CARA Cara Therapeutics Inc.

15.5
-0.1  -1%
Previous Close 15.6
Open 15.5
52 Week Low 11.22
52 Week High 29.6473
Market Cap $776,394,008
Shares 50,089,936
Float 49,119,725
Enterprise Value $616,195,920
Volume 181,411
Av. Daily Volume 1,830,251
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
KORSUVA (CR845/difelikefalin) oral
Chronic Liver Disease-Associated Pruritus
Phase 2
Phase 2
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

Drug Stage Notes
KORSUVA (CR845/difelikefalin)
Atopic dermatitis patients with moderate-to-severe pruritus
Phase 3
Phase 3
Phase 2 trial did not meet primary endpoint - April 29, 2021. Phase 3 trial planned for end of 2021.
KORSUVA (CR845/difelikefalin) injection
Chronic kidney disease (CKD) on hemodialysis (HD) with Moderate-to Severe Pruritus
Approved
Approved
FDA approval announced August 23, 2021.
Oral KORSUVA (difelikefalin injection)
Pruritus and Notalgia Paresthetica
Phase 2
Phase 2
Phase 2 enrollment to be completed by year-end 2021.
KORSUVA (CR845/difelikefalin) oral
Stage 3-4 Chronic Kidney Disease-Associated Pruritus
Phase 3
Phase 3
Phase 3 trial to be initiated 2H 2021.
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.

Latest News

  1. AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR

    • First and only therapy approved by the FDA for the treatment of pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis
    • Promotional launch of KORSUVA™ injection in the U.S. is expected in Q1 2022, with reimbursement in H1 2022

    Regulatory News:

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210823005635/en/

    Vifor Pharma and Cara Therapeutics (NASDAQ:CARA) today announced that the U.S. Food and Drug Administration (FDA) has approved KORSUVA™ (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. KORSUVA™…

    AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR

    • First and only therapy approved by the FDA for the treatment of pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis
    • Promotional launch of KORSUVA™ injection in the U.S. is expected in Q1 2022, with reimbursement in H1 2022

    Regulatory News:

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210823005635/en/

    Vifor Pharma and Cara Therapeutics (NASDAQ:CARA) today announced that the U.S. Food and Drug Administration (FDA) has approved KORSUVA™ (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. KORSUVA™ injection is a first-in-class kappa opioid receptor (KOR) agonist that targets the body's peripheral nervous system. The KORSUVA™ injection New Drug Application (NDA) received Priority Review by the FDA, which is granted to therapies that, if approved, would offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

    "We are very excited about the FDA approval of KORSUVA™ injection," said Abbas Hussain, Chief Executive Officer of Vifor Pharma. "There is a significant unmet medical need for a targeted therapy, and we believe that KORSUVA™ injection can fundamentally change the treatment paradigm for adult CKD-aP patients undergoing dialysis. We are committed to bringing this first-in-class medicine to U.S. hemodialysis patients as fast as possible, together with our partner Cara Therapeutics."

    "The FDA approval of KORSUVA™ injection is a transformational milestone for Cara and a significant advancement for the substantial number of adult hemodialysis patients suffering from moderate-to-severe pruritus," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "We look forward to working closely with our commercial partner, Vifor Pharma, to launch KORSUVA™ injection in the U.S. in the coming months. We extend our deepest gratitude to the patients who participated in our KALM-1 and KALM-2 clinical trials, the study investigators, and especially our employees, as their commitment through over 10 years of collective effort made this important milestone possible."

    "We are pleased to see that KORSUVA™ injection has received FDA approval as the first treatment option approved for moderate to severe pruritus in adult CKD patients on hemodialysis," commented Dr. Frank Maddux, Global Chief Medical Officer of Fresenius Medical Care. "Participating in the robust clinical trial program we have learned that KORSUVA™ injection represents an effective treatment option. We have seen substantial improvement in symptoms and meaningful relief for people suffering from severe and debilitating itch."

    This approval is based on the New Drug Application filing that was supported by positive data from two pivotal phase-III trials – KALM-1, conducted in the U.S. (New England Journal of Medicine 2020; 382:222-232), and the global KALM-2, as well as supportive data from an additional 32 clinical studies. KORSUVA™ injection was found to be generally well tolerated.

    Vifor Pharma and Cara have agreed to an exclusive license to commercialize KORSUVA™ injection in the United States. That agreement features a Cara 60%, Vifor Pharma 40% profit-sharing arrangement in non-Fresenius Medical Care clinics in the U.S. Under a previous agreement, Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics have agreed to market KORSUVA™ injection to Fresenius Medical Care North America dialysis clinics in the U.S. under a Cara 50%, Vifor Pharma 50% profit-sharing arrangement.

