Full Press Release Details
Cara Therapeutics Reports Fourth Quarter and Full Year 2015
Conference call today at 4:30 p.m. ET
SHELTON, CONN., March 10, 2016 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 fourth quarter and full year ended December 31, 2015.
2015 was full of important development milestones, as we initiated an adaptive pivotal trial of I.V. CR845 in acute postoperative pain following
abdominal surgery, met the primary endpoint in our Phase 2 study of I.V. CR845 in uremic pruritus, and demonstrated positive Phase 2a data on Oral CR845 in osteoarthritis patients, said Derek Chalmers, Ph.D., D.Sc. President and Chief
Executive Officer of Cara Therapeutics.
We look forward to promptly resolving the IND clinical hold on our CLIN3001 trial in postoperative pain.
Furthermore, we believe our strong balance sheet enables us to continue to execute on all of our planned clinical development activities for I.V. and Oral CR845.
Fourth Quarter and Recent Business Highlights
Expected Upcoming Milestones
Quarter 2015 Financial Results
Net Loss: The Company reported a net loss of $9.5 million, or $0.35 per basic and diluted share, for the fourth
quarter of 2015 compared to a net loss of $4.2 million, or $0.18 per basic and diluted share, for the same period of 2014.
Revenues: The Company
did not recognize any revenues during the fourth quarter of 2015. For the fourth quarter of 2014, collaborative revenue was $399,000, comprising revenue that had been deferred upon entry into the license agreement with Maruishi Pharmaceutical
Company Ltd. and clinical compound revenue was $515,000 from the sale of clinical compound to Maruishi.
Research and Development (R&D) Expenses:
R&D expenses were $7.6 million in the fourth quarter of 2015 compared to $3.5 million in the same period of 2014. The higher R&D expenses in the fourth quarter of 2015 were principally due to a net increase in direct preclinical studies
and clinical trial costs, consultant services in support of preclinical studies and clinical trials, and an increase in payroll and related costs for R&D personnel.
General and Administrative (G&A) Expenses: G&A expenses were $2.2 million in the fourth quarter of 2015 compared to $1.8 million in the same
period of 2014. The increase in the fourth quarter of 2015 was primarily due to increases in payroll and related costs and stock option expense. Those increases in costs were partially offset by decreases in professional and consultant fees.
Full Year 2015 Financial Results
Net Loss: The Company reported a net loss of $24.7 million, or $1.00 per basic and diluted share, for 2015 compared to a net loss of $17.7 million, or
$0.85 per basic and diluted share for 2014.
Revenues: License and milestone fees revenue was $1.7 million for 2015 (representing $1.1 million of
the $1.7 million milestone payment earned in September 2015 under the Maruishi License Agreement, which was attributable to the previously delivered license, and $600,000 from the two milestone payments earned by the Company under the CKD License
Agreement in July and September 2015) compared to $302,000 for 2014 (representing the earned portion of the milestone payment received from Maruishi).
Collaborative revenue was $2.1 million for 2015 (consisting of $600,000 of the $1.7 million milestone payment earned in September 2015 under the Maruishi
License Agreement, which was attributable to the fully delivered R&D services deliverable, and $1.5 million of revenue that had been deferred upon entry into the Maruishi License Agreement) compared to $2.2 million for 2014 (comprising revenue
that had been deferred upon entry into the Maruishi License Agreement).
Clinical compound revenue for 2015 and 2014 was $0 and $674,000, respectively,
from the sale of clinical compound to Maruishi.
Research and Development (R&D) Expenses: R&D expenses were $21.2 million in 2015 compared
to $15.1 million in 2014. The higher R&D expenses in 2015 were principally due to a net increase in direct preclinical studies and clinical trial costs, consultant services in support of preclinical studies and clinical trials, and an increase
in payroll and related costs for R&D personnel.
General and Administrative (G&A) Expenses: G&A expenses were $7.8 million in 2015
compared to $6.2 million in 2014. The increase in 2015 was primarily due to increases in payroll and related costs, mostly due to increases in headcount, public/investor relations costs, insurance costs, professional fees, including legal fees
and accounting and audit fees and stock option expense. Those increases were partially offset by a decrease in consultant fees.
