Puretech Health Aktie

Greetings, and welcome to the PureTech Health 2026 Half Year Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Allison Mead Talbot, Senior Vice President of Communications. Thank you, Allison. You may begin.

Thank you, and thank you, everyone, for joining us for PureTech's 2026 Half Year Results webcast at puretechhealth.com. I would like to remind you that during today's call, we will be making certain forward-looking statements. These statements are subject to various risks, uncertainties and assumptions that could cause our actual results to differ materially, and we ask that you refer to our half year report for a complete discussion of these items. We undertake no obligation to revise or update any forward-looking statements or information, except as required by law.

I also want to remind you that we will be referring to certain non -- the presentation of this non-IFRS financial information is not intended to be considered in isolation or as a substitute for financial information presented in accordance with IFRS. A reconciliation of the IFRS to non-IFRS measures that we will be referring to today can be found in this presentation and is also available on our Investor Relations website at investors.puretechhealth.com. I'm joined today by members of our management team: Robert Lyne, Chief Executive Officer; Eric Elenko, Co-Founder of PureTech and Acting Chief Executive Officer of Gallop; and Greg Zugates, Vice President of Research and Innovation. With that, I'll turn the call over to Rob.

Thank you, Allison. Welcome, everyone, and thank you for joining us today. We have made significant progress in 2026 and meaningfully executed against the refined strategy that we outlined last year. Today, I'll discuss that progress and how we are evolving the PureTech model to create value with greater capital efficiency and translate that value more directly to shareholders. Across the portfolio, Seaport completed a successful IPO on NASDAQ, raising $260 million. Celea secured $180 million in external financing and initiated Phase III and Gallop received Fast Track designation, validating the exciting potential of this treatment for rare blood cancer.

We also continue to retain potential future economics from Cobenfy as part of our model and are advancing our innovation engine. We ended the first half of 2026 with PureTech level cash, cash equivalents and short-term investments of $220 million, and we continue to expect our operational runway to extend at least through the end of 2028. Together, this progress demonstrates the significant value embedded across our portfolio and the strength of our hub-and-spoke model.

For those newer to our story, PureTech is a Boston-based LSE-listed biotherapeutics company operating a hub-and-spoke model with a proven clinical and financial track record. At the center of our model is an innovation engine focused on areas where PureTech has a proven ability to create value, those opportunities grounded in validated pharmacology. We generate and derisk these programs internally and then seek to scale them through founded entities or our spoke companies backed by external capital.

This approach also improves how we allocate capital. By bringing in external capital at the founded entity level, we can preserve our PureTech balance sheet while retaining long-term upside through equity milestones and royalties. Historically, the timing of external financing has varied. Going forward, we intend to seek external capital earlier in the development stage than we have done with our most recent founded entity, Celea Therapeutics.

Importantly, because we develop programs internally, we typically begin with full ownership of the assets and proprietary intellectual property, which allows us to retain meaningful equity even after dilution as well as the potential for nondilutive economics in the form of royalties and milestones, reflecting our role in creating these programs. The result is a model designed to generate attractive overall returns while limiting risk concentration.

This model has produced 3 FDA-approved therapeutics, including Cobenfy and has generated sufficient evergreen capital through opportunistic monetization of founded entities to advance our portfolio without the need for dilutive raises at the PureTech level. Slide 7 provides a snapshot of our portfolio and the distinct components of value it contain, equity interest in our founded entities, royalty and milestone payments and our innovation engine, which is designed to generate future opportunities.

Celea is our most recent spinout. It is a Phase III pulmonary company advancing deupirfenidone, which follows our model of validated pharmacology aimed to transform the treatment paradigm for IPF patients by taking FDA-approved pirfenidone and dramatically improving its efficacy through deuteration. Following the significant clinical and regulatory work completed at PureTech, Celea secured $180 million from leading health care investors and immediately initiated the global Phase III SURPASS-IPF trial.

The financing provided external validation of the program and delivered on our commitment to establish an independently financed path for continued development. Today, PureTech holds a 35.4% equity interest and retains meaningful long-term economics through royalties, milestones and sublicense income rights. Gallop Oncology is a Phase II-ready oncology company that is well positioned to attract external capital. We have successfully shepherded the company through the completion of its end of Phase I meeting with the FDA and secured Fast Track designation in relapsed/refractory high-risk MDS.

We currently own 100% of Gallop and intend to leverage external capital before initiating the Phase II STRIDE-MDS trial. Seaport Therapeutics is a Phase II CNS company that we launched in 2024, having developed its platform at PureTech. Following its oversubscribed private raises in 2024, Seaport Therapeutics led by PureTech Founder, Daphne Zohar, successfully IPO-ed on NASDAQ in May, raising $250 million in gross proceeds. This proprietary Glyph platform is designed to unlock the therapeutic potential of clinically validated mechanisms by addressing limitations that have historically constrained them.

We hold a 31.2% equity stake in Seaport valued at approximately $360 million as of September 18, 2026, and also retain royalty and milestones in this company. The fourth component is our remaining economic interest in Cobenfy, an FDA-approved treatment for schizophrenia marketed by Bristol Myers Squibb. PureTech invented Cobenfy using our approach of building on clinically validated pharmacology and housed the program in our founded entity, Karuna Therapeutics.

Through Karuna's development and subsequent acquisition by Bristol Myers Squibb, we have generated more than $1 billion from our collective Karuna and Cobenfy economics, and we retain potential Cobenfy-related royalty and milestone payments, which is a fundamental and differentiating element of the PureTech model. Based on analyst consensus as of mid-August, we estimate approximately $50 million in potential future proceeds to PureTech from our remaining Cobenfy economic rights.

Because this estimate is based on analyst consensus rather than our own forecast, it may change as consensus evolves. While the current estimates represent a material downgrade in potential economics from our last update at the full year, they also reinforce the value of our derisking transaction with Royalty Pharma in 2023, which delivered upfront cash of $100 million into PureTech and allowed us to realize significant value before Cobenfy reached commercial maturity while still retaining participation in future upside.

We will continue to provide update at our full and half year results on PureTech's economic outlook in Cobenfy sales based on evolving market consensus. Turning to cash flows. We do not factor any potential inflows from founded entities into our runway assumptions, such that any monetization events represent pure upside. In line with our refined strategy, we are increasingly committed to ensuring that shareholders participate more directly as the value across our portfolio is realized. In practice, this means that we will prioritize maintaining an appropriate operational runway, selectively deploying capital where we see compelling risk-adjusted opportunities across the portfolio and returning capital to shareholders.

As of June 30, PureTech level cash, cash equivalents and short-term investments were $220 million, which continues to provide operational runway at least through the end of 2028. I'll discuss financial updates in more detail later on. I would now like to welcome Eric Elenko, PureTech's Co-Founder and Gallop's acting CEO, to discuss the latest development of our wholly-owned founded entity, Gallop Oncology.

Thank you, Rob. Gallop Oncology is our latest wholly owned founded entity, and I'm excited about the first-in-class mutation agnostic approach we are advancing for patients with relapsed or refractory high-risk MDS. Our lead candidate LYT-200 is a Phase II-ready monoclonal antibody targeting Galectin-9, an oncogenic driver and potent immunosuppressor that plays a role in some of the most difficult to treat cancers. LYT-200 has a dual mechanism of action. It is designed to directly kill cancer cells while also restoring antitumor immune function.

By addressing both tumor intrinsic and tumor-mediated pathways, this approach is differentiated from existing therapies and has the potential to drive meaningful responses while maintaining a favorable safety profile. High-risk MDS is a serious blood cancer associated with poor outcomes with patients typically surviving less than 2 years following diagnosis. Frontline treatment typically involves a hypomethylating agent or HMA. However, the vast majority of patients do not respond or eventually stop benefiting.

Once disease relapses or becomes refractory, survival is often limited to only a few months. Treatment options in the relapsed/refractory setting are extremely limited. Only one therapy has been approved specifically for relapsed/refractory high-risk MDS in the past 2 decades, and it targets a mutation found in only approximately 3% of patients. There is, therefore, a significant need for new treatment options that can benefit the broader patient population. Positive Phase Ib results established a compelling clinical foundation for LYT-200 in relapsed or refractory high-risk MDS.

We completed a successful end of Phase I meeting with the FDA, which highlights the compelling clinical efficacy and consistent safety profile of LYT-200 in high-risk MDS patients who have relapsed or become refractory to prior treatment with an HMA. The FDA meeting provided clarity on the Phase II STRIDE-MDS trial and Fast Track designation further strengthens Gallop's position as we seek external capital to support the next stage of development.

STRIDE-MDS will be a randomized double-blinded, placebo-controlled Phase II trial enrolling approximately 125 patients with relapsed or refractory high-risk MDS. Patients will be randomized 2:2:1 to receive LYT-200 at a dose of 12 milligrams per kilogram plus an HMA. LYT-200 at 7.5 milligrams per kilogram plus an HMA or placebo plus an HMA. The trial will assess the efficacy of LYT-200 based on the rate of complete and partial responses and support dose selection.

The goals of STRIDE-MDS are to confirm the efficacy of LYT-200 that was previously observed in the Phase Ib study and the inclusion of 2 doses is intended to fulfill the dose selection requirements in accordance with FDA's Project Optimus. The purpose of Project Optimus is to ensure that the sponsor companies prioritize the optimal biological dose over the maximum tolerated dose in oncology. We intend to initiate STRIDE-MDS following the completion of external financing. The amount of capital we will be target raising would support Gallop through the readout of the STRIDE-MDS trial.

As Gallop reaches this important financing and development inflection point, I am pleased to have taken the role of Gallop's acting CEO as I will be dedicating significant time and focus to this advancement. At the same time, I will remain actively involved in PureTech's innovation activities, working closely with the team as we advance the next wave of opportunities.

With that, I'd like to introduce Greg Zugates, PureTech's Vice President of Innovation and Research. Greg and I have worked together at PureTech for more than a decade, and he has been instrumental in refocusing our innovation engine around the areas where PureTech has historically demonstrated the greatest ability to create value. He has been leading our innovation efforts on a day-to-day basis, and I'm pleased to have him walk through our innovation framework today.

Thank you, Eric. As Rob noted, our innovation strategy is now firmly centered on validated pharmacology. PureTech's greatest successes have come from identifying mechanisms or molecules that have already demonstrated meaningful activity in humans, understanding the limitations that have prevented them from reaching their full potential and design differentiated solutions to overcome those limitations. We call this framework our LIFE model, launching innovation from existing pharmacology. As shown on this slide, our LIFE model begins with a focus on patients by identifying areas with significant unmet medical need.

We then identify mechanisms or molecules with demonstrated clinical efficacy that have been otherwise held back from reaching their full potential due to reasons unrelated to efficacy. Using this clinically validated framework, we design novel therapeutic concepts that are specifically intended to preserve efficacy while overcoming those limitations. We evaluate each solution using focused proof-of-concept experiments, which are preclinical studies designed to determine if our therapeutic concepts meet key predefined success criteria and overcome the previous limitations.

We also require each opportunity to support the development of a strong intellectual property portfolio and offer a compelling proposition for physicians and payers with blockbuster potential. By building on pharmacology that has already been validated in humans, we believe that this approach can enable us to innovate with greater speed, lower technical risk and greater capital efficiency than traditional de novo drug discovery. Each year, we aim to advance at least 3 opportunities to the concept stage with the goal that these may form the foundation of future development candidates.

We expect to share additional detail on our progress in the first half of 2027. The approach within our LIFE framework emulates the same innovation principles that produce Karuna Therapeutics and Cobenfy, Seaport Therapeutics and Celea Therapeutics. Each began with a significant patient need and clinically validated pharmacology whose potential has been constrained by a specific limitation.

The PureTech team then designed a novel solution to address that limitation, generated proprietary intellectual property and conducted focused proof-of-concept experimentation to substantially derisk the concept. These programs have generated compelling clinical data and in the case of Cobenfy ultimately led to FDA approval in a new medicine for patients suffering from debilitating mental illness. They provide important validation of the capabilities and approach we are now applying systematically to create PureTech's next wave of opportunity. I'm proud of the work we have underway, and I look forward to sharing more about our progress next year. With that, I'll hand the call back to Rob.

Thanks, Eric and Greg. The work they have described represents 2 important sources of future value for PureTech, advancing Gallop through its next inflection point and applying a focused capital-efficient approach to generate the next wave of opportunities for patients and shareholders.

Turning to our financial highlights. PureTech remains in a strong financial position, supported by our business model and continued focus on capital discipline. At the PureTech level, we ended June 2026 with cash, cash equivalents and short-term investments of approximately $220 million compared to cash, cash equivalents and short-term investments of $277.1 million at year-end 2025. On a consolidated basis, our cash, cash equivalents and short-term investments were $220.1 million at the end of June 2026 as compared to cash, cash equivalents and short-term investments of $277.3 million at year-end 2025.

From this $220 million cash figure, I note that the balancing $17.5 million of the overall $30 million we contributed to raise was completed just after the half year, and therefore, this $17.5 million will come out of the $220 million cash figure I mentioned. In addition, going forward, we have reserved $70 million for future investment into Celea. Whilst not legally committed, we think it's prudent to have this provision to allow strategic optionality to preserve and support our interest in this important company whilst preserving the flexibility to respond to specific deal terms and other opportunities to allocate capital within the PureTech model.

On a consolidated basis, operating expenses were $55.9 million in the first 6 months of 2026 as compared to $49.8 million in the same period in 2025. The increase between the 2 periods reflects higher R&D spend in the first half of 2026 associated with the preparation of Celea's Phase III trial of deupirfenidone. Importantly, the majority of OpEx in this first half is attributable to Celea and Gallop heavily skewed towards Celea. As future expenses related to deupirfenidone have now shifted to Celea, PureTech expects a significant reduction in overall operating expenses moving forward.

Looking ahead, based on our existing financial assets as of June 30, 2026, we reiterate our operational runway at least through the end of 2028. This runway excludes any inflows from potential future monetization events and assumes full deployment of the additional $70 million that PureTech has reserved for potential future investments in Celea. To close, the progress made in 2026 so far demonstrates both the value embedded across our portfolio and the meaningful execution underway against our strategy. Celea has entered Phase III with the backing of leading external investors.

Seaport has completed a successful IPO on the NASDAQ. Gallop has achieved important clinical and regulatory milestones and is positioned for external financing and Phase II development. And our innovation team is applying our proven approach to innovation to generate the next wave of opportunities. At the same time, we are substantially reducing the capital required at the PureTech level and taking an increasingly disciplined approach to how we deploy future proceeds.

