Cara Therapeutics, Inc.

Good afternoon, and welcome to CARA Therapeutics' third quarter 2021 financial results conference call. All participants are now in the listen-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.

Good afternoon. This is Will Gramig with Stern Investor Relations. and welcome to Kara Therapeutics' third quarter 2021 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.karatherapeutics.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 company's ability to commercialize Corsuva injection, including the timing of additional regulatory submissions and approvals, the company's ability to maintain coverage and adequate reimbursement for Corsuva injection, the performance of our commercial partners, including V4 Pharma, 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, the potential for the company's product candidates to be alternatives in therapeutic areas investigated, the company's expected cash reach, and the potential impact of COVID-19 on the company's commercial launch, 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 Kara 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 today's call 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. Participating on today's call are Dr. Derek Chalmers, CARA's President and Chief Executive Officer, Mr. Christopher Posner, CARA's incoming President and Chief Executive Officer, and Mr. Thomas Riley, CARA's Chief Financial Officer. I'll now turn the call over to Dr. Chalmers.

Great, thank you, Will, and good afternoon, everybody, and thanks for joining us today. CARA has had a truly transformative third quarter this year, highlighted by the FDA approval on August 23rd of Kursuva injection for the treatment of moderate to severe pruritus associated with chronic kidney disease in hemodialysis patients. As the first and only treatment approved by the FDA for chronic kidney disease-associated pruritus, Trusova injection represents a true paradigm shift in the treatment of pruritus. This approval is also a testament to the long-term diligence and the collective effort of the entire CARA team to bring this drug over the finish line. With the FDA approval in hand, we continue to be focused, along with our U.S. commercial partner, V4 Pharma, on preparation for the launch of Kursuva injection in the first half of 2022. We are also continuing to make important progress in our oral Kursuva programs, and following guidance from the FDA, aim to initiate Phase III programs with oral Kursuva for the treatment of pruritus in both atopic dermatitis and non-dialysis-dependent chronic kidney disease patients in the first quarter of 2022. So, as we reach this transformative stage in CARA's development with the anticipated U.S. commercial launch for Kursuva injection, with great momentum in our oral Kursuva franchise as we plan to move into registration programs, and with a strong balance sheet in place allowing us to execute on all our strategic goals, I believe that the present moment marks a natural point to transition leadership. As we announced last week, I'll be stepping down from my current role as President and Chief Executive Officer of Cara and transitioning to a senior advisor role with the company, and Chris Posner will move into the President and CEO position. Now, having worked closely with Chris since he joined Cara as a board member, I'm confident in his ability to successfully lead the company through its next phase of development, and I look forward to working with him and the Cara leadership to ensure a smooth transition. Now, I'd like to invite Chris to say a few words and introduce himself. Chris, please.