CARA Cara Therapeutics Inc.

14.53
-0.24  -2%
Previous Close 14.77
Open 14.83
52 Week Low 8.88
52 Week High 26.67
Market Cap $681,264,492
Shares 46,886,751
Float 41,039,088
Enterprise Value $566,297,312
Volume 706,029
Av. Daily Volume 354,083
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Upcoming Catalysts

Drug Stage Catalyst Date
KORSUVA (CR845/difelikefalin) injection
Chronic kidney disease (CKD) on hemodialysis (HD) with Moderate-to Severe Pruritus
NDA Filing
NDA Filing
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KORSUVA (CR845/difelikefalin) oral
Atopic dermatitis patients with moderate-to-severe pruritus
Phase 2
Phase 2
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KORSUVA (CR845/difelikefalin) oral
Chronic Liver Disease-Associated Pruritus
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
KORSUVA (CR845/difelikefalin) oral
Stage 3-4 Chronic Kidney Disease-Associated Pruritus
Phase 2
Phase 2
Phase 2 data met primary endpoint but secondary missed - December 3, 2019. Phase 3 trial to be initiated 4Q 2020.
KORSUVA (CR845/difelikefalin) injection - KALM-1
Chronic kidney disease (CKD) on hemodialysis (HD) with Moderate-to Severe Pruritus
Phase 3
Phase 3
Phase 3 data met primary endpoint - May 29, 2019.
IV CR845
Acute pain
Phase 3
Phase 3
Phase 3 data released June 27, 2018. Company noted primary endpoint met but data mixed.
CR845
Osteoarthritis (OA)
Phase 2b
Phase 2b
Phase 2b data released June 29, 2017 - trial failed.

Latest News

  1. – Conference call today at 4:30 p.m. ET –

    STAMFORD, Conn., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (NASDAQ:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors (KORs), today announced financial results and operational highlights for the second quarter ended June 30, 2020.

    "In the second quarter, we continued to advance our clinical development programs for both KORSUVA™ Injection and Oral KORSUVA. Following positive top-line data from our KALM™-2 pivotal Phase 3 trial of KORSUVA Injection for chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis patients, we remain on track…

    – Conference call today at 4:30 p.m. ET –

    STAMFORD, Conn., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (NASDAQ:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors (KORs), today announced financial results and operational highlights for the second quarter ended June 30, 2020.

    "In the second quarter, we continued to advance our clinical development programs for both KORSUVA™ Injection and Oral KORSUVA. Following positive top-line data from our KALM™-2 pivotal Phase 3 trial of KORSUVA Injection for chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis patients, we remain on track to submit our first New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "We also successfully completed a planned interim statistical analysis of our KARE Phase 2 dose-ranging trial of Oral KORSUVA for moderate-to-severe pruritus in atopic dermatitis (AD) patients and expect the trial to be fully enrolled by the fourth quarter."

    Second Quarter and Recent Developments:

    KORSUVA Injection: Chronic Kidney Disease-Associated Pruritus (CKD-aP): Hemodialysis

    In April 2020, the Company announced positive top-line results from its KALM-2 global pivotal Phase 3 trial of KORSUVA Injection in hemodialysis patients with moderate-to-severe CKD-aP. The trial met the primary endpoint, with a statistically significant proportion of patients on KORSUVA Injection achieving a three-point or greater improvement from baseline in the weekly mean Worst Itching Intensity Numeric Rating Scale (NRS) versus placebo (p=0.02) at week 12. The trial also met the key secondary endpoint, with a statistically significant proportion of patients on KORSUVA Injection achieving a four-point or greater improvement from baseline in the weekly mean Worst Itching Intensity NRS versus placebo (p=0.01) at week 12. KORSUVA Injection was generally well-tolerated through 12 weeks of treatment with a safety profile consistent with prior clinical trials.

    All safety databases are now closed with more than 1,500 total patient exposures achieved, including more than 700 patients completing at least six months of treatment and more than 400 patients completing one year of treatment.

    The Company remains on track to submit an NDA for KORSUVA Injection to the FDA in the fourth quarter of 2020.

