PureTech Health - Earnings Call - H1 2025

Transcript

Speaker 6

Hello everyone, and thank you for joining the PureTech Health 2025 Half Year Earnings webcast. My name is Sammy, and I'll be coordinating your call today. During the presentation, you can register a question by pressing star followed by one on your telephone keypad. If you change your mind, please press star followed by two on your telephone keypad to remove yourself from the question queue. I'd now like to hand over to your host, Allison Mead Talbot, Senior Vice President of Communications, to begin. Please go ahead, Allison.

Speaker 3

Thank you everyone for joining us for PureTech Health'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, Salia 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 filing.

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

Speaker 5

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 Health, 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 continued 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. Here we're setting out on this slide three 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 the UK capital market, and this we're going to be doing through a renewed focus on our LSE listing. We're very grateful to our UK 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 two new non-executive directors to the board going forward, and we will be looking to ensure that there is UK 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, and 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 Cabenfi for the treatment of schizophrenia, and that was a significant patient success for patients, but also a significant financial success for PureTech. 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 three key founded entities in this presentation: C-Port Therapeutics, Gallop Oncology, and our most recent founded entity of Salia 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've also had an Interim Chair appointment following the departure of our previous Chair. One opportunity that this gave us was for Sharon Barber-Lewy, the Interim Chair on my side, 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 of value within PureTech.

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 three core founded entities which we think have the potential to deliver very significant upside financially to PureTech and our shareholders, but also to deliver really exciting new treatments for patients. Those three founded entities that we are now considering core are set out here: Salia Therapeutics, Gallop Oncology, and C-Port 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, de-risked 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.

C-Port Therapeutics was spun out last year. We have often had many questions on C-Port about the post-money valuation of that business. We still own just over 35% of the equity in C-Port 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 C-Port, 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 we thought it'd be helpful today to confirm that there was a $733 million post-money valuation on C-Port at the Series B, a fairly recent financing which was led by absolutely top-tier validated venture capital investors.

We also have two of our newest founded entities here, Gallop Oncology and Salia 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 two 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 as shareholders if we focus on the three that we've set out there. As well as those core components of value from the founded entities, we also have a royalty and milestone income relating to Cabenfi.

Again, this is a great advantage of our model, which is that because the drug was developed internally at PureTech, we have these non-dilutive 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. We have 2% on royalties of Cabenfi sales of about $2 billion annually, and then also we're entitled to certain regulatory and commercial milestones on Cabenfi. We've been listening to shareholders very carefully about their feedback on the Cabenfi 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. 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. Here we have a slide which sets out the potential forecasts for the economics around Cabenfi. 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 Cabenfi. 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 Cabenfi 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 Cabenfi 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 forecasts and taken a simple average of those forecasts and then modeled 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 validation 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 in seeing this indicative projection as they look at the significant value that we see within PureTech. We're turning now to C-Port Therapeutics. This is the first of the three core founded entities that we wanted to talk about today. We see this as another successful example of the discipline innovation model that we've adopted and which has produced C-Port Therapeutics.

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 C-Port 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, and sub-licensed payments around the drugs that C-Port is advancing. We see that as a key advantage of the PureTech model. C-Port 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. This includes the likes of ARCH, Third Rock, Sotheby's, General Atlantic, T. Rowe Price, and others. That we see as an important validation of C-Port, 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 C-Port 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. The key individuals here at C-Port, Daphne Zohar, who many shareholders will know, former CEO of PureTech, she moved into the founder/CEO role at C-Port last year. She has been joined by Dr. Steve Paul. He's another founder of C-Port. He was the former CEO and CFO at Karuna, which was spun out of PureTech and developed Cabenfi. Steve Paul is a former president of Validity 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.

We see this as a crucial part of the value in C-Port and also as a great indicator of the potential for huge success with this business. Looking at what C-Port is actually doing at the moment, they've got a robust pipeline of three 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 built on mechanisms where we've already seen demonstrated clinical efficacy, but they were held back by an issue that C-Port is now addressing using the proprietary Glyph platform. The 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 infusion to be taken orally. 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. We are really excited by C-Port Therapeutics and are looking forward to keeping you updated on their progress as they move forward. We now turn to the second of the three core founded entities that we're discussing today. This is Salia 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 Salia.

