Half Year 2026 PureTech Health PLC Earnings Call
Speaker #1: Greetings, and welcome to the PureTech Health 2026 Half-Year Results Conference Call. At this time, all participants are in a listen-only mode.
Speaker #1: After the speaker's prepared remarks, there will be a Q&A session. Instructions will follow at that time. As a reminder, this conference is being recorded.
Speaker #1: It is now my pleasure to introduce your host, Alison Mead Talbot, Senior Vice President of Communications. Thank you, Alison. You may begin.
Speaker #2: Thank you. And thank you, everyone, for joining us for the PureTech 2026 Half-Year Results webcast. Our half-year report is available on the Investors page of our website at puretechhealth.com.
Allison Mead Talbot: Thank you. Thank you everyone for joining us for PureTech's 2026 H1 results webcast. Our half-year report 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. 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-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.
Allison Mead Talbot: Thank you. Thank you everyone for joining us for PureTech's 2026 H1 results webcast. Our half-year report 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. 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-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.
Speaker #2: 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. We ask that you refer to our half-year report for a complete discussion of these items.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: A reconciliation of the IFRS 2 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.
Allison Mead Talbot: 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 am joined today by members of our management team. Robert Lyne, Chief Executive Officer, Erich Golinko, co-founder of PureTech and acting Chief Executive Officer of Gallop, and Greg Dugay, Vice President of Research and Innovation. With that, I will turn the call over to Rob.
Allison Mead Talbot: 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 am joined today by members of our management team. Robert Lyne, Chief Executive Officer, Erich Golinko, co-founder of PureTech and acting Chief Executive Officer of Gallop, and Greg Dugay, Vice President of Research and Innovation. With that, I will turn the call over to Rob.
Speaker #2: I'm joined today by members of our management team: Robert Line, Chief Executive Officer; Eric Galinko, co-founder of PureTech, and Acting Chief Executive Officer of Gala.
Speaker #2: And Greg Zugate, Vice President of Research and Innovation. With that, I'll turn the call over to Rob.
Speaker #3: Thank you, Alison. 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.
Robert Lyne: 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 will 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 its phase III. Gallop received Fast Track designation, validating the exciting potential of its treatment for rare blood cancer. We also continue to retain potential future economics from KarXT as part of our model and are advancing our innovation engine.
Robert Lyne: 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 will 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 its phase III. Gallop received Fast Track designation, validating the exciting potential of its treatment for rare blood cancer. We also continue to retain potential future economics from KarXT as part of our model and are advancing our innovation engine.
Speaker #3: 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.
Speaker #3: Across the portfolio, Seaport completed a successful IPO on NASDAQ, raising $260 million. Thalia secured $180 million in external financing and initiated Phase 3. Gallup received fast-track designation.
Speaker #3: Validating the exciting potential of its treatment for rare blood cancers. We also continue to retain potential future economics from Cabenci as part of our model, and are advancing our innovation engine.
Speaker #3: We ended the first half of 2026 with PureTech-level cash, cash equivalents, and short-term investments of $220 million. We continue to expect our operational runway to extend at least through the end of 2028.
Robert Lyne: We entered H1 2026 with PureTech level 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 de-risk 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.
Robert Lyne: We entered H1 2026 with PureTech level 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 de-risk 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.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: We generate and de-risk 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.
Speaker #3: 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.
Robert Lyne: 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 non-dilutive 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.
Robert Lyne: 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 non-dilutive 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.
Speaker #3: 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 recently founded entity, Thalia Therapeutics.
Speaker #3: 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 non-dilutive economics in the form of royalties and milestones, reflecting our role in creating these programs.
Speaker #3: The result is a model designed to generate attractive overall returns while limiting risk concentration. This model has produced three FDA-approved therapeutics, including Cabenci, 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.
Robert Lyne: This model has produced three FDA-approved therapeutics, including KarXT, 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 seven provides a snapshot of our portfolio and the distinct components of value it contains. 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 spin-out. It is a phase III pulmonary company advancing dupilumab, which follows our model of validated pharmacology. Aiming to transform the treatment paradigm for IPF patients by taking FDA-approved tafamidis and dramatically improving its efficacy through deuteration. Following the significant clinical and regulatory work from CJ at PureTech, Celea secured $180 million from leading healthcare investors and immediately initiated the global Phase 3 SURPASS-IPF trial.
Robert Lyne: This model has produced three FDA-approved therapeutics, including KarXT, 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 seven provides a snapshot of our portfolio and the distinct components of value it contains. 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 spin-out. It is a phase III pulmonary company advancing dupilumab, which follows our model of validated pharmacology. Aiming to transform the treatment paradigm for IPF patients by taking FDA-approved tafamidis and dramatically improving its efficacy through deuteration. Following the significant clinical and regulatory work from CJ at PureTech, Celea secured $180 million from leading healthcare investors and immediately initiated the global Phase 3 SURPASS-IPF trial.
Speaker #3: Slide 7 provides a snapshot of our portfolio and the distinct components of value it contains: equity, interest, and our founded entities, as well as royalty and milestone payments.
Speaker #3: And our innovation engine, which is designed to generate future opportunities. Thalia is our most recent spin-out. It is a phase 3 pulmonary company advancing Jupiteridone, which follows our model of validated pharmacology, aiming to transform the treatment paradigm for IPS patients by taking FDA-approved profenidone and dramatically improving its efficacy through deterioration.
Speaker #3: Following the significant clinical and regulatory work completed at PureTech, Thalia secured $180 million from leading healthcare investors and immediately initiated the global Phase 3 SURPASS-OPS trial.
Speaker #3: The financing provided external validation of the program and delivered on our commitment to establish an independently financed cost for its continued development. Today, PureTech holds a 35.4% equity interest and retains meaningful long-term economics through royalties, milestones, and sub-licensed income rights.
Robert Lyne: The financing provided external validation of the program and delivered on our commitment to establish an independently financed path for its continued development. Today, PureTech holds a 35.4% equity interest and retains meaningful long-term economics through royalties, milestones, and sub-license income rights. Gallop Oncology is a Phase 2-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 1 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 2 STRIDE-MDS trial. Seaport Therapeutics is a Phase 2 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'd on NASDAQ in May, raising $260 million in gross proceeds.
Robert Lyne: The financing provided external validation of the program and delivered on our commitment to establish an independently financed path for its continued development. Today, PureTech holds a 35.4% equity interest and retains meaningful long-term economics through royalties, milestones, and sub-license income rights. Gallop Oncology is a Phase 2-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 1 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 2 STRIDE-MDS trial. Seaport Therapeutics is a Phase 2 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'd on NASDAQ in May, raising $260 million in gross proceeds.
Speaker #3: Gallup Oncology is a Phase 2-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 1 meeting with the FDA and secured Fast Track designation in relapsed/refractory high-risk MDS.
Speaker #3: We currently own 100% of Gallup and intend to leverage external capital before initiating the Phase 2 STRIDE MDS trial. Seaport Therapeutics is a Phase 2 CNS company that we launched in 2024, having developed its platform at PureTech.
Speaker #3: Following its oversubscribed private raises in 2024, Seaport Therapeutics, led by PureTech founder Daphne Zohar, successfully IPO'd on NASDAQ in May, raising $260 million in gross proceeds.
Speaker #3: Its 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 milestone interests in this company.