    Oral KORSUVA: CKD-aP: Non-Hemodialysis

    In December 2019, the Company announced positive top-line results from its Phase 2 dose-ranging trial of Oral KORSUVA for the treatment of pruritus in patients with stage III-V (moderate-to-severe) CKD. The Company plans to conduct an End of Phase 2 Meeting with the FDA in the first quarter of 2021. In advance of that meeting, the Company intends to initiate the safety portion of the Phase 3 program in the fourth quarter of 2020.

    Oral KORSUVA: Atopic Dermatitis (AD)

    In June 2020, the Company announced the completion of an interim conditional power assessment of its ongoing KARE Phase 2 dose-ranging trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in AD patients. The trial is evaluating the safety and efficacy of three tablet strengths (0.25 mg, 0.5 mg and 1.0 mg, twice daily) of Oral KORSUVA versus placebo for 12 weeks, followed by a 4-week active extension phase.

    Based on the recommendation of the Independent Data Monitoring Committee, the size of the trial was increased from an original enrollment target of 320 patients to 410 patients, to maintain the prespecified statistical power of 80% or greater on the trial's primary endpoint of change from baseline in the weekly mean of the daily 24-hour Worst Itching Intensity NRS and key secondary endpoint of the proportion of patients achieving a four point or greater improvement in Worst Itching Intensity NRS score at week 12. The prespecified interim conditional power assessment was conducted after approximately 50% of the originally targeted patient number had completed the designated 12-week treatment period. The Company expects the trial to be fully enrolled in the fourth quarter of 2020 and aims to report top-line results in the first half of 2021, subject to any delays related to the ongoing COVID-19 pandemic.

    Oral KORSUVA: Chronic Liver Disease-Associated Pruritus (CLD-aP): Primary Biliary Cholangitis (PBC)

    The Company is conducting a Phase 2 trial of Oral KORSUVA for the treatment of pruritus in patients with hepatic impairment due to PBC. The trial is evaluating the safety and efficacy of Oral KORSUVA (1.0 mg tablet, twice daily) versus placebo for 16 weeks. The Company continues to screen patients and aims to have top-line data in the first half of 2021, due in part to delays related to the ongoing COVID-19 pandemic.

    Board of Directors Expansion and Appointment

    In June 2020, the Company expanded its Board of Directors by appointing Susan Shiff, Ph.D., M.B.A., as a new Director. Dr. Shiff currently serves as Senior Vice President and Head of the Center for Observational and Real-World Evidence at Merck, known as MSD outside the United States and Canada.

    COVID-19 Impacts and Business Operations

    Due to the ongoing COVID-19 pandemic and in accordance with the FDA's updated guidance for conducting clinical trials, the Company has implemented numerous clinical and operational measures to prioritize the health and safety of patients, employees and study investigators and minimize potential disruptions to its ongoing clinical studies. Cara is working closely with its clinical and commercial manufacturing partners to continue to ensure sufficient supply of KORSUVA is available for its clinical trials.

    Based on guidelines from the Centers for Disease Control and Prevention and the State of Connecticut, all Cara employees continue to work remotely and business travel has been restricted.

    Upcoming Activities

    The Company expects to make presentations at the following upcoming conferences:

    • 40th Annual Canaccord Genuity Growth Conference, August 11-13, 2020
    • Cantor Fitzgerald Global Healthcare Conference, September 15-17, 2020
    • American Society of Nephrology Kidney Week, October 19-25, 2020
    • Stifel Healthcare Conference, November 17-18, 2020
    • Jefferies Global Healthcare Conference, November 17-19, 2020
    • Piper Sandler Health Care Conference, December 1-3, 2020

    Second Quarter 2020 Financial Results

    Net Loss: Net loss was $25.1 million, or $0.54 per basic and diluted share, for the three months ended June 30, 2020, compared to a net loss of $23.0 million, or $0.58 per basic and diluted share, for the same period of 2019.  

    Revenues: Total revenue was $5.6 million for the three months ended June 30, 2020, compared to $5.2 million during the same period of 2019. Total revenue consisted of:

    • The Company recognized $4.5 million and $5.2 million of license and milestone fees revenue for the three months ended June 30, 2020 and 2019, respectively, related to its license agreement with Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP).

