PureTech Health - Earnings Call - H2 2024

Transcript

Operator (participant)

Welcome to the PureTech Health 2024 Year End Financial Results Conference call. At this time all participants are in listen only mode. Later we will conduct a question and answer session and introductions will follow at that time. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Allison Mead Talbot, Senior Vice President of Communications. Thank you, Allison. You may begin.

Allison Mead Talbot (Senior VP of Communications)

Thank you for joining us today for PureTech's 2024 financial results webcast. Our annual report will be made available later today, portions of which are also filed with our Form 20-F. This information is available on the Investors page of our website at PureTech.com. PureTech is guided by a seasoned leadership team with a strong track record of translating scientific innovation into impactful medicines and long term shareholder value. Today I'm pleased to be joined by members of the senior team including Bharatt Chowrira, Chief Executive Officer, Eric Elenko, Co-founder and President, Chip Sherwood, General Counsel, and Michael Inbar, Chief Accounting Officer. I would like to remind you that during today's call we will be making certain forward looking statements.

These statements are subject to various risks, uncertainties and assumptions that could cause our actual results to differ materially and we ask that you refer to our annual report and our SEC filings for a complete discussion of these items. We undertake no obligation to revise or update any forward looking statements or information except as required by law. I also want to remind you that we will be referring to certain non IFRS measures in this presentation. The presentation of this non IFRS financial information is not intended to be considered in isolation or as a substitute for financial information presented in accordance with IFRS. A reconciliation of the IFRS to non IFRS measures that we will be referring to today can be found in this presentation and is also available on our investor relations website at investors.puretechhealth.com and in our SEC filings.

I will now turn the call over to Bharatt Chowrira, PureTech's Chief Executive Officer.

Bharatt Chowrira (CEO)

Thank you, Allison. Welcome, everyone, and thank you for joining us today. 2024 was a defining year for PureTech, a year in which we delivered meaningful progress across our portfolio and achieved important value-driving milestones. Underpinning our success is our R&D engine, which is translating scientific innovation into real-world impact for patients. In 2024 and 2025 post period, we announced unprecedented results from our successful IIb trial of deupirfenidone, our wholly owned program for idiopathic pulmonary fibrosis, or IPF. The open-label extension portion of the Phase 2b study is ongoing, and based on preliminary analysis, we continue to see strong, durable data. Our oncology program LYT-200 delivered strong clinical data from a Phase 1b trial in AML as well as positive results from the recently completed Phase 1b trial in solid tumors. Our co-founder and president, Dr.

Eric Elenko will walk us through both of these programs today. Finally, a standout achievement in 2024 was the FDA approval of Cobenfy, which was invented at PureTech for the treatment of schizophrenia in adults, marking a long overdue advance for patients and a major validation of the scientific foundation we established at PureTech. We supported these achievements with strong financial execution. As of March 31 we had approximately $339.1 million. At the PureTech level, our efficient and proven hub and spoke R&D model allows us to advance a broad portfolio without incurring dilution at the PureTech level. In 2024 alone our founded entities raised $397.5 million with over 88% coming from third party investors.

We also generated $327.4 million in proceeds from founded entity monetization events including via our equity holdings and milestone payments which enabled us to return $100 million to shareholders via a tender offer, all the while continuing to advance our wholly owned programs in parallel. Coming off of this strong momentum, we are at a key strategic inflection point. Today we will share our strategic priorities for 2025, highlight our clinical momentum and discuss how we are positioned to reshape treatment paradigms and deliver long term value for the shareholders. Let us start with the foundation of our business. Our core mission is to give life to new classes of medicine that can transform lives of patients with devastating diseases.

We are delivering on this mission through our innovative hub and spoke R&D model that is the engine behind our clinical and financial success and has enabled us to build a robust pipeline of high value programs. This R&D model is guided by three core principles: validated efficacy, clear patient benefit, and efficient de risk clinical development. We begin with drugs that can address significant unmet need and have already demonstrated some level of efficacy or clinical signals but are held back by key limitations. We then apply innovative science or technology or an approach to overcome these limitations, unlocking greater patient benefit and meaningful commercial potential. From there we advance these programs through key de risking milestones. If a program does not meet our predefined thresholds, we reallocate resources forward towards some more promising opportunities.

