The clock strikes 3:00 P.M., and we welcome viewers here to Vivesto's Business Update. Today we will hear about the company with a focus towards the company's project portfolio, specifically Paccal Vet and Cantrixil, in the midst of a capital raise. We will hear from internal speakers of the company, as well as external speakers from both clinic and academia. We will, of course, finish with a Q&A. To those viewers who are joining us from home, you can ask your questions in the chat, and I will post a chat here to show you where you post that in the live chat during the broadcast. For those viewers who are joining us here in the studio today, you may only raise your hand. First and foremost, and without further ado, we now turn to Chairman Peter Sonnebend. Welcome.
Thank you. Good day, everyone, and thank you for joining us. My name is Peter Sonnebend, and I'm the Chairman of Vivesto, representing Arvidsruh, Vivesto's main owner and long-term supporter. It's a pleasure to speak with you about the journey this company has undertaken and the opportunities that lie ahead. Arvidsruh has been a steadfast, long-term owner, providing stability, capital, and confidence that has allowed Vivesto to successfully navigate the period of major transformation. Shareholder support has enabled the company to rebuild and refocus, emerging today as a lean, oncology-driven biotech with a clear strategic direction and strong operational discipline. Vivesto has evolved from a broad R&D organization into a targeted oncology company, one that applies advanced delivery technologies to address real medical needs, both in human and veterinary medicine.
Thanks to that focused effort, Vivesto is now stronger, more agile, and positioned for sustainable growth, with a clear mission and structure built for results. Today, you'll hear more about Vivesto's dual-track strategy in both human and veterinary oncology, which provides multiple paths to value creation. Vivesto is truly at an inflection point, with a sharpened portfolio, strong ownership backing, and significant potential to make a difference in cancer treatment for patients and companion animals. The board of directors fully supports the recently announced financing plans and the strategy that Eric and his team are pursuing. We are confident that this approach positions Vivesto for both scientific impact and shareholder value. With that, I'd like to hand things over to Eric, who will walk us through the details of the strategy and introduce some of the experts joining us today.
They'll speak about the tremendous unmet medical need that Vivesto is addressing through its innovative treatments. Eric, the floor is yours.
Thank you. Thank you so much, Peter, for those kind words. Thank you, Arvidsruh and Per. Let me also heartily welcome you all here at Investor Studios, those who are joining us online and those who are listening in after the live broadcast. I will introduce the program for today, starting with the agenda, which is divided up into six different blocks, starting with the introduction, followed by our focus programs being Paccal Vet, Cantrixil, and then followed by a brief update on the commercial potential of these programs as well. I will then summarize prior to us moving into a Q&A session. This slide depicts the speakers of today. You just heard Peter Sonnebend, who is the Chairman of the Board and also the representative of our main owner, Arvidsruh, in the board as well.
We have also Henrik Rönnberg, who's a veterinarian professor and specialized in oncology, who will talk on the general medical need in veterinarian medicine and the opportunities that follow that as well. Jim Perry will talk on the specific medical needs that our program has the potential to serve, namely hemangiosarcoma and solid cancers in cats. He's also the medical responsible person for our ongoing studies in the U.S. Today, we have also the honor of welcoming Björn-Tore Hjertzen, who is an MD and a professor in hematology, who will specifically address the unmet medical needs within acute myeloid leukemia. Teresa Fernandez Zafra will talk on the programs and update you on the positive results that we've seen in both our programs, both Paccal Vet and Cantrixil. Johanna Rostin, Chief Regulatory Officer, will address the next steps, the development plns taking us to market approval for these programs.
Nina Herner, who's a PhD and MBA, will then describe the commercial potential of our focus programs. This slide depicts the pipeline that we have within Vivesto. It is the human medicine pipeline with Cantrixil, which is in the late stage preclinical, and Apealea, which has gone through a registrational study for ovarian cancer. Within veterinary medicine, we have Paccal Vet for dog, where we have an ongoing pilot study in hemangiosarcoma, which we recently presented very positive interim results for. For Paccal Vet, we're also running a dose-finding study in cats. Our aim is to leverage value in the existing project portfolio. For Paccal Vet, we have paclitaxel in a proprietary micellar formulation. In addition to that, we had, through previous clinical studies in dogs, quite extensive positive safety and efficacy data supporting the now initiated pilot study in hemangiosarcoma in dogs.
Cantrixil is our new proprietary chemotherapy agent, with which we looked at various cancer opportunities and found that we had a combination of both unmet medical need and strong data supporting to continue within hematological cancer, and hence decided to initiate preclinical studies aiming at a preclinical proof of concept within this area. For Apalea, the opportunity to unlock value within that program is to find partners. We have a first licensing agreement with Shida Pharma, who have not only the rights to the commercialization for the Chinese market, but also production. As said, we recently had positive data in our focus programs, that is, within Paccal Vet, where we saw strong data in the interim analysis that was recently performed.
With that, if we have similar data when concluding this study in the second quarter of next year, that will support a pivotal and registrational study and the way to the market. What's also very positive is that we've seen positive efficacy data, promising efficacy data in the cat dose-finding study, in addition to good tolerability in the doses tested up to now. For Cantrixil, we've done a number of studies in the preclinical field. We've looked at difficult-to-treat human cell lines, both for acute myeloid leukemia, lymphoma, and multiple myeloma, and seen very strong effects in these cell lines. In addition, in an animal model, again, with a difficult-to-treat acute myeloid leukemia cell line, we saw effects not only with monotherapy, but also in combining the drug with standard of care agents.
What this has done is given us support to continue the development, not only for human use, but we also see opportunities within veterinary medicine, and we'll come back to that. Why the interest in veterinary oncology? You will hear more about that throughout this afternoon. There is strong underlying growth, which is explained by the increasing number of dogs and cats around the world, and in addition, dogs and cats living for a longer period of time. In addition to that, pet owners are increasingly willing to pay for advanced therapy, therapy which is similar to that offered to humans. Also, the market dynamics are attractive in that the time to market is fast, explained by less documentation needed by the regulatory agencies supporting the unmet medical need within the pet veterinary medicine field.
There is strong support also from the regulatory agencies to bring new treatment opportunities to the market. In addition to that, there is limited competition, which means that once you have a drug on the market, there is a great opportunity to expand the use. We have a planned rights issue, which is fully supported by guarantors and existing shareholders. This will give us a runway until mid-2027. The proceeds will be used to finish the ongoing pilot study in dogs, where we expect to have top lines during the second quarter of 2026. Also during the first half of next year, the results from the ongoing dose-finding study in cats. In addition to that, we will run a PK tox study supporting both the human and the planned veterinary medicine opportunities running the first half of next year.
With the data from that, we will be able to initiate the pilot study in dogs, which should support not only the human next steps, but also a veterinarian medicine program. This is planned to run during the second half of next year and the first half of 2027. In parallel with this, we intend to initiate partnering activities for both these programs, Paccal Vet and Cantrixil. With the strong data that we have received already, we plan to initiate this early next year. We believe that the data received so far will create partnering opportunities already at this stage. Why partnering then? The simple explanation is that this will increase the speed and the effectiveness of development and also the commercialization of these drugs by adding capabilities necessary both in terms of production and marketing.
It will also add necessary capital to finalize the late-stage development documentation and activities necessary. In addition to that, there will be the possibility to add complementary expertise and experience within late-stage production, clinical development, regulatory, and commercial. With that introduction, I'd like to hand over to Professor Henrik Rönnberg, who will talk about the therapeutic alternative needs within veterinary medicine and the opportunities that come together with that. Henrik, please.