    Vifor Pharma and Cara Therapeutics are in the process of submitting the required documentation to the U.S. Centers for Medicare and Medicaid Services (CMS) to ensure timely reimbursement and patient access to KORSUVA™ injection. Vifor Pharma expects to begin to market KORSUVA™ injection in Q1 2022 with reimbursement expected in H1 2022, subject to CMS timelines.

    About Vifor Pharma Group

    Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange ((SIX Swiss Exchange, VIFN, OTC:GNHAF).

    For more information, please visit viforpharma.com.

    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 completed Phase 2 trials for the treatment of pruritus in patients with CKD and AD and is currently in Phase 2 trials in PBC and NP patients with moderate-to-severe pruritus.

    About KORSUVA™ injection

    KORSUVA™ injection is a kappa opioid receptor agonist developed in Cara laboratories and indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). KORSUVA injection is not a federally controlled substance.

    Breakthrough Therapy Designation was received from the FDA for KORSUVA™ injection for the treatment of CKD-aP in HD patients and the New Drug Application was evaluated by the FDA with Priority Review.

    Important Safety Information

    Warnings and Precautions

    Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances: These adverse reactions, including falls, have occurred in patients taking KORSUVA™ and may subside with continued treatment. Concomitant use of centrally acting depressant medications, sedating antihistamines, and opioid analgesics may increase the likelihood of these adverse reactions and should be used with caution during treatment with KORSUVA™.

    Risk of Driving and Operating Machinery: Dizziness, somnolence, and mental status changes have occurred in patients taking KORSUVA™. KORSUVA™ may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car and operating machinery. Advise patients not to drive or operate dangerous machinery until the effect of KORSUVA™ on their ability to do so is known.

    Adverse Reactions

    The most common adverse reactions (incidence ≥2% and ≥1% higher than placebo) were diarrhea (9.0%), dizziness (6.8%), nausea (6.6%), gait disturbances, including falls (6.6%), hyperkalemia (4.7%), headache (4.5%), somnolence (4.2%), and mental status changes (3.3%).

    Use in Specific Populations

    Severe Hepatic Impairment: The influence of severe hepatic impairment on the pharmacokinetics of KORSUVA™ in subjects undergoing hemodialysis (HD) has not been evaluated; therefore, use of KORSUVA ™in this population is not recommended. Geriatric Use: The incidence of somnolence was higher in KORSUVA™-treated subjects aged 65 years and older (7.0%) than in KORSUVA™-treated subjects less than 65 years of age (2.8%). The incidence was comparable in both placebo age groups (3.0% and 2.1%, respectively).

    Indication

    KORSUVA™ is indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).

    Limitation of Use: KORSUVA™ has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.

    Please see KORSUVA™ injection full Prescribing Information at www.korsuva.com.

    About Chronic Kidney Disease-associated Pruritus

    CKD-aP is an intractable systemic itch condition that occurs with high frequency and intensity in patients with chronic kidney disease undergoing dialysis. Pruritus has also been reported in patients with stage III-V CKD who are not on dialysis. Aggregate, longitudinal, multi-country studies estimate the weighted prevalence of CKD-aP to be approximately 40% in patients with end-stage renal disease (ESRD), with approximately 25% of patients reporting severe pruritus. The majority of dialysis patients (approximately 60 to 70%) report pruritus, with 30 to 40% reporting moderate or severe pruritus.1,2,3 Recent data from the ITCH National Registry Study showed that among those with pruritus, approximately 59% experienced symptoms daily or nearly daily for more than a year. Given its association with CKD/ESRD, most afflicted patients will continue to have symptoms for months or years, with currently employed antipruritic treatments, such as antihistamines and corticosteroids, unable to provide consistent, adequate relief. Moderate-to-severe chronic pruritus has repeatedly been shown to directly decrease quality of life, contribute to symptoms that impair quality of life (such as poor sleep quality), and is associated with depression.4 CKD-aP is also an independent predictor of mortality among hemodialysis patients, mainly related to increased risk of inflammation and infections.

    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 potential timeline for launch of KORSUVA™ injection, the potential timeline for reimbursement and the potential of KORSUVA™ injection to be a therapeutic option for CKD-aP in dialysis dependent 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 Annual Report on Form 10-K for the year ended 31 December 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.

    References:

    1 Pisoni RL, et al. Pruritus in haemodialysis patients: international results from the Dialysis Outcomes and Practice Patterns Study. Nephrol Dial Transplant. 2006; 21:3495-3505.

    2 Ramakrishnan K, et al. Clinical characteristics and outcomes of end-stage renal disease patients with self-reported pruritus symptoms. International Journal of Nephrology and Renovascular Disease. 2014; 7: 1-12.

    3 Sukul et al. Self-reported Pruritus and Clinical, Dialysis-Related, and Patient-Reported Outcomes in Hemodialysis Patients. Kidney Med. 2020 Nov 21;3(1):42-53.

