Welcome, everyone, and thank you for joining this investor webcast. My name is Megan Richards. I'm the Vice President of Investor Relations, Communications, and Portfolio Strategy, and I will be moderating the session today. Next slide. We refer to the typical investment disclaimers. Today, you will hear from Vicore's Chief Executive Officer, Ahmed Moussa, and our Chief Financial Officer, Hans Jeppsson. They will spend some time walking through the recent news from Vicore, and we will then open up the call for Q&A. So with that, I will turn it over to Ahmed Moussa.
Wonderful. Thank you, Megan, and thank you all for joining. As Megan mentioned, I'll do some introduction, talk about the case for Vicore, then I'll talk about the phase IIb study that we've announced today that we've initiated. I'll turn it over to Hans to talk a little bit about the transaction we've also announced today, including its structure, and then we'll be very happy to take questions via phone and via chat as well. At the outset, right, you know, just to recap really on what we're trying to achieve at the core and what we're spending as a high priority on in terms of our time, our resources, and our efforts, is the advancement of buloxibutid, a potentially transformational therapy for IPF, forward towards, you know, approval.
I think the case comes in three pillars. First is an upstream mechanism of action with an incredibly strong preclinical and translational dataset. Buloxibutid has a mechanism that goes after the source of the disease, where it agonizes and activates a tissue repair system on these alveolar epithelial stem or progenitor cells. And this allows for a replenishment of the epithelium in the air sac. And this is quite distinct from the other ways of going after IPF that are seen in the standard of care and emerging standard of care, which are instead only blocking the fibrosis further downstream. But rather, you know, within the Vicore mechanism action, you're able to both address the injury that's the center or the inception of the disease.
You can then also have a resolution of the fibrosis further downstream. That's the really first pillar of this case. And this disease-modifying mechanism that can repair the epithelium and resolve the fibrosis is then evident in the phase IIa dataset that we've seen, where we've shown at 36 weeks the ability to improve lung function in IPF patients by over 200 ml. And that's something that's quite tremendous and is consistent with this mechanism of action. You know, one question that many ask about anti-fibrotic or potential therapies for IPF is whether the effect will be sustained. And so to see over 36 weeks that you're able to have this effect on IPF patients is quite outstanding, and the consistency and robustness of the dataset is also quite outstanding.
Most patients, 65%, have an improvement in lung function when what you'd expect with an IPF patient who's untreated, is a decline in lung function by 180 ml. All subgroups are performing above baseline at both mean and median, which is also really reflecting this robustness and consistency across the dataset, and I think it's not to be understated that the drug has an excellent safety and tolerability profile. We do not see the GI side effects associated with the standard of care and some of the emerging standard of care, the nausea, the diarrhea, and then other side effects like photosensitivity, are not present in the Vicore molecule and mechanism of action.
I think that this is tremendous because it's something that allows this drug to behave as a frontline therapy for the disease state. It allows it to be combined, if that's what's most suitable. And it's also a reflection of the difference between this mechanism and many of the other mechanisms that are pursued, where blocking you know kind of downstream wound-healing processes can also interfere with normal processes to maintain you know tissue homeostasis and extracellular matrix. And by going for a different approach where you're looking to you know repair and resolve, you can also do so in a very safe and well-tolerated way based on the data that we have to date. And the third point I'll make about you know our phase IIa dataset links it back to the first pillar.
The biomarkers that we see in the phase IIa dataset demonstrate the mechanism that we see in our preclinical dataset, so we see in the IPF patients a trend in decrease of TGF-beta1, which is this pro-fibrotic cytokine that drives the production of new collagen and new fibrosis, and then we also see a significant upregulation in the IPF patients in their blood of MMP-13, a collagenase matrix metalloproteinase that is responsible for chopping up or digesting existing fibrosis. So basically, we're showing in our dataset also biomarkers that are suggestive that we're both stopping or slowing down new fibrosis buildup and getting rid of or digesting or resolving fibrosis that already exists, which is quite, quite excellent as well, and then the third pillar is really that this next experiment that we've now initiated, this phase IIb, is the experiment. It is robust. It is.
has the regulatory or the approval endpoint, a fifty-two-week change in forced vital capacity. It is large, 270 patients for this patient population, a robust size. It is designed with the commercial label in mind, which is as a frontline therapy that can be combined with the standard of care, and it has a global footprint, where we'll be enrolling this study from fourteen different countries. So maybe from here, I'll step forward and talk about the phase IIb even a little bit more, right? I've mentioned the attributes that make us so excited about this, the robustness, the size. We've also sought to make it very patient-friendly and accessible, both because we want to be focused on ultimately serving the patients, but also because we want to have an efficient enrollment.
