- Currently enrolling three late stage studies with CR845 totaling over 900 patients -
- Top line data expected in 1H 2017 -
- Conference call today at
"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
Third Quarter and Recent Business Highlights
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).
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.
October 2016, initiated Phase 1 study with Oral CR845 in hemodialysis patients.
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 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.
Third Quarter 2016 Financial Results
Net Loss: The Company reported a net loss of
Revenues: The Company did not recognize any revenue during the third quarter of 2016. During the third quarter of 2015, total revenue recognized 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: As of
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 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.
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.
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
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||$||-||$||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|
|CONDENSED BALANCE SHEETS|
|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|
Steve SilverStern Investor Relations, Inc. 212-362-1200 Steve@sternir.com MEDIA CONTACT: Annie Starr6 Degrees 973-415-8838 firstname.lastname@example.org
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