    4 Mathur VS, et al. A longitudinal study of Uremic Pruritus in hemodialysis patients. Clin J Am Soc Nephrol. 2010; 5(8):1410-1419.

    View Full Article Hide Full Article
    • First and only therapy approved by the FDA for the treatment of pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis
    • Promotional launch of KORSUVA™ injection in the U.S. is expected in Q1 2022, with reimbursement in H1 2022
    • Company to host conference call today at 5.00 p.m. ET

    STAMFORD, Conn. and ST. GALLEN, Switzerland, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Cara Therapeutics (NASDAQ:CARA) and Vifor Pharma today announced that the U.S. Food and Drug Administration (FDA) has approved KORSUVA™ (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis . KORSUVA™ injection is a first-in-class kappa opioid receptor (KOR…

    • First and only therapy approved by the FDA for the treatment of pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis
    • Promotional launch of KORSUVA™ injection in the U.S. is expected in Q1 2022, with reimbursement in H1 2022
    • Company to host conference call today at 5.00 p.m. ET

    STAMFORD, Conn. and ST. GALLEN, Switzerland, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Cara Therapeutics (NASDAQ:CARA) and Vifor Pharma today announced that the U.S. Food and Drug Administration (FDA) has approved KORSUVA™ (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis . KORSUVA™ injection is a first-in-class kappa opioid receptor (KOR) agonist that targets the body's peripheral nervous system. The KORSUVA™ injection new drug application (NDA) received Priority Review by the FDA, which is granted to therapies that, if approved, would offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

    "The FDA approval of KORSUVA™ injection is a transformational milestone for Cara and a significant advancement for the substantial number of adult hemodialysis patients suffering from moderate-to-severe pruritus," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "We look forward to working closely with our commercial partner, Vifor Pharma, to launch KORSUVA™ injection in the U.S in the coming months. We extend our deepest gratitude to the patients who participated in our KALM-1 and KALM-2 clinical trials, the study investigators, and especially our employees, as their commitment through over 10 years of collective effort made this important milestone possible."

    "We are very excited about the FDA approval of KORSUVA™ injection," said Abbas Hussain, Chief Executive Officer of Vifor Pharma "There is a significant unmet medical need for a targeted therapy, and we believe that KORSUVA™ injection can fundamentally change the treatment paradigm for adult CKD-aP patients undergoing dialysis. We are committed to bringing this first-in-class medicine to U.S. hemodialysis patients as fast as possible, together with our partner Cara Therapeutics."

    "We are pleased to see that KORSUVA™ injection has received FDA approval as the first treatment option approved for moderate to severe pruritus in adult CKD patients on hemodialysis", commented Dr. Frank Maddux, Global Chief Medical Officer of Fresenius Medical Care, "Participating in the robust clinical trial program we have learned that KORSUVA™ injection represents an effective treatment option. We have seen substantial improvement in symptoms and meaningful relief for people suffering from severe and debilitating itch."

    This approval is based on the New Drug Application filing that was supported by positive data from two pivotal Phase 3 trials – KALM-1, conducted in the U.S. (New England Journal of Medicine 2020; 382:222-232), and the global KALM-2, as well as supportive data from an additional 32 clinical studies.KORSUVA™ injection was found to be generally well tolerated.

    Vifor Pharma and Cara have agreed to an exclusive license to commercialize KORSUVA™ in the United States. That agreement features a Cara 60%, Vifor Pharma 40% profit-sharing arrangement in non-Fresenius Medical Care clinics in the U.S. Under a previous agreement, Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics have agreed to market KORSUVA™ injection to Fresenius Medical Care North America dialysis clinics in the U.S. under a Cara 50%, Vifor Pharma 50% profit-sharing arrangement.

    Vifor Pharma and Cara Therapeutics are in the process of submitting the required documentation to the U.S. Centers for Medicare and Medicaid Services (CMS) to ensure timely reimbursement and patient access to KORSUVA™ injection. Vifor Pharma expects to begin promoting KORSUVA™ Injection in Q1 2022 with reimbursement expected in H1 2022, subject to CMS timelines.

    Conference Call

    Cara management will host a conference call today at 5:00 p.m. ET to discuss the approval of KORSUVA injection for the treatment of moderate-to-severe pruritus in hemodialysis patients.

    To participate in the conference call, please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 1485906. 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.

    Contacts and further information:

    Media Contact

    Claire LaCagnina 

    6 Degrees 

    315-765-1462 

    clacagnina@6degreespr.com 
    Investor Contact

    Janhavi Mohite

    Stern Investor Relations, Inc.

