CorMedix Inc.

the first step before we put forward a proposal for any uses in oncology. Once we have feedback from FDA and alignment on our proposal related to TPM, we can then craft a proposed study for use in oncology. The decision to prioritize TPM for submission and FDA discussion was based upon the expected timing and cost of the clinical program being proposed relative to the expected market size. Though oncology is potentially a larger market opportunity, we've elected to prioritize the potentially faster program first. Assuming acceptable feedback from the agency in June, anticipate submission of an oncology proposal to FDA later this year. Lastly, from a supply chain perspective, in our efforts to de-risk our reliance on a single finished dose manufacturer, earlier this week we submitted a supplement to our NDA, adding 6-3 to Hamelin's site as an alternate manufacturing Pending a successful FDA review of the supplement, we anticipate Siegfried coming online as a manufacturer as early as the end of 2020. CoreMedix has now grown to approximately 90 employees, and I'm proud of what we have accomplished over these recent months. I would now like to turn the call over to Matt to discuss the company's first quarter financial results and financial position.

Matt? Thanks, Joe, and good morning, everyone. I am pleased to be here today to provide an overview of our first quarter of 2024 financial results, as well as an update on CoreMedix's cash position. The company has filed its quarterly report on Form 10-Q for the quarter ended March 31st, 2024. I urge you to read the information contained in the report for a more complete discussion of our financial results. With respect to our first quarter of 2024 financial results, Our net loss was approximately $14.5 million, or $0.25 per share, compared with the loss of $10.6 million, or $0.24 per share, in the first quarter of 2023. The higher net loss recognized in 2024 compared with 2023 was driven by an increase in SG&A expenses versus the first quarter of 2023, partially offset by the sale of New Jersey NOLs for $1.4 million. Operating expenses in the first quarter of 2024 increased approximately 44% to $15.9 million, compared with $11 million in the first quarter of 2023. R&D expense decreased by approximately 75% to $0.8 million, driven by the approval of the FENCAP. As a result of the post-FDA approval commercial operations, costs related to medical affairs and certain personnel expenses that supported R&D efforts prior to the FDA approval of the FENCAP have been recognized in SG&A expense. SG&A expense increased approximately 98% to $15 million in the first quarter of 2024, compared with $7.6 million in the first quarter of 2023. This increase was primarily attributable to increases in personnel expenses due to the hiring of sales force, medical affairs, and marketing personnel. In addition, certain costs related to medical affairs and certain personnel expenses that had been previously recognized in R&D are now recognized in SG&A following the FDA approval of the FENCAP. To a lesser extent, the increase was also driven by increases in non-cash charges for stock-based compensation and increases in consulting fees. We recorded net cash used in operations during the first quarter of 2024 of $17.3 million, compared with net cash used in operations of $10.4 million in the first quarter of 2023. The increase is primarily driven by an increase in net loss and decreases in accrued expenses and accounts payable. The company has cash and cash equivalents of $58.6 million as of March 31, 2024. As we have discussed previously, we expect our operating expenses, especially SG&A, to remain at increased levels given the growth of the company and the cost driven by the commercial launch of DefendCath. Cormetics anticipates 2024 quarterly operating expenses to range from around $15 to $18 million to support commercial infrastructure and the ongoing launch of DefendCath. We believe our cash, cash equivalents, short-term investments, and projected future operating cash flow gives the company the ability to fund operations for at least 12 months and to fund the commercial launch of DefendCath through to anticipated profitability, which may occur on a run rate basis by the end of 2024, assuming we are able to achieve our internal base case assumptions for defend cap demand, uptake, net pricing, and reimbursement. I will now turn the call back over to Joe for closing remarks. Joe?

Thanks, Matt. CoreMedix is executing well on our key objectives and is hopeful to provide more substantive updates on sales progress on our next quarterly call in August. I appreciate everyone's continued support in CoreMedix, and I'm happy to now take questions.