- Currently enrolling three late stage studies with CR845 totaling over 900 patients - - Top line data expected in 1H 2017 - - Conference call today at 4:30 p.m. ET - STAMFORD, CONN., Nov. 03, 2016 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq:CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors, today announced financial results for the third quarter ended September 30, 2016. "We are pleased to be actively enrolling late stage studies with both IV and oral formulations of CR845 for three significant unmet medical indications," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "2017 will be an exciting and transformative year for the Company as we look forward to sharing top-line data from all three of our late-stage clinical programs." Third Quarter and Recent Business Highlights
- In September 2016, announced the initiation of enrollment in a Phase 2b trial of Oral CR845 in approximately 330 patients for the treatment of pain associated with osteoarthritis (OA).
- In September 2016, presented positive data at PAINWeek from the Phase 2a study of Oral CR845 in OA.
- In September and October 2016, hosted industry symposia at PAINWeek and the Orthopaedic Trauma Association 2016 Annual Meeting, respectively, titled "Moving Beyond Mu with Kappa Opioid Receptor Agonists - Leaving the Baggage Behind", which included data from our 2014 human abuse liability study of I.V. CR845 showing low potential for human abuse.
- In October 2016, initiated Phase 1 study with Oral CR845 in hemodialysis patients.
- 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 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.
- Top-line data expected in the first 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 first half of 2017 from the 330 patient Phase 2b trial of Oral CR845, for the treatment of pain associated with OA.
- Interim conditional power analysis expected in the first half of 2017 from CLIN-3001, Cara's 450 patient adaptive Phase 3 trial of I.V. CR845 in postoperative pain.
Conference CallCara management will host a conference call today at 4:30 p.m. ET to discuss its third quarter 2016 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 90388150. 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 biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral 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. Forward-looking Statements 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 and trial designs of the Company's planned clinical trials, the potential results of ongoing and planned clinical trials, future 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 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, 2015 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.|
|CONDENSED STATEMENTS OF OPERATIONS|
|(amounts in thousands, except share and per share data)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|License and milestone fees revenue||$||-||$||1,710||$||-||$||1,710|
|Clinical compound revenue||-||-||86||-|
|Research and development||9,671||5,584||28,976||13,653|
|General and administrative||2,102||1,865||7,195||5,609|
|Total operating expenses||11,773||7,449||36,171||19,262|
|Loss before benefit from income taxes||(11,597||)||(4,987||)||(35,587||)||(15,410||)|
|Benefit from income taxes||55||200||279||250|
|Net loss per share:|
|Basic and Diluted||$||(0.42||)||$||(0.19||)||$||(1.29||)||$||(0.64||)|
|Weighted average shares:|
|Basic and Diluted||27,282,863||25,545,164||27,275,133||23,737,443|
|CARA THERAPEUTICS, INC.|
|CONDENSED BALANCE SHEETS|
|September 30,||December 31,|
|Cash and cash equivalents||$||5,426||$||15,101|
|Income tax receivable||663||384|
|Total current assets||77,018||108,934|
|Property and equipment, net||1,665||1,263|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||6,825||$||5,268|
|Total current liabilities||6,825||5,268|
|Deferred lease obligation||1,525||585|
|Commitments and contingencies||-||-|
|Additional paid-in capital||211,954||209,943|
|Accumulated other comprehensive income (loss)||20||(35||)|
|Total stockholders' equity||71,802||105,044|
|Total liabilities and stockholders' equity||$||80,152||$||110,897|
INVESTOR CONTACT:Steve SilverStern Investor Relations, Inc.212-362-1200 Steve@sternir.comMEDIA CONTACT:Annie Starr6 Degrees973-415-8838 email@example.com