Good afternoon, everyone. I appreciate the opportunity to speak with you today.

We all see the disclaimer. We don't need to go through that.

Like I said, I appreciate the opportunity to speak to you today as a new Executive Chairman of Tissue Regenix. So I have a brief statement that I think is appropriate at this time, an important time for our business.

Today, we reported some softness in sales, revenues, and we are working to strengthen our commercial approach. We also reported that we are conducting a comprehensive review of our cost structure, and we'll be announcing the results of that review in the coming weeks.

The focus of the Board is on strengthening our capabilities to secure both near-term performance and long-term sustainable growth, and we believe that is achievable. What makes Tissue special is its leading-edge technology and products, its people and its ability to make a lasting impact on people's lives.

I remain confident that by sharpening our focus, we will deliver on that potential and create meaningful value for both patients and shareholders. I look forward to sharing more about our progress in the coming weeks and working together with you as we build the future of this company, and I look forward to a very productive discussion today.

Thank you.

So I'd like to introduce the presenters. So I'm Daniel Lee, I'm the Chief Executive Officer, for Tissue Regenix.

I was appointed Chief Executive Officer in November 2020, originally joined Tissue Regenix as President of the U.S. Operations in January 2019.

My background is I have over 30 years of experience in technical as well as commercial roles in biologics as well as medical device companies. And these range from start-ups to established companies.

So my interest, my passion with Tissue Regenix is that we have this global opportunity to help patients with our tissue-based products, whether they're made from allograft or xenograft tissue. Not many companies have this very unique opportunity.

Brandon?

Yes. My name is Brandon Largent.

I've been appointed the Interim Chief Financial Officer effective August 1. So it's a recent appointment.

I've had a varied background in multiple industries over the last 25 years, starting in public accounting and then moving into the corporate world with various financial planning and analysis roles and corporate controller and smaller company CFO roles. I started with Tissue Regenix back in September of 2020, took a brief hiatus to pursue some other interest and been back with the company early 2025 and with the recent appointment to the interim CFO position.

Happy to be here and looking forward to a long and prosperous career here.

So very quickly, an overview of the company for those who are not familiar with Tissue Regenix, but we are a global health care company focused on the area of regenerative medicine. Regenerative Medicine is a specific and medical discipline where you try to regrow, repair, replace cells, organs and tissue using the body's innate ability to heal itself.

What Tissue Regenix has developed is we developed tissue-based scaffold products using 2 core technology platforms, BioRinse as well as dCELL. Both of these platforms share the same objective of preserving the inherent biologic, biochemical, biomechanical properties of tissue, but rendering the tissue safe through a gentle processing process.

We produce products in the United States as well as the U.K. as well as in Germany.

Our product portfolio is quite extensive. It's developed from numerous tissue platforms, which are formed from bone, tendons, dermis as well as birth tissue.

And these products all address diverse surgical markets. We have -- from a distribution, a commercial standpoint, we have significant strategic partnerships.

We also to have our own strong distribution in a number of our markets. At the end, the company is well positioned to be a contributor in transforming health care through regenerative medicine.

So a little bit about our first half 2025. In the first half of 2025, we did see some downturns, which we began to see in our business in H2 of 2024, and these did carry over into 2025.

Revenues for the group were down 6% in H1 2025 versus H1 2024. Our BioRinse business, which is a U.S.

business composed of finished good products, RDT, which is our release donor tissue and a business outside the United States, that business was down 7%. I'd like to note that in the H1 of 2024, we filled nearly $600,000 in back orders from 2023 and H1 of 2024.

Our dCELL business, which again is another big component, which is primarily our direct dermis business in the United States as well as outside the United States with our xenograft tissue products, that business was down 4%. Gross profit decreased as we've seen decreases in yields from the tissue we received.

As you know, when it comes to human donor tissue, there is -- the tissue can be variable. Our adjusted EBITDA also decreased on a year-over-year basis.

In H1 of 2025, we concluded our strategic review. We determined that the timing was not conducive to the receipt of an appropriate offer or an appropriate evaluation for the Tissue Regenix Group.

Now during the first half of 2025, we did see some good highlights, good advances. Despite the ordering declines that we've seen with our strategic partners, we did see a 4% increase in orders for our demineralized bone matrix products.

Demineralized bone matrix products are the bulk of our BioRinse business. Our dCELL business, which is more of a direct business, that business grew by 10% year-over-year in H1 despite the order decline that we saw with a specific strategic partner.