Thank you, Erik. Thank you, everybody, for coming here and being online. My name is Henrik Rönnberg. This is not my regular costume. I'm much more happy being in scrubs, as you can see there, performing clinical and clinical research in veterinary oncology. I will share some views on veterinary oncology in general, and then we will have more specific information on the clinical trial currently ongoing in the U.S. Pets have become true family members emotionally and economically. We hear that from names like pet parenting for dog owners and cat owners and so on. Pet ownership drives well-being, mental health, and lifestyle choices. We can feel that we are much better off when we have our dogs and cats together with us. Pet humanization fuels strong demand for advanced healthcare. Owners seek more good years, not just more years.
It is very important that the pets are feeling good when they are treated for different diseases. The human-animal bond has really evolved. Pets are family, and society now expects veterinary medicine to deliver the same kind of quality of care we expect for ourselves. It is market-driven by longevity and willingness to invest in pets. Global companion animal health markets is estimated to have a $40 billion annual growth, which is a lot. You can see references for that in the bottom of the slides. Owners spend more per pet each year. It is really a growing market, and that is going to be on diagnostic, cancer care, and also wellness. Interestingly enough, there are international publications coming up as well on the willingness for owners to care more about their dogs. 80% of owners say that they will pursue advanced treatment if available.
That's also a thing that we need to develop more available treatments. The longevity trend and that rising lifetime healthcare spend per animal. Longevity, a success story with new health challenges, I would say. We have, over the years, got better food, vaccines, and diagnostics, which in itself will create longer lives. We see in our niche that age-related diseases really now dominate morbidity. Cancer is the leading cause of death in dogs over 10 years of age and mirrors human medicine a lot. Success leads to chronic disease management. As pets live longer, cancer becomes inevitable. It's an old man and old dog disease and old cat disease. Addressing it defines more modern veterinary care, I would say. Cancer in dogs then, scopes and relevance. It's a high lifetime risk. One out of 3 dogs will develop cancer.
As I said in the earlier slide, over 10 years, it's the major cause of death in dogs. Frequent cancers that we see in the clinic are lymphoma, mammary tumors, osteosarcoma, and hemangiosarcoma. We see that large breeds and pure breeds are overrepresented to get these cancers. It's also interesting to know that tumor biology closely parallels human oncology. Spontaneous cancer in dogs are not only a major welfare concern, I would say, that they are also two comparative models for human oncology, which I have done a lot of clinical research over the years. More and more interest in spending more finances on that, we'll see that. How do you treat cancer today then? Surgery is still a cornerstone both for human and for veterinary cancer, and that's specifically for local disease.
We also have radiation, which works really well in a lot of indications. It is effective, but unfortunately, limited access to that currently in veterinary medicine. Then we have chemotherapy, which is the main systemic approach for a lot of different tumors. We see more and more development into immunotherapy and target cancer treatments, but they are still in early stage, I would say, and a lot in clinical research development and in the comparative space as well. Most dogs still rely on the classic cytotoxic chemotherapy that we are well aware of. Veterinary oncology has the same goals that human oncology, but unfortunately, far fewer dedicated tools available. There are few drugs developed for dogs, so most that we see are off-label. The majority of anti-cancer drugs that we use today, they are human generics, so-called off-label. Only a handful of veterinary-specific chemotherapeutics are approved globally.
I would say that it's 5 to 7. Species-specific development increases scientific credibility and also safety information for us as clinicians. It enables individualized dosing, optimized efficacy, toxicity balance, and improved quality of life. Developing drugs specifically for dogs, I wouldn't say that that's a luxury. It's really essential for credibility, owner's trust, and true precision medicine in veterinary oncology. Some people tell me that chemotherapy is really for the past, but it really remains foundational, I would say. It's still the backbone of multimodal cancer therapy. Multimodal cancer therapy is a word meaning that you use different treatment options for treating the cancer. Sometimes you can then use lower dose intensity for each treatment. You can go for less surgery, less radiation if you combine them, and you can also do less chemo if you combine the other two.
Multimodal cancer therapy is definitely what we try to use in the clinic. The key roles for chemo are adjuvant in surgery settings or post-surgical treatment, rescue, or conditioning for immune therapy, which they work on the immune system. You have that to make the immune therapies work better. Many new modalities depend on the combination with chemotherapy. We really need reliable, well-tolerated formulations, which remains a cornerstone of veterinary cancer care. Chemotherapy is definitely evolving, just not disappearing. It is a platform upon which next-generation treatments are really built. The one health continuum then, natural occurring cancer in dogs, they bridge human and veterinary medicine. Comparative oncology informs drug metabolism, resistance, and immune response. Shared knowledge, they really accelerate progress for both pets and people. Innovation in veterinary oncology exemplifies really the one medicine in practice.
Every step forward for canine cancer care strengthens the one health link between animals and humans. That is why I think it is really interesting that Vivesto has these shared tracks of human and animal oncology. I think that was it. Please.
Thank you, Henrik. After Henrik has been providing a more broader perspective on veterinary oncology, I'm going to be focusing on our Paccal Vet program and the reasons why we believe this is a compelling marketing opportunity. As you may already know, paclitaxel is a well-established chemotherapeutic agent that has been used for decades in the treatment of human cancers. However, the formulations that are used for humans are unfortunately not available in veterinary medicine as cats and dogs are not able to tolerate it. This is because the formulations are causing hypersensitivity reactions, but also they can lead to immunogenic reactions. This has limited the use of paclitaxel in veterinary medicine. This is exactly where Vivesto's technology is coming into play.
We have already demonstrated that paclitaxel, when it's administered in our XR17 proprietary formulation, is both safe and efficiently can be given to animals. It is therefore we think we have a unique positioning for this program, and we are currently building up the value by having two studies that are ongoing in the U.S., one in dogs and one in cats, which I'm going to be focusing on in my next slides. As I just mentioned, we are running a pilot study in dogs that have splenic hemangiosarcoma, which is an aggressive cancer that occurs commonly in dogs. The dogs are receiving surgery as the standard of care. After that, for this particular trial, they are receiving as well 4 doses of paclitaxel every 3 weeks. The treatment phase is 12 weeks.
After that, the dogs are entering in a follow-up phase where they're being monitored with rechecks for tracking their health status, but also the treatment response. The trial is ongoing in the U.S. in eight different veterinary clinics, which are spread across four different states. Currently, we have recruited 13 dogs out of the 18 that we have planned for completing the study. We expect top-line data in the second quarter of 2026 based on the current recruitment rate. As Erik has already mentioned, a couple of weeks ago, we came out with some very exciting interim results from the ongoing study. The results are based on the first 11 dogs that entered. We have compared these results to standard of care, which is the dogs treated only with surgery.
According to different publications, the overall survival of these dogs ranges around 60-86 days. However, in our ongoing study, we have seen that a median overall survival for the dogs receiving surgery and Paccal Vet increases to 138 days. That is what the black line is depicting in the graph here. The 90% confidence interval ranges between 111 days and 163 days. That is shown by these dashed lines that are red and blue. What that means is that the end results are with 90% confidence likely to be within this range. That is very encouraging because even on the lower end, 111 days is already above this median overall survival for the surgery-alone dogs. You can also see in the graph that we have some dogs that have also been surviving for longer than 160 days.
In general, Paccal Vet seems to be doubling the survival of these dogs, which is extremely encouraging. Moving to the cat study, this is actually the first study being conducted in cats. It was therefore important to test which dose the cats could tolerate. This is a study that is being done in escalation until we can find the maximum tolerated dose. We are recruiting cats that have different types of solid tumors, usually hard to treat or that have failed previous treatment modalities. Just like the dogs, these cats are also receiving 4 doses of Paccal Vet every 3 weeks. The study is also being run in 3 sites in the U.S. We have recruited 8 cats out of the 12 planned. We expect top-line data in the first half of 2026.