We will prioritize maintaining an appropriate operational runway, investing selectively where we see compelling risk-adjusted opportunities and looking to return capital to shareholders. With significant value embedded across our portfolio, a strong financial position and a repeatable innovation engine, we believe PureTech is well positioned to create meaningful long-term value for patients and shareholders.

With that, I'll turn the call back to the operator, and we'll be pleased to take your questions.

Our first question comes from Sean Conroy from Shore Capital.

I'll start on the planned design of STRIDE-MDS. I appreciate there's clearly a benefit to pursuing a mutation agnostic approach in this setting. But has the FDA or are you planning to look at any specific biomarkers in this study? And then second question, just thinking about sort of the next wave of programs that you've guided to that you guided you will unveil next year. I mean, how should we be thinking about that? I mean, obviously, you said clinically validated targets. But in terms of disease areas and willingness to be [Audio Gap].

Thanks, Sean. I'll ask Eric just to speak to the STRIDE-MDS trial design as acting CEO of Gallop.

Hi Sean. Thanks so much for the question. And you're right that the approach here is a mutation-agnostic one. And that really [Audio Gap] KRAS pathway, BCOR, PNTT. So what we do feel is, although as you sprout the number of mutations across the number of patients we had, of course, that means any one mutation was only represented to a smaller extent. It does mean that the sampling in mutations was more representative of what we might see in a subsequent study. And so that made us feel quite good about the approach. The FDA was fine with a mutation agnostic approach and did not require any type of biomarker selection. And as of this time, we don't have plans for biomarker selection.

And then, Sean, just on your other question, I believe, around in terms of our areas of focus for future innovation, I'll ask Greg to speak in a moment, very high level [Audio Gap] are generally agnostic, but we do have a little bit of a bias, particularly in areas where we've had success before. But I'll just ask Greg to say a few words to that.

Yes. Thanks for the question, Sean. So far this year, we have multiple opportunities we've identified that potentially fit our model and includes opportunities based on validated pharmacology as you had noted, and they can form the basis for developmental candidates in the future. These opportunities, as Rob mentioned, continue to expand in areas that have been historically successful for PureTech, and that includes a continued focus on small molecule-based therapeutics. And also CNS is a therapeutic area for identifying additional indications.

Specifically within CNS, we had success with Cobenfy and Seaport in looking at opportunities in neuropsychiatry and that's an area we're continuing to explore. That said, as you also -- as we discussed, we do remain somewhat agnostic indication to an extent because we believe our model is broadly applicable and to bring impactful therapies to patients suffering for disorders outside of CNS and still have blockbuster potential. So we're happy to provide more details in 2027.

Our next question comes from Miles Dixon from Peel Hunt.

If I could just follow up on the STRIDE-MDS trial for a moment. I appreciate you're not guiding for a kind of cost window for that. But can you just help me understand what the time line for that trial might look like? Is it similar in format, at least for the time for TIBSOVO? And then secondly, Rob, if I can ask a broader question on -- perhaps on Celea first. I mean, obviously, since that's now spun out, you guys have a smaller control holding of that. Now Seaport obviously has phenomenally successfully built out its programs and platform offering. Is there any plans at Celea to do a similar thing? Or is it a pure-play IPF single asset? Many thanks.

Thanks, Miles. I'll speak to the Celea question first and then hand over to Eric on Gallop. So yes, as you say, obviously, Seaport has really done great things in terms of building out their pipeline of programs. At the moment, Celea has publicly stated it has its single asset, the IPF asset, which is obviously now in Phase III. I would note, of course, that is now a pivotal registrational trial. So to some extent, they have a different stage of development of that business and they are now have line of sight through to readout, which we hope obviously will be registrational.

To date, there hasn't been any disclosures from Celea about additional assets that they may or may not bring in or develop. But obviously, that is something that the company will consider as it matures. We have previously guided that obviously, we're pleased with the raise they did in the summer raising enough cash due to year-end, but it is inevitable that they will need to raise additional money in order to complete the Phase III. That may bring opportunities for them to consider other programs that they may wish to advance. But if and when that's something they wish to do, we will make announcement for that in the future. In terms of the Gallop program, I'll just hand over to Eric just to talk on that piece.

Thanks so much, Miles, for the question. So the Gallop trial will commence following receipt of external capital. So just also to make that part of any timing clear. The initial projections, which are on the more conservative side, so I just want to get that caveated. This would be probably somewhat under 3 years to complete the study as currently contemplated. And again, those are using a somewhat more conservative projections in terms of recruitment rates. Now of course, what's going to happen is the actual time line, is that more around 30 months or 33 months will depend also ultimately on the number of sites that are selected as well as the ultimate recruiting rates that are observed in those sites. But as we think about the go forward, we'd like to think about things on the more conservative side.

Perhaps I can just follow up on Gallop specifically. You've had a variety of formats, but how are you thinking about financing? Is that more partnership or syndication, strategic partnerships with pharma? And then lastly, Rob, if I can, on capital allocation. Obviously, you've got a phenomenal amount of, let's call it, resources that dwarf the market cap. How are you thinking about capital allocation moving forward?

Yes. So on that point, Miles, so yes, we're looking at a range of options for Gallop at this stage. We believe both the indication, the data we have are exciting enough that it opens up different possibilities. So what we're looking at really and this maybe linking a little bit into your question on cash allocation, the way we do really think about it is it's all about the relative cost of capital. So different funding structures, whether it's equity, whether it's a pharma partnership or whatever it may be, they all come with different costs to them, whether it's equity dilution, whether it's capping upside, some of them can come with upfront cash.

So we want to remain open-minded about that as we think about the relative cost of capital of the different options to help gain external cash in order to take that forward. And obviously, as and when we complete any arrangements there, we will make that known. We've guided that we really want to complete that financing by the first half of next year. And part of the reason for that timing is to give us the opportunity to really take the whole of market approach to looking at the optimal funding sources that we can leverage there without being forced to rush into any particular avenue.

So looking forward in due course to explaining where we get to with that. More broadly, as you say, yes, we do see multiple pockets of value across the business in terms of resources that we have, which we think about in terms of capital allocation. As I think we indicated in some of the remarks this morning, our focus really is we want to make sure that we have operational runway within the business. We don't want to be holding too much cash, notwithstanding rises in rates at the moment.

Obviously, we are not generating great returns in terms of cash pile, that isn't where we create value. We create value by putting those dollars to work and in other instances, where we can by returning them to shareholders so that shareholders can reinvest them as they see fit. So we are focused on not holding too much cash, but we want to make sure that we have sufficient cash runway without any pressure or concern about any dilutive raises at the PureTech level.

When we then think within the portfolio, one of the advantages of our model is that we have different opportunities to deploy capital, and these can range really from very late-stage opportunities. For example, we've reserved $70 million for future Celea financing, which will be if needed to help that company get through to a pivotal trial readout, all the way at the other end of the spectrum to the early-stage innovation programs that Greg and the team are working on.

And so when we're thinking about how we allocate capital within that, we are looking at what kind of a return we can make and what sort of a money multiple we will get, recognizing that obviously, there are different time horizons for returns that may come from those investments. And then the other component that we have talked about this morning, of course, is considering capital return to shareholders. We are very conscious that there is substantial value within PureTech. And whilst we cannot control obviously where the share price trades, we recognize that capital returns are a mechanism to ensure that shareholders directly benefit from the cash that we -- and value that we generate within PureTech.

So we do think about those different components, and we look to balance them but we feel that we're in a good place now with where things are in terms of the assets in the company to have choices ahead of us on those decisions.

Sounds good, Rob. And yes, look forward to the first half next year hearing about some of those new programs.

The next question comes from Christian Glennie from Stifel.

I guess just a follow-up, another one on Gallop and STRIDE trial. I guess, just some -- set the case, I guess, is this largely a best case sort of trial design as you could have imagined it sort of running in on those discussions you've had with the FDA as you then think about the -- presumably, this is supportive of the financing potential partnerships that presumably have had some discussions already that it sort of ticks those boxes.

And then in terms of the trial itself, obviously, the objective here, dose selection and secondary on response. But given the unmet need, if you do get a very strong response, is it potentially a pivotal trial? Or is that probably a bit of a stretch too far at this point?

Thanks. I'll ask Eric to speak to those points.

Thanks so much, Christian, for the question. Yes, we were happy with the results of the FDA meeting, which provided a very clear direction forward. And the goals of the trial really are twofold. One is to confirm the efficacy that was observed in the Phase Ib study. And the other is to satisfy the FDA's Project Optimus requirements in terms of dose as you indicated, that's one of the key goals. Project Optimus really being the idea that instead of driving towards the maximum tolerated dose, one is driving towards a biologically meaningful and active dose. And so we feel the FDA meeting was a very important step in terms of getting clarity, and we are happy with the trial design. And of course, we're also very happy with the Fast Track designation, which the FDA granted, which validates the view that LYT-200 in fact, is an active drug.

And so in terms of the implications of this trial, what differs from the Phase Ib versus the Phase II STRIDE-MDS study is not only the greater number of subjects, but also the fact that it's a double-blind randomized study. And so the idea is to not only confirm what we saw before, but do it in the context where there will be this very clear discernment of the contribution of effect of LYT-200 in the context of combination with HMA, which is very important.

And so what would be the implications of that? We think that if, in fact, we're able to show similar results and in fact, show efficacy and confirm efficacy of LYT-200 coming out of STRIDE-MDS particularly if it had a similar safety profile that was observed in the Phase Ib, which was excellent. We think that will put Gallop in a very good position in terms of optionality that optionality is both, we think, commercial and financial kind of what I think you're getting at. And then it could offer the possibility of more streamlined next steps in terms of development. Of course, that would depend on the data and discussions with the FDA.

And just to be very explicit about the third part of your question, we are not guiding that this is a pivotal study. And so -- but having said that, the data that would come out of this, we would view it as extremely meaningful.

That's helpful. And then if I can, on the overall sort of development strategy, just a bit more in terms of how many -- I mean you talked about the 3 concept stage programs. It sounds like you're going to be announcing maybe one new specific development candidate in early next year, first half of next year. I mean, typically, how many of these things are sort of running in parallel at any one time, you have the bandwidth to run in parallel? And then what's the sort of decision -- what's in the mix in terms of decision points about identifying that candidate?

Yes. Thanks, Christian. So look, I'll hand over a minute to Greg to talk about some of the factors we take into account when we're considering how to advance those programs. But overall, as you say, we've guided that we want at least 3 concept stage programs per year. We're currently running ahead of that, I'm pleased to say. And so we've been pleasantly surprised by both the quantity but also the quality of the opportunities we have there. As you said, Christian, we aren't planning to talk about any of those in detail until next year.

But I think as and when we are able to speak about them, I think many people who follow the PureTech story will certainly recognize the PureTech hallmarks on those programs in terms of having come from the LIFE model and we'll see a lot of similarities with the success that we've had with Karuna, Cobenfy and more recently with Seaport and Celea. But I'll just hand over to Greg to talk a little bit just about some of the factors we take into account when we're considering whether to advance or deprioritize these programs internally.

Yes. Thank you for the question. We go through a very rigorous process. We kind of outlined it here and I would say broad strokes to give you a sense for how we approach these opportunities. But it starts with an analysis of the unmet clinical need. We progress through and look for molecules and mechanisms that have validation and we look for their limitations, but specifically diving in a little bit more, we really pressure test that clinical data and really discuss it with leading clinicians in the field and really understand the weight of the clinical evidence that's behind it.

As we advance programs through preclinical stage, we have a set of predefined criteria for our preclinical experiments that we'll look for. And so yes, we advance them through, I would say, key proof-of-concept experiments that are really designed to see if we've addressed the underlying limitation. And once we do that, that can then form the basis for a development candidate that we would advance forward.

Our next question comes from Karl Keegan who asks, you flagged that shifting LYT-100 costs to Celea should contribute significantly to lower OpEx going forward. Can you quantify that even directional?

Sure, absolutely. So yes, quite right. One of the key drivers for spinning out Celea is obviously these late-stage clinical programs require very significant operational capital spend to continue advancing them. And so a priority for us was to ensure that we could externalize that spend and take it away from PureTech's P&L. As that completed just over the half year, we're now expecting that to significantly benefit PureTech cash flows in H2 this year.

In terms of go-forward cash burn, we're looking at the moment on a clean basis to be having cash burn, including overhead, but also crucially our innovation spend somewhere between $30 million and $40 million a year. That is obviously a significant reduction from the roughly $90 million a year cash burn we had when we were running some of these later-stage clinical programs internally.

We have a follow-up question from Karl, which is you've targeted at least 3 concept stage programs progressed per year. How many are currently in that pipeline today? And what would you need to be true for one to be named as a new founded entity candidate?

A very good question. I think we've probably addressed that earlier by saying that, as Greg outlined it, there's a really rigorous process that we go through. And again, that's informed not just by the innovation team and the work they're doing, but also the broader corporate knowledge and history we have at PureTech. There are many people working hard in the field of drug development. But within PureTech, we really do have the benefit of having taken programs all the way through to registration approval and dosing to patients.

And really for us, that benefit of having that institutional knowledge of what it means to take a program all the way to ideation through to benefiting patients, that is a really valuable perspective that we can bring to these early-stage programs when we're thinking about whether to greenlight them, how far to take them forward and what the best way is of advancing this program.

We have a next question from Julie Simmonds from Panmure Liberum.

Just more on the innovation pipeline. Just wondering when you're going to tell us about these programs? At what stage are they going to be? Is that sort of where you've still got more preclinical work to do? Or is it going to be so they're actually going into the clinic in your for the first time?

It's a good question, Julie. So I think really where they will get to, there may still be a degree of preclinical work that's being done. But I think the key thing is, as Greg was outlining earlier, that we will have done some of the really key derisking experiments. So the great advantage of our LIFE model is that we know what problem we're trying to fix. And we feel that even the preclinical studies that we do can be very meaningful in indicating whether or not we've really fixed that problem. A big advantage as we move into the clinic, of course, is that the Phase I studies are significantly derisking even in healthy volunteers.

There is every chance that, that study in itself will be very, very indicative as to whether we really overcome the limitation that we were seeking to fix. So there may still be a bit of preclinical work to be done at the time we're talking about these programs, but we would only be really putting the covers off the stage where we have a high degree of confidence that there's really a strong chance of success going forward with them.

Thank you. That's all we have time for today. Thank you all for joining, and you may now disconnect your lines.