    212-363-1200

    janhavi.mohite@sternir.com 

      
    Vifor Pharma contacts:

    Media Relations


    Nathalie Ponnier

    Global Head Corporate Communications

    +41 79 957 96 73

    media@viforpharma.com
    Investor Relations

    Julien Vignot

    Head of Investor Relations

    +41 58 851 66 90

    investors@viforpharma.com
      

    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 completed Phase 2 trials for the treatment of pruritus in patients with CKD and atopic dermatitis and is currently in Phase 2 trials in primary biliary cholangitis and notalgia paresthetica patients with moderate-to-severe pruritus.

    About Vifor Pharma Group

    Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange ((SIX Swiss Exchange, VIFN, OTC:GNHAF).

    For more information, please visit viforpharma.com

    About KORSUVA™ Injection

    KORSUVA is a kappa opioid receptor agonist developed in Cara laboratories and indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). KORSUVA Injection is not a federally controlled substance.

    Breakthrough Therapy Designation was received from the FDA for KORSUVA Injection for the treatment of CKD-aP in HD patients and the New Drug Application was evaluated by the FDA with Priority Review.

    Important Safety Information

    Warnings and Precautions

    Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances: These adverse reactions, including falls, have occurred in patients taking KORSUVA and may subside with continued treatment. Concomitant use of centrally acting depressant medications, sedating antihistamines, and opioid analgesics may increase the likelihood of these adverse reactions and should be used with caution during treatment with KORSUVA.

    Risk of Driving and Operating Machinery: Dizziness, somnolence, and mental status changes have occurred in patients taking KORSUVA. KORSUVA may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car and operating machinery. Advise patients not to drive or operate dangerous machinery until the effect of KORSUVA on their ability to do so is known.

    Adverse Reactions

    The most common adverse reactions (incidence ≥2% and ≥1% higher than placebo) were diarrhea (9.0%), dizziness (6.8%), nausea (6.6%), gait disturbances, including falls (6.6%), hyperkalemia (4.7%), headache (4.5%), somnolence (4.2%), and mental status changes (3.3%).

    Use in Specific Populations

    Severe Hepatic Impairment: The influence of severe hepatic impairment on the pharmacokinetics of KORSUVA in subjects undergoing hemodialysis (HD) has not been evaluated; therefore, use of KORSUVA in this population is not recommended.

    Geriatric Use: The incidence of somnolence was higher in KORSUVA-treated subjects aged 65 years and older (7.0%) than in KORSUVA-treated subjects less than 65 years of age (2.8%). The incidence was comparable in both placebo age groups (3.0% and 2.1%, respectively).

    Indication

    KORSUVA is indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).

    Limitation of Use: KORSUVA has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.

    Please see KORSUVA™ injection full Prescribing Information at www.korsuva.com.

    About Chronic Kidney Disease-associated Pruritus

    CKD-aP is an intractable systemic itch condition that occurs with high frequency and intensity in patients with chronic kidney disease undergoing dialysis. Pruritus has also been reported in patients with stage III-V CKD who are not on dialysis. Aggregate, longitudinal, multi-country studies estimate the weighted prevalence of CKD-aP to be approximately 40% in patients with end-stage renal disease (ESRD), with approximately 25% of patients reporting severe pruritus. The majority of dialysis patients (approximately 60 to 70%) report pruritus, with 30 to 40% reporting moderate or severe pruritus.1,2,3 Recent data from the ITCH National Registry Study showed that among those with pruritus, approximately 59% experienced symptoms daily or nearly daily for more than a year. Given its association with CKD/ESRD, most afflicted patients will continue to have symptoms for months or years, with currently employed antipruritic treatments, such as antihistamines and corticosteroids, unable to provide consistent, adequate relief. Moderate-to-severe chronic pruritus has repeatedly been shown to directly decrease quality of life, contribute to symptoms that impair quality of life (such as poor sleep quality), and is associated with depression.4 CKD-aP is also an independent predictor of mortality among hemodialysis patients, mainly related to increased risk of inflammation and infections.

    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 potential timeline for launch of KORSUVA™ injection, the potential timeline for reimbursement and the potential of KORSUVA™ injection to be a therapeutic option for CKD-aP in dialysis dependent 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 Annual Report on Form 10-K for the year ended 31 December 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.

    References:

    1 Pisoni RL, et al. Pruritus in haemodialysis patients: international results from the Dialysis Outcomes and Practice Patterns Study. Nephrol Dial Transplant. 2006; 21:3495-3505.

    2 Ramakrishnan K, et al. Clinical characteristics and outcomes of end-stage renal disease patients with self-reported pruritus symptoms. International Journal of Nephrology and Renovascular Disease. 2014; 7: 1-12.

    3 Sukul et al. Self-reported Pruritus and Clinical, Dialysis-Related, and Patient-Reported Outcomes in Hemodialysis Patients. Kidney Med. 2020 Nov 21;3(1):42-53.

