– End-of-Phase 2 Meeting With FDA Informs Phase 3
Clinical Development Program for Novel Kappa Opioid I.V. CR845
–
– Conference Call Today at 4:30 p.m.
ET –
Cara Therapeutics, Inc. (Nasdaq:CARA), a biotechnology company
focused on developing and commercializing new chemical entities
designed to alleviate pain and pruritus by selectively targeting
kappa opioid receptors, today announced financial results for the
first quarter ended March 31, 2015 and provided an update on its
Phase 3 Program for I.V. CR845.
"The first half of 2015 continues to be an important period for
the Company as we work to finalize and initiate our Phase 3 Program
for I.V. CR845, which offers the potential for post-operative pain
relief without typical opioid side effects," said Derek Chalmers,
Ph.D., D.Sc., President and Chief Executive Officer of Cara
Therapeutics.
End-of-Phase 2 Meeting Overview
- Based on discussions with the U.S. Food and Drug Administration
(FDA), the Company currently anticipates the first trial of its
I.V. CR845 Phase 3 Program to be a pivotal adaptive trial designed
to meet FDA criteria for an adequate and well-controlled
clinical trial. The trial will evaluate several doses of I.V.
CR845, administered both pre- and post-operatively, in patients
undergoing abdominal laparoscopic surgery, including laparoscopic
hysterectomy. Cara expects to initiate the trial in the third
quarter of 2015, with completion expected in 2016.
- The FDA provided guidance on optimum methodology to assess the
impact of I.V. CR845 on postoperative nausea and vomiting.
- The FDA advised the Company that its non-clinical and
toxicology packages appear adequate for NDA submission; CMC
strategy deemed supportive of NDA submission.
"We look forward to initiating the first trial of our I.V. CR845
Phase 3 Program," said Dr. Chalmers. "Based on discussions at our
End-of-Phase 2 meeting, we believe that our currently proposed
trials will better position I.V. CR845 for the strongest possible
regulatory submission. We were also encouraged by FDA guidance on
our non-clinical and toxicology packages and current CMC
strategy."
"During the first quarter of 2015, we also continued to execute
on our Phase 2 proof-of-concept study in uremic pruritus and expect
to report top-line data from the trial in the second quarter of
2015," added Dr. Chalmers. "Additionally, we have finalized the
Phase 2 protocol for the oral formulation of CR845 and expect to
initiate that trial in the third quarter of 2015, with top-line
data expected by year-end 2015."
First Quarter and Recent Business/Corporate
Highlights
- Held End-of-Phase 2 meeting with the FDA.
- Presented data from human abuse liability study of I.V. CR845
in oral session at the 3rd Conference on the Therapeutic
Potential of Kappa Opioids.
- Hired Heads of Clinical Development and Clinical
Operations.
Expected Upcoming Milestones
- Initiate I.V. CR845 Phase 3 Program in 3Q'15 with pivotal
adaptive trial in laparoscopic abdominal surgery, with two
additional Phase 3 trials in laparoscopic hysterectomy and
bunionectomy to begin in 1H'16.
- Report top-line efficacy data from the Phase 2 trial of I.V.
CR845 in uremic pruritus in 2Q'15.
- Initiate Phase 2 trial for Oral CR845 in OA (osteoarthritis)
patients in 3Q'15.
- Report top-line data from Phase 2 trial of Oral CR845 by the
end of 2015.
First Quarter 2015 Financial Results
Net Loss: Net loss was $4.7 million, or $0.21 per basic and
diluted share, for the first quarter of 2015, compared to net loss
of $3.4 million, or $0.22 per basic and diluted share for the same
period of 2014.
Revenues: Collaborative revenue was $489,000 for the first
quarter of 2015, compared to $151,000 for the same period of 2014,
comprising revenue that had been deferred upon entry into the
license agreement with Maruishi Pharmaceutical Company Ltd.
(Maruishi). Clinical compound revenue was $0 for the first quarter
of 2015 compared to $27,000 for the same period of 2014, from the
sale of clinical compound to Maruishi.
Research and Development (R&D) Expenses: R&D expenses
were $3.4 million in the first quarter of 2015, compared to $2.2
million for the same period of 2014. The higher R&D expenses in
the first quarter of 2015 were principally due to a net increase in
direct preclinical studies and clinical trial costs, an increase in
consultant services in support of preclinical studies and clinical
trials, and increases in payroll, recruiting and related costs,
including stock option expense, associated with R&D
personnel.
