Cara Therapeutics, Inc.

Good afternoon and welcome to Kara therapeutics fourth quarter and full year 2020 financial results conference call all participants are now in listen only mode. There will be a question and answer session at the end, please be advised that this call is being recorded at Kara's request. I would now like to turn the call over to charity, please proceed.

Good afternoon. This is Jack Hildik-Smith with Stern Investor Relations and welcome to CARA Therapeutics' fourth quarter and full year 2020 financial results and update conference call. The news release became available just after 4 p.m. today and can be found on our website at www.caratherapeutics.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 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 Corsupa IV, the potential for the company's product candidates to be alternatives in the therapeutic areas investigated, 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 factors section of the company's most recently filed quarterly report on Form 10Q 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 day 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 day on which they were made. Participating in today's call are Dr. Derek Chalmers, CARE President and CEO, and CARE Chief Financial Officer Thomas Riley. I'll now turn the call over to Dr. Chalmers.

Thank you, Jack. Good afternoon, everybody. and thanks for joining us on the call this afternoon. So despite the circumstances that we're all painfully aware of, 2020 was certainly a significant and very productive year for CARA. As we advanced the late stage clinical development of our lead product candidate, Kursuva, for the treatment of the virus across a range of patient populations. Culminating, as we announced today, in the recent acceptance and filing of our NDA for Cursiva injection for the treatment of pruritus in hemodialysis patients. This NDA filing marks a truly significant milestone for our company, and most importantly, for the large proportion of hemodialysis patients who suffer from this intractable, untreatable pruritus that is so detrimental to their quality of life. And I'd like to thank the entire CARA team who've worked tirelessly to bring this first-in-class therapeutic from in-house discovery through development to the completion of FDA filing. And we look forward to working with the FDA throughout the review process and if granted priority review, potential approval, and commercial launch in the second half of this year. Now, with respect to Cursiva injection commercial launch, we were also very pleased to execute a strategic license agreement with V4 Pharma in Q4 of last year for the commercialization of Cursiva injection in U.S. dialysis clinics. We believe that V4's established U.S. nephrology sales force and productive relationships with U.S. dialysis organizations will provide a basis for increased launch momentum and adoption of Drosuva injection in the U.S. market. And I'll cover the details for that arrangement in a little bit. Lastly, we also expanded our oral Drosuva clinical development program with the initiation of a fourth phase two trial in patients suffering from neuropathic-related pruritus. specifically Natalja Parasetica patients. Evaluating the ability to treat pruritus of a neuropathic origin, in addition to our ongoing clinical development programs in systemic and dermatological chronic pruritus, will further support the use of oral Cruciva as a future broad anti-pruritic agent. Building on this momentum from 2020, In addition to protected approval and launch of prosuva injection in the second half of 21, we expect major clinical data readouts and advancements throughout the upcoming year. And on the call today, I'll provide a brief update on each of our programs and what to expect throughout 2021. Before I get to that, 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. And I'm pleased to say that due to the entire CARA team's continuous dedication and hard work, we remain on track today to meet our main clinical and regulatory goals for the year and continue to enroll patients across ongoing oral Cursiva trials. So getting to the program, starting with our lead program for Cursiva injection in hemodialysis patients with CKD-associated pruritus. As a reminder, this is a patient population where there is significant unmet need with approximately 40 to 50 percent of patients suffering from moderate to severe pruritus with no therapies currently approved in the U.S. or in Europe. So we believe prosuva injection has potential to fundamentally change the treatment paradigm for these patients. With the NDA for prosuva injection now filed, we remain focused, along with our U.S. licensing partner, V4 Pharma, on preparation for an anticipated U.S. commercial launch as early as the second half of this year. Now, as a reminder, under the terms of the V4 license agreement, Carrier received an upfront payment of $150 million, composed of $100 million in cash and $50 million in equity purchase. Upon U.S. approval, CARA is eligible to receive a further $50 million equity purchase, and there is potential U.S. commercial sales milestones of up to $240 million. VIFAR will have the exclusive rights to commercialize Cursiva injection in non-frazenious medical care North America dialysis clinics in the U.S. under a CARA 60% v for 40% profit-sharing arrangement. and that's based on profit from net non-Fresenius medical care clinic sales. Recall from our original CARA V4 Fresenius license agreement that we executed in 2018, we have an established 50-50 profit split arrangement in Fresenius clinics already in place for the US. So overall, we see this as an ideal agreement which allows us to both leverage V4 has established commercial infrastructure and capabilities and retained commercial upside from our profit sharing arrangement. Transition of both medical affairs and commercial launch activities to the V4 teams have progressed well since we executed that agreement over the last two quarters and we're well prepared for a potential Cursiva injection US launch as early as the second half of this year. Moving on to our pipeline programs focused on oral Kursuva. And let's start with our program in predialysis CKD patients with moderate to severe pruritus. We have previously reported positive top line results from our 12-week phase 2 trial, evaluating the safety and efficacy of three tablet strands of oral Kursuva, 0.25, 0.5, and 1 milligram once daily. Based on that data, we identified the one milligram tablet strength of oral Krasuva as the dose level to take forward into phase three. To that end, we will be conducting an end of phase two meeting with the FDA in Q2 of this year, which will enable a projected pivotal phase three trial initiation in the second half of 2021. Moving on to atopic dermatitis and their ongoing care, Phase II dose-ranging trial. In Q2 of 2020, we completed a planned interim unblinded conditional power assessment conducted after approximately 50% of the originally targeted patient number completed the designated 12-week treatment period. Based on the Independent Data Monitoring Committee's recommendation and to maintain a conservative statistical power on our main endpoints, we increased the target trial size by approximately 28%. In Q4 of last year, we announced the trial was fully enrolled at approximately 400 patients, and we currently expect to read our top line data in the first half of this year. Finally, with the goal of further establishing the broad antichorotic applicability of PROSUVA across patient populations, We recently announced the initiation of a phase two proof of concept trial for the treatment of moderate to severe pruritus in patients suffering from Natalgia Parasitica, or NP, as a nerve disorder characterized by chronic pruritus of the upper to middle back. It's estimated that chronic pruritus affects up to 13% of the United States population, and about 8% of these patients suffer from some form of neuropathic itch, including NP. There is currently no well-defined treatment for NP, and conventional treatments such as antihistamines and topical steroids are largely ineffective. So there remains a significant opportunity for oral Cursiva as a novel therapeutic approach for these patients. So overall, our progress in 2020 has laid the foundation for a transformative year ahead at CARA. We very much look forward to the projected approval and commercial launch of Cursiva injection in the second half of 2021. Top line data readout from our CARE phase two trial of oral Cursiva in atopic dermatitis in the first half of 21. Initiation of our phase three registration trials for oral Cursiva in stage three to five predialysis CKD patients in the second half of this year, as well as continued progress on ongoing phase two trials in liver disease patients and NP patients. And we'll be bringing updates on the progress across all of these programs in the coming quarters. So with that, I'll now turn over to Tom to detail the financial results for the quarter and for the full year. Tom.