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CorMedix Inc.
8/12/2021
Greetings and welcome to the Corps Medics, Inc. Second Quarter 2021 Earnings Conference Call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If you would like to ask a question, please press star 1 on your telephone keypad. If anyone should require operator assistance during the conference, please press star 0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Dan Ferry with LifeSci Advisors. Thank you. Please go ahead.
Good afternoon and welcome to the Corps Medics second quarter 2021 earnings conference call. Leading the call today is Kosa Baloche, Chief Executive Officer of Corps Medics. He is joined by Dr. Phoebe Mounts, Executive Vice President and General Counsel, and Dr. Matt David, Executive Vice President and Chief Financial 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 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 are 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, cost, results, and interpretations thereof, projections as to the company's future capital raising and spending in 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 CoreMedx 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 CoreMedx. CoreMedx may not actually achieve the goals or plans described in these forward-looking and investors should not place undue reliance on these statements. Please note that Corps Medics 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 Corps Medics. 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 second quarter 2021 financial information and the overall progress CoreMedix is making in bringing DefendCats 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 and Matt. Let me begin the first item for discussion. During the last earnings call on May 13th, we provided an update on the progress that CoreMedix has made to date on addressing the deficiencies identified by the FDA at the third-party manufacturing facility. The work has continued and we are reiterating that at present, we are on schedule to be able to resubmit the DEFENCAS NDA in quarter four, 2021. Phoebe will provide information on our progress since our last update. We are also balancing our preparation for launching defendCAS while limiting our cash burn so that financially we have the resources required to efficiently bring defendCAS to patients in the US market when FDA approval is received. Matt will provide you an update on our second quarter 2021 financials and provide color regarding the strength of CoreMedix balance sheet. Despite the continued COVID pandemic, CoreMedix has continued to function efficiently with a total remote workforce. I will provide an update on the potential impact of COVID-19 on CoreMedix. Now let's move to the first topic, that is with the regulatory update. Phoebe?
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