Cara Therapeutics, Inc. (NASDAQ:CARA) Q3 2019 Results Earnings Conference Call November 5, 2019 4:30 PM ET Company Participants Jane Urheim - Stern Investor Relations Derek Chalmers - President & Chief Executive Officer Mani Mohindru - Chief Financial Officer & Chief Strategy Officer Conference Call Participants Chris Howerton - Jefferies David Amsellem - Piper Jaffray Annabel Samimy - Stifel Pete Stavropoulos - Cantor Fitzgerald Esther Hong - Janney Chris Howerton - Jefferies Operator Good afternoon, and w ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER 001-36279 CARA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 75-3175693 (State or other jurisdiction of incorporation ...

Cara Therapeutics, Inc. (NASDAQ:CARA) Q2 2019 Earnings Conference Call August 7, 2019 4:30 PM ET Company Participants Jane Urheim - Stern Investor Relations Derek Chalmers - President & Chief Executive Officer Mani Mohindru - Chief Financial Officer & Chief Strategy Officer Conference Call Participants Jason Gerberry - Bank of America David Amsellem - Piper Jaffray Nick Rubino - Stifel Charles Duncan - Cantor Fitzgerald Alan Carr - Needham & Company Esther Hong - Janney Operator Good afternoon and welcome t ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER 001-36279 CARA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 75-3175693 (State or other jurisdiction of incorporation or organization) (I.R.S ...

KORSUVA™ Development Programs - KORSUVA™ Injection is in Phase 3 development for CKD-associated pruritus (CKD-aP) in hemodialysis patients, with positive topline data from the KALM-1 trial reported in May 2019 and topline data from the KALM-2 trial expected in 2H19[3] - Oral KORSUVA™ has multiple programs including a Phase 2 trial ongoing for CKD-aP in non-dialysis patients with data expected in 2H19, a Phase 2 trial expected to initiate in 2Q19 for chronic liver disease-associated pruritus, and a Phase 2 trial expected to initiate around mid-year 2019 for atopic dermatitis[3] - The FDA has conditionally accepted KORSUVA™ as the trade name for CR845 / difelikefalin for pruritic indications[8] Market Opportunity - Chronic kidney disease-associated pruritus (CKD-aP) affects approximately 40% to 50% of patients with renal failure[5] - Approximately 20% to 30% of patients with cholestatic liver disease experience pruritus[5] - In the U S, approximately 50% of the 20 million atopic dermatitis (AD) patients seek treatment for pruritus[6] - In the U S, approximately 50% of the 8 million psoriasis patients seek treatment for pruritus[7] - Approximately 60% to 70% of hemodialysis (HD) patients report pruritus[10] - Approximately 30% to 40% of hemodialysis patients with CKD-aP have moderate to severe itch intensity[10] - There are approximately 468,000 patients on dialysis in the US[11] KALM-1 Trial Results - In the KALM-1 Phase 3 trial, 51% of KORSUVA™-treated subjects achieved ≥3 point improvement in weekly mean of daily worst itching intensity NRS (WI-NRS) compared to 28% in the placebo group (p = 000019)[21] - In the KALM-1 Phase 3 trial, 39% of KORSUVA™-treated subjects achieved ≥4 point improvement in weekly mean of daily WI-NRS compared to 18% in the placebo group (p = 000032)[22] Financial Status - As of March 31, 2019, the company had $1561 million in cash and marketable securities[38]

