PureTech Health PLC (PRTC) 2020 Q2 法說會逐字稿

Greetings and welcome to the PureTech Health 2020 Half Year Results Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

It is now my pleasure to introduce you to your host, Allison Mead Talbot, Head of Communications. Thank you, Allison. You may begin.

Thank you for joining us today for PureTech's 2020 half year results webcast. We hope you've had a chance to review our press release and report, which were issued earlier this morning. This press release, along with a few slides that you may find helpful while you listen to this call, may be accessed on the Investor Relations portion of our website at puretechhealth.com.

PureTech is led by a proven and seasoned management team of business leaders dedicated to discovering and developing important new medicines, delivering them to market and maximizing shareholder value. Today, I am pleased to be joined virtually by the senior team, including Daphne Zohar, our Founder and Chief Executive Officer; Bharatt Chowrira, President and Chief of Business and Strategy; Eric Elenko, Chief Innovation Officer; Joe Bolen, Chief Scientific Officer; Steve Muniz, Chief Operating Officer; and Joep Muijrers, Chief of Portfolio Strategy.

As a reminder, during today's call, we will be making certain forward-looking statements. These statements reflect PureTech's current expectations regarding future events, including, but not limited to, statements regarding financial performance, clinical and regulatory activities, patent applications, timing of product launches and statements relating to market acceptance and commercial potential. Forward-looking statements involve risks and uncertainties, and actual events could differ materially from those projected herein. We caution you to consider the important risk factors that could cause the actual results to differ materially from those in the forward-looking statements, in the press release and this conference call. These risk factors are described in today's press release as well as on Slide 2 of this presentation. These forward-looking statements speak only as of today's date, the 27th of August 2020. Finally, an archive of today's call will be posted to the PureTech website in the Investor Relations section.

I will now turn the call over to Daphne Zohar, PureTech's Founder and Chief Executive Officer.

Thank you, Allison. The first half of 2020 has been an exceptional period for PureTech, and we are delighted with the achievement of multiple notable regulatory milestones, important clinical progress and substantial financing and monetization events across our Wholly Owned Pipeline and our Founded Entities.

In the month of June alone, we announced the FDA clearance of Akili's EndeavorRx and the European marketing authorization of both Gelesis' Plenity and Akili's EndeavorRx, 2 products initiated and developed from PureTech's unique and productive R&D engine. We are proud to have delivered on our commitment to patients in 2 areas of medicine where great need exists, and we look forward to reporting on the U.S. launch of both products in the near term.

During this period, we have also progressed our Wholly Owned Pipeline with the initiation of a Phase I study for LYT-100, which we plan to advance into 2 studies later this year: one for the potential treatment of serious respiratory complications that persist following the resolution of COVID-19 infection and another for breast cancer-related, upper limb secondary lymphedema. We also plan to file an IND and initiate a Phase I study of LYT-200 for the treatment of solid tumors before year-end.

This year, we achieved another important milestone in that we generated significant nondilutive cash. Since January, we have generated approximately $346 million from the sale of shares in certain of our Founded Entities to help fuel the future growth of PureTech, and approximately $101 million of that was realized just yesterday and is not yet accounted for in our half year financials.

We are proud of our track record of rapidly advancing therapies that could prove transformational for millions of people who have long struggled to find effective treatments. Across our Wholly Owned Pipeline and our Founded Entities, we now have 24 products and product candidates, including 13 that are clinical stage and 2 that have been cleared by the FDA and granted marketing authorization in Europe. All of the underlying programs and platforms, supporting these products and candidates were initially identified or invented and then advanced by the PureTech team through key validation points based on our unique insights in the biology of the brain, immune and gut, or BIG, systems and the interface between those systems or what we like to call the BIG Axis.

Our proven track record of innovation and unbiased scientific validation has demonstrated high probabilities of clinical success, particularly in the stages where industry failures are typically high. This has enabled us to rapidly convert these findings into valuable therapeutic products and candidates.

