Greetings, and welcome to the PureTech Health twenty twenty one Half Year Results Conference Call. At this time, all participants are in listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time. As a reminder, this conference is being recorded. It's now my pleasure to introduce your host, Alison Mead Tolbrook, Head of Communications.
Thank you, Alison. You may now begin.
Thank you for joining us today for PureTech's 2021 half year results webcast. The press release and report we issued earlier this Morning, along with slides, can be found on the Investor Relations portion of our website at puretechhealth.com. Our HAPQ report has also been filed with SEC and is available on the SEC website. Virtek is a biotechnology company based in Boston, and we are dedicated to the development of novel therapeutics for the treatment of serious conditions or significant medical needs. Today, I'm pleased to be joined by the senior team, including Daphne Zohar, Founder and Chief Executive Officer Brad Chirera, President and Chief of Business and Strategy George Farmer, Chief Financial Officer Eric Alenko, Chief Innovation Officer And Joe Bolen, Chief Scientific Officer.
During today's call, we will be making certain forward looking statements and ask You refer to our half year report and our SEC filings for a complete discussion of potential risks and uncertainties associated with such statements. I also want to remind you that when we refer to certain non IFRS measures in this presentation, a reconciliation of the IFRS to non IFRS measures can be found on Slide 18 of this presentation, and it is also available in the appendix to our corporate deck, which is available on our Investor Relations website at investors. Curetechhealth.com. I will now turn the call over to Daphne Zohar, Curetech's Founder and Chief Executive Officer.
Thank you, Alison. Over the past several months, we have continued to advance our mission of rapidly advancing scientific breakthroughs to patients with devastating diseases who have limited or no treatment options. We are proud of our clinical track record And inspired to note that our work has led to 25 potential new medicines for devastating diseases, including 15 that are clinical stage and 2 that have secured FDA and European regulatory clearances by our founded entities. Part of the unique approach that has enabled the success is a foundation of clinically validated biology, while bringing new insights and intellectual property from PureTech and our collaborators, Enabling us to leverage work from our industry where others have invested 1,000,000,000 of dollars in R and D, but where our insights enable a key step in development and where significant patient needs remain. This slide summarizes the components that make up our value and outlines our rapidly advancing wholly We expect these programs to serve as key value drivers for PureTech going forward.
Across the bottom half of the slide, you can see our founded entities, which bring continued validation, catalysts and significant value to us. You'll also see that we have a strong financial position with $409,700,000 in cash and cash equivalents at the PureTech level as of June 30. Our founded entities are also well positioned, having raised over $1,600,000,000 over the last few years. On the top of this slide, you will see the progress we've made across the wholly owned program so far in 2021. We initiated 3 additional Phase 1 clinical studies of LYT-one hundred to further build on our strong data package.
We anticipate all three to read out later this year. We are also planning our potential registration enabling development plans in IPF and expect to provide additional guidance in the Q4 of 2021 following discussion with regulatory agencies. Results from the first portion of the Phase onetwo LYT-two hundred study are also anticipated in the Q4 of 2021. If those results are favorable, we are well positioned to expand our clinical development of LYT-two hundred, both as a single agent and also in combination with a well studied anti PD-one agent that B gene is supplying to us at no cost. We also initiating a clinical trial of LYT-three hundred, which came out of our Glyph lymphatic targeting platform by the end of this year.
Additionally, we recently announced that Imbrium Therapeutics has exercised a licensing option to LYT-five zero three, A non opioid therapeutic candidate being developed for interstitial cystitis or bladder pain syndrome, which resulted in a $6,500,000 up We are also eligible to receive up to $53,000,000 in additional development milestone payments for this program, as well as royalties on product sales. This program is one of several coming from the OLIVIO platform. The rest of those programs and the underlying platform are all fully owned. Across the bottom half of the slide, our founded entities have also achieved many financial milestones this year, such as VAR's $203,000,000 IPO, Karuna's $270,000,000 underwritten public offering, and JELIS' Merger agreement with CapStar Special Purpose Acquisition Corp, which is expected to close in the Q4 of 2021. With the close of JELOSYS' SPAC merger at its expected valuation, these 3 public founded entities will have a combined value of over 5,400,000,000 as of June 30th.
