Cara Therapeutics, Inc.

Good afternoon and welcome to CARA Therapeutics First Quarter 2021 Financial Results Conference Call. All participants are now in a reason-only mode. There will be a question and answer session at the end. Please be advised that this call is being recorded at CARA's request. I would now like to turn the call over to the CARA team. Please proceed.

Jack Hildik- Good afternoon. This is Jack Hildik-Smith with Stern Investor Relations and welcome to Care Therapeutics first quarter 2021 financial results and update conference call. The news release became available just after 4pm today and can be found on our website at www.caretherapeutics.com. You may also listen to a live webcast and replay of today's call on the investor section of the website. Before we begin, let me remind you that statements made on today's call 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 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, including the company's projected timeline for FDA review and potential approval and commercial launch of Corsuva injection for dialysis-dependent CKDAP, the expected timeline for conducting meetings with the FDA concerning the company's product candidates, including oral Corsuva for NDD, CKDAP, and ADAP, the potential for the company's product candidates to be alternatives in the therapeutic areas investigated, the potential impact of COVID-19 on the company's clinical development and regulatory timelines and plans, and the company's expected cash reach. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in care therapeutics filings with the Securities and Exchange Commission, including the risk factor 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 made in today's call speak only as of the date on which they were made, CARE 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. Participating on today's call are Dr. Derek Chalmers, CARE President and CEO, and CARE Chief Financial Officer, Thomas Riley. I will now turn the call over to Dr. Chalmers.