       
    • The Company recognized $0.6 million of license and milestone fees revenue for the three months ended June 30, 2020 related to the achievement of a milestone related to its license agreement with Chong Kun Dang Pharmaceutical Corp.

       
    • The Company recognized $0.5 million of clinical compound revenue from the sales of clinical compound for the three months ended June 30, 2020 to Maruishi Pharmaceutical Company Ltd. and VFMCRP. There were no sales of clinical compound for the three months ended June 30, 2019.

    Research and Development (R&D) Expenses: R&D expenses were $26.1 million for the three months ended June 30, 2020 compared to $24.4 million for the three months ended June 30, 2019. The higher R&D expenses in 2020 were primarily due to increases in stock-based compensation expense, payroll and related costs and cost of clinical compound sales, partially offset by a net decrease in clinical trial costs, conferences, and travel and related costs.

    General and Administrative (G&A) Expenses: G&A expenses were $5.4 million for the three months ended June 30, 2020 compared to $5.0 million for the three months ended June 30, 2019. The increase in 2020 was primarily due to increases in consultants' costs, legal fees, and insurance costs, partially offset by decreases in stock-based compensation expense.

    Other Income, Net: Other income, net was $634,000 for the three months ended June 30, 2020 compared to $947,000 for the three months ended June 30, 2019. The decrease in 2020 was due to a decrease in accretion and interest income resulting from a lower yield on our portfolio of investments in the 2020 period.

    Cash and Cash Equivalents and Marketable Securities Position: At June 30, 2020, cash and cash equivalents and marketable securities totaled $153.0 million compared to $218.2 million at December 31, 2019. The decrease in the balance of cash and cash equivalents and marketable securities primarily resulted from cash used in operations of $66.0 million, partially offset by proceeds of $0.3 million from the exercise of stock options.

    Financial Guidance

    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 June 30, 2020 will be sufficient to fund its currently anticipated operating expenses and capital expenditures into the second half of 2021, without giving effect to any potential milestone payments under existing collaborations. 

    Conference Call

    Cara management will host a conference call today at 4:30 p.m. ET to discuss second quarter 2020 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 7669087. A live webcast of the call can be accessed under "Events & 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 biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA (CR845/difelikefalin), a first-in-class KOR agonist that targets KORs located in the peripheral nervous system and on immune cells. In the Company's KALM-1 and KALM-2 Phase 3 trials and two Phase 2 trials, KORSUVA Injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in pruritus-related quality of life measures in hemodialysis patients with moderate-to-severe CKD-aP. Cara has successfully completed its Phase 2 trial of Oral KORSUVA for the treatment of pruritus in patients with CKD and is currently conducting Phase 2 trials of Oral KORSUVA in AD and PBC patients with moderate-to-severe pruritus.

    The FDA has conditionally accepted KORSUVA as the trade name for difelikefalin injection. CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    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 of the enrollment and data readouts from the Company's ongoing clinical trials, the potential results of ongoing clinical trials, timing of future regulatory and development milestones for the Company's product candidates, including the Company's projected timeline for the submission of its NDA for KORSUVA Injection for CKD-aP, the expected timeline for conducting meetings with the FDA concerning the Company's product candidates, the potential for the Company's product candidates to be alternatives in the therapeutic areas investigated, the Company's expected cash reach, and the potential impact of COVID-19 on the Company's clinical development and regulatory timelines and plans. 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 most recent Quarterly Report on Form 10-Q 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) 

    (unaudited) 

               
       Three Months Ended June 30,

      Six Months Ended June 30,

     
       2020  2019  2020  2019 
              
    Revenue:            
     License and milestone fees $  5,099  $  5,208  $  13,120  $  9,450 
     Clinical compound revenue   535    -     607    140 
    Total revenue   5,634    5,208    13,727    9,590 
                  
    Operating expenses:            
     Research and development   26,108    24,356    59,644    47,964 
     General and administrative   5,410    4,994    9,968    8,902 
    Total operating expenses   31,518    29,350    69,612    56,866 
    Operating loss   (25,884)   (24,142)   (55,885)   (47,276)
                  
