Loading, Please Wait...
STAMFORD, Conn., March 12, 2019 (GLOBE NEWSWIRE) -- 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
KORSUVA 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.
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.
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 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.
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.
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,|
|License and milestone fees||$||5,533||$||-||$||13,436||$||530|
|Clinical compound revenue||-||-||33||68|
|Research and development||22,799||11,576||75,531||48,524|
|General and administrative||4,711||2,995||15,320||11,872|
|Total operating expenses||27,510||14,571||90,851||60,396|
|Loss before benefit from income taxes||(20,777||)||(14,203||)||(74,402||)||(58,329||)|
|Benefit from income taxes||125||26||389||204|
|Net loss per share :|
|Basic and Diluted||$||(0.52||)||$||(0.43||)||$||(2.06||)||$||(1.86||)|
|Weighted average shares:|
|Basic and Diluted||39,441,640||32,635,706||35,892,786||31,202,842|
|CARA THERAPEUTICS, INC.|
|Cash and cash equivalents||$||15,081||$||9,388|
|Income tax receivable||664||731|
|Restricted cash, current||361||-|
|Total current assets||168,139||95,058|
|Marketable securities, non-current||21,396||-|
|Property and equipment, net||880||1,177|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||13,622||$||8,506|
|Current portion of deferred revenue||26,825||-|
|Total current liabilities||40,447||8,506|
|Deferred revenue, non-current||15,184||-|
|Deferred lease obligation||1,562||1,718|
|Commitments and contingencies|
|Additional paid-in capital||428,059||307,158|
|Accumulated other comprehensive loss||(114||)||(70||)|
|Total stockholders’ equity||133,630||86,780|
|Total liabilities and stockholders’ equity||$||190,823||$||97,004|
Stern Investor Relations, Inc.