So we've really done our best to limit the number of in-person visits at clinical sites, so that we can make it easy for patients to participate. But we also want to continue engaging with the patients to ensure that they are doing okay on the study, and so we've included a number of virtual, by phone or video, visits with the patients throughout the study as well. As I, you know, kind of, also indicated, the robustness includes also some dose response testing, where we'll be including the same dose level as the phase IIa, 100 mg twice daily, but we'll also be exploring a lower dose, 50 mg twice daily, over that 52-week period. And then maybe if I could speak a little bit more about the powering as well, right?
What we saw in the phase IIa, which is reflected in the graph in the left in the green, is this 200 ml improvement in lung function or over 200 ml improvement in lung function, when you would expect a 180 ml decline in this patient population over 36 weeks. That's a 400 ml treatment effect. You know, quite, quite outstanding what we saw in the phase IIa. But actually, when we think about how we're powering the phase IIb, we're doing so quite conservatively, in the sense that we're powering the study to detect a stabilization of lung function out to 52 weeks. While it'll be quite outstanding if we're able to observe an improvement in lung function, even a stabilization in lung function would both produce a positive clinical result and a blockbuster multibillion-dollar commercial opportunity in our view.
So that's one of the reasons also why it was important for us to power this study conservatively and robustly. And then, as we'd mentioned, we're going for fourteen countries, approximately 100 clinical sites. The sites are now coming online. As we mentioned, we'd received regulatory approval to initiate the study from the U.S. FDA, as well as other health authorities, and looking forward to enrolling patients in due course. So maybe from here, I'll turn it over to Hans to talk a little bit about today's transaction as well.
Thanks for that, Ahmed. So next slide, please. So the rights issue is approximately 782 million SEK, equivalent to $75 million. We have subscription and guarantee commitments for approximately 80% of the rights issue, corresponding to approximately 626 million SEK. The main purpose of the rights issue is to finance the expanded phase IIb ASPIRE trial of buloxibutid in IPF, but also to carry out phase III preparatory activities, including process and commercial development. And in addition to that, also further development of the ATRAG platform and to extend the cash runway of the company to the first half of 2028.
In addition to the rights issue, Vicore may carry out the directed issue to selected institutional investors, provided that the rights issue has been subscribed to at least 80% without any utilization of guarantee undertakings. Terms of the rights issue is a one-to-one ratio, so one subscription right for every one share held on the record date, and every one subscription right entitle each shareholder to subscribe for one new share. The subscription price is seven SEK per share. Next slide, please. So we are very happy with the significant support from existing shareholders, which, together with management and the support from the board of directors, in total, sum up to approximately 50% of the rights issue, which is approximately 389 million SEK, which is exceptionally high compared to many other rights issues.
Members of the board of directors and management, including the chairman of the board, have undertaken to subscribe to approximately two million SEK in the rights issue. Due to restrictions on participation of U.S. persons in the rights issue, the CEO, Ahmed, has undertaken to purchase shares on the market corresponding to approximately one million SEK. Underwriting commitments correspond to approximately 237 million SEK or 30% of the offering. They have been secured at an underwriting fee of 5% in cash, which is extremely low. A few important dates to keep in mind. We have the publication of the prospectus on 18 September . The subscription period runs from 20 September until 4 October , and we expect to announce the outcome of the rights issue around 7 October . With that, I hand over to Megan for the Q&A.
Excellent. Thank you, Hans. We will first take questions from those dialing in on the phone, and then we will move to questions from the chat.
If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Dan Akschuti from Pareto Securities. Please go ahead.
Thank you for taking my questions, just two broader questions. So you're preparing the phase III package as well. Are you aiming to have basically everything, also commercial manufacturing ready by end of the phase IIb trial, that you can manufacture at commercial scale at least? And, with regards to the period for the phase IIb, which I would assume you don't want to guide specifically, but could we expect, like, full enrollment around year-end 2025 or latest early 2026, and then the results comes obviously one year later? And, during that period, until later 2026, could we expect some other kind of news flow, and what kind of news flow? Thank you.
Yeah, thank you for the question, Dan. So on your first question, regarding commercial preparation, absolutely. So, you know, it's very important to actually start working on, the preparatory activities, and that spans a number of things, but the biggest is the CMC or formulation and manufacturing. So actually this year we're intending to select the commercial manufacturer for the program, and to initiate the scale up, both in terms of like the scale quantity as well as the quality further development of the process to be appropriate for a commercial, setting.