Greetings, and welcome to the PureTech Health 2025 Annual Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Allison Mead Talbot, Senior Vice President of Communications. Thank you, Allison. You may begin.

Thank you, everyone, for joining us for PureTech's 2026 Annual Results Webcast. Our annual report will be made available later today, portions of which are also filed with our Form 20-F. This information is available on the Investors page of our website at puretechhealth.com.

I would like to remind you that during today's call, we will be making certain forward-looking statements. These statements are subject to various risks, uncertainties and assumptions that could cause our actual results to differ materially, and we ask that you refer to our annual report and our SEC filings for a complete discussion of these items. We undertake no obligation to revise or update any forward-looking statements or information, except as required by law.

I also want to remind you that we will be referring to certain non-IFRS measures in this presentation. The presentation of this non-IFRS financial information is not intended to be considered in iCeleation or as a substitute for financial information presented in accordance with IFRS. A reconciliation of the IFRS to non-IFRS measures that we will be referring to today can be found in this presentation and is also available on our Investor Relations website at investors.puretechhealth.com and in our SEC filings.

I'm joined today by members of our senior management team: Robert Lyne, Chief Executive Officer; Eric Elenko, Co-Founder and President; Chip Sherwood, General Counsel; Michael Inbar, Chief Accounting Officer; as well as Sven Dethlefs, CEO of our founded entity, Celea Therapeutics. Rob and Eric will discuss our strategic vision and path to value creation, including updates across our portfolio and our differentiated innovation engine. They will also provide a deep dive into the Gallop program, review our financial highlights and outline our anticipated catalysts for the remainder of the year. With that, I will now turn the call over to Rob, our Chief Executive Officer.

Thank you, Allison. Welcome, everyone, and thank you for joining us today. We are at a pivotal moment in the company's trajectory. Having announced our near-term operational focus in December, I'm pleased today to walk you through our refined strategy and portfolio progress. This next phase of our evolution is designed to translate our proven innovation model into greater shareholder value.

As a reminder, PureTech is a Boston-based LSE-listed biotherapeutics company operating a hub-and-spoke model with a proven clinical and financial track record. Programs originate within the PureTech hub based on a thesis of targeting molecules with validated pharmacology and are then advanced through early clinical and technical derisking. At defined value inflection points, we scale them through founded entities backed primarily by external capital. This model is both powerful and differentiated for two reasons. First, it improves how we innovate. We focus on opportunities where the underlying mechanism has already shown evidence in humans, allowing us to reduce technical risk while improving probability of success. Secondly, it improves how we allocate capital.

By leveraging external capital at the founded entity level, we maintain portfolio breadth, preserve balance sheet strength and retain long-term upside through equity milestones and royalties. Because we develop these programs internally, we typically begin with full ownership of assets and proprietary IP to which we can attach nondilutive milestones and royalties. This means that in contrast to traditional venture capital investors, we do not need to continue to write large checks for every subsequent funding round in order to preserve a meaningful equity stake. Instead, our model allows for prudent equity dilution, allowing us to retain large equity positions in multiple founded entities whilst they diversify their own shareholder registers. Having a balanced shareholder register makes it easier to raise external equity and is vital if our founded entities are to IPO.

Throughout this process, our royalties and milestones are protected, providing optionality for derisking ahead of inflection points and preservation of long-term value for PureTech. This result is a model designed to create superior overall financial returns while limiting concentration risk. Through this model, we have developed meaningful clinical and regulatory success. We have generated 3 FDA-approved therapeutics from our innovation engine to date, including the schizophrenia treatment, Cobenfy. We've also achieved substantial cash flow, generating over 1 billion growth from monetization of our economics in our founded entities, all while continuing to build a diversified pipeline of future opportunities.

Looking ahead, our focus is clear: sharpen execution, strengthen capital discipline and ensure that PureTech's distinctive model continues to translate breakthrough science into meaningful value for both patients and shareholders. To deliver on our strategy, we have focused on 4 pillars of operational refinement, a streamlined structure. We intend to operate a significantly leaner and more efficient hub following the completion of the CLA financing. As part of this initiative, we announced this morning our intention to voluntarily delist from NASDAQ, recognizing that the vast majority of our trading remains on the LSE some 5 years after our initial NASDAQ list. This step simplifies our structure and reduces cost and administrative burden for the business, whilst retaining our primary London listing, providing access to both U.K. and global investment community.

Launching founded entities early. In recent years, we've advanced certain programs further internally before transitioning them to founded entities. While this allows us to retain larger equity stakes, it required greater capital and operational infrastructure at the PureTech hub level. Going forward, we intend to establish and capitalize these entities earlier in the development life cycle once programs have reached key clinical value inflection points. Since return on capital is typically higher early in the cycle, this approach will allow for the creation of a greater number of founded entities. And we believe, therefore, that overall financial performance from the portfolio will improve.

A refined innovation focus. Our innovation engine remains the foundation of future growth. Led by my colleague, Eric Elenko, our expanding innovation team continues to progress their work with this goal in -- over the next 3 years, we plan to generate up to 2 development candidates, each of which has the potential to become a new founded entity supported by external capital, allowing us to drive the next wave of growth for PureTech.

Moving to capital returns. Finally, this refreshed strategy strengthens our capital discipline and enhances our flexibility. To ensure shareholders benefit directly from our success, we intend to return a greater proportion of future cash generation to shareholders, particularly in the event of an outsized return, whilst maintaining appropriate operational runway for the business. PureTech's value today is underpinned by multiple distinct components. These include our economics in Cobenfy, Seaport Therapeutics, Celea Therapeutics and Gallop Oncology as well as an innovation engine capable of generating future opportunities. We believe this diversified structure is a meaningful strategic advantage and one that is not fully reflected in our current valuation.

Across our portfolio, I'm pleased with the progress that was made during 2025 and so far this year. Celea is our most clinically advanced founded entity developing deupirfenidone for the treatment of idiopathic pulmonary fibrosis. Deupirfenidone demonstrated a robust efficacy with the potential to replace standard of care treatments in its Phase IIb trial and is now Phase III ready. I'm pleased to share today that Celea's fundraising is substantially complete, subject to continued negotiations. Plea has secured multiple nonbinding commitments from external investors in addition to participation from PureTech. Whilst mindful of macro factors, Celea is targeting to close the financing by early in the third quarter of 2026. The financing is intended to support the Phase III SURPASS-IPF trial, which Celea expects to commence in close proximity to closing the financing. This would represent an important value inflection point both for Celea and for PureTech.

Next is Gallop, which is another founded entity, which we currently own 100% of. Last week, we announced positive top line data from the Phase Ib trial of LYT-200 in relapsed/refractory high-risk myelodysplastic syndrome, or MDS, and relapsed/refractory acute myeloid leukaemia. We are pleased with the data, which guided our strategic focus to advance LYT-200 for relapsed/refractory high-risk MDS. Gallop is now preparing to engage with the FDA regarding a potentially registration-enabling trial design in this indication. As Eric will discuss shortly, we believe Gallop represents another strong example of our model in action, differentiated science, disciplined development and the ability to attract external capital at the appropriate stage.

Seaport is our most operating advanced founded entity. The company has progressed 2 clinical trials for neuropsychiatric conditions in 2025 and 2026. And as many of you will have seen, Seaport filed a registration statement for a potential initial public offering on NASDAQ. This progress further validates our ability to create and scale attractive stand-alone biotechnology companies from within the PureTech hub-and-spoke model.

Beyond our core founded entities, we also retained rights to Cobenfy, a commercial stage product that originated in our innovation engine. PureTech is a co-inventor of Cobenfy, which we house in a founded entity called Karuna Therapeutics. Karuna was acquired by Bristol-Myers Squib $14 billion, though we continue to hold significant non-dilutive economic rights. Based on current analyst consensus of BMS sales expectations, the projected value of PureTech is approximately $160 million from these rights through 2033. Due to the nature of our Cobenfy economics, we are only exposed to the early performance of Cobenfy sales and any reduction in analyst forecast of early sales, even if modest, can therefore have a material impact on projected inflows. Nonetheless, we expect substantial financial inflows of PureTech from COBENFY and are confident that it will improve the lives of large numbers of patients around the world.

Going forward, we intend to provide regular updates to PureTech's economic forecast of Cobenfy sales based upon evolving marketing consensus at important points during our earnings webcast in the future. We also note that any monetization events from any of our funded entities, including the Cobenfy economics, represent pure upside. We do not factor any potential inflows from these entities into our runway assumptions. Indeed, whilst we have the option to collect royalties and milestones as they fall due, we also have the flexibility to monetize such rights ahead of time. This was the case with Cobenfy, where we have already secured approximately $125 million in payments to date from a previous royalty sale. This provided PureTech with capital that is unaffected by future commercial sales fluctuations and demonstrates our disciplined approach to structuring founded entities and managing upside thoughtfully.

Beyond these founded entities, we also maintain the interest in what I'll call our legacy holdings. These are historical founded entities that continue to have the potential to be a source of capital to us, but they are not a current focus of our capital allocation, nor do we currently expect them to have a material impact on the overall value of PureTech moving forward. As our founded entities continue to mature and secure external funding, we intend to provide greater transparency around valuation benchmarks where appropriate. This is consistent with our capital-efficient model of maintaining a lean hub while creating value through externally financed founded entities. It also builds on Seaport post-money disclosure, which we introduced last year.

Our objective is straightforward: to help investors better model the embedded upside across our portfolio, bridge what we believe is a disconnect between intrinsic value and current market value and ultimately support stronger shareholder returns. As part of this transparency, we are today providing an update on our Q1 cash position with PureTech level cash and cash equivalents as of March 31, '26, standing at approximately $248 million on an unaudited basis.

I would now like to welcome Eric Elenko, our Co-Founder and President. It is no overstatement to say that Eric has been instrumental to our many successes to date. He will walk us through the latest progress at Gallop Oncology as well as share what he and the innovation team are currently working towards.

Thank you, Rob, and thanks for the kind introduction. As Rob mentioned, PureTech is focused on how we translate scientific opportunity into programs that can ultimately deliver a meaningful impact for patients and value for shareholders. At PureTech, that involves both identifying new opportunities and making disciplined decisions about how to advance them, where to focus, how to allocate capital and how to position programs to reach their next value inflection point. Gallop Oncology being a recent example of our disciplined approach. Last week, we announced positive top line results from the Phase Ib trial of LYT-200, which is being developed through our 100% owned subsidiary, Gallop Oncology. I will briefly review the data, but more importantly, what it means for the program and how we are thinking about the path forward.

LYT-200 is a monoclonal antibody that targets galectin-9. It is thought to work through 2 complementary mechanisms in the context of the haematological malignancies we studied in our trial. First, it relieves immunosuppression to enable the immune system to act on the cancer cells. Second, it directly kills cancer cells by inducing cell death through DNA damage and apoptosis. The trial was in relapsed/refractory high-risk myelodysplastic syndrome, or MDS, and relapsed/refractory acute myeloid leukaemia or AML, which are closely related to blood cancers where patients unfortunately typically have poor outcomes.

The trial evaluated LYT-200 in a dose escalating manner, both as a monotherapy and in combination with a hypomethylating agent or HMA in patients with MDS and in combination with an HMA and venetoclax in patients with AML. All the patients were heavily pretreated. For example, 100% of the MDS patients had previously received an HMA. The objectives of the study were straightforward, establish safety, identify a dose for further development and generate the data needed to determine whether Gallop should prioritize MDS or AML for a subsequent study. We achieved all 3 objectives. LYT-200 had an excellent safety profile with no dose-limiting toxicities or myeloid suppression, which has historically been a challenge in developing treatments for MDS. We also observed a dose-dependent efficacy response and identified 12 mg per kg of LYT-200 as a dose for the next study. The data were strong across both patient populations studied. And importantly, the study provides the clarity needed to define our next step.

I want to provide some additional context on how we arrived at the decision to prioritize relapsed/refractory high-risk MDS as our next indication. This decision reflects both the clinical data generated in the study and strategic considerations. Going into the study, we had preclinical data supporting the potential for LYT-200 in AML, whereas MDS is a more challenging setting to study preclinically. AML and MDS are both myeloid malignancies and are closely related. MDS can progress to AML and they share underlying disease biology. Because of this, it's common in early-stage oncology development to evaluate therapies across both populations within a single Phase I study to efficiently assess safety and initial activity.

As a result, the trial was designed to generate the clinical data needed to inform indication prioritization. The data were strong in both MDS and AML. Advancing a potentially registrational enabling study requires significant capital and our clinical strategy has to intersect with our financing strategy. We seek to balance dilution for PureTech with ensuring that a founded entity is sufficiently capitalized to reach a meaningful value inflection point. As a result, it is important to prioritize where we believe we can create the greatest near- to medium-term value.

If capital were unconstrained, we would consider advancing both MDS and AML in parallel. We decided to prioritize MDS given that it emerged as a particularly compelling opportunity. Historically, nothing has meaningfully moved the needle for patients with relapsed/refractory high-risk MDS following HMA failure. In fact, literature suggests that 0% to 5% of these patients respond if they're treated again with an HMA. Against this backdrop, the activity we observed in this study was particularly encouraging. The broader competitive landscape, both commercially and in terms of clinical trial patient recruitment are also compelling for MDS. There is only one approved drug, which is applicable to only 3% to 5% of the population. An efficacious drug with an excellent safety profile of the type observed in Phase I would have blockbuster potential. And the competitive pipeline is thread there, and therefore, there is less competition to recruit patients compared to AML.

At the same time, we continue to believe LYT-200 has broader potential across other haematological malignancies, including AML, which we intend to explore over time. Consistent with this approach, Gallop intends to pursue third-party capital to support a potentially registration-enabling trial in MDS with the majority expected to come from external investors. Our objective is to ensure the program is sufficiently funded to reach a meaningful value inflection point while maintaining discipline around dilution for PureTech. The next step is interacting with the FDA later this year.

In parallel, we are actively generating the next set of programs that will form the basis for future founded entities. Historically, many of our programs and PureTech's greatest successes have come from identifying therapies with validated pharmacology and addressing the specific issues that limited their potential. Our founded entities, Karuna Therapeutics, Seaport Therapeutics and Celea Therapeutics all exemplified the approach.

