- Reported statistically significant positive top-line results from Part A of Phase 2/3 trial for I.V. CR845 in chronic kidney disease (CKD)-associated pruritus -
- Completed public offering of common stock, raising net proceeds of
- Conference call today at
"During the quarter, we were pleased to announce positive data from Part A of our Phase 2/3 trial of I.V CR845 in CKD-associated
pruritus, where we observed sustained clinical benefit over the entire two-month treatment period, supporting the potential viability of I.V CR845 as a long-term therapeutic approach for this unmet medical need," said
First Quarter and Recent Business Highlights
March 2017, announced positive top-line data from Part A of Phase 2/3 trial of I.V. CR845 in chronic kidney disease (CKD)-associated pruritus, demonstrating improved symptoms and quality of life in 174 patients.
- Met primary endpoint with 68 percent reduction in worst itching scores versus placebo after eight-week treatment period (p < 0.0019)
- Met secondary endpoint with 100 percent improvement in quality of life domains versus placebo after eight-week treatment period (p < 0.0007)
April 2017, Cara completed a public offering of 5,117,500 shares of its common stock, including full exercise of the underwriters' option to purchase additional shares at $18.00per share, raising approximately $86.5 millionin net proceeds after deducting underwriting discounts and commissions, but before deducting estimated offering expenses payable by the Company.
April 2017, reported positive results from a Phase 1 safety trial observing that I.V. CR845 did not significantly differ from placebo across three quantitative measures of respiratory drive in healthy individuals.
Expected Upcoming Milestones
- Top-line data expected in the second quarter of 2017 from the Phase 2b trial of Oral CR845, for the treatment of chronic pain associated with osteoarthritis.
- Interim conditional power analysis expected in the second quarter of 2017 from CLIN-3001, the Company's 450-patient adaptive Phase 3 trial of I.V. CR845 in postoperative pain.
- Data expected in the second quarter of 2017 from a pharmacokinetic safety trial of multiple doses of Oral CR845 in hemodialysis patients to define bioequivalent tablet strengths to inform the ability to develop an oral tablet formulation for moderate-to-severe uremic pruritus.
- Initiation of an open-label 52-week safety study of I.V. CR845 in hemodialysis patients as part of the pivotal program in CKD-associated pruritus in the second quarter of 2017.
- Request an End of Phase 2 meeting with the
U.S. Food and Drug Administrationto discuss trial design for Part B of CKD-associated pruritus study.
First Quarter 2017 Financial Results
Net Loss: The Company reported a net loss of
Revenues: In the first quarter of 2017, the Company earned revenue of
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Other Income: Other income was
Cash and Cash Equivalents and Marketable Securities Position: At
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 will be sufficient for the Company to fund its operating expenses and capital expenditure requirements into 2019, without giving effect to any potential milestone payments under existing collaborations.
Cara management will host a conference call today at
To participate in the conference call, please dial 855-445-2816 (domestic) or 484-756-4300 (international) and refer to conference ID 10052639. 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.
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, led by CR845, that target the body's peripheral nervous system and have demonstrated, in Phase 2 trials, preliminary efficacy in patients with moderate-to-severe pain and pruritus without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.
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 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 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
Financial tables follow
|STATEMENTS OF OPERATIONS|
|(amounts in thousands, except share and per share data)|
|Three Months Ended |
|License and milestone fees||$||530||$||-|
|Clinical compound revenue||68||7|
|Research and development||20,836||8,546|
|General and administrative||2,400||2,447|
|Total operating expenses||23,236||10,993|
|Loss before benefit from income taxes||(22,235||)||(10,837||)|
|Benefit from income taxes||31||145|
|Net loss per share :|
|Basic and Diluted||$||(0.81||)||$||(0.39||)|
|Weighted average shares:|
|Basic and Diluted||27,299,678||27,259,589|
|Cash and cash equivalents||$||5,306||$||12,092|
|Income tax receivable||558||852|
|Restricted cash, current||700||700|
|Total current assets||41,031||61,445|
|Property and equipment, net||1,499||1,614|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||12,512||$||11,533|
|Total current liabilities||12,512||11,533|
|Deferred lease obligation||1,518||1,570|
|Commitments and contingencies|
|Common stock subscribed in a follow-on offering||5||-|
|Additional paid-in capital||300,151||212,866|
|Accumulated other comprehensive income||24||3|
|Total stockholders' equity||29,269||50,725|
|Total liabilities and stockholders' equity||$||43,299||$||63,828|
Michael SchaffzinStern Investor Relations, Inc. 212-362-1200 email@example.com MEDIA CONTACT: Annie Starr6 Degrees 973-415-8838 firstname.lastname@example.org
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