Full Press Release Details
Cara Therapeutics Reports First Quarter 2015 Financial Results
- End-of-Phase 2 meeting with FDA informs Phase 3 clinical
development program for novel kappa opioid, I.V. CR845 -
- Conference call today at
SHELTON, CONN., May 12th, 2015 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
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
Expected Upcoming Milestones
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
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.
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
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
Forward-looking 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)
| 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.
| 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 |
Baumgartner, Stern Investor Relations, 212-362-1200
Annie Starr, 6 Degrees PR, 973-415-8838