    4 Mathur VS, et al. A longitudinal study of Uremic Pruritus in hemodialysis patients. Clin J Am Soc Nephrol. 2010; 5(8):1410-1419.



    Primary Logo

    View Full Article Hide Full Article
  2. – New Drug Application (NDA) Filing for KORSUVA™ Injection in CKD-aP under Priority Review by U.S. Food and Drug Administration (FDA); PDUFA Target Action Date August 23, 2021 –

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

    STAMFORD, Conn., Aug. 09, 2021 (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, 2021.

    "Having completed the late-cycle review of our NDA for our lead asset KORSUVA™ Injection with the FDA during the second quarter of the year…

    – New Drug Application (NDA) Filing for KORSUVA™ Injection in CKD-aP under Priority Review by U.S. Food and Drug Administration (FDA); PDUFA Target Action Date August 23, 2021 –

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

    STAMFORD, Conn., Aug. 09, 2021 (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, 2021.

    "Having completed the late-cycle review of our NDA for our lead asset KORSUVA™ Injection with the FDA during the second quarter of the year, we remain on track for an expected Prescription Drug User Fee Act (PDUFA) target action date of August 23, 2021 and continue to be focused, along with our commercial partner, Vifor Pharma, on preparation for the U.S. launch of KORSUVA Injection in the second half of 2021, if approved," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "We also continue to make good progress in our Oral KORSUVA programs across a range of patient populations where pruritus treatment remains a significant unmet need and, pending the outcome of our scheduled End-of-Phase 2 meeting with the FDA, aim to initiate our first Oral KORSUVA Phase 3 program in mild-to-moderate atopic dermatitis patients by year-end of 2021."

    Second Quarter and Recent Developments:

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

    In February 2021, the FDA accepted the filing of the NDA for KORSUVA Injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. Shortly after this decision, the FDA granted Priority Review for the NDA filing of KORSUVA Injection in March 2021 with an expected PDUFA target action date of August 23, 2021. Following these decisions, the potential FDA approval and subsequent U.S. commercial launch of KORSUVA Injection could take place in the second half of 2021. If approved, KORSUVA Injection would be the first treatment for CKD-aP in hemodialysis patients.

    In March 2021, the Company and Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP) announced that the European Medicines Agency (EMA) accepted to review the Marketing Authorization Application (MAA) for difelikefalin injection for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients. The EMA will review the application under the centralized marketing authorization procedure. If approved, difelikefalin injection would receive marketing authorization in all member states of the European Union (EU), as well as in Iceland, Liechtenstein, and Norway. The EMA is expected to render a decision on the EU MAA in the second quarter of 2022.

    The Company is party to a license agreement with Vifor (International) Ltd. (Vifor) dated October 2020 under which it granted Vifor an exclusive license to commercialize KORSUVA Injection for the treatment of pruritus in hemodialysis patients in the United States under a Cara 60%, Vifor 40% profit-sharing arrangement. Under the terms of the agreement, upon U.S. regulatory approval of KORSUVA Injection, the Company will be eligible to receive a $50.0 million common stock investment at a 20% premium to the 30-day trailing average price of the Company's common stock as of such date. In addition, the Company is eligible to receive payments of up to $240.0 million upon the achievement of certain sales-based milestones.

    Oral KORSUVA: Atopic Dermatitis (AD)

    In April 2021, the Company announced top-line results from its Phase 2 KARE dose-ranging clinical trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in mild-to-severe atopic dermatitis patients. The study did not meet its primary endpoint of Worst Itch – Numeric Rating Scale (WI-NRS) change from baseline at week 12 or secondary endpoint of 4-point responder analysis in the intent to treat (ITT) patient population. However, in a pre-specified analysis of mild-to-moderate (BSA <10%) AD patients (64% of ITT patient population), the study met its primary endpoint of WI-NRS change and secondary endpoint of 4-point responder analysis in this patient population. Additionally, a statistically significant improvement was demonstrated in the 4-point responder analysis, which we expect will be the Phase 3 registrational endpoint, in mild-to-moderate AD patients, with 32% of KORSUVA-treated patients achieving a greater than 4-point reduction vs. 19% in placebo group (p=0.03). Oral KORSUVA was generally well-tolerated across all doses.

    The Company is scheduled to conduct an End of Phase 2 Meeting with the FDA in the third quarter of 2021 and, subject to discussions with the FDA, plans to initiate a Phase 3 program in mild-to-moderate AD patients by year-end 2021.

    Oral KORSUVA: Non-Dialysis Dependent (NDD) CKD-aP

    In April 2021, the Company held an End of Phase 2 Meeting with the FDA to discuss the results of the Phase 2 trial of Oral KORSUVA in NDD CKD-aP and the potential Phase 3 program. The FDA indicated the acceptability of Stage 5 pre-dialysis CKD patients as a viable patient population for a Phase 3 trial. The FDA also indicated the potential to use data from the Company's previous trials of KORSUVA Injection in dialysis patients to support an approval based on a single Phase 3 clinical trial of Oral KORSUVA in the Stage 5 pre-dialysis population. The Company plans to meet with the FDA in the fourth quarter of 2021, to discuss the potential inclusion of earlier stage CKD patients in a Phase 3 program.

