"In 2016, we advanced our three late-stage trials in indications of high unmet need where existing therapies are ineffective or are limited by significant side effects and the high potential for abuse," said
Fourth Quarter and Recent Business Highlights
September 2016, initiated Phase 2b trial evaluating three doses of oral CR845 in chronic pain patients with osteoarthritis (OA).
October 2016, delivered presentation and hosted industry symposium at the 10th Annual Pain & Migraine Therapeutics Summit and ANESTHESIOLOGY® 2016, respectively, at which the Company discussed CR845 as a novel approach to acute and chronic pain management due to its unlikeliness to lead to physical dependence.
November 2016, announced the completion of enrollment in Part A of an adaptive Phase 2 / 3 trial of I.V. CR845, which was initiated in June 2016in dialysis patients suffering from moderate-to-severe uremic pruritus (UP), an intractable systemic itch condition in patients with chronic kidney disease (CKD), for which there are no approved therapies in the United States.
November 2016, presented two posters at Kidney Week, the American Societyof Nephrology's Annual Meeting, which included positive data from the Company's Phase 2 study of I.V. CR845 in UP.
Expected 2017 Milestones
- Top-line data expected in the first quarter of 2017 from Part A of the adaptive Phase 2/3 trial of I.V. CR845 in 160 dialysis patients suffering from moderate-to-severe UP.
- Trial completion expected in the first quarter of 2017, with data readout 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 UP.
- Top-line data expected in the second quarter of 2017 from the Phase 2b trial of Oral CR845, for the treatment of pain associated with OA.
- Interim conditional power analysis expected in the second quarter of 2017 from CLIN-3001, our 450 patient adaptive Phase 3 trial of I.V. CR845 in postoperative pain.
- Data expected in the second quarter of 2017 from a Phase 1 trial to quantitatively assess any effects of I.V. CR845 on respiratory drive after bolus infusion in healthy volunteers.
Fourth Quarter 2016 Financial Results
Net Loss: The Company reported a net loss of
Revenues: The Company did not recognize any revenues during the fourth quarter of 2016 or 2015.
Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Full Year 2016 Financial Results
Net Loss: The Company
reported a net loss of
Revenues: License and milestone fees revenue was
Collaborative revenue was
Clinical compound revenue for 2016 and 2015 was
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 as of
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 70053458. 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 that target the body's peripheral nervous system and have demonstrated initial efficacy in patients with moderate-to-severe pain 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 ||Year Ended |
|License and milestone fees||$||-||$||-||$||-||$||1,710|
|Clinical compound revenue||-||-||86||-|
|Research and development||20,277||7,568||49,253||21,221|
|General and administrative||2,038||2,161||9,233||7,770|
|Total operating expenses||22,315||9,729||58,486||28,991|
|Loss before benefit from income taxes||(22,160||)||(9,677||)||(57,748||)||(25,087||)|
|Benefit from income taxes||189||147||468||397|
|Net loss per share :|
|Basic and Diluted||$||(0.81||)||$||(0.35||)||$||(2.10||)||$||(1.00||)|
|Weighted average shares:|
|Basic and Diluted||27,290,548||27,240,369||27,279,008||24,620,372|
|Cash and cash equivalents||$||12,092||$||15,101|
|Income tax receivable||852||384|
|Restricted cash, current||700||-|
|Total current assets||61,445||108,934|
|Property and equipment, net||1,614||1,263|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||11,533||$||5,268|
|Total current liabilities||11,533||5,268|
|Deferred lease obligation||1,570||585|
|Commitments and contingencies|
|Additional paid-in capital||212,866||209,943|
|Accumulated other comprehensive income (loss)||3||(35||)|
|Total stockholders' equity||50,725||105,044|
|Total liabilities and stockholders' equity||$||63,828||$||110,897|
Michael SchaffzinStern Investor Relations, Inc. 212-362-1200 firstname.lastname@example.org MEDIA CONTACT: Annie Starr6 Degrees 973-415-8838 email@example.com
News Provided by Acquire Media