Cara Therapeutics, Inc.

Thank you for standing by, and welcome to Kara Therapeutics' fourth quarter and full year 2023 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 1 on your telephone. To remove yourself from the question queue, you may press star 1 1 again. I would now like to hand the call over to Matt Murphy, Manager of Investor Relations. Please go ahead.

Thank you, Operator, and good afternoon. After market closed today, CARA issued a news release announcing the company's financial and operating results for the fourth quarter and full year 2023. Copies of this news release can be found in the Investor section of our website at caratherapeutics.com. Before we begin, let me remind you that during the course of this conference call, we will be making certain forward-looking statements about CARA and our program based on management's current plans and expectations. These statements are being made under the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties. Actual results may differ materially due to various factors, and CARA undertakes no obligation to update or revise these statements publicly as a result of new information or future results or developments. Investors should read the risk factors set forth in CARES 10-K for the year ended December 31st, 2022, and any subsequent reports filed with the SEC, including its Form 10-Q for the quarter ended September 30th, 2023. With that said, I'd like to turn the call over to Chris Posner, CARES Chief Executive Officer. Chris?

Thanks, Matt. Good afternoon, and thank you for joining our call. With me today are Ryan Maynard, our Chief Financial Officer, and Dr. Joanna Consalves, our Chief Medical Officer. Significant developments in 2023 led us to sharpen CARIS strategy and focus. We announced in January of this year that we have prioritized the program with the highest likelihood of clinical and commercial success, oral diphelicapillin for Nataljia parasitica, or NP. Focusing all our resources on NP extends our cash runway into 2026, which allows us to reach all value inflection milestones in this program. NP is a highly underserved neuropathic condition with a sizable patient population and no approved therapies. We are optimistic that oral diphellocephalin, if approved, could become the first and only oral antipyretic therapy for NP. I want to highlight why MP has such potential and detail how our late-stage oral diphelic Keflin clinical program can address it. Notalgia parasitica is an unexplored neuropathy, and yet MP is relatively common. The disease is a chronic neuropathic pruritic condition characterized by pruritus of the upper back, often leading to pigment changes as a result of excessive scratching. Natalgia parasitica has been dramatically understudied. But as I will highlight in a bit, anecdotal evidence suggests and we believe that chronic neuropathic pruritus is often as onerous as chronic pain in terms of impacting the quality of life of patients. And while chronic pain has been targeted and studied extensively, chronic neuropathic pruritus has not. An estimated 34 million U.S. patients, or 13% of the adult population, suffer from chronic pruritus. And approximately 2.7 million, or 8% of them, have chronic neuropathic pruritus. Now, out of those chronic neuropathic pruritus patients, 650,000, or 24%, are Notalgia Parasitica patients under the care of a healthcare provider, predominantly a dermatologist. This number does not account for the many missed or undiagnosed patients. Notalgia parasitica has a significant impact on the quality of life of patients, including on their mood, sleep, and self-care activities. And yet, this significant health challenge has no current treatment or wide-ranging efforts to address it. Anecdotal feedback from patients suggests that their pruritus is often constant, and is as debilitating as pain. There are no approved treatments for notalgia parasitica and off-label use of other therapies, frequently topical and systemic treatments indicated for neuropathic pain are mostly ineffective or associated with significant side effects. In market research, almost 90% of MP patients responded that the treatments that they had been offered for MP had been minimally or not at all helpful. As a result, almost 75% of responders stated that they were not currently on any therapy for MP. It is clear from the literature in our market research that there is a significant unmet need for an effective, safe, and well-tolerated treatment for MP. Our oral DFK program could lead the way to target and address notalgia parastatica's hallmarked chronic neuropathic pruritus. We believe Oral-DFK's neuromodulatory action presents an ideal mechanistic approach to treating chronic neuropathic pruritus. In our phase two proof of concept study in MP, Oral-DFK at a two-mig BID dose showed a statistically significant separation from placebo on the worst itch NRS scale as early as day one. It also showed sustained efficacy throughout the double-blind eight-week treatment period. The publication of these data in the February 2023 New England Journal of Medicine has attracted a lot of attention from thought leaders, investigators, and patients. Highlighting the significant unmet need, this excitement has resulted in rapid enrollment in the ongoing dose-finding portion of our Phase 2-3 Courage One study. I am pleased to announce that we have completed enrollment in Courage One Part A ahead of schedule, putting us on track to report top-line efficacy and safety results in Q3 of this year. As a reminder, Courage One is comprised of two parts. Part A, the dose-finding portion of the study, is a double-blind, placebo-controlled eight-week study comparing three dosage strengths of oral DFK to placebo. We currently have 53 active sites in North America and Europe, and we plan to include additional sites for the pivotal portion of the program. The primary endpoint is the proportion of patients with a greater than four point improvement at week eight from baseline in the worst itch NRS scale. The readout from this portion of the trial will provide key information, specifically the dose and sample size to initiate the phase three pivotal portion of the program. Part B of Courage One and the second study Courage Two. Ahead of these top line data, we will be hosting a panel of renowned dermatology KOLs to discuss the unmet need in MP and the potential role of oral DFK in this underserved disease and wide open therapeutic indication. We will issue an announcement with details of this event in the coming days and we hope you will join us. Moving on to course of injection. In the fourth quarter of 2023, we saw a strong quarter-to-quarter demand growth of 22% as reflected by the vial shipped to individual clinics. This continued growth in demand is a clear testament to the value and clinical benefit Corsuva offers to patients and their providers. However, with unfavorable reimbursement changes following the end of the Tdapa period on March 31st this year, we anticipate that DOs, dialysis organizations, will modify current treatment protocols and significantly restrict access to Corsuva. As a result, we do not expect meaningful revenue contributions from Corsuva going forward. Let me conclude by reiterating the following over the three months. We have taken decisive and swift action. We have evolved our strategy and meaningfully extended our cash runway by sharpening our focus on the program with the highest potential. Notalgia Parasetic has the ingredients for a breakout program with a high probability of clinical and commercial success. I am confident and optimistic that we are on the right path to unlock CARA's growth potential and create sustainable value for all our stakeholders. I would now like to turn the call over to Ryan for additional details on our fourth quarter results. Over to you, Ryan.