Robert Lyne: Its 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 18 September 2026, and also retain royalty and milestones in this company. The fourth component is our remaining economic interest in KarXT, an FDA-approved treatment for schizophrenia marketed by Bristol Myers Squibb. PureTech invented KarXT 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 KarXT economics, and we retain potential KarXT-related royalty and milestone payments, which is a fundamental and differentiating element of the PureTech model.
Robert Lyne: Its 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 18 September 2026, and also retain royalty and milestones in this company. The fourth component is our remaining economic interest in KarXT, an FDA-approved treatment for schizophrenia marketed by Bristol Myers Squibb. PureTech invented KarXT 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 KarXT economics, and we retain potential KarXT-related royalty and milestone payments, which is a fundamental and differentiating element of the PureTech model.
Speaker #3: The fourth component is our remaining economic interest in Cabenci, an FDA-approved treatment for schizophrenia marketed by Bristol-Myers Squibb. PureTech invented Cabenci using our approach of building on clinically validated pharmacology and housed the program in our founded entity, Karuna Therapeutics.
Speaker #3: Through Karuna's development and subsequent acquisition by Bristol-Myers Squibb, we have generated more than $1 billion from our collective Karuna and Cabenci economics. We also retain potential Cabenci-related royalty and milestone payments, which is a fundamental and differentiating element of the PureTech model.
Speaker #3: Based on analyst consensus, as of mid-August, we estimate approximately $50 million in potential future proceeds to PureTech from our remaining Cabenci economic rights. Because this estimate is based on analyst consensus, rather than our own forecast, it may change as consensus evolves.
Robert Lyne: Based on analyst consensus as of mid-August, we estimate approximately $50 million in potential future proceeds to PureTech from our remaining KarXT 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 de-risking transaction with Royalty Pharma in 2023, which delivered upfront cash of $100 million into PureTech and allowed us to realize significant value before KarXT reached commercial maturity while still retaining participation in future upside. We will continue to provide updates on our full and H2 results on PureTech's economic outlook in KarXT sales based on evolving market consensus dates.
Robert Lyne: Based on analyst consensus as of mid-August, we estimate approximately $50 million in potential future proceeds to PureTech from our remaining KarXT 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 de-risking transaction with Royalty Pharma in 2023, which delivered upfront cash of $100 million into PureTech and allowed us to realize significant value before KarXT reached commercial maturity while still retaining participation in future upside. We will continue to provide updates on our full and H2 results on PureTech's economic outlook in KarXT sales based on evolving market consensus dates.
Speaker #3: While the current estimates represent a material downgrade in potential economics from our last update of the full year, they also reinforce the value of our de-risking transaction with Royalty Pharma in 2023, which delivered upfront cash of $100 million into PureTech and allowed us to realize significant value before Cabenci reached commercial maturity, while still retaining participation in future upside.
Speaker #3: We will continue to provide updates on our full and half-year results, and on PureTech's economic outlook in Cabenci 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 as any monetization events, which represent pure upside.
Robert Lyne: Turning to cash flows, we do not factor any potential inflows from founded entities into our runway assumption, 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 30 June, PureTech level cash equivalents, and short-term investments was $220 million, which continues to provide operational runway at least through the end of 2028. I will discuss financial updates in more detail later on. I would now like to welcome Erich Golinko, PureTech's co-founder and Gallop's acting CEO, to discuss the latest developments of our wholly-owned founded entity, Gallop Oncology.
Robert Lyne: Turning to cash flows, we do not factor any potential inflows from founded entities into our runway assumption, 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 30 June, PureTech level cash equivalents, and short-term investments was $220 million, which continues to provide operational runway at least through the end of 2028. I will discuss financial updates in more detail later on. I would now like to welcome Erich Golinko, PureTech's co-founder and Gallop's acting CEO, to discuss the latest developments of our wholly-owned founded entity, Gallop Oncology.
Speaker #3: In line with our refined strategy, we are increasingly committed to ensuring that shareholders participate more directly as value across our portfolio is realized.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: I will discuss financial updates in more detail later on. I would now like to welcome Eric Lenko, PureTech's co-founder and Gallup's acting CEO, to discuss the latest developments of our wholly-owned founded entity, Gallup Oncology.
Speaker #2: Thank you, Rob. 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.
Erich Golinko: 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 prone to 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.
Eric Elenko: 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 prone to 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.
Speaker #2: Our lead candidate, LYK200, is a Phase 2-ready monoclonal antibody targeting Glutton-9. It is an oncogenic driver and prone to immunosuppression, playing a role in some of the most difficult-to-treat cancers.
Speaker #2: LYK200 has a dual mechanism of action. It is designed to directly kill cancer cells while also restoring anti-tumor 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.
Speaker #2: High-risk MDS is a serious blood cancer associated with poor outcomes, with patients typically surviving less than two years following diagnosis. Frontline treatment typically involves a hypomethylating agent, or HMA.
Speaker #2: However, the vast majority of patients do not respond, or eventually stop benefiting. Once the disease relapses or becomes refractory, survival is often limited to only a few months.
Erich Golinko: 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 a relapse refractory setting are extremely limited. Only one therapy has been approved specifically for relapsed/refractory high-risk MDS in the past two 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. POSITIV phase I-B 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 highlighted the compelling clinical efficacy and consistent safety profile of LYT-200 in high-risk MDS patients who had relapsed or become refractory to prior treatment with an HMA.
Eric Elenko: 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 a relapse refractory setting are extremely limited. Only one therapy has been approved specifically for relapsed/refractory high-risk MDS in the past two 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. POSITIV phase I-B 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 highlighted the compelling clinical efficacy and consistent safety profile of LYT-200 in high-risk MDS patients who had relapsed or become refractory to prior treatment with an HMA.
Speaker #2: Treatment options in the relapse-refractory setting are extremely limited. Only one therapy has been approved specifically for relapse-refractory high-risk MDS in the past two decades, and it targets a mutation found in only approximately 3% of patients.
Speaker #2: There is, therefore, a significant need for new treatment options that can benefit the broader patient population. Positive Phase 1b results established a compelling clinical foundation for LYK200 in relapsed or refractory high-risk MDS.
Speaker #2: We completed a successful end-of-Phase 1 meeting with the FDA, which highlighted the compelling clinical advocacy and consistent safety profile of LYK200 in high-risk MDS patients who had relapsed or become refractory to prior treatment with an HMA.
Speaker #2: The FDA meeting provided clarity on the Phase 2 STRIDE MDS trial, and fast-track designation further strengthens Gallup's position as we seek external capital to support the next stage of development.
Erich Golinko: 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 two to two to one 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 a 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.
Eric Elenko: 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 two to two to one 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 a 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.
Speaker #2: STRIDE MDS will be a randomized, double-blinded, placebo-controlled Phase 2 trial enrolling approximately 125 patients with relapsed or refractory high-risk MDS. Patients will be randomized 2:2:1 to receive LYK200 at a dose of 12 milligrams per kilogram plus an HMA, LYK200 at 7.5 milligrams per kilogram plus an HMA, or a placebo plus an HMA.
Speaker #2: The trial will assess the efficacy of LYK200 based on the rate of complete and partial responses, and support dose selection. The goals of STRIDE MDS are to confirm the efficacy of the LYK200 1b study, and the inclusion of a few doses is intended to fulfill the dose selection requirement in accordance with the FDA's Project Optimus.
