Good morning and welcome to the CORE Medix second quarter 2026 earnings and corporate update conference call. Today's conference call is being recorded. There will be a question and answer session at the end of today's presentation and instructions on how to ask a question will be given at that time. At this time, I would like to turn the conference call over to Dan Ferry from LifeSci Advisors. Please go ahead.

Good morning, and welcome to the Corps Medics second quarter 2026 earnings and corporate update conference call. Leading the call today is Joe Todisco, Chairman and Chief Executive Officer of Corps Medics. He is joined by Liz Hurlburt, EVP and Chief Operating and Commercial Officer, and Susan Blum, EVP and Chief Financial Officer. In addition, Beth Zelnick-Kaufman, EVP and Chief Legal and Compliance Officer and Corporate Secretary, and Dr. Matt David, EVP and Chief Business Officer, are on the line and will be available during the Q&A session. 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 Thank you for joining us. and investors should not place undue reliance on these statements. CoreMedix does not intend to update these forward-looking statements except as required by law. During this call, the company will discuss certain non-GAAP measures of its performance. GAAP to non-GAAP financial reconciliations and supplemental financial information are provided in CoreMedix earnings release and the current report on Form 8K filed with the SEC. This information is also available on the investor relations section of CoreMedix website. At this time, it is now my pleasure to turn the call over to Joe Todisco, Chairman and Chief Executive Officer of CoreMedix. Joe, please go ahead.

Thank you, Dan. Good morning, everyone, and thank you for joining us on this call. In the second quarter, we continue to execute on our core strategic initiatives, solidifying DefendCat's market position as we navigate the evolving posted apple landscape, meaningfully advancing our high-value pipeline, highlighted by the positive phase three respect data for RISEO, and now working collaboratively with Moody Pharma towards their submission of the SMBA for Uzair in the prophylaxis of invasive fungal disease. And lastly, deploying our capital in a disciplined manner to drive long-term value for shareholders while building an increasingly diversified and resilient business. We announced this morning second quarter consolidated revenue of $101.9 million and adjusted EBITDA of $58.7 million. Susan will provide more granular details of second quarter financial results. Today we also announced that we've signed a multi-year commercial supply agreement for DefendCat with an additional large dialysis organization, or LDO. With this agreement, CoreMedix now has commercial supply agreements in place with all five of the top dialysis providers in the U.S. The newly signed LDO has placed initial order and will initially begin a pilot of DefendCat in the third quarter of this year with a potential opportunity to expand utilization in 2027. We view the signing of this agreement as an important milestone and validation of DefendCat's clinical value proposition with the largest providers in the U.S. dialysis market. Turning to guidance, we are reaffirming our full-year 2026 revenue guidance with a range of $325 million to $345 million and raising our full-year adjusted EBITDA guidance to a new range of $125 to $140 million. We will revisit guidance as the year progresses and as we gain additional visibility into post-DAPA ordering patterns. While we're only a few weeks into the third quarter, Bankath order volumes in July have tracked consistent with the posted APA forecast underlying our financial guidance. In addition to the new LDO agreement, we have signed contract amendments with our major customers covering third and fourth quarter 2026 pricing, and in some instances, pricing and volume commitments for 2027. These amendments give us improved visibility into pricing and utilization through year end and are designed to keep patients on therapy through the reimbursement transition. We continue to focus significant internal resources on the DefendCat growth strategy through Medicare Advantage contracting, and I'm pleased with the progress of those discussions to date. Contracting cycles with these plans can be lengthy, and we have not assumed a contribution from Medicare Advantage in our 2026 guidance. We continue to believe Medicare Advantage represents a meaningful long-term growth avenue for DefendCat. Thank you. Thank you. trial results from the RESPECT study, a Phase III clinical study evaluating Roseo for the prophylaxis of invasive fungal disease in adult immunosuppressed patients of invasive fungal disease, or IFD. Assuming timely submission and FDA acceptance of the filing, We would anticipate agency action in the first half of the year, including the anticipated addition of 15 to 20 positions across both commercial and medical. These investments are sized to allow us to move quickly in approval while preserving flexibility of regulatory timeline shift and are already reflected in our narrowed full-year cash-off X guidance of $145 to $155 million. As a reminder, our CashFX guidance excludes non-cash charges such as stock-based compensation. I would now like to turn the call over to our Chief Operating Commercial Officer, Liz Hurlburt, to provide an update on clinical activities. Liz, please go ahead.

