Cara Therapeutics, Inc. (Nasdaq:CARA), a biotechnology company
focused on developing and commercializing new chemical entities
designed to alleviate pruritus and pain by selectively targeting
kappa opioid receptors, today announced financial results for the
fourth quarter and full year ended December 31, 2017.
“We are very pleased with the progress we have
made with both I.V. and oral KORSUVA across our ongoing clinical
programs in pruritus and with CR845/difelikefalin in pain,
including the recent initiation of our first pivotal Phase 3 trial
of I.V. KORSUVA in hemodialysis patients with chronic kidney
disease-associated pruritus (CKD-aP),” said Derek Chalmers, Ph.D.,
D.Sc., President and Chief Executive Officer of Cara
Therapeutics. “In 2018, we expect to continue to expand our
development programs with KORSUVA for the treatment of other
significant unmet pruritus indications, including patients with
chronic kidney disease who are not on dialysis, patients with
chronic liver disease as well as other dermatological
conditions.”
Fourth Quarter and Recent
Developments:
KORSUVA Injection: Chronic Kidney Disease-Associated
Pruritus (CKD-aP): Hemodialysis
- In January 2018, the Company initiated the first pivotal Phase
3 efficacy trial (KALM-1) of KORSUVA (CR845/difelikefalin)
injection in the United States for the treatment of CKD-aP in
patients undergoing hemodialysis. In addition, the Company is also
conducting a 52-week Phase 3 safety study of KORSUVA
(CR845/difelikefalin) injection in patients undergoing hemodialysis
with CKD-aP.
- In October 2017, the Company completed the End-of-Phase 2
Meeting with the U.S. Food and Drug Administration (FDA) and
established the Phase 3 program to support a New Drug Application
(NDA) for KORSUVA injection for the treatment of moderate-to-severe
CKD-aP in hemodialysis patients.
- In November 2017, the Company presented clinical data from the
Phase 2b efficacy trial of KORSUVA injection in hemodialysis
patients with moderate to severe pruritus at the American Society
of Nephrology's Annual Meeting.
Oral KORSUVA: Chronic Kidney Disease-Associated Pruritus
(CKD-aP): Non-Hemodialysis
- In October 2017, the Company announced initiation of the Phase
1 pharmacokinetic (PK) and safety trial of Oral KORSUVA tablets in
patients with stage III-V CKD who are not on dialysis. Data from
the trial will inform the dose selection and design of the planned
Phase 2 trial in non-hemodialysis patients with CKD-aP.
Oral KORSUVA: Chronic Liver Disease-Associated Pruritus
(CLD-aP)
- In February 2018, the Company announced dosing of the first
patient in a Phase 1 PK and safety trial of Oral KORSUVA in
patients with CLD. Data from this trial will inform the design/
doses for the planned Phase 2 trial of Oral KORSUVA in patients
with moderate-to-severe CLD-aP.
I.V. CR845/Difelikefalin: Acute Post-Operative
Pain
- The adaptive Phase 3 trial of I.V. CR845 for the treatment of
acute postoperative pain in patients undergoing abdominal surgery
is nearing enrollment completion. Data from this trial are expected
in the second quarter of 2018.
- In October 2017, the Company presented clinical data on the
respiratory effects of I.V. CR845 at ANESTHESIOLOGY® 2017, the
American Society of Anesthesiologists' annual meeting.
Oral CR845/Difelikefalin: Chronic Pain
- In November 2017, the Company presented data from its Phase 2b
study of Oral CR845 in patients with osteoarthritis of the hip or
knee at the American College of Rheumatology ACR/ARHP Annual
Meeting.
- The Company does not intend to further develop Oral CR845 for
chronic pain on its own and expects to seek partnerships and
collaborations with companies with expertise in chronic pain.
Expected 2018 Milestones
- Completion of enrollment and top-line data from the adaptive
Phase 2/3 trial of I.V. CR845/difelikefalin for the treatment
of acute post-operative pain.
- Initiation of a placebo-controlled Phase 2 trial of Oral
KORSUVA in patients with stage III-V CKD who are not on
dialysis.
- Initiation of an international Phase 3 trial of KORSUVA
injection in hemodialysis patients with CKD-aP.
- Initiation of Phase 2 trial of Oral KORSUVA in patients with
CLD-aP.
Upcoming Activities:
The Company expects to make presentations at the following
medical conferences through May, 2018:
- National Kidney Foundation Spring Clinical Meeting, April
10-14, 2018
- American Academy of Pain Medicine’s Annual Meeting, April
26-29, 2018
- International Investigative Dermatology Meeting, May 16-19,
2018
Fourth Quarter 2017 Financial
Results
Net Loss: The Company reported a net loss of
$14.2 million, or $0.43 per basic and diluted share, for the fourth
quarter of 2017 compared to a net loss of $22.0 million, or $0.81
per basic and diluted share, for the same period of 2016.