(Expense), net: Other income was $101,000 of interest income and dividends earned on cash and cash equivalents, marketable securities and restricted cash in 2015 compared to $126,000 of interest income in 2014. The decrease from the year ended
December 31, 2014 was due to lower interest rates on a higher average balance in 2015.
Cash and Cash Equivalents and Marketable Securities Position: At December 31, 2015, cash and cash
equivalents and marketable securities totaled $106.7 million, compared to $52.7 million at December 31, 2014. The increase in the balance of cash and cash equivalents and marketable securities resulted from the receipt of net proceeds of $75.2
million from the Company s follow-on offering of common stock which closed in August 2015, cash received from the exercise of stock options of $300,000, partially offset by $21.5 million of cash used in operations.
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, 2015 will be sufficient for the Company to fund its operating
expenses and capital expenditure requirements through the end of the first quarter of 2018, 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 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 56780146. 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 holding of a Type A meeting with the FDA to discuss the IND clinical hold,
the potential removal of the clinical hold and resumption of the CLIN3001 trial, the expected timing of the Company s other 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, 2015 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 December 31, | Year Ended December 31, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Revenue: | ||||||||||||||||
| License and milestone fees | $ | $ | $ | 1,710 | $ | 302 | ||||||||||
| Collaborative revenue | 399 | 2,093 | 2,201 | |||||||||||||
| Clinical compound revenue | 515 | 674 | ||||||||||||||
| Total revenue | 914 | 3,803 | 3,177 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 7,568 | 3,459 | 21,221 | 15,068 | ||||||||||||
| General and administrative | 2,161 | 1,791 | 7,770 | 6,181 | ||||||||||||
| Total operating expenses | 9,729 | 5,250 | 28,991 | 21,249 | ||||||||||||
| Operating loss | (9,729 | ) | (4,336 | ) | (25,188 | ) | (18,072 | ) | ||||||||
| Other income (expense), net | 52 | 22 | 101 | 126 | ||||||||||||
| Loss before benefit from income taxes | (9,677 | ) | (4,314 | ) | (25,087 | ) | (17,946 | ) | ||||||||
| Benefit from income taxes | 147 | 142 | 397 | 201 | ||||||||||||
| Net loss | $ | (9,530 | ) | $ | (4,172 | ) | $ | (24,690 | ) | $ | (17,745 | ) | ||||
| Net loss per share : | ||||||||||||||||
| Basic and Diluted | $ | (0.35 | ) | $ | (0.18 | ) | $ | (1.00 | ) | $ | (0.85 | ) | ||||
| Weighted average shares: | ||||||||||||||||
| Basic and Diluted | 27,240,369 | 22,790,676 | 24,620,372 | 20,965,935 |
CARA THERAPEUTICS, INC.
| December 31, | ||||||||
| 2015 | 2014 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 15,101 | $ | 52,663 | ||||
| Marketable securities | 91,640 | |||||||
| Income tax receivable | 384 | 200 | ||||||
| Interest receivable | 80 | |||||||
| Prepaid expenses | 1,729 | 287 | ||||||
| Total current assets | 108,934 | 53,150 | ||||||
| Property and equipment, net | 1,263 | 2,084 | ||||||
| Restricted cash | 700 | 700 | ||||||
| Total assets | $ | 110,897 | $ | 55,934 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 5,268 | $ | 1,946 | ||||
| Deferred Revenue | 1,452 | |||||||
| Total current liabilities | 5,268 | 3,398 | ||||||
| Deferred lease obligation | 585 | 874 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock | ||||||||
| Common stock | 27 | 23 | ||||||
| Additional paid-in capital | 209,943 | 131,840 | ||||||
| Accumulated deficit | (104,891 | ) | (80,201 | ) | ||||
| Accumulated other comprehensive loss | (35 | ) | ||||||
| Total stockholders equity | 105,044 | 51,662 | ||||||
| Total liabilities and stockholders equity | $ | 110,897 | $ | 55,934 |
Stern Investor Relations, Inc.