Going forward, innovation will focus on validated pharmacology. We have refined and formalized this approach over the last few decades into what we call the light model, launching innovation from existing pharmacology. As shown on this slide, the life model is a systematic framework for identifying areas of high unmet need, selecting drugs with demonstrated human efficacy, understanding what has constrained their full potential and designing targeted solutions to fully unlock their value. We then conduct focused pillar experiments with rigorous predefined success criteria established in advance of data readout to ensure this process remains highly capital efficient. In addition, any solution must support strong intellectual property and be attractive to both physicians and payers.

Importantly, this approach allows us to innovate with greater speed, lower technical risk and significantly greater capital efficiency than traditional de novo drug discovery. Using this approach, we expect to focus primarily on small molecules while remaining open to traditional biologics such as antibodies where the opportunity is compelling. While we consider opportunities across a range of therapeutic areas, we anticipate an emphasis on areas of traditional strength such as CNS.

Looking ahead, we aim to progress up to three concept stage pharma programs with modest capital deployment. We define a concept stage program as a therapeutic opportunity that has passed initial internal diligence and is continuing to be derisked. We are currently progressing several promising programs to a concept stage process with the goal of nominating up to two development candidates over the next three years that could serve as the basis for future funded entities.

Innovation has historically been the foundation of value creation of PureTech. We're excited about leveraging the best approaches we have learned and applying them to develop new therapies that have the potential to help patients and create value for our shareholders. Now I'll turn it back to Rob.

Thanks, Eric. We are indeed very excited about the potential with Gallop and the work of the innovation team in progressing the next wave of founded entities. Now I'd like to go over our financial highlights.

At the PureTech level, we ended 2025 with cash, cash equivalents and short-term instruments of $277.1 million compared to $366.8 million at the end of 2024. On a consolidated basis, our cash, cash equivalents and short-term investments were $277.3 million at the end of '25 compared to $367.3 million at the end of '24. At the PureTech level, as of March 31, '26, we held unaudited cash and cash equivalents of $248.1 million.

On a consolidated basis, our cash and cash equivalents were $248.2 million. Based on our existing financial assets as of December 31, '25, we expect to have operational runway at least through the end of 2028, which is inclusive of our expected participation in certain and fundraisings. Our revenues are mostly driven by milestone-based payments and royalties from license agreements and are expected to continue to fluctuate from year-to-year.

On a consolidated basis, our revenues in '25 were $4.7 million compared to $4.8 million in 2024. We reported a lower operating loss of $98.5 million in 2025 compared with $136.1 million in 2024. This decrease is largely due to lower G&A expense as a result of the deconsolidation of Seaport in 2024, which reduced workforce-related costs, including payroll and noncash stock-based compensation expenses and new stock awards granted to founders, directors, employees and executives of Seaport in 2024 prior to its deconsolidation.

Decrease is also attributed to lower R&D expenses in 2025, mainly as a result of the deconsolidation of Seaport in 2024. On a consolidated basis, we reported a net loss of $110.1 million for 2025 compared to net income of $27.8 million for 2024. The change primarily due to the absence of $151.8 million onetime gain from the Seaport deconsolidation, which was recognized in 2024. By excluding that item, we saw improvement in operating costs in both G&A and R&D, as mentioned above.

Looking ahead, we expect to streamline expenses and operate the lean model following the completion of the SLA fundraise in line with our refined strategy. This measured approach allows us to protect our balance sheet and preserve capital flexibility to fund opportunities with asymmetric value potential. In summary, I am pleased with the operational and clinical progress we are making at PureTech and across our founded entities. At the same time, we remain focused on execution. In 2026, our priorities include advancing SLA and Gallop, both operationally and financially, driving value from our founded entities opportunistically and progressing our innovation engine towards new candidate nominations. We believe our refined strategy positions us well to do so with greater focus, discipline and capital efficiency.

In closing, I'd like to thank the various stakeholders who make PureTech what it is today, including our team, shareholders and the broader clinical community who are vital to the important work we do. It's a privilege to lead PureTech at this important moment. We have a differentiated model, a strong foundation and meaningful opportunities ahead, and we remain firmly focused on translating that potential into sustained progress and value creation. I'll now turn to the operator to take questions.

[Operator Instructions] Our first question comes from Miles Dixon from Peel Hunt.

Forgive me if some of the questions go over topics that you've already talked about, my line dropped a few times. But can I just double check on cash, firstly, I mean, it's a change in the guidance from into 2028 to the end of 2028. Can I just double check on two important points. Firstly, this is at least until the end of 2028, subject to further realization and that it's inclusive of any participation, I know as you said, in entity fundraising, but also specifically for Celea, where the trial cost might be slightly higher? That's the first one.

Myles, thanks for joining. Yes, no, absolutely. As you say, it's at least through 2028, and that reflects the conservative approach that we take to cash runway. So as you say, we don't factor in any realizations into that cash guidance, and we are assuming commitments into SLA and also support for Gallop as well in that runway guidance.

Brilliant. And then moving on to LYT-100 and Celea. I mean, obviously, the IPF landscape continues to evolve and heat up, suggesting more and more people are looking at it. But -- and clearly, your data today is great, but how are talks progressing with the funding partners? You said you've used the word substantially complete. But can you give us anything on the profile of this potential partner in the endeavor? Or in the earlier comments that we've just made about cash, I'm assuming that the majority of the kind of liability is going to be settled by the partner in this. If you can just give a bit more color, that would be really helpful.

Yes, absolutely. So as we're updating today, we've made very substantial progress on this fundraise. Obviously, these things are never done until they're done, and there are various things that need to fall into place before we'll be able to announce any completion of the fundraising. However, we've made very substantial progress now, and we have a clear line of sight to getting this done. As you've indicated, Myles, we are looking to raise a very significant amount of capital in this raise, but the majority of that capital is very much coming from external partners, and that is reflecting our model of leveraging external capital whilst providing the commitments that we need in order to maintain meaningful equity stakes in these founded entities.

Great. And now just moving on to the other exciting bit of clinical data news Gallop Oncology. Eric, I think I caught you talking about the selection of MDS versus AML. And I very much understand that it was about capital. But could I also ask whether there's any read across from trials, whether it be TIBSOVO and this label extension when you were thinking about potential patient cohort size? And should we make any read across from that? I think it was 170-patient expansion from AML into MDS for TIBSOVO.

Yes. Myles, thanks for the question. We're prioritizing MDS because of the very compelling clinical data. And really, as you indicated, there's really only the one drug approved in the relapsed/refractory population, which is TIBSOVO. And TIBSOVO because it's appropriate for patients with a specific mutation, that's really why it's limited to that 3% to 5% of the relapsed/refractory population. And that really creates a tremendous need. And if you look more generally with regards to the pipeline and what exists and what's being developed, it's really thread there. And what that means is that a drug that if it is approved in the relapsed/refractory high-risk MDS population has blockbuster potential. It also means from a clinical trial perspective that there's less competition for patients when it comes to recruiting. So the decision with regard to prioritization was driven by the very compelling clinical data we had, but also the other factors that I was describing.

Great. And then lastly for me before I get back in the queue on Seaport, obviously, some more progress currently being made. Robert, can I just ask, I mean, obviously, the S-1 registration document suggested that you have, I think it was 42% or 43% versus the original 35% that was disclosed. Will you guys be thinking about taking a board seat post any IPO? And I mean, again, you talked about the 3% to 5% tiered royalties that you would have. Is that on all Glyph products on that potential platform or just those in the existing pipeline? Any color that you can give me on those topics would be great.

Absolutely, Miles. Obviously, we're limited in what we can say at the moment about Seaport given that they're on file for IPO in the U.S. But it is our general practice with founded entities that we don't take board seats once they IPO. And that is a general approach that we've taken in the past and we would expect to be taking going forward. It's also the case that we do have royalties beyond just the GLP application in terms of the economics that we have there from -- and again, that stems from the -- obviously, the developmental work that was done at PureTech around that technology.

We will now move on to our written questions. Our first question is, are you keen to hold a significant stake in Seaport beyond future funding rounds?

It's a great question because it really goes to the heart of our hub-and-spoke model. We -- obviously, because as indicated just with the Gallop platform, because we undertake developmental work on these programs internally at PureTech at the hub level, we typically start out with 100% ownership of our founded entities. What that means is as we leverage external capital, we often retain very large equity stakes in our founded entities even once they've raised large amounts of capital. So very often, you'll see that even through private rounds and even potential public fundraisings, we typically may end up even at that stage still being the largest individual shareholder. So why do we end up in that situation?

Well, look, for us, it has two benefits. One is to PureTech. It means we don't have to keep writing ever-increasing checks to hold our corner and to maintain a significant equity percentage. instead at the PureTech level, we can allocate that cash to other programs, typically earlier-stage innovation, where we will often see the potential for a higher return on capital than we would in investing in later-stage rounds of our founded entity fundraisings as well as capital allocation within PureTech and aiming to increase our overall financial returns, it also allows the founded entities to diversify their shareholder registers.

This is vital if they're going to raise external capital, particularly if they do ever want to IPO, that would not be practical in a situation where PureTech was the 100% shareholder of the business. So we see that dilution as beneficial both to PureTech and to the founded entities, but also it's allied with the nondilutive economics, which we retain in founded entities, which obviously are unaffected by the equity dilution that we may see.

Our next question comes from Christian McGlenny from Stifel.

I just follow up then on the -- around the new asset formation, the concept stage. Just a bit more around that. I mean, is this sort of ballpark figure in terms of how much it costs to do those sort of concept stage assets? And then just to clarify, were you talking about new candidates on the candidate side, 2 assets, was that over a 3-year period? Or was that 2 assets per year? And then just finally, therapeutic areas of focus here. I mean, you've got a pretty broad spread in terms of your existing portfolio. Is that likely to continue fairly agnostic on therapeutic area? Or do you see some areas where you think are particularly of interest for those sort of new concept assets?

Thanks for the questions, Christian. Look, just taking them in order, what we find so exciting about innovation is we can actually make really significant progress with pretty modest amounts of capital. So when we're doing very early derisking or proof-of-concept studies, we can make really great progress with 6-figure -- modest 7-figure amounts of investment. And maybe to one of the earlier questions that we just spoke to, you can give an idea then of the kind of return of capital that we can make on that kind of modest early capital deployment compared to later-stage investments in founded entities. So that's one of the reasons that we find innovation so exciting, both in terms of what we can do for patients, but also in terms of the financial returns that we can generate there. And just to your specific question, we're looking at two developmental candidates over a 3-year period in terms of the cadence going forward. In terms of sort of therapeutic areas and how we think about that, I might turn that over to Eric to answer that piece of the question.

Yes. A lot of our focus is really in areas where we've had historic success and strength. For example, central nervous system CNS is an area of great focus. There are other areas of interest, for instance, I&I. We do maintain a therapeutic area agnostic policy so that if we do see an opportunity that we want to pursue that's available to us -- but given that our approach is proactive, we do tend to concentrate in certain areas and again, particularly CNS being really one of the biggest areas of focus.

Our next question is, thank you for the transparency on the runway to 2028. It's good that you don't pencil in any credency realizations in this guidance. Can you clarify how this runway might be impacted from a more rationalized group post Celea finance completion? Also, what monies have you set aside for funding some of these financing rounds as well?

So as we indicated, we take a conservative approach in terms of our runway guidance. And so I'm quite right to identify that we don't have any commentary realizations. We also don't assume any other realizations from any founded entities that may come through. We are looking and in our assumptions, we are planning for some reduction in our cost base following the spinout of Celea. Once we get that spinout completed, we'll be looking to revisit that cost reduction and try and reduce that as far as possible to see if we can stretch that runway even further as well as not including any income from any monetizations.

We have included participation in both the Celea fundraise, which as we've indicated, is now coming up to a place where we think we've got line of sight to completion in due course. We also are reserving more modest amounts for supporting Gallop oncology as well, which we've guided that we'll be looking to commence fundraising towards the end of this year, looking to try and complete a fundraise by the first quarter of next year. The exact amounts there are still to be determined because it's subject to commercial negotiations on the 2 fundraising structures. But it's in terms of guidance, we certainly expect a significant commitment into the Celea round given the scale of fundraising necessary there for a Phase III, and we would be considering a more modest commitment into Gallop. And obviously, as and when we're in a position to complete those financings, we'll be able to provide full detail on the capital commitment that PureTech will be making.

Our next question is, should we be ascribing any value or realizations from Silica, Vedanta, Sunday, Elvio or Integra?

Look, we're very proud of the innovation and work that went into these founded entities. However, in terms of helping shareholders understand where we see value in the business at the half year last year, we introduced the concept of legacy holdings, which is where we're now bucketing these founded entities. We are continuing to support those that have operations still where we think that we may still be able to extract some value. However, in terms of modeling guidance, we are guiding that we do not expect material financial returns from any of these assets. To the extent that changes, we'd obviously be delighted to update shareholders. But for modeling purposes, we don't ascribe material prospect of material inflows from these founded entities.

Our next question is, can you outline your thinking on capital allocation, specifically in terms of where potential capital return sits in terms of your updated priorities?

Certainly. So one of our focuses since we've been refining our strategy over the last 9 months or so has been to put an emphasis on capital returns. We recognize that ensuring that our shareholders participate in the scientific, but also most important, the financial success of PureTech is absolutely critical. This is one of the reasons why we've deliberately taken a cautious approach to our cash runway, ensuring that we are able to fund an ongoing business without relying on realizations coming into the business. Because of that, we will be looking to ensure that when we do have significant financial inflows into the company, which we've had in the past, and we see potential for again in the future, that we will be looking to return meaningful proportions of those inflows back to shareholders directly. The exact form of that return would need to be decided at the time, but it is our intention that those significant wins back into PureTech will result in financial flows back to shareholders directly.

Thank you. That's all we have time for today. I'd like to thank you all for joining, and you may now disconnect your lines.

Good evening, everybody. Thank you so much for joining us today on day 3 of the JPMorgan Healthcare Conference. My name is Bhavana Balakrishnan. I'm an associate with the Healthcare Investment Banking team. Today, we're joined by the management of PureTech. And with us, we have Robert Lyne, Chief Executive Officer; Eric Elenko, Co-Founder and President. Over to you, Robert.

Wonderful. Thank you very much, Bhavana, and thank you for everyone who's turned up today and for those who are joining on the webcast. I'm delighted to be here and thank JPMorgan for the opportunity to present to you all. So as Bhavana said, I'm Robert Lyne. I'm the CEO here at PureTech Health. I've been in the business 2 years now. I've previously held a number of senior leadership roles and CEO roles in various London-listed life science businesses and was delighted to step into the CEO role here at PureTech at the end of last year. So as we move through the presentation, there may be a number of forward-looking statements that we'll be making. I'll refer you to our SEC filings in that regard.