As the study is ongoing, we only have preliminary results, but they are extremely promising. The first two groups that have completed the dosing have tolerated the treatment extremely well. We haven't seen any dose-limiting toxicities. We are moving up to a third group that is currently ongoing at 80 mg per sq m. Not only are the cats tolerating the treatment very well, but some clinical responses have also been observed in this study in different kinds of tumors, for example, in lymphoma and carcinoma. Jim, who is joining us from the U.S., will be talking a little bit more in detail about both the cat and the dog studies and the medical need around that. With that, I hand over to Jim. Thank you.
Hi, good afternoon. Thank you, Teresa, for that nice introduction and talk. My name is Jim Perry. Similar to Henrik, I'm a veterinary oncologist. I practice based in the U.S. In addition to my clinical oncology duties as a veterinarian, and probably the reason I'm here today is I'm also co-founder and CEO of Caster Alliance, which is the contract research organization that is running these Paklita trials, both the canine hemangio trial and the feline dose-finding study. Enough about Caster. I want to move into the studies in general and why we're here. Teresa, thank you again for doing a brief overview of the results of the interim analysis of the hemangiosarcoma study and some of our early findings in the cat study.
I think why I'm here and one of the goals of my part of the talk is just to really further explain the unmet need and the justification for what we're doing in these studies. I'll start with hemangiosarcoma. As many of you know, hemangiosarcoma is a tumor of blood vessels. It's very common in our veterinary population. It's actually a similar disease to what's seen in people. Also, it tends to be called angiosarcoma in people. It's also aggressive in us and people as well. It's extremely rare in people. Just setting the tone of not only is this a dog problem, but it's also a human problem as well.
Just perspective on how common it is, a recent study looking at it is the Golden Retriever Lifetime Study where they are tracking Golden Retrievers specifically. They found 1 in 5 Goldens have a lifetime risk of developing hemangiosarcoma. Very, very common. To add to that, about 70% of cancer-related deaths in Golden Retrievers is from hemangiosarcoma. I do not want to just focus on Goldens. I mean, various, you will see in our pet population of breeds in the study, which is in the lower right. We have a smattering of different breeds. German Shepherds is another very common breed. Portuguese Water Dogs. Obviously, mixed breeds are not immune to hemangiosarcoma either. Overall, it is very common, which proves that yes, there is a market for these treatments for hemangiosarcoma.
One other point I wanted to make as far as this disease is that dogs with the disease are not necessarily showing any clinical signs until it is kind of at the life-threatening part. Dogs can kind of harbor this disease as it is growing in the spleen or potentially other organs. When it becomes significant is when they actually grow to the point that the mass bleeds. Most of these dogs are presenting to emergency services or their primary vet on emergency with acute collapse secondary to bleeding. Just polling our emergency service, our docs here see about 3 to four cases per week of dogs with spontaneous rupture or bleeding within their abdomen that could be hemangiosarcoma. The reason I emphasize this is just these dogs are coming in in essentially critical condition and their pet parents are faced with a life-or-death decision.
Do they send the dog to surgery to remove the spleen and stop the bleeding, or do they elect hemaneuthanasia? Not to get too into the weeds here, but essentially, hemangiosarcoma is not the only disease that can cause rupture of the spleen or hemoabdomen. What happens is when dogs come in, since hemangiosarcoma is relatively common and currently the prognosis is relatively bleak, a lot of pet parents will decide to euthanize their pet versus going to surgery under the assumption it might be hemangiosarcoma. Just another perspective is as a surgeon and oncologist, we probably see 1 to 2 of these cases going to surgery. I'd say one to every other week we see one of these cases going to surgery. A lot of these pets are being euthanized.
Statistically, about 30-40% of these pets being euthanized for a ruptured spleen may not even have hemangiosarcoma. Long story short, one of the goals of finding a treatment for hemangiosarcoma is not only to improve survival in dogs with hemangiosarcoma, but it might also decrease, if there's a better prognosis with it, the number of dogs getting euthanized just with hemoabdomen. Kind of important from two points. I just added here kind of the average with surgery alone, the average survival is, as Teresa mentioned, about one to two months. What we're seeing, at least in the interim analysis in a relatively diverse population of dogs in the study so far, the survival time is about 4.6 months. We are seeing a high likelihood that there's some single-agent positive effect to Paccal Vet against hemangiosarcoma.
That is important essentially, or especially because if we have a veterinary approved, if this gets through the approval process and we still see this benefit, this will provide not only an approved single-agent drug for this disease, but we can also potentially add it to other therapies that are not approved right now, but may have an additive effect against the treatment for this disease. Very, very exciting data. Hopefully we can continue to see that trend. That is the hemangiosarcoma study. Going back here, I just wanted to emphasize two of our pets as well that we have seen. The German Shepherd in the upper right-hand corner was our first patient and really set the stage for the trial. He was essentially the perfect patient every day coming into the trial.
He'd walk in very noble and tolerated the treatment very well, got through all four treatments. The other dog, the Husky in this thing, very similarly tolerated, did need some supportive care throughout, but got through all treatments and really helped shift the curve in the right direction as far as showing improved survival. Now moving on to the cat study. I will just right off the bat say we're especially excited by the fact that Vivesto is interested in this treatment for cats as well, just because right off the bat, cats are very much underserved, not only veterinary patients, but oncology patients. And it's not because they're necessarily underrepresented from a pet standpoint. I mean, looking statistically, there are more cats in U.S. households than dogs with over 75 million cats, sorry for the typo but cats present in U.S. households alone.
There is definitely a market for therapies for these animals. Importantly, there are no FDA or USDA-approved cancer therapies in cats. In dogs, there are a few, so there are still not that many in our other species, but cats are especially underrepresented. Another big part of the cat picture is that the cancers that cats get do have a very similar, I guess there is a lot of the cancers that cats get are similar to the human side that are treated with paclitaxel. The fact that they have a similar distribution of cancers as people that get that treatment, having a treatment for cats that is paclitaxel-based is hopeful that we will be able to treat these cats in general.
I've just put a graph here that shows kind of the more common cancers that we've seen in cats and how they are similar to what is on the human side that are treated with Paclitaxel. Oral squamous cell carcinoma is probably one of the most common cancers we see in cats. It's the most common oral tumor of cats. It also utilizes a model for the oral squamous cell carcinoma in people. Cats also get essentially the equivalent of triple-negative breast cancer, a highly malignant cancer in cats that is also treated with Paclitaxel in people. Lastly, lymphoma is probably the most common malignant tumor we see in cats, is commonly seen too. The way we design the study in cats is that we're looking essentially at all measurable tumors.
Since Paklitaxel, really very few cats have been treated with Paklitaxel based on how the traditional formulation is not tolerated well, no cats have received Paklitaxel. One of the important parts of transitioning to this study is, one, find a dose that is safe for cats, make sure that they tolerate it. Also, in the recruiting of cats, we're doing all tumor types that are measurable. That will hopefully allow us to find a potential tumor type that might respond to Paklitaxel or Paklitaxel. The design of this study is essentially we're starting at a relatively lower dose just to make sure we don't overshoot tolerability. We're enrolling 3 cats per group per dose. As they receive the dose, we escalate the dose and continue to monitor responses. So far, we've enrolled nine cats.
Eight cats have received treatment so far with the ninth cat planned to receive treatment today. The data are pretty preliminary, but I'm very excited to see a lot of these response or cats we've seen so far have had at least stable disease as well as some partial responses, which may not sound extremely exciting, but in the context of treating feline tumors specifically and also just any gross tumor, any response to chemotherapy to me is a positive. While we may not be curing these tumors, one advantage of potentially using chemo in this setting is we might be able to use it in combination with surgery or other modalities to try to get that cure. I just wanted to show an example. These are two cats that we've enrolled so far.