In addition to our equity holdings across all of our founded entities, We also do royalties on potential product sales from JELOSYS, KARUNA and Follica. Royalties due to us from each of these programs Could be worth as much as or more than our equity in each program respectively, depending on the extent of future product sales. It's important to note that while we are very proud of the progress and successes of our publicly listed founded entities, We believe that there is significant underappreciated value in our clinical stage wholly owned pipeline and also our privately held founded entities. As demonstrated with our founded entities, our seasoned team at Tur Tec has the ability and track record to generate significant shareholder value. The team is bringing the same rigor and innovative insights into developing and advancing therapeutics in our wholly owned pipeline, focusing on well established and validated biology and in many instances clinically derisked mechanisms, which we believe have the potential to transform the care of millions of people who have long struggled to find effective treatment.
We expect our wholly owned pipeline as well as the additional candidates generated from our drug discovery engine to further advance this mission. Our wholly owned pipeline currently consists of 6 therapeutic candidates, including LYT-one hundred or Duparcinatum, which is an advanced clinical study including for inflammatory and fibrotic conditions and disorders of lymphatic as well. LYT-two hundred, which targets a foundational immunosuppressor, GLEKTA-nine, for the potential treatment of a range of cancer indications OYT-two ten, which targets immunomodulatory gamma delta-one T cells in development for a range of cancer indications. LYT-three hundred, which is an oral version of allopregnanolone, developed through our BLIF platform in development for a range of neurological and neuropsychological conditions. LYT-five hundred, an orally administered therapeutic candidate Developed through our OLIVIO platform in development for inflammatory bowel disease and LYT-five zero three, a potential non opioid treatment for bladder pain That is currently being developed by Imbrium Therapeutics.
You'll note that we also have 4 distinct innovative lymphatic and inflammation platforms. We believe that these platforms will yield additional therapeutic candidates and or partnership opportunities going forward. Our most advanced therapeutic candidate is LYT-one hundred, a selectively deuterated form of perfinidone, which has a long IP life with composition of matter exclusivity up to 2,033 and additional patent applications to potentially extend this through 2,040. We think that LYT-one hundred has a potential for significant patient benefit in idiopathic pulmonary fibrosis And potentially other progressive fibrosing interstitial lung diseases, long COVID and lymphedema. As a reminder, LYT-one hundred retains the beneficial pharmacology of profenidone, one of 2 standard of care drugs Approved for the treatment of idiopathic pulmonary fibrosis or ITF.
LYT-one hundred is expected to be metabolized slower with less variability. Given these properties, we are evaluating whether GI related tolerability issues that have historically been associated with carcinodone can be mitigated with LYT-one hundred. And we also believe LYT-one has a range of other potential benefits to patients, such as less frequent dosing. According to our clinical advisors, as well as information gathered from peer reviewed publications and independent market research. GI tolerability issues with persinodone Significantly affect treatment compliance in IPF patients and result in poor disease management.
Accordingly, we believe that alternatives such as LYT-one hundred are desperately needed. This year, we initiated 3 additional Phase 1 clinical trials of LYT-one hundred to explore further The pharmacokinetics dosing and tolerability in healthy volunteers. One of these trials is an extension of the previously completed multiple ascending dose study of LYT-one hundred and is designed to determine the maximum Tolerated dose of LYT-one hundred in healthy volunteers. Results from these trials are anticipated in the Q4 of 2021 and are expected to provide additional data to inform future clinical development of LYT-one hundred across multiple indications. We also announced the formation of a clinical advisory board for IPF and related lung disorders in May of this year.
Important to note that the advisory group includes the world leaders in the clinical development of novel therapies In progressive fibrosing, interesting to show lung diseases and we are really fortunate to be collaborating with them on the trial design and an implementation. We also continue to enroll patients in 2 Phase 2 studies, evaluating LYT-one hundred for the potential treatment of respiratory complications associated with long COVID and a proof of concept trial of breast cancer related secondary lymphedema. We are finalizing the trial design that will potentially support registration of LYT-one hundred ILD for the treatment of IPF and other PFIOBs. We intend to provide additional guidance in the Q4 of 2021 following discussion with regulatory agencies. Following LYT-one hundred is LYT-two hundred, our novel fully human monoclonal antibody targeting Galacta9.
We are advancing LYT-two hundred to inhibit the multiple effects of Galectin-nine to potentially remove a key immunosuppressive barrier It gets in the way of the immune system's ability to attack and destroy tumors. The Phase 1 safety, tolerability, dose escalation portion of a Phase onetwo trial is expected to read out in the Q4 of this year. Pending the results from the Phase 1 portion of this study, We intend to evaluate LYT-two hundred further, both alone as a single agent and in combination with BeiGene's agent or chemotherapy. Agene's agent is an anti PD-one immune checkpoint inhibitor, which we have access to through an agreement we announced earlier this year. LYT-three hundred was developed through our GLIF lymphatic targeting platform and is an oral form of a natural neuro steroid called allopregnanolone.