Revenues: The Company did not recognize any
revenues during the fourth quarter of 2017 or 2016.
Research and Development (R&D) Expenses:
R&D expenses were $11.6 million in the fourth quarter of 2017
compared to $20.3 million in the same period of 2016. The lower
R&D expenses in the fourth quarter of 2017 were principally due
to a net decrease in direct clinical trial costs, which were
partially offset by an increase in payroll and related costs for
R&D personnel.
General and Administrative (G&A) Expenses:
G&A expenses were $3.0 million in the fourth quarter of 2017
compared to $2.0 million in the same period of 2016. The
increase in the fourth quarter of 2017 was primarily due to
increases in stock-based compensation expense and payroll and
related costs.
Other Income: Other income was $368,000 in the
fourth quarter of 2017 compared to $155,000 in 2016. The increase
in the fourth quarter of 2017 was primarily due to higher dividend
and interest income resulting from higher interest rates on a
higher average balance in the Company’s portfolio of
investments.
Full Year 2017 Financial Results
Net Loss: The Company reported a net loss of
$58.1 million, or $1.86 per basic and diluted share, for 2017
compared to a net loss of $57.3 million, or $2.10 per basic and
diluted share, for 2016.
Revenues: Total revenue in 2017 was $911,000 as
compared to $86,000 in 2016. Total revenue consisted of:
- License and milestone fees revenue of $530,000 in 2017 related
to a sub-license fee received from Maruishi Pharmaceuticals in
connection with its sub-license agreement with Kissei
Pharmaceuticals. No license and milestone fees revenue was
recognized in 2016.
- Collaborative revenue of $313,000 in 2017 related to a
sub-license fee received from Maruishi. No collaborative revenue
was recognized in 2016.
- Clinical compound revenue of $68,000 and $86,000 for 2017 and
2016, respectively, for the sale of clinical compound to Maruishi.
Research and Development (R&D) Expenses:
R&D expenses were $48.5 million in 2017 compared to $49.3
million in 2016. The lower R&D expenses in 2017 were
principally due to a net decrease in direct clinical trial costs
and in rent, which were partially offset by increases in stock
compensation expense and payroll and related costs for R&D
personnel.
General and Administrative (G&A) Expenses:
G&A expenses were $11.9 million in 2017 compared to $9.2
million in 2016. The increase in 2017 was primarily due to
increases in payroll and related costs, stock-based compensation
expense, and public/investor relations costs, which were partially
offset by decreases in rent and amortization.
Other Income: Other income was $1.2 million in
2017 compared to $652,000 in 2016. The increase in 2017 was
primarily due to higher dividend and interest income resulting from
higher interest rates on a higher average balance of the Company’s
portfolio of investments in the 2017 period.
Cash and Cash Equivalents and Marketable
Securities Position: At December 31, 2017, cash and cash
equivalents and marketable securities totaled $92.6 million
compared to $58.3 million at December 31, 2016. The increase in the
balance of cash and cash equivalents and marketable securities
primarily resulted from the net proceeds of $86.2 million from the
Company’s follow-on public offering of common stock in April 2017,
from the proceeds of the exercise of stock options and from
restricted cash that was reclassified to cash and cash equivalents,
partially offset by cash used in operations of $54.8 million.
Financial Guidance
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, 2017 will be sufficient
for the Company to fund its operating expenses and capital
expenditure requirements into the first half of 2019, without
giving effect to any potential milestone payments under existing
collaborations.
Conference Call
Cara management will host a conference call
today at 4:30 p.m. ET to discuss fourth quarter and full year 2017
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 2689187. 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 and pain by selectively targeting
peripheral kappa opioid receptors (KORs). Cara is developing a
novel and proprietary class of product candidates, led by KORSUVATM
(CR845/difelikefalin), a first-in-class KOR agonist that targets
the body's peripheral nervous system, as well as certain immune
cells. In Phase 2 trials, KORSUVA injection has demonstrated
statistically significant reductions in itch intensity and
concomitant improvement in quality of life measures in hemodialysis
patients with moderate-to-severe chronic kidney disease-associated
pruritus (CKD-aP) and is currently being investigated in Phase 3
trials in hemodialysis patients with CKD-aP. Additionally,
CR845/difelikefalin has demonstrated initial signs of efficacy in
patients with moderate-to-severe pain, without inducing many of the
undesirable side effects typically associated with currently
available opioid pain therapeutics.
