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Investing in Life Science 2025

Sep 25, 2025

Evy Lundgren-Åkerlund
CEO, Xintela

I'm really glad to be here and present the progress by Xintela. I also have Stijn Heessen here, business development from Xintela. So Xintela is a public clinical- stage biopharma company that develops and commercializes best-in-class stem cell therapies, and also first-in-class targeted cancer therapies, and that is through our subsidiary Targinta. I will not talk about Targinta today; we'll focus on Xintela. We're a team of about 15 people at Medicon Village in Lund. Xintela is listed on Nasdaq First North, and we're happy to have Flerie as our major shareholder. Xintela is dedicated to making XSTEM, our stem cell product, to the leading stem cell therapy platform for osteoarthritis and other indications through partnering and licensing. I will start by sharing some really great news.

Last night we came out with a press release, the final results from our completed osteoarthritis clinical study, and really showing fantastic data, so our Xintela stem cell product, XSTEM, shows safety and sustained positive efficacy results two years after treatment in the osteoarthritis clinical study. I mean, we talk about here two years, and I'll show you some great data, so this is really fantastic news for us and a huge milestone. How do we get to this? How did we get here? Well, of course, mesenchymal stem cells, that's our product. Fantastic cells, huge therapeutic potential that regenerate, repair damaged tissues, and develop into different cell types like chondrocytes to replace dead and damaged cells. And also they secrete factors, important factors, growth factors, immuno modulatory, and inflammatory factors. And we isolate the MSCs from adipose tissue from healthy donors.

But we do something that others don't do, and this is really key for having a unique and high-quality product, and that is our selection technology that we use. So we have a proprietary stem cell marker integrin α10β1 . So we use this marker. It's expressed on MSCs but not on other cells. So that we can use this stem cell marker to select the MSCs from the cell preparations to get rid of the non-MSCs and to get pure and potent MSC preparation. You see here, here we have heterogeneous, like a mix of cells, all sources from that you isolate MSCs from contain a mixed cells. So we use then our integrin marker, the antibody, so we can get pure and high-quality stem cells. And these have great both functional and regulatory advantages.

We've seen improved differentiation, increased secretion of these important factors, also improved homing and adhesion to damaged tissue like cartilage, and no donor-to-donor variability, so it's a great consistency. We have done a number of great preclinical data, two studies in horses showing safety and efficacy, but I'll show you one really key preclinical experiment that we did. We labeled our human product XSTEM with iron and with a fluorescence marker, and then injected into a knee with a cartilage damage. So this is the knee, the cartilage damage, and then we can see how our labeled cells home to the damage and stay there. And then, actually, we can see by the fluorescence marker, the red cells and the green, the cartilage protein, so we actually can see how the cells then differentiate into cartilage cells and start to produce cartilage.

This is also part of understanding how XSTEM works. Another important asset is also that we have a GMP facility in-house and also that generates revenue, important. We produce XSTEM in-house, several advantages, full control of the manufacturing process, great flexibility, and reduced costs. And also it generates revenue by providing development, process development, and manufacturing to other cell therapies. Then now to our target indication of osteoarthritis. There is no disease-modifying therapy available today. Osteoarthritis is painful, many of you know that, debilitating joint disease affecting millions of people worldwide, and it's characterized by degradation of cartilage, which then exposes the bone to greater impact and damage. Over 2.5 million knee replacements are performed yearly in Europe alone.

So today, primarily treatments focus on symptoms, pain, and inflammation, and there is no, as I said, no existing disease-modifying therapy that can actually reduce the degradation of cartilage or stimulate or regenerate the cartilage and actually restore the function of the joint. That's what we want. So we performed the clinical studies of phase I/IIa on OA patients with grade 2 to 3. So this is a single injection of MSCs into the OA joint. We did a dose escalation study, three different doses, four , eight, 16, and eight patients per dose. We had safety as the primary outcome and the secondary effect. We look at pain, joint function, cartilage and bone structure, and so on. So now this clinical study is completed and we have the final data. First of all, what we found is that it's safe.

No adverse events overall the allogeneic MSCs at all dose levels. They're considered safe and well tolerated. Check on that. Then, to the more exciting results, here I show the effect, the positive effect on cartilage and bone. If you want to measure cartilage degradation, you can use X-ray and look at the joint space, the space between the bones. When that is decreasing, cartilage is degrading. We can measure the joint space width, and that's what we see in the middle figure here. After 18 and 24 months, compared to the baseline, compared to the start, after treatment, 4 million, 8 million, or 16 million.

So we can see there is still quite a great deal of degradation of cartilage and decrease in the joint space width with the 4 million, also some with 8 million, but with the 16 million, we see no change in joint space width suggesting a stop in cartilage breakdown. Also in the bone, we measure with MRI and we can see the structure of the bone. We can measure what is called bone marrow lesions, and that shows the structure of the bone. Also here, with the highest dose, we can see a reduction of bone marrow lesion and an improvement in the subchondral bone structure. And this is really, really great news in OA treatment. I will show other data also that it's, of course, extremely important for the patients that the pain is reduced.

