Full Press Release Details
Cara Therapeutics Reports Fourth Quarter and Full Year 2018
Conference call today at 4:30 p.m. ET
STAMFORD, Conn., March 12, 2019 Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on
developing and commercializing new chemical entities with a primary focus on pruritus as well as pain by selectively targeting peripheral kappa opioid receptors, today announced financial results and operational highlights for the fourth quarter and
full year ended December 31, 2018.
During 2018, we made significant clinical and corporate advancements with our late-stage pruritus programs,
including the initiation of both Phase 3 pivotal trials with KORSUVA Injection for chronic kidney disease-associated pruritus, or CKD-aP, in hemodialysis patients. Additionally, the execution of our
Licensing Agreement with VFMCRP, a joint company of Vifor Pharma Group and Fresenius Medical Care, the world s largest dialysis company, will help provide momentum for the commercial launch of KORSUVA Injection in the U.S. and Europe, if
approved, said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. We anticipate 2019 to be a transformative year for the Company with significant clinical readouts expected from both pivotal Phase 3
trials of KORSUVA Injection, and from our Phase 2 trial of Oral KORSUVA in pre-dialysis patients with CKD-aP. We also expect to broaden our clinical pruritus
program for Oral KORSUVA with the initiation of Phase 2 trials in both liver disease and dermatological conditions, including atopic dermatitis.
2018 & Recent Highlights and Outlook
Injection: Chronic Kidney Disease-Associated Pruritus (CKD-aP): Hemodialysis
Oral KORSUVA: Chronic Kidney
Disease-Associated Pruritus (CKD-aP): Non-Hemodialysis
Oral KORSUVA: Chronic Liver Disease-Associated Pruritus (CLD-aP)
I.V. CR845/Difelikefalin: Acute Post-Operative Setting
Vifor Fresenius Medical Care Renal Pharma Ltd. License Agreement
Expected 2019 Clinical Milestones
Upcoming Meeting Activities
The Company expects to make
presentations at the following upcoming conferences:
Fourth Quarter and Full Year 2018 Financial Results
Cash, cash equivalents and marketable securities at December 31, 2018 totaled $182.8 million compared to $92.6 million at December 31,
2017. The increase in the balance resulted primarily from $92.1 million of net proceeds raised in a follow-on offering of the Company s common stock in July 2018, as well as proceeds of
$70.0 million related to the license agreement with VFMCRP, partially offset by cash used in operations.
For the fourth quarter of 2018, net loss was $20.7 million, or $0.52 per basic and diluted share,
compared to a net loss of $14.2 million, or $0.43 per basic and diluted share, for the same period in 2017.
For the full year ended December 31, 2018, net loss was $74.0 million, or $2.06 per basic and diluted share, compared to a net loss of
$58.1 million, or $1.86 per basic and diluted share, for the year ended 2017.
(1) License and milestone fees revenue of $13.4 million
for the full year ended December 31, 2018 was recognized by the Company related to its license agreement with VFMCRP. The Company recognized license and milestone fees revenue of $530,000 in 2017 related to a
sub-license fee received from Maruishi Pharmaceutical Co. Ltd., or Maruishi, in connection with its sub-license agreement with Kissei Pharmaceutical Co. Ltd.
(2) There was no collaborative revenue recognized for the full year ended December 31, 2018. Collaborative revenue of $313,000 was
recognized for the year ended 2017 related to a sub-license fee received from Maruishi.
Company recognized $33,000 and $68,000 of clinical compound revenue during the full year ended December 31, 2018 and 2017, respectively, in connection with the sale of clinical compound to Maruishi.
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, 2018 will be sufficient to fund its currently anticipated operating expenses and capital expenditures into 2021, 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 2018 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 5381969. 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.