With this model, we have created significant value across our Founded Entities, and we are poised to replicate the success through our Wholly Owned Pipeline. Through this capital-efficient R&D model, we have established 3 major components that make up our value. Historically, new medicines we created were housed in what we call our Founded Entities, a structure that enabled us to partner with venture capital investors in sharing the cost of early development. As these programs have succeeded and PureTech's resources have grown, we've been able to develop our own wholly owned programs, where we maintain 100% ownership, while benefiting from the growth of our Founded Entities, where we also maintained sizable equity ownership.

In addition to our Wholly Owned Pipeline and Founded Entities, PureTech is well capitalized with sufficient cash resources to fund our operations into the first quarter of 2024, which does not account for new infusion of capital from Founded Entity monetization events and does not account for yesterday's post period sale. So we believe it's a conservative projection.

To further recap the financial results for the first 6 months of 2020, PureTech has a very strong cash position. On a PureTech level, our cash reserves grew by $189 million within the period, and we ended the first 6 months of 2020 with a cash reserve of $310.5 million. For the first 6 months of 2020, revenue was $6.8 million, primarily driven by collaborations within our Wholly Owned Pipeline, with additional contribution from our Founded Entities.

Our operating loss decreased by $17.5 million from a loss of $70.3 million for the first 6 months of 2019 to $52.8 million for the first 6 months of 2020. The largest driver of the year-over-year decline in operating loss was a decrease in R&D and G&A expenses driven by the deconsolidation of Vor, Karuna and Gelesis in 2019.

With that said, during the first half of 2020, despite the COVID-19 pandemic, our R&D expenses within our Internal segment grew by $6.9 million or 64% year-over-year as we continue to advance those programs within our Wholly Owned Pipeline to significant milestones.

Our Founded Entities strengthened their collective balance sheets during the first 6 months of 2020, attracting $136.5 million in equity investments and nondilutive funding, $135.5 million of which came from third-party investors. Those Founded Entities are in a very strong cash position, having raised over $890 million since July 2018, with 92% coming from third parties.

Our Founded Entities have started the year strong with multiple regulatory milestones, excellent clinical progress and validating strategic findings. These Founded Entities contain significant value and have growth potential. On the next few slides, I will highlight some of these recent successes and upcoming catalysts.

Karuna Therapeutics, a company that was founded, is a great example of the validation of our unique R&D model. In 2019, Karuna reported impressive Phase II data with its lead candidate, KarXT, a product we coinvented, which achieved the primary end point in the Phase II clinical trial of acute psychosis in patients with schizophrenia, a devastating condition that is estimated to affect up to 1% of the population.

The data announcement around the Phase II results led to significant appreciation and evaluation of Karuna. And since January, we have monetized a small portion of our ownership stake for approximately $346 million in proceeds. We still maintain a 12.8% equity interest as well as the right to receive royalties from future sales given our role as a coinventor.

In June of this year, Karuna announced next steps in the EMERGENT program, the clinical program evaluating KarXT for the treatment of adults with schizophrenia, following the completion of a successful end-of-Phase II meeting with the FDA. The positive outcome of that meeting supports the progression of KarXT into Phase III development. And Karuna plans to initiate 2 5-week inpatient trials evaluating the efficacy and safety of KarXT for the treatment of acute psychosis in adults with schizophrenia. The first Phase III trial, EMERGENT-2, is expected to begin by the end of 2020, and details of the second efficacy trial, EMERGENT-3, will be finalized by the end of 2020, with initiation expected in the first half of 2021.

Karuna also expects top line results from a Phase Ib clinical trial, evaluating the safety and tolerability of KarXT in healthy elderly volunteers by the end of 2020. While we have monetized some of our initial stake in Karuna, we remain extremely excited about the potential of Karuna going forward.

In June, we were proud to announce that Akili received both FDA clearance and European marketing authorization for EndeavorRx, which is the first game-based digital therapeutic to be cleared by the FDA. EndeavorRx, which is based on a technology that PureTech advanced after forming Akili and licensing the core technology from UCSF, is now indicated to improve attention function as measured by computer-based testing in children ages 8 to 12 years old, with primarily inattentive or combined-type ADHD, who have demonstrated an attention issue. Akili expects that the EndeavorRx treatment will be available with a prescription to families in the U.S. soon. Akili partnered with Shionogi to advance this product in Japan and Taiwan and is also considering various expansion opportunities in Europe as a global part of its strategy.

