CorMedix Inc.

Greetings and welcome to the Core Medix Incorporated third quarter 2020 earnings call. During the presentation, all participants will be in a listen only mode. Afterwards, we will conduct a question and answer session. At that time, if you have a question, please press the one followed by the four on your telephone. If at any time during the conference you need to reach an operator, please press star zero. As a reminder, this conference is being recorded Thursday, November 5th, 2020. I would now like to turn the conference over to Dan Ferry from LifeSci Advisors. Please go ahead.

Good afternoon and welcome to the CoreMedix third quarter 2020 earnings conference call. Leading the call today is Kosa Baloch, Chief Executive Officer of CoreMedix. 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 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 and marketing approval, for DefendCath, and the U.S. and other product candidates, future financial position, future revenues and projected costs, and potential market acceptance of DefendCath, Nutralyn, 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, and 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. CoreMedx may not actually achieve the goals or plans described in these forward-looking statements, and investors should not place due reliance on these statements. Please note that CoreMedx 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 CoreMedx. 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 several topics with you on the overall progress CoreMedix is making in bringing defense cats to the U.S. market for its first indication for use as a catheter rock solution for hemodialysis patients to prevent cat-related bloodstream infections with subsequent expansion into other indications. Joining me on this call are Phoebe and Matt. The four topics I will cover are regulatory, our board of directors update, commercial planning, and our annual meeting logistics. So let me begin with the first point, which is regulatory. As we disclosed on August 31st, 2020, the submission to the FDA of the new drug application or NDA for , which was completed in June, have been accepted for filing. In addition, the FDA granted priority review and set a prescription drug use of the Act, PDUFA, date of February 28, 2021. We are delighted to have a review period that is shorter than the 10-month standard review and appreciate the hard work of the core medics team to achieve this accomplishment. As mentioned in our August 31st, 2020 press release, the FDA also noted that it is planning to hold an advisory committee meeting to discuss the application and that it had not identified any potential review issues at that time. During this call, Phoebe will provide you an update on the advisory committee. The second item that I'd like to update you on is the changes at the board level. As you saw in our press release of September 17th, Paolo Costa joined the Corps Medics Board. Paolo is a tremendous addition to our board, given his decades of leadership experience in the pharmaceutical sector and significant strategic experience gained in part during his time spent as chairman of Amlin Pharmaceuticals through its successful sale to BMS and AstraZeneca. Paolo's leadership experience included time as president and CEO of Novartis U.S. Corporation from 2005 to 2008 and presidency of Novartis Pharmaceuticals U.S. from 1999 to 2005. Prior to joining Novartis, Paulo spent 30 years at Johnson & Johnson, including as president of his pharmaceutical business. We also announced on November 2nd that Mahmoud Khan, who has been a board member for the last three years, has stepped down due to policies related in his new role and responsibilities within an investment organization. While I'm disappointed that Mehmood had to step down, I very much appreciated the insight and advice Mehmood had provided over the years. I wish Mehmood continued success and thank him both personally and on behalf of Core Medix. Replacing Mehmood is another pharmaceutical industry veteran, Greg Duncan, who brings decades of senior executive commercial experience across a range of medicines as well as strategic leadership experience. Greg has spent the majority of his career in senior leadership roles in commercial stage pharmaceutical companies, including having served as president of UCB's North American business. In addition to acting on the executive committee and guiding the strategic direction for the company's specialty biopharma business, Greg was responsible for managing A multi-billion dollar global business and overseeing the launch of multiple new products. Prior to his roles with UCB, Greg spent approximately 18 years at Pfizer, where he gained significant experience across sales and marketing functions, including serving as Senior Vice President of U.S. Marketing and later as President of Pfizer's Latin American business. The addition of Paolo and Greg to our CoreMedix board further augments the expertise in commercial and corporate strategy at the board level and will be invaluable to CoreMedix as we plan our progression into a commercial stage company over the year ahead. On the third item, during the last quarter, the CoreMedix team has continued to prepare for DefendCat's anticipated commercial launch and continue to have discussions with many key players in the dialysis space, including the dialysis organizations and CMS. The interactions have been positive and clearly positions CoMedix to ensure that once defendCAT is approved by the FDA, it will be in the best possible position to successfully launch in the U.S. market. And finally on the fourth topic, I'd like to highlight that our upcoming annual meeting is scheduled for December 16th. Due to the ongoing pandemic, we are planning to hold it virtually. The agenda will include directors reelection and reconfirmation of our auditors. With that, now let's move on to the first topic, regulatory update. Phoebe.