Elutia, Inc.

Thank you for joining us today. Bernadine Cherniak, please go ahead.

Thank you, Operator, and thank you all for participating in today's call. Earlier today, Elutia released financial results for the second quarter ended June 30, 2026. A copy of the press release is available on the company's website. Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the federal securities laws, which are pursuant to the safe harbor provision of the Private Securities Litigation Reform Act. of 1995. Any statements contained in this call that do not relate to matters of historical facts or relate to expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements, including without limitation those relating to our operating trends and future financial performance, are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For lists and descriptions of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our public filings with the SEC, including Elutia's annual report on Form 10-K for the year ended December 31, 2025, and in our subsequent periodic reports on Form 10-Q and 10-K, accessible on the SEC's website at www.sec.gov. Such factors may be updated from time to time in Elutia's other filings with the SEC. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 13, 2026. Elutia displays any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements because of new information, future events, or otherwise. Also, during this presentation, we refer to gross margins, excluding intangible asset amortization, which is a non-GAAP financial measure. A reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure is available on the company's financial results released for the second quarter and June 30, 2026, which is accessible on the SEC's website and posted on the investors' page of the Elutia website at www.elutia.com. and with that, I will turn the call over to Elutia's CEO, Randy Mills.

Thank you, Bernadine, and thank you everyone for joining us today. The second quarter was another solid quarter of execution for Elutia, so let's get right into it. Here's how we'll spend our time today. I'll start with why we are concentrating the company's efforts on the reconstruction opportunity. I'll walk through the highlights of the quarter, including our strength and balance sheet and some exciting new survey data Matt will take you through the financials and capital position, then we'll open the lineup for questions. Four things defined this quarter. First, we're funded. Up to $26 million of additional capital with no equity offering. We believe that carries us through the NXT 41X clearance decision in the first full year of commercial launch in 2028 and beyond. The company is becoming more focused as our strategic divestitures are being completed. We signed a definitive agreement to sell Simpliderm for up to $11 million and the cardiovascular process is progressing well. The purpose of this activity is to align the company's capital and attention on the one thing that will drive the greatest value for patients and shareholders. the commercialization of NXT 41X. Third, we now have real data on surgeon demand for NXT 41X. In an independent blinded survey of 50 board certified plastic and reconstructive surgeons, 96% expressed interest in adopting NXT 41X and 92% said that they would champion it at their hospital's value analysis committee. I'm going to spend some time on this study today because it's important. And fourth, our regulatory and manufacturing teams continue to advance towards launch on schedule. This quarter, we had a productive meeting with FDA and the NXT 41 program remains on track for what we believe will be a favorable clearance decision in the fourth quarter. Perhaps more importantly, we believe NXT 41X, the ultimate goal, is well positioned for clearance in the first half of 2027. In preparation, our automated manufacturing process has been qualified for commercial production of NXT 41X at scale. For those newer to the Aleutia story, here is a short version of what we are uniquely great at. We combine a biological matrix with sustained local antibiotic delivery at the surgical sites. The objective is straightforward. Create a surgical implant that can prevent bacterial colonization before it has the chance to become an infection. and importantly, we have done this before. Our first generation drug eluting product, Elupro, was the first FDA cleared antibiotic eluting bioenvelope. We developed it, we cleared it, we commercialized it and last October, we sold that business to Boston Scientific for $88 million. We are now applying that same technology to solving the very real problems that exist in plastic and reconstructive surgery. The United States market for breast cancer surgery is valued at $1.5 billion and importantly, it is an established market. Surgeons already use biological matrices in breast procedures today. We do not have to create a new category. At the same time, The clinical problem is substantial. Published data show postoperative infection rates remain between 15% to 20% following mastectomy. So the opportunity for us comes from the combination of three things, a large existing market, a significant unresolved clinical problem, and a technology platform that directly addresses it. A platform we created. And the magnitude of the problem is hard to ignore. These are published data, not Aleutia estimates. Approximately one in three women experiences a serious complication following reconstruction. 15 to 20% experience post-operative infection. Up to 21% experience an implant loss. And the average hospital cost of a reconstruction with an infection is more than $48,000. That is a patient problem, a hospital problem, and it is a surgeon problem. Now, we've shown you infection statistics before. What this slide shows are the consequences. Let's start with the patient. She's fighting cancer. That's why she's in the operating room. When an infection takes hold, chemotherapy stops, radiation stops, and she is looking at pain, fear, and more trips to the operating room. And if she loses the implant, more than half of the women in that situation never go back and finish the reconstruction process. It ends. The hospital incurs an added cost. mostly without reimbursement. It gives up revenue generating operating room time slot and hospital beds and it takes the reputational hit regarding its infection rate. But the surgeon pays a unique price and they pay it over and over again. Keep this in mind because they are the ultimate decision makers regarding what gets used in the operating room. Let's look at a surgeon who does 140 cases a year and has the average infection rate of 17%. That means they are getting called back into the hospital every 15 days irrespective of the time of day, the day of the week, or whether it's a holiday. That significantly impacts their quality of life. If you don't think so, think about this. The reconstructive specialty in plastic surgery is by itself an independent risk factor for burnout among plastic surgeons. And when those surgeons walk away, women lose access to reconstruction. So now that you understand what we are doing and