General and Administrative (G&A) Expenses: G&A expenses
were $1.8 million in the first quarter of 2015, compared to $1.4
million in the same period of 2014. The increase in the first
quarter of 2015 was primarily due to increases in professional
fees, public/investor relations costs, payroll and related costs,
mostly due to increases in headcount, and directors' and officers'
insurance costs.
Interest Income: Interest income was $14,000 for the first
quarter of 2015, compared to $22,000 for the same period of
2014.
Cash Position: At March 31, 2015, cash and cash equivalents were
$47.4 million, compared to $52.7 million at December 31,
2014. The decrease was principally related to cash and cash
equivalents used in operating activities during the first quarter
of 2015.
Conference Call
Cara management will host a conference call today at 4:30 p.m.
ET to discuss first quarter 2015 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 41947428. 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 biotechnology company
focused on developing and commercializing new chemical entities
designed to alleviate pain and pruritus by selectively targeting
kappa opioid receptors. Cara is developing a novel and proprietary
class of product candidates that target the body's peripheral
nervous system and have demonstrated efficacy in patients with
moderate-to-severe pain without inducing many of the undesirable
side effects typically associated with currently available pain
therapeutics.
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 for the Company's
clinical trials and the reporting of clinical trial results, the
acceptability to the FDA of the Company's proposed Phase 3 Program
for I.V. CR845, the potential results of ongoing and planned
clinical trials and future regulatory and development milestones
for the Company's product candidates, and the potential for CR845
to provide a new therapeutic approach to treating uremic pruritus.
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, 2014 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 March 31, |
|
2015 |
2014 |
|
|
|
Revenue: |
|
|
Collaborative revenue |
$ 489 |
$ 151 |
Clinical compound revenue |
-- |
27 |
Total revenue |
489 |
178 |
|
|
|
Operating expenses: |
|
|
Research and development |
3,385 |
2,201 |
General and administrative |
1,822 |
1,398 |
Total operating expenses |
5,207 |
3,599 |
Operating loss |
(4,718) |
(3,421) |
|
|
|
Interest income |
14 |
22 |
Loss before benefit from income taxes |
(4,704) |
(3,399) |
|
|
|
Benefit from income taxes |
15 |
16 |
Net loss |
$ (4,689) |
$ (3,383) |
|
|
|
Loss per share: |
|
|
Basic and Diluted |
$ (0.21) |
$ (0.22) |
|
|
|
Weighted average shares: |
|
|
Basic and Diluted |
22,808,479 |
15,654,079 |
|
|
CARA THERAPEUTICS,
INC. |
BALANCE
SHEETS |
(in thousands) |
(unaudited) |
|
|
|
|
March 31, 2015 |
December 31,
2014 |
|
|
|
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ 47,422 |
$ 52,663 |
Income tax receivable |
215 |
200 |
Prepaid expenses |
1,420 |
287 |
Total current assets |
49,057 |
53,150 |
Property and equipment, net |
1,897 |
2,084 |
Restricted cash |
700 |
700 |
Total assets |
$ 51,654 |
$ 55,934 |
|
|
|
Liabilities and stockholders'
equity |
|
|
Current liabilities: |
|
|
Accounts payable and accrued
expenses |
$ 2,464 |
$ 1,946 |
Deferred Revenue |
963 |
1,452 |
Total current liabilities |
3,427 |
3,398 |
|
|
|
Deferred lease obligation |
803 |
874 |
|
|
|
Commitments and contingencies |
|
|
|
|
|
Stockholders' equity: |
|
|
Preferred stock |
-- |
-- |
Common stock |
23 |
23 |
Additional paid-in capital |
132,291 |
131,840 |
Accumulated deficit |
(84,890) |
(80,201) |
Total stockholders' equity |
47,424 |
51,662 |
Total liabilities and stockholders'
equity |
$ 51,654 |
$ 55,934 |
CONTACT: INVESTOR CONTACT:
Jesse Baumgartner
Stern Investor Relations, Inc.
212-362-1200
Jesse@sternir.com
MEDIA CONTACT:
Annie Starr
6 Degrees
973-415-8838
astarr@6degreespr.com
Cara Therapeutics (NASDAQ:CARA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Cara Therapeutics (NASDAQ:CARA)
Historical Stock Chart
From Jul 2023 to Jul 2024