This disciplined approach enables us to operate with exceptional capital efficiency and ensures that we are optimizing every stage of R&D life cycle to truly bring impactful therapies to patients. This innovative R&D model has enabled us to build a robust and strategically structured portfolio of therapeutic programs which generally fall into two categories. Some are wholly owned and continue to be developed internally at PureTech. Others are being advanced through our founded entities with external investments. After being identified and de-risked by PureTech through key validation and value inflection points, these founded entities provide long term non-dilutive capital back to us through our retained equity ownership as well as our right to certain milestones, royalties and sublicense income. This model allows us to self-fund our operations and continue fueling our innovation engine by protecting our balance sheet and minimizing dilution.

Our hub-and-spoke R&D model has enabled us to avoid raising capital through public markets for more than seven years, thereby protecting shareholder value. Our unique hub and spoke R&D model that we pioneered offers significant upside potential while shielding investors from downside risk. As shown on the left side of this slide, our balance sheet accounts for almost all of our current market capitalization, which means that nothing else in our portfolio that includes several important components of value are recognized by the market. This value disconnect ought to provide a compelling opportunity for new investors to get into the story. Let's now turn to the right side of the slide for a few examples of key components that make up our intrinsic value.

Deupirfenidone, our lead wholly owned program, achieved a major value validating milestone with the successful completion of the Phase 2b clinical trial in December 2024. The program has the potential to supplant the current standard of care treatments in IPF treatments that despite limited patient uptake, have reached multibillion dollar annual sales. This program alone presents a compelling value proposition. LYT-200, our wholly owned program, is a first in class monoclonal antibody being developed for the treatment of hematological malignancies and solid tumors. To date, the program has generated robust clinical data supporting its differentiated mechanism. Additionally, we also maintain equity stakes across five public and private founded entities, including our significant holding in Seaport Therapeutics, which raised over $325 million across two oversubscribed financing rounds in 2024.

Beyond the equity stakes, we are also entitled to additional economics across our founded entities, including up to $400 million in potential milestone payments related to sales from Royalty Pharma, 2% royalties on Cobenfy annual sales above $2 billion and 3%-5% royalties on certain Seaport programs as the inventor. Despite this significant upside potential, our market valuation continues to reflect a heavy discount to intrinsic value, a disconnect we are committed to addressing in 2025. Delivering shareholder value remains our top priority for this year. Our core mission has always been and continues to be to advance life saving new medicines to positively impact patients with devastating disease and to translate that into meaningful value for the shareholder.

While 2024 was a particularly defining year for us, it also punctuated more than a decade of scientific innovation, clinical advancement and financial discipline that has yielded three FDA approved products and multiple clinical successes. Despite this unparalleled track record, our market capitalization has not consistently reflected the intrinsic value of our business over time. We have taken a number of steps in light of this value disconnect to try and bridge the value divide, including share buybacks. We did a tender offer last year, a dual listing on Nasdaq, engaging in significant investor outreach and capital market activities both in the U.S. and outside the U.S. and making strategic refinements to our R&D model. We continue to believe there is an opportunity to better align our valuation with the underlying strength of our programs and track record of execution.

This has of course been recognized by external parties as highlighted by the cash offer that was recently made public for the business. The Board carefully considers all such opportunities that arise to try and address the value disconnect and create value for our shareholders and will continue to do so. Looking ahead we remain committed to maximizing shareholder return in a way that reflects the maturity of our business, the strength of our assets and financial position and the opportunity that lay ahead. We will continue to thoughtfully evaluate opportunities to unlock value for our shareholders via a number of pathways and we'll continue to assess these options and including any potential transactions across our business with a view to addressing the value disconnect in ways that are in the best interest of our shareholders.

We will maintain our focus on capital discipline and strategic execution, deploying resources towards our highest impact programs and preserving our strong balance sheet, particularly in the current macroeconomic environment. In 2025, this strategic focus will translate into several key actions that highlight our capital allocation across the business. One of those areas of capital allocation involves advancing our wholly owned programs. Coming off the successful Phase 2b trial of deupirfenidone in idiopathic pulmonary fibrosis, we are committed to advancing deupirfenidone while maintaining capital efficiency. We intend to discuss these results with the FDA before the end of the third quarter of 2025 to align on a potential registration pathway with the goal of initiating a phase lll clinical trial by the end of this year. We anticipate providing further guidance later this year following the finalization of the trial design and the FDA interactions.