The cat with the large neck mass in the first picture on the right says carcinoma cervical. This cat presented with a large mass next to his trachea, whether it being thyroid versus other type of carcinoma in the laryngeal region. This was very invasive based on palpation and had been resistant to other chemotherapies. Once we started the Paccal Vet trial, there was a noticeable shrinking. Also along with that, it became more movable. The hope was that we were going to be able to have a surgical option with this with more treatment with Paccal Vet. We continued. It got to the point where we felt it was more surgical. We did a CT scan, but unfortunately, there was evidence of spread to the bone.
We were not able to pursue surgery here, but it definitely provided an example of where neoadjuvant therapy with Paccal Vet might help us improve survival times. Lastly, I will end with the orange cat named Henry, who presented essentially in respiratory distress to our medicine department and was diagnosed with laryngeal and peritracheal lymphoma. The owners, knowing that the lymphoma prognosis is so poor in general with standard chemotherapies, wanted to try a new therapy. Paccal Vet in this study put the cat into a strong partial remission to where essentially it could breathe normally and have a good quality of life again while on therapy. The downside of this study is, or not downside, but just the way the study works. The study outlines 4 doses of Paccal Vet. The carcinoma cat got through all four.
As I'll mention on the next slide, the owners really wanted to continue Paccal Vet, which just goes to show that people are wanting this therapy. The lymphoma cat, unfortunately, had to move away from our clinical site, so it was not able to complete the full course of study. Unfortunately, that cat's disease progressed pretty quickly once it was off therapy. The hope is here as we learn more about Paccal Vet or Paccal Vet in cats, we will be able to potentially dose it in a longer setting or make changes and really help more cats with these diseases as well. I'll end with just kind of the preliminary data that both I and Teresa presented definitely shows promise for Paccal Vet in the setting of hemangiosarcoma in dogs as well as feline solid tumors in general, including carcinomas, lymphoma, and potentially others.
Importantly too, I think the data speaks for itself, but also just what people are saying. That is what really excites us as well. Not only the data, but just hearing what other oncologists have to say and also what the pet parents are saying. I will leave you with just the last discussion I had with one of our clinical sites. The PI there just really essentially said, "Thank you for bringing this trial to us." How much just the promise of new therapies and that we are working toward that is really helpful for their team and engagement and staying excited about the profession, especially when it can be pretty stressful seeing these pets progress and not have good treatment options.
Lastly, the pet parents that enrolled in this study are just overall really happy with allowing their pets to be part of something that might not only help their pet, but also progress to helping other pets in the future. As I mentioned with the cat, one of the clients was really, really hoping to get more. I do not want to say addiction, but it is nice to see people wanting to continue with the therapy that they are receiving. Getting cats and other animals involved where everything else has failed is really nice and nice to give them an option. With that, I just wanted to say thank you. If there are any questions, I will be happy to entertain those. Next up, we will have Johanna talk about how this drug is being pushed through the manufacturing and study progress.
Thank you. My name is Johanna Rostin, and I will talk about the Paccal Vet Program going forward. First, let me start with a brief background to this project. The Paccal Vet Program actually builds on a strong foundation of previous development work, a lot of documented data, and a history of regulatory interactions. Starting with safety, we have, through previous clinical trials, gained a lot of knowledge about the tolerability and safety of Paccal Vet. It has been shown to be tolerable to administer to dogs. It does have an acceptable safety profile. It has been given to more than 300 dogs in previous studies. With the recent clinical trial in hemangiosarcoma, I think we are up to about 330 dogs. Efficacy next.
In the studies performed previously, we have seen that Paccal Vet has indicated anti-tumor activity in several different cancer forms: squamous cell carcinoma, mast cell, and mammary tumors. These are published data. When it comes to the manufacturing process, Paccal Vet is manufactured by the same manufacturing process as our human product, Apealea. That means the process has been developed, validated, and approved by EMA for human use. It is a well-defined process which manufactures drugs to a high quality. Regarding the regulatory interactions, there have been many regulatory interactions with authorities, FDA in the U.S. and EMA in Europe. Recently, we've had regular interactions with FDA, the Center for Veterinary Medicine, on the hemangiosarcoma development program. They've actually been very helpful and interested in this program. FDA also granted Paccal Vet the so-called MUMS designation. MUMS stands for minor use or minor species.
This designation is the veterinary version of human orphan drug designation. It provides nice incentives to the sponsor companies and urges companies to take on development. The EMA has also granted limited market classification, which is the European version of the MUMS or minor use. Yeah. Looking then into the Paccal Vet development program for market approval. Right now, you've heard we are conducting a pilot study in hemangiosarcoma dogs and a dose-finding study in cats. The top-line data are we anticipate them to come in the second quarter of next year. In order to be able to continue this development, we need a partner. There are two major blocks of activities that will be performed before we can get full approval and place a product on the market. When it comes to the manufacturing process, as I said, we have a reliable process in place.
However, it needs to be set up at a commercial manufacturer, a company that is willing to take on long-term manufacturing of a veterinary oncology product. It has to have the right capabilities, scale, regulatory knowledge. The second major block of activities relates to the pivotal clinical trial. In this trial, and just to be clear, we will focus on the dog pathway going forward. It's a program that has come the furthest. In this pivotal clinical trial, Paccal Vet will be compared with standard of care and statistically evaluated for safety and efficacy. When can we anticipate to get market approval? This regulatory strategy, of course, needs to be aligned with the partner. Our current thinking is to file first with EMA for a conditional approval.
This is enabled by the limited market classification where a filing can be made based on very limited clinical data. That application could be submitted after the CMC part of the commercial manufacturing process is in place. This is, of course, very beneficial to place a product come early to market. When it comes to the U.S. FDA, we are now thinking to target the full approval pathway and await the clinical trial data from the pivotal trial. These different strategies relate to the different regional regulations and have to do with the exclusivity periods that are obtained at market approval in combination with the commercial strategy. With this, we switch over to Cantrixil. Please let me introduce Björn-Tore Hjertzen. He is a professor in hematology and will address the medical need in human AML.
Thanks for that kind introduction.
Acute myeloleukemia is the most aggressive blood cancer we have in adults. In contrast to children's leukemia, which is a lymphoid leukemia, acute myeloleukemia is a more heterogeneous disease where the majority of patients are in the higher age groups. There is about 4 per 100,000 per year with new AML patients. That is overall. If you go into the age groups above 70 years of age, it is 17 per 100,000 per year. With an aging population, we are going to see an increasing number of patients. It is a heterogeneous disease. Of course, from patient perspective, age, as we have mentioned, comorbidities. What we are mostly focused on in this area, in a way, is the genetics of the disease. There are mutations that are present more or less in all of the patients.
Some of these recurrent mutations are very important for establishing and planning the therapy of the patients. What's new in the field and what's moving forward is now that it's more panels of mutations that are taken into consideration. We also see outline of more protein-based biomarkers and other ways to molecularly characterize the disease. Patients that we consider fit and are in the age between 18 and 65, they have an expected long-term survival, five or seven years, of about 55%. That's not really it has its limitations. Unfortunately, in the higher age groups, these therapies are not available or too toxic. For unfit patients, we can get disease control, but still, cure is very complicated and maybe not possible, for example, because of the lack of consolidation therapy in the form of allogeneic stem cell transplantation.