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 Company’s planned clinical trials, the
potential results of ongoing and planned clinical trials, future
regulatory and development milestones for the Company’s product
candidates and the Company’s expected cash reach. 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
Annual Report on Form 10-K for the year ended December 31, 2017 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. |
STATEMENTS OF OPERATIONS
|
(amounts in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
License and milestone
fees |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
530 |
|
|
$ |
- |
|
|
Collaborative
revenue |
|
|
- |
|
|
|
- |
|
|
|
313 |
|
|
|
- |
|
|
Clinical compound
revenue |
|
|
- |
|
|
|
- |
|
|
|
68 |
|
|
|
86 |
|
Total
revenue |
|
|
- |
|
|
|
- |
|
|
|
911 |
|
|
|
86 |
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
11,576 |
|
|
|
20,277 |
|
|
|
48,524 |
|
|
|
49,253 |
|
|
General and
administrative |
|
|
2,995 |
|
|
|
2,038 |
|
|
|
11,872 |
|
|
|
9,233 |
|
Total
operating expenses |
|
|
14,571 |
|
|
|
22,315 |
|
|
|
60,396 |
|
|
|
58,486 |
|
Operating
loss |
|
|
(14,571 |
) |
|
|
(22,315 |
) |
|
|
(59,485 |
) |
|
|
(58,400 |
) |
|
|
|
|
|
|
|
|
|
|
Other
income |
|
|
368 |
|
|
|
155 |
|
|
|
1,156 |
|
|
|
652 |
|
Loss before
benefit from income taxes |
|
|
(14,203 |
) |
|
|
(22,160 |
) |
|
|
(58,329 |
) |
|
|
(57,748 |
) |
|
|
|
|
|
|
|
|
|
|
Benefit
from income taxes |
|
|
26 |
|
|
|
189 |
|
|
|
204 |
|
|
|
468 |
|
Net
loss |
|
$ |
(14,177 |
) |
|
$ |
(21,971 |
) |
|
$ |
(58,125 |
) |
|
$ |
(57,280 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss
per share : |
|
|
|
|
|
|
|
|
Basic and
Diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.81 |
) |
|
$ |
(1.86 |
) |
|
$ |
(2.10 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted
average shares: |
|
|
|
|
|
|
|
|
Basic and
Diluted |
|
|
32,635,706 |
|
|
|
27,290,548 |
|
|
|
31,202,842 |
|
|
|
27,279,008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
CARA THERAPEUTICS, INC. |
BALANCE SHEETS |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
9,388 |
|
|
$ |
12,092 |
|
|
Marketable
securities |
|
|
83,181 |
|
|
|
46,184 |
|
|
Income tax
receivable |
|
|
731 |
|
|
|
852 |
|
|
Other receivables |
|
|
123 |
|
|
|
87 |
|
|
Prepaid
expenses |
|
|
1,635 |
|
|
|
1,530 |
|
|
Restricted cash,
current |
|
|
- |
|
|
|
700 |
|
Total
current assets |
|
|
95,058 |
|
|
|
61,445 |
|
Property
and equipment, net |
|
|
1,177 |
|
|
|
1,614 |
|
Restricted
cash |
|
|
769 |
|
|
|
769 |
|
Total
assets |
|
$ |
97,004 |
|
|
$ |
63,828 |
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable and
accrued expenses |
|
$ |
8,506 |
|
|
$ |
11,533 |
|
Total
current liabilities |
|
|
8,506 |
|
|
|
11,533 |
|
|
|
|
|
|
|
Deferred
lease obligation |
|
|
1,718 |
|
|
|
1,570 |
|
|
|
|
|
|
|
Commitments
and contingencies |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Preferred stock |
|
|
- |
|
|
|
- |
|
|
Common stock |
|
|
33 |
|
|
|
27 |
|
|
Additional paid-in
capital |
|
|
307,158 |
|
|
|
212,866 |
|
|
Accumulated
deficit |
|
|
(220,341 |
) |
|
|
(162,171 |
) |
|
Accumulated other
comprehensive income (loss) |
|
|
(70 |
) |
|
|
3 |
|
Total
stockholders’ equity |
|
|
86,780 |
|
|
|
50,725 |
|
Total
liabilities and stockholders’ equity |
|
$ |
97,004 |
|
|
$ |
63,828 |
|
|
|
|
|
|
|
INVESTOR CONTACT:Michael Schaffzin Stern
Investor Relations, Inc.212-362-1200 michael@sternir.com
MEDIA CONTACT:Annie Starr6 Degrees973-415-8838
astarr@6degreespr.com
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