Another important point of validation for our model came last year, with our first FDA-cleared product, Plenity, which was coinvented by members of the PureTech team. In June of this year, Gelesis also received approval to market Plenity as a Class III medical device indicated for weight loss in Europe. Plenity is a prescription aid for weight management in adults with a BMI of 25 to 40 kilograms per meter squared, when used in conjunction with diet and exercise. The label granted by FDA last year is broad enough to expand to approximately 150 million people in the U.S. with overweight and obesity, the most of any prescription weight management aid. The safety and efficacy profile of Plenity makes it well suited for those individuals. The full safety information can be found in the instruction for use at myplenity.com. We currently maintain a 21% equity interest as well as the right to receive royalties from future sales given our role as a coinventor.

Gelesis has also announced in June a partnership with the commercialization of Plenity in China, which included an upfront payment of $35 million, with the potential for an additional $388 million in future milestone payments and royalties. There are multiple catalysts on the horizon for Gelesis, including the initiation of the Phase III study of GS500 in functional constipation as well as a Phase II study of GS300 in NASH/NAFLD, both expected this year.

In 2021, top line results are expected from a Phase II study of Gelesis200 in weight management and glycemic control in adults with type 2 diabetes and prediabetes. We also look forward to the full launch of Plenity in the U.S. in 2021.

Another Founded Entity that is making exciting progress is Vedanta Biosciences, which is pioneering rationally-defined, human microbiome-derived bacterial consortia-based product candidates to address infectious and immune-mediated diseases. Vedanta currently has 4 orally administered clinical-stage product candidates in development for the potential treatment of serious infection, cancer, food allergy and inflammatory bowel disease. And in June, Vedanta announced positive top line results from 2 Phase I studies of its IBD candidate, VE202. Vedanta also recently raised a total of $71.1 million in the Series C financing round to support the advancement of this growing clinical pipeline.

And we can expect top line results from multiple clinical studies as we look ahead to 2021. We believe that the microbiome field is on the cusp of major validation and that Vedanta is a leader in the field on multiple levels.

We are also pleased with the continued progress of Follica's regenerative biology platform, which is designed to treat androgenetic alopecia, epithelial aging and other related conditions of aging. In June, Follica announced positive feedback from an end-of-Phase II meeting with the FDA for its program to treat male androgenetic alopecia, and the company plans to advance the program as a Phase III development in the second half of 2020.

As you may recall, Follica announced a successful safety and efficacy optimization study in December 2019, which, together with 3 previously conducted clinical trials, provide important validation for Follica's proprietary approach for the treatment of androgenetic alopecia. This is an exciting progress towards Phase III development and brings us another step closer to a potential new treatment for the millions of people to the safe, effective, nonsurgical treatments to grow new hair.

The last Founded Entity I plan to highlight today is Vor Biopharma, which is a great example of our innovative R&D process and the tremendous value and potential of our Founded Entities. A company we cofounded with Professor Sid Mukherjee at Columbia University, Vor has garnered significant interest from top-tier investors. In the July 2020 post period, Vor announced $110 million Series B financing, which is a strong testament to the strength of its scientific platform and its potential for cell-based treatment of cancer, an approach designed to target cancer cells while sparing healthy blood cells. In January of this year, Vor held a pre-IND meeting with the FDA for its lead product candidate, VOR33, and Vor expects to issue a Phase I study for acute myeloid leukemia in 2021.

Our expertise in the BIG Axis has enabled us to continue to advance and strengthen our Wholly Owned Pipeline, which is a major, new and important driver of our future growth. Focused on the lymphatic system and related immunological disorders, our Wholly Owned Pipeline includes LYT-100, a clinical-stage product candidate for the potential treatment of a range of conditions involving fibrosis, inflammation and impaired lymphatic flow. LYT-200 and 210, which are our 2 preclinical product candidates for intractable cancers, and 3 discovery platforms, the most advanced of which has generated a product candidate, LYT-300, for a range of devastating neurological conditions.