Erich Golinko: The goals of STRIDE-MDS are to confirm the efficacy of LYT-200 that was previously observed in the phase I-B study, and the inclusion of two doses is intended to fulfill the dose selection requirement 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 on the role of Gallop's acting CEO, as I will be dedicating significant time and focus to its advancement.
Eric Elenko: The goals of STRIDE-MDS are to confirm the efficacy of LYT-200 that was previously observed in the phase I-B study, and the inclusion of two doses is intended to fulfill the dose selection requirement 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 on the role of Gallop's acting CEO, as I will be dedicating significant time and focus to its advancement.
Speaker #2: The purpose of Project Optimus is to ensure that 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.
Speaker #2: The amount of capital we will be targeting to raise would support Gallup through the readout of the STRIDE MDS trial. As Gallup reaches this important financing and development inflection point, I am pleased to have taken on the role of Gallup's acting CEO, as I will be dedicating significant time and focus to its advancement.
Speaker #2: 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.
Erich Golinko: 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 Dugay, 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.
Eric Elenko: 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 Dugay, 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.
Speaker #2: With that, I'd like to introduce Greg Zugate, 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.
Speaker #2: He has been leading our innovation efforts on a DNDA basis, and I'm pleased to have him walk through our innovation framework today.
Speaker #3: 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.
Greg Dugay: Thank you, Erich. 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 designing 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.
Greg Zugates: Thank you, Erich. 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 designing 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.
Speaker #3: Understanding the limitations that have prevented them from reaching their full potential, and designing differentiated solutions to overcome those limitations. We call this framework our Life Model—launching innovation from existing pharmacology.
Speaker #3: As shown on this slide, our life model begins with a focus on patients by identifying areas with significant unmet medical needs. We then identify mechanisms or molecules with demonstrated clinical efficacy that have otherwise been held back from reaching their full potential due to reasons unrelated to efficacy.
Speaker #3: 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.
Greg Dugay: 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 enables 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 three 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 H1 2027.
Greg Zugates: 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 enables 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 three 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 H1 2027.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: Each year, we aim to advance at least three opportunities to the concept stage, with the goal that these may form the foundation of future development candidates.
Speaker #3: We expect to share additional details on our progress in the first half of 2027. The approach within our Life framework emulates the same innovation principles that produced Karuna Therapeutics, Cobenzi, C4 Therapeutics, and Solia Therapeutics.
Greg Dugay: The approach within our LIFE framework emulates the same innovation principles that produced Karuna Therapeutics and KarXT, Seaport Therapeutics, and Celea Therapeutics. Each began with a significant patient need and clinically validated pharmacology whose potential had 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 de-risk the concept. These programs have generated compelling clinical data, and in the case of KarXT, ultimately led to FDA approval in a new medicine for patients suffering from facilitating mental illness. They provide important validation of the capabilities and approach we are now applying systematically to create PureTech's next wave of opportunities. I am proud of the work we have underway, and I look forward to sharing more about our progress next year. With that, I will hand the call back to Rob.
Greg Zugates: The approach within our LIFE framework emulates the same innovation principles that produced Karuna Therapeutics and KarXT, Seaport Therapeutics, and Celea Therapeutics. Each began with a significant patient need and clinically validated pharmacology whose potential had 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 de-risk the concept. These programs have generated compelling clinical data, and in the case of KarXT, ultimately led to FDA approval in a new medicine for patients suffering from facilitating mental illness. They provide important validation of the capabilities and approach we are now applying systematically to create PureTech's next wave of opportunities. I am proud of the work we have underway, and I look forward to sharing more about our progress next year. With that, I will hand the call back to Rob.
Speaker #3: Each began with a significant patient need and clinically validated pharmacology whose potential had been constrained by a specific limitation. The PureTech team then designed a novel solution to address that limitation.
Speaker #3: Generated proprietary intellectual property and conducted focused, proof-of-concept experimentation to substantially de-risk the concept. These programs have generated compelling clinical data, and, in the case of Cobenzi, ultimately led to FDA approval of a new medicine for patients suffering from debilitating mental illness.
Speaker #3: They provide important validation of the capabilities and approach we are now applying systematically to create PureTech's next wave of opportunities. I'm proud of the work we have underway, and I look forward to sharing more about our progress next year.
Speaker #3: With that, I'll hand the call back to Rob.
Speaker #1: Thanks, Eric and Greg. What they have described represents two important sources of future value for PureTech: advancing Gallup through its next inflection point and applying a focused, capital-efficient approach to generate the next wave of opportunities for patients and shareholders.
Robert Lyne: Thanks, Erich and Greg. The work they have described represents two important sources of future value for PureTech. Advancing Gelesis 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 equivalents, and short-term investments of approximately GBP 220 million, compared to cash equivalents, and short-term investments of GBP 277.1 million at year-end 2025. On a consolidated basis, our cash equivalents, and short-term investments were GBP 220.1 million at the end of June 2026, as compared to cash equivalents, and short-term investments of GBP 277.3 million at year-end 2025.
Robert Lyne: Thanks, Erich and Greg. The work they have described represents two important sources of future value for PureTech. Advancing Gelesis 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 equivalents, and short-term investments of approximately GBP 220 million, compared to cash equivalents, and short-term investments of GBP 277.1 million at year-end 2025. On a consolidated basis, our cash equivalents, and short-term investments were GBP 220.1 million at the end of June 2026, as compared to cash equivalents, and short-term investments of GBP 277.3 million at year-end 2025.
Speaker #1: 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.
Speaker #1: 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.
Speaker #1: From the $220 million cash figure, I note that the balancing $17.5 million of the overall $30 million we contributed to Solia raised was completed just after the half-year. Therefore, the $17.5 million will come out of the $220 million cash figure I've mentioned.
Robert Lyne: From this GBP 220 million cash figure, I know that the balancing GBP 17.5 million of the overall GBP 30 million we contributed to Celea raised was completed just after the H1, and therefore this GBP 17.5 million will come out of the GBP 220 million cash figure I have mentioned. In addition, going forward, we have reserved GBP 70 million for future investment into Celea. While not legally committed, we think it prudent to have this provision to allow strategic optionality to preserve and support our interest in this important company, while reserving 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 GBP 55.9 million in the first six months of 2026, as compared to GBP 49.8 million in the same period in 2025.
Robert Lyne: From this GBP 220 million cash figure, I know that the balancing GBP 17.5 million of the overall GBP 30 million we contributed to Celea raised was completed just after the H1, and therefore this GBP 17.5 million will come out of the GBP 220 million cash figure I have mentioned. In addition, going forward, we have reserved GBP 70 million for future investment into Celea. While not legally committed, we think it prudent to have this provision to allow strategic optionality to preserve and support our interest in this important company, while reserving 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 GBP 55.9 million in the first six months of 2026, as compared to GBP 49.8 million in the same period in 2025.
Speaker #1: In addition, going forward, we have reserved $70 million for future investment into Solia. While not legally committed, we think it prudent to have this provision to allow strategic optionality to preserve and support our interest in this important company, while reserving the flexibility to respond to specific deal terms and other opportunities to allocate capital within the PureTech model.
Speaker #1: On a consolidated basis, operating expenses were $55.9 million in the first six months of 2026, as compared to $49.8 million in the same period in 2025.
Speaker #1: The increase between these two periods reflects higher R&D spend in the first half of 2026, associated with the preparation for Solia's phase 3 trials of Duplication.