An IV version of allopregnanolone is approved by the FDA and marketed in the U. S. As brexanolone or ZULRESSO. RULESO is administered as a 60 hour IV infusion, which is greatly limited to usage in postpartum depression disorder and would likely be a limitation for other indications. We believe that LYT-three hundred has the potential to overcome these challenges and may be applicable to treating a range of neurological and neuropsychological conditions.
We plan to advance LYT-three hundred into a Phase 1 trial to assess PK and target engagement in healthy volunteers by the end of this year. Our most recent addition to our wholly owned pipeline, LYT 500, is derived from our Livio technology platform, which we have fully integrated into our wholly owned programs. LYT-five hundred is an orally administered therapeutic candidate In development for the treatment of IBD. LYT-five hundred contains 2 active agents and is designed to promote both mucosal healing And inflammation simultaneously by using the Alivio technology, which is designed to enable direct targeting of the drugs to sites of inflammation, while potentially having minimal impact on healthy tissues. Finally, I'm very pleased to call out a separate announcement made this month that Doctor.
Julie Croft will be joining the PureTech team as Chief Medical Officer to oversee the clinical development of our rapidly advancing clinical stage wholly owned pipeline. Julie has overseen the development 8 therapeutics that advance through Phase 3 development, including 3 FDA approvals. And she has extensive I would now like to welcome George Farmer, Sureteq's Chief Financial Officer to the call so we can provide a recap of our 2021 half year results that were announced earlier this morning.
Thank you, Daphne. PureTech continues to be in a very strong financial position That is stronger than it has ever been. At the PureTech level, we ended the first half of twenty twenty one with cash and cash equivalents $409,700,000 compared to our balance of $349,400,000 at the end of 2020 and $120,600,000 at the end of 2019. This increase in cash includes $118,000,000 of proceeds From sales of our stake in a founded entity in February earlier this year, which has contributed to our expected cash runway guidance into the Q1 of 2025, which we confirm today. This guidance is based off of our conservative budget projections and does not include potential non diluted capital inflows from possible additional monetization of positions in our funded entities, Future strategic partnerships, equity financing or grant funding.
On a consolidated basis, Our cash and cash equivalents were $439,700,000 at the end of the first half of twenty twenty one compared with $403,900,000 at the end of 2020 $162,400,000 at the end of 2019. Our revenues were mostly driven by payments from our pharma collaborations and are expected to continue to fluctuate from year to year. On a consolidated basis, our revenues in the first half of twenty twenty one were $5,800,000 primarily driven by grant revenue, collaboration and license payment. Our first half twenty twenty one operating loss was $68,100,000 compared to $52,800,000 in the first half of twenty twenty, largely driven by the rapid clinical advancement of our wholly owned program. Our G and A and R and D expenditures increased approximately 20% and 26%, respectively.
On a consolidated basis, we reported a net loss of $77,600,000 for the first half of 2021 compared to net income of $123,700,000 for the first half of twenty twenty. It's important to note that this difference is driven by IFRS accounting rules and reflects considerable gain on investments held at fair value in 2020 and increased equity method accounting based losses in 2021. During the 1st 6 months of 2021, Our founded entities raised an aggregate sum of $636,200,000 99.8 percent of which came from 3rd party investors. I would now like to provide an operational update related to our response to the COVID-nineteen pandemic and new ways of infection. For the safety of our employees and our community, we continue to have COVID safety protocols in place, including daily employee and visitor health Screenings and twice per week mandatory on-site COVID testing.
We have also put in place an infectious disease outbreak response plan to enable I'd also like to highlight that we are increasing our efforts around environmental, social and governance While we have embraced ESG efforts, we aim to report on things we are doing to benefit the environment and community as well as on our governance practices. ESG values are fully aligned with our approach to building sustainable business so that we can deliver on our mission to treat patients with underserved diseases. As a testament to our Commitment to further building on this strong foundation, the Board established a standalone ESG committee in 2020, Shared by our Non Executive Director, Kieran Mazumundar Shah to manage, review and advance ESG issues within the business and drive enhanced reporting through the ESG report each year. In accordance with this, we issued our very first ESG report, which can be found in our 2020 annual report and accounts available on our website at puretechhealth.com. We're also proud to be one of only 9 companies in the 5,250 to have a woman CEO as well as a diverse Board and team of senior executives, including Doctor.