While we don't intend to fully fund a phase lll trial on our own based on historical data from other Phase 3 IPF studies, we also don't believe our current cash balance would be sufficient to fully fund such a study. We have therefore initiated discussions to explore a range of funding mechanisms, including a potential spin out of the program into a new founded entity and accessing external equity financing. This would be similar to our approach we took with Karuna and Seaport. We'll also look at project or royalty financing and strategic partnerships or a combination of these three options to support the program's continued development. We will continue to fund the program in the interim to maintain development momentum.

Michael Inbar (Chief Accounting Officer)

While we seek external funding.

Bharatt Chowrira (CEO)

In parallel, we continue to support the development of LYT-200 through our founded entity Gallop Oncology. Top line results from the ongoing Phase 1b trial in AML and MDS are expected in Q3 2025 and the patients on the study can elect to remain on treatment. Given the potential life saving nature of LYT-200, we are pursuing third party financing to support Gallop Oncology's next phase of growth and will continue to fund the program in the interim to maintain development momentum. We may also launch new founded entities or make additional investments into our existing founded entities when we believe it will preserve or enhance our ownership position and generate long term value. Initial expenditures associated with any new innovation and sourcing activities would be relatively low.

Finally, while our primary focus remains on scientific and operational execution, we recognize the importance of direct capital returns to the shareholders to help address the value disconnect to a certain extent. Therefore, the Board may evaluate additional capital return opportunities in the future as part of our broad strategy to maximize shareholder value. Our ability to deliver long term value is driven by six core components, our strong balance sheet, our wholly owned programs, our equity stakes in our founded entities, future revenue stream from royalties and milestones, capital returns to shareholders, and most importantly, our exceptional team that's driving the innovation forward. Our capital efficient R&D model has been tested and proven over the last decade, enabling us to protect our balance sheet while maintaining strategic flexibility.

Michael Inbar (Chief Accounting Officer)

A volatile market environment.

Bharatt Chowrira (CEO)

PureTech offers a compelling investment opportunity, especially given the significant value disconnect where the diversified risk profile and the various components of value provide downside protection while the upside potential is really uncapped. I remain confident in our ability to continue building value through disciplined execution and strategic agility. With that, I'd like to now turn the call over to our Co-founder and President, Dr. Eric Elenko, who will walk us through our key programs and recent clinical progress. Eric

Eric Elenko (President)

Thank you Bharatt. We're very excited about the progress across our portfolio and today I'll highlight our wholly owned programs and the value they represent for both patients and shareholders. Let's start with deupirfenidone, which we're developing as a potential new treatment for IPF. For those less familiar, IPF is a rare, progressive and fatal lung disease that affects more than 232,000 people in the U.S. and the EU five countries, with a median survival of just two to five years after diagnosis. Despite generating peak annual revenues in the billions of dollars, the current standard of care treatments only modestly slow lung function decline. Their effectiveness is limited by tolerability challenges at higher doses, which creates a tolerability ceiling, preventing patients from reaching dosing levels that could more meaningfully improve outcomes. This leads to suboptimal efficacy, reduced patient uptake and lack of adherence. Importantly, in the U.S.

Only one in four people living with IPF has ever been treated with either FDA approved therapeutic. There is an urgent need for better treatment options that can deliver meaningful disease management without compromising tolerability. Our deupirfenidone program is a deuterium-modified form of pirfenidone, a molecule that is strategically engineered to improve the stability of its bonds without changing the overall pharmacology. With this targeted change, deupirfenidone retains the clinically validated efficacy of pirfenidone while offering a differentiated and more favorable tolerability profile. We believe deupirfenidone has the potential to become standard of care in IPF. In our successful Phase 2b trial, from which top line results were shared in December, deupirfenidone demonstrated the potential to stabilize lung function decline over at least 26 weeks without sacrificing tolerability.

Importantly, the deupirfenidone 825 mg three times a day or TID arm had an effect size compared to placebo that was 50% greater than that seen with pirfenidone. Additionally, preliminary pharmacokinetic results indicate that deupirfenidone 825 mg TID achieved about a 50% higher exposure than pirfenidone 801 mg TID, corresponding with the greater efficacy results demonstrated with deupirfenidone 825 mg TID. I'm also pleased to share for the first time today that as of March 14, 2025, 140 patients have continued in the open-label extension and 85 patients have received at least 52 weeks of treatment with deupirfenidone. Preliminary data from those receiving deupirfenidone 825 mg TID indicate the significant slowing of lung function decline observed in part A of the trial has been sustained through 52 weeks of treatment, supporting the durability of the treatment effect with this dose and its potential to stabilize lung function decline over time.