Robert Lyne: The increase between these two periods reflects higher R&D spend in the H1 of 2026, associated with the preparation for Celea's phase III trials of dupilumab. Importantly, the majority of OpEx in this H1 is attributable to Celea and Gelesis, heavily skewed towards Celea. As future expenses related to dupilumab 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 30 June 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 GBP 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.
Robert Lyne: The increase between these two periods reflects higher R&D spend in the H1 of 2026, associated with the preparation for Celea's phase III trials of dupilumab. Importantly, the majority of OpEx in this H1 is attributable to Celea and Gelesis, heavily skewed towards Celea. As future expenses related to dupilumab 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 30 June 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 GBP 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.
Speaker #1: Importantly, the majority of opex in this first half is attributable to Solia and Gallup, heavily skewed towards Solia. As future expenses related to Duplication have now shifted to Solia, PureTech expects a significant reduction in overall operating expenses moving forward.
Speaker #1: 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.
Speaker #1: 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 investment in Solia.
Speaker #1: 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.
Speaker #1: Solia has entered Phase 3 with the backing of leading external investors. C4 has completed a successful IPO on the NASDAQ. Gallup has achieved important clinical and regulatory milestones and is positioned for external financing and Phase 2 development.
Robert Lyne: Celea has entered phase III with the backing of leading external investors. Seaport has completed a successful IPO on NASDAQ. Gelesis has achieved important clinical and regulatory milestones and is positioned for external financing and phase II development. 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.
Robert Lyne: Celea has entered phase III with the backing of leading external investors. Seaport has completed a successful IPO on NASDAQ. Gelesis has achieved important clinical and regulatory milestones and is positioned for external financing and phase II development. 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.
Speaker #1: And our innovation team is applying our proven approach to innovation to generate the next wave of opportunities. At the same time, we have substantially reduced the capital required at the PureTech level and are taking an increasingly disciplined approach to how we deploy future proceeds.
Speaker #1: 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.
Speaker #1: With that, I'll turn the call back to the operator, and we would be pleased to take your questions.
Robert Lyne: With that, I will turn the call back to the operator, and we would be pleased to take your questions.
Robert Lyne: With that, I will turn the call back to the operator, and we would be pleased to take your questions.
Speaker #2: Thank you. We will now begin today's Q&A session. To ask a question, please press star followed by 1 on your telephone keypad now. If you change your mind, please press star followed by 2.
Operator: Thank you. We will now begin today's Q&A session. 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 a question, please ensure your device is unmuted locally. Our first question comes from Sean Conroy from Shore Capital. Go ahead, Sean. Your line is now open.
Operator: Thank you. We will now begin today's Q&A session. 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 a question, please ensure your device is unmuted locally. Our first question comes from Sean Conroy from Shore Capital. Go ahead, Sean. Your line is now open.
Speaker #2: When preparing to ask a question, please ensure your device is unmuted locally. Our first question comes from Sean Conroy from Shore Capital. Go ahead, Sean, your line is now open.
Speaker #4: Hi there. Thanks for taking my question—just a couple. I'll start with the planned design of STRIDE MDS. I appreciate there's clearly a benefit to pursuing a mutation-agnostic approach in this setting.
Sean Conroy: Hi there. Thanks for taking my question. Just a couple. I will start on the planned design of STRIDE-MDS. I appreciate there is clearly a benefit to pursuing a mutation-agnostic approach in this setting. Has the FDA or are you planning to look at any specific biomarkers in this study? My second question, just thinking about the next wave of programs that you have guided you will unveil next year. How should we be thinking about that? Obviously, you have said clinically validated targets, but in terms of disease areas and willingness to be. Thanks.
Sean Conroy: Hi there. Thanks for taking my question. Just a couple. I will start on the planned design of STRIDE-MDS. I appreciate there is clearly a benefit to pursuing a mutation-agnostic approach in this setting. Has the FDA or are you planning to look at any specific biomarkers in this study? My second question, just thinking about the next wave of programs that you have guided you will unveil next year. How should we be thinking about that? Obviously, you have said clinically validated targets, but in terms of disease areas and willingness to be. Thanks.
Speaker #4: But has the FDA, or are you planning to look at any specific biomarkers in this study? And then, sort of a second question, just thinking about the next wave of programs that you've guided your alumni on for next year.
Speaker #4: I mean, how should we be thinking about that? Obviously, you've said clinically validated targets, but in terms of disease areas and willingness to be...
Speaker #4: Thanks.
Speaker #1: Thanks, Sean. I'll ask Eric to speak to the STRIDE MDS trial design as acting CEO of Gallup.
Robert Lyne: Thanks, Sean. I will ask Erich just to speak to the STRIDE-MDS trial design as acting CEO of Gelesis.
Robert Lyne: Thanks, Sean. I will ask Erich just to speak to the STRIDE-MDS trial design as acting CEO of Gelesis.
Speaker #3: Hi, Sean. Thanks so much for the question. And you're right that the approach here is a mutation-agnostic one. And that really need is in this space.
Erich Golinko: Hi, Sean. Thanks so much for the question. You are right that the approach here is a mutation-agnostic one, and that really need is in this space. In relapse refractory K-RAS pathway, BCOR, TP53. 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 were representative of what we might see in a subsequent study. 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. As of this time, we do not have plans for biomarker selection.
Eric Elenko: Hi, Sean. Thanks so much for the question. You are right that the approach here is a mutation-agnostic one, and that really need is in this space. In relapse refractory K-RAS pathway, BCOR, TP53. 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 were representative of what we might see in a subsequent study. 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. As of this time, we do not have plans for biomarker selection.
Speaker #3: In the last refractory, KRAS pathway, B-core, PNTP—so what we do feel is, although as you spread out, 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.
Speaker #3: It does mean that the sampling and mutations were representative of what we might see in a subsequent study, and so that made us feel quite good about the approach.
Speaker #3: 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.
Speaker #1: Perfect. Thanks for that. Keith, 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.
Greg Dugay: Perfect. Thanks, Rob.
Sean Conroy: Perfect. Thanks, Rob.
Robert Lyne: Thanks. Sean, just on your other question, I believe, around in terms of our areas of focus for future innovation. I will ask Greg to speak in a moment, very high level. They are generally agnostic, but we do have a little bit of a bias, particularly in areas where we have had success before. I will just ask Greg to say a few words to that.
Robert Lyne: Thanks. Sean, just on your other question, I believe, around in terms of our areas of focus for future innovation. I will ask Greg to speak in a moment, very high level. They are generally agnostic, but we do have a little bit of a bias, particularly in areas where we have had success before. I will just ask Greg to say a few words to that.
Speaker #1: Very high. I'd say we 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 on that.
Speaker #3: Yeah, thanks for the question, Sean. So far this year, we have identified multiple opportunities that potentially fit our model. These include opportunities based on validated pharmacology that you've noted, and they can form the basis for developmental candidates in the future.
Greg Dugay: Yeah. Thanks for the question, Sean. So far this year, we have multiple opportunities we have identified that potentially fit our model, and includes opportunities based on validated pharmacology, as you have noted. 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. Also CNS is a therapeutic area for identifying additional indications. Specifically within CNS, we had success with KarXT and Seaport in looking at opportunities in neuropsychiatry, and that is an area we are continuing to explore. That said, as we discussed, we do remain somewhat agnostic to indication to an extent because we believe our model is broadly applicable and could bring impactful therapies to patients suffering from disorders outside of CNS and still have blockbuster potential.
