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 5789617. A live webcast of the call can
be accessed under "Events and Presentations" in the News &
Investors section of the Company's website at
www.CaraTherapeutics.com.
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 KALMTM-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. The FDA has
accepted and granted Priority Review for the NDA for KORSUVA
(difelikefalin) Injection for the treatment of moderate-to-severe
pruritus in hemodialysis patients. The PDUFA target action date for
KORSUVA is August 23, 2021. Oral KORSUVA has completed Phase 2
trials for the treatment of pruritus in patients with CKD and AD
and is currently in Phase 2 trials in PBC and NP patients with
moderate-to-severe pruritus.
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.
Forward-looking Statements
Statements contained in this press release
regarding matters that are not historical facts are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Examples of these
forward-looking statements include statements concerning the
expected timing of the initiation, enrollment and data readouts
from the Company’s planned and ongoing clinical trials, the
potential results of ongoing clinical trials, timing of future
regulatory and development milestones for the Company’s product
candidates and potential commercialization of KORSUVA Injection for
CKD-aP, the expected timeline for conducting meetings with the FDA
concerning the Company’s product candidates, including Oral KORSUVA
for NDD CKD-aP and AD, the potential for the Company’s product
candidates to be alternatives in the therapeutic areas
investigated, the Company’s expected cash reach, and the potential
impact of COVID-19 on the Company’s clinical development and
regulatory timelines and plans. Because such statements are subject
to risks and uncertainties, actual results may differ materially
from those expressed or implied by such forward-looking
statements. Risks are described more fully in Cara
Therapeutics’ filings with the Securities and Exchange Commission,
including the “Risk Factors” section of the Company’s most recent
Annual Report on Form 10-K and its other documents subsequently
filed with or furnished to the Securities and Exchange
Commission. All forward-looking statements contained in this
press release speak only as of the date on which they were
made. Cara Therapeutics undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made.
Financial tables follow
CARA
THERAPEUTICS, INC. |
|
CONDENSED
STATEMENTS OF OPERATIONS |
|
(amounts in
thousands, except share and per share data) |
|
(unaudited) |
|
|
|
|
Three Months Ended |
|
|
|
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
License and
milestone fees |
|
$
1,192 |
|
$
8,021 |
|
|
Collaborative revenue |
|
706 |
|
- |
|
|
Clinical
compound revenue |
|
37 |
|
72 |
|
Total revenue |
|
1,935 |
|
8,093 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and
development |
|
19,131 |
|
33,536 |
|
|
General and
administrative |
|
6,365 |
|
4,558 |
|
Total operating expenses |
|
25,496 |
|
38,094 |
|
Operating loss |
|
(23,561) |
|
(30,001) |
|
|
|
|
|
|
|
|
Other income, net |
|
260 |
|
957 |
|
Loss before benefit from income taxes |
|
(23,301) |
|
(29,044) |
|
|
|
|
|
|
|
|
Benefit from income taxes |
|
- |
|
122 |
|
Net Loss |
|
$ (23,301) |
|
$ (28,922) |
|
|
|
|
|
|
|
|
Net Loss per share: |
|
|
|
|
|
Basic and diluted |
|
$
(0.47) |
|
$
(0.62) |
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
Basic and diluted |
|
49,917,990 |
|
46,724,951 |
|
|
|
|
|
|
|
|
CARA
THERAPEUTICS, INC. |
CONDENSED
BALANCE SHEETS |
(in thousands) |
(unaudited) |
|
|
|
|
|
March
31, |
|
December
31, |
|
2021 |
|
2020 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
22,519 |
|
|
$ |
31,683 |
|
Marketable securities |
|
149,063 |
|
|
|
149,242 |
|
Income tax receivable |
|
1,507 |
|
|
|
1,507 |
|
Other receivables |
|
2,244 |
|
|
|
557 |
|
Prepaid expenses |
|
13,018 |
|
|
|
12,076 |
|
Total current assets |
|
188,351 |
|
|
|
195,065 |
|
Operating lease right-of-use assets |
|
3,963 |
|
|
|
4,279 |
|
Marketable securities, non-current |
|
56,728 |
|
|
|
70,565 |
|
Property and equipment, net |
|
778 |
|
|
|
840 |
|
Restricted cash |
|
408 |
|
|
|
408 |
|
Total assets |
$ |
250,228 |
|
|
$ |
271,157 |
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
14,880 |
|
|
$ |
16,881 |
|
Operating lease liabilities, current |
|
1,639 |
|
|
|
1,602 |
|
Total current liabilities |
|
16,519 |
|
|
|
18,483 |
|
|
|
|
|
Operating lease liabilities, non-current |
|
3,250 |
|
|
|
3,673 |
|
|
|
|
|
Commitments
and contingencies |
|
- |
|
|
|
- |
|
|
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock |
|
- |
|
|
|
- |
|
Common stock |
|
50 |
|
|
|
50 |
|
Additional paid-in capital |
|
646,015 |
|
|
|
641,195 |
|
Accumulated deficit |
|
(415,618 |
) |
|
|
(392,317 |
) |
Accumulated other comprehensive income |
|
12 |
|
|
|
73 |
|
Total
stockholders’ equity |
|
230,459 |
|
|
|
249,001 |
|
Total
liabilities and stockholders’ equity |
$ |
250,228 |
|
|
$ |
271,157 |
|
|
|
|
|
INVESTOR CONTACT:Janhavi MohiteStern Investor
Relations, Inc.212-362-1200 Janhavi.Mohite@sternir.com
MEDIA CONTACT:Claire LaCagnina6
Degrees315-765-1462 clacagnina@6degreespr.com
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