Detailed OLE results will be presented in upcoming Scientific Forum. These results are unprecedented, especially for a monotherapy, and to our knowledge this is an achievement unmatched by any other investigational IPF therapeutic to date. Based on the strength of our data, deupirfenidone has the potential to offer benefits to three patient segments, the subgroup of those currently on treatment, those who discontinued due to side effects, and those who never start treatment at all with currently available options. By demonstrating a meaningful improvement in lung function decline over six months and the potential for stabilization without compromising tolerability, deupirfenidone has potential to become a next generation IPF treatment by pushing for levels of efficacy that have not been possible for the past 10+ years and reach far more patients than today's therapies and to do so in a way that supports sustained disease management.

We believe deupirfenidone represents a sizable commercial opportunity with a total addressable market or TAM that continues to expand. The IPF market was valued at approximately $5 billion in 2024. With increased disease awareness, early diagnosis and the availability of new treatment options, the market is expected to grow to nearly $10 billion a year by 2033. With its highly differentiated efficacy and safety profile, deupirfenidone has blockbuster commercial potential in IPF with additional upside in other interstitial lung diseases or ILDs such as progressive pulmonary fibrosis or PPF. While significantly enhancing patient impact, there remains a clear need for better treatment options in IPF and based on the data to date, we believe deupirfenidone has potential to become a next generation standard of care. We'll present additional details from the phase ll data at the American Thoracic Society International Conference this May.

We also intend to discuss these results with the FDA before the end of the third quarter of 2025 to align on a potential registration pathway with the goal of initiating a phase lll trial by the end of the year. We anticipate providing further guidance later this year following the finalization of the trial design and FDA Interact. The next program I'll highlight today is LYT-200, our wholly owned oncology program being advanced by our founded entity Gallop Oncology. We're taking a differentiated approach to cancer treatment by targeting the pro-tumor mechanisms of galectin-9 in acute myeloid leukemia or AML, and high-risk myelodysplastic syndrome or MDS and head and neck cancers. The FDA has granted orphan and Fast Track designation for LYT-200 in AML as well as Fast Track designation in head and neck cancers, reinforcing the urgency and potential impact of this program.

Both preclinical and human data underscored the importance of galectin-9 as a potent oncogenic driver and immunosuppressive protein, with LYT-200 demonstrating direct cytotoxic anti-leukemic effects through multiple mechanisms as well as antitumor activity. We're very encouraged by the clinical data we've generated to date across our LYT-200 trials. On the left of this slide is new interim data from our ongoing Phase 1b trial in AML and high-risk MDS evaluating LYT-200 as a monotherapy and in combination with venetoclax and hypomethylating agents. At a high level, LYT-200 has shown a favorable tolerability profile across both arms and all dose levels with no dose-limiting toxicities, as well as evidence of clinical efficacy, hematological improvement, and sustained disease management.

We last shared a detailed update on this trial at the American Society of Hematology Annual Meeting in December, noting that the combination arm had achieved two complete responses at that time. Today I'm pleased to share that as of April 28th we have seen four additional complete responses in this arm, bringing the total to six. I want to remind you that this trial is being conducted in a heavily pretreated relapsed refractory AML MDS population whose time progression tends to be less than one month and whose overall survival average is 1.7-2.4 months with standard of care therapy. We're very pleased with the data generated to date in this indication, which is in desperate need of innovation and we look forward to sharing top line results from this trial in the third quarter of this year.

On the right of the slide is something we're also sharing for the first time today, top line data from the recently completed Phase 1b trial in relapsed/refractory solid tumors including head and neck cancers. This study evaluated LYT-200 both as a monotherapy and in combination with tislelizumab, and across all cohorts LYT-200 demonstrated a favorable safety profile along with disease control and early signs of efficacy. Together, these data highlight the broad potential of LYT-200 across both hematological malignancies and solid tumors. As we look ahead, we expect 2025 to be another catalyst-rich year across our wholly owned and founded entity programs including the phase lll initiation of deupirfenidone in IPF and Phase 1b readout of LYT-200 in AML, to name a few.