So as an introduction to PureTech Health, we have a proven hub-and-spoke model for drug development. So what does that mean? And how does that differentiate us from other drug development businesses? Well, what we do is we take a derisked diversified approach to developing a number of potential new therapeutic treatments for patients. We do this with a hub approach where a centralized lean, efficient hub looks at novel opportunities to develop dramatically different treatments for patients in areas of high unmet need. And then we look to spin out those programs into what we term our spokes. So those are stand-alone businesses that leverage external capital to take those programs forward, hopefully advancing those treatments all the way through to registration so that they can get to market and be available to patients and also so that they can generate significant value on a financial basis back into PureTech that we can then use to benefit our shareholders.

We see 2 distinct advantages to this portfolio approach. One is that we have the opportunity to seed a large number of potential companies and therefore, advance a greater number of therapies than we could if we were focusing on just one asset alone. But also from a financial perspective, we have the ability to balance risk here. Everything we do has empirical risk. We're very cognizant of that. And by having a portfolio approach, we can smooth that out and generate a greater chance of getting a hit across the portfolio and also generate a smoother and we think overall larger return for our shareholders financially.

So when we look at the track record of the business so far, we're incredibly proud of our remarkable success in clinical trials so far. Around 80% of our clinical trials that have been run by PureTech or by our founded entities have hit their primary endpoints. For us, that we think is really remarkable, and that is testament to the derisked approach, which I'll talk about in a moment, which we think has led to that very high probability of success. So far as a business, we've had 3 FDA-approved treatments, including very recently Cobenfy, formerly KarXT, which was originally developed by PureTech and spun out into Karuna Therapeutics, which has been one of our most successful founded entity spin-outs to date. We've seen this model work previously at PureTech, and we have a strong confidence that we can repeat this performance as we go forward.

So if we look at our innovative approach to drug development, how is this different to how others might do it? Well, a key starting point for us is we look at validated pharmacology in the targets that we're working on. So typically, we'll look at assets that have already been in human trials that have been either left on the shelf or haven't been advanced for some reason. And what we'll do is we'll look at what was holding that drug back, what was holding that molecule back. And then what we do is apply an innovative approach to that to think, okay, what can we do differently here? What modification could we make? What combination could we make that would allow us to then overcome whatever has been holding that drug back.

We think this has distinct advantages. First of all, it gives us a higher probability of success that we'll then be successful when we move that drug through, and we believe that the clinical trial success rate that I previously talked about demonstrates that. But also from our perspective, we're then leveraging the capital and time that others have already put into that molecule, meaning we're sort of one step ahead than we would otherwise be if we're looking at totally novel mechanisms of action.

So in addition to that differentiated approach that we have, we also, as with many others, we will look at making sure there's high unmet need in the patient population that we're targeting. We're also very focused to make sure that there's a defined regulatory and commercial path to success for that drug, so that it will be able to get to patients, and it will be able to generate a material financial return to us. Again, as I mentioned previously, because we have this portfolio approach, we also, across a number of different potential therapeutic targets, we're looking at making sure that we allocate our capital efficiently there.

So what that means is we will very often look at a potential drug. Eric is very fond of saying, we'll look at something and think what do we not want to see in a clinical trial in an early proof-of-concept study, and then we'll run that, and we'll see. And if we see what we didn't want to see, we will move on and we will divert our capital elsewhere where we feel it's more efficient. For us, we think that is a distinct advantage over other vehicles, which are maybe following a single asset. We don't have a bias to continue any particular program. We have a bias to make sure that we are pursuing the ones that have the greatest chance of success.

So what has this meant in terms of patient impact? For us, our mission at PureTech is to deliver meaningful new treatments, which will transform the paradigm for the patients that we're targeting. We've already done this with Cobenfy. This is already now being prescribed to patients. Obviously, schizophrenia has been an area of huge unmet need. Cobenfy was the first new novel treatment to be approved in 50 years in this indication, a very large patient population, and we're really excited to now see the sales have been rolled out by Bristol-Myers Squibb, which has acquired Cobenfy and is now bringing that out to patients.

As we look forward, we have a number of other spokes, which we're spinning out in the form of Celea Therapeutics and Gallop Oncology. And we also have Seaport Therapeutics which span out of PureTech last year. Each of these companies is targeting really meaningful patient populations and each of them have transformative treatments that we think will make an enormous difference to patients when they come through.

So as we look at what makes us PureTech and particularly from the components of value, as previously mentioned, we have these spokes that we've spun out. We have Seaport Therapeutics, and I'll talk a little bit more about that later, which is the most advanced in terms of its corporate development. It's an independent entity that's been spun out. It's raised significant financing, $325 million from top-tier investors. We still, however, retain the largest shareholding in that business at just over 35%. And in addition, we have meaningful nondilutive economics that attach to those drug assets. And for that, we see that as an important differentiator of the model. Because when we look at these early opportunities, we are typically carrying out novel work on these molecules. We will be developing proprietary IP, which then gives PureTech not only this equity interest, which naturally will be diluted as we spin out these programs, but also these nondilutive economics that we typically attach in the form of royalties and milestones. So we have 2 opportunities to deliver value back into PureTech and to our shareholders from these programs.

In addition to Seaport, which has already successfully spun out, we're now in the process of spinning out Celea Therapeutics and Gallop Oncology, each of which I'll talk about later. In terms of historic success, Cobenfy, we still have these nondilutive economics which attach to Cobenfy. We've seen an enormous financial return already back into PureTech from the equity stake that we have in that business. However, we continue to have royalties and milestones due to us on sales of Cobenfy, which will produce meaningful income back into PureTech.

We also are proud of the balance sheet that we have. It was $320 million at the 2025 half year. All of that is capital that has been generated by the PureTech model. We haven't had to raise capital in nearly 8 years. So we've demonstrated that we can become a self-funding business with no need to dilute our shareholders and ample capital to move our programs forward. And finally, a focus of the business is the next wave of innovation, what we're going to be looking at and what we're going to be working on in order to build the new founded entities of the future. At this stage, we've got a few exciting things cooking. We're not ready to share too much of that today. But as and when we start to bring some of those programs forward, many of you, I'm sure, will recognize some of the PureTech hallmarks of the PureTech model in terms of these derisked assets where we already have validated pharmacology, typically some early trial data, but we think we can really transform these drugs and their efficacy and side effect profile to transformative treatments.

So an overview of some of the founded entities we have. We'll start with Celea Therapeutics. So this is a company that we're spinning out at the moment. I'm delighted to be joined in the audience by Sven, the CEO of this business, who has been busy at this conference. Celea is an incredibly exciting opportunity for us. It's developing a new treatment here for idiopathic pulmonary fibrosis. For those who don't know, this is a devastating illness where there's currently no cure and it is at this stage, a fatal disease. It affects a large number of patients across Europe and North America. At the moment, because of the paradigm of treatments that are available, 3 out of 4 patients who get this disease never even start on the antifibrotics, which are already approved for treatment of this indication.

We see this as a huge unmet need and also a huge potential that we can address through the drug that we've been developing, which is deupirfenidone. So this is a novel oral small molecule, and it is a next-generation antifibrotic. So how does deupirfenidone differentiate itself? It's a deuterated form of pirfenidone, which is one of the approved existing standard-of-care treatments for IPF. As I've already mentioned, in the PureTech model, this is somewhere where we already have a high degree of confidence as to how we think this can play out and how this can work.

So what happens here? You'll see on the left hand of the slide here, we have the results from the ELEVATE Phase IIb trial, where deupirfenidone was being dosed in IPF patients. Against placebo, it achieved a statistical significant response. We see a very meaningful reduction in the lung function decline, which is the measurement of disease progression in this indication. And that progression was reduced to such an extent that it actually approached the lung function decline, which we see in naturally occurring healthy older adults. So for us, this was an incredibly exciting signal. We were also encouraged from the 26-week data we have from a Phase IIb trial to then see the open-label extension, which we ran. Around 90% of patients transferred from Part A into the Part B open-label extension. Again, we saw that as very, very encouraging. And the 52-week data that you'll see here on the right of the slide shows the strong and durable response we saw where discontinued arresting of the lung function decline approaching natural healthy older adult lung function decline was demonstrated.

I'll now move on to Gallop Oncology. This is the oncology asset, which we've spun out into this business, Gallop Oncology. It's a novel antibody targeting galectin-9, and it's for the treatment of blood cancer, specifically AML. Again, it has the hallmark of a significant unmet need here. Currently, it's being dosed in the Phase I trial in a fourth-line setting. These are relapsed/refractory patients who have a life expectancy at this stage of around 2.5 months. So it is a really desperate need for these patients to have further treatment options.

If we look at the data that we've seen from the Phase I trial, this has been achieved through a novel 2-gear mechanism that LYT-200 targets. So not only does the drug directly kill cancer cells, but it also has a second effect of activating the immune system and having a cancer cell killing effect there. So if we look at the latest cut of the data, and this is still maturing and still improving, but the latest cut of the data we have on the right-hand side here, we see the critical overall survival data that was coming out of the Phase I trial. Recent FDA guidance has emphasized the importance of overall survival in this indication as the primary endpoint, and we're very encouraged to see that the 13.2 months median overall survival that we're already seeing is well ahead of the 9-month KOL-defined benchmark of success. As with Celea Therapeutics, Gallop is a program that we are actively fundraising for. We've seen a lot of positive engagement from potential investors. And these are the 2 programs that we're looking to spin out of the business with external capital to allow them to take these 2 important programs forward.

We then come on to Seaport Therapeutics. As mentioned at the opening of the presentation, this is the most advanced in the corporate setting of the companies that we have. It was spun out last year, 2 years ago now, nearly. It's raised $325 million from top-tier investors across 2 rounds. Despite that significant capital raising, we remain the largest shareholder in this business with a very meaningful 35% equity stake here. And this has 3 therapeutic candidates within its portfolio. Two of these are clinical stage, GlyphAllo targeting major depressive disorder and GlyphAgo targeting generalized anxiety disorder. And again, if one looks at the hallmarks of PureTech assets, these are programs that are based on validated targets on approved therapies where we believe we can transform their effect through the novel application of the proprietary Glyph platform.

So from a financial perspective, what can this model deliver for us? We have here an example of the financial returns that we've made here to date so far from Cobenfy. So as I mentioned, this is the KarXT as was previously developed by Karuna, which was spun out from PureTech. And you can see here the enormous potential for financial return that we can deliver. We invested $18.5 million into the development work of Cobenfy. That has to date delivered over $1.1 billion back into PureTech on a gross basis. So an enormous financial return. And that is an example of what we can do by leveraging external capital, carrying out these very early lean, efficient derisking activities that demonstrate the potential of the drug, which then allow us to leverage external capital and allow the program to be taken forward by others while still returning significant value into PureTech.

Because of the model here, because Cobenfy was invented by PureTech, we were lead inventor here on the patents is sitting next to me. We retain these nondilutive economics, as I've mentioned previously. We've been modeling these on a basis simply on a simple average of analyst forecasts and the milestones and royalties that are due to us through 2033, we're valuing at around $300 million based simply on those average of analyst forecasts. That's without any discount for time. But that gives an idea of still the significant value that can come back into PureTech from the success we've had. And also, this is a sort of model that one can expect to see us repeat across our other founded entities as they mature and spin out.

So as we look to 2026, we're pleased to build on the tremendous success that we've had in 2025. We have operational priorities, which is to secure funding for Gallop Oncology and Celea Therapeutics. We want to make sure that those programs are fully funded through their next trials. And in each case, we believe that those -- that funding can get each of those programs through to pivotal trial readouts, which would be incredibly exciting for us. In addition, at a hub level, as we progress the business and as we mature PureTech, we want to spin those programs out that will allow us to operate a lean, efficient hub model, which will then continue that future innovation on a very capital-efficient basis.

As we have that financial development going through the year, we also have clinical progress that we expect from our programs. In the case of Celea Therapeutics, we'll be looking to initiate the Phase III trial once we have that funding in place. And from Gallop Oncology, we're expecting important additional efficacy data and that key final overall survival data in the first half of this year. Whilst we rebuild the business so that we can deliver those strategic priorities, we're also making sure that we have an efficient hub that can deliver the next wave of innovation, which will provide the further generation of founded entities that can generate further value for PureTech, but most importantly, a range of important new treatment options for patients.

So thank you very much for that. I'm joined now by Eric Elenko, my colleague, Co-Founder and President of PureTech for the Q&A.

Thank you so much, Robert. If anybody has questions, please do raise your hands, and we'll get you a mic. Rob, you recently stepped into the role of the CEO. Could you tell us more about sort of your vision for the next phase of the company?

Yes, certainly. So look, I've always been -- when I stepped into the CEO role, I was delighted to be asked and I always admired PureTech as a business. One of the things just to give you an idea about what attracted me to the company and where I think we can really be transformative, I have a history working in venture capital and a lot of the VCs do great work. But it's also always struck me the number of VCs that despite enormous success they have, don't necessarily actually ever get a drug to market. So the track record of PureTech, when I was asked to come and join the business, we've just seen the positive Phase III readout from Karuna. It was very clear to me and obviously many others that, that was going to get approved. That alongside the other 2 FDA approvals that the business have had, I found that a hugely exciting prospect. And it was very clear that there's a very special company here.

So from my perspective, it was a hugely attractive opportunity to come and join the business. In terms of the vision going forward, what we want to do is ensure that we have a continuous generation of new ideas. How do we do that? We want to make sure that we have the right people and resources within our hub so that we can be generating exciting new programs, but also from a financial perspective that we have the right resources to move those programs on. That means doing the early derisking experiments that I talked about, but it also means making sure that we can leverage external capital at the right time so that we can then return additional capital in and generate new programs and continue the cycle. So my vision is that when we get these programs spun out, we're going to be able to have a lean, efficient hub of the business that we've already seen has a great track record of drug development, and we will be able to marry that alongside what should be a very successful financial performance from the successful founded entities that we're spinning out.

Yes. And that sort of leads into my next question. As we think about the new wave of programs as sort of core to your hub-and-spoke model, how do you think about your innovation strategy there? And are there any specific therapeutic areas that have...

Eric, do you want to...

Sure, absolutely. One thing that really distinguishes PureTech is how we do innovation. And Rob described this emphasis on validated pharmacology, meaning looking at a drug where there's clear human data that, that drug is having a positive effect, but there was something holding back that drug, so it wasn't realizing its full potential. And then what we'll do is we'll apply new thinking or technologies to solve whatever problem was holding back that drug. And that's what happened in the case of Karuna, that Seaport, that Celea.

