Full Press Release Details
Cara Therapeutics Reports First Quarter 2016 Financial Results
Conference call today at 4:30 p.m. ET
SHELTON, CONN., May 5, 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 first quarter ended March 31, 2016.
We look forward to reinitiating our adaptive pivotal trial of I.V. CR845 for postoperative pain this month, said Derek Chalmers, Ph.D., D.Sc.,
President and Chief Executive Officer of Cara Therapeutics. We also remain on track to initiate our registration program for I.V. CR845 in hemodialysis patients suffering from uremic pruritus during the second quarter of 2016, and a
Phase 2b trial of Oral CR845 in chronic pain in the second half of 2016. This will significantly expand our later-stage pipeline in indications in which we have already seen positive proof-of-concept data.
First Quarter and Recent Business Highlights
Expected Upcoming Milestones
First Quarter 2016 Financial Results
Net Loss: The Company reported a net loss of $10.7 million, or $0.39 per basic and diluted share, for the first quarter of 2016 compared to a net loss
of $4.7 million, or $0.21 per basic and diluted share, for the same period of 2015.
Revenues: The Company recognized $7,000 of clinical compound
revenue during the first quarter of 2016 from the sale of clinical compound to Maruishi Pharmaceutical Company Ltd. ( Maruishi ). For the first quarter of 2015, collaborative revenue was $489,000, comprising revenue that had been deferred
upon entry into the license agreement with Maruishi.
Research and Development (R&D) Expenses: R&D expenses were $8.5 million in the first
quarter of 2016 compared to $3.4 million in the same period of 2015. The higher R&D expenses in the first 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 our Shelton, Connecticut facility prior to the relocation of our
corporate headquarters to Stamford, Connecticut and increased rent.
General and Administrative (G&A) Expenses: G&A expenses were $2.4 million in the first quarter of
2016 compared to $1.8 million in the same period of 2015. The increase in the first quarter of 2016 was primarily due to increases in payroll and related costs, in investor relation costs and in professional and consultant fees, in franchise
taxes and in rent and the acceleration of amortization of the leasehold improvements as noted above.
Other Income (Expense), net: Other income was
$149,000 of interest income and dividends earned on cash and cash equivalents and marketable securities during the first quarter of 2016 compared to $14,000 of interest income during the same period in 2015. The increase in the first quarter ended
March 31, 2016 was primarily due to an increase in interest income and dividends earned on a more diverse portfolio of investments in 2016, including marketable securities, 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 our follow-on offering of common stock, which closed in August 2015.
and Cash Equivalents and Marketable Securities Position: As of March 31, 2016, cash and cash equivalents and marketable securities totaled $96.2 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 $9.8 million of cash used in operations and $0.8 million of cash that was restricted to serve as collateral for the letter of credit issued to the landlord of our
Stamford, Connecticut lease.
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 March 31, 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 first 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 1233026. 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
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 timing of the resumption of the CLIN3001 trial, the expected timing and trial designs of the Company s other
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.
STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2016 | 2015 | |||||||
| Revenue: | ||||||||
| Collaborative revenue | $ | $ | 489 | |||||
| Clinical compound revenue | 7 | |||||||
| Total revenue | 7 | 489 | ||||||
| Operating expenses: | ||||||||
| Research and development | 8,546 | 3,385 | ||||||
| General and administrative | 2,447 | 1,822 | ||||||
| Total operating expenses | 10,993 | 5,207 | ||||||
| Operating loss | (10,986 | ) | (4,718 | ) | ||||
| Interest income | 149 | 14 | ||||||
| Loss before benefit from income taxes | (10,837 | ) | (4,704 | ) | ||||
| Benefit from income taxes | 145 | 15 | ||||||
| Net loss | $ | (10,692 | ) | $ | (4,689 | ) | ||
| Loss per share: | ||||||||
| Basic and Diluted | $ | (0.39 | ) | $ | (0.21 | ) | ||
| Weighted average shares: | ||||||||
| Basic and Diluted | 27,259,589 | 22,808,479 |
CARA THERAPEUTICS, INC.
| March 31, 2016 | December 31, 2015 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 7,922 | $ | 15,101 | ||||
| Marketable securities | 88,322 | 91,640 | ||||||
| Income tax receivable | 529 | 384 | ||||||
| Other receivables | 128 | 80 | ||||||
| Prepaid expenses | 2,573 | 1,729 | ||||||
| Total current assets | 99,474 | 108,934 | ||||||
| Property and equipment, net | 1,070 | 1,263 | ||||||
| Restricted cash | 1,469 | 700 | ||||||
| Total assets | $ | 102,013 | $ | 110,897 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 6,089 | $ | 5,268 | ||||
| Total current liabilities | 6,089 | 5,268 | ||||||
| Deferred lease obligation | 997 | 585 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock | ||||||||
| Common stock | 27 | 27 | ||||||
| Additional paid-in capital | 210,479 | 209,943 | ||||||
| Accumulated deficit | (115,583 | ) | (104,891 | ) | ||||
| Accumulated other comprehensive income (loss) | 4 | (35 | ) | |||||
| Total stockholders equity | 94,927 | 105,044 | ||||||
| Total liabilities and stockholders equity | $ | 102,013 | $ | 110,897 |
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