We are proud that our efficient and proven hub and spoke model has enabled us to maintain a strong financial position even in a volatile market environment as we remain steadfast in our mission to deliver life changing medicines. With that, I'll turn it back to Bharatt for a recap of our 2024 financial results and closing remarks.

Bharatt Chowrira (CEO)

Thanks Eric. I'm pleased to report that PureTech's cash position remains strong, reflecting our business model, track record of clinical success, and commitment to financial discipline. At the PureTech level, we ended 2024 with cash, cash equivalents, and short term investments of $366.8 million compared to $326 million at the end of 2023. On a consolidated basis, our cash, cash equivalents, and short term investments were $367.3 million at the end of 2024 compared to $327.1 million at the end of 2023. At the PureTech level as of March 31, 2025, we held unaudited cash, cash equivalents, and short term investments of $339.1 million. On a consolidated basis, our cash, cash equivalents, and short term investments were $339.5 million. Based on our existing financial assets as of December 31, 2024, we expect our operational runway into at least 2027.

Our revenues are mostly driven by milestone based payments and royalties from license agreements as well as grants and are expected to continue to fluctuate from year to year. On a consolidated basis, our revenue in 2024 was $4.8 million compared to $3.3 million in 2023. We reported a lower 2024 operating loss of $136.1 million compared to $146.2 million in 2023. This was largely due to a decrease in R&D expenses and driven by the completion of deupirfenidone Phase 2b clinical trial development of glymphatic platform candidates now being advanced by our founded entity Seaport Therapeutics as well as deconsolidation of Seaport.

The decrease in R&D expenses is partially offset by an increase in G&A expenses that was largely driven by non-cash stock-based compensation expenses for new stock awards granted to founders, directors, executives, and employees of Seaport Therapeutics in 2024 prior to its deconsolidation. On a consolidated basis, we reported a net income of $27.8 million for 2024 compared to a net loss of $66.6 million for 2023. This was largely due to a $151.8 million gain that was recognized upon the deconsolidation of Seaport coupled with the decrease in operating loss driven by the decrease in R&D expenses mentioned earlier. I am pleased that our balance sheet remains strong. We are committed to maintaining financial discipline by allocating capital efficiently to high-impact programs while actively pursuing external funding opportunities.

This measured approach allows us to protect our balance sheet and preserve strategic flexibility even in today's volatile market environment. In closing, I'd like to thank the patients, caregivers, advocates, clinicians and partners. We are deeply grateful for the engagement, participation and belief you have placed in us and our team. I would also like to extend a sincere thank you to every member of the PureTech team, including our Board of Directors and advisors, for their invaluable contributions to our work and culture. What we have accomplished together is both rare and highly meaningful. Finally, I'd like to thank our shareholders for continuing to support our journey to bring new classes of medicines to patients in need. We value our recent and continued engagement and your feedback as we remain steadfast in our commitment to maximizing positive patient impact value for shareholders.

Your trust and support have been essential to our journey, especially over the past year as I stepped into the role of the CEO. I'm proud of the progress we have made and we remain focused on advancing our science to improve the lives of the patients. Thank you and we will now take your questions.

Operator (participant)

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

Miles Dixon (Research Analyst of Healthcare and Life Sciences)

Good morning, Bharatt. Eric, thank you so much.

Bharatt Chowrira (CEO)

I've got a few.

Miles Dixon (Research Analyst of Healthcare and Life Sciences)

Maybe we can take them one by one, but let's start with them. Let's call it KarXT rather than Cobenfy, but can you tell us a little bit about what your understanding is of how sales have started, please, with BMS.

Bharatt Chowrira (CEO)

Thank you, Miles.

Appreciate you joining the call.

Miles Dixon (Research Analyst of Healthcare and Life Sciences)

Yeah.

As you know, Cobenfy was approved last year by the U.S. FDA for the treatment of schizophrenia in adults. BMS, who acquired Karuna, has launched this product in the U.S. I believe in the last quarter of 2024. They recently announced their first quarter sales, which according to their.

Announcement it.

Is going quite well. The sales ramp has gone quite well. They, I think, generated about $27 million in the first quarter, which currently it's around $40 million to $50 million. Yeah, around 48% above the average analyst estimate.

It's a good sign.

It's getting a lot of attention and traction and momentum. We will continue to monitor that and watch that growth as BMS launches this product across the U.S.