Greg Zugates: Yeah. Thanks for the question, Sean. So far this year, we have multiple opportunities we have identified that potentially fit our model, and includes opportunities based on validated pharmacology, as you have noted. 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. Also CNS is a therapeutic area for identifying additional indications. Specifically within CNS, we had success with KarXT and Seaport in looking at opportunities in neuropsychiatry, and that is an area we are continuing to explore. That said, as we discussed, we do remain somewhat agnostic to indication to an extent because we believe our model is broadly applicable and could bring impactful therapies to patients suffering from disorders outside of CNS and still have blockbuster potential.
Speaker #3: These opportunities, as Rob mentioned, continue to expand in areas that have been historically successful for PureTech. That includes a continued focus on small molecule-based therapeutics, and also CNS as a therapeutic area for identifying additional indications.
Speaker #3: Specifically, within CNS, we had success with Cobenzi and Cport in looking at opportunities in neuropsychiatry, and that's an area we're continuing to explore. That said, as we discussed, we do remain somewhat agnostic to indication.
Speaker #3: To an extent, because we believe our model is broadly applicable and could bring impactful therapies to patients suffering from disorders outside of CNS and still have blockbuster potential.
Speaker #3: So we're happy to provide more details in 2027.
Greg Dugay: We are happy to provide more details in 2027.
Greg Zugates: We are happy to provide more details in 2027.
Speaker #1: Great, perfect. Thanks for that. I'll jump back in the queue.
Robert Lyne: Great. Perfect. Thanks for that. I will jump back to the queue.
Sean Conroy: Great. Perfect. Thanks for that. I will jump back to the queue.
Speaker #2: Thank you. Our next question comes from Miles Dixon from PureHunt. Miles, your line is open. Please go ahead.
Operator: Thank you. Our next question comes from Miles Dixon from Peel Hunt. Myles, your line is open. Please go ahead.
Operator: Thank you. Our next question comes from Miles Dixon from Peel Hunt. Myles, your line is open. Please go ahead.
Speaker #5: Thank you. Good morning. Hopefully, you can hear me. If I could just follow up on the STRIDE and MDS trial for Miles. I appreciate you're not guiding for a kind of cost window for that, but can you just help me understand what the timeline for that trial might look like?
Miles Dixon: Thank you. Good morning. Hopefully you can hear me. If I could just follow up on the STRIDE-MDS trial for a moment. I appreciate you are not guiding for a cost window for that, but can you just help me understand what the timeline for that trial might look like? Is it similar in format, at least, or for the time for TIBSOVO? Secondly, Rob, if I can ask a broader question perhaps on Celea first. Obviously since that is now spun out you guys have a smaller control holding of that. 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? Make sense.
Miles Dixon: Thank you. Good morning. Hopefully you can hear me. If I could just follow up on the STRIDE-MDS trial for a moment. I appreciate you are not guiding for a cost window for that, but can you just help me understand what the timeline for that trial might look like? Is it similar in format, at least, or for the time for TIBSOVO? Secondly, Rob, if I can ask a broader question perhaps on Celea first. Obviously since that is now spun out you guys have a smaller control holding of that. 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? Make sense.
Speaker #5: Is it similar in format, at least, or in terms of timing for tifzogo? And then secondly, Rob, if I can ask a broader question—perhaps on Salea first.
Speaker #5: I mean, obviously, since that's now spun out, you guys have a smaller controlling holding of that. Now, Cport obviously has phenomenally successfully built out its programs and platform offering.
Speaker #5: Is there any plan at Salea to do a similar thing, or is it a pure-play idea for something like that? Any thanks.
Speaker #1: Thanks, Miles. I'll speak to the Salea question first, and then hand over to Eric on Gallup. So, yeah, as you say, obviously, Cport has really done great things in terms of building out their pipeline of programs.
Robert Lyne: Thanks, Myles. I will speak to the Celea question first and then hand over to Erich on Gallop. As you say, obviously Seaport has really done great things in terms of building out their pipeline of programs. At the moment, Celea has obviously 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. To some extent, they have a different stage of development there at that business than they are, now have line of sight through to a readout, which we hope obviously will be registrational. To date, there has not 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.
Robert Lyne: Thanks, Myles. I will speak to the Celea question first and then hand over to Erich on Gallop. As you say, obviously Seaport has really done great things in terms of building out their pipeline of programs. At the moment, Celea has obviously 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. To some extent, they have a different stage of development there at that business than they are, now have line of sight through to a readout, which we hope obviously will be registrational. To date, there has not 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.
Speaker #1: At the moment, Salea has probably stated it has its single asset — the IPS asset, which is obviously now in phase three. I would note, of course, that it is now a pivotal registrational trial.
Speaker #1: So, to some extent, they have a different stage of development there at that business, and they now have line of sight through to the readout, which we hope, obviously, will be registrational.
Speaker #1: To date, there haven't been any disclosures from Salea about additional assets that they may or may not bring in or develop. But obviously, that is something the company will consider as it matures.
Speaker #1: 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 Three.
Robert Lyne: We have previously guided that we are 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 is something they wish to do, Celea will make announcements of that in the future. In terms of the Gallop program, I will just hand over to Erich just to talk on that piece.
Robert Lyne: We have previously guided that we are 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 is something they wish to do, Celea will make announcements of that in the future. In terms of the Gallop program, I will just hand over to Erich just to talk on that piece.
Speaker #1: That may bring opportunities for them to consider other programs that they may wish to advance. But even when that's something they wish to do, Salea will make announcements of that in the future.
Speaker #1: In terms of the Gallup program, I'll just hand over to Eric to talk about that piece.
Speaker #3: Thanks so much, Miles, for the question. So the Gallup 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 just want to get that caveat is this would be probably somewhat under three years to complete the study is currently contemplated.
Erich Golinko: Thanks so much, Myles, for the question. The Gallop trial will commence following receipt of external capital. Just also to make that part of any timing clear. The initial projections, which are on the more conservative side, so just want to get that caveat is this would be probably somewhat under 3 years to complete the study as currently contemplated. Again, those are using somewhat more conservative projections in terms of recruitment rates. Now, of course, what is going to happen is the actual timeline is at 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 a go forward, we like to think about things on the more conservative side.
Eric Elenko: Thanks so much, Myles, for the question. The Gallop trial will commence following receipt of external capital. Just also to make that part of any timing clear. The initial projections, which are on the more conservative side, so just want to get that caveat is this would be probably somewhat under 3 years to complete the study as currently contemplated. Again, those are using somewhat more conservative projections in terms of recruitment rates. Now, of course, what is going to happen is the actual timeline is at 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 a go forward, we like to think about things on the more conservative side.
Speaker #3: And again, those are using somewhat more conservative projections in terms of recruitment rates now. Of course, what's going to happen is the actual timeline is at more around 30 months or 33 months.
Speaker #3: It will also ultimately depend on the number of sites that are selected, as well as the recruiting rates that are observed in those sites.
Speaker #3: But as we think about it going forward, we like to think about things on the more conservative side.
Speaker #5: Great, thank you. Perhaps I can just follow up on Gallup specifically. You've had a variety of formats, but how are you thinking about financing?
