"We are particularly pleased with the progress made in our pruritus program this quarter, including successful completion of our end-of-Phase 2 meeting with the
Third Quarter and Recent Business Highlights
I.V. CR845: Chronic Kidney Disease Associated Pruritus (CKD-aP): Hemodialysis
October 2017, the Company announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration(FDA). The Company, in consultation with the FDA, has established the key elements of the Phase 3 registrational program for the treatment of moderate-to-severe CKD-aP in patients undergoing hemodialysis. The Company expects to initiate the first pivotal trial of I.V. CR845 in hemodialysis patients with CKD-aP in 4Q17.
Oral CR845: Chronic Kidney Disease Associated Pruritus (CKD-aP): Non-Hemodialysis
October 2017, the Company announced dosing of the first patient in a Phase 1 pharmacokinetic and safety trial of Oral CR845 tablets in patients with Stage III-V CKD who are not on dialysis. Data from the trial are expected to inform dose selection and design of the planned Phase 2 trial in non-hemodialysis patients with CKD-aP.
I.V. CR845: Acute Post-Operative Pain
- The ongoing adaptive Phase 3 trial of I.V. CR845 for the treatment of acute postoperative pain continues to enroll patients undergoing abdominal surgery, with enrollment completion expected by year-end 2017 or early 2018.
August 2017, the Company announced the appointment of Mani Mohindru, Ph.D., as Chief Financial Officer and Chief Strategy Officer. Josef Schoell, who had held the CFO position at Cara for more than a decade, retired from the company.
The Company expects to make presentations at the following conferences through
- Oral and poster presentation of Phase 2 I.V. CR845 data in CKD-aP at
Kidney Week 2017, the
American Society of Nephrology'sAnnual Meeting, on Friday, November 3and Saturday, November 4, 2017in New Orleans, LA.
- Late-breaking poster presentation of Phase 2b Oral CR845 data in patients with osteoarthritis of the hip or knee at the
American College of Rheumatology ACR/ARHPAnnual Meeting on Tuesday, November 7in San Diego, CA.
- Stifel 2017 Healthcare Conference on
Tuesday, November 14, 2017in New York, NY.
- Jefferies 2017
London Healthcare Conferenceon Thursday, November 16, 2017in London, UK.
- 29th Annual
Piper Jaffray Healthcare Conferenceon Tuesday, November 28, 2017in New York, NY.
Third Quarter 2017 Financial Results
Net Loss: The Company reported a net loss of
Revenues: The Company did not recognize any revenue during the third quarter of 2017 or 2016.
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 1853199. 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.
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 ongoing and planned clinical trials, the potential results of ongoing and planned clinical trials, expected industry and investor presentations 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
|CONDENSED STATEMENTS OF OPERATIONS|
|(amounts in thousands, except share and per share data)|
|Three Months Ended ||Nine Months Ended |
|License and milestone fees revenue||$||-||$||-||$||530||$||-|
|Clinical compound revenue||-||-||68||86|
|Research and development||9,151||9,671||36,948||28,976|
|General and administrative||3,805||2,102||8,877||7,195|
|Total operating expenses||12,956||11,773||45,825||36,171|
|Loss before benefit from income taxes||(12,589||)||(11,597||)||(44,126||)||(35,587||)|
|Benefit from income taxes||145||55||178||279|
|Net loss per share:|
|Basic and Diluted||$||(0.38||)||$||(0.42||)||$||(1.43||)||$||(1.29||)|
|Weighted average shares:|
|Basic and Diluted||32,591,550||27,282,863||30,729,752||27,275,133|
|CONDENSED BALANCE SHEETS|
|Cash and cash equivalents||$||11,792||$||12,092|
|Income tax receivable||705||852|
|Restricted cash, current||700||700|
|Total current assets||105,976||61,445|
|Property and equipment, net||1,302||1,614|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||7,272||$||11,533|
|Total current liabilities||7,272||11,533|
|Deferred lease obligation||1,701||1,570|
|Commitments and contingencies||-||-|
|Additional paid-in capital||305,165||212,866|
|Accumulated other comprehensive income||40||3|
|Total stockholders' equity||99,074||50,725|
|Total liabilities and stockholders' equity||$||108,047||$||63,828|
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