Cara Therapeutics, Inc.

Good afternoon. My name is Denise, and I will be your conference facilitator. I would like to welcome everyone on the Terra Therapeutics second quarter 2022 financial results and update conference call. All lines have been playing on 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, please press star and the number one on your telephone keypad. Please be advised, this call is being recorded. At this time, I'd like to introduce Iris Francisconi, Chief Strategy Officer and Head of Investor Relations from Cara Therapeutics. Ms. Francisconi, you may begin your call.

Thank you, Denise, and good afternoon. Just after market closed today, we issued a press release detailing our corporate progress and financial results for the second quarter 2022. The press release 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. Participating in today's call are Chris Posner, CARA's President and Chief Executive Officer, Rick Makara, CARA's Interim Chief Financial Officer, and Dr. Joanna Gonsalves, CARA's Chief Medical Officer. Before we begin, let me remind you that statements made on today's call regarding matters that are not historical, in fact, 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 successfully commercialize Corsiva injection and Capruvia, risks that Corsiva injection and Capruvia revenue, expenses, and costs may not be as expected, planned future regulatory meetings and or submissions, and potential future regulatory approvals, the performance of the company's commercial partners, including V4, expected timing of the initiation, 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, including NP, and the potential for oral difalocaflin to address additional pruritic indications, the size and growth of the potential markets for pruritus, the company's expected cash reach, and the potential impact of COVID-19, geopolitical tensions, and macroeconomic conditions on the company's 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 CARES Therapeutics filings 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 31, 2021, and its other documents subsequently filed with or furnished to the Securities and Exchange Commission including its Form 10-Q for the quarter ended June 30, 2022. 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, except as required by law. With this, I will now turn it over to Chris.

Thanks, Iris, and good afternoon, everyone. The second quarter was truly foundational for CARA, building the base for our continued growth this year and in the years ahead. We made big strides towards our goal of creating a differentiated company and becoming the world leader in pruritus. Our focus is on treating this distressing, underserved condition that affects millions of patients across many diseases. The second quarter showed us we are on the right path. with concrete validation of our strategy. Along with our partner V4 Pharma, we made significant progress in the launch of course of injection. For the second quarter, we recorded in total revenues of 23 million. This consisted of 8 million in profit sharing revenue from course of injection and 15 million in a milestone payment from the EU approval of Capruvia in April. In addition, Our strong Phase II proof-of-concept data in Notalgia Parasetica highlighted the broad potential of our oral difelocephalin platform. I will give more details on our progress this quarter, and Rick will follow with a review of our 2Q financial results. After that, we will take your questions. In the first quarter on the market, Corsuva's adoption dynamics improved. are in line with our expectations and in line with the only recent branded product launch in the setting. Specifically, independent and midsize dialysis organizations have been the first to adopt and administer course of injection. The more rapid product adoption by these organizations is predominantly due to, A, shorter contract negotiations, B, simpler technical implementation of product information, pricing and reimbursement in respective EMR systems, and C, faster establishment of treatment protocols. We have heard positive anecdotal feedback from the field on the performance of the product. Week to week, we have seen an increase in the total number of clinics ordering, and we have seen repeat orders across the majority of clinics. Turning to the large dialysis organizations, which make up 75 percent of the market, They are more complex and therefore take somewhat longer with regard to all these steps. However, we are pleased to report that those key elements are in place at the LDOs, and they have started to order Corsuva early in the third quarter. These early launch dynamics, which are typical of the dialysis market, support our reported product launch metrics. V4's net sales of Corsuva injection was 17 million. This comprises mostly the initial stocking at the wholesaler based on the anticipated demand from LDOs coming online. We expect that a significant portion of this inventory will get sold into dialysis clinics in the third quarter. The wholesaler shipment to dialysis clinics was about 2,000 vials, reflecting the early but rapid adoption in the independent and midsize organizations. We have seen demand from this market segment also accelerating. As we head into the third quarter, more firepower has been added to develop the market and help drive product adoption. Specifically, we are pleased with the addition of the Fresenius Renal Pharma sales force to the promotion of course of injection. The Fresenius sales force will focus exclusively on Fresenius dialysis clinics and affiliated healthcare providers. This will significantly increase our share of voice in Fresenius clinics and we expect Fresenius to be a major driver of product sales in the coming quarters. It is also important to note that VFOR's promotional plan has not changed, and its sales force will continue to promote Corsuva to healthcare providers associated with both Fresenius and non-Fresenius clinics. Lastly, We are pleased with the recent CMS rule proposal that includes a request for information regarding an appropriate payment mechanism for drugs with TdapA designation post the TdapA period. We generally believe that the different payment mechanisms outlined in CMS's proposal would provide adequate reimbursement for Kursuga post the expiration of its TdapA period. we further support the concept of linking drug payment to drug utilization in appropriate patients. While we do not expect a final decision by CMS regarding the post-TADAPA reimbursement mechanism this year, we are confident that CMS is focused on ensuring long-term access to innovative drugs like Corsuva. Our pipeline is another potential exciting driver of long-term growth. we continue to validate oral difelocephalus potential across many indications and diseases. The recent positive top line results in our COMFORT Phase II proof of concept trial for oral difelocephalus in Notalgia peristatica shows the potential broad applicability of DFK in chronic pruritus. MP is a nerve disorder characterized by chronic pruritus of the upper to middle back and treated by medical dermatologists. Like all our other programs, there are no approved treatment options for MP, and currently used treatments have limited efficacy or safety concerns. The comfort study met its primary endpoint of change from baseline in daily WI NRS score at week eight, showing a highly statistically significant difference from placebo. Oral difelocephalin had a rapid onset of efficacy as early as week one, which was sustained throughout the entire study period. DFK also reached statistical significance on the additional endpoint of proportion of patients with a four-point improvement in the WI-NRF score starting at week two and through week eight. DFK was well-tolerated with a safety profile consistent with prior studies and other indications. We plan to share the detailed clinical data from this study at an upcoming medical meeting. We also expect to meet with the FDA in the second half of 2022 to discuss the next steps in the development for Notalgia Parasetica. We will provide more details for this exciting program at a later time. In our other pipeline programs, we continue to expect releasing top line results for our phase two proof of concept study in primary biliary cholangitis in the second half of 2022. Our phase three programs in atopic dermatitis and non-dialysis dependent chronic kidney disease, which we initiated in the first quarter of 2022, continue to track to our previously announced timelines. In summary, The second quarter has set the foundation for both our near and long-term growth, and we are executing on our three strategic priorities. The first priority is to maximize the commercial potential of course of injection with our partner, V4 Pharma. One quarter into the launch, we are tracking to our expectations. Demand was initially driven by independent and mid-sized dialysis organizations. LDOs have started to order. and the key demand levers are in place, including more sales force firepower. We like the cadence of how these are coming together to drive an acceleration of demand in the coming months. We continue to execute on our second strategic priority of advancing our Phase III programs for oral diphthalocouplement in advanced chronic kidney disease and atopic dermatitis. And we made significant progress on our third priority to expand the clinical utility of oral difelocephalin across the spectrum of disease categories associated with pruritus. The positive Phase II NP data validate the broad applicability of the oral difelocephalin platform. We are excited and confident for what is ahead. The progress across our strategy in the second quarter is a foundational step toward delivering long-term sustainable growth and value for our shareholders. Now I'd like to hand it over to Rick for details on our second quarter results. Over to you, Rick.