On the next few slides, I will share some of the key developments and progress from the first 6 months of 2020 across our Wholly Owned Pipeline. The lead candidate from our Wholly Owned Pipeline is LYT-100 or deupirfenidone, which has the potential to treat a range of conditions involving fibrosis, inflammation and impaired lymphatic flow. While we initially came to this program through our focus on lymphedema, a serious lymphatic flow disorder, we are pleased to note that there are several additional important indications we are able to pursue, which I will detail shortly.

Lymphedema is a chronic condition that afflicts approximately 1 million people in the U.S. and is characterized by severe swelling in parts of the body due to the buildup of lymph fluid and inflammation and fibrosis. Currently, there are no FDA-approved drug therapies to treat lymphedema. Through our relationships with some of the world's leading lymphatic experts, we became aware of unpublished preclinical work showing that pirfenidone, which is an anti-inflammatory, antifibrotic agent approved for the treatment of idiopathic pulmonary fibrosis, or IPF, reduces tail volume to close to baseline in a well-established preclinical model of lymphedema.

In the lymphedema mouse model, we have shown that LYT-100 treatment halted progression of lymphedema and decreased the [tail] lymphedema change by 71% compared to the control group, nearly returning the tail volume back to the presurgical baseline.

Pirfenidone is a successful drug for IPF, a condition for which there are very few viable treatment options. Pirfenidone has generated significant sales revenues as shown on the top right side of the slide. However, pirfenidone is not a well-tolerated drug, which results in significant discontinuations or dose titrations and reductions that come at the expense of efficacy.

So LYT-100 is an oral deuterium-containing analogue of pirfenidone. It retains the same intrinsic pharmacology of pirfenidone and has shown a differentiated and superior pharmacokinetic profile compared to pirfenidone in human studies. It was also previously evaluated in a Phase I clinical trial conducted by Auspex Pharmaceuticals, which was acquired by Teva.

In March 2020, we initiated a multiple ascending dose study to evaluate the safety, tolerability and pharmacokinetic profile LYT-100 in healthy participants. The results are anticipated this year.

A proof-of-concept trial in people with breast cancer-related, upper limb secondary lymphedema is also expected to begin in the second half of 2020, with top line results expected in 2021. Secondary lymphedema is the most prevalent form of lymphedema. And it can develop after surgery, infection or trauma and is frequently caused by cancer or cancer treatments. There are approximately 500,000 breast cancer survivors with secondary lymphedema in the U.S.

As I mentioned, we believe the potential advantages of LYT-100 over pirfenidone include enhanced exposure, less frequent dosing, improved tolerability and potential for increased efficacy. We also have a strong intellectual property position around LYT-100, which is a new chemical entity, with composition of matter IP.

Emerging data suggests that a high proportion of COVID-19 patients are at risk of persistent respiratory complications driven by fibrosis or lung scarring and impaired lung function. Recent publications suggest a high proportion of mild, moderate and severe COVID-19 patients resigned of lung fibrosis at 3 weeks after symptom onset. In SARS process, patients develop persistent lung fibrosis, and up to 1/3 of MERS patients have lung fibrosis after recovery.

In May, we announced our plans to advance LYT-100 as a potential treatment for these serious respiratory complications linked to inflammation and fibrosis that persist following the resolution of COVID-19 infection. The unique antifibrotic and anti-inflammatory properties of LYT-100 have therapeutic potential to address post-recovery complication in COVID-19.

Along with clinical data on LYT-100, we have preclinical data that has demonstrated the antifibrotic and anti-inflammatory activity of LYT-100, which produces pro-inflammatory cytokines like Il6 and TNF alpha and suppresses TGF-beta and downstream signaling to inhibit fibrosis. The global randomized placebo-controlled Phase II trial is expected to begin in Q3 of this year, with top line results expected in mid-2021.