Thank you, Joe, and good morning, everyone. As Joe mentioned, we were pleased to announce preliminary top-line results of the RESPECT study at the end of April, and following a constructive pre-MDA meeting with the FDA, are working diligently with our partner, Mundi Pharma, in support of their submission of the FNDA for Roseo in prophylaxis in the third quarter. As a reminder, the RESPECT study met its primary endpoint for FDA of fungal-free survival at day 90, showing non-inferiority versus the standard antifungal regimen, or SAR, meeting the pre-specified non-inferiority margin. In addition, results showed a favorable profile across multiple secondary endpoints, Most notably in the treatment of emergent, treatment emergent adverse events leading to dose reduction, interruption or withdrawal of study drugs and study discontinuation. As we stated previously, the objective with the RESPECT study was to show comparable efficacy to standard of care while also demonstrating a favorable overall safety profile with regard to drug-drug interactions and toxicity. We believe the study has achieved this objective and that the results position RISEIO, if approved, as a differentiated option for prophylaxis of IFD with a meaningful potential commercial opportunity. It's important to remember that this was a global study conducted by our partner, Mundi Pharma, who owns Global IP Rights and will pursue regulatory approvals outside of the United States. Mundi Pharma is currently the holder of the US NDA, and under the terms of our agreement, transfers ownership of the NDA to CoreMedix following approval of an FNDA for the prophylaxis indication. at which point CoreMedix would own and control the U.S. assets. Under our agreements, the parties must work together on the publication of data and any submissions to FDA. In terms of data publication, we currently expect additional data from the Phase III Respect Study to be published later this year at one or more medical conferences during the fourth quarter. Turning to DefendCast, we also expect additional real-world evidence to be published in the fourth quarter with multiple abstracts having been submitted to both ASN and ID Week. Assuming acceptance, these publications will present the final results from the U.S. Renal Care Real-World Evidence Study, which at interim analysis showed a meaningful impact on infection-related hospitalizations and catheter-related bloodstream infections, as well as two other external studies. The first will highlight the demonstrated efficacy of DefendCast when used in combination with chlorhexidine antimicrobial caps. And the second is expected to highlight the clinical and economic benefits of DefendCas in the outpatient hemodialysis setting related to a meaningful reduction in TPA use by facilities. All combined, we expect that these data will add to the growing body of evidence supporting the clinical and pharmacoeconomic value of DefendCas. Shifting gears to our Phase III TPN study, We recently submitted a protocol amendment to FDA that narrows certain exclusion criteria, which we believe can support increased enrollment in the coming months, and we have additionally activated additional sites. We will continue to update investors on our progress as we move through the year, and we continue to expect study completion in 2028. I would now like to turn the call over to Susan to discuss the company's second quarter financial results and financial division.

