CorMedix Inc.

and welcome to CoreMedix Inc. Second Quarter 2023 Earnings Call. 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 your host, Dan Ferry, from LifeSci Advisors. Thank you, Mr. Ferry. You may begin.

Good morning, and welcome to the Corps Medics second quarter 2023 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, Liz Hurlburt, EVP of Clinical and Medical Affairs, 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 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, an NDA approval for DefendCath in the U.S. or other product candidates, future financial position, future revenues and projected costs, and reimbursement 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, including projections regarding the sufficiency of the company's current cash resources to potentially bring the company through to break even profitability, expectations as to the timing and nature of anticipated regulatory actions, reimbursement decisions, possible product licensing, business development or other transactions, any commercial plans and expectations, intellectual property protections for our product candidates, 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 Chromatic Filings with the SEC including the latest quarterly report on Form 10-Q and the annual report on Form 10-K, copies of which were 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. Over the last three months, the company has announced a number of key milestone achievements. Most importantly, the announcement that the NDA for DefendCat had been resubmitted to the FDA following a Type A meeting and was subsequently accepted for review with a target action date of November 15, 2023. Phoebe will provide a brief update today on regulatory affairs activities leading up to our action date. In addition to the resubmission, we announced that the Center for Medicare and Medicaid Services, or CMS, issued its Inpatient Prospective Payment System proposed 2024 rule that included an NTAP of up to $17,111 per hospital stay for reimbursement of the FENCAS. We're happy to now announce that this past week, TMS published its final rule in this regard, providing for final approval of the NTAP of up to $17,111 per hospital stay for DefendCath reimbursement, conditioned upon the DefendCath NDA obtaining FDA approval prior to July 1st of 2024. The company also announced that the US Patent and Trademark Office had issued a notice of allowance of patent claims directed to the composition of a catheter lock solution for preventing infection and reduce blood flow in central venous catheters. CoreMedix has paid the issue fee and the application has now moved to issuance. This newly allowed U.S. patent application reflects the unique and proprietary nature of DefendCast and will extend our current intellectual property protection to an anticipated expiration date in 2042, which is beyond the 10 and a half years of marketing exclusivity available upon an FDA approval of the DefendCast NDA. As a reminder, the 10 and a half years of marketing exclusivity anticipates five years of new chemical entity exclusivity plus five years of QIDP exclusivity plus six months of additional exclusivity for conducting a post-approval pediatric study. During that 10 and a half year exclusivity period, the FDA would be barred from approving any ANDA that references the PhenCas as its comparator drug. More recently, The company announced the pricing of an underwritten public offering of its common stock and pre-funded warrants in which the total gross proceeds before fees and expenses were approximately $40 million. In addition, we are pleased to announce today that the underwriters fully exercised the over-allotment option of approximately 1.5 million shares, yielding additional gross proceeds of roughly $6 million before fees and expenses. The successful completion of this financing provides CoreMedix with considerable medium- to long-term financial resources. The proceeds from the offering, together with our existing cash, cash equivalents, short-term investments, and available resources, will enable us to fund the launch of DefendCast through to anticipated profitability, assuming we are able to obtain a timely approval of the DefendCast NDA on our target action date. and commence commercial launch in the first quarter of 2024, as well as achieve other internal base case assumptions. This financing also added new institutional investors to our shareholder base and broadened our relationships across Wall Street. I will now turn the call over to Phoebe for a brief regulatory update and to discuss progress toward potential FDA approval. Phoebe?