Some other milestones during the first half of 2025, we saw in our dCELL as well as our OrthoPure XT business. In the first half of 2025, we received an EU patent on our dCELL process.

So this protects our IP position for this platform technology for years to come. And then with respect to our XT business, which is the OrthoPure XT, this is the very novel product.

It is a nonhuman tissue graft or ligament reconstruction. And during the first half of 2025, we noted that we had our -- the shipment of our over 1,000 units that the manuscript that highlights the 5-year clinical results of this novel product was accepted for publication, and I can happily report that it was actually published last week in the Journal of Experimental Orthopaedics.

And then another milestone for the organization that we received MDR certification. Those of you who are familiar with medical devices know that the change from MDD to MDR is quite a substantial lift.

And we can happily say that our group in Garforth achieved MDR certification. Next slide.

This slide highlights a letter that we -- that was sent by The American Association of Tissue Banks to the Food and Drug Administration. This highlights that the certificates to foreign governments, otherwise known as CFGs, is an issue, which we thought impacted our business alone, but it apparently has impacted others within the human tissue industry.

Certificates of foreign governments are required by the FDA to enable you to export medical products to countries outside the United States. For us, it impacted our ability to ship finished goods or our RDT, which is a release donor tissue.

Changes to this CFG process were unanticipated. Historically, this has taken weeks to receive your CFGs, but now it is taking months to time frames that approach 1 year.

So normally, with the ebbs and flows with our business with various customers, we can offset that with new customers and new opportunities as we grow our business. So not being able to get these CFGs impacted the timing of when we're able to bring on this new business.

And new business for markets outside the United States is one of the growth pillars for our organization. So the delays in obtaining the CFG regulatory approvals impacted our RDT business.

That business was hurt the most, where we saw a 45% decrease year-on-year. Okay.

At this point, I'll turn the meeting over to Brandon, and he will highlight some of the financial results in the first half of '25.

Thank you, Danny. So with the group revenues, as discussed earlier with Danny, we continue to see a slowdown in the first half of 2025 versus the second half of 2024.

One thing to note in the first half of '24, we did contain approximately $600,000 of back orders from the second half of 2023, which was not repeated in the first half of the 2025 period. Tracking -- gross profit tracking is at 42% currently.

This is primarily attributable to the increased inventory costing and decreased production we are currently experiencing on our production. We're currently addressing those yield -- production yield issues, and hopefully, they will be solved through the end of the year.

With the reduced revenue and decreased gross profit, EBITDA has reduced as well. We're currently working to reduce the fixed cost in order to alleviate some of these shortfalls in the first half of '25, and we'll continue to monitor these on a weekly basis.

Moving to cash position. the cash reduction is primarily impacted by the current inventory increases.

Our trade receivables are trending with our reduction in revenue, slowdown in sales, slowdown in the receivables. Even though we are seeing a decrease, we are still collecting cash at a 98% rate, which is fairly consistent over the last 18 to 24 months.

Our inventory levels are primarily due to our manufacturing materials and finished goods increased as a result of some second half 2024 decisions regarding product purchasing. We should see those level start to -- those inventory levels stabilize by the end of the year.

Although our building and term loans have decreased on principal, we have pulled a little more on our revolving line of credit versus the first half of 2024 to bridge some current operations and increased inventory costs. Trade and other payables have increased due to working through purchasing impacts from the fourth quarter of '24, first quarter of '25 that have increased our manufacturing supplies and annual costing increases of those supplies.

Addressing the accounting issues, with me coming on board as the Interim CFO on August 1, we started a reevaluation of estimates of our inventory and cost of goods sold previously reported. We expect to have this analysis completed by the end of October and report as necessary.

And just to reiterate, this is an inventory cost of goods sold issue, not a revenue issue. I'll turn it back over to Danny.

Here on the summary side, I just wanted to communicate that with -- for the last several years, we've talked about our 4S strategy and the growth pillars. And this has set and continues to set the direction for the company and provide a structure and clear direction for everything that we do.

But as Jay has mentioned earlier that this is a restart for our organization. We need to reestablish our growth trajectory and our revenue growth.

We are implementing changes to focus our resources in areas offering the best opportunities to do that. With our new Board, we'll revisit opportunities to operate the company more effectively and achieve the profitability objectives.

Regulatory approvals, which have delayed our ability to export or import tissue products into new markets with new partners. We expect those to potentially continue.