And what we really see going forward is given how impactful that strategy has been to really continue looking at opportunities and innovation based on validated pharmacology. Going forward, we really see the emphasis on small molecules. And in terms of therapeutic areas, while we're open, we will be spending more time in thinking about those areas where we've historically had experience and had success. So for example, CNS is an area of high interest for us as we look to new innovation.

If you could just wait for the mic.

So when you're taking drugs that have been shelved for any reason, are you doing any actually new chemistry? Or is it more finding the right patient population for that drug?

Yes. It's very case dependent. And so typically, we're in a situation where we take a drug that's in the clinic, and we actually bring it back to be preclinical, and we're doing something. And that could be something in terms of chemistry, for instance, making a prodrug. It could be something formulation. In the case of Karuna, it was combining one drug with another drug. So PureTech isn't based on a single technology platform, but it's more about the process of taking a drug solving the problem, and that's very bespoke to each drug that we're working on. Our strategy is very product focused and very asset focused, and that's something that we anticipate going forward.

You talked about Karuna and Cobenfy as one of the validations of your model. What gives you the confidence that we -- it is replicable and there's opportunity for future success?

Well, I think partly what we've seen already in terms of companies that we've been able to spin out. So in the case of Seaport Therapeutics, as we say, a number of absolutely top-tier blue-chip investors were very keen to get into those funding rounds. They clearly see the potential and the opportunity in that business. And a similar approach, as Eric was saying, was taken there in the broad sense in terms of drug development as we have with Karuna. So we feel we've already had a number of validations going forward. It's not easy. We're very open about that. These opportunities are not just sort of lying around. They take a lot of work and a lot of thought to identify and to execute on properly. So we don't shy away from that. But we feel that we've had a track record of success that, that is continuing, and we can see a path forward to that, as I say, repeating itself in the future.

Yes. It's -- if you look at Karuna, we would argue it's not happenstance. Now we can't guarantee that everything we work on will result in the exact same success as Karuna. I think that might have been the fine print that Rob was showing in the disclaimer in the beginning. But if you look, there are some key elements that were present in the case of Karuna, and we really see those going forward with other opportunities. One was there's a very large unmet need, and Rob described that in his presentation. The second is there was clearly a drug that was having an impact on patients.

A third was we could clearly identify the problem associated that was causing the adverse events with that drug. Fourth, we could come up with a clear solution that made sense pharmacologically. And fifth, we had a very clear path and way of testing that, that solution was going to work. And if you look at all those elements, you see that in the programs that we currently have, and that's really going to be the strategy as we move forward.

And you've been self-funded for the last 8 years or so. How do you think about capital allocation and financial discipline looking forward?

Yes, it's a great question. I mean, for us, as I say, because of our portfolio approach, actually, we see that as a real strength of the business. As I mentioned, we don't have any bias to continue an individual program. Our bias is to get the best return from the capital that we're deploying financially and also in terms of patient impact. So for us, when we think about capital allocation, we have a range of opportunities. We have later-stage assets. We have existing founded entities. We have early innovation programs. We also have the potential to make returns directly to our shareholders.

So we think very carefully about the capital that we have and where it is best used across that spectrum. And for us, we think that's a real advantage to the model. It means that we're very happy to cease programs where we don't see a future or we don't see that they're going to be as efficient in terms of the return on capital and the impact that can have us elsewhere. So that healthy competition within the business, we think, is a key advantage in terms of efficient capital allocation for us.

And maybe talking about Celea Therapeutics for a moment, and welcome, Sven. You recently met with the FDA to talk about Phase IIb. What more can you tell us about your upcoming Phase III?

Yes. Sure, absolutely. So the Phase III design, which is really going to be centered around comparing deupirfenidone to pirfenidone is based on conversations we had with a number of key stakeholders. So physicians, patients, of course, key opinion leaders and very importantly, as you indicated, the FDA. So we had an end of Phase II meeting in December of last year. And that resulted in the design, which is centered around the comparison of deupirfenidone to show superiority to pirfenidone. Now really, if you look at the study that we did previously, ELEVATE versus the study we plan on carrying out, it's really what's changing is the arms, right? Those 2 arms versus an ELEVATE, we had 2 different doses of deupirfenidone and a placebo.

However, the other core elements are essentially the same. The primary endpoint of forced vital capacity, FVC, the patient population. And really, the idea is we are going to go and reproduce what we did in ELEVATE, but in this Phase III trial with these 2 different arms. And given the difference in effect that we saw between deupirfenidone and pirfenidone in ELEVATE, that really gives us confidence as we move into this Phase III trial.

Great. I wanted to open up for any final questions. If not, Rob, I want to turn it over to you for any closing comments that you might have.

Thanks, Bhavana. So look, as I was saying earlier, for us, 2025 has been a transformative year. We ended last -- the start of the year off the back of the incredibly exciting Phase IIb ELEVATE data in the IPF study. That has provided an enormous boost to the business during the course of the previous year. 2026 for us is going to be pivotal. We're now in a situation where we've got these 2 major programs that we're spinning out. We're looking to raise that external capital during the course of 2026. That will be transformative to PureTech. It's going to crystallize significant value within the business when those assets are spun out. It will also allow us to have a lean hub that remains after those spinouts, which will then be working on this exciting new wave of innovation. As ever, our main mission is to bring forward these important treatments to patients so that they can get to market and help people. But also, we see the potential to generate significant value through these programs and through that, to generate a positive return for our shareholders.

Great. Thank you so much, Rob. Thank you, Eric.

Thank you, Bhavana.

Thank you.

Hello, everyone, and thank you for joining the PureTech Health 2025 Half Year Earnings Webcast. My name is Sami, and I'll be coordinating your call today. [Operator Instructions] I would now like to hand over to your host, Allison Talbot, Senior Vice President of Communications, to begin. Please go ahead, Allison.

Thank you, everyone, for joining us for PureTech's 2025 Half Year Results Webcast. Our half year report was made available this morning and filed with the SEC. You can find the materials on the Investors page at puretechhealth.com. I'm joined today by members of our senior management team: Robert Lyne, Interim Chief Executive Officer; Eric Elenko, Co-Founder and President; Chip Sherwood, General Counsel; and Michael Inbar, Chief Accounting Officer. We're also pleased to welcome Dr. Sven Dethlefs and Luba Greenwood, who are leading our newest founded entities, Celea Therapeutics and Gallop Oncology.

Before we begin, I would like to remind you that during today's call, we will be making certain forward-looking statements. These statements are subject to various risks, uncertainties and assumptions that could cause our actual results to differ materially, and we ask that you refer to our annual report and our SEC filings for a complete discussion of these items. We undertake no obligation to revise or update any forward-looking statements or information, except as required by law.

I also want to remind you that we will be referring to certain non-IFRS measures in this presentation. The presentation of this non-IFRS financial information is not intended to be considered in isolation or as a substitute for financial information presented in accordance with IFRS. A reconciliation of the IFRS to non-IFRS measures that we will be referring to today can be found in this presentation and is also available on our Investor Relations website at investors.puretechhealth.com and in our SEC filings.

With that, I'll turn the call over to Rob, our Interim Chief Executive Officer.

Thank you very much, Allison, and thank you, everybody, for joining today. We appreciate you taking the time. For those of you who are new to PureTech, just as a bit of a quick introduction, we are a Boston-based LSE-listed biotherapeutics company with a hub-and-spoke model developing new medicines for patients. We entered 2025 with significant momentum in terms of our clinical progress and also this continued through the first half of the year as we continue to release further data from our lead program, deupirfenidone, LYT-100, which we'll talk about more later in this presentation. We see this clinical progress as underscoring the strength of our portfolio and also demonstrating the effectiveness of our business model.

In the presentation today, I'm going to be outlining the priorities that we have for the remainder of the year, how we're positioned to deliver long-term value for both patients, but also how we're going to be delivering value for our shareholders. So here, we're setting out on this slide 3 key strategic pillars that we are prioritizing and focusing on as we move the business forward. At the core of our business is developing new treatments for patients. This is still absolutely a fundamental part of what we do as a business. We're looking at moving these programs forward with operational discipline, but also patient-centered urgency. And that reflects the fact that we look to treat new diseases with new treatments where there's very high unmet need.

We're also looking as we go forward to strengthen our engagement with U.K. capital markets. And this we're going to be doing through a renewed focus on our LSE listing. We're very grateful to our U.K. shareholder base who've been with us in many cases since the IPO, and we want to ensure that we're continuing to work to deliver for those shareholders. As part of this, we're announcing today that we're going to be appointing up to 2 new nonexecutive directors to the Board going forward, and we will be looking to ensure that there is U.K. capital markets expertise in those appointments so that we can strengthen the Board in that way.

The third pillar that we're focusing on as we look at strategic execution going forward is our disciplined capital allocation approach. This is a big advantage of the model that we have through the hub-and-spoke development of assets. What this means in practice is that we can take assets at an early stage, deploy modest amounts of capital, perform killer experiments to see whether really we think that there is a potential drug there or not and discontinue early if we don't see promising results. What it also allows us to do is to develop and deploy significant capital into areas where we think there is the potential for a new exciting treatment that will have a big impact for patients, but also deliver significant financial rewards for PureTech.

This is best exemplified by Karuna Therapeutics, which many of you will be familiar with, where we allocated only $18.5 million of capital spend to bring that program forward. It was spun out into a separate entity and later floated on NASDAQ raised significant external capital there and successfully took its asset KarXT through to approval, which is now being marketed as Cobenfy for the treatment of schizophrenia, and that was a significant patient success for patients, but also a significant financial success for PureTech. So that is the disciplined capital allocation approach that we look for as we operate our model, and we're looking to repeat that pattern with our latest founded entities. We'll be talking about the 3 key founded entities in this presentation, Seaport Therapeutics, Gallop Oncology and our most recent founded entity, Celea Therapeutics.

On this slide now, we've got an opportunity to look at our current portfolio and value for shareholders. As many will be aware, we've had some management changes at PureTech in the recent weeks. I was asked by the Board to step into the role of Interim CEO, and we also had an interim Chair appointment following the departure of our previous Chair. One opportunity that this gave us was for Sharon Barber-Lui, the Interim Chair and myself to meet with a number of shareholders, listen to our shareholders, understand their views on PureTech and what they wanted to see from us in terms of helping both existing shareholders, but also prospective shareholders understand what we see as the really hugely exciting programs and value within PureTech.

So to try and address this, we are taking the opportunity today to present our core components of value slightly differently from how we have done in the past. We really see that at the moment, we have 3 core founded entities, which we think has the potential to deliver very significant upside financially to PureTech and our shareholders, but also to deliver really exciting new treatments for patients. So those 3 founded entities that we are now considering core are set out here, Celea Therapeutics, Gallop Oncology and Seaport Therapeutics.

These are all founded entities which began as programs within PureTech, where we either developed the assets ourselves or in-licensed them and worked on them, derisked them, took them through clinical trials ourselves and then reached a point where depending on the maturity of the asset, we've decided it was right to spin them out. So Seaport Therapeutics, that was spun out last year. We have often had many questions on Seaport about the post-money valuation of that business. We still own just over 35% of the equity in Seaport Therapeutics. We also have tiered royalties on the drug products within that company because they were developed within PureTech originally.

In terms of the valuation of Seaport, we have a valuation in our accounts, which is available publicly, but we have been asked in the past about the Series B valuation. And so we thought it would be helpful today to confirm that there was a $733 million post-money valuation on Seaport at the Series B, so a fairly recent financing, which was led by absolutely top-tier validated venture capital investors. We also have 2 of our newest founded entities here, Gallop Oncology and Celea Therapeutics, which are also now being formed into separate businesses such that they can also attract external funding as they move their programs forward.

This is the example of our hub-and-spoke model in action, where we are seeking to leverage external capital to continue those assets whilst retaining significant economics. Each of these founded entities is 100% owned by PureTech at the moment. We are seeking external capital there. That will enable us to shift the future R&D and cost of those programs off the balance sheet of PureTech into these separate entities such that they can leverage external capital to take those programs forward. I'm delighted that we're being joined by the leaders of those 2 programs, Sven Dethlefs and Luba Greenwood, who are going to be presenting later on.

There are some other legacy assets, which we won't be focusing on so much today. We feel that whilst those assets have been doing important work and they have the potential for significant upside, we don't necessarily at the moment, feel that they are making a material contribution to the value of the business. And therefore, we feel it is more helpful for shareholders if we focus on the 3 that we've set out there. So as well as those core components of value from the founded entities, we also have a royalty and milestone income relating to Cobenfy.

Again, this is a great advantage of our model, which is that because the drug was developed internally at PureTech, we have these nondilutive economics, which continue to return value into PureTech despite the fact that the asset was spun out into a separate entity and then actually acquired delivering an equity return to us. So we have 2% on royalties of Cobenfy sales above $2 billion annually. And then also, we're entitled to certain regulatory and commercial milestones on Cobenfy.

We've been listening to shareholders very carefully about their feedback on the Cobenfy economics. We have repeatedly been asked whether we can give some indications around potential value by reference to third-party analyst forecasts. We'll be talking about that today, and we've taken the opportunity to do some indicative modeling around what those economics could look like against consensus analyst forecasts, and it's coming out as a value of around $300 million over time, and we'll talk a little bit more about that later on.

And then finally, a key element because of the huge success we've had in terms of generating value historically, we are in the fortunate position of having a very healthy balance sheet. We still have just under $320 million of cash at the PureTech level. We haven't had to raise money for many years. We've become a self-funding business, which has meant we haven't had to dilute our shareholders, and we're in the position of having operational runway well into 2028. And obviously, that can extend further as founded entities spin out and reduce the R&D and cash burn on the PureTech hub. So here, we have a slide which sets out the potential forecast for the economics around Cobenfy.

So as I mentioned in the prior slide, we've been listening very carefully to our shareholders around how we can help be as transparent as possible about the potential value that we see within PureTech. And one comment we have repeatedly is a request to give some more clarity around the potential value of these future economics around Cobenfy. We do have commercial confidentiality around some of these payments. However, what we thought would be helpful would be to give the current analyst forecasts for Cobenfy sales. We get these from independent bank analysts that cover Bristol Myers Squibb, the large pharma, which bought Karuna. But there's a number of very high-quality independent analysts who are giving forecasts of what the Cobenfy sales are likely to look like up to 2033, which is when our royalty period ends.

