Full Press Release Details
Cara Therapeutics Reports Second Quarter 2016 Financial Results
Conference call today at 4:30 p.m. ET
STAMFORD, CONN., August 4, 2016 Cara Therapeutics, Inc. (NASDAQ: CARA), a clinical-stage biotechnology company focused on developing and
commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors, today announced financial results for the second quarter ended June 30, 2016.
This quarter we were pleased to resume enrollment in the adaptive pivotal trial of I.V. CR845 for postoperative pain, as well as initiate our adaptive
Phase 2/3 trial in dialysis patients suffering from moderate-to-severe uremic pruritus, said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. With both studies enrolling on schedule and our Phase
2b trial of Oral CR845 in osteoarthritis expected to begin in the third quarter of this year, Cara will soon have three ongoing late-stage studies addressing distinct clinical populations.
Second Quarter and Recent Business Highlights
Expected Upcoming Milestones
Second Quarter 2016 Financial Results
Net Loss: The Company reported a net loss of $13.1 million, or $0.48 per basic and diluted share, for the second quarter of 2016 compared to a net loss
of $5.7 million, or $0.25 per basic and diluted share, for the same period of 2015.
Revenues: The Company recognized $79,000 of clinical compound
revenue during the second quarter of 2016 from the sale of clinical compound to Maruishi Pharmaceutical Company Ltd. ( Maruishi ). For the second quarter of 2015, collaborative revenue was $874,000, comprising revenue that had been
deferred upon entry into the license agreement with Maruishi.
Research and Development (R&D) Expenses: R&D expenses were $10.8 million in
the second quarter of 2016 compared to $4.7 million in the same period of 2015. The higher R&D expenses in the second quarter of 2016 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, an increase in payroll and related costs for R&D personnel, the acceleration of amortization of the leasehold improvements at the Company s Shelton, Connecticut facility prior
to the relocation of the Company s corporate headquarters to Stamford, Connecticut in May 2016 and increased rent, including rent expense for the Stamford lease for the second quarter of 2016 and the remaining rent payments due for the Shelton
lease through its term.
General and Administrative (G&A) Expenses: G&A expenses were $2.6 million in the second quarter of
2016 compared to $1.9 million in the same period of 2015. The increase in the second quarter of 2016 was primarily due to increases in payroll and related costs, in franchise taxes and in rent and the acceleration of amortization of the
leasehold improvements, as noted above.
Other Income: Other income was $172,000 of interest income and dividends earned on cash and cash
equivalents and marketable securities during the second quarter of 2016 compared to $13,000 of interest income during the same period in 2015. The increase in the second quarter ended June 30, 2016 was primarily due to our investments in marketable
securities in the 2016 period but not in the 2015 period, as well as higher interest rates on a higher average balance of cash and cash equivalents and marketable securities in 2016 as a result of the Company s follow-on offering of common
stock, which closed in August 2015.
Cash and Cash Equivalents and Marketable Securities Position: As of June 30, 2016, cash and cash equivalents and
marketable securities totaled $84.8 million compared to $106.7 million at December 31, 2015. The decrease in the balance of cash and cash equivalents and marketable securities primarily resulted from $21.3 million of cash used in operating
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 June 30, 2016 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 its second quarter 2016 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 50082596. 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
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 peripheral 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 initial 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 and trial designs of the Company s planned clinical trials, the potential results of ongoing and planned clinical trials, future 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.
CONDENSED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenue: | ||||||||||||||||
| Collaborative revenue | $ | $ | 874 | $ | $ | 1,363 | ||||||||||
| Clinical compound revenue | 79 | 86 | ||||||||||||||
| Total revenue | 79 | 874 | 86 | 1,363 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 10,760 | 4,684 | 19,305 | 8,069 | ||||||||||||
| General and administrative | 2,645 | 1,922 | 5,092 | 3,744 | ||||||||||||
| Total operating expenses | 13,405 | 6,606 | 24,397 | 11,813 | ||||||||||||
| Operating loss | (13,326 | ) | (5,732 | ) | (24,311 | ) | (10,450 | ) | ||||||||
| Interest income | 172 | 13 | 321 | 27 | ||||||||||||
| Loss before benefit from income taxes | (13,154 | ) | (5,719 | ) | (23,990 | ) | (10,423 | ) | ||||||||
| Benefit from income taxes | 79 | 35 | 224 | 50 | ||||||||||||
| Net loss | $ | (13,075 | ) | $ | (5,684 | ) | $ | (23,766 | ) | $ | (10,373 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and Diluted | $ | (0.48 | ) | $ | (0.25 | ) | $ | (0.87 | ) | $ | (0.45 | ) | ||||
| Weighted average shares: | ||||||||||||||||
| Basic and Diluted | 27,282,863 | 22,828,612 | 27,271,226 | 22,818,601 |
CARA THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
| June 30, 2016 | December 31, 2015 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,545 | $ | 15,101 | ||||
| Marketable securities | 81,219 | 91,640 | ||||||
| Income tax receivable | 608 | 384 | ||||||
| Other receivables | 373 | 80 | ||||||
| Prepaid expenses | 3,398 | 1,729 | ||||||
| Total current assets | 89,143 | 108,934 | ||||||
| Property and equipment, net | 1,433 | 1,263 | ||||||
| Restricted cash | 1,469 | 700 | ||||||
| Total assets | $ | 92,045 | $ | 110,897 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 8,168 | $ | 5,268 | ||||
| Total current liabilities | 8,168 | 5,268 | ||||||
| Deferred lease obligation | 1,289 | 585 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock | ||||||||
| Common stock | 27 | 27 | ||||||
| Additional paid-in capital | 211,177 | 209,943 | ||||||
| Accumulated deficit | (128,657 | ) | (104,891 | ) | ||||
| Accumulated other comprehensive income (loss) | 41 | (35 | ) | |||||
| Total stockholders equity | 82,588 | 105,044 | ||||||
| Total liabilities and stockholders equity | $ | 92,045 | $ | 110,897 |
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