Miles Dixon: Great. Thank you. Perhaps I can just follow up on Gallop specifically. You have had a variety of formats, but how are you thinking about financing? Is that more partnership or syndication, strategic partnerships with pharma? Then lastly, Rob, if I can on capital allocation. Obviously you have got a phenomenal amount of, let us call it resources that dwarf the market cap. How are you thinking about capital allocation moving forward? Thank you.
Miles Dixon: Great. Thank you. Perhaps I can just follow up on Gallop specifically. You have had a variety of formats, but how are you thinking about financing? Is that more partnership or syndication, strategic partnerships with pharma? Then lastly, Rob, if I can on capital allocation. Obviously you have got a phenomenal amount of, let us call it resources that dwarf the market cap. How are you thinking about capital allocation moving forward? Thank you.
Speaker #5: 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.
Speaker #5: How are you thinking about capital allocation moving forward? Thank you.
Speaker #1: Yeah, so on that point, Miles, yes, we're looking at a range of options. For Gallup, at this stage, we believe both the indication and the data we have are exciting enough that it opens up different possibilities.
Robert Lyne: Yeah. On that point, Myles, yes, we are looking at a range of options for Gallop at this stage. We believe both the indication of the data we have are exciting enough that it opens up different possibilities. What we are looking at really, and this maybe links in a little into your question on capital allocation. The way we do really think about it is it is all about the relative cost of capital. Different funding structures, whether it is equity, whether it is pharma partnership, whatever it may be, they all come with different costs to them, whether it is equity dilution, whether it is 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.
Robert Lyne: Yeah. On that point, Myles, yes, we are looking at a range of options for Gallop at this stage. We believe both the indication of the data we have are exciting enough that it opens up different possibilities. What we are looking at really, and this maybe links in a little into your question on capital allocation. The way we do really think about it is it is all about the relative cost of capital. Different funding structures, whether it is equity, whether it is pharma partnership, whatever it may be, they all come with different costs to them, whether it is equity dilution, whether it is 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.
Speaker #1: So what we're looking at really in this, maybe links even a little bit into your question on capital allocation. The way we really think about it is, it's all about the relative cost of capital.
Speaker #1: So, different funding structures—whether it's equity, whether it's pharma partnership, or whatever it may be—all come with different costs. Whether it's equity dilution, capping upside, or some coming with upfront cash, each has its own implications.
Speaker #1: 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.
Speaker #1: 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.
Robert Lyne: And obviously, as and when we complete any arrangements there, we will make that known. We have guided that we really want to complete that financing by H1 of next year. Part of the reason for that timing is to give us the opportunity to really take a whole of market approach to looking at the optimal funding sources that we can leverage there without being forced to rush into any particular avenues. 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.
Robert Lyne: And obviously, as and when we complete any arrangements there, we will make that known. We have guided that we really want to complete that financing by H1 of next year. Part of the reason for that timing is to give us the opportunity to really take a whole of market approach to looking at the optimal funding sources that we can leverage there without being forced to rush into any particular avenues. 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.
Speaker #1: And part of the reason for that timing is to give us the opportunity to really take hold of a market approach, looking at the optimal funding sources that we can leverage there, without being forced to rush into any particular avenues.
Speaker #1: 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.
Speaker #1: As I think we indicated in some of the remarks this morning, our focus really is to make sure that we have operational runway within the business.
Speaker #1: We don't want to be holding too much cash, notwithstanding raises in rates at the moment. Obviously, we are not generating great returns in terms of the cash pile.
Robert Lyne: We do not want to be holding too much cash, notwithstanding raises in rates at the moment. Obviously, we are not generating great returns in terms of cash pile. That is not 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 provide capital, and these can range really from very late-stage opportunities.
Robert Lyne: We do not want to be holding too much cash, notwithstanding raises in rates at the moment. Obviously, we are not generating great returns in terms of cash pile. That is not 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 provide capital, and these can range really from very late-stage opportunities.
Speaker #1: 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.
Speaker #1: 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.
Speaker #1: When we then think within the portfolio, one of the advantages of our model is that we have different opportunities to put away capital. And these can range really from very late-stage opportunities—for example, we've reserved $70 million for future Salea financing, which will be used if needed to help that company get through to a pivotal prior readout.
Robert Lyne: For example, we have reserved $70 million for future Celea financing, which will be, if needed, to help that company get through to a pivotal file 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. When we are thinking about how we allocate capital within that, we are looking at what kind of a return we can make, 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. The other component that we have talked about this morning, of course, is considering capital returns to shareholders. We are very conscious that there is substantial value within PureTech.
Robert Lyne: For example, we have reserved $70 million for future Celea financing, which will be, if needed, to help that company get through to a pivotal file 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. When we are thinking about how we allocate capital within that, we are looking at what kind of a return we can make, 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. The other component that we have talked about this morning, of course, is considering capital returns to shareholders. We are very conscious that there is substantial value within PureTech.
Speaker #1: All the way at the other end of the spectrum, compared 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 return we can make, what sort of money multiple we will get, recognizing that, obviously, there are different time horizons for returns that may come from those investments.
Speaker #1: And then, the other component that we have talked about this morning, of course, is considering capital returns to shareholders. We are very conscious that there is substantial value within PureTech.
Speaker #1: 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 and value that we generate within PureTech.
Robert Lyne: 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 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 are 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.
Robert Lyne: 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 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 are 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.
Speaker #1: 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.
Speaker #5: Great. Sounds good, Rob. And yeah, Greg, I look forward to the first half of next year, hearing about some of those new programs. Thank you.
Miles Dixon: Great. Sounds good, Rob. Greg, look forward to the H1 next year hearing about some of those new programs. Thank you.
Miles Dixon: Great. Sounds good, Rob. Greg, look forward to the H1 next year hearing about some of those new programs. Thank you.
Speaker #3: Thank you.
Robert Lyne: Thank you.
Greg Zugates: Thank you.
Speaker #2: Thank you. The next question comes from Kristen Glennie from Stifel. Your line is now open. Please go ahead.
Operator: Thank you. The next question comes from Christian Glennie from Stifel. Your line is now open. Please go ahead.
Operator: Thank you. The next question comes from Christian Glennie from Stifel. Your line is now open. Please go ahead.
Speaker #5: Hi, morning, guys. Thanks for taking the question. Just a follow-up on Gallup and the STRIDE trial. I just wanted to set the case, I guess.
Christian Glennie: Hi. Morning, guys. Thanks for taking the question. I guess just to follow up, another one on Gallop and STRIDE trial, I guess just set the case. Is this largely a best-case sort of trial design as you could have imagined it sort of running in on those discussions you 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. Then in terms of the trial itself, obviously the objective here, dose selection, secondary on response. 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.
Christian Glennie: Hi. Morning, guys. Thanks for taking the question. I guess just to follow up, another one on Gallop and STRIDE trial, I guess just set the case. Is this largely a best-case sort of trial design as you could have imagined it sort of running in on those discussions you 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. Then in terms of the trial itself, obviously the objective here, dose selection, secondary on response. 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.
Speaker #5: Is this largely a best-case sort of trial design as you could have imagined it, sort of running in on those discussions you 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.
Speaker #5: And then, in terms of the trial itself, obviously, the objective here is dose selection, secondary on response. But given the unmet need, if you do get a very strong response, is it potentially a pivotal trial?