And that takes significant investment, but is necessary to start from now, because it does take some time, and we want to be in exactly the right position, as you suggest, when we're finished with the phase IIb, to be able to move forward very efficiently, and not to have to delay for any manufacturing or other product development activity. So that is a significant portion of the raise, and it's also a very important portion of the raise, because certainly finishing the phase IIb and then stopping for some years to undertake those activities would not be acceptable in terms of both, you know, bringing a drug to patients as quickly as possible, but also from an investment perspective. Your second question was related to the timing of the study.
While we're not gonna formally guide, I think that the timing that you indicated, you know, seeking to enroll patients by the end of 2025, is not unreasonable, based on how long it takes companies that have run studies of similar size with a similar global footprint. So that's certainly something, you know, that we could keep in mind as a potential timeline. The last question that you asked is then news flow in between now and then, and I would say that while we've allocated a modest amount of capital towards the early stage platform, we think it's gonna be quite impactful. And so we're really excited to be continuing to advance early stage programs, including into the clinic over the time period.
We're very excited to be continuing to develop data sets that demonstrate the efficacy of this molecule for IPF as we continue to advance it, and that's, you know, translational data sets and preclinical data sets that help us characterize the molecule better, including with the standard of care and emerging standard of care, and that'll help us position it commercially as best as possible. We are really pleased and look forward to talking more over time about that with the community, and then also even looking at this mechanism of action and the follow-on molecules that we'll be advancing to the clinic, as we mentioned, in other indications, where we think this mechanism has that same transformative potential as it does in IPF.
So we're also excited about the things that we're going to be able to talk to with the investor community over time as well. Thanks for your questions, Stan.
Thank you.
The next question comes from Arvid Necander from Carnegie. Please go ahead.
Thanks for taking my questions. So I guess you raised roughly $50 million last year, and as I understood it, at least this was the primary purpose to finance ASPIRE, and take the company into 2027, which should, by most estimates out there, be past top line data. So just sort of wondering what has ended up costing more than initially estimated and whether or not you have changed anything since then, in the study design? I'll start there.
Yeah, no. Thanks for, thanks for joining, and thanks for the question, Arvid. I think first and foremost, the study size was increased, so it went from 200 to 270. And, as I alluded to in the presentation, this provides for a more robust powering, so that we can detect even a stabilization of lung function. Part of the increased powering was also through new developments that were seen in the IPF landscape, even after that financing. So in particular, we keep a close eye on how placebo groups should be performing in IPF trials, and there were some late-stage IPF trials that had relatively mild placebo group in terms of lung function decline.
And when you see these types of data sets, it points you in the direction of increasing study size to ensure that your study is sufficiently powered to hit its p-value for a particular effect. So that's the first component, is the size. The second component is really thinking carefully, you know, the team as we plan forward on the right level of quality and robustness for the study. And some of that is seen in the details, but the details matter if you wanna create an impactful inflection point that can bring you to a commercial launch or have the right, you know, discussions with potential strategics as well. And so, for example, we're targeting currently up to 30% of the patients enrolled out of the United States and other high-quality jurisdictions.
So that's quite important for us as well. And then, you know, the other piece of the puzzle is also having the appropriate staffing footprint to effectively not only, you know, enroll the study, but to effectively execute the study over the entire course. So, for example, we'll be hiring clinical science liaisons in the different territories where we'll be conducting the studies, and this allows for efficient execution across it. Because you want to both enroll the patients, and you want to keep the clinical sites and the patients engaged over a, you know, one-year study for each patient as they come in. And it's quite important in order to collect the right data set, to make sure that your patients are staying on the study, and this is a challenge for older IPF patients.
And so we thought a lot about the details and how to make this study as robust as possible, and that does have an expense, but that expense is exactly worth it. The next point that I'll make is the product development, the CMC, is critical, right? And as I mentioned, our current plan is now to have the commercial manufacturer selected by the end of this year. And these investments, you know, require capital at the outset, but, you know, we're basically going to be taking that time period between now and the phase IIb readout, and we're going to fully take advantage of it in order to have a commercial formulation, that's, you know, suitable for a launch and for a phase III.
Right. Okay. Yeah, I mean, all very valid points, but I guess 270 patients, that was already guided for last year and, you know, adding-
No. So sorry to-
-that amount.
Sorry to interrupt you, Arvid.
Yeah. Sorry about it.
I joined the company in September, and the plan when I joined in September, which was after the financing, was a 200-patient study. And then we reevaluated that after I joined in September of 2023, and then determined to increase it to 270. And again, one of the factors in that determination was also Galecto had a phase IIb IPF readout that also came in September of 2023. So this was after the financing, which was in July of 2023, before I joined the company. Sorry, sorry to interrupt you, though.