Thank you, Jack. Good afternoon, everybody, and thanks for joining us on the call this afternoon. We have continued to make very important progress across our Kursuva development pipeline in the first quarter of 2021, culminating with the FDA acceptance of our first NDA filing for our lead product candidate, Kursuva injection. With priority review granted, we look forward to our PDUFA target action date of August 23rd of this year. Our interactions with the FDA on the NDA review have progressed on schedule, and through the completion of our mid-cycle review, no advisory committee is planned to date. With our PDUFA date tracking for next quarter, our commercial license agreement with V4 Pharma in place, we remain focused on preparation for the U.S. launch of Kursuva injection in the second half of this year. As a reminder, CARA executed a strategic license agreement with V4 Pharma in the fourth quarter of last year for the commercialization of Cursiva injection in U.S. dialysis clinics. We're confident that V4's established U.S. nephrology sales force and relationships with U.S. dialysis organizations, both large and small, will support increased launch momentum and adoption of Cursiva injection in the U.S. marketplace. The financial considerations received on entering into the VFOR agreement contribute significantly to the current strength of our balance sheet. Further to the terms of that agreement, upon U.S. regulatory approval for Cursiva injection, the company will be eligible to receive an additional $50 million common stock investment, and then post-launch be eligible to receive payments of up to $240 million in sales-based commercial milestones. Turning to ex-U.S. commercialization planning, we were also very pleased to announce in the first quarter that the European Medicines Agency accepted the marketing authorization application for difelocephalin injection for the treatment of pruritus associated with chronic kidney disease and hemodialysis patients. will review the application under the centralized marketing authorization procedure. Under our 2018 license agreement with V4 Fresenius, they will be responsible for the commercialization of Trasuva injection across European territories, with CARA eligible to receive tiered double-digit royalty payments based on annual net sales and up to $440 million in tiered commercial milestones all of which are sales related. The EMA is expected to render a decision in the second quarter of 2022. Moving on to progress on our oral Kursuva pipeline, we recently announced top line results from the care phase two dose ranging trial of oral Kursuva for the treatment of moderate to severe pruritus in mild to severe atopic dermatitis patients. The trial was a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of oral cruciva for moderate to severe pruritus in 401 adult subjects with atopic dermatitis. Patients were stratified across treatment groups by disease severity, with approximately 64% of patients characterized by mild to moderate atopic dermatitis, and approximately 36 percent of patients characterized by moderate to severe atopic dermatitis. Patients were randomized to three tablet strands of oral Cruciva, 0.25, 0.5, and 1 milligram, taken twice daily versus placebo for 12 weeks, followed by four weeks of an active extension phase. While care did not meet the main endpoints in the ITT population, In a pre-specified analysis, a statistically significant change in the primary efficacy endpoint was observed in the mild to moderate patient population, which was evident at week one and sustained through the treatment period. A statistically significant improvement was also observed in the four-point responder analysis in the mild to moderate patient population, with 32 percent of Krasuva-treated patients achieving a four-point or greater reduction in NRS at week 12 versus 19% in the placebo group. These care results have provided key information related to a defined patient group that is mild to moderate, an active dose range, which corresponds to that observed in our previous oral Krasuva CKD Phase II trial, an effect size on the registration four-point responder endpoint from which to design phase three trials. With this in hand, we plan to conduct an end of phase two meeting with the FDA to discuss the clinical path forward with the goal of initiating a phase three program for oral cursiva in mild to moderate AD patients by year end. We also plan to present additional data analysis from the CAER trial at an upcoming medical meeting. Moving on to our program in predialysis CKD patients with moderate to severe pruritus. We have previously reported positive top-line results from our 12-week Phase II trial, evaluating the safety and efficacy of the three tablet strands of oral Cruciva, 0.25, 0.5, and 1 milligram once daily. and identified the 1-meg tablet strength to take forward into Phase III. To that end, we recently conducted an end-of-Phase II meeting with the FDA with the goal of defining a Phase III program in predialysis CKD patients, which would allow us to leverage the substantial clinical efficacy and safety dataset we've compiled with Gresuva injection in hemodialysis patients. The FDA has indicated the viability of stage five predialysis CKD patients as a population for a phase three program, and also indicated the potential to use data from our previous trials of Kursuva injection and dialysis patients to support an approval based on a single phase three clinical trial. We believe this approach could provide an expeditious path to an NDA, for oral Krasuva and predialysis CKD patients, and we currently plan to initiate our phase three program by year end. We also plan to continue our discussion with the agency on the potential inclusion of earlier stage CKD patients in the same program. Before moving on to our ongoing trials with oral Krasuva, Let me remind you that due to the ongoing COVID-19 pandemic and in accordance with the FDA's updated guidance for conducting clinical trials, we have implemented numerous clinical and operational measures to prioritize the health and safety of patients, our employees and study investigators, and to minimize potential disruptions to our ongoing clinical studies. Due to the entire CARA team's continued dedication and hard work, We remain on track to meet our main clinical and regulatory goals for the year and continue to enroll patients across oral Cursiva trials. Moving on to our program in patients with primary biliary cholangitis, we're conducting an ongoing proof of concept phase two trial of oral Cursiva in PBC patients with moderate to severe pruritus. As pruritus is a common symptom of cholestatic liver diseases, 20 to 30% of patients experience pruritus, including up to 70% of patients with PBC. Our 16-week trial is designed to evaluate the safety and efficacy of the one milligram tablet of oral Krasuva taken twice daily versus placebo. The primary endpoint is the change from baseline, the weekly mean of the daily 24-hour worst HNRS score at week 16. We aim to report top-line data from this study in the second half of 2021. Finally, with the goal of further establishing the broad antipyretic applicability of Kursuva across patient populations and underlying pathologies, we recently announced the initiation of a Phase II POC trial of oral Kursuva for the treatment of moderate to severe pruritus in patients suffering from Natalgia Parasitica, a nerve disorder characterized by chronic pruritus in the upper to middle back. It is estimated that chronic pruritus affects up to 13% of the U.S. population, and about 8% of these patients suffer from neuropathic itch, including metallurgia parasitica. There is currently no well-defined treatment of NP, and conventional treatments such as antihistamines and topical steroids are largely ineffective treatments. So there remains a significant opportunity for oral Kosova as a novel therapeutic approach here. And I'm happy to report that this trial is currently enrolling very well at over 20 active sites in North America. So overall, our progress through Q1 and recent months has laid the foundation for a very significant second half of 2021. We very much look forward to the projected approval and commercial launch of Cursiva injection. With a strong balance sheet, we're well positioned to support our goal of initiating our phase three programs in both atopic dermatitis and predialysis CKD patients by year end, as well as continue to progress our ongoing phase two trials in PBC and NP patients. And we'll be updating you on all of the progress across each of these programs in the coming quarters. So with that, let me turn it over to Tom to detail the financial results for the first quarter of this year. Tom.