In addition to our planned trials in lymphedema and respiratory complications following COVID-19 recovery, we intend to explore LYT-100 for a range of additional inflammatory and fibrotic conditions. For example, there are several lung diseases with a common mechanism of fibrosis and inflammation, acute diseases with high mortality or that lead to long-term fibrosis, chronic diseases linked to a specific cause like a virus or autoimmune disease and diseases like IPF, where the cause is less clear.

In these various lung conditions, outside of IPF, for which pirfenidone is approved, there are no approved treatments that address inflammation and fibrosis. Many of these diseases can increase risk for worsening lung fibrosis, and there's a clear unmet need to stop inflammation and fibrosis and preserve lung function. We are actively evaluating LYT-100 for the treatment of additional fibrotic and inflammatory disorders where we think the advantages of deupirfenidone over pirfenidone such as potentially improved safety, tolerability, efficacy and less frequent dosing could be critical for these vulnerable patient populations.

To summarize our development plan for LYT-100, we expect data from our multiple ascending dose study in healthy participants this year, followed by initiation of a proof-of-concept study in breast cancer-related lymphedema later this year as well. As I mentioned, there are currently no approved therapy for lymphedema. The proof-of-concept study will look at exploratory end points, including bioimpedance spectroscopy, serum inflammatory biomarkers, relative limb volume and patient-reported outcome measures.

In Q3 of this year, we also plan to initiate a Phase II study of LYT-100 for the treatment of serious respiratory complications that persist following resolution of COVID-19 infection, as I mentioned, with top line results anticipated in mid-2021. We are also exploring the potential application of LYT-100 in additional respiratory conditions, including idiopathic pulmonary fibrosis, IPF, and interstitial lung diseases, ILDs.

Beyond LYT-100, we are pleased with the progress of our 2 novel, fully human monoclonal antibody candidates targeting powerful immunosuppressors to treat intractable cancers and other immune disorders. We're advancing LYT-200, which targets galectin-9 for a range of cancer indications, and LYT-210, which targets gamma delta-1 T cells for a range of solid tumors and autoimmune disorders.

For LYT-200, we presented promising finding supporting our novel monoclonal antibody targeting galectin-9 at the American Association for Cancer Research Virtual Annual Meeting in June 2020. The new data established galectin-9 as a novel target for cancer immunotherapy and provided evidence that therapies targeting galectin-9 may enable the immune system to attack an array of solid tumors. We plan to file an IND for LYT-200 and initiate a Phase I study in solid tumors later this year, with the results anticipated in 2021.

Over the past few months, we have also made great progress advancing our Glyph technology platform, which employs the body's natural lipid absorption and transport process to orally administered drugs via the lymphatic system and bypass first half metabolism. Our first and most advanced product candidate derived from this platform is LYT-300, which is an oral form of the FDA-approved allopregnanolone, currently marketed in the U.S. as Zulresso, which may be applicable to a range of neurological conditions. Unlike LYT-300, which is an orally available version of allopregnanolone, Zulresso is administered as a 60-hour intravenous infusion. This extensive IV administration has greatly limited the usage of Zulresso in postpartum disorder and would likely be a limitation for other indications.

Allopregnanolone is a vital neurosteroid that has been long evaluated in both clinical and preclinical studies. Despite these studies pointing to the potential of allopregnanolone as a therapy across a wide range of neurological conditions, such as seizures, sleep and neuropsychiatric disorders, medical use has been limited, as I mentioned, due primarily to its inability to be given orally.

While others in the industry have sought to create chemical analogues, we have been able to acquire uniquely effective Glyph technology to create prodrugs, which allow you to give back the same allopregnanolone molecule that is endogenously present and which has shown efficacy in a range of studies. We are excited about this progress as it enables us to explore a number of neurological indications. In preclinical studies thus far, we have demonstrated oral bioavailability with LYT-300 and have shown plasma exposures that should suggest therapeutically relevant human plasma levels may be achieved. We expect to initiate first-in-human clinical studies by the end of 2021. Given the approval of the parent molecule, we also expect an efficient downstream regulatory pathway.