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

    The Company is currently 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 in this ongoing Phase 2 trial, and primarily due to the ongoing effects of the COVID-19 pandemic on patient enrollment, currently expects to report top-line data in the first half of 2022.

    Oral KORSUVA: Notalgia Paresthetica (NP)

    The Company initiated a Phase 2 trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in patients suffering from NP, a nerve disorder characterized by chronic pruritus of the upper back, in early 2021. Currently, the Phase 2 trial has exceeded 50% patient enrollment and is expected to be fully enrolled by year-end 2021.

    The Phase 2 multicenter, randomized, double-blind, placebo-controlled 8-week study is designed to evaluate the efficacy and safety of Oral KORSUVA for moderate-to-severe pruritus in approximately 120 subjects with NP. Subjects will be randomized to receive Oral KORSUVA 2.0 mg twice daily versus placebo for 8 weeks, followed by a 4-week active extension period. The primary efficacy endpoint is the change from baseline in the weekly mean of the daily 24-hour WI-NRS score at week 8 of the treatment period. Secondary endpoints include change from baseline in itch-related quality of life scores and a change from baseline in itch-related sleep disturbance subscale at the end of week 8.

    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. The Company is working closely with its clinical and commercial manufacturing partners to continue to ensure sufficient supply of KORSUVA is available for its ongoing and planned 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 Meeting Activities

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

    • Cantor Fitzgerald Global Healthcare Conference, September 27-30, 2021
    • Stifel Healthcare Conference, November 16-17, 2021
    • Jefferies Global Healthcare Conference, November 16-18, 2021
    • Piper Sandler Health Care Conference, November 30-December 2, 2021

    Second Quarter 2021 Financial Results

    Cash, cash equivalents and marketable securities at June 30, 2021 totaled $207.4 million compared to $251.5 million at December 31, 2020. The decrease in the balance primarily resulted from cash used in operating activities of $44.7 million, partially offset by proceeds of $1.0 million from the exercise of stock options.

    For the three months ended June 30, 2021, net loss was $30.7 million, or $0.61 per basic and diluted share, compared to a net loss of $25.1 million, or $0.54 per basic and diluted share, for the same period in 2020.

    Revenues: There was no revenue for the three months ended June 30, 2021, compared to $5.6 million during the same period of 2020. The Company recognized $5.1 million of license and milestone fees revenue during the three months ended June 30, 2020, $4.5 million of which related to its license agreement with VFMCRP and $0.6 million of which related to the achievement of a development milestone related to its license agreement with Chong Kun Dang Pharmaceutical Corp. The Company also 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.

    Research and Development (R&D) Expenses: R&D expenses were $25.2 million for the three months ended June 30, 2021 compared to $26.1 million in the same period of 2020. The lower R&D expenses in 2021 were principally due to a net decrease in costs associated with clinical trials, stock compensation expense and cost of compound sales, partially offset by a $10.0 million milestone earned by Enteris Biopharma, Inc. during the three months ended June 30, 2021, increases in payroll and related costs, and increases in travel and related costs.

    General and Administrative (G&A) Expenses: G&A expenses were $5.7 million for the three months ended June 30, 2021 compared to $5.4 million in the same period of 2020. The higher G&A expenses in 2021 were principally due to an increase in payroll and related costs, commercial costs and legal fees, partially offset by decreases in stock compensation expense and consultants' costs.

    Other Income, net: Other income, net was $0.1 million for the three months ended June 30, 2021 compared to $0.6 million in the same period of 2020. The decrease in other income, net was primarily due to a decrease in interest income resulting from a lower yield on the Company's portfolio of investments in the 2021 period.

    Financial Guidance

    Based on timing expectations and projected costs for current clinical development plans, Cara expects that its existing unrestricted cash and cash equivalents and available-for-sale marketable securities as of June 30, 2021 will be sufficient to fund its currently anticipated operating expenses and capital expenditures into 2023, without giving effect to any potential milestone payments or potential product revenue under existing collaborations. 

    Conference Call

    Cara management will host a conference call today at 4:30 p.m. ET to discuss second quarter 2021 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 1568596. 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 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. The FDA has accepted and granted Priority Review for the NDA for KORSUVA (difelikefalin) Injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA is August 23, 2021. Oral KORSUVA has completed Phase 2 trials for the treatment of pruritus in patients with CKD and AD and is currently in Phase 2 trials in PBC and NP 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 initiation, enrollment and data readouts from the Company's planned and ongoing clinical trials, the potential results of ongoing clinical trials, timing of future regulatory and development milestones for the Company's product candidates and potential commercialization of KORSUVA Injection for CKD-aP, the expected timeline for conducting meetings with the FDA concerning the Company's product candidates, including Oral KORSUVA for NDD CKD-aP and AD, 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 Annual Report on Form 10-K 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.