Julie Krock, who recently joined us as Chief Medical Officer. We have made great progress this year and have a lot to look forward to over the ensuing months and beyond. I will now turn the call back over to Daphne.
Thank you, George. In summary, as you look across our wholly owned pipeline and our founded entities, We believe the remainder of 2021 is going to be exceedingly catalyst rich, which includes multiple value drivers across our wholly owned pipeline and our founded entities, including at least 4 expected clinical study initiations and 7 expected clinical readouts. I would like to thank the entire PureTech team on their continued hard work this year as we achieve more historic milestones as an organization. I would also like to extend my gratitude to our tremendous Board and R and D Committee for their wise counsel and strategic oversight. We are fortunate to have a dedicated team and outstanding scientific collaborators who are committed to continue to develop highly differentiated medicine For patients who have long struggled to find effective treatments.
To our shareholders, thank you for your continued vision and the trust that you place in our team. And in particular, I'd like to thank the patients and clinicians that are participating in our clinical trials. Lastly, 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
Thank Our first question today comes from Amy Walker from Peel Hunt. Amy, please go ahead. Your line is now open.
Thank you. Good afternoon, team. I have a few questions, please. The first is on the Phase 2 trials currently ongoing for LYT-one hundred, Could you give us a little insight into the progress of enrollment on both of those studies? I know you've commented that you expect the data in long COVID to happen by the end of this year.
But based on current enrollment progress, where sort of within 2022 do you currently the readout for lymphedema to land and what are the trends you're seeing in enrollments, particularly on the lymphedema study, please? That's the first one. I'll ask a couple of follow ups afterwards.
Thanks, Amy. It's good to hear from you. So, we are Progressing well on enrollment. I think that with all of these studies, we continue to track COVID epidemiology. So we're very pleased that we are where we are today.
But I would say that We're going to continue to track it. And in the case of the long COVID study, we're looking to Have data towards the end of the year. In the case of lymphedema, I'd say, I think we've guided first half, but closer to the middle of the year in that first half.
Thanks, Daphne. And then just to follow-up on that. I think from one of the earlier slides, I know the answers, but I just wanted to confirm, PureTech's view is that neither of those studies Is likely to be fileable, but in both instances, there will need to be follow-up trials before filing with FDA. Is that correct?
That's definitely the case for the Lincedema study. And we can't really comment with regard to the long COVID study since that's really an emerging indication. But once we see the data, we'll be in a better position to guide as to what we expect with regard to registration.
Got it. And then my last question, thank you, is just around Genesis And the $1,300,000,000 that was mentioned as a valuation attached to the merger announcement, I wondered, can you comment whether that valuation included any assumptions around the contribution from GS 200 in type 2 diabetes, given we're expecting a readout from that in the second half. I just want to understand how much That was baked in or discounted in that $1,300,000,000
That's a great question. We think that most of the valuation is resting on the Plenity product, which is gearing up for our broad launch now, has just started their broad launch. So we don't think that there's a lot of value baked in for the additional products. So we believe there's significant value there. Thanks for pointing that out.
That's great. Thank you. That's all I had.
Thanks Amy.
Thank you. Our next question today comes from Todd Smith from SVB Leerink. Please go ahead, Tom. Your line is now open.
Hi, everyone. This is Mike on for Tom. I guess one from our end is, what are we going to learn from the Phase 1 PK studies that were initiated earlier this year for LYT-one hundred? And more specifically, can you discuss the additional dosing levels and regimens that you're exploring in these studies? Are you going to be testing Higher doses or less frequent dosing, any color there?
Yes. Thanks, Mike, and Tom as well, I understand you're not traveling right at this moment. So I'm going to ask Eric Alenko to answer that question. Eric?
Absolutely. So the Phase 1 studies are indeed looking at Morning, additional doses. So in our original MAD study, we didn't hit a maximum tolerated dose. So we are extending that dosing. And then we have additional studies that really are In the category of really confirming important information, dotting i's and crossing t's, For instance, confirming confirmation of the dose to carry forward in future studies, which would be most Similar to the approved dose of profundone that's currently used.
