Good afternoon, ladies and gentlemen, and welcome to the Malin Corporate Update Call, which follows the release of Malin's interim financial statements for the 6-month period to 30th of June 2022 this morning. At this time, all participants are in listen-only mode. After the presentation, we will conduct a question and answer session and the instructions on how to ask a question will follow at that time.
As a reminder, today's conference call is being recorded. I will now hand over to Fiona Dunlevy, Malin's Company Secretary.
Good afternoon, ladies and gentlemen, and welcome. I'm joined on the call today by Darragh Lyons, our Chief Executive Officer, and Dara will be walking through our 2022 interim results presentation, which is available within the investors section of our website, www.malinplc.com.
Dara will provide some of the highlights of our progress in 2022 to date, what that means for our intrinsic equity value per share, and he will look ahead to the milestones we're targeting for the remainder of this year and into next year.
There will be an opportunity for questions at the end of the call. Finally, may I draw your attention to the disclaimer contained within the presentation. I will now hand over to Dara.
Good afternoon, ladies and gentlemen. We're pleased with the progress made by Malin and our investee companies during 2022 to date with some important clinical, operational and transactional milestones achieved by our investee companies, despite the very difficult biotech capital markets environment.
Poseida entered into a broad strategic collaboration with Roche to focus on the research and development of allogeneic CAR-T therapies directed towards hematological malignancies, under which Poseida could receive payments of up to $6 billion. Both Poseida and Immunocore took advantage of some improvement in the biotech equity capital markets in recent months to raise $80 million and $140 million respectively, thereby significantly extending both companies' cash runways.
Beyond these transactional and capital achievements, several important clinical and operational milestones were achieved by our companies during 2022 to date, including two drug approvals from the portfolio with the US FDA approval of Immunocore's lead product candidate, KIMMTRAK and VIVJOA through its successor company, Mycovia. Turning to our financial position then on Slide 4.
Following the return of EUR 95 million of cash to our shareholders during 2021, Malin opened the year with cash of EUR 32.7 million. Malin's corporate cash balance at 30 June 2022 was EUR 27.9 million. The most significant investment outflow during the period to June was an additional purchase of Immunocore shares in January 2022, with an outlay of $2.7 million.
Post period end in August 2022, we acquired an additional 2.2 million shares in Poseida for consideration of approximately EUR 7.4 million. We also sold approximately 380,000 shares in Immunocore during August, yielding proceeds of approximately EUR 20 million. At 5 September 2022, Malin's corporate cash balance was 40.4 million, an increase of EUR 12.5 million over the 30 June 2022 position.
The sale of a small portion of our holding in Immunocore was triggered by the strong share price momentum in Immunocore stock following the completion of their PIPE financing, which reduced Malin's stake in Immunocore from 5.7% to 5.2%. Our sale of 380,000 shares was completed at an average price of $54.15 per share.
We had previously taken advantage of some market weakness in Immunocore to acquire 128,000 shares in the market during December 2021 and January 2022 at an average price of $28.89 per share. Malin retains a 4.5% stake in Immunocore, currently valued at approximately EUR 110 million, and we see significant potential upside for this position from Immunocore's important clinical and operational milestones in the months ahead.
Corporate cash operating expenses for the first half of the year were EUR 1.5 million. We also incurred EUR 1.6 million of exceptional costs during the period, including over EUR 1 million of litigation-related costs in preparing for the Irish High Court proceedings initiated by the holders of A ordinary shares in Malin against the company.
Our key investee companies are set out on Slide 5 of the presentation and beyond the transactional activity, several clinical and operational milestones were also achieved by our other investee companies during 2022 to date. I'll discuss these milestones in a few moments, along with the milestones we are targeting in our investee companies over the next year and beyond.
I believe that these events can be the catalyst to further transactional activity in our companies in the months ahead. Before doing that, I'll work through the intrinsic equity value calculations. As set out on Slide 6 of the presentation, the estimated fair value of our investee companies at 30 June 2022 was EUR 231 million compared to EUR 263 million at 31 December 2021.
The decrease in the aggregate fair value during the first six months of 2022 was primarily attributable to the decline in the public market share prices of Poseida in that period. The fair value of our interest in Viamet is EUR 6 million lower than the December 2021 estimate based on a reassessment of the timing to gain meaningful commercial traction with the product in the U.S. and other markets, particularly in light of the contraindication for women of reproductive potential.
We updated the 30 June 2022 fair value to take account of the current market prices of Immunocore and Poseida. At 5 September 2022, the aggregate fair value of our investee companies was EUR 309 million.
This increase is driven by the improvement in the public market share prices of Immunocore and Poseida over the summer months, in line with a broader biotech market improvement and buoyed by the achievement of some notable strategic and operational milestones and progress by both companies over the past few months.