Speaker 1

Thank you, Rob, and hello everyone. Many of you have probably seen from the website that I've actually been working with PureTech Health for over a year as an entrepreneur in residence. I'm excited to lead Salia Therapeutics as I believe we have the potential to bring a truly groundbreaking therapy to patients suffering from idiopathic pulmonary fibrosis (IPF). What is IPF? IPF is a progressive lung disease with a median survival of just two to five 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. Unfortunately, as a result, treatment uptake is low. Only one in four patients with IPF in the U.S.

has ever been treated, and even for those who start therapy, more than 40% eventually discontinue due to side effects and a lack of efficacy. Yet, despite these limitations, the combined peak sales of the two 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 treatments or those who have discontinued treatment, but also those who have actually already started treatment with one of the other two 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 milligrams t.i.d. in our ELEVATE study. ELEVATE was the Phase IIb study that we just completed last year in December. There are three elements that I would like to highlight. One is the potential for lung function stabilization. What we've seen with deupirfenidone 825 milligrams, 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 repeats standard of care when you compare it to an active comparator that we used in the trial, deupirfenidone, where we've seen a 50% greater treatment effect with our 825 milligrams t.i.d. We can also say that we not only had an active comparator, but we also had the comparison, of course, to placebo.

Since we've seen that both placebo and deupirfenidone behave as expected, as shown in other trials before, we know that we have run a high-quality trial and that the treatment effect is having real potential for these patients, especially since we can support the observations with pharmacokinetic data that has shown that deupirfenidone 825 milligrams has 50% greater exposure with deupirfenidone, which may have driven the greater efficacy observed. 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 based off the Phase IIb trial of ELEVATE. That is the continuation after the blinded phase for another 26 weeks. We have overall 52-week data.

What you would expect in over 52 weeks in idiopathic pulmonary fibrosis patients is a decline of around 200 to 350 mL without treatment. That is based on historical data. What we've shown with our patients that have been on 825 milligrams over 52 weeks is 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. That gives us confidence that what we have seen in the first phase of the trial, the first 26 weeks in the blinded phase, is actually confirmed also in the open-label extension trial. That is, 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. 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 idiopathic pulmonary fibrosis treatments, and for that reason, we believe deupirfenidone can be the new standard of care for patients suffering from idiopathic pulmonary fibrosis. Let me also spend a moment on why we believe this program is differentiated versus other idiopathic pulmonary fibrosis programs in the industry. The nature of the disease is idiopathic. For that reason, new mechanisms of action for this disease have an inherent risk linked to it. Our program is based on deupirfenidone, 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 other programs that you would see in idiopathic pulmonary fibrosis.

We have that complemented with a really robust and broad-based two trials over 26 weeks within 52-week open-label extension data that I just took you through. 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 in 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 non-active comparator with deupirfenidone and placebo gives us confidence that we have a very good data set in our hands. 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 deupirfenidone 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 2025, and pending alignment with the U.S. FDA, we anticipate the Phase III initiation in the first half of 2026. Thank you very much.

Speaker 5

Thanks very much for that, Sven. We are really proud of the launch of Salia. 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 Salia's further development entirely from our own balance sheet. This is 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. 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 Salia, but also with C-Port, 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.

Speaker 2

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 galactanide, 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 two-gear approach. This dual mechanism is critical in oncology because past efforts relying on a single mechanism often fall short. That is why we're extremely pleased about the progress we're making with LYT-200. We have received multiple FDA designations, including FastTrack and Orphan Drug designation for AML and FastTrack 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 two 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're seeing responses that suggest LYT-200 may meaningfully enhance current therapies, with patients achieving complete responses, hematological improvement, 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, subplan 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 de-risk 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 and tocilizumab 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 two years, as well as a partial response 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.

Speaker 5

Thank you very much for that, Luba. Gallop Oncology is still wholly owned by PureTech Health 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, we often expect these catalysts to take the form of data and regulatory interactions. As you'll see, the cadence of these milestones across the core program is a direct result of our hub and spoke model, and this is something we're very proud of. Just turning now to the financial highlights, I'm pleased to say at the outset that we have ended the half year with a strong cash position. This is a result of an evergreen business model.