But at least now we are aware and we can plan around those -- that headwind. Our business remains diversified and the opportunity with that is that it gives us the ability to focus in markets where demand and performance are strong.

So with that, we'd like to open up to questions from the audience.

Thank you, Alex. Thank you, Jay.

Questions that have come in from investors. One we have here is that Tissue Regenix has excellent products.

What plans does the new Board have to infuse medical professionals about their potential in new applications.

Do you want me to take that one? Danny, do you want to take that?

Go ahead, Jay, and I'll chime in.

I think what we want -- what we'd like to do is do some more clinical trials on the efficacy of our products. We haven't been able to do that in the past, and we're looking forward to doing that in the future.

And we need the clinical trial data to get in front of more medical professionals in different parts of the world, especially the U.S. So we are looking at this from a commercial perspective on how we can accelerate the commercial applications of some of our products, which while are very good, don't have the clinical data to support some of the things that we're seeing.

Yes. As Jay has mentioned, we -- clinical data is a key driver in achieving adoption by clinicians for the best products for their patients.

Our company has historically had a hybrid distribution strategy. We rely on strategic partners for some -- in some of our markets for clinical engagement.

But then in the markets in which we have more direct distribution, there are things that we could work on to -- in terms of getting a bigger distribution footprint, continue our existing marketing efforts and expanding those marketing efforts. We do post things on social media with case studies, including the expansion of clinical indications for our products.

We do go to some clinical meetings and -- but a very important part is supporting the marketplace with clinical publications.

Thanks, Danny. The next question is, why did we drop $3 million of sales that provided $1 million of gross margins if we didn't have the sales of better margin products waiting to replace them.

As a follow-up question, they've asked, has the $800,000 of fixed overhead related to those sales actually have been saved and the timing of the decision obviously has had an impact in their view on the share price.

Okay. I don't think that this question is necessarily related to the interims because we didn't have a drop in $3 million in sales, maybe more of a discussion around year-end.

What I would like to say about this one is let us look at this question a little bit more and provide a written response.

Thank you. And are you able to talk a bit more about the board changes that were made at the beginning of the month and what the strategic benefits will be seen by the group moving forward.

Well, I can take that, Danny. Look, I think the former Board did a very good job.

I think the Board and some of the major investors took a look at the business and wanted to bring a more commercial approach to just some of the things that we were doing. My experience, which I didn't highlight before, it was on the slide when I was talking, is in global commercialization in the Medical Diagnostics business.

I've been CEO of Celsis International. I was on the Board at Bioquell.

I'm currently running Source BioScience based in the U.K. And the common theme is you've got to get the commercial side of the business right.

And I think the Board felt we weren't doing as good as we could be doing to say it nicely that way. And I also think we've got a situation where we're looking at the financials.

And we are committed to looking at the financial business and fixing the business. And I think the Board felt comfortable bringing me in to help Danny and the team come in and really fix this business and put it on the right trajectory.

So I think that was what we were looking at when they decided to ask me to join the board.

Thank you, Joe. A question regarding your expectation to restore growth and deliver sustainable growth across all the divisions.

Does this mean that you expect to see market headwinds abating?

Let's see. Some headwinds may still impact certain markets, but we will focus on the opportunities to grow the business within each division.

And so we need to really remain flexible with the opportunities that are presented.

And then looking at how you might expand, one investor has asked, are there other areas you're targeting for geographic expansion and why.

Sure. So with respect to geographic expansion, the success of our geographic expansion is dependent on a number of factors.

Regulatory is one of them. Some markets regulate human tissue products differently from medical devices.

Another aspect is finding the right distribution partner in a market who will take the initiative to make this product successful. XT, which is our OrthoPure XT, which is a medical device, it's now received its MDR certification.

We will expand into those markets, which accept the CE mark. But with respect to our core business, which has been human tissue, we need to identify the markets where the time, effort and cost of introducing allograft tissue does not -- does not require extensive regulatory requirements, including an extensive clinical studies.

So we've tried to avoid some of those markets due to those legal and regulatory hurdles. So -- but we are opportunistic with new markets where we can get into those markets fairly quickly that we can get reimbursement levels that are profitable.

So this may be countries in the Europe, Middle East, Asia, Australia, Central and South America are certainly -- are markets that we're currently looking at right now.