In addition to these product candidates, our R&D team has been incredibly productive in advancing other mechanisms to modulate lymphatic flow throughout the body and brain. Lymphatic flow also plays a critical role in the immune and GI systems. As demonstrated on the previous slide, our insights into these connections have guided our development of these powerful discovery platforms.

We've also progressed our Orasome technology platform, which utilizes a number of vesicle components, including those isolated from milk. The platform is designed to transport and target (inaudible) macromolecules such as messenger RNAs to various cells in the intestinal tract that would enable the body to produce its own therapeutic proteins and peptides, such as antibodies within mucosal cells, which would then be secreted into the lymphatic vascular network for subsequent systemic distribution.

Using our Orasome technology, it may be possible for a patient to take an oral drug product that will permit their own GI tract cells to make virtually any type of therapeutic protein. This approach is also -- has the potential to provide a more convenient and significantly less expensive means to deliver biological medicines. We anticipate preclinical proof-of-concept data in the second half of 2020 and additional results from a nonhuman primate proof-of-concept study in 2021.

We also continue to progress our meningeal lymphatics platform, which aims to correct lymphatic dysfunction in the brain and potentially improve outcomes for a range of neurodegenerative and neuroinflammatory conditions that are not currently effectively treated, such as Alzheimer's disease and Parkinson's disease. We intend to submit data from this work to a peer-reviewed publication, too.

We are very proud of our highly successful approach, which has resulted in substantial returns back to the PureTech parent company. To date, we have seen a 33x return on investment in Karuna and a 47% IRR across our Founded Entities. Additionally, over the past 2 years, we've also achieved strategic collaborations with large pharma companies, resulting in upfront and milestone payments, 2 FDA clearances and European market authorization for 2 products we coinvented, 12 clinical readouts and over $890 million raised in financings for our Founded Entities from top-tier coinvestors. We believe our achievements have significantly outpaced our market capitalization. By comparing the relative value of Karuna equity and PureTech's cash position, it is apparent that our Founded Entities and our Wholly Owned Pipeline are significantly more valuable than our current market cap reflects.

Our team is fully aware of this value disconnect, and we are committed to proactively addressing it. As part of our commitment to driving value for shareholders, we are currently engaged in efforts to broaden our access to the U.S. capital markets, including actively advancing a potential U.S. listing on NASDAQ of American depositary shares.

As a representation of our unique and productive R&D engine, captured here are some of those exciting catalysts that we've already achieved this year across our Wholly Owned Pipeline and Founded Entities as well as the multiple value drivers as expected, including at least 3 more clinical trial readouts and 7 initiations in 2020. In addition, there is also the possibility of potential financing and strategic transactions across the Founded Entities in the second half of 2020.

Looking ahead, we anticipate another catalyst-rich year in 2021, with additional clinical readouts and initiation. I'm lucky to have a wonderful team around me that is dedicated to executing and delivering results. And we are fortunate to work closely with our tremendous Board and R&D Committee as we advance our clinical candidates. Our Board of Directors and R&D committee includes former CEOs and CFOs of major pharma companies, along with academic, clinical and business leaders, who are dedicated to our mission and engaged in a hands-on way with our unique R&D model.

Let me close by saying that we are energized by the progress from the first half of the year, and we aim to continue this momentum across our Wholly Owned Pipeline and our Founded Entities as we collectively work to deliver highly differentiated medicines for patients and value for our shareholders. Thank you, everyone. We will now take questions.

(Operator Instructions) We have a question from Ted Tenthoff from Piper Sandler.

Congrats on all the progress in the first half. I wanted to get an understanding a little bit with respect to affiliate company Gelesis. With the approvals in hand, what are kind of next steps in preparation for launch of Plenity, both here in the U.S. and also now in Europe?

Thanks, Ted. Thanks to everybody for joining us today. So they are currently in the midst of limited launch program, where they are basically working out the details about the distribution and a whole range of different factors. That's going very well. And they're planning to scale up to the full launch. They've been limited primarily by supply. And as the supply comes available, they plan to move forward towards a full launch. So it's going very well. We're very excited about it.

We have a question from Amy Walker of Peel Hunt.