    Other income, net    634    947    1,591    2,036 
    Loss before benefit from income taxes   (25,250)   (23,195)   (54,294)   (45,240)
                  
    Benefit from income taxes   182    235    304    320 
    Net loss $  (25,068) $  (22,960) $  (53,990) $  (44,920)
                  
    Net loss per share:             
    Basic and Diluted $  (0.54) $  (0.58) $  (1.15) $  (1.13)
                  
    Weighted average shares:            
    Basic and Diluted   46,799,703    39,818,162    46,762,327    39,685,954 
                  



    CARA THERAPEUTICS, INC.
    CONDENSED BALANCE SHEETS
    (in thousands) 
    (unaudited) 
           
      June 30,  December 31, 
      2020  2019 
         
    Assets     
    Current assets:     
     Cash and cash equivalents$  56,967  $  18,305 
     Marketable securities  73,218    136,701 
     Income tax receivable  1,120    816 
     Other receivables  486    971 
     Prepaid expenses   10,124    8,863 
    Total current assets  141,915    165,656 
     Operating lease right-of-use asset  2,825    3,036 
     Marketable securities, non-current  22,861    63,159 
     Property and equipment, net  604    700 
     Restricted cash  408    408 
    Total assets$  168,613  $  232,959 
           
    Liabilities and stockholders' equity     
    Current liabilities:     
     Accounts payable and accrued expenses$  13,952  $  19,665 
     Operating lease liability, current  1,006    967 
     Current portion of deferred revenue  9,768    22,262 
    Total current liabilities  24,726    42,894 
           
     Operating lease liability, non-current  2,959    3,352 
           
    Commitments and contingencies   -     - 
           
    Stockholders' equity:     
     Preferred stock  -     - 
     Common stock  47    47 
     Additional paid-in capital  594,963    587,223 
     Accumulated deficit  (454,717)   (400,727)
     Accumulated other comprehensive income  635    170 
    Total stockholders' equity  140,928    186,713 
    Total liabilities and stockholders' equity$  168,613  $  232,959 
           



    INVESTOR CONTACT:

    Janhavi Mohite

    Stern Investor Relations, Inc.

    212-362-1200

    MEDIA CONTACT:

    Annie Starr

    6 Degrees

    973-415-8838

     

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  2. STAMFORD, Conn., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (NASDAQ:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs, today announced that Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer, will participate in a fireside chat at the Canaccord Genuity 40th Annual Growth Conference on Thursday, August 13, 2020 at 8:00 a.m. ET.

    A live webcast of the presentation can be accessed under "Events & 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 for…

    STAMFORD, Conn., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (NASDAQ:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs, today announced that Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer, will participate in a fireside chat at the Canaccord Genuity 40th Annual Growth Conference on Thursday, August 13, 2020 at 8:00 a.m. ET.

    A live webcast of the presentation can be accessed under "Events & 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 for approximately 30 days.

    About Cara Therapeutics

    Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist that targets the body's peripheral nervous system, as well as certain immune cells. In two Phase 3 trials, KORSUVA Injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). Cara has successfully completed its Phase 2 trial of Oral KORSUVA for the treatment of pruritus in patients with CKD and is currently conducting Phase 2 trials of Oral KORSUVA in atopic dermatitis and primary biliary cholangitis patients with moderate-to-severe pruritus.

    The FDA has conditionally accepted KORSUVA™ as the trade name for difelikefalin injection. CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    INVESTOR CONTACT:

    Janhavi Mohite

    Stern Investor Relations, Inc.

    212-362-1200

    MEDIA CONTACT:

    Annie Starr

    6 Degrees

    973-415-8838

    Primary Logo

    View Full Article Hide Full Article
  3. STAMFORD, Conn., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (NASDAQ:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs, today announced that the Company will host a conference call and live audio webcast on Monday, August 10, 2020, at 4:30 p.m. ET to report second quarter 2020 financial results and provide a corporate update.