We can easily divide the patient group into 3. The third group is, in a way, the patients that relapse after therapy. The first one was mentioned as the fit patients. This is actually a therapy, intensive chemotherapy, given in courses of about four weeks at a time, 3 to five or seven courses. It can actually cure the patient. We consider stem cell transplantation as a necessity to be able to offer a good standard of care in this patient group. It is because of the transplant that we actually see 55% long-term survival in the group overall. In unfit patients, there is happening quite a lot of quite exciting developments. We can now establish control of the disease in a majority of the patients. Some of the patients, they have a median survival of more than 40 months.
The problem is we are missing consolidation therapy. If we are not able to bring them shape-shaped to a transplant situation, it's very difficult to cure these patients, and a relapse will emerge. For the relapsed AML, as you understand that is the majority of these patients, there is no such standard of care treatment. The therapeutics mentioned here is an example of combination chemotherapy. The first one, Flugitaxel Venetoclax, is an intensive regime, while the other one is somewhat intermediate, where we get good disease control. However, in this landscape, all new therapeutics that are as good as or better than the options we already have are very, very welcome. We foresee that these patients need to be treated more in a kind of program. As mentioned, the majority will relapse. We need a second option, and we need a second option that is tolerated nicely.
On the left side, you see a stuffed bone marrow where most of the cells are malignant. There are some mature cells. Of course, these mature cells, for example, making platelets or red blood cells, as you can see indicated here, these cells need to be preserved if the therapy is going to be successful. We have some new formulations now, very exciting drugs, simple to give. They can be provided and administrated on an outpatient basis, but they still are hampered with adverse events. We need new therapeutic options. If you foresee Cantrixil into a development plan for acute myeloid leukemia, it's quite natural that we start out testing the drug, the dose-finding parts in relapse refractory AML. There are plenty of these patients, as mentioned. It's not very difficult to recruit patients to clinical trial.
These clinical trials, they will need to explore combinations, sequences that are beneficial. In all new drug development programs, it's very important to think about biomarker strategies and searching for subsets that are more sensitive than others. The current landscape of conventional chemotherapeutics, it is a fact that we know that some patients will really have benefit from the drugs, but we cannot foresee which of the patients will be the beneficial responders to the treatment. Combinations and genetic subsets, for example, as a starter, are very important to bring with us also from the first patients that we treat. If we have a clear biomarker strategy, it's quite obvious that the first-line treatment that is given today is also in a kind of shift. There is interest for less intensive therapy, which can bring the patient to the consolidation therapy currently as allohematopoietic stem cell transplantation.
With those words, I would hand over the words to Teresa.
Thank you so much, Björn-Tore. I'll be focusing now on our Cantrixil program, which is a new class of chemotherapy that we are developing for hard-to-treat hematological cancers. Cantrixil is a potent and selective third-generation benzopyrene that has a unique mode of action. We've previously shown that it can actually target the full spectrum of cancer cells, including those more resistant tumor-initiating cancer cells that are thought to drive cancer relapse in patients. As you already know, we are currently in preclinical development, and we have previously also shared throughout these years and the previous years some positive results within the program.
However, we haven't really been able to share many details on these results because we were working on filing a patent, and it is therefore very important to keep those results confidential. We have now filed that method of use patent, which means that I'm happy to be able to share the results that form the basis of that patent with you today. We still have some preclinical work ahead of us, so we are expecting to enter in clinical development sometime after 2026. I would like to guide you through the first set of experiments and results we obtained within the hematological cancer sphere. Here, we began by testing Cantrixil in a panel of different cell lines derived from patients with diverse hematological malignancies.
We selected these cell lines based on different mutations and disease backgrounds to sort of have a good starting point to understand whether Cantrixil could be effective in all of them or maybe just in a subset. What you can see in the graph is that Cantrixil was effective and had strong effects throughout all of these cell lines. What the bars are representing is that the shorter they are, the stronger the effect of Cantrixil was. It was very, very interesting for us to see that we obtained the strongest results in the cell lines that were coming from patients with relapse. It was because of that, with these results and also the high unmet medical need and the strategic business potential that we decided to move on to AML as an indication.
As Björn-Tore has already explained, AML is often treated with multiple drugs. We wanted to set Cantrixil in the context and understand whether it could enhance the effect of standard of care agents already used today. Here you have 3 graphs where Cantrixil was tested alone, but also in combination with Venetoclax in blue. We have Azacitidine in green and Cytarabine in orange. In the same way here, the shorter the bars, the strongest the effect. The bars that are striped are the ones showing the effect of Cantrixil in combination with these standard of care agents. What the graphs are telling us is that Cantrixil actually had synergistic effects with all of these different agents, which is interesting and important moving forward in the development.
These results were obtained in vitro, and obviously, it was also important to understand whether these effects are also consistent when we move into animals. We performed some experiments using a mouse model of AML. Basically, these mice are injected with cell lines derived from an AML patient that are then left to spread around the body to cause tumors. The tumor growth can be followed, and we can also follow the overall survival of these mice. What you can see on the graph on the left is the effect of Cantrixil in the tumor growth as compared to a control group that was treated with cell line. We had 3 different groups where Cantrixil was dosed at different levels. In all of the 3 groups, we saw that the tumor growth was statistically significant.
It was lower than in the control group. What we also saw is in a different set of experiments, we compared the standard of care with Venetoclax and Acesitidine to a group having also Cantrixil, so basically a triple combination group. It was interesting to see that, firstly, these animals tolerated the triple combination treatment extremely well, which is important because we do not want to be adding any extra toxicity to this group. We also saw a significant improvement in the overall survival of the mice when Cantrixil was added together with the standard of care. Although in the curve, it does not look as a very big difference on the days, I want to highlight that this is a very aggressive model, and small differences in the days are expected, but they were still significant, statistically significant.
Of importance is that the survival curves are not really overlapping. That adds also a level of significance to these results. The results I have presented to you today are comprising the patent application that has now been filed and hopefully can extend the IP for Cantrixil until 2044. With that, I leave the floor to Johanna.
Okay, I will talk about a potential development program for Cantrixil in human AML. Vivesto is now preparing to perform an exploratory PK tox study in dogs. We will investigate the pharmacokinetic properties and toxicity in dogs, a larger animal model this time. This will be performed during the first half of next year. In order then to continue the development program, we need a partner.
Since Cantrixil is now entering in clinical phase with a new indication, we would start with a phase I study and then progress to the conventional phase II and III. We also need a partner to support in the CMC development. There remains work to be done and to optimize that process. With that said, I would like to switch over to talk about Cantrixil for veterinary use. We think this is a really interesting opportunity given Cantrixil's unique mechanism of action and promising safety profile. It may be very beneficial and a good option for treating animals. First, to explain a little bit more about the synergies that we see between Cantrixil human and veterinary medicine development and to do those pathways in parallel.
With a synergistic development pathway, we mean that the study data from any in vivo study can be useful in adding information both to the human development as well as to the veterinary programs. For example, the upcoming PK talk study in dogs will support rationale and justifications for guiding on the dosing in both animals and humans. A lot of research has been done on Cantrixil already, and we now have knowledge about the biological effects across species. We have gained positive results in multiple species and several different cancer indications. We see that costs and timelines can be shared and thereby reduced in preclinical work as well as on the development of manufacturing process. The Cantrixil development program in dogs then would look like this.
Once more, I already described the PK talk study that we are planning for to be conducted first half of next year. We are also planning to initiate a pilot study in cancer sick dogs. That will provide a very important milestone. It will give information on the safety and efficacy in cancer sick dogs, and that will guide us also to predict on the human side if it has potential. In order to continue the development program, we need a partner. We need to do a regulatory required safety study, the clinical pivotal trial, and also CMC development, which could be a joint effort then with the human development work. I will stop there, and I will give the word to Nina Herner and talk about the commercial potential.
Thank you, Johanna.
