CorMedix Inc.

Good afternoon and welcome to the Corps Medics first 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 this conference call over to Mr. Daniel Ferry from LifeSci Advisors. Please go ahead. You may begin.

Good afternoon and welcome to the Corps Medics first quarter 2021 earnings conference call. Leading the call today is Kosa Baloche, Chief Executive Officer of CoreMedix. He is joined by Dr. Phoebe Mounts, Executive Vice President and General Counsel, Dr. Matt David, Executive Vice President and Chief Financial Officer, Ms. Liz Massen Herbert, Executive Vice President for Clinical Operations, and Mr. Tom Nuspickel, Executive Vice President and Chief Commercial Officer. 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 meetings 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 facts regarding management's expectations, beliefs, goals, and plans about the company's prospects, including its clinical development program 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 DefendCath, Neutralin, and other product candidates. More specifically, forward-looking statements include any statements about our clinical development plans and the timing, costs, results, 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 Mr. Koso Baloche, Chief Executive Officer of CoreMedix. Koso, please go ahead.

Thank you, Dan. Good afternoon, everyone, and thank you for joining us on this call. On today's earnings call, we will discuss the first quarter of 2021 financial information and the overall progress CoreMedix is making in bringing defend cap 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. Joining me on this call are Phoebe, Matt, Liz, and Tom Nuspickel, who joined CoreMedix this morning. So let's begin on the people side first. As announced this morning, I'm pleased to have Tom Nuspickel join CoreMedix as Executive Vice President and Chief Commercial Officer. Tom brings with him a depth of experience on the commercial side from his time at Amgen, Pfizer, and Opco. Of particular note for CoreMedix was Tom's time at Amgen, where he gained several years of experience operating in the hemodialysis space, both in the U.S. and internationally. Tom brings marketing, market access, and government affairs experience that will augment the commercial expertise of the team that CoreMedix has already built. We're pleased to have Tom join us at this important stage for CoreMedix as we continue to refine our launch plans. Although today is Tom's first day, we have already started the process of bringing Tom up to speed on the ongoing activities and strategic priorities for the company. Later during this call, Tom will share some of his thoughts So welcome, Tom. On April 14th, CoreMedx issued a press release that provided an update of our meeting with the FDA. What we stated in that press release included that there was an agreed upon protocol for manual extraction study identified in the CRL, that FDA is requiring us confirmation of an in-process control to demonstrate that the label volume can be consistently withdrawn from the vial. In addition, addressing FDA's concern regarding the qualification of the filling operation at the third-party manufacturing facility may necessitate adjustments in the process and generation of additional data on operating parameters for the manufacturing of defend caps. During this call, Phoebe will provide you an update of the progress CoreMedix has made to date on addressing the deficiencies identified by FDA at the third-party manufacturing facility. In addition to the continued effort to bring DefendCath across the finish line for hemodialysis patients, CoreMedix has been making progress by initiating the work required for label expansion of different cath for use in TPN and oncology patients using a central venous catheter once the FDA has approved the NDA for the initial indication for use. What Liz will provide is an update of the work her team, in conjunction with the medical group and the regulatory group, are doing to prepare the groundwork required to enter into clinical study for label expansion when defend cap is approved. We are proceeding with these plans while limiting our cash burn so that financially we have the resources required to successfully bring defend caps to patients in the US. Matt will provide you an update of our quarter one 2021 financials and provide color regarding the strength of core medics balance sheet. So now let's move to the first topic, the introduction of Tom Naspickel. Tom?