Cara Therapeutics, Inc.

Good afternoon. My name is May and I will be your conference facilitator. I would like to welcome everyone to CARA Therapeutics first quarter 2022 financial results and update conference call. All lines have been placed in mute to avoid any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star and the number one on your telephone keypad. If you would like to withdraw your question, press the pound on your telephone keypad. Please be advised that this call is being recorded. I would now like to introduce Iris Francesconi, Interim Head of Investor Relations from Kara Therapeutics. Ms. Francesconi, you may begin the call.

Thank you, May, and good afternoon. Just after markets closed today, we issued a press release detailing our corporate progress and financial results for the first quarter of 2022. The press release can be found on our website at www.careoftherapeutics.com. You may also listen to a live webcast and replay of today's call on the investor section of the website. Participating in today's call are Chris Hosner, CARES President and Chief Executive Officer. Tom Riley, CARES Chief Financial Officer, and Dr. Joanna Goncalves, CARES Chief Medical Officer. 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 Mitigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the company's ability to successfully commercialize procedure injection and Capudia, including the timing of product launches, planned future regulatory submissions, and potential future regulatory approvals, the company's ability to obtain and maintain coverage and adequate reimbursement for procedure injection, the performance of our commercial partners, including B4 Pharma, expected timing of the initiation of enrollment and data readouts, from the company's plans and ongoing clinical trials, the potential results of ongoing clinical trials, timing of future regulatory and development milestones for the company's product candidates, the potential for the company's product candidates to be alternatives in the therapeutic areas investigated, the size and growth of the potential markets for pruritus management, the company's expected cash rates and the potential impact of COVID-19, and the company's commercial launches 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 for such forward-looking statements. Risks are described more fully in care of therapeutic silence with the Securities and Exchange Commission, including the risk factors section of the company's annual report on Form 10-K for the year ending December 31st, 2021. and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained 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. With this, I will now turn the call over to Chris.

Thanks, Iris, and good afternoon, everyone. The first quarter was pivotal for Kara, as we are now a commercial stage company, moving our growth story forward. The first few weeks of Corsuba Injections US launch have proceeded as planned, and all of our programs, many of which we have recently detailed to you, remain on track. I will give some highlights on our encouraging progress in a moment. Tom will follow with the financial update, and after that, we will be available to take your questions. Kera Therapeutics has a unique mission, focus and value proposition. We are building the world leader in pruritus. We see this as a differentiated value proposition and opportunity. Chronic pruritus is often a severe, intractable problem for patients in a wide range of diseases, and it is underserved by currently used treatments. This quarter, we continue to execute on our three strategic priorities which we believe will put CARA on a firm path to sustainable growth. Of course, our first priority is to maximize the commercial potential of Corsuba injection. We are now in full launch mode in the U.S. As you will recall, the commercialization efforts in the U.S. are being led by our partner, V4 Pharma, a leading renal pharmaceutical company in the U.S. Now, we are still at a very early stage of the launch, so what we will share with you today is largely qualitative. Beginning in Q2, we will provide more quantitative data, which will paint a more detailed picture. Now, our primary objectives in the first four weeks of launch were to, A, have products shipped to wholesalers, B, have contract negotiations underway with the top dialysis organizations, C, Have DO systems updated with product pricing and reimbursement information to allow product ordering. D, pivot the sales force from disease awareness and patient identification to promoting course of injection. And E, enhance patient awareness to help steepen the launch trajectory. Now, I am pleased to report we are tracking to our expectations and are seeing very encouraging progress across all of these goals. Let me elaborate. First, course of injection is available to be ordered by dialysis clinics nationwide. The V4 team has been working diligently to ensure that the product pricing and reimbursement information is loaded into the respective systems so that orders can be placed. That means a physician can prescribe it to a patient when they are identified as a candidate for the product. And remember, Korsuga injection reimbursement is in place via Medicare and need to DAPA qualification. Now, V4 has shipped product to wholesalers, and wholesalers have started to ship product to dialysis clinics. I am pleased to report that patients have received commercial product at this point. Second, nephrologists are aware of Korsuga injection and ready and starting to prescribe. Since the launch meetings in March, the V4 sales force has transitioned from patient identification to product promotion. They are promoting course of injection to physicians, advanced practice providers, and nurses. And I am pleased to report that they have reached the majority of HCPs at least once in the past four weeks. Now, anecdotally, palpable excitement is also evident within the nephrology community around the introduction of this new breakthrough first-in-class product. After the National Kidney Foundation meeting in March, one nephrologist wrote that pursued injection is poised to change the treatment of uremic pruritus. And feedback from the field ride suggests similar tangible interest in this product. Third, patient outreach is expanding through new channels. Significant efforts have already been underway to raise patient awareness for pruritus and hemodialysis. And as you know, patients can be key drivers of demand for a product like Coursive Injection. The latest activity is the first large-scale education and awareness campaign on pruritus with chronic kidney diseases by the American Kidney Fund with support from BFOR. Now, the payoff to all this work is that patients finally can receive a treatment for a longstanding unmet need. And I'd like to remind you that this is an underreported, underserved patient population. We are confident that the addressable market is about 40% of the total hemodialysis patients. This is a baseline of roughly 200,000 U.S. hemodialysis patients with moderate to severe pruritus associated with chronic kidney disease. They are looking for answers, and our product can provide one. Looking ahead, in the second quarter, we expect to share more quantitative metrics for you to track our progress. We will disclose net sales of course of injection, as well as CARES revenue of the profit share. We will also update you on the units shipped from wholesalers to dialysis clinics. This is a really good proxy for end user demand, since dialysis clinics do not carry much inventory. Now turning to markets outside the U.S., the opportunity in Europe is squarely in our sights. Capruvia is now the first therapy available in Europe for the treatment of pruritus in hemodialysis patients. On April 28th, we announced Capruvia was approved by the European Commission. The U.K. followed with its approval the next day. As we mentioned before, the EU approval triggered a $15 million cash milestone payment from our ex-U.S. partner, V4 Percentius Medical Care Renal Pharma. This payment adds even more strength to our balance sheet. We expect the launch of Capruvia by our partner in the EU to commence in the second half of 2022. Stay tuned. Now let's turn to our second strategic priority of advancing our oral Coursula Phase III pruritus programs for non-dialysis-dependent advanced chronic kidney disease and atopic dermatitis. These pivotal Phase III oral programs have started and are moving forward as anticipated. Now, just to remind you, these programs address significant markets. In the U.S., about 400,000 patients have moderate to severe pruritus with advanced kidney disease. in atopic dermatitis, about 12 million patients suffer from pruritus. Now, we believe we have the right programs to capitalize on these opportunities. There are no FDA-approved therapies for pruritus in either disease area, and currently used treatments have been insufficient. As you recall, our third strategic priority is to expand the clinical utility of oral Coursiva in other therapeutic areas, including Natalya Parasetica, and chronic liver disease. And our next catalyst is approaching quickly. The phase two proof of concept trial for Natalya Parasetica is on track to report top line data in the second quarter. This trial is looking for an efficacy signal to establish a proof of concept clinical benefit in treating pruritus in Natalya Parasetica. We will use this data to inform the development path in this indication. In addition, the Phase II data readout in primary biliary cholangitis associative pruritus remains on schedule for the second half of this year. Simply put, our pipeline is progressing well. Our approved product is starting to reach patients, so we are accelerating to full-scale ACARA. Now I'd like to turn the call over to Tom for details on our first quarter results. Over to you, Tom.