On slide seven, we've included our estimate of the intrinsic value per share of Malin, which we regard as the most important and robust metric for assessing the performance of Malin. This is calculated based on our estimate of the aggregate fair value of our investee companies and adjusted for our corporate cash position, divided by the total number of outstanding issued ordinary shares.
As I said earlier, our cash at 30 June was EUR 27.9 million and this has increased to EUR 40.4 million at 5 September.
Malin's estimated intrinsic equity value per share then at 30 June was EUR 7.61 per share, compared to EUR 8.70 per share at 31 December 2021. The decrease is due to the reduction in the aggregate value of our investee companies in the six-month period to 30 June, which as I said earlier, was primarily attributable to the decline in the public share price of Poseida.
Based on the updated current market values of Immunocore and Poseida, together with our updated cash position, Malin's estimated intrinsic equity value per share at 5 September 2022 was EUR 9.08, a 19% increase over the 30 June 2022 value of EUR 7.61 per share. This current intrinsic equity value per share is 4% higher than the 31 December 2021 value of EUR 8.70 per share.
I'll now give some thoughts on the position and prospects of our most significant investee companies starting on slide eight. Turning to Immunocore first. Immunocore has a very positive 2022 to date following the U.S. FDA approval of KIMMTRAK in January 2022. This drug is now approved in over 30 countries for the treatment of metastatic uveal melanoma and commercial launches are progressing.
Immunocore recognized over $46 million of revenue for the first six months ending 30 June 2022. Beyond KIMMTRAK, Immunocore continues to advance its broad clinical pipeline. The company will present initial phase 1 data from its PRAME targeting ImmTAC at the ESMO Congress in Paris on Friday of this week. We are encouraged by the promising data included in the abstract released by ESMO last Monday and look forward to seeing more extensive and mature data on Friday.
The company is also committed to reporting complete data from its phase 1 study of its ImmTAC that targets the MAGE-A4 cancer antigen, which is expressed on multiple solid tumor indications, as well as initial data from the ovarian expansion arm before the end of 2022.
Immunocore also recently announced that it will initiate a randomized phase 2/3 trial of tebentafusp in previously treated advanced melanoma patients before the end of 2022, having previously reported very promising survival benefit for tebentafusp in metastatic cutaneous melanoma.
Immunocore completed a $140 million PIPE financing transaction in July 2022, which the company expects will enable cash runway to be extended through 2025. Our conviction on Immunocore remains strong, and we maintain a significant interest in the company through our 4.5% stake.
We look forward to the initial PRAME data later this week, the MAGE-A4 updated data in the months ahead, as well as many other clinical and commercial milestones Immunocore can deliver over the next year and beyond. Turning to Poseida on slide 9.
Poseida entered into a strategic collaboration and license agreement with Roche in August 2022, which is focused on the research and development of allogeneic CAR-T therapies directed to hematologic malignancies utilizing Poseida's proprietary genetic engineering platforms.
Under the agreement, Roche gains exclusive rights or options to develop and commercialize a number of allogeneic CAR-T therapies in Poseida's portfolio that are directed to hematologic malignancies, including Poseida's BCMA-targeted allogeneic CAR-T program that is currently in a phase 1 study.
Poseida will receive $110 million upfront from Roche and could potentially receive payments of up to $6 billion in aggregate value, as well as tiered sales royalties into the low single digits. Sorry, low double digits across the multiple programs.
Following the announcement of the Roche collaboration, Poseida completed an underwritten public offering of shares, raising gross proceeds of approximately $80 million. Malin acquired approximately 2.2 million shares in the offering for consideration of approximately $7.5 million. Malin's equity stake in Poseida following the completion of the offering is approximately 14%.
Poseida now expects that the cash, its cash runway extends through at least mid-2024. Poseida's also made important progress in clinical and pre-clinical pipeline programs during 2022 to date.
Poseida dosed the first patient in the phase 1 study of its BCMA-targeting allogeneic CAR-T treatment of relapsed or refractory multiple myeloma patients and also initiated dosing in its phase 1 study of its MUC1-C-targeting allogeneic CAR-T being developed for the treatment of solid tumors derived from epithelial cells, including breast and ovarian cancers.
Poseida is also progressing a phase 1 clinical trial of its PSMA-targeting autologous CAR-T product candidate that's being developed to treat patients with metastatic castration-resistant prostate cancer. Poseida has recently added salivary gland carcinoma to its clinical protocol, and Poseida has a second-generation allogeneic program targeting PSMA in preclinical development also.
Poseida is also advancing multiple gene therapy programs in liver-directed disease, including its wholly owned P-OTC-101 program for the in vivo treatment of urea cycle disease caused by congenital mutation in the ornithine transcarbamylase or OTC gene.