I will talk about the two programs that Vivesto has and some data around and information around the markets that they are targeting. First, I would like to start with why Vivesto and its owner consider the global veterinary industry to be a very interesting industry. The global veterinary industry is fast growing, and there are mainly two reasons for this. One has to do with the pet owners' mindset, and the other has to do with the industry as a whole. As Henrik Rönnberg talked about before, and I'm just summarizing and repeating what he said here, there is a change in the mindset of the pet owners, such as they view their pets in a different way. They consider them more to be family members than to be pure animals.
With this, there is a willingness to pay not just for treatments, but for other benefits as well for these new family members. This means that they want their animals to live as long as possible. With good nutrition and good treatments, there is an aging pet population. With this, they will also suffer and be exposed to new types of diseases, including cancers. This means that there is a growing need for treatments that are not just investigated, but also developed for pets. On the industry side, there is a change in the landscape. There is a growing interest from the big pharma companies to move into animal health. They do this in a focused manner by having focused animal health companies to be specialized on new treatments for pets.
With this, there is also an unprecedented rise in an ecosystem around the animal health industry, which has a clear focus on pharmaceuticals and biotechs. There are new inventions and new treatments coming into this industry. This means that the global companion animal health market has more or less doubled in the last 10 years. If you're looking on the top 10 companies within the animal health companies, they are growing faster today than the top 10 pharma companies. The estimated value in 2023 of the top 10 global animal health companies was up to $143 billion. We now move into the Paccal Vet program with a clear focus within dog cancer, but also cat. I will only speak about the dog cancer today. There is a growing number of pets, especially on the dog side.
The estimated market size in 2025 was nearly 94 million registered dogs in the U.S., close to 100 million in Europe, and in the rest of the world, almost 300 million. The prevalence of the disease target or the targeted disease that we have or indication within the Paccal Vet program, which is hemangiosarcoma, is 53 dogs out of 100,000. We believe that Tanovea, which is a recently approved drug for lymphoma, is a good benchmark for setting the pricing for Paccal Vet within hemangiosarcoma, both in the U.S. and Europe. The estimated pricing then will land between $3,000-$3,500 for a full treatment.
There is a good market for Paccal Vet within hemangiosarcoma, but there is also a good opportunity outside hemangiosarcoma because, as we talked about before, there is one in 3 dogs that will develop tumors, and 1 in 2 dogs will actually, over 10 years, suffer from cancer. The incidence in dogs is close to 400 dogs per 100,000 dogs that will suffer from cancer at some stage in life. There is a large opportunity here to expand into other tumors outside hemangiosarcoma, such as squamous cell carcinoma, where we already have data, but also mast cell and mammary tumors. Moving into the Cantrixil in AML. A few words here on the market within AML. The market size here in the 8 major markets, and now we are counting the U.S., Europe, Japan, and China as well. The estimated number of patients within 2032 will be close to 96,000 patients.
The market value of that will be close to $3.7 billion. As Björn-Tore talked about, even if there are treatments today, standard of care treatments, there is still a large unmet medical need within this patient population group. The incidence is around 4.3 patients per 100,000. The prognosis is very poor. Five-year relative survival is close to 33%. Björn-Tore talked about a little bit where there is the greatest need within AML, and there is a large need within the relapsing and refractory patients where there is no standard of care, and where Cantrixil could be a drug to meet that unmet medical need. To give you a sense of possible pricing of Cantrixil within AML, we look towards Venetoclax, which was recently approved for AML patients.
Here we're looking towards an annual pricing around $80,000 in the U.S., in Europe, half of that, and in Japan, roughly the same as in Europe. Now we're moving over to summary to Eric. Back to you.
Thank you so much, Nina. And thank you all the speakers for today. I think it's been a really exciting afternoon. Thank you to everyone in the room listening still and also online. I think we've had not only an exciting afternoon, but an exciting year as well. We've had really positive results that will help us in the upcoming year as well. Those positive results really pave the way to the next steps in the program and also the expansion of the programs in terms of the cat study when it comes to Paccal Vet and the Cantrixil vet study as well.
With the planned rights issue, we will have investments that will take us through very important milestones also next year, those being the completion of the dog pilot study the second quarter next year and the cat study sometime the first half of next year, enabling not only initiating pivotal registrational study, but a conditional approval along the way in Europe. We will also have a PK and tox study in Cantrixil during the first half of next year, supporting both continued human and veterinarian medicine clinical development and a pilot study with Cantrixil in dogs starting towards the second half of next year and continuing the first half of the year after that. In parallel, we will initiate partnering activities starting early next year on the back of the positive results that we've seen so far.
With that, the presentations are concluded, and I asked the Vivesto team to come up. We will also have the experts available. If you have not already mailed your questions, please do so now. Yeah, we will be ready to take any questions you have.
Thank you very much. It was a long presentation, but I think it was very giving for investors. I think we should begin with the Q&A. We have a lot of questions from the viewers, but I will begin with a general question about the company. Considering that we have talked about a lot of drugs in development currently, Paccal Vet and of course Cantrixil, I am also curious about Apealea, because it seems like you are stepping into one part of business into another when you start in these developments.
What sort of key highlights do you take with you from the time with Apalea into the time now that you're developing new drugs?
I think that's what we were alluding to somewhat, and what also Peter gave us a background is that we are a much more focused company now. The company had previously the ambition to do both early discovery, preclinical work, development, production, and commercialization. I think what we've learned throughout those years is that given also the development of the capital markets, it's better to be focused. Hence the focus on the current programs and relying upon partners not only for those programs at the latest stage, but also leveraging the value in Apalea. What are your expectations ahead? Can we expect in the super long term perhaps that you will add more programs? I think so.
Still focusing on late stage preclinical and early clinical, that's certainly possible. As we heard today, veterinary medicine is a great opportunity, and there's a great medical need as well. It's not unlikely that we will look at programs in that field.
We'll move on to your liquidity and capital raise. You're raising capital of SEK 53.8 million. Considering your current portfolio projects, I know that you spoke about this in a presentation, Eric, but what will you be able to achieve with this capital raise?
The capital raise will take us through the important milestones that we outlined. I think on the back of the very positive results that we've seen, we will also be able to initiate partnering activities. They will be curious to see and excited to see the data that we've shown so far.
With the capital raise, we will be able to complete the ongoing activities, which I think will enable us to actually strike deals also with partners that will be able to add the resources necessary to the programs.
If you were asked how much capital will be added to the bank after the rights issue is completed, do you see any income within the next two years, or shall we calculate another rights issue in 2027?
I think that that's a very valid question. We have in our budget for enabling these various activities, not anticipated partnership deals being struck. On the other hand, if they do, we will expect significant upfronts, which will help us to continue. As we said, now the runway is some to the mid of 2027. That would certainly extend that as well.
What I'd like to be clear about is that the continuation of the programs, as we've said, also requires partners who we expect to actually provide not only resources in terms of capabilities and expertise, but also financial resources.
Peter here with Arwidsro, you're supporting this capital raise, of course, during your prorata, as we say. Which other significant shareholders are committing to this issue?
I think we are the largest one by far. We have seen interest from the other ones on the top 10 shareholder list. Given our size, it's obviously most important that we not only take our prorata share, but we have also committed to SEK 50 million in the underwriting.
Y our support isn't really limited to just being shareholders. It's also a credit facility that Vivesto has, SEK 10 million, five of which has been utilized so far.
What are the terms of the credit facility?
The credit facility that was put in place earlier this year was SEK 10 million at 8% interest rate. It is the same terms. It is the same terms, yes.
8%.
All right. Tell me, Eric, is it reassuring to have the largest shareholder being this sort of pillar of support?
