CorMedix Inc.

Greetings and welcome to DecorMedics, Inc., fourth quarter and full year 2020 Touring School. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce to your host, Dan Ferry. Thank you, Dan. You may begin.

Good morning, and welcome to the Corps Medics fourth quarter and full year 2022 earnings conference call. Leading the call today is Joe Tedisco, Chief Executive Officer of Corps Medics, and he is joined by Dr. Matt David, Executive Vice President and CFO, Dr. Phoebe Mounts, EVP and General Counsel, and Aaron Mistry, EVP 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 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, an NDA approval for DefendCath in the US or other product candidates, future financial position, future revenues and projected costs, and potential market acceptance of DefendCath or other product candidates. More specifically, forward-looking statements include any statements about our clinical development plans and the 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, including the latest 10-K filing, 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 Joe Tedisco, Chief Executive Officer of CoreMedix. Joe, please go ahead.

Thanks, Dan. Good morning, everyone, and thank you for joining us on this call. Since our last earnings call in November, the company has continued to make excellent progress toward our goal of resubmitting the DefendCath NDA, as well as preparing for commercialization following a potential approval. We have made a number of key hires on the commercial leadership team, in the areas of marketing, market access, and distribution. As well as on the medical affairs team, we're building out a knowledgeable team of medical science liaisons, or MSLs, to engage in disease state awareness and medical education. As the initial focus of our potential launch is targeted to the inpatient segment, we have begun engaging in discussions with key stakeholders at hospitals, health systems, and IDNs, and the feedback we have received has further validated our decision to pursue launch in this segment. Catheter-related bloodstream infections, or CRBSIs, are a critical unmet medical need both in the hospital inpatient as well as outpatient dialysis setting, and there is a vital need for a preventative therapy that can meaningfully reduce the incidence of CRBSI across multiple settings of care. A February report from the CDC has further emphasized CRBSIs as the pervasive risk for hemodialysis patients. highlighting the 10,000% increased risk of contracting a bloodstream infection when receiving hemodialysis through a CBC versus the non-dialysis population. We believe that DefendCast, if approved, can have a meaningful impact on reducing CRBSIs across multiple settings of care. Earlier this month, we announced our intention to submit a Type A meeting request to the FDA, seeking guidance for resubmission using Pathway 1, which is our existing CMO and our existing Heparin API supplier, or pathway two, which is our existing CMO and a new Heparin API supplier. Both pathways, number one and number two, potentially allow for the fastest means to resubmission and hopefully final approval. I am pleased to announce that we submitted the request to FDA for the type A meeting in mid-March, and the FDA has granted our request with the meeting scheduled for mid-April. Phoebe will provide a more detailed update on our meeting with FDA, as well as potential timelines for pathways number one and number two shortly. With respect to pathway number three, which we view as our backup manufacturing site, we announced in early March a delay in the availability of submission data until at least the third quarter of 2023. This shift was due to delays in our ability to complete our manufacturing validation and validation of analytical methods at Alphabets. While we continue to work through these hurdles with our partner, Alchemy, in order to shore up our backup plan, we have also signed an agreement with Siegfried AG to utilize their site in Hamel, Germany, as an additional backup CMO. This site previously manufactured the product for Europe as a medical device under the trade name Neutralin, and to that extent, we have already completed the tech transfer of our manufacturing process and analytical methods to the Siegfried site. In addition, the Hamill site has been inspected multiple times by FDA and has an excellent track record for quality supply. Ensuring the resubmission of our DefendCath NDA is the company's top priority, and we will mobilize all resources required to do so. Data availability for Pathway 3 is still targeted for the end of the third quarter of 2023. At this point in time, it's our expectation to qualify a backup site as a post-approval supplement, and we are hopeful to pursue initial NDA approval using Pathway 1 or Pathway 2, depending on the outcome of April's meeting with the FDA. I will now turn the call over to Phoebe to discuss our type A meeting with FDA and pathways number one and number two in more detail. Phoebe?