We have not had to raise external capital for many years. We ended the half year with cash, cash equivalents, and short-term investments of just under $320 million. This is 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 equivalents and short-term investments were also just under $320 million at the half year. This is 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 had costs which moved out of the PureTech Health hub into C-Port Therapeutics 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 six months of 2025. The same period last year was at $66.7 million. One can see the reduction there as C-Port Therapeutics 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 spin-outs of Gallop Oncology and Salia Therapeutics. 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 Health 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. I would also personally like to thank the PureTech Health team and board who have been working hard to make sure that we can have a positive impact both for patients and for our shareholders. With that, we'll now open the call for questions.

Speaker 6

Thank you very much. To ask a question, please press star followed by one on your telephone keypad now. If you change your mind, please press star followed by two. When preparing to ask your question, please ensure your device is unmuted locally. Our first question comes from Miles Dixon from Peel Hunt LLP. Your line is open, Miles. Please go ahead.

Speaker 5

Great, thank you. Rob and team, thank you for the presentation. That was really helpful. It's 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 cost in the first half of 2025 was $49 million. I think we've seen half on half for three reporting periods now that's coming down. Can you give me a, I mean, I assume that there's very little in there that's a contribution towards C-Port Therapeutics 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, you know, operating and R&D expenses into Salia Therapeutics and Gallop Oncology? Just a rough guide if you could. Certainly, Miles.

The majority of the R&D spend obviously is attributed to Salia Therapeutics and to Gallop Oncology. As we've indicated, I think obviously the priority at the moment is looking to get those two 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 Health level, the P&L. 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.

Speaker 6

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

Speaker 5

That's absolutely right, Miles. The other element in terms of cash runway, we've got two components really to it that are influenced by the Salia and Gallop funding. 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 also, at the moment, will be making capital contributions, we expect to, into those two financings because those are live financings that we are currently putting together. We're not in a position to say 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.

It will also then enable us to give much greater clarity around where we see our cash pile post those two 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.

Speaker 6

Great, thank you. If I could just ask on Salia Therapeutics, given that it's the newest entity in the portfolio, you've obviously got a pretty busy period coming up: third quarter FDA meeting that you mentioned, fourth quarter trial design, and then the first half of 2026 beginning. Is the trial design something that you 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 timeline for partnering is.

Speaker 5

It's a great question, Miles. 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. For us, we think the fundamental attractiveness and potential of deupirfenidone is there, and we know 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. Obviously, that doesn't stop the active work that is going on at this stage to look at putting that financing package together.

Speaker 6

Great, thank you. Just one more, I'll get back in the queue. I obviously have my own forecast for Cabenfi and what the future economics might mean for PureTech, but I was particularly interested by the—not necessarily the trajectory that you were modeling, but there were 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.

Speaker 5

Certainly, Miles.

Speaker 6

That's a milestone.

Speaker 5

Exactly. It's in the milestones. 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. Also, 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. We thought it'd be helpful to set that out. 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 Royalty Pharma paid nearly $15 billion for Karuna, and 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 are being very significant sales for this drug going forward.

Speaker 6

Thank you. Our next question comes from Faisal Kershid from Leerink Partners LLC. Your line is open, Faisal. Please go ahead.

Speaker 0

Hi, this is Heidi Danielle Jacobson on Professor Kershid. Thanks for taking our questions. What are the key variables you need to discuss with the FDA regarding Phase III trial design for LYT-100? We have a quick follow-up.

Speaker 5

Sure. 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. Sven, would you mind taking that?

Speaker 1

Yes, thank you, Rob. 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. 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. I would say from my experience around Phase III trial designs and what you have in discussions in this particular approach that we took, 505(b)(2), it's all pretty straightforward and very easy to ask the FDA to agree to. Thank you.

Speaker 0

Got it. Thank you. Just to 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?

Speaker 5

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. 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 the potential for a drug there. That work does continue as and when there are assets that we feel are promising enough and that we really feel that, you know, 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 sharing them a little bit more. 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.

Speaker 0

Got it. Thanks so much for taking our questions.

Speaker 6

We now have another question from Miles Dixon from Peel Hunt LLP. Your line is open. Please go ahead.