     

        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,  
        2021  2020  2021  2020 
           
    Revenue:             
     License and milestone fees $ - $ 5,099 $ 1,192 $ 13,120 
     Collaborative revenue  -  -  706  - 
     Clinical compound revenue  -  535  37  607 
    Total revenue  -  5,634  1,935  13,727 
                   
    Operating expenses:             
     Research and development  25,225  26,108  44,356  59,644 
     General and administrative  5,651  5,410  12,016  9,968 
    Total operating expenses  30,876  31,518  56,372  69,612 
    Operating loss  (30,876)  (25,884)  (54,437)  (55,885) 
                   
    Other income, net  131  634  391  1,591 
    Loss before benefit from income taxes  (30,745)  (25,250)  (54,046)  (54,294) 
                   
    Benefit from income taxes  -  182  -  304 
    Net loss $ (30,745) $ (25,068) $ (54,046) $ (53,990) 
                   
    Net loss per share:             
    Basic and Diluted $ (0.61) $ (0.54) $ (1.08) $ (1.15) 
                   
    Weighted average shares:             
    Basic and Diluted  50,059,984  46,799,703  49,989,379  46,762,327 
                   



    CARA THERAPEUTICS, INC. 
    CONDENSED BALANCE SHEETS 
    (in thousands) 
    (unaudited) 
           
       June 30, December 31, 
        2021   2020  
         
    Assets     
    Current assets:     
     Cash and cash equivalents $22,335  $31,683  
     Marketable securities  132,841   149,242  
     Income tax receivable  697   1,507  
     Other receivables  305   557  
     Prepaid expenses  8,295   12,076  
    Total current assets  164,473   195,065  
     Operating lease right-of-use assets  3,641   4,279  
     Marketable securities, non-current  52,216   70,565  
     Property and equipment, net  716   840  
     Restricted cash  408   408  
    Total assets $221,454  $271,157  
           
    Liabilities and stockholders' equity     
    Current liabilities:     
     Accounts payable and accrued expenses $13,493  $16,881  
     Operating lease liabilities, current  1,677   1,602  
    Total current liabilities  15,170   18,483  
           
     Operating lease liabilities, non-current  2,818   3,673  
           
    Commitments and contingencies  -   -  
           
    Stockholders' equity:     
     Preferred stock  -   -  
     Common stock  50   50  
     Additional paid-in capital  649,784   641,195  
     Accumulated deficit  (446,363)  (392,317) 
     Accumulated other comprehensive (loss) income (5)  73  
    Total stockholders' equity  203,466   249,001  
    Total liabilities and stockholders' equity $221,454  $271,157  
           

    INVESTOR CONTACT:

    Janhavi Mohite

    Stern Investor Relations, Inc.

    212-362-1200

    Janhavi.Mohite@sternir.com

    MEDIA CONTACT:

    Claire LaCagnina

    6 Degrees

    315-765-1462

    clacagnina@6degreespr.com



    Primary Logo

    View Full Article Hide Full Article
  3. STAMFORD, Conn., Aug. 02, 2021 (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, today announced that the Company will host a conference call and live audio webcast on Monday, August 9, 2021 at 4:30 p.m. ET to report second quarter 2021 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 1568596. A live webcast of the call can be accessed under "Events & Presentations" in the News & Investors section of the Company's…

    STAMFORD, Conn., Aug. 02, 2021 (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, today announced that the Company will host a conference call and live audio webcast on Monday, August 9, 2021 at 4:30 p.m. ET to report second quarter 2021 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 1568596. 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. The FDA has accepted and granted Priority Review for the NDA for KORSUVA (difelikefalin) Injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA is August 23, 2021. Oral KORSUVA has completed Phase 2 trials for the treatment of pruritus in patients with CKD and AD and is currently in Phase 2 trials in PBC and NP 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:

    Claire LaCagnina

    6 Degrees

    315-765-1462

    clacagnina@6degreespr.com

    INVESTOR CONTACT:

    Janhavi Mohite

    Stern Investor Relations, Inc.

    212-362-1200

    janhavi.mohite@SternIR.com



    Primary Logo

    View Full Article Hide Full Article
  4. DALLAS, June 11, 2021 /PRNewswire/ -- SWK Holdings Corporation (NASDAQ:SWKH), a life sciences focused specialty finance company catering to small- and mid-sized commercial-stage companies, today announced that its wholly-owned subsidiary, Enteris BioPharma, received a $10 million milestone payment from Cara Therapeutics (NASDAQ:CARA) related to the license agreement for the Peptelligence® oral formulation technology utilized in Oral KORSUVA™, the oral formulation of Cara's first-in-class KOR agonist, CR845/difelikefalin. Enteris is entitled to retain $3.9 million of this payment per the contractual splits agreed to in the Enteris acquisition agreement.  