What we've set out here is the range of the low to high forecast and taken a simple average of those forecasts and then model out what that would look like both in terms of the 2% royalty above $2 billion annual sales, but also milestones that would be triggered. This is not our internal value of the economics here, but we thought it would be helpful to provide a third-party view neutrally based upon these consensus-based forecasts from the analysts. We think that there is real significant upside from here.

It's worth noting that these forecasts are very often based, in some cases, just around the existing approval for schizophrenia. And there is a pivotal trial readout coming up at the end of the year in Alzheimer's psychosis. And if that is positive, then that has the potential to significantly increase potential sales, particularly in the later period. We hope that this is something that shareholders will find helpful when seeing this indicative projection as they look at the significant value that we see within PureTech.

So we're turning now to Seaport Therapeutics. This is the first of the 3 core founded entities that we wanted to talk about today. We see this as another successful example of the disciplined innovation model that we've adopted and which has produced Seaport Therapeutics. So this is a clinical stage biopharmaceutical company, and it's focused on advancing novel neuropsychiatric medicines. Similar to the setup you'll have seen in Karuna, we've maintained actually meaningful economic interest in Seaport through the equity position.

As you see, we're a very significant shareholder at 35.1%, but we also have rights to tiered royalties, milestone & sublicense payments around the drugs that Seaport is advancing. We see that as a key advantage of the PureTech model. Seaport was founded in April 2024. Since then, it's raised over $325 million. But crucially for us, this money has been raised from top-tier life science investors. So this includes the likes of ARCH, Third Rock, Sofinnova, General Atlantic, T. Rowe Price and others. That we see as an important validation of Seaport, and it was great to see that so many really high-quality investors were excited about the opportunity here as we were.

Another key validation point here is that Seaport is led by a really high-quality seasoned leadership team and crucially that has actually a track record of success in neuropsychiatric drug development and in bringing those new medicines to patients. So the key individuals here at Seaport, Daphne Zohar, who many shareholders will know, so former CEO of PureTech. She moved into the Founder, CEO role at Seaport last year. She has been joined by Dr. Steve Paul. He's another founder of Seaport. He was the former CEO and CSO at Karuna, which was spun out of PureTech and developed Cobenfy.

Steve Paul is a former President of Lilly Research Labs, and he in his career has been involved in developing many, many important neuropsychiatric medicines, including big blockbuster drugs, which some of you may be familiar with, such as Cymbalta, Zyprexa and Prozac. So we see this as a crucial part of the value in Seaport and also as a great indicator of the potential for huge success with this business. Looking at what Seaport is actually doing at the moment. So they've got a robust pipeline of 3 novel medicines, which are being progressed. All of these programs that you see here have the potential to become first-in-class treatments.

Crucially as part of the PureTech model that we've seen with other founded entities such as Karuna, they've already -- they're built on mechanisms where we've already seen demonstrated clinical efficacy, but they were held back by an issue that Seaport is now addressing using the proprietary Glyph platform. Glyph platform was initially advanced at PureTech. It's really quite an elegant solution. And what it does is it allows one to cloak drugs in such a way that the body recognizes them as dietary fats.

Now the advantage of doing this is that one can substantially reduce the side effects, often including liver stress, which enable drugs that would otherwise only be delivered via an infusion to be taken orally. And this can have a significant impact on the attractiveness of these drugs. This is an area of very high interest for both pharma companies and investors, many of whom are on the hunt for what could be the next obesity-like opportunity in medicine given the potential market opportunity here.

So we are really excited by Seaport Therapeutics and are looking forward to keeping you updated on their progress as they move forward. So we now turn to the second of the 3 core founded entities that we're discussing today. This is Celea Therapeutics. This has been launched in recent weeks under the leadership of Sven Dethlefs. I'm very pleased now to introduce Sven, who is going to talk more about Celea.

Thank you, Rob, and hello, everyone. Many of you have probably seen from the website that I've actually been working with PureTech for over a year as entrepreneur-in-residence. I'm excited to lead Celea Therapeutics as I believe we have the potential to bring a truly groundbreaking therapy to patients suffering from IPF. So what is IPF? IPF is a progressive lung disease with a median survival of just 2 to 5 years after diagnosis. The current standard of care treatment offers only modest efficacy in slowing lung function decline. In addition, the side effects of standard of care treatments prevent patients from reaching higher, more effective doses. And unfortunately, as a result, treatment uptake is low. Only 1 in 4 patients with IPF in the USA has ever been treated.

And even for those who start therapy, more than 40% eventually discontinue due to side effects and the lack of efficacy. Yet despite these limitations, the combined peak sales of the 2 medications approved have reached over $5 billion in annual sales. And that, of course, underscores the enormous opportunity that a new treatment for IPF would have. Deupirfenidone has the potential to be used across multiple patient segments. What we aim for is a therapy that can be used for patients who currently are not on treatment or those who have discontinued treatment, but also those who have actually already started treatment with one of the other 2 medications because we believe this drug has a very nice profile between efficacy and tolerability, which will be attractive for all patients that are suffering from IPF.

We believe in the potential of deupirfenidone because of the unprecedented efficacy that we have seen with deupirfenidone 825 milligram TID in our ELEVATE study. ELEVATE was the Phase IIb study that we just completed last year in December. And there are 3 elements that I would like to highlight. One is the potential for lung function stabilization. What we've seen with deupirfenidone 825 milligram, so our high dose, was that the efficacy approached the natural lung function decline expected in healthy or older adults. That was unexpected. The efficacy will beat standard of care when you compare it to an active comparator that we used in the trial, pirfenidone, where we've seen a 50% greater treatment effect with our 825 milligram TID.

And what we can also say is that we not only had an active comparator, but we also had the comparison, of course, to placebo. And since we've seen that both placebo and pirfenidone behaved as expected as shown in other trials before, we know that we have run a high-quality trial and that this treatment effect is having real potential for these patients and especially since we can support the observations with pharmacokinetic data that has shown that deupirfenidone 825 milligram has 50% greater exposure versus pirfenidone, which may have driven the greater efficacy observed. So we have here a nice correlation between the pharmacokinetic data and the efficacy in the trial.

And I think the whole package of efficacy and tolerability data points to the enormous potential this drug has. I would also like to share the data from our open-label extension data of the Phase IIb trial of ELEVATE. That is the continuation after the blinded phase for another 26 weeks. So we have overall 52-week data. What you would expect over 52 weeks in IPF patients is a decline of around about 200 to 350 ml without treatment. So that's based on historical data. And what we've shown with our patients that have been on 825 milligram over 52 weeks that they have only a decline of measured here 32.8 ml, and that is comparable to healthy older adults as we all lose lung function when we age. And that gives us confidence that what we have seen in the first phase of the trial.

So the first 26 weeks in the blinded phase is actually confirmed also in the open-label extension trial. So that's, of course, a data set that we will take to the FDA and it reinforces the completeness of the package that we have for our Phase III trial design. So we have here also a nice additional data set. We believe if this can be replicated in Phase III, it would constitute a substantial improvement over current IPF treatments. And for that reason, we believe deupirfenidone can be the new standard of care for patients suffering from IPF.

Let me also spend a moment on why we believe this program is differentiated versus other IPF programs in the industry. So the nature of the disease is idiopathic for that reason, new mechanisms of actions for this disease have an inherent risk linked to it. Our program is based on pirfenidone, a medication that has been established for over 10 years. It's well studied. And since we have a deuterated version, the molecule itself is already having a different risk profile than the other program that you would see in IPF. We have that complemented with a really robust and broad Phase II trial over 26 weeks with a 52-week open-label extension data that I just took you through.

And then, of course, we also had a statistically significant outcome on the high dose versus placebo, although the trial was not powered for that effect. We also saw a very good study quality itself due to low variability in our trial. It was a high-quality trial. And as I mentioned before, the availability of an active and nonactive comparator with pirfenidone and placebo gives us, of course, confidence that we have a very good data set in our hand. So now going forward, what does it mean for Phase III? The Phase III design will recapitulate key aspects of the ELEVATE trial, focusing on the high dose, and that is something that provides us with a complete package to develop a drug that will not only be potentially successful, but also a new standard of care.

In closing, we believe the deuterated pirfenidone program is positioned to become the next standard of care. We have a complete data package, as I've shown you here, we will share more of the data at the upcoming European Respiratory Society Congress in Amsterdam that's happening in September, where we show more of the Phase IIb data and especially the open-label extension phase. Our end of Phase II meeting is expected at the end of the third quarter of '25. And of course, pending alignment with the FDA, we anticipate the Phase III initiation in the first half of 2026. Thank you very much.

Thanks very much for that, Sven. We are really proud of the launch of Celea. We see this as a great example of the PureTech model in action, and we're really looking forward to the enormous impact, which we think deupirfenidone is going to have on patients worldwide and the potential value that this can generate for PureTech. We are not actually looking to fund Celea's further development entirely from our own balance sheet. This is us using the hub-and-spoke model to ensure that we leverage external capital and to take this program forward, and that is a key area of focus for us and Sven at this time as we secure the Phase III trial design.

So next up, I'm delighted that we're now being joined by Luba Greenwood, who is the CEO of Gallop Oncology. Gallop houses PureTech's oncology assets, which we have spun out into this separate entity. We see this as another clear example of our model in action and the repeatability of that model, as you've seen with Celea, but also with Seaport, which has already raised external funding and historically with Karuna, which was successfully acquired. I'm delighted to hand over to Luba to talk us through this company.

Thank you, Rob. I'm excited to be here today to walk through the latest developments at Gallop Oncology. At Gallop Oncology, our mission is to move boldly and decisively to bring forward novel treatments for patients facing some of the most challenging cancers. Our lead program, LYT-200 is a monoclonal antibody targeting galectin-9, which is an oncogenic driver and a potent immunosuppressor in cancer. By activating the immune system and driving direct tumor cell killing in acute myeloid leukemia or AML and other leukemias, LYT-200 takes a differentiated 2-gear approach. This dual mechanism is critical in oncology because past efforts relying on a single mechanism often fall short.

That's why we're extremely pleased about the progress we're making with LYT-200. We have received multiple FDA designations, including Fast Track and Orphan Drug designation for AML and Fast Track for recurrent and metastatic head and neck cancer in combination with anti-PD-1. These designations not only highlight the urgent need in these indications, but also reflect the quality of the efficacy and safety data that we have generated so far. We're very encouraged by the clinical data we have generated to date across our LYT-200 trials.

As of this month, we have completed enrollment in Phase Ib AML and high-risk myelodysplastic syndromes or MDS trial, which is evaluating LYT-200 as a monotherapy and in combination with venetoclax and hypomethylating agents. The trial is in patients with relapsed/refractory disease, where the overall survival is approximately 2 months, and there are no established standard of care options to date. As monotherapy, LYT-200 has demonstrated a clear clinical benefit. In combination with venetoclax and hypomethylating agents, we are seeing responses that suggest LYT-200 may meaningfully enhance current therapies with patients achieving complete responses, hematological improvements and even transfusion independence.

We last shared data in April for nearly 60 patients across both arms. Since then, we enrolled nearly 30 additional patients and continue to see meaningful and sustained clinical benefit, resulting in longer treatment durations and extended follow-up. This has allowed for the collection of more mature data sets. And I am pleased to share that we have selected a dose that we intend to propose to regulators for advancement into Phase II. With the strength of the responses observed to date and the longer treatment durations achieved, top line efficacy results are now expected in the fourth quarter of 2025 with additional efficacy and overall survival data anticipated in the first half of 2026.

These milestones will provide a more robust foundation for regulatory discussions and will help further derisk the design of Phase II studies and inform the broader development strategy. I'm also pleased to share that we have completed our Phase Ib trial of LYT-200 in solid tumors, where outcomes for relapsed/refractory patients remain poor. The trial evaluated LYT-200 both as a monotherapy and in combination with anti-PD-1 antibody tislelizumab and confirmed a favorable safety profile across all cohorts with particularly promising efficacy signals in head and neck cancer, where we observed a complete response lasting more than 2 years as well as a partial responses and stable disease.

Taken together, the growing body of data across hematologic malignancies and solid tumors reinforces LYT-200's potential as a differentiated therapy with very broad applicability. With key data readouts expected beginning later this year, we look forward to building on this momentum and unlocking the full value of this program for patients.

Thank you very much for that, Luba. Gallop is still wholly owned by PureTech today. We see significant value creation potential within those programs, consistent with our model. We're in a position to get external funding to help take those programs forward that allows us to retain economics. As we look at these catalysts across the core programs, given the nature of our business, these catalysts often -- expected catalysts take the form of data and regulatory interactions. As you'll see, the cadence of these milestones across the core programs is a direct result of our hub-and-spoke model, and this is something we're very proud of. So just turning now to the financial highlights.

I'm pleased as I said at the outset that we have ended the half year with a strong cash position. Again, this is a result of an evergreen business model. We have not had to raise external capital for many years. So we ended the half year with cash, cash equivalents and short-term investments of just under $320 million. This compared to an equivalent number at the end of 2024, at the end of the full year of just over $366 million. On a consolidated basis, our cash, cash equivalents and short-term investments were also just under $320 million at the half year. This compared to a figure at the full year, at the end of 2024 of $367 million.

In terms of our cash burn, during the first half of this year, we've been looking to implement strategies to drive efficient operations, both in terms of our R&D spend, but also in terms of our G&A overhead. We did see that reduce year-on-year, reflecting the fact that we have costs which moved out of the PureTech hub into Seaport when it was spun out in 2024. That had an impact on our R&D and G&A. On a consolidated basis, we had operating expenses of just under $50 million in the first 6 months of 2025. The same period last year was at $66.7 million. So one can see the reduction there as Seaport has spun out. And we expect going forward that we will see a continued reduction in R&D and G&A expense as we progress the spinouts of Gallop and Celea.

Thank you very much for your attention. I hope that has been a helpful presentation. We really do want to thank all of the stakeholders who help make PureTech what it is, the clinical trial participants, their caregivers, advocates, clinicians, the partners who are all absolutely crucial to the operational work of our business, but also to our shareholders who have been incredibly supportive of this company and have enabled us to achieve what we have achieved. And also personally, I'd like to thank the PureTech team and Board who have been working hard to make sure that we can have a positive impact both for patients but also for our shareholders. And with that, we'll now open the call for questions.

[Operator Instructions] Our first question comes from Miles Dixon from Peel Hunt.