Daphne, you mentioned that PureTech is actively advancing a potential U.S. listing. I just wondered if you could give us a bit more color in terms of exactly what that means, what actions are underway, what the gating factor to initiating the listing is. Because I think it's been more than a year since this was first mooted. And how should we think about this in the context of the fact that your capital requirements are fully covered, I mean, you say conservatively through to the first quarter of 2024? If you could just help us think that through.

Well, thanks, Amy. So we have cash -- we had cash through the first quarter of 2024 prior to this additional infusion of cash. So we expect to update our guidance accordingly.

With regard to the U.S. listing and with regard to generally broadening our shareholder base, we've been -- first of all, we've had so many exciting catalysts, and we've really been assessing internally what our needs are, what we want to do going forward. And as you point out, cash is not something that we need right now. So it's really been a matter of trying to understand the timing and trying to understand the best -- the method to go forward for PureTech and for our shareholders. And we're excited to be advancing this actively now. I think we just can't guide to any specifics at this point until we formally guide. So thanks for the question, Amy.

We have a question from Gary Hatton of Granahan Investment Management. If pirfenidone is the proven drug for the IPF with $1 billion in sales, why isn't it the lead indication to go after?

Yes. That's a great question, Gary. Thank you. So we do indeed plan to pursue IPF, and we plan to provide guidance regarding the next steps on that program after we confer with FDA regarding the requirements for approval. Thank you for that question.

We have a question from Peter Welford of Jefferies.

I've got a couple, maybe pretty easy if I do them one by one. Firstly, just on the sort of broader business development, wondering if you could give us an update on your thoughts at the moment as to, I guess, firstly, whether or not you're actively still pursuing in-licensing and the sort of assets you're looking for and, I guess, whether or not you've been impeded at all by the COVID-19 situation or whether or not there's still been good progress and whether or not you can give us any sort of feeling as to when we might expect a potential business development deal to be announced by you. And I've got a couple more, but maybe I'll come back in a minute.

Yes. Bharatt, do you want to take that one? I think you wanted to comment a little bit more about LYT-100 and its potential.

Yes. So we ongoing -- we have very active discussions with potential partners, and we continue to do that. In fact, the COVID-19 hasn't really slowed that in any way. In fact, people have a little more time, I think, to get on Zoom and have this conversation than actual scheduling an in-person meeting. So those discussions are ongoing. I mean we can't really guide to the timing as to when we'll have a partnership. We are looking at both in-licensing. We know we continue to look at potential clinical-stage assets to add to our growing pipeline. But at the same time, we're also looking at potentially partnering with one or more companies regarding our wholly owned programs. And of course, our Founded Entities, also have discussions ongoing to the extent that we are aware of, and so that hasn't changed.

So LYT-100, for example, has multiple indication opportunities. And we talked about the lymphedema and the COVID-19 respiratory complications, but also, we're looking at other indications like IPF and such. But those could also potentially be indications for potential partnerships in the future. So we are exploring all of those.

With our Orasome technology, this is the oral biotherapeutics, we expect to generate some data. And once we have that validation, we should be able to work with one or more of these companies to advance that platform forward.

Similarly, for the Glyph platform, this is -- so we announced the LYT-300 as a new program that we are advancing, and there's significant interest in that. We plan to take that into the clinic next year. And similarly, we're talking to companies regarding potential partnerships for using their technology for their proprietary molecules as well. So a number of these discussions are ongoing, and it wouldn't be appropriate for me to guide at this point the timing of any of those discussions leading to a partnership.

Great. Then the second question actually just touches on what you just covered regarding the Orasome platform. I wondered if you can just talk a little bit about the Roche collaboration in terms of was that, do you think, a sort of molecule target specific issue that they had? Or what sort of findings did you discover from the Roche collaboration that could be useful in the future? And I guess, why did -- did they not find the technology -- was able to be applied to their oral oligonucleotides?