Of course. Arwidsro has been there for the long haul, and we are really, really grateful for them continuing to support us. I think that sends a strong signal. Peter and I have very frequent contacts, and I think that should send a strong signal also to other investors that we are on the right track in the new strategy, in the focus portfolio, and especially since we have received these very positive results now recently as well.
Of course, there's also milestone payments in the pipeline, as far as I understand, linked to Apealea and the deal with China in Shida, $5.85 million in milestones plus royalty. How much of that package do you consider to be achievable, and on what sort of time horizon?
I think all of it is achievable. I mean, we have already performed the pivotal trial, and that led to a market approval in Europe. We don't think that the regulat ory agencies will look very differently upon those data that's been achieved previously. Obviously, there is some activities that need to be done. Some complementary studies will be needed in China, as well as setting up a new production since Shida Pharma will actually produce the drug, at least for the Chinese market as well.
There's a couple of years needed before we get any significant milestones and royalties, I would say
. If you were asked if there's any signal from the Chinese party that want to move forward to sell Apealea on the market, and when can that happen? We have some interest from various territories in the world. Nothing concrete at this stage. This is not our focus. We do think that there's some value there, but it necessitates new partners as well. Obviously, if the Chinese companies are successful, they would be able to produce this, provided that they get the approval in other territories as well. With production in place and approval in China, it would be more attractive to expand into other territories as well.
Yes, exactly. That leads me to the other question from the viewer.
Are any partners being sought for any other markets here, example, Latin America and European?
To be honest, I think Europe may be challenging. We've been there already. Both Middle East and Latin American and African countries would probably be of more interest. These are areas where some of the major other pharma companies are not as active, and there are other players who actually successfully can find margins and success in those territories.
I'll continue to ask questions openly, and anyone can just jump in, because now we'll move on to Paccal Vet. I'm curious, considering the sort of niche towards pets and animals, dogs and cats, how does the regulatory process differ from working with drugs for humans?
In general, the requirements are maybe not lower, but less extensive proof of burden on the sponsor companies, I would say.
Where we would have multiple studies with hundreds of patients in human cancer type, it doesn't really have to be that many patients on the veterinary side, and the studies can be much shorter. I mean, it's from a safety, it's from an ethical standpoint as well, maybe not as high requirements on the veterinary side as on the human side.
What does that mean in terms of timelines?
It does mean that the timelines can be significantly shorter than compared to human program. It's difficult to say exactly how, but in general, the regulatory required studies are not so many on the vet side.
Assuming that the final pilot data in dogs remain in line with the interim readout, what are the next concrete regulatory steps to sort of determine whether or not you will move into a pivotal registration enabling trial?
I would say that the first thing we would do is to share the clinical study report with the FDA. We submit that to our open INAD that we have, and then go for start preparing for quite extensive scientific advice meeting, both with EMA and FDA. It's very important to align the strategies and activities with the regulatory expectations.
What would be the minimal viable design that still satisfies regulatory and future commercial partner?
What do you mean?
What is the minimum viable design that still satisfied regulators and a future commercial partner?
I think it will somewhat depend upon the final results we get from the study. But if we see similar effects as outlined by Teresa earlier, it's a quite limited study.
The regulatory agencies will require safety data, given what Johanna also outlined in terms of we have already since before 314 dogs, and we're adding to that. I think the efficacy will be what actually steers the number of dogs required in the pivotal study. We are expecting at least 100 dogs, but somewhere between 100 and 150 dogs.
Remind me, when do you expect this to be on the market?
On the market, I think it depends on the partner. Of course, we hope for a strong partner that can support us very efficiently. I would say 3
years or four years, something like that. 3 years. We might add to that also that in terms of initiating such a study, obviously there needs to be a regulatory agency interaction, and we plan an international study, and I think a partner will agree.
To start that, we need clinical trial material also, and there is existing clinical trial material. It is not a bottleneck. Johanna outlined the need to start commercial production. That will be sort of the limiting factor in terms of getting approval and reaching the market as well. The sooner we can get a partner, the better.
It sounded also in the presentation that you need a partner. Can you elaborate a little bit on why having a partner is so important in this and why you can't do it on your own?
I mean, the obvious reason is the capabilities in terms of production and a marketing organization, as well as financing the program. I think ideally we would find a partner amongst the 10 largest veterinary medicine companies.
If it would be such a company or a company that would like to focus on one territory, then I think that based upon that and validated by that, we could seek additional funding. That is not the first option. It is sort of a second option as well. I think that finding a partner is both finding the resources, but also finding the validation of the program. You have heard quite a lot of support for both the medical need and the commercial potential of these programs as well.
I think an additional such validation will be through a partner as well. That is an additional factor for why it is important. Without telling us too much, have you already initiated discussions with potential partners?
We have had a couple of very few preliminary discussions, but that has been more sort of circumstantial.
I think that as I indicated, we will start a process more in the beginning of next year. What I can tell you is that we are looking into the possibility of working with business development consultants to make this as effective and professional as possible. This is something that we have put in the budget for next year and the first part of the year following that as well.
It is also a matter of finding the right partner. There is a viewer in the chat who expressed a little bit of concern that one might find a partner, but the partner might not take the product to market. How do you ensure that that won't happen?
One reason for choosing a very professional business development partner is to actually get the boxes checked in terms of the resources and the capabilities to actually take a program and take it successfully, not only through development, but also in production and also commercialization of the programs.
The same viewer also expresses a little bit of concern about the market that Paccal Vet will meet in terms of, for instance, dog insurance, etc., and the sort of payment power of the pet owner/customer. Can you elaborate a little bit on the sort of market you will enter into the U.S. with Paccal Vet?
I think, as we heard throughout the afternoon, this is certainly an increasing market, not only in terms of numbers, but also in terms of willingness to pay.
We're seeing that through not only the few products that are actually approved for veterinary oncology, but the prices paid. What we've become more and more aware of is that there are actually activities ongoing in terms of developing drugs specifically for the veterinary market, even drugs that will have really high prices because these are biologics and more expensive to produce as well. It is not only us that believe that this is a growing and very interesting market, but there is also some competition, even if it's not the same as in pharma.
We're also going to talk about Cantrixil. Before we do that, I will turn to the ground and see if there's any questions here. No. All right. We'll move on to Cantrixil, giving the synergistic effect seen with standard of care drugs.
Do you envision the first AML trial as monotherapy dose escalation study followed by combination, or would you move directly into combination trial?
I think that the first trial needs to be a monotherapy, but you start then with the combination therapy and work towards a monotherapy once on the market. I would turn to if you have any comment on what a development program for Cantrixil would look like.
Yeah. Development of these drugs in such a complex disease can have different solutions in a way. One model can be to launch a phase one trial, which is designed with the idea that it can be adapted. First, we determine the dosing, looking for signals of therapeutic effect, and then eventually build it up with one or a few combinations in small arms.
One of the designs that I fancy myself just now is a small design that we use in academic trials where we try to repurpose labeled drugs. 8 patients, for example. If we strictly define clinical benefit, then you can say that if there is one or more clinical benefits, then we can scale it up plus 16 patients. In that way, you have a go/no-go level at all stages. I think that's very important. If there is unforeseen toxicity or problems or a group of patients that do not should have this treatment, it's important to identify them early on. What's maybe more interesting is the fact that in these early trials, you can get signals on who are actually really responders. Of course, we are searching for exceptional responders the whole time. That's what we hope that you have in your portfolio. Thank you.
Thank you.
Assuming that you reached full funding, what are the next steps and time frames to get Cantrixil to first clinical study?
I think Johanna, could you take that question?
Assuming that you have reached your funding, what are the next steps to get Cantrixil to first clinical study?