Great. Thank you for the presentation. That was really helpful. Particularly good to be able to drill down and focus on the core programs. I've got a few questions, but maybe if I could just ask this one first and then I'll go back. The operating costs in first half '25 of $49 million. I think we've seen half-on-half for 3 reporting periods now that's coming down. Can you give me -- I mean, I assume that there's very little in there that's a contribution towards Seaport given that, that was spun out in December. But can you give me an idea as to what proportion of that $49 million is for operating and R&D expenses into Celea and Gallop? Just a rough guide, if you could.

Certainly, Miles. So the majority of the R&D spend, obviously, is attributed to Celea and to Gallop. So as we've indicated, I think, obviously, priority at the moment is looking to get those 2 assets funded with external capital. As they formally spin out, that will remove the majority of that spend from our balance sheet and from the sort of PureTech level P&L. So from that perspective, we would expect that as we go forward to have a further reduction on our R&D overhead as we move into 2026.

And I presume then that particularly the guidance around cash runway that any catalysts around financing or partnering would have a positive impact then on your cash runway. Am I reading into that correctly?

That's absolutely right, Miles. And also the other element in terms of cash runway, we've got 2 components really to it that are influenced by the Celea and Gallop funding. So one is positive impact on our cash runway extending it further as the R&D spend moves off the PureTech books and goes into these independent entities. We, at the moment, also will be making capital contributions we expect to into those 2 financings.

Because those are live financings that we are currently putting together, we're not in a position to guide publicly as to what those contributions would be. But obviously, once those fundings have been completed, that will give us both greater clarity, and we will be sharing that with shareholders around what our future cash burn would look like, but it will also then enable us to give much greater clarity around where we see our cash pile post those 2 financings. And that would also be a natural opportunity for us to consider how that cash may be used to help generate returns for shareholders.

Great. And if I could just ask on Celea, given that the newest entity in the -- well, not necessarily the asset, the newest entity in the portfolio. You've obviously got a pretty busy period coming up, 3Q FDA meeting that you mentioned, fourth quarter trial design and then a first half '26 beginning. Is the trial design something that you would consider or would think that it would be necessary for partners to have a look at? Or is this something that you're supremely confident in pursuing regardless of partner interest? I'm trying to do a bit of digging around what the time line for partnering is.

It's a great question, Miles. And look, what's important for us around deupirfenidone is that there is such exciting great data that we got at the end of last year and crucially that's been confirmed by the 52-week open-label extension study, which came out earlier in this year. So for us, we think the fundamental attractiveness and potential of deupirfenidone is there, and we know that, that is something that we are getting positive responses from.

As you say, naturally, when one is structuring the financing, it ties very closely to what the trial design will look like. We are very confident around the trial design. But obviously, we do need to have those engagements with the FDA at the end of this month. There is a process that follows there to make sure that we get agreement as to what that trial looks like. And that is a natural data point which certain funders would be looking for before actually committing any funds. But obviously, that doesn't stop the active work that is going on at this stage to look at putting that financing package together.

Great. And then just one more, and I'll get back in the queue. So I obviously have my own forecast for KarXT, Cobenfy and what the future economics might mean for PureTech. But I was particularly interested by the -- not necessarily the trajectory that you're modeling, but there was clearly some lumpy bits in the early years. I was wondering if you could just give me a high-level indication of what the mechanics are that drive some of that up and down on the economics that fall to PureTech.

Certainly, Miles. Exactly. It's in the milestone. So there's the 2% royalty, which is obviously fairly easy to calculate and one can sort of separate that out from the numbers that have been put out today. But also then beneath that are these various milestone arrangements that we have. Those arrangements are with multiple parties and are commercially confidential. So we aren't able, I'm afraid, to provide the sort of full breakdown, but they are obviously influenced in part by the sales projections that we see. And so we thought it would be helpful to set that out.

But it's worth noting, as you say, Miles, everybody has their own view on this. I think it's fair to say we internally are more bullish than the consensus. And it's always worth remembering that BMS paid nearly $15 billion for Karuna. And so those guys obviously have their own view as to what they think this drug can do in terms of sales, and they wouldn't have paid nearly $15 billion in cash if they weren't very confident that there being very significant sales for this drug going forward.

Our next question comes from Faisal Khurshid from Leerink Partners.

This is Heidi Jacobson on for Faisal Khurshid. What are the key variables you need to discuss with FDA regarding Phase III trial design for LYT-100? And then we have a quick follow-up.

Sure. Well, I'll pass that over to Sven Dethlefs, who's joining us, and he can speak to the Phase III interaction trial design that we're having. So Sven, would you mind taking that?

Yes. Thank you, Rob. So the briefing book for the Phase III trial design has been submitted to the FDA. As you've seen, we have the meeting expected to be at the end of September with the FDA. What we submitted are questions about the trial design if the FDA agrees. And these are all classical questions that you would expect for a Phase III trial design that gives you at the end -- approval at the end of Phase III. So I would say, without going into further details, we will, of course, share all the details about the intended trial design after we had confirmation with the FDA. But I would say from my experience around Phase III trial designs and what you have is discussions in this particular approach that we took 505(b)(2), it's all pretty straightforward and very [indiscernible] that we asked the FDA to agree to. Thank you.

Got it. And just a follow-up. When should investors expect disclosure of pipeline activities beyond LYT-100 and LYT-200? And is BD still possible to expand the pipeline?

So certainly, I mean, we are continually looking at new opportunities for innovation. We have a number of assets that are currently under review internally. Our approach historically, which we've always found to be most successful is to try and sort of perform these clear experiments very early on these assets. So we do a lot of both sort of modeling and thinking around potential drug assets and development pathways and also commercial attractiveness. But then also there's work that we can do to really understand if we think there is a potential for a drug there.

So that work does continue as and when there are assets that we feel are promising enough and that we really feel that this is something we could be taking forward and putting material capital behind. That's then when we would be pulling the covers off, if I may, and showing them a little bit more. So there are assets like that, that we are working on at the minute. We haven't got anything that's at a stage that we think is right to share yet. But when we do, that is something that we will bring forward and can explain more about what we're working on.

We now have another question from Miles Dixon from Peel Hunt.

If I could just follow up on a question I should have asked on Celea. Could I just ask if there is any preference for the format of partnering it? I mean, is it potentially syndication partnering, royalty, all of the above, still considering them? Just give me if there's anything more you can give me.

Sure, Miles. Well, look, I mean, I'd say the most sort of honest answer is we look at where the best cost of capital comes from. And so that's really where the judgment gets made. We would expect that normally, and we've seen this with our other founded entities that equity contributions from external parties are the most natural way of funding assets such as this. So I think if one were to think of that as perhaps the default, that probably makes a lot of sense. But obviously, we do look opportunistically at other forms of capital that we can either augment or replace with depending on the relative cost of that capital and the terms that are being offered. So I would think around the standard spinout with equity contributions from external funders as the default. But then as I say, we do think creatively and opportunistically about other structures that we can use as well.

Great. And one for Luba, if I could, on Gallop. There's obviously some interesting data coming in there from both solid and liquid, particularly intrigued by the stable disease between monotherapy and combination therapy, but the response is stepping up quite materially with combo. I was just wondering, I mean, are partnering discussions focused mostly on -- or interest focused mostly on liquid? Or is it split equally, liquid-solid.

Sure. Do you want to go ahead with that, Luba?

Sure, absolutely. So we are right now focusing on the liquid and AML. So that's where the focus is in our partnering discussions. But certainly, we're open to all discussions with potential partners and having those ongoing at this time.

We now move on to any questions from the webcast. And we start with, is UBS planning to research PureTech?

So many thanks. Conscious, this is a question that we have had raised by a number of shareholders since we appointed UBS as joint broker at the start of the year. As I'm sure many will be aware, obviously, initiation of research coverage is independent by analysts. That's an important aspect, obviously, the way the model of the system works, such that it ensures the independence of that analyst coverage. So we continue to engage with a number of analysts, including those at UBS. And obviously, we always welcome initiation and coverage, and it is good when that happens, but it is obviously because of the independent nature of that coverage, it isn't something that we can control.

Our next question reads, please, could you provide some rationale into sticking with London as the primary listing?

Certainly. So very happy to respond to this. Our perspective has been there's -- there were fundamental reasons why PureTech listed in London around a decade ago rather than any other exchange. We've always seen, and I think this still holds true that London has a natural attractiveness for portfolio approach businesses such as ourselves. The NASDAQ and U.S. markets, they are important sources of interaction for us, and we have a number of very important U.S. shareholders.

But we also do find that a lot of U.S. and specialist investors are not necessarily so naturally drawn towards the portfolio composite approach that we offer. We do find and continue to find that, that resonates well with a number of U.K. holders. We're also conscious that a number of our U.K. holders, for various reasons, can only hold U.K. listed shares, and therefore, it's important that we have a strong and vibrant London listing. So for us, we do not see that there's any need to shift our focus away from London, and we want to make sure that we are continuing to respect and reward our U.K. shareholders who've been so much to fund this company and ensure a success since our IPO.

Our third question is in 4 parts, and it reads, can shareholders in PureTech get access to the proposed financings of the individual spokes? And how do we get access to those opportunities and access to their structures so we can better understand that what we own by providing transparency into financing agreements? And if you do not allow current investors this opportunity to fund the spokes, are you diluting the value of PureTech investors? And do leaders of the spokes have a conflict of interest with PureTech stakeholders?

Very interesting questions and obviously, a few bits for that. So if I just sort of try and unpack a few elements there. So I think there's a request there to access proposed financing of the individual spokes. The fact at the moment, and this is obviously live ongoing with Celea and with Gallop is that when we look to put financing arrangements around that, we follow the traditional -- typically, as I was indicating, VC model where we look to engage with high-quality VCs who are able to diligence and assess those programs and then write checks both for the current financing that we're raising, but also would then be in a position to provide follow-on financing to help continue to move that company forward over time.

So because of the way those rounds are typically put together, they are private rounds with a number of specialist biotech VC investors. That's typically the structure, sometimes some strategics as well. Those financings, just the way it is done is they are conducted as private rounds typically and in a confidential manner. So I'm afraid it is not possible for us practically to open up the terms of those financings while we're putting them together nor is it possible for us to open up participation more broadly.

Having said that, conscious about the question around understanding the structures and transparency. Obviously, we put out our percentage interest on a fully diluted basis in our core founded entities. We have today included an external data point around the Series B valuation for Seaport, and we see that perhaps that goes some way to helping with the transparency point that's been asked there.

I think there was also a question about if you're not allowing opportunity to fund spokes directly, does this dilute the value to PureTech shareholders?

Perhaps one way of looking at this is, for us, it's consistent with our derisking and portfolio approach here. So although there's a degree of dilution there, there's also a degree of risk sharing as well. The reality is that biotech and drug development is inherently risky. There are enormous rewards as we've seen in the past when one gets it right. But we also need to be aware that it is difficult and it is risky. And part of what we see is the attraction of the PureTech platform and approach is that we have this portfolio model, which allows our shareholders to benefit in balanced exposure to multiple assets. So I guess it depends which way you look at it. One person might see it as dilution, the other people might see it as sort of balancing risk. So that's maybe just one way of thinking about that.

I think the final part of that question was do the leaders of the spokes have a conflict of interest with PureTech shareholders?

Our view is that there is actually alignment there in as much as when the spokes win, PureTech wins. So we see that as important that we are all aligned and all benefit from the success of the spokes. Obviously, the critical job of management and the Board of PureTech is that we are working to ensure that when there is success of the spokes, that translates into value at the PureTech level for our shareholders. And that work is a key area of focus for myself and the Board as we move forward.

Can you share with investors the exact capital structure and economic interest in Seaport so that investors and analysts can model potential results?

So I think maybe there's a little bit of overlap perhaps here with obviously the question which we just answered in terms of there are restrictions when these companies spin out, although they are very much PureTech founded entities, and we're very proud to maintain the association with those businesses. They do become separate companies with confidentiality around their financing structures, which is confidential to that company, but also to the other private investors in there. So we are somewhat limited in what we can say. Again, I hope that a little bit of disclosure around the post-money valuation of Seaport might be a data point that some investors may find helpful as they are looking at modeling.

I think there was also a question maybe around the economic interest in Seaport. So we have the equity position. We also have tiered royalties. We've put out publicly that that's a 3% to 5% range. The bit of guidance, if it's helpful, the higher percentage, those are really on very significant sales. So it really depends how successful Seaport is. We think that there are, as we're indicating, huge potential for those drugs. Unfortunately, these depressive disorders are very, very widespread. It's an enormous market opportunity, which unfortunately reflects the wide prevalence of those diseases. But obviously, we have potential there for very significant royalties if that asset is successful as it moves forward.

What key clinical milestones have been funded for Seaport?

So I think, again, similar theme, and this is certainly something we want to work on in terms of being as transparent as we can be, but Seaport hasn't guided publicly as to the sort of runway in terms of its different programs. What I can say, obviously, is it's raised its Series A and B last year. So it was very successful in raising capital there over $325 million. That clearly -- and one can see the sort of level of spend we were having on the Glyph programs before they span out into Seaport. They're clearly moving them a lot further, but $325 million is a very significant amount of capital. And so I think investors can be confident that they do have runway and they will be able to make significant progress with the current capital that they have.

Our sixth question says, can current shareholders have access to funding Gallop?

So again, maybe a little bit of overlap again with the previous question. And so the nature of these rounds...

[Technical Difficulty]

It seems we have lost connection to Robert. Please bear with me while I attempt to reconnect him.

Eric is going to take over for the time being while we establish reconnection with Robert. Eric, please go ahead.

Yes. Just to continue the answer that Rob was giving. Given the nature of the financings and that the financings for our founded entities are ones where institutional investors are the ones providing the capital, it doesn't provide the opportunity for all of the shareholders who are shareholders of PureTech to necessarily participate. However, shareholders of PureTech do get the benefit of ownership of those companies through -- get the benefit of the ownership of the founded entities through their ownership in PureTech.

Our next question reads, what is a reasonable time line for an appointment of a permanent CEO?

Yes. So right now, Rob is the interim CEO, and he is continuing as the interim CEO, and the Board is aware of the status of the CEO position. But for the moment, Rob is continuing on in that role.

Our next question reads, there has been some strategic interest in the company recently. Can you provide any color on where you stand and when these approaches happen?

Basically, as a public company, of course, anyone can approach us at any time. That's not something that's in our control. And if that happens, of course, the Board has a fiduciary obligation to consider any offer that might come its way.

Thank you very much. That is all we have time for today. We thank everyone for joining the call. You may now disconnect your lines.