Financial Data and Key Metrics Changes - For Q1 2019, the company reported a net loss of $22 million or $0.56 per share, compared to a net loss of $16.8 million or $0.51 per share in Q1 2018 [27] - R&D expenses increased to $23.6 million from $13.4 million in the same period of 2018, primarily due to higher clinical trial costs and increased stock compensation and payroll-related costs [28] - G&A expenses were $3.9 million in Q1 2019, slightly up from $3.7 million in Q1 2018, attributed to increased legal and consulting costs [29] - Cash and marketable securities totaled $15.1 million as of March 31, 2019, down from $182.8 million at the end of 2018, mainly due to cash used in operations of $27.5 million [30] Business Line Data and Key Metrics Changes - The lead drug candidate, KORSUVA, is advancing in clinical trials for chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis patients, with two pivotal Phase III trials (KALM-1 and KALM-2) ongoing [6][10] - KORSUVA Injection has received breakthrough therapy designation from the FDA for CKD-aP, indicating significant unmet medical need [14] - The company is also progressing Oral KORSUVA in a Phase II trial for pre-dialysis CKD-aP patients, with plans to initiate additional trials for chronic liver disease and atopic dermatitis [9][25] Market Data and Key Metrics Changes - It is estimated that there are at least 2.5 million Stage III to V CKD patients in the U.S. suffering from pruritus, with current treatments primarily consisting of generic corticosteroids and antihistamines [22] - The company is targeting a significant market opportunity in pruritus across various patient populations, including those with chronic liver disease and atopic dermatitis [10][25] Company Strategy and Development Direction - The company aims to develop KORSUVA as a first-in-class therapeutic for hemodialysis patients suffering from pruritus, with multiple late-stage clinical readouts expected throughout the year [6][21] - The strategy includes expanding clinical trials to assess the efficacy of KORSUVA in various patient populations, thereby broadening its market potential [10][25] - The company is focused on meeting regulatory requirements and expediting the path to NDA filing through additional safety studies [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of clinical programs and the potential of KORSUVA to address significant unmet needs in pruritus [26] - The company anticipates top-line data from KALM-1 and KALM-2 trials by the end of 2019, which will be critical for future development and commercialization efforts [21][41] - Management acknowledged the increased clinical trial expenses and revised cash runway guidance to extend into Q4 2020, reflecting the accelerated development plans [31] Other Important Information - The company has initiated a second open-label safety study to satisfy long-term safety exposure requirements per ICH guidelines, enrolling up to 400 patients [20] - The company plans to provide more details on the design of upcoming trials for chronic liver disease and atopic dermatitis as they are initiated [25] Q&A Session Summary Question: Expectations for long-term safety exposure requirements - Management indicated that standard ICH guidelines require 100 exposures at the one-year mark and 300 at the six-month mark [33] Question: Enrollment rate in KALM-2 and interim data analysis - Management stated that they do not provide specific enrollment updates but expect top-line data by the end of the year [41] Question: Specific patient subgroups for the liver study - Management noted that the focus will likely be on patients with primary biliary cholangitis due to the consistent and severe pruritus observed in this subgroup [46][47] Question: Commercial preparation strategy and timing - Management indicated that commercial preparations will begin after confirming efficacy in the first Phase III trial, with initial planning already underway [58][59] Question: Severity of CKD patients in the study - Management reported that the average patient has been on hemodialysis for 5 to 6 years and experiences moderate-to-severe pruritus [62]