    To participate in the conference call, please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 7669087. A live webcast of the call can be accessed under "Events & Presentations" in the News & Investors section of the…

    STAMFORD, Conn., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (NASDAQ:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs, today announced that the Company will host a conference call and live audio webcast on Monday, August 10, 2020, at 4:30 p.m. ET to report second quarter 2020 financial results and provide a corporate update.

    To participate in the conference call, please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 7669087. A live webcast of the call can be accessed under "Events & 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 biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist that targets the body's peripheral nervous system, as well as certain immune cells. In two Phase 3 trials, KORSUVA Injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). Cara has successfully completed its Phase 2 trial of Oral KORSUVA for the treatment of pruritus in patients with CKD and is currently conducting Phase 2 trials of Oral KORSUVA in atopic dermatitis and primary biliary cholangitis patients with moderate-to-severe pruritus.

    The FDA has conditionally accepted KORSUVA™ as the trade name for difelikefalin injection. CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    MEDIA CONTACT:

    Annie Starr

    6 Degrees

    973-415-8838

    INVESTOR CONTACT:

    Janhavi Mohite

    Stern Investor Relations, Inc.

    212-362-1200

    Primary Logo

    View Full Article Hide Full Article
  4. STAMFORD, Conn., June 30, 2020 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (NASDAQ:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs, today announced the appointment of Susan Shiff, Ph.D., M.B.A., to its Board of Directors. Dr. Shiff currently serves as Senior Vice President and Head of the Center for Observational and Real-World Evidence (CORE) at Merck, known as MSD outside the United States and Canada.

    "Susan brings a wealth of experience in the health economics and outcomes research (HEOR) and market access fields, and joins the Board at a pivotal time as we prepare to transition to a commercial…

    STAMFORD, Conn., June 30, 2020 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (NASDAQ:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs, today announced the appointment of Susan Shiff, Ph.D., M.B.A., to its Board of Directors. Dr. Shiff currently serves as Senior Vice President and Head of the Center for Observational and Real-World Evidence (CORE) at Merck, known as MSD outside the United States and Canada.

    "Susan brings a wealth of experience in the health economics and outcomes research (HEOR) and market access fields, and joins the Board at a pivotal time as we prepare to transition to a commercial organization," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "Her insights and skillset will be valuable resources as we develop and implement evidence-based medicine, patient access and pricing strategies across the KORSUVA development pipeline."

    "I am pleased to be joining the Cara Board at such an exciting time, as the Company prepares to submit its first New Drug Application (NDA) to the U.S. Food and Drug Administration later this year," said Dr. Shiff. "I look forward to working with the Cara team to optimize commercialization strategies for all ongoing development programs."

    Dr. Shiff has over 20 years of experience in the pharmaceutical industry as a leader in the development and implementation of evidence, access and pricing strategies for products globally. Before joining Merck, she served as Vice President of Global Health Economics, Data Sciences and Evidence-Based Medicine at Teva Pharmaceuticals. Prior to that, Dr. Shiff was Vice President of Evidence-Based Medicine and Market Access in Global Primary Care as well as Vice President of HEOR and Epidemiology in Emerging Markets at Pfizer. She has also held senior positions at Roche and Johnson & Johnson. Dr. Shiff began her career at the Centers for Disease Control and Prevention. She holds an M.B.A. from Cornell University and a Ph.D. from the University of California, Los Angeles. Dr. Shiff currently serves on the Boards of Synthace Limited and the Merck Global Health Innovation Fund. In 2016, she was selected as one of FiercePharma's Top 15 Women in Biopharma, in 2017 Proclinical named her as one of today's most inspiring women in the pharmaceutical industry and in 2018 CB Insights named CORE as one of the most innovative Corporate Labs in healthcare.

    About Cara Therapeutics

    Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist that targets the body's peripheral nervous system, as well as certain immune cells. In two Phase 3 trials, KORSUVA Injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). Cara has successfully completed its Phase 2 trial of Oral KORSUVA for the treatment of pruritus in patients with CKD and is currently conducting Phase 2 trials of Oral KORSUVA in atopic dermatitis and primary biliary cholangitis patients with moderate-to-severe pruritus.