Okay. No, no, fair. Okay. I'm just trying to sort of square that up. It still seems like this is, you know, overshoots what it would cost to add those patients by quite a margin. So is it the CMC that is actually the main component here that was a bit undersized in what you raised last year?
Yeah, I think it's across the board. I think that, right, the additional patients do cost a lot of money. I think that the selection around how you're going to run the study, it makes a difference, right? It makes a difference what countries you pick, and it makes a difference how you do it. And some of that, those items, they maybe are not in the headlines in terms of how we, you know, kind of present things, but they do matter in terms of the cost, and they do matter in terms of the ultimate impact. And then, yes, absolutely, also on the CMC. I mean, the one thing I will say is that if you look at every single other biotech company that's running an IPF study of this size, we are still the most cost competitive.
I have not seen another biotech company run, like, you know, a study like this as cost efficiently as we will, including this financing. So I will say that we're quite fiscally disciplined. Again, if you, for example, look at... We said we did a $50 million cash raise in last year, US dollar cash raise or 500 million SEK. Currently, we have, you know, a forty-something, mid-forties cash position, forties, you know, 42 million, I think, cash position as at the end of last quarter. We've really actually been quite careful with our capital, and we're deploying it towards the right aim. Quality costs money, but it's worth it in the end, I think is the top-level message I would give there.
Okay. Yeah, fair enough. Just the last question then. So do you expect? Sorry, with the capital that you're raising now, will you be able to accelerate the Aspire timeline meaningfully as to what you were expecting, previously?
That's a great question. I think, you know, Dan had also asked about the general timing. We're not going to formally guide yet. I think that Dan had mentioned, you know, "What do you think about enrolling your patients by the end of 2025?" And I indicated that I think that's not unreasonable when you look at the other studies that have been conducted, you know, of this size and of this clinical footprint. We'll have to see as we get into the study, but we are looking to try to find the ways to make this enroll as efficiently as possible. So the clinical science liaisons are part of that. The, you know, limiting the number of visits at the clinical sites for the patients is part of that.
To be honest with you, even the nature of Buloxibutid, it's an easy-to-take oral small molecule, is part of that. So we've tried to make this study as easy as possible, and we've certainly tried to engage with clinical sites, patient communities, to make it as exciting as possible, and we'll just have to see how the timing goes. We also, as I mentioned, are going for about a hundred clinical sites, and that is an increase over, you know, some of the prior plans, and that also impacts then, you know, the ability to run this, you know, in a speedier way.
Okay, great. Thank you so much. Those were all my questions.
Thank you, Arvid. Appreciate it.
The next question comes from Sushila Hernandez from Van Lanschot Kempen. Please go ahead.
My questions, I have, two, if I may. So given the number of clinical trials in IPF, could you elaborate on the efforts that you will be undertaking to fully recruit this study? Have some of the sites already been activated, and what are your key messages shared with the participants? And also, with the phase IIb powered for disease stabilization, is your assumption that you can move into a single phase III study following a successful phase IIb? Thank you.
... Yeah. Hi, Sushila. Great questions. I think you're then maybe answering your kind of last question first. You're asking the powering of the study. Powering the study as, yeah, it was said is for a stabilization of disease under the assumption of a, you know, potentially mild placebo arm. Let's see how it enrolls and how it turns out, but a conservative powering. The base case is to run a single phase III. We do not think that we would be required to run two, certainly. The upside case is that we could persuade the regulatory authorities for some sort of accelerated or conditional approval. This is country-by-country dependent, and I think it depends on the effect size and the broader IPF landscape.
So it's something harder to, you know, comment on, you know, further with any certainty right now, but it is certainly something that we would, you know, continue to watch and continue to advocate for with a readout in hand, particularly from a study of this robustness. Sorry, can you mention your... You had two other questions, if I recall?
Yes. Thank you. So given the number of clinical trials in IPF, could you elaborate on the efforts that will be undertaken to fully recruit this study? Have some of the sites already been activated, and what are the key messages shared with these participants? Thank you.
Yeah, so, great question. First of all, it starts with country selection. The countries were selected based on an understanding of, you know, what countries would be most amenable to a protocol like this, and also what studies are being run in what countries during what time period, and then that same analysis is applied to the clinical sites as they're selected. So for example, we have conversations with the clinical sites about what other clinical trials they are enrolling at a particular time, and of course, IPF is a rare disease, and patients tend to go for specialized centers.