Michael Inbar (Chief Accounting Officer)

Great, thank you. Sticking on the same subject, you've obviously got quite a complicated but potentially profitable load of economics in there, whether it be the sublicense and royalty payments with BMS, but also the milestones with Royalty Pharma. I wondered, can you give us any more color on what may happen, for instance with BMS, with the sublicense agreement and what the milestone structure might be with Royalty? Is it too simplistic for me to imagine that those milestones may fall due $500 million, $1 billion, $1.5 billion, for instance, before they revert. Thank you.

Bharatt Chowrira (CEO)

Yeah.

Miles Dixon (Research Analyst of Healthcare and Life Sciences)

As you mentioned, Cobenfy was invented at PureTech. We licensed that to Karuna and as part of that license we were eligible for a 3% royalty on product sales. We monetized that 3% royalty with Royalty Pharma. We received $100 million upfront. We are eligible for up to another $400 million in milestones. Most of those milestones are sales threshold related and there are a few smaller milestones on approvals. We received a small milestone on the approval of Cobenfy in the U.S. There is another small milestone due for a second indication when that happens. Most of the remaining up to $400 million milestones are sales threshold achievement driven. We have not broken that down into different layers for obvious reasons. Royalty Pharma and we have a confidentiality related to those tiers of milestones.

We're not able to disclose any more specifics in terms of those tiers of milestones. In addition to those milestones, we are eligible for 2% royalty above sales of $2 billion for Cobenfy. That, depending on when those sales ramps hit, we should start seeing that 2% royalty above $2 billion from the sales of Cobenfy. In addition, we have small milestones from Bristol Myers Squibb as they advance the program through other indications. We have those small milestones due to us. If they sublicense in other countries, you know, we are eligible for small sublicense income, but we believe that given BMS's global footprint, we are unlikely to actually expect.

Bharatt Chowrira (CEO)

I don't think we expect BMS to.

Michael Inbar (Chief Accounting Officer)

Sublicense this in other parts of the world. Primarily, it's small milestones on development milestones as well as Royalty Pharma milestones based on the monetization of the royalty.

Miles Dixon (Research Analyst of Healthcare and Life Sciences)

Got it, thank you. Presumably the lower the sublicense income, the higher the potential royalty payment from BMS if they do commercialise it elsewhere. If I could move on maybe to LYT-100. You obviously had some brilliant trial data last year, but you've indicated the potential trial costs might be beyond that of your balance sheet, which is why you're looking to partner. Can you just break down for me a little bit what it is about that potential trial? Is it the scope, the timeline that means that it's going to be more than your typical respiratory trial? Thank you.

Michael Inbar (Chief Accounting Officer)

Yeah, thank you for that, Miles.

It is a combination of the two.

When you look at LYT-100 that we are advancing for idiopathic pulmonary.

Fibrosis or IPF, when you look at historical phase lll trials that people have.

Run, other companies have run in this space, they're generally a 52 week study. It's a one year treatment study which takes around two years to enroll a phase lll study in IPF, depending on the size of the study and the number of patients required in that study and depending on the trial design.

Historically that's sort of what we.

Have seen is a one-year treatment.

That takes about two to three years.

To read out, top line results to read out. We are looking at, from the start of the study, three year duration for the top line results to be announced. The most recent example is Boehringer Ingelheim who ran a phase lll study. They had about 400 patients per arm and they had I think two or three arms. You can imagine the size of that study. I'm not saying that that's the trial design we are going to follow, but that is an example of the phase lll study that the FDA has required BI to run. We will of course have a discussion with the FDA.

Bharatt Chowrira (CEO)

We will discuss our Phase 2b data.

Michael Inbar (Chief Accounting Officer)

With the FDA in the third quarter of this year, we'll reach alignment with them regarding the trial design, and we'll have a better sense for what the study design and the scope of the study and the duration of that study could look like. We'll be able to provide better guidance. Our goal coming out of those discussions is to try and initiate a phase lll study before the end of this year.

Miles Dixon (Research Analyst of Healthcare and Life Sciences)

Great, thank you. Yeah, I think Boehringer's was 400 locations. Incredible. Lastly, if I can just ask one more on Seaport, obviously now a kind of arm's length company if you like, but you're a significant shareholder. They raised a huge amount of money. Can you just give me a bit of a flavor for what's going on? How's the funding going in Seaport? I know that we've seen some early safety data on SPT-300, but have they got everything they need? Thank you.