why, let me turn to how we funded the plan. This quarter, We secured up to $26 million of additional capital without an equity offering. It comes from two places. First, a $15 million credit facility with Avenue Capital Group, $10 million of which is already in the bank, and another $5 million that is available to us upon NXT 41X clearance. That is not only a substantial infusion of cash, but also an unequivocal endorsement of our plan by a sophisticated healthcare lender who conducted extensive due diligence. The second is the Simplet Earn transaction, which provides for up to $11 million in consideration. That includes $8 million in cash at closing and up to $3 million in tech transfer and commercial milestone payments. On top of that, at the start of the fourth quarter, we anticipate receiving the full $8 million in escrow from Boston Scientific. Now look at the bottom of the slide because the timing is the point. We believe this capital will take us through the NXT 41 clearance decision in the fourth quarter of this year the anticipated NXT 41X clearance in the first half of 2027 and the full year launch in 2028 and beyond. We are now fully funded. The divestitures are a key part of the strategy. We made a deliberate decision to stop spreading capital and management attention across multiple businesses and Concentrate Aleutia where we believe we can create the greatest value. The Simpliderm transaction is now signed with closing expected in the third quarter. And the previously announced strategic process for cardiovascular continues to advance with a potential transaction in the 2026. When that work is complete, Aleutia will be solely focused on one primary opportunity, NXT 41X and the approximately $1.5 billion plastic and reconstructive surgery market. That was intentional, and we are nearly done. Now to the part of the quarter I'm most excited about. For two years, we've been telling you the demand for NXT 41X is out there. This quarter, we quantified it. We hired an independent market research firm to run a blinded survey. 50 board-certified plastic and reconstructive surgeons, eight states, averaging 11.6 years in practice and about 140 implant-based reconstructions a year. 42% practice in academic hospitals, and the group is split about evenly between east and west of the Mississippi. These are exactly the surgeons who will decide whether NXT 41X is ultimately adopted. A quick word about Method. It was blinded. These are not our friends. We did not pick the respondents. Elutia was never named. Nobody was being nice to a sponsor because nobody knew who the sponsor was. Interest was measured using the standard with Wilson 95% confidence intervals. The first question was whether surgeons themselves see infection as a significant unresolved problem. They estimated the surgical site infection rate at 17%. and that's right in the range of what the published literature says it is. The more striking result is on the right side. 86% of surgeons surveyed said the matrices they use today actually increase the risk of surgical site infection. And I want to be precise about that. That is not Aleutia making a comparative claim about another company's product. It is the surgeons describing the product they currently use as an infection risk factor. Taken together, postoperative infection is a real problem that needs a better solution. The next topic was whether the NXT 41X concept made sense to them. 96% rated the combination of rifampin and minocycline effective at reducing surgical site infection. 64% said it was extremely effective, and not a single surgeon rated the antibiotic combination as ineffective. And 98% view NXC41X as new and different from products on the market today. The specific product characteristics they found most compelling were also telling. Local antibiotic concentrations above the minimum inhibitory concentration for 30 days, a bactericidal antibiotic combination directed against known surgical site pathogens, and prevention of bacterial colonization ranked one, two, and three respectively. Those are not branding attributes. They are fundamental mechanisms of how our product works. And remember, there was no Aleutia brand attached to any of the survey. They were reacting to the actual product specifications. The third question is the one that matters commercially. Would you use it? For high-risk patients, including diabetic patients and those with high BMI, 100%, all 50 surgeons indicated they would use NXT41X. Those two groups together represent approximately one-third of reconstruction patients, an enormous opportunity in itself. But a full 96% said they were interested in incorporating NXT41X into their general practice. And then there's the number on the right. 92% indicated a willingness to approach their hospital's value analysis committee in support of NXT 41X. I think that number deserves particular attention. Hospital adoption is not simply a matter of a surgeon liking a product or a product getting approved. Someone has to be willing to make the case internally and move the product through the hospital's VAC process. 46 out of 50 surgeons indicated they were willing to do that for this product. So let me put the whole study on one slide. We asked if the problem was real. 86% said the matrix they used today increased risk infection. We asked if our approach would work. 96% rate the antibiotic combination as effective. We asked if they would use it. 96% expressed interest in incorporating it into their practice. We asked if they would fight for it. And 92% said they would champion it at their own hospital's vac. 50 surgeons, blinded and independent. Demand for NXT 41X is no longer theoretical. Turning to regulatory, I am very happy to say that for both programs, they remain on track and on schedule. NXT 41, the underlying biologic surgical matrix without drug is currently under FDA review. We recently had a productive meeting with the agency and we continue to expect a favorable FDA clearance decision for NXT 41 in the fourth quarter of 2026. That dialogue has also increased our confidence in our preparation of the NXT 41X submission. We expect FDA clearance for NXT 41X in the first half of 2027. Those remain the key regulatory milestones in front of us. Manufacturing readiness is advancing in parallel with the regulatory work. This quarter, we completed installation and operational qualification of the automated drug coding system. That system has already produced NXT 41X. For NXT 41X, we deliberately chose to own the manufacturing process ourselves. There is no contract manufacturer, license, or sole source supplier. The product is ours end to end. We also developed proprietary quality control assays and test methods to meet the FDA's very specific release criteria. The process is designed for scale, consistency, and efficiency, and we continue to target gross margins greater than 80% at scale. And it is now up and running at our GMP facility in Gaithersburg, Maryland. All in all, a very solid quarter for the Ilusia crew, and I thank each and every one of them for their remarkable efforts. And with that, let me turn the call over to Matt.