So it's not that you go for clinical sites that don't have IPF patients or don't have other clinical studies, but you make sure that it's within a reasonable range so that you're able to have a good chance of accessing patients. The key messages that we deliver in order to execute on the study, and the ones that we think resonate the most, are first and foremost that this is a very well-tolerated drug. Like, you know, when you're thinking about IPF patients that are being provided the opportunity or have expressed an interest in participating in a clinical trial, you know, I think the notion that you're not going to impair their quality of life is one that's attractive for both the clinician and for the patients. So that's certainly a message that we deliver, you know, quite loudly.
This drug has now been exposed to over 366 patients and volunteers in different clinical studies and shows a really nice safety and tolerability profile, including over an extended dosing period, and that is different than a number of the other IPF drugs that are being currently tested, and so I think that's a huge selling point. The second one is not every clinical trial can go on top of a standard of care therapy that we're able to nicely combine with nintedanib. Standard of care means that a patient who's taking nintedanib can stay on that drug and participate in the clinical trial, and that's attractive both to the physician and to the patient as well. And then, of course, we have this amazing efficacy signal that you see in the phase IIa, right?
So there's not only the, you know, kind of, well-tolerated therapy, but there's a promise or a potential, to have, a disease-modifying effect, and I think that, can be quite attractive and exciting, for the clinical community and for patients as well. And I think particularly for clinicians that tend to be more scientifically focused, that this mechanism is so distinct from the emerging standard of care, means that you have a number of physicians who are excited to test it in their hands and to see if actually we can make a category change in terms of the types of drugs that we're developing for IPF and not just a target, a target change. So we're hopeful and optimistic that those items will, help us engage quite effectively. As I'd mentioned, we're bringing sites online now.
You know, in the United States will be the first country to have sites online, and I think they're coming online in a matter of, you know, weeks, this month, certainly.
Okay. Thank you.
Yeah. Thanks, Sushila.
There are no more questions at this time, so I hand the conference back to the speakers for any written questions.
Excellent. Thank you all so much for the great engagement on the phone. So we've had some good questions coming in here on the chat. We wanted to start off with one, and maybe, Ahmed, you could take the lead on this one: Why did you decide that now is the right time for the company to raise capital?
Yeah, I think there are two key reasons, and the first is really the most important. When you start a clinical study of this nature, from both kind of like an ethical and a corporate perspective, it's our view and the board's view that the trial needs to be fully funded, right? This, you know, involves a great deal of sacrifice on the part of patients who have this terminal disease. And, you know, it's important to ensure that we're able to treat the patients for the entirety of the clinical study and have the readout. I think that also is quite important to many investors, right? So to ensure that, you know, because we can't bring any inflection with only half of the capital needed for a study or a portion of the capital needed for a study.
So it's quite important from our perspective, for a number of reasons, that the study be fully funded as it's beginning. And I think the second reason is a little bit more strategic, but I think it's great to also, as you start the study, be independent of the capital need through the inflection and completely remove the financing overhang, which is what we're doing with this transaction.
... Thank you, Ahmed. Another question that has come up a few times, there are some that are curious about the involvement of US specialist investors in this capital raise. Hans, can you speak to that?
Yes, sure. So we have a policy not to comment on specific individual investors. However, we have subscription undertaking from a number of investors that are mentioned in the press release. We would, however, like you to know that some funds are restricted from legal point of view to provide undertakings.
Great, and, another question here that is actually more focused on the phase IIb ASPIRE trial. This person is curious why we are including a 50 mg cohort since the side effect profile of the 100 mg group was excellent. Ahmed, can you speak to this?
Yeah. It's a great question. I think there are two key reasons for that: one is expectation of health authorities. There are a number of health authorities that, as a requirement in drug development, like to see some exploration of dose. For example, we've had explicit discussions with the U.S. FDA on this subject, and aligned with them on this clinical trial protocol and their expectation to see, you know, some exploration of dose and dose response. That is one reason, you know, why we went for a second dose in our phase IIb study. The second reason is, if you might recall, in the phase IIa, we did have a minority of patients, 19%, that had some hair thinning or hair loss.
It was mild to moderate, and it was reversible, and because IPF is a fatal disease, you know, largely of older men, we believe the side effect profile will ultimately be manageable and will be a very attractive drug. At the same time, of course, if we can make this drug even easier for people to take and even more attractive by having a lower dose that doesn't have that effect, that would be quite outstanding as well.
Thank you, Ahmed. So we've actually gotten through quite a number of the questions in the chat, so I think this is a good place to conclude the call. So, Ahmed, I will turn it over to you for any closing remarks.
Thank you, Megan, and thank you all for your attention, for your support, and we're really looking forward to initiating and successfully executing on this clinical trial and delivering an incredible return for investors, hopefully with a positive readout, as well as a transformational therapy for IPF patients. I hope you have a great afternoon and a great day.