"During the quarter, we continued to make good progress with our CR845 development programs in acute postoperative pain, chronic osteoarthritis pain and chronic kidney disease-associated pruritus. Importantly, we were very pleased to receive Breakthrough Therapy designation from the
Second Quarter and Recent Business Highlights
June 2017, reported the Independent Data Monitoring Committee's recommendation that Cara continue testing both doses of I.V. CR845 in its Phase 3 trial for the treatment of postoperative pain following a pre-specified interim conditional power analysis.
June 2017, received Breakthrough Therapy designation from the U.S. Food and Drug Administration(FDA) for I.V. CR845 for the treatment of moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis patients.
June 2017, initiated a Phase 3, open-label, 52-week safety study evaluating the long-term safety of I.V. CR845 in 240 hemodialysis patients as part of the pivotal program in CKD-aP.
June 2017, reported top-line results from a Phase 2b trial of Oral CR845 in chronic pain patients with osteoarthritis of the hip or knee.
July 2017, reported summary data from a Phase 1 trial of Oral CR845 identifying tablet strengths exhibiting appropriate plasma levels for potential use in the non-hemodialysis CKD-aP population.
Expected Upcoming Milestones
- End of Phase 2 meeting with the
FDAin the third quarter of 2017 to finalize pivotal program for I.V CR845 for the treatment of CKD-aP in hemodialysis patients; initiation of a Phase 3 pivotal trial expected in the fourth quarter of 2017.
- Initiation of a Phase 1 trial of Oral CR845 in CKD-aP non-hemodialysis patients expected in fourth quarter of 2017.
- Investigational New Drug application submission for Oral CR845 in patients with chronic liver disease-associated pruritus expected in the fourth quarter of 2017.
- Completion of enrollment for CLIN-3001, the Company's ongoing adaptive pivotal Phase 3 trial of I.V. CR845 for the treatment of acute postoperative pain, expected in the fourth quarter of 2017.
Second Quarter 2017 Financial Results
Net Loss: The Company reported a net loss of
Revenues: The Company recognized
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A
expenses were substantially unchanged at
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 57769313. 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 planned clinical trials, the potential results of ongoing and planned clinical trials 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 ||Six Months Ended |
|License and milestone fees revenue||$||-||$||-||$||530||$||-|
|Clinical compound revenue||-||79||68||86|
|Research and development||6,961||10,760||27,797||19,305|
|General and administrative||2,672||2,645||5,072||5,092|
|Total operating expenses||9,633||13,405||32,869||24,397|
|Loss before benefit from income taxes||(9,302||)||(13,154||)||(31,537||)||(23,990||)|
|Benefit from income taxes||2||79||33||224|
|Net loss per share:|
|Basic and Diluted||$||(0.29||)||$||(0.48||)||$||(1.06||)||$||(0.87||)|
|Weighted average shares:|
|Basic and Diluted||32,239,877||27,282,863||29,783,424||27,271,226|
|CONDENSED BALANCE SHEETS|
|Cash and cash equivalents||$||9,416||$||12,092|
|Income tax receivable||560||852|
|Restricted cash, current||700||700|
|Total current assets||115,805||61,445|
|Property and equipment, net||1,399||1,614|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||7,190||$||11,533|
|Total current liabilities||7,190||11,533|
|Deferred lease obligation||1,563||1,570|
|Commitments and contingencies||-||-|
|Additional paid-in capital||302,920||212,866|
|Accumulated other comprehensive (loss) income||(13||)||3|
|Total stockholders' equity||109,220||50,725|
|Total liabilities and stockholders' equity||$||117,973||$||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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