Bharatt Chowrira (CEO)

Yeah.

Michael Inbar (Chief Accounting Officer)

They're private companies, so there is a limited amount of information that they have shared regarding the timing and progress of their programs internally. What we have previously disclosed is that the lead program, LYT-300, is advancing towards a Phase 2b study initiation in major depressive disorder, and they are on track for that. They haven't provided any more guidance in terms of the timing of that study. They also have a second study that's initiating a phase l clinical study, which is in SPT-320, which is a glymphatic version of agomelatine, and they are studying that for generalized anxiety disorder. They expect to start that study sometime this year. Beyond that, we have not provided any additional guidance. They have a third program which is slightly further behind in preclinical, and they're well funded.

They raised $325 million across two venture rounds. They are well capitalized and they should be able to execute on these programs in the foreseeable future.

Miles Dixon (Research Analyst of Healthcare and Life Sciences)

Thank you, Bharatt. I just thought I'd try my luck.

Eric Elenko (President)

Thank you.

Operator (participant)

Our next question comes from Faisal Khurshid from Leerink Partners. Your line is now open. Please go ahead.

Hey guys, thank you so much for taking the questions. Just want to ask as you think about the path forward for LYT-100, like what could those potential paths look like and how are you thinking about retaining upside in the program?

Michael Inbar (Chief Accounting Officer)

Yeah, thanks first of all and thanks for your question. We are very bullish on LYT-100 or deupirfenidone. Based on the unprecedented data from Phase 2b that we announced in December, we have built quite a lot of momentum around this program. The key opinion leaders we have spoken to are really excited about the data, especially the ability of deupirfenidone to potentially stabilize lung function. We believe it's a really big deal for this indication. We are committed to advancing this forward. We have looked at a number of different approaches to try and bring together the funding necessary to advance this into phase III. One of them is of course what we have historically done, which is to house the program into a new founded entity and bring in external capital like Venture Round.

Part of the funding required for phase lll we believe would come from such equity financing from external sources, similar to what we have done with Karuna and most recently with Seaport Therapeutics. In addition, we are also speaking to.

People who provide what we call project.

Financing or synthetic royalty type financing, where these firms actually lend you the money to run the phase lll study at risk. If the study is successful, then they would get some backend economics in return for that. This is a very common way of funding some of the large phase lll studies. Another portion of the phase lll funding required would come potentially from a project financing. A third approach we are also looking at in parallel is speaking to potential strategics pharma companies for regional rights.

Bharatt Chowrira (CEO)

We would potentially keep the U.S.

Michael Inbar (Chief Accounting Officer)

Rights and then license out outside the U.S. and then use some of those upfront proceeds to then also provide funding for the phase lll. This could be a combination of these three. Maybe there are other ways to bring in some additional funding to advance this program into phase lll. That is sort of how we are looking at it. How do we maintain the upside is primarily through equity ownership as well as because we have generated significant amount of intellectual property around this program over the years that we would be eligible for milestones and royalties as the programs would move forward. Very similar to what we have done with Karuna and Seaport.

Got it.

Bharatt Chowrira (CEO)

Great.

You mentioned kind of like your perceived value disconnect between the stock price and just the value of your cash and like the RX economics. Can you talk a little bit more about how you're thinking about that and what the potential options could look like to sort of rectify that?

Michael Inbar (Chief Accounting Officer)

Yeah, we share the frustration of our shareholders in terms of the value disconnect. We've been looking at different ways to try and address this. We have a range of options that we can look at. We have looked at them in the past. We have done share buybacks. We did a $50 million share buyback last year. In 2024, we did a $100 million tender offer. We continue to evaluate other potential opportunities to try and unlock the value. Most recently, there was an announcement that we had to put out prematurely because of some media speculation about some discussions with a private equity firm to potentially explore ways to take the company private. We're looking at a number of those opportunities, and the board and the management team regularly evaluate those opportunities on an ongoing basis. We'll continue to do that.

Our focus in 2025 is going to be not only in executing and advancing our pipeline programs and portfolio, but also spend a lot of time trying.

Bharatt Chowrira (CEO)

To figure out how to bridge this value.

Eric Elenko (President)

Disconnect.

Got it. Thank you for taking the questions.

Operator (participant)

Thank you. In the interest of time, we unfortunately have to conclude this Q and A. You may now disconnect your lines.