Susan? Thanks, Liz, and good morning, everyone. We are pleased to announce our second quarter results, which reflect strong execution across the business, continued demand for DefendCast, and a contribution from the acquired Melinda portfolio. As a reminder, because the Melinda acquisition closed in August 2025, the second quarter of 2026 includes a full quarter of Melinda operations, while the second quarter of 2025 does not. Accordingly, year-over-year comparisons are heavily influenced by the broader product portfolio and cost structure of the combined company. We also filed our Form 10-Q this morning, and I encourage investors to review it for additional details and important disclosures. Turning to the numbers, second quarter 2026 consolidated revenue was $101.9 million, compared with $39.7 million in the second quarter of 2025. Second quarter revenue included $66.1 million in sales of DefendCast, and 35.8 million in revenue associated with the acquired Melinta portfolio. The FENCAS sales increased year over year, largely due to the onboarding of a large dialysis customer in mid-2025. Operating expenses were 34.2 million in the quarter, compared with 18.3 million in the second quarter of 2025, an increase of approximately 87%. The increase of 15.9 million over the prior year period was driven primarily by the contribution of operating expenses from the Malenta acquisition for the full quarter and reflects the larger combined company. Research and development expenses were 6.7 million in the second quarter of 2026, compared with 2.4 million for the same period in 2025. The increase was due primarily to higher personnel and clinical trial services in support of ongoing clinical programs including pediatric studies for several brands, and continued investment in the development of DefendCast for the TPN indication. Selling and marketing expense increased approximately 95% to $12.4 million in the second quarter of 2026 from $6.4 million in the second quarter of 2025. The increase was due primarily to higher personnel costs associated with a larger product portfolio and related marketing programs. General and administrative expenses increased approximately 59% to $15.1 million in the second quarter of 2026, from $9.5 million in the second quarter of 2025. The increase was driven by higher costs associated with operating as a combined company following the acquisition, including branded prescription drug fees and higher personnel, information technology, legal, and facilities costs. G&A expenses in the quarter also reflects a reduction to expense of $4.2 million, which represents the amount of expected insurance reimbursement of legal fees incurred by the company to support its ongoing securities litigation. Of the $4.2 million credit reported in the second quarter, $2.7 million related to legal fees that were incurred in prior periods. On the bottom line, CoreMedix recorded net income of $26.0 million, or 33 cents and 29 cents per basic and diluted share, respectively, in the second quarter of 2026, compared with net income of 19.8 million or 29 cents and 28 cents per basic and diluted share, respectively, in the second quarter of 2025. In addition to net revenue and operating expenses, EPS was impacted by income tax expense of 12.7 million as well as non-operating income and expenses net of approximately $4.2 million associated with the mark-to-market of marketable equity securities and contingent consideration, which reflects the approximate fair value of future milestones and royalties payable to former Melinda shareholders. On a non-GAAP basis, adjusted EBITDA was $58.7 million for the second quarter of 2026 compared with adjusted EBITDA of $22.4 million in the second quarter of 2025. This adjusted EBITDA metric excludes non-cash items such as depreciation, amortization, stock-based compensation, interest and other income and expenses net, taxes, and certain non-recurring items. We ended the second quarter with $256.7 million in cash and cash equivalents. For the six months of 2026, net cash provided by operating activities was $128.6 million, compared with $49.7 million for the first six months of 2025. As Joe mentioned, we are confident in our fiscal year 2026 financial guidance, which includes full year 2026 consolidated revenue of $325 million to $345 million, full-year DefendCast revenue guidance of $175 million to $195 million and revised full-year adjusted EBITDA guidance of $125 million to $140 million. We continue to believe we are well positioned with a strong balance sheet, meaningful cash generation, and the financial flexibility to support our operating priorities, pipeline development, and shareholder value creation. and now I will turn the call back to Joe for closing remarks. Joe?

Thank you, Susan. I'm confident where the company stands today and the opportunity ahead of us. For Medix has built meaningful momentum through the first half of 2026 across all three pillars of our investment thesis. First, DefendCast continues to perform in line with our internal expectations at the DAPA expiration, demonstrating durable underlying utilization, which we believe positions the franchise to remain a meaningful value generator following the reimbursement transition. Second, we are advancing a pipeline of high-value late-stage opportunities, including Resale for Prophylaxis and DefendCast in TPN, which could meaningfully expand our long-term revenue opportunity. and third, we have delivered significant profitability in cash generation over the last year. $277.8 million of adjusted EBITDA over the trailing 12 months and $267 million of combined cash and investments at quarter end, which allows us to reinvest in growth and pursue business development opportunities. We remain confident in our outlook for this year and our past sustained growth and profitability beyond it. This concludes our prepared remarks and I'll ask the operator to open up now for questions.

We will now begin the question and answer session. To ask a question, you may press star then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. Our first question comes from Rowana Ruiz with LeRank. Please go ahead.

Hi, guys. This is Anna on for Rowana. Thanks so much for taking our question and congrats on the progress. Just wanted to check in on how the new multi-year agreement with the LDO is expected to impact your 2027 expectations and if you could give any color on how long it takes for a new site to reach this steady state production in line with other operators. And I have a follow up.

Okay. Thanks, Anna. So, you know, we just recently signed that agreement and they're rolling out a pilot. We, you know, we're waiting to see kind of actually what they're looking for and we're hopeful for additional utilization. So once we get better visibility, will be in a position probably to talk more about 2027. There's a lot of variables that go into 2027 guidance. I don't expect we'll be in a position to comment on it until either late this year or early next year. So there's just a lot of pushes and pulls. We don't have any cause now to either adjust the top or bottom of that guidance. But as we move through the year and we get better visibility, we can provide updates.

Sure, thanks. And is any of that LVO pilot included in the 2026 guidance?

No, no. Right now, it's, well, obviously, it's tracking the revenue, so it's within, the revenue that we're seeing from the pilot is within our existing guidance. And, right, for DefendCath, we are right now tracking to the kind of mid-top part of the DefendCath guidance. So, you know, let's see where we go through the year and, As I said, we'll update as we go.

Great. Thanks so much.