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 biopharmaceutical company focused on developing and commercializing new chemical entities with a primary focus on
pruritus as well as pain by selectively targeting peripheral kappa opioid receptors (KORs). Cara is developing a novel and proprietary class of product candidates, led by KORSUVATM
(CR845/difelikefalin), a first-in-class KOR agonist that targets the body s peripheral nervous system, as well as certain immune cells. In Phase 2 trials,
KORSUVA Injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in pruritus-related quality of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) and is currently being investigated in Phase 3 trials in hemodialysis patients with CKD-aP.
The FDA has conditionally accepted KORSUVA as the trade name for difelikefalin injection.
CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.
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 of the data readouts from the Company s ongoing clinical trials, the expected timing for initiation of the Company s planned clinical trials, the potential results of ongoing and planned clinical trials,
future regulatory and development milestones for the Company s product candidates, the potential for the Company s product candidates to be alternatives in the therapeutic areas investigated, 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, 2018 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.
CARA THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenue: | ||||||||||||||||
| License and milestone fees | $ | 5,533 | $ | $ | 13,436 | $ | 530 | |||||||||
| Collaborative revenue | 313 | |||||||||||||||
| Clinical compound revenue | 33 | 68 | ||||||||||||||
| Total revenue | 5,533 | 13,469 | 911 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 22,799 | 11,576 | 75,531 | 48,524 | ||||||||||||
| General and administrative | 4,711 | 2,995 | 15,320 | 11,872 | ||||||||||||
| Total operating expenses | 27,510 | 14,571 | 90,851 | 60,396 | ||||||||||||
| Operating loss | (21,977 | ) | (14,571 | ) | (77,382 | ) | (59,485 | ) | ||||||||
| Other income | 1,200 | 368 | 2,980 | 1,156 | ||||||||||||
| Loss before benefit from income taxes | (20,777 | ) | (14,203 | ) | (74,402 | ) | (58,329 | ) | ||||||||
| Benefit from income taxes | 125 | 26 | 389 | 204 | ||||||||||||
| Net loss | $ | (20,652 | ) | $ | (14,177 | ) | $ | (74,013 | ) | $ | (58,125 | ) | ||||
| Net loss per share : | ||||||||||||||||
| Basic and Diluted | $ | (0.52 | ) | $ | (0.43 | ) | $ | (2.06 | ) | $ | (1.86 | ) | ||||
| Weighted average shares: | ||||||||||||||||
| Basic and Diluted | 39,441,640 | 32,635,706 | 35,892,786 | 31,202,842 |
CARA THERAPEUTICS, INC.
| December 31, | ||||||||
| 2018 | 2017 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 15,081 | $ | 9,388 | ||||
| Marketable securities | 146,302 | 83,181 | ||||||
| Income tax receivable | 664 | 731 | ||||||
| Other receivables | 926 | 123 | ||||||
| Prepaid expenses | 4,805 | 1,635 | ||||||
| Restricted cash, current | 361 | |||||||
| Total current assets | 168,139 | 95,058 | ||||||
| Marketable securities, non-current | 21,396 | |||||||
| Property and equipment, net | 880 | 1,177 | ||||||
| Restricted cash | 408 | 769 | ||||||
| Total assets | $ | 190,823 | $ | 97,004 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 13,622 | $ | 8,506 | ||||
| Current portion of deferred revenue | 26,825 | |||||||
| Total current liabilities | 40,447 | 8,506 | ||||||
| Deferred revenue, non-current | 15,184 | |||||||
| Deferred lease obligation | 1,562 | 1,718 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock | ||||||||
| Common stock | 39 | 33 | ||||||
| Additional paid-in capital | 428,059 | 307,158 | ||||||
| Accumulated deficit | (294,354 | ) | (220,341 | ) | ||||
| Accumulated other comprehensive loss | (114 | ) | (70 | ) | ||||
| Total stockholders equity | 133,630 | 86,780 | ||||||
| Total liabilities and stockholders equity | $ | 190,823 | $ | 97,004 |
Stern Investor Relations, Inc.