Speaker #5: Or is that probably a bit of a stretch too far at this point? Thanks.
Robert Lyne: Thanks, Christian. I will ask Erich just to speak to those points.
Robert Lyne: Thanks, Christian. I will ask Erich just to speak to those points.
Speaker #1: There you go. Thanks, Christian. I'll ask Eric to speak to those points.
Speaker #3: Thanks so much, Christian, for the question. Yeah, we were happy with the results of the FDA meeting, which provided a very clear direction forward.
Erich Golinko: Thanks so much, Christian, for the question. We were happy with the results of the FDA meeting, which provided a very clear direction forward. The goals of the trial really are twofold. One is to confirm the efficacy that was observed in the phase I-B study, and the other is to satisfy the FDA's Project Optimus requirements, in terms of dose, as you indicated. That is 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. We feel the FDA meeting was a very important step in terms of getting clarity, and we are happy with the trial design. Of course, we are 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.
Eric Elenko: Thanks so much, Christian, for the question. We were happy with the results of the FDA meeting, which provided a very clear direction forward. The goals of the trial really are twofold. One is to confirm the efficacy that was observed in the phase I-B study, and the other is to satisfy the FDA's Project Optimus requirements, in terms of dose, as you indicated. That is 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. We feel the FDA meeting was a very important step in terms of getting clarity, and we are happy with the trial design. Of course, we are 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.
Speaker #3: And the goals of the trial really are twofold. One is to confirm the efficacy that was observed in the Phase 1b study, and the other is to satisfy the FDA's Project Optimist requirements in terms of dose, as you indicated.
Speaker #3: That's one of the key goals. Project Optimist is really the idea that, instead of driving toward the maximum tolerated dose, one is driving toward a biologically meaningful and active dose.
Speaker #3: 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.
Speaker #3: And of course, we're also very happy with the Fast Track designation, which the FDA granted, which validates the view that LYQ200, in fact, is an active drug.
Speaker #3: And so, in terms of the implications of this trial, what differs from the Phase 1b versus the Phase 2 STRIDE MPF study is not only the greater number of subjects, but also the fact that it's a double-blind, randomized study.
Erich Golinko: In terms of the implications of this trial, what differs from the phase I-B versus the phase II STRIDE-MDS study is not only the greater number of subjects, but also the fact that it is a double-blind randomized study. 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. What would be the implications of that?
Eric Elenko: In terms of the implications of this trial, what differs from the phase I-B versus the phase II STRIDE-MDS study is not only the greater number of subjects, but also the fact that it is a double-blind randomized study. 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. What would be the implications of that?
Speaker #3: And so the idea is to not only confirm what we saw before, but to do it in the context where there will be this very clear discernment of the contribution of the effect of LYQ200 in the context of combination with HMA.
Speaker #3: 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 LYQ200 coming out of STRIDE MDS—particularly if it had a similar safety profile to what was observed in the Phase 1b, which was excellent—we think that will put Gallup in a very good position in terms of optionality. That optionality is both, we think, commercial and financial, which I think is what you're getting at.
Erich Golinko: We think that if, in fact, we are 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 I-B, 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 are getting at. 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. Just to be very explicit about the third part of your question, we are not guiding that this is a pivotal study. Having said that, the data that would come out of this, we would view as extremely useful.
Eric Elenko: We think that if, in fact, we are 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 I-B, 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 are getting at. 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. Just to be very explicit about the third part of your question, we are not guiding that this is a pivotal study. Having said that, the data that would come out of this, we would view as extremely useful.
Speaker #3: 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.
Speaker #3: And just to be very explicit about the third-party aspect of the question, we are not guiding that this is a pivotal study. However, having said that, the data that would come out of this, we would view as extremely useful.
Speaker #5: Thanks, 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 three concept-stage programs.
Christian Glennie: Thanks. That's helpful. If I can on the overall sort of development strategy, just a bit more in terms of how many. You talked about the three concept stage programs. Sounds like you are going to be announcing maybe one new specific development candidate in early next year, H1 of next year. Typically, how many of these things are sort of running in parallel? At any one time, you have the bandwidth to run in parallel. What's in the mix in terms of decision points about identifying that candidate? Thanks.
Christian Glennie: Thanks. That's helpful. If I can on the overall sort of development strategy, just a bit more in terms of how many. You talked about the three concept stage programs. Sounds like you are going to be announcing maybe one new specific development candidate in early next year, H1 of next year. Typically, how many of these things are sort of running in parallel? At any one time, you have the bandwidth to run in parallel. What's in the mix in terms of decision points about identifying that candidate? Thanks.
Speaker #5: 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?
Speaker #5: 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?
Speaker #5: Thanks.
Speaker #3: Yeah, thanks, Christian. So, look, I'll hand over in a minute to Greg to talk about some of the factors we take into account when we're considering how to advance those programs.
Robert Lyne: Yeah. Thanks, Christian. Look, I will hand over in a minute to Greg to talk about some of the factors we take into account when we are considering how to advance those programs. Overall, as you say, we guided that we want at least three concept stage programs per year. We are currently running ahead of that, I am pleased to say. We have been pleasantly surprised by both the quantity, but also quality of the opportunities we have there. As you said, Christian, we are not planning to talk about any of those in detail until next year.
Robert Lyne: Yeah. Thanks, Christian. Look, I will hand over in a minute to Greg to talk about some of the factors we take into account when we are considering how to advance those programs. Overall, as you say, we guided that we want at least three concept stage programs per year. We are currently running ahead of that, I am pleased to say. We have been pleasantly surprised by both the quantity, but also quality of the opportunities we have there. As you said, Christian, we are not planning to talk about any of those in detail until next year.
Speaker #3: But overall, as you say, we’re guided that we want at least three concept stage programs per year. We’re currently running ahead of that, I’m pleased to say.
Speaker #3: 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.
Speaker #3: 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 will see a lot of similarities with the success that we've had with Karunika, Bemphi, and more recently with Seaport and Saleer.
Robert Lyne: 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 will see a lot of similarities with the success that we have had with Karuna, KarXT, and more recently with Seaport and Celea. I will just hand over to Greg to talk a little bit just about some of the factors we take into account when we are considering whether to advance or deprioritize these programs internally.
Robert Lyne: 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 will see a lot of similarities with the success that we have had with Karuna, KarXT, and more recently with Seaport and Celea. I will just hand over to Greg to talk a little bit just about some of the factors we take into account when we are considering whether to advance or deprioritize these programs internally.
Speaker #3: But I'll just hand over to Greg to talk a little bit about some of the factors we take into account when we're considering whether to advance or deprioritize these programs internally.
Speaker #2: Yeah, thank you for the question. We go through a very rigorous process; we kind of outlined it here, and I would say in broad strokes, to give you a sense for how we approach these opportunities.
Greg Dugay: Yeah. Thank you for the question. We go through a very rigorous process. We kind of outlined it here in, I would say, broad strokes to give you a sense for how we approach these opportunities. 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. 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 is behind it. As we advance programs through the preclinical stage, we have a set of predefined criteria for our preclinical experiments that we will look for.
Greg Zugates: Yeah. Thank you for the question. We go through a very rigorous process. We kind of outlined it here in, I would say, broad strokes to give you a sense for how we approach these opportunities. 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. 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 is behind it. As we advance programs through the preclinical stage, we have a set of predefined criteria for our preclinical experiments that we will look for.