Product Development and Trials - KORSUVA (CR845/difelikefalin) injection has shown statistically significant reductions in itch intensity in Phase 2 trials for hemodialysis patients with moderate-to-severe CKD-associated pruritus (CKD-aP) and is currently in Phase 3 trials[170]. - KORSUVA (CR845/difelikefalin) injection has received Breakthrough Therapy Designation from the FDA in June 2017, indicating its potential in treating CKD-aP[179]. - The product candidate pipeline includes ongoing Phase 3 trials for KORSUVA (CR845/difelikefalin) injection in CKD-aP and Phase 2 trials for Oral KORSUVA in CKD and chronic liver disease[179]. - The first pivotal Phase 3 efficacy trial of KORSUVA (CR845/difelikefalin) injection for CKD-aP treatment in hemodialysis patients was initiated in Q1 2018, with top-line data expected in Q2 2019[182]. - KALM-1 Phase 3 trial enrolled over 350 hemodialysis patients across approximately 60 clinical sites, with top-line data expected in Q2 2019[184]. - The second Phase 3 trial (KALM-2) began in August 2018, aiming to enroll patients in the U.S. and multiple countries, with top-line data expected in H2 2019[185]. - A 52-week Phase 3 safety trial initiated in Q2 2017 is evaluating KORSUVA injection's long-term safety, with approximately 150 patients having completed at least six months of treatment[186]. - A new open-label Phase 3 safety trial was initiated in Q2 2019, expected to enroll up to 400 hemodialysis patients[187]. - The Phase 2 trial of Oral KORSUVA for CKD patients began in July 2018, with top-line data expected in H2 2019[194]. - The investigational new drug application for Oral KORSUVA for chronic liver disease-associated pruritus was submitted in Q4 2017, with a Phase 1 trial completed[198]. - A multi-dose Phase 2 trial for Oral KORSUVA in atopic dermatitis is expected to be initiated around mid-2019[201]. - CR845/difelikefalin is being investigated for acute postoperative pain relief, designed to avoid mu opioid receptor stimulation[202]. - CR845/difelikefalin injection achieved statistical significance for pain relief over 24 hours with the 1.0 mcg/kg dose versus placebo (p=0.032)[204]. - The Phase 2b trial of Oral CR845/difelikefalin showed a statistically significant 39% reduction in mean joint pain score for patients with OA of the hip on the 5.0 mg dose (p=0.043)[216]. Financial Performance - Total revenue recognized to date is $5.3 million from clinical development or regulatory milestone payments and sub-license fees[219]. - Total revenue for the three months ended March 31, 2019, was $4.38 million, a 100% increase compared to the same period in 2018[231]. - License and milestone fees revenue was $4.24 million for the three months ended March 31, 2019, with no revenue reported for the same period in 2018[232]. - Research and development (R&D) expenses totaled $23.61 million for the three months ended March 31, 2019, representing a 76% increase from $13.43 million in 2018[234]. - Direct clinical trial costs increased to $17.74 million, a 90% rise compared to $9.35 million in the prior year[234]. - Other income increased to $1.09 million for the three months ended March 31, 2019, a 250% increase from $311,000 in 2018[238]. - General and administrative expenses for the three months ended March 31, 2019, were $3.91 million, a 6% increase from $3.70 million in 2018[237]. - Net losses for the three months ended March 31, 2019, were $22.0 million, compared to $16.8 million for the same period in 2018, with an accumulated deficit of $316.3 million as of March 31, 2019[256]. Cash and Capital Management - The company had $156.1 million in unrestricted cash and cash equivalents as of March 31, 2019, sufficient to fund operations into Q4 2020[248]. - The company expects existing cash and cash equivalents will be sufficient to fund anticipated operating expenses into the fourth quarter of 2020[264]. - The company may need to raise additional capital to meet development objectives, particularly for I.V. and Oral CR845/difelikefalin, which could dilute existing stockholders' ownership[263]. - The company plans to use proceeds from its recent underwritten offering to fund clinical trials and research development activities, including Phase 3 programs for KORSUVA[246]. - As of March 31, 2019, the company had invested $142.0 million in marketable securities with a yield of approximately 2.65%[281]. - Net cash used in operating activities for the three months ended March 31, 2019, was primarily due to a net loss of $22.0 million and cash outflows from changes in operating assets and liabilities totaling $3.3 million[269]. - Net cash provided by investing activities was $26.4 million for the three months ended March 31, 2019, mainly from maturities of available-for-sale marketable securities[273]. Risks and Uncertainties - The successful development of product candidates is highly uncertain, with numerous risks associated with clinical trials and regulatory approvals[260]. - The company has incurred significant operating and net losses since inception, with expectations to continue incurring such losses in the near future[256]. - The anticipated operating expenses will increase due to ongoing development of KORSUVA (CR845/difelikefalin) injection and Oral KORSUVA, as well as the establishment of sales and marketing infrastructure[257]. - The safety profile of CR845/difelikefalin injection was generally well tolerated across multiple studies with no clinically significant changes in ECG characteristics[209]. - The most common adverse events reported for CR845/difelikefalin included dizziness (8%), headache (6%), dry mouth (6%), and constipation (12%)[216]. - CR845/difelikefalin injection demonstrated no significant respiratory safety events in a Phase 1 trial with 15 healthy volunteers[212]. - The company does not intend to develop Oral CR845/difelikefalin for OA pain independently and will seek potential partners for further development[218]. Regulatory and Collaboration Efforts - The company has filed a shelf registration statement for aggregate offerings of up to $300 million to fund future operations and clinical trials, effective since April 4, 2019[175]. - The company retains all rights to KORSUVA (CR845/difelikefalin) in the United States and will promote it in U.S. dialysis clinics under a profit-sharing agreement with VFMCRP[170]. - The company aims to establish additional collaborations for its product candidates to enhance commercialization efforts[163]. - The company is eligible for up to $470 million in regulatory and commercial milestone payments under the VFMCRP Agreement[250]. - Under the Maruishi Agreement, the company could earn up to $6.0 million in clinical development milestones and $4.5 million in regulatory milestones[251].

Cara Therapeutics, Inc. (NASDAQ:CARA) Q4 2018 Earnings Conference Call March 12, 2019 4:30 PM ET Company Participants Jane Urheim - Stern Investor Relations Derek Chalmers - President and Chief Executive Officer Mani Mohindru - Chief Financial Officer and Chief Strategy Officer Conference Call Participants Christopher Howerton - Jefferies & Company, Inc. Jason Gerberry - Bank of America Merrill Lynch David Amsellem - Piper Jaffray Charles Duncan - Cantor Fitzgerald & Co. Annabel Samimy - Stifel, Nicolaus & ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K | --- | --- | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------| | CARA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) \nDelaware (State or other jurisdiction of incorporation or organization) | 75-3175693 (I.R.S. Employer Id ...