Yes. I'm happy to touch on that. So we have -- what's really great about our internal pipeline is that we have these platforms, which have very broad application. And we're applying those platforms internally for specific programs, which we're advancing. And we expect to see those platforms be basically a source of pipeline expansion, in addition to other methods of expanding our pipeline as we grow and move forward. And what's exciting about those platforms is that there's a range of known core applications that we can pursue together with partners. Given the very early-stage nature of both the Orasome platform and the Glyph platform, we anticipate that there's a number of early discovery collaborations. There's some that we've entered into and some that we anticipate could be possible that don't give up core rights.

And what's great about those collaborations is that cash comes in and helps us advance the platform. So we're extremely encouraged and very excited about the progress that the science team has made on the Orasome platform. And I think that the cash that came in from that collaboration was very helpful to moving that platform forward. So I think as you pointed out, it was a very specific application that was deprioritized, but we expect that, that platform is going to be yielding some exciting additional results. And look forward to updating on those soon.

Great. And then the last question, if I can, just on Vedanta. Obviously, a lot going on at Vedanta. There's already a number of studies going on. I'm just wondering, particularly with regards to the IBD indication, is Vedanta keen? And do they have the resources to initiate a Phase II study in IBD themselves? Or what's the thinking with regards to furthering that indication after the initial data now in-house?

Yes. So they are planning to move that forward themselves. And as you know, the microbiome field has been, on the one hand, extremely productive in terms of the academic research and findings of its importance. On the other hand, there's been some setbacks. For example, the [Series] data was a huge step back a few years ago, but then this positive data that was just announced was a very, I think -- is -- enables the field to really move forward in a way that we were all anticipating.

So we feel like the microbiome field was really on the cusp of major value inflection. And Vedanta is, in our view, the leading company in that space and has the potential to really be a leader in that field.

We have a question from Alistair Campbell of Liberum.

I had a couple of questions actually. The first one was on LYT-300. I mean the product was on the market at the moment with allopregnanolone as a continuous infusion. So the technology you've got looks like it could solve the first problem, which is clearly getting up to more acceptable bioavailability threshold but also thinking in terms of the half-life of the active, which seems quite short. Will you also be able to get an oral format that will have a sort of usable frequency of dosing sort of once or twice daily?

Second question really is on Vor. They've had obviously 2 financings in Series A in February last year, a Series B this year. And your ownership has been -- percentage ownership has been falling. But just a question in terms of the implied valuation of each of those financing rounds. Has that been progressing forward such that your stake has actually been holding or progressing forward as well?

Yes. I'll answer the second one first and just say that the valuations for pretty much all of these Founded Entities have been very positively progressing. And in the case of Vor, that's the case as well. And that the value of our holdings has been growing as these financings happen. So I'm not sure who wants to take the first question. Eric, would you like to take that? Or would someone else...

I can comment, and then Bharatt, please feel free to comment also or Joe. So allopregnanolone, as you pointed out, there is proven pharmacology, but it really has been held back by administration and PK issues. And so if there is an oral form of that drug, which could capture the known pharmacology and that efficacy but also solve some of the issues that have held back the wider usage of allopregnanolone, that could potentially be quite valuable.

And if you think about the strategy with Karuna was, let's take known proven pharmacology and solve the fundamental issue that was an impediment to that pharmacology being realized in patients. It's a very similar type of story here in terms of underlying pharmacology but trying to remove an impediment to usage. And if that is successful, there are a number of different diseases for which LYT-300 could be applicable. I don't know if Bharatt or Joe, if you wanted to add anything to that.

Joe, do you want to say anything?

No. I -- this is Joe Bolen. Thanks, Eric, I believe that captured it quite nicely.

That's all the time we have for the Q&A today. I will hand the call back to Daphne Zohar.

Thank you so much. I'd like to thank everybody for taking the time to call in today. I would like to wish you and your family as well. We know it's a really unusual time, and we really appreciate the support of our major shareholders.

And I personally would like to thank the team. The PureTech team has done an outstanding job working really all hours of the day and night in the last few months to advance a number of our strategic goals so I'm really lucky and thankful. And I wish everybody well, and thank you so much for your time.

Thank you.

Ladies and gentlemen, this concludes today's call. Thank you for joining. You may now disconnect your lines.