CorMedix Inc.

Good afternoon and welcome to the Corps Medics third quarter earnings conference call. Today's conference 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. At this time, I would like to turn the conference call over to Daniel Ferry from LifeSci Advisors. Please go ahead.

Good afternoon and welcome to the Corps Medics third quarter 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 meeting 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 of the CENTCAS in the U.S. and other product candidates, future financial position, future revenues and projected costs, and potential market acceptance of Defendcat, Neutralin, and other product candidates. More specifically, forward-looking statements include any statements about our clinical development plans and the submission and timing, 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 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 CoreMedix 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 CoreMedix. CoreMedix 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 CoreMedix 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 of CoreMedix. Matt, please go ahead.

Good afternoon, everyone, and thank you for joining us on this call. Today marks the first earnings call since Phoebe and I have taken on additional roles within the company, as we announced on October 4th. While it has been an incredibly busy month, we are pleased 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 third quarter 2021 financial information and the overall progress CoreMedix is making in bringing DefendCath to the U.S. market for its first indication for use as a catheter lock solution for hemodialysis patients to reduce catheter-related bloodstream infections. Let's begin with the topics for discussion today. In September, we announced that Chormetics had encountered delays at its third-party contract manufacturer, or CMO, and we were informed by the CMO that there were issues that are unrelated to the DfenCaf manufacturing activities. We also indicated that the timeline for Chormetics and the CMO to address deficiencies at the facility that are required for resubmission of the DfenCaf NDA became uncertain. The DefendCast team, including a group of specialized consultants, has continued to work closely with our CMO, and we are pleased to share with you that we are making progress on this front. Phoebe will provide information on our progress here since the last update. Also, we are balancing our preparations for launching DefendCast while limiting our cash burn so that financially we have the resources required to efficiently bring DefendCast to patients in the U.S. market when FDA approval is received. I will provide an update on our third quarter 2021 financials and provide color regarding the strength of Cormedex's balance sheet. A couple weeks ago in October, we shared some abstracts that the Cormedex team has now presented at two recent conferences, Association of Managed Care Pharmacy and American Society of Nephrology. The analyses described in these abstracts and the epidemiologic data that stem from this work are incredibly important, as they underscore the purpose of the work we are doing here at CoreMedix. I will provide some additional color on these items and how we plan to use these data as we prepare to bring DefendCast to patients in the hemodialysis community who are at risk for life-threatening catheter-related bloodstream infections. Now let's move to the first topic. Phoebe will provide the regulatory and manufacturing update. Phoebe?