As I said, we will run our PK tox study. We will do a pilot study in the dogs. We have for Cantrixil a lot of data in various models, animal models, and we also have in humans. Still, we might need to do a gap analysis on the GLP tox to do some complementary work there. We need to have CMC development coming a bit further before we could start Cantrixil phase one.
What is your strategy regarding partnerships to Cantrixil? How does it differ from Paccal Vet?
For Cantrixil, we wish to get a partner also at this stage to actually enable the activities that Johanna outlined. I think the expectation in terms of Cantrixil is perhaps a more specialized pharma company, and it could be a global player, could also be a regional player. We are quite open in terms of the structure of such a deal, but we certainly do want a partner before taking the next steps. What we will do is the preparatory activities in terms of the PK talks that's covered by the planned rights issue and also the pilot study.
As Johanna sort of mentioned in the beginning of this Q&A, the regulatory times and the process, it differs a lot. What about when looking for partnerships, comparing the veterinarian line towards the human line?
Yeah, that's going to be quite different.
I myself have a background with human medicine as well, so I know business development quite well and how to optimize that in terms of human medicine. I'm not as familiar about veterinary medicine and partnerships in that field. Obviously, there are some similarities in terms of companies having a veterinary medicine arm as well as human medicine. There are separate veterinary medicine companies that are amongst the largest as well. All in all, this is a good reason for why we want to find and identify a business development consultant who actually is knowledgeable, especially about the veterinary medicine field, but also human medicine and a potential partner for Cantrixil as well.
We will soon turn to Jim Perry, who will join us via link. Before we do that, we will turn to the audience again if there are any questions.
Yeah, if you just, yeah, I can just a reminder about the toxicity profile of Cantrixil and how it, if it's overlapped with drugs like venetoclax and azacitidine, perhaps.
At the moment, in the preliminary results that we have seen, we have actually not seen any toxicity. Usually, when you do studies in mice, you would like to see that they do not lose more than 10% of weight, and we have been within that level. That is the reason why now we would like to do this PK tox in dogs to see that these results are replicating. I know that venetoclax, and especially azacitidine, are quite toxic. If we would be able to add Cantrixil, that maybe would allow us to have a lower dosing on these venetoclax and azacitidine as well to have a more powerful, effective treatment.
That is the reason why it is so important to see synergy in these results, but also that there is no overlapping toxicity. We need to look a little bit more in depth now, and that is why we want to turn to do the dog studies, which is a species that resembles humans much more than mice.
Also, out of curiosity, why do you think you see better results in the cell lines with resistant tumors?
It is very interesting. I know that we have already data from other cancer types, and we have seen the same. Perhaps it has to do with the mechanism of action of Cantrixil. I mean, it is very encouraging, and I hope that we can dig into that much further. At the moment, we were happy to see these results and also interested.
What has been observed previously is that there is an effect on stem cells. Maybe that could be one of the factors actually explaining that finding.
Okay. Thank you so much.
Thank you as well. Are there any other questions from the audience? No. All right. We turn to Jim Perry, who gave us a slide here in the presentation. Jim, from your perspective as a study operator, what will the pilot study need to show to justify moving into a larger registration enabling trial? Jim, from your perspective as study operator, what will the pilot study need to show to justify moving into a larger registration enabling trial ?
Hi. Sorry about that. Getting my mic. Can you hear me okay? Excellent.
I think from my perspective, again, as medical monitor and running the studies in the U.S., I think just seeing a continued promising benefit of efficacy in the pilot study would gear that next step to justifying a pivotal trial and also continuing to see a tolerable dose that we can use to kind of match the potential efficacy.
There are more owners today willing to pursue advanced care for their pets. How strong is the demand today for more effective veterinary oncology treatments?
I mean, my perspective is mostly just on the clinician side. I just see the pets that come to me. Speaking for sheer numbers is a little difficult from my perspective, but just from my clinical practice, we see our schedules are filled up with patient clients that are willing to pursue treatments for their pets.
At least from an on-the-ground perspective, there's kind of no limitation on the number of pets that we see. Relative to the available veterinary specialists to treat these pets, we see plenty of willingness to move forward with advanced treatments and costly treatments, to be honest.
Henrik showed a slide that 80% is willing to pursue these advanced care, if I'm not mistaken. What about the other 20%? Why do they not want to move on to advanced care?
I'm sorry. Can you repeat that again? From Henrik's slide, I saw a statistic that was 80% of owners want to pursue advanced care. I'm curious more about the 20%, why they do not wish to pursue more advanced care.
Yeah. I mean, I think, and Henrik, I don't know if you want to add to that. I mean, I can give my perspective.
A lot of it comes in not necessarily cost, but also after the discussion of giving the estimated prognosis with a certain treatment as well as cost. Another big component is just ability to come to the clinic and spend time based on the pet parent's schedule. Is that something that they can do feasibly, not just financially, but from a time standpoint? I think that's my best estimate of why we do have a fair number of people not able to pursue treatment, or they like to pursue other non-traditional therapies based on what their feelings are.
What can you tell us about how it's treated today?
Yeah. I mean, that's a good point. We didn't go too in depth about, and specifically hemangiosarcoma, but it's kind of 2 points of standard of care throughout these studies.
We're comparing it a lot to surgery alone, but a step above, which most treatments of their clients that are pursuing chemotherapy for hemangiosarcoma were using doxorubicin as a single agent. That's off-label, so not approved for veterinary medicine, but it's obviously generic and a long-running chemotherapy. Standard chemotherapy for hemangiosarcoma right now is doxorubicin and also has single-agent efficacy shown throughout many trials, or not necessarily trials, but just experience. Importantly, with doxorubicin, while it is tolerated fairly well in most animal patients, it does have a unique toxicity that makes it not necessarily available for all pets. It has very specific cardiotoxicity. It also has a limited number of doses you can give based on that toxicity. Not only having another efficacious drug out there for hemangiosarcoma, it might be able to be used, Paccal Vet could be used instead of doxorubicin in those patients.
There is potential, once we get more information on the use of Paccal Vet in hemangiosarcoma, there might be an option to combine it with doxorubicin or other modalities that are yet to be out there. I think it's not a direct competition with doxorubicin or other drugs we use now, but it's potentially complementary. Just having more options out there is useful in my perspective from a clinician.
Another statistic that I noticed in the presentation, I don't recall if it was yours or Henrik, but one in 3 dogs get cancer. If we compare that to other domestic animals and even humans, how does that statistic sort of compare?
Yeah. I mean, I can't comment too much. I mean, from other veterinary species, cats as well, that we develop a lot of cancers.
I think it just more represents the, that's a lot of numbers out there. I don't know if I have a specific answer to shift, but there's definitely the need there.
Can I just?
Of course.
My response to that from a human medicine perspective would be that we're getting better and better to actually prevent and treat cardiovascular disease for humans. It's becoming less common. Because of that, cancer is becoming more and more common in humans as well. It's a disease of the elderly as well. Probably, if you look a number of years ahead, it would be the most common reason for dying as humans as well. Perhaps neurodegenerative diseases as well. It could be that we're getting more healthy in a way, similar to our pets.
As I now head into the final question, I will turn to the crowd once more and see if there's any questions here. All right. Moving on towards the new year and 2026, 2027, can you share with us some highlights that investors should look forward to?
Oh, of course. Those following Vivesto have a lot to look forward to. We've had a very exciting 2025 and look forward to an even more exciting 2026 in delivering these programs, both in terms of the cat and the dog study for Paccal Vet and the continued Cantrixil studies. What we also have ahead of us, I think, is news as we move along 2026 in terms of partnering as well.
Team at Vivesto, thank you very much for giving us a very comprehensive business update today and very comprehensive answers to our questions.
Thank you so much.
Thank you.
Thank you.