This is a scale like the patients are reporting their pain in the knee. We can see strong reduction in pain already within one month after treatment, and then it actually lasts up to 24 months, up to two years. This is for the highest dose. When we analyze the joint function, and this is also a subjective scoring by the patient, they report knee pain, other symptoms, functioning activities of daily living, functioning in sports and recreation, and knee-related quality of life. Then that is summarized. You can see what fantastic data we get. Here we have one month, six months, 18 months, 24 months. Above this line, it is clinically meaningful or clinically relevant. We see again here, great response already within one month, six months, and then you can see how it increases.

So we actually see the best effect after 24 months, after one single XSTEM treatment. Really fantastic data. So as a summary, safety was shown at all dose levels. Pain is significantly reduced. Knee function is significantly improved. Cartilage and bone structure is improved. And then the highest dose shows the best therapeutic effect. And importantly, the results also support a disease-modifying potential of XSTEM in the treatment of osteoarthritis. And that's really what we want, what we're after, what we would like to see. Remember, XSTEM is a product platform. So we're now reporting data from osteoarthritis. We're also in difficult-to-heal wounds. In clinical study, we have performed the preclinical studies in acute respiratory distress syndrome, a lung complication, very deadly. And we also have, of course, other indications in line. And importantly, granted product patents for all therapeutic uses of XSTEM. I think I have two more slides.

So what's next? What's next for us is really partnering and commercial deals with XSTEM. Parallel, also preparing development plan for the next clinical study in OA, complete our clinical phase I/IIa study in difficult-to-heal wounds, and definitely also to expand our revenue-generating GMP service. Just want to mention, quite recently, we also made a deal or an agreement, a collaboration license agreement with EQGen Biomedical, and that's the horse MSCs that we have developed. So we have a license agreement with them, and so that's also an exciting story. So my final slide here. So Xintela's XSTEM platform offers a highly competitive therapy investment opportunity. We have clinical proof that XSTEM is safe and disease-modifying. We have the disease-modifying potential. With this huge market, definitely a part of that, we have a blockbuster product, revenue-generating in-house GMP facility. That's also a way to finance the company.

Platform pipeline and preclinical and clinical- stage and multiple ongoing partnering discussions, so that is pretty exciting. Thank you very much.

Operator

Thank you, Evy. A couple of questions on the study. Someone wants to know if you think it would be possible to increase the dose and get an even better effect.

Evy Lundgren-Åkerlund
CEO, Xintela

That is possible, and that is definitely what we are looking at when we are planning for the next study. For the next study. Yes. I can also mention that we had these, we did preclinical studies in horses, so that was also similar, really great effect in horses, similar dose as the highest dose that we used here. But we have to remember, I say highest dose, but it's still quite low if we compare with what others are using for in stem cell therapy, four, eight, and 16.

But that's because we have pure MSCs, so we can work with pretty low numbers.

Operator

Could you explain why the effects improve over time rather than decline? Do you know why this happens?

Evy Lundgren-Åkerlund
CEO, Xintela

Well, we know from our preclinical studies. We know from both in vivo and in vitro studies, mechanism of action. So I showed the data in the rabbits, that the cells adhere to the damage that is very likely happening and then directly participating in the regeneration. Then we have their secretion of factors and anti-inflammatory factors and so on. So the MSCs are doing what MSCs should do, and they're doing it so well. So we have a long-lasting effect. And hopefully also in the future, we will be able to see also a regeneration of the cartilage when we move this forward. Remember, this is a small study, eight people in each group.

So to be able to really see a large effect in disease-modifying, we need a lot more patients in each arm.

Operator

Also, questions about other possible indications if it could be used for, for example, in the hip or to use to speed healing of ligaments and that sort of thing.

Evy Lundgren-Åkerlund
CEO, Xintela

No, absolutely. You just mentioned a couple there. No, absolutely. Other musculoskeletal diseases, other joints, of course. As you say, we have hip, the hands. The hands are also very affected by osteoarthritis. And you talked about ligaments as well. And so definitely there are many skin diseases. There's a wide potential. Definitely.

Operator

And I actually have to say, because we're about to run out of time, but I've had someone here ask when they can hope that they can get access to the product to help their knee. So you already have potential there.

Evy Lundgren-Åkerlund
CEO, Xintela

Yeah.

Now we do get a lot of emails from osteoarthritis patients that are very interested in participating. So just write to us and we will, yeah, we'll keep them in mind.

Operator

Well, thank you so much, Evy.

Evy Lundgren-Åkerlund
CEO, Xintela

Thank you.

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