CorMedix Inc.

Good afternoon, and welcome to the Corps Medics fourth quarter earnings conference call. Today's call is being recorded. There will be a question and answer session at the end of today's presentation, and instructions on how to ask a question will be given at that time. I would now like to turn the conference over to Daniel Ferry from LifeSci Advisors. Please go ahead.

Good afternoon, and welcome to the Corps Medics fourth quarter and year-end 2021 earnings conference call. Leading the call today is Dr. Matt David. Interim Chief Executive Officer and Executive Vice President and Chief Financial Officer of CoreMedix. He is joined by Dr. Phoebe Mounts, Executive Vice President and General Counsel. Before we begin, I would like to remind everyone that during the call, management may make what are known as forward-looking statements within the meaning set forth in the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties and include, but are not limited to, any of the following. Any statements other than statements of historical fact regarding management's expectations, beliefs, goals, and plans about the company's prospects, including its clinical development program, manufacturing activities, and marketing approval for DefendCath, in the U.S. and other product candidates. Future financial position, future revenues and projected costs, and potential market acceptance of DefendCast, Neutralin, and other product candidates. More specifically, forward-looking statements include any statements about our clinical development goals, clinical development plans, excuse me, and the cost, progress, results, estimates, and interpretations thereof, projections as to the company's future capital raising and spending and cash position, expectations as to the timing and nature of anticipated regulatory actions, possible product licensing, business development, or other transactions, any commercial plans and expectations, market projections for our product candidates, and expectations as to the manufacturing and product component costs. Actual results may differ materially from these projections or estimates due to a variety of important factors, including but not limited to uncertainties related to clinical development, regulatory approvals, and commercialization. These risks are described in greater detail in Coromatics' filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from Coromatics. Coromatics may not actually achieve the goals or plans described in these forward-looking statements, and investors should not place undue reliance on these statements. Please note that Coromatics does not intend to update these forward-looking statements except as required by law. At this time, it is now my pleasure to turn the call over to Dr. Matt David, Interim Chief Executive Officer and Chief Financial Officer of CoreMedix. Matt, please go ahead.

Thank you, Dan. Good afternoon, everyone, and thank you for joining us on this call. While it has been an incredibly busy time, we are excited to be here this afternoon to discuss CoreMedix updates as well as reflect on our priorities as a company over the coming months. On today's earnings call, we will discuss the fourth quarter and full year 2021 financial information and the overall progress CoreMedix is making in bringing DefendCast to the U.S. market for its first indication for use as a catheter lock solution for the hemodialysis patients to reduce catheter-related bloodstream infections. Let's begin with the topics for discussion today. On February 28th, we announced that Cormedex had resubmitted the DefendCath NDA to the FDA in parallel with our third-party contract manufacturer, or CMO, submitting responses to the deficiencies identified at the manufacturing facility in the post-application action letter issued by the FDA concurrently with the CRL in 2021. The Cormedex team, led by Phoebe, worked tirelessly in conjunction with our CMO in order to reach that important milestone for Cormedex. Yesterday, we were very pleased to share that the FDA has accepted the NDA resubmission for filing and begun the review process. Phoebe is here to provide details on our progress on the regulatory and manufacturing fronts since our last update. As we continue to chart a course toward the potential of the FENCAP approval and launch, Cormedex announced recently that the Board has appointed Joe Tedisco as Chief Executive Officer. Joe brings significant experience in commercial operations, leadership, and business strategy to our organization and has spent the last 10 years building and leading commercial organizations globally across multiple therapeutic areas. Most recently, Joe served as Chief Commercial Officer of Amil's Specialty Business, where he was responsible for managing and growing a $400 million run rate business with roughly 200 employees. Everyone at Quamatics joins me in welcoming Joe, and we look forward to working with him when he joins on or before May 16th. We have continued to balance our preparations for launching DefendCat while limiting our cash burn so that financially we have the resources to efficiently bring DefendCat to patients in the U.S. following an anticipated FDA approval. With the NDA resubmission now being reviewed, we expect to see some increases in spend in the coming quarters as we ramp pre-commercial activities and manufacturing activities in planning for a potential launch. I will provide an update on our fourth quarter and full year 2021 financials and provide color regarding our cash position. During our earnings call in November, we discussed some of the work that the CoreMedix team had completed to highlight the magnitude of catheter-related bloodstream infections in the hemodialysis patient population via abstracts that were presented at industry conferences. The last topic today is to provide some color on the continued work by our commercial team and medical affairs team as we prepare to bring DefendCast to patients following an FDA approval. While we are a modest-sized team, this important work leverages consultants, market research firms, and thought leaders as we continue to expand our understanding of, one, the hemodialysis market opportunity across the spectrum of care, two, reimbursement dynamics, and three, pharmacoeconomic considerations that will each factor into our commercial strategy for DefendCath. Now let's move to the first topic. Phoebe will provide the regulatory and manufacturing update. Phoebe?