I appreciate this probably isn't a question you can answer, but it's come up a lot on the questions coming through is about providing some clarity on the inaccurate or on the reporting of inventory and cross-sale estimates. I mean other than the fact that you've said that you expect to clarify that next month and that any restatement won't affect the company's revenues for numbers for full year 2024.

There isn't really anything else that you can say on that at the moment, and do you expect to clarify that in the next month, right?

We do, we do. And like we said before, it's not necessarily inaccurate reporting.

It's based on some estimates that we were using beforehand. And since I've come on board as the interim, that's one of the first projects that I took on is to make sure that what we're reporting is accurate.

And so we're currently in that process and look to be getting at least a path forward before the end of the month. And we'll report on that as we see -- as information becomes available.

And do you see the regulatory landscape changing? Will that help reduce delays?

Well, I think we can expect further changes and continuing regulatory delays and uncertainties for human tissue products. I say that because when we first started counter the CFG, the certificate to foreign supporting government issue, we thought it was something unique to our group.

But then, of course, then we learned that it was -- the industry was being impacted. So the actions and the current dialogue from the FDA here in the United States, of course, changes.

And we feel that they may place additional scrutiny on human tissue and impact regulatory approvals. But the thing is at least now we can work and plan around those issues.

One evolution that we are doing as a company is that we are evolving from a processor of human cell and tissue products to one that has the capacity to produce medical devices and eventually -- and having the medical device, the opportunity to produce medical products will give us flexibility not only in the domestic market, but also in many markets outside the United States.

You talked about commercial diversity. Could you just add some more color on how you're doing this?

Sure. Our products have utility in many areas of surgery.

But currently, we currently -- and when we initiated -- certainly initiated distribution, we focused in certain surgical specialties because we were a small and growing player in the tissue business. For example, our direct distribution, our DermaPure business, we have a very versatile product and which can offer advantages over some other competitive products.

But we don't have -- currently, we do not have full distribution coverage across the United States. And our sales team calls on clinicians focused on limb salvage and podiatry.

We have begun to expand into other surgical specialties. As we get our product into the institutions, it's on the shelf in a certain hospital or an institution and the clinicians or the podiatrists are using the product.

Now having that issue in that product in the hospital gives other clinicians within that institution the opportunity to use the product. So this could be a general surgeon.

It could be a colorectal surgeon, a plastic surgeon. So that's what we've been working on within institutions in which we have our product.

We're being able to expand and have clinicians generate clinical data around using our products into other surgical specialties.

There's a question regarding the decline in dCELL revenues. What are the reasons for the decline.

But also what are you doing to rectify it and to turn the situation around.

So the decline in the dCELL business, the minus 4% that we saw in the first half of '25 versus '24, sadly was just really with respect to one strategic partner where their business H1 '25 versus H1 '24 decreased by 37%. If we remove that from the equation, I already mentioned that our dCELL business just for our DermaPure product actually increased by 10%.

So certainly, we will look very closely at continuing, of course, the growth that we have with our existing business, but also that of our strategic partner.

Thank you. There have been a lot of questions on finances, on issues that might not be able to be addressed on this call right now.

All of those questions that have been asked will be answered in written submissions, which we'll put on afterwards. But there is a final question, which I'll address to Jay, if I can, which is a couple of investors have mentioned about good to hear the reassurance that you provided, but also talking about the clinical data that you look to produce to drive sales.

Could you comment about the financial ability to do that, the sort of financial resources to achieve that kind of those clinical data?

That's a great question. I think certainly, clinical trials, there are different types of clinical trials, 510(k)s, which we need aren't overly expensive.

If you want to get into a larger study, it's going to cost more. I think the question we have is, can we afford not to do these trials?

And I think the answer is no, we cannot afford not to do them. We're spending about $12 million on SG&A, and that's a lot of money.

So maybe there's areas that we're spending on now we can spend in clinical trials. So we're going to take a look at the cost base and figure out how we can do what's most effective to grow the business.

And that's what I committed to you as investors and the Board.

Yes. I just want to reiterate what I said in my opening statement is that it's very important that we're having this meeting today with the investors.

Certainly, we reported results that were less than stellar. We are making the corrections needed to on the commercial side.

We are going to take a look at the cost structure, as Brandon said, and we are committed to sharpening the focus of the business to deliver on what we said we were going to do. So I do welcome these questions, and we will answer them.

And I'm looking forward to working with the entire team at Tissue to bring this company back. And as Danny said, sort of this restart, and we're going to get started.

And we've already been started as I joined as the new Exec Chair.