Speaker 5

Great, thank you. If I could just follow up on a question I should have asked on Salia. Could I just ask if there is any preference for the format of partnering? I mean, is it potentially syndication partnering, royalty, all of the above, still considering them? You just give me if there's anything more you can give me. Sure, Miles. I think that the most sort of honest answer is, you know, we look at where the best cost of capital comes from, and 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. I think if one were to think of that as, you know, perhaps the default, that probably makes a lot of sense.

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. I would think around the standard spinout with equity contributions from external funders as the default, but, as I say, we do think creatively and opportunistically about other structures that we can use as well.

Speaker 6

Great, thank you, Rob. One is to Luba if I could on Gallop. There's obviously some interesting data coming in there from both solid and liquid. I'm 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, are partnering discussions focused mostly on, or interest focused mostly on liquid, or is it split equally liquid to solid? Thank you.

Speaker 5

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

Speaker 2

Absolutely. We are right now focusing on the liquid and AML, so that's where the focus is in our partnering discussions. Certainly, we're open to all discussions with potential partners and having those ongoing at this time.

Speaker 6

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

Speaker 5

Many thanks. I'm 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, initiation of research coverage is independent by analysts. That's an important aspect of the way the model, the system works, such that it ensures the independence of that analyst coverage. We continue to engage with a number of analysts, including those at UBS, and 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.

Speaker 6

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

Speaker 5

Certainly. Very happy to respond to this. You know, our perspective has been there were fundamental reasons why PureTech Health 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-approached businesses such as ourselves. The NASDAQ and U.S. markets, you know, 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 UK holders.

We're also conscious that a number of our UK holders, for various reasons, can only hold UK-listed shares, and therefore, it's important that we have a strong and vibrant London listing. For us, you know, 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 UK shareholders who've done so much to fund this company and ensure its success since our IPO.

Speaker 6

Thank you very much. Our third question is in four 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 what we earn by providing transparency into financing agreements? 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?

Speaker 5

Thanks. Yeah, very interesting questions, and obviously a few bits to that. I'll just sort of try and unpack a few elements there. I think there's a request there to access proposed financing of the individual spokes. The practice at the moment, and this is obviously live ongoing with Salia 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. 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, are conducted as private rounds typically and in a confidential manner. 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 % 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 C-Port, 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 de-risking and portfolio approach here. 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. 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. I guess it depends which way you look at it.

One person might see it as dilution, other people might see it as sort of balancing risk. 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. 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 at 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.

Speaker 6

Thank you, Rob. Can you share with investors the exact capital structure and economic interest in C-Port Therapeutics so that investors and analysts can model potential results?

Speaker 5

Thanks. I think maybe there's a little bit of overlap perhaps here with obviously the question which we just answered in terms of, you know, 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. We are somewhat limited in what we can say. I hope that a little bit of disclosure around the post-money valuation of C-Port 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 C-Port. 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 that it's helpful, the higher percentage, those are really on very significant sales. It really depends how successful C-Port is. We think that there are, as we were 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. We have potential there for very significant royalties if that asset is successful as it moves forward.

Speaker 6

Thank you very much. What key clinical milestones have been funded at C-Port?

Speaker 5

I think, again, similar team, and this is certainly something we want to work on in terms of being as transparent as we can be, but C-Port Therapeutics 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 platform programs before they spun out into C-Port Therapeutics. They've clearly moved them a lot further, but $325 million is a very significant amount of capital. 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.

Speaker 6

Thank you very much. Our sixth question says, can current shareholders have access to funding Gallop Oncology?

Speaker 5

There may be a little bit of overlap with the previous question. You know, the nature of these rounds.

Speaker 6

Apologies. It seems we have lost connection to Robert. Please bear with me while I attempt to reconnect him. Thank you all for your patience. Eric is going to take over for the time being while we establish reconnection with Robert. Eric, please go ahead.

Speaker 4

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 the benefit of the ownership of the founded entities through their ownership in PureTech.

Speaker 6

Thank you. Our next question reads, what is a reasonable timeline for an appointment of a permanent CEO?

Speaker 4

Yes, right now, Robert Lyne is the Interim CEO, and he is continuing as the Interim CEO. The board is aware of the status of the CEO position. For the moment, Robert Lyne is continuing on in that role.

Speaker 6

Thank you very much. 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 happened?

Speaker 4

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

Speaker 6

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.