Speaker #2: But it starts with an analysis of the unmet clinical needs. We progress through and look for molecules and mechanisms that have validation, and we look for their limitations.
Speaker #2: 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.
Speaker #2: As we advance programs through the preclinical stage, we have a set of predefined criteria for our preclinical experiments that we'll look for. And so, yeah, 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.
Greg Dugay: And so, yeah, we advance them through, I would say, key proof of concept experiments that are really designed to see if we could address the underlying limitation. Once we do that can then form the basis for a developmental candidate that we advance forward.
Greg Zugates: And so, yeah, we advance them through, I would say, key proof of concept experiments that are really designed to see if we could address the underlying limitation. Once we do that can then form the basis for a developmental candidate that we advance forward.
Speaker #2: And once we do that, that can then form the basis for a developmental candidate that we would advance forward.
Speaker #5: Great. That's helpful. Thank you.
Christian Glennie: Great. That's helpful. Thank you.
Christian Glennie: Great. That's helpful. Thank you.
Speaker #1: Thank you. Our next question comes from Carl Kagan. As you flagged, shifting LYT100 costs to Salea should contribute significantly to lower OPEX going forward. Can you quantify that, even directionally?
Karl Keegan: Thank you. Our next question comes from Karl Keegan. You reflect that shifting LYT-100 cost to Celea should contribute significantly. So lower OpEx going forward, can you quantify that, even directional?
Operator: Thank you. Our next question comes from Karl Keegan. You reflect that shifting LYT-100 cost to Celea should contribute significantly. So lower OpEx going forward, can you quantify that, even directional?
Robert Lyne: Sure, absolutely. 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. 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 H1, 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.
Robert Lyne: Sure, absolutely. 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. 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 H1, 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.
Speaker #3: Sure, absolutely. So yes, that's quite right. One of the key drivers for spinning out Salea is, obviously, these late-stage clinical programs require very significant operational capital spend to continue advancing them.
Speaker #3: 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.
Speaker #3: In terms of go-forward cash burn, we're currently looking, on a clean basis, at cash burn that includes overhead, but also, crucially, our innovation spend.
Speaker #3: And somewhere between $30 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.
Speaker #1: Thank you. We have a follow-up question from Carl, which is: you've targeted at least three concept-stage programs progressed per year. How many are currently in that pipeline today?
Karl Keegan: Thank you. We have a follow-up question from Carl, which is, you've targeted at least three concept stage programs progressed per year. How many are currently in that pipeline today? What would you need to be true for one to be named as a new founded entity candidate?
Operator: Thank you. We have a follow-up question from Carl, which is, you've targeted at least three concept stage programs progressed per year. How many are currently in that pipeline today? What would you need to be true for one to be named as a new founded entity candidate?
Speaker #1: And what would need to be true for someone to be named as a newly founded entity candidate?
Robert Lyne: A very good question, but I think we've probably addressed that earlier to saying that, as Greg outlined, there's a really rigorous process that we go through. 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.
Robert Lyne: A very good question, but I think we've probably addressed that earlier to saying that, as Greg outlined, there's a really rigorous process that we go through. 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.
Speaker #3: Very good question, but I think we've probably addressed that earlier by saying that, as Greg outlined, there's a really rigorous process that we go through.
Speaker #3: And again, that's informed not just by the innovation team and the work they're doing, but also by the broader corporate knowledge and history we have at PureTech.
Speaker #3: 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.
Speaker #3: And really, for us, that benefit of having that institutional knowledge of what it means to take a program all the way through ideation 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.
Robert Lyne: Really for us, that benefit of having that institutional knowledge of what it means to take a program all the way through 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 green light them, how far to take them forward, and what the best way is of advancing this program.
Robert Lyne: Really for us, that benefit of having that institutional knowledge of what it means to take a program all the way through 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 green light them, how far to take them forward, and what the best way is of advancing this program.
Speaker #1: Thank you. We have a next question from Julie Simmons from Pameo Librium. Your line is open, Julie. Please go ahead.
Operator: Thank you. We have a next question from Julie Simmons from Panmure Liberum. Your line is open, Julie. Please go ahead.
Operator: Thank you. We have a next question from Julie Simmons from Panmure Liberum. Your line is open, Julie. Please go ahead.
Speaker #4: Thank you very much. Just more on the innovation pipeline. I was just wondering, when you’re going to tell us about these programs, at what stage are they going to be?
Julie Simmons: Thank you very much. Just more on the innovation pipeline. Just wondering, when you are going to tell us about these programs, at what stage are they going to be? Is that where you have still got more preclinical work to do, or is it going to be so they are actually going into the clinic in your format the first time?
Julie Simmonds: Thank you very much. Just more on the innovation pipeline. Just wondering, when you are going to tell us about these programs, at what stage are they going to be? Is that where you have still got more preclinical work to do, or is it going to be so they are actually going into the clinic in your format the first time?
Speaker #4: 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 format for the first time?
Speaker #3: 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 de-risking experiments.
Robert Lyne: It is a good question, Julie. I think really where they will get to, there may still be a degree of preclinical work that is being done. I think the key thing is, as Greg was outlining earlier, that we will have done some of the really key de-risking experiments. The great advantage of our LIFE model is that we know what problem we are trying to fix, and we feel that even the preclinical studies that we do can be very meaningful in indicating whether or not we have really fixed that problem. A big advantage as we move into the clinic, of course, is that the phase I studies then are significantly de-risking even in healthy volunteers. There is every chance that that study in itself would be very indicative as to whether we have really overcome the limitation that we were seeking to fix.
Robert Lyne: It is a good question, Julie. I think really where they will get to, there may still be a degree of preclinical work that is being done. I think the key thing is, as Greg was outlining earlier, that we will have done some of the really key de-risking experiments. The great advantage of our LIFE model is that we know what problem we are trying to fix, and we feel that even the preclinical studies that we do can be very meaningful in indicating whether or not we have really fixed that problem. A big advantage as we move into the clinic, of course, is that the phase I studies then are significantly de-risking even in healthy volunteers. There is every chance that that study in itself would be very indicative as to whether we have really overcome the limitation that we were seeking to fix.
Speaker #3: 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.
Speaker #3: A big advantage of moving into the clinic, of course, is that the phase one studies are significantly de-risked—even in healthy volunteers—as every chance exists that the study itself will be very indicative as to whether we've really overcome the limitation that we were seeking to fix.
Speaker #3: So there may still be a bit of preclinical work to be done at the time we're talking around these programs, but we would only really be pulling the covers off at a stage where we have a high degree of confidence that there's a strong chance of success going forward with them.
Robert Lyne: There may still be a bit of preclinical work to be done at the time we are talking around these programs, but we would only be really pulling the covers off at a stage where we have a high degree of confidence that there is really a strong chance of success going forward with them.
Robert Lyne: There may still be a bit of preclinical work to be done at the time we are talking around these programs, but we would only be really pulling the covers off at a stage where we have a high degree of confidence that there is really a strong chance of success going forward with them.
Speaker #4: Lovely. Thank you.
Julie Simmons: Lovely. Thank you.
Julie Simmonds: Lovely. Thank you.
Operator: Thank you. That's all we have time for today. Thank you all for joining, and you may now disconnect your lines.
Operator: Thank you. That's all we have time for today. Thank you all for joining, and you may now disconnect your lines.