Got it. That's very helpful. And then I guess just as one follow-up. In terms of LYT-one hundred in IPF, You cited regulatory agencies are going to help you shape the guidance in 4Q 2021. Can you provide any additional color on Whether or not the discussions have already been scheduled and when you expect those discussions to take place?
Yes, thank you. Yes, those discussions have already been scheduled and that is definitely been taken into account as we Say that we'll be able to provide more guidance later this year. So, we are Excited to be able to share more information about that as soon as we've completed those discussions.
Thanks everyone. Thank you, guys. Thanks
so much.
Our next question today comes from Lucy Codrington from Jefferies. Lucy, please go ahead. Your line is now open.
Hi there. Thank you for taking my question. Just a follow-up on the ITS trial design. I wonder if you can share What you anticipate to be or what has been any potential sticking points when designing the trial? And if possible, can you share what your kind of Blue Sky scenario would be in terms of the path to market for that product?
Thank you.
Thanks so much, Lucy. I don't know that we I mean, I think we have our own Blue Scotiched scenarios, but I would hesitate about sharing something like that because we also have other scenarios that would be Perfectly fine with us. So, I will ask Eric to weigh in on whether he can provide more guidance on that question. Eric?
I think that your answer is a very clear one. We have in mind Various designs that we're contemplating for the trial and as we have interactions, as we were discussing With regulatory authorities, and we get data coming in, of course, just confirming Certain details, for instance, from the Phase 1s will be able to guide more later this year.
One thing I'll add, Lucy, is that we're really fortunate that we're working with the PIs that basically ran all of the IPF and some of the related studies in progressive fibrosis and interstitial lung diseases. So We have a lot of insights into what has been done before, what's actually sort of The standard practice right now and where are there places that one could improve with regard to, for example, potential enrollment and things like that. So, we have some really good information here and there's different parameters that we're Going to explore together with regulatory agencies. I'm sorry that we can't provide more detail at this point.
No worries. That all makes sense. Thank you.
Thanks so much, Lucy.
Our next question comes from Edward A. Temthoff. His question is, what can we expect from Aurisome clinical data this year and development plans in 2022.
Thank you. Can you just repeat what can we expect from what was the word before clinical data? Aurasome. Aurizome. Okay.
Yes. Thank you so much. So I'm going to point that question over to Bharat Chirira.
Yes. So in terms of the Aurizomes, we continue to actually evaluate the platform. It's It's quite exciting. It's for the prospect of potentially administering biologics orally and have the body actually make the therapeutic proteins. And we have indicated that we should have Some preclinical data later this year to kind of test the initial proof of concept and we're on track for that With respect to the Aurizome, we're also looking at administration of a number of different Payloads, including messenger RNA and other expression systems that can be administered orally, which would be
Thank you. Our next question comes from Simon Tao, which is, please can you point to any positives coming from the NASDAQ listing? Clearly, the share rating hasn't benefited as yet, But do you believe that U. S. Investors are showing any extra interest and may become buyers?
Thanks so much. So, we the NASDAQ listing, we did not do an offering together with that NASDAQ listing. So, While what we've had happen is a lot more interest from U. S. Investors, people Beginning to take a lot more meetings, digging in, really learning about the wholly owned pipeline.
So we think that that's been beneficial and we think that that will play out as we move forward and more investors become aware of our story. Thank you very much.
We have no further questions. So at this time
I think we have questions.
We have one final question, which is from a follow-up from Simon Tow. Please let me know if we'd like, which is your largest shareholder stake is clearly perceived as an overhang as it is held in the U. K. Income funds, which are having large redemptions. Is the Board being proactive on this front and trying to move things on.
Yes. Thank you. The Board and the The executive team is very aware and we've been very focused on How to unlock the value? So as I think it has been noted by a couple of these questions, there is a significant value disconnect between even if you just Take our stake in our public founded entities, our cash, and don't even account fully for The royalties that are due to us from the founded entities potentially if things go well, which could be worth more than The entire equity stake we own public funded entities, our private funded entities and our advanced There is clearly a value disconnect. And I can assure you that our entire executive team and our Board of Directors is very well aware of this.
And we are very committed to making sure that the full value of CureTek and that what we've generated And what we will generate will pass them on to our shareholders. So, I can assure you that this is a huge priority for us. And what we're really excited about is that we've been able to execute and deliver on results. So that's a great position to be in, Strong cash and we are looking at all of these other dynamics as well. Sorry about my cat in the background.
We have no further questions today. And so that concludes today's conference call. Thank you so much for your time. You may now disconnect.