    The FDA has conditionally accepted KORSUVA™ as the trade name for difelikefalin injection. CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    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 Cara's transition to a commercial organization and the timing of Cara's anticipated submission of its first NDA. 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's filings with the Securities and Exchange Commission, including the "Risk Factors" section of Cara's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 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. Except to the extent required by law, Cara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    MEDIA CONTACT:

    Annie Starr

    6 Degrees

    973-415-8838

    INVESTOR CONTACT:

    Jane Urheim

    Stern Investor Relations, Inc.

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  5. - Patient enrollment increased approximately 28% to maintain >80% statistical power for primary endpoint and key registration endpoint of  >4-point improvement responder analysis -

    - Full trial enrollment expected in fourth quarter of 2020 -

    STAMFORD, Conn., June 17, 2020 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (NASDAQ:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs, today announced the completion of a planned sample size re-estimation of its KARE Phase 2 dose-ranging trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in atopic dermatitis patients.

    Based on…

    - Patient enrollment increased approximately 28% to maintain >80% statistical power for primary endpoint and key registration endpoint of  >4-point improvement responder analysis -

    - Full trial enrollment expected in fourth quarter of 2020 -

    STAMFORD, Conn., June 17, 2020 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (NASDAQ:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs, today announced the completion of a planned sample size re-estimation of its KARE Phase 2 dose-ranging trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in atopic dermatitis patients.

    Based on the Independent Data Monitoring Committee's (IDMC) recommendation, KARE's trial size will be increased by approximately 28%, from an original enrollment target of 320 patients to 410 patients, to maintain the prespecified statistical power of 80 percent or greater on the trial's primary endpoint of change from baseline in the weekly mean of the daily 24-hour Itch Numeric Rating Scale (Itch NRS) and key secondary endpoint of proportion of patients achieving a >4 point improvement in Itch NRS score at week 12. The IDMC's recommendation was based on the results of a prespecified interim conditional power assessment conducted after approximately 50% of the originally targeted patient number completed the designated 12-week treatment period.

    "We are pleased with this IDMC recommendation that, with a modest increase in  target patient enrollment, keeps us on track for our trial's conservative statistical power goals for the key secondary >4-point responder endpoint, which is the accepted clinically meaningful endpoint for regulatory approval of therapeutics for pruritic dermatological indications," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "Pruritus treatment continues to be a significant unmet need for patients with atopic dermatitis and we believe Oral KORSUVA has the potential to be a first-in-class anti-pruritic product with a favorable safety profile."

    KARE Phase 2 Trial Design

    The KARE Phase 2 trial is a randomized, double-blind, placebo-controlled study that is designed to evaluate the efficacy and safety of Oral KORSUVA for moderate-to-severe pruritus in approximately 410 adult subjects with atopic dermatitis. Subjects are randomized to three tablet strengths of Oral KORSUVA: 0.25mg, 0.5mg and 1mg taken twice daily (BID) versus placebo for 12 weeks followed by 4 weeks of an active extension phase.

    KARE's primary efficacy endpoint is the change from baseline in the weekly mean of the daily 24-hour Itch NRS score at week 12 of the treatment period. The key secondary endpoint for KARE is the assessment of proportion of patients achieving an improvement from baseline of ≥4 points with respect to the weekly mean of the daily 24-hour Itch NRS score at week 12. Itch-related quality of life scores at the end of week 12 are assessed by the total Skindex-10 and 5-D itch scales.

    About Cara Therapeutics

    Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist that targets the body's peripheral nervous system, as well as certain immune cells. In two Phase 3 trials, KORSUVA Injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). Oral KORSUVA has successfully completed a Phase 2 trial for the treatment of pruritus in patients with CKD and is currently in Phase 2 trials in atopic dermatitis and primary biliary cholangitis patients with moderate-to-severe pruritus.

    The FDA has conditionally accepted KORSUVA™ as the trade name for difelikefalin injection. CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    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 ongoing trials and future development of Oral KORSUVA for pruritus in patients with atopic dermatitis and the potential for Oral KORSUVA to be a first-in-class anti-pruritic product with a favorable safety profile for these patients.  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's filings with the Securities and Exchange Commission, including the "Risk Factors" section of Cara's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 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. Except to the extent required by law, Cara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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