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…

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…

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…

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…

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.