Our next question comes from Leonid Timashev with RBC Capital Markets. Please go ahead.

Hey, guys. Thanks for taking my question. I want to ask on maybe if you can comment on what you're seeing in terms of volume growth in the existing channels thus far in this quarter, just given that we're in the post-DAPA period now. And then related to that, just as a follow-up, how are you thinking about the potential for the final ESRD guidance to increase the payment? Thanks.

All right. Thanks, Leo. So, look, in terms of volume growth, I think what we're seeing in July is really kind of stabilized volumes with the larger players, which is what we expected, and some attrition with the really small players, which is also what we expected. I think to really see volume growth in the FENCAS, one of two things can happen. The new LDO is going to have to come in meaningfully. That takes effect early next year and starts to really impact the FENCAS volume. Those are really the two levers that I see from the FENCAS standpoint. The quarterly mechanism, I expect there's going to be a lot of comment on that. Not sure if that's actually what will make it into the final rule, but we'll expect the final rule in November, and then we'll adjust accordingly.

Our next question comes from Jason Butler with Citizens. Please go ahead.

Hi. Thanks for taking the questions. First one, can you give any more color on the size or scope of the pilot study being conducted by the new LBO? And then for Roseo and Profi, can you talk about, you know, since you had the phase three results, the feedback you're getting from potential prescribers, just what the reception to that data has been as you think about a potential label expansion? Thank you.

Yeah. Look, you know, right now, the size and scope of the pilot, we've Shipped initial order, we think it's a couple hundred clinics. We'll see where we can go from there. I don't want to get out over my skis on the pilot yet, Jason. So right now, we're really happy to have finally gotten that LDO kind of over the hump and to the point of commercialization. So we're taking that one day by day. On the zeoprophy, the full data set is not yet out, so we really haven't been able to conduct a robust market research. As we said in the script, we are working with our partner, Mundi Pharma. We would expect it to be published later in the fourth quarter at one or more medical conferences. And once we have that data available, we'll be able to have more substantive discussions around the data itself with clinicians.

Great. Thank you.

Our next question comes from Serge Ballinger with Needham & Company. Please go ahead.

Hi, good morning. Thanks for taking the question. I guess first on the new LDO, first, congratulations, even if it's just a pilot program. I guess my question is why did the LDO decide to enter an agreement now when the product's been available for two years, and I know the company had some meaningful efforts to sign them up. Secondly, on Roseo, Following your FDA meeting, just curious what your expectations are for potential labeling of the product. I believe a phase three trial was conducted in allogenic HSCT patients. Curious if you'll be able to address the broad patient population that could benefit from Rezeo.

Thanks. Thanks, Serge. Look, I'm a new LDL and I really can't speak to the motivations of the company. in terms of timing. Obviously, we have built a wealth of real-world evidence around the clinical efficacy and the pharmacoeconomic benefits of DefendCast. And as I said, we're happy that now they are choosing to begin implementation of DefendCast. On Roseo, look, it's going to be a label review issue. So until we work through this process, just coming out of the pre-NDA meeting, we don't have yet visibility of what the final label will be.

Our next question comes from Brandon Folks with HC Wainwright. Please go ahead.

Hi, thanks for taking my question and congrats on the progress. Maybe just one from me. Can you just talk about the SG&A in the quarter and the updated guidance? You know, did you take any actions in the quarter, you know, whether it's, especially on the sales and marketing infrastructure, right, just on DefendCast? or the existing Malinta portfolio. Just any color there on the expense discipline on the SG&A line.

Thank you. Thanks, Brandon. I'll let Susan comment. You know, we didn't take any deliberate actions. We're obviously trending a little bit light on the expense side. You know, some of the staffing that we're bringing on is coming in later in the year. Yeah.

And also we did and we disclosed this in our form 10Q. We had a A reduction of GNA for $4.2 million in the quarter. So it's reflecting artificially low because of that. $2.7 million of that was incurred primarily in Q1 of 2026. So we added the deductible under our insurance policies for the litigation costs. So we were able to claim the reimbursement of those. And that's what we recorded in the second quarter. So it essentially eliminates those litigation legal fees. that we had incurred in Q1 and in Q2 during the second quarter. So if you think about the run rate for expenses, it would be maybe, it would be $2.7 million higher because of what we reversed from prior periods. Does that make sense?

It does. And then just to confirm, so, you know, there's been no actions taken on the defend CAF This concludes our question and answer session. Thank you for attending today's presentation.

You may now disconnect.