    This milestone payment was triggered by confirmation from Cara of the completion of an End-of-Phase…

    DALLAS, June 11, 2021 /PRNewswire/ -- SWK Holdings Corporation (NASDAQ:SWKH), a life sciences focused specialty finance company catering to small- and mid-sized commercial-stage companies, today announced that its wholly-owned subsidiary, Enteris BioPharma, received a $10 million milestone payment from Cara Therapeutics (NASDAQ:CARA) related to the license agreement for the Peptelligence® oral formulation technology utilized in Oral KORSUVA™, the oral formulation of Cara's first-in-class KOR agonist, CR845/difelikefalin. Enteris is entitled to retain $3.9 million of this payment per the contractual splits agreed to in the Enteris acquisition agreement.  

    This milestone payment was triggered by confirmation from Cara of the completion of an End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) for Oral KORSUVA in patients with non-dialysis dependent (NDD) chronic kidney disease (CKD-aP). Cara has indicated that it currently plans to initiate a Phase 3 program by year-end 2021. Enteris received two previous milestone payments totaling $5 million during the fourth quarter of 2020 of which Enteris retained $3 million. Enteris is eligible to receive additional potential milestone payments over the next several quarters, subject to the achievement of certain development milestones for Oral KORSUVA.

    "This is the third and largest milestone payment generated by the Cara Therapeutics licensing agreement for Oral KORSUVA, validating Enteris' ability to produce value for its pharmaceutical partners and SWK's shareholders," stated Winston Black, Chairman and CEO of SWK. "The milestones generated from the Cara licensing agreement also highlight the ongoing potential to monetize Enteris' Peptelligence and ProPerma™ technologies, given the numerous market and patient advantages of developing oral tablet formulations of peptides and small molecules.  Enteris' oral delivery technologies, combined with its manufacturing capacity and CDMO capabilities, make it a potentially attractive partner to a range of pharmaceutical and biotechnology companies."

    Oral KORSUVA was engineered using Enteris' Peptelligence technology, which is designed to enable the oral delivery of peptides and BCS class II, III and IV small molecules. Oral KORSUVA is currently the subject of four separate clinical programs for pruritus in patients with hepatic impairment due to primary biliary cholangitis (PBC), stage III-V chronic kidney disease (CKD), atopic dermatitis (AD) and notalgia paresthetica (NP). These programs have multiple milestones anticipated to be achieved throughout 2021, including top line Phase 2 data from the PBC program and the initiation of a Phase 3 trial in atopic dermatitis.

    In August 2019, Enteris and Cara entered into a licensing agreement whereby Enteris granted to Cara a non-exclusive, royalty-bearing license to the Peptelligence technology to develop, manufacture and commercialize Oral KORSUVA worldwide, excluding Japan and South Korea.  Enteris is eligible to receive milestone payments upon the successful achievement of certain development, regulatory and commercial milestones and low single-digit royalties based on net sales in the licensed territory.  

    About SWK Holdings:

    SWK Holdings Corporation is a specialized finance company with a focus on the global healthcare sector. SWK partners with ethical product marketers and royalty holders to provide flexible financing solutions at an attractive cost of capital to create long-term value for both SWK's business partners and its investors. SWK believes its financing structures achieve an optimal partnership for companies, institutions and inventors seeking capital for expansion or capital and estate planning by allowing its partners to monetize future cash flow with minimal dilution to their equity stakes. SWK also owns Enteris BioPharma, whose Peptelligence® and ProPerma™ drug delivery technologies create oral formulations of peptide-based and BCS class II, III, and IV small molecules. With Enteris, SWK has the opportunity to grow its specialty finance business by actively building a wholly-owned portfolio of milestones and royalties through licensing activities. Additional information on the life science finance market is available on the Company's website at www.swkhold.com.

    Safe Harbor Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect SWK's current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" and elsewhere in SWK's Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein, could affect the Company's future financial results and could cause actual results to differ materially from those expressed in such forward-looking statements. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause the Company's actual results to differ materially from expected and historical results. You should not place undue reliance on any forward-looking statements, which speak only as of the date they are made. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

    Cision View original content:http://www.prnewswire.com/news-releases/swk-holdings-subsidiary-enteris-biopharma-receives-10-million-milestone-payment-from-cara-therapeutics-301310664.html

    SOURCE SWK Holdings Corporation

    View Full Article Hide Full Article
View All Cara Therapeutics Inc. News