Poseida is also advancing its Factor VIII gene therapy program, which is partnered with Takeda for the in vivo treatment of hemophilia A. Poseida continues to face share price pressure in the market with the current market cap representing a discount to its pro forma cash position.
However, we remain steadfast on the scientific and clinical differentiation offered by Poseida cell and gene therapy technology platforms and the potential of its broad group of programs to deliver clinically meaningful benefits to patients. The recently executed Roche and Takeda collaborations underline the strengths and potential of the company's technology and platforms.
Turning to Viamet on slide 10. Mycovia, the successor company to Malin's investee company, Viamet, obtained FDA approval of VIVJOA for the treatment of RVVC in females with a history of RVVC and who are not of reproductive potential.
Mycovia has now initiated the commercial launch of the drug in the U.S., and we are working with the Mycovia team to understand the implication of the drug being contraindicated in women of reproductive potential, as well as the possible strategies they will pursue.
We expect that gaining significant commercial traction for the drug will take several years and may require further work by Mycovia. Malin, alongside other shareholders in Viamet, will benefit from milestones in sales royalties linked to the global commercialization and development success of the drug committed to by Mycovia under the agreement through which Mycovia acquired Viamet's antifungal drug back in 2018.
Turning to Xenex then, which following a blowout year in 2020 and into 2021 triggered by the COVID pandemic, reverted to a more sustainable level of growth during the second half of 2021 and again during the first half of 2022. The company is working on several initiatives to further expand its footprint and differentiate its technology.
Beyond these assets, we continue to work closely with our early stage and legacy assets to support their innovation and development, with the aim of helping these companies to mature into viable and more valuable enterprises and to generate capital realization opportunities for Malin. This work yielded a gain of $3 million from one of our legacy assets in January 2022, when we divested of our previously written off interest in Jaan Health.
We've also seen some encouraging progress from Novan, a company with nitric oxide-focused technology with multiple potential therapeutic applications. The targeted milestones and value inflection potential from where our companies are today are set out on slide eleven of the presentation. For Immunocore, we're looking to see continued growth and traction for KIMMTRAK sales globally.
We expect average duration of therapy to continue to grow, allied with the strong reimbursement and pricing to underpin the significant value of this asset. We look forward to the initial data on the PRAME program at the ESMO conference later this week, having been encouraged by the abstract released last Monday. The company will also possibly report more mature data from the PRAME program at some point during 2023.
The company has also signaled further data update on the MAGE-A4 program before the end of 2022 following the encouraging data released late last year. Immunocore has also initiated a HIV study which could demonstrate the effective application of the technology in infectious disease, which opens up another large opportunity for the company.
Poseida expects to present initial clinical data from the phase 1 studies of both its BCMA-targeting allogeneic CAR-T for the treatment of relapsed or refractory multiple myeloma and its MUC1-C targeting allogeneic CAR-T targeting solid tumors before the end of 2022.
Poseida also expects to give an update on its PSMA targeting autologous CAR-T therapy being developed to treat patients with metastatic castration-resistant prostate cancer during 2023, having presented encouraging preliminary results in February.
For Viamet, we're looking to see some initial commercial traction of the newly launched drug, VIVJOA, through its successor company, Mycovia in the US. Progress and clarity on future development efforts are also something we'd be looking to see. We also expect further approvals of the drug in other jurisdictions, including Europe and China, during 2023 and beyond.
For Xenex then, we're targeting steady state top-line growth and some news flow from the business initiatives that the management team are working on.
In terms of our strategy and outlook, as set out on slide 12 of the presentation, we remain committed to maximizing shareholder returns by protecting and enhancing the value of positions in existing investee companies and deploying additional capital into existing and new asset opportunities with suitable value risk and maturity profiles and which are strategically aligned to our business.
Excess capital of the business, having taken account of the expected capital deployment opportunities and corporate spending needs of the business, will be returned to shareholders. Our current intrinsic equity value per share is double our current share price. While the decline in our share price since the start of the year has been based on very light traded volumes, the fall is nevertheless very disappointing.
We will continue to assess the options to support the share price in the months ahead, but ultimately we believe that shareholder returns will be underpinned by our return of excess capital of the business to our shareholders. We look forward to the remainder of the year with optimism that the clinical and operational progress that our companies are making will further translate into tangible value creation for all. I'll now hand over the call to the operator, who will open it up for Q&A.
Thank you. We will now take questions from the call. If you would like to ask a question, please press star followed by one on your telephone keypad. If you would like to remove your question, please press star followed by two. When preparing to ask your question, please ensure your phone is unmuted locally. We take our first question from Colin Grant from Davy. Please go ahead, Colin.
Yeah. Hello, everybody. And thanks for doing the call, taking questions. A couple from me, please. Just firstly, on Immunocore, where you sold 380,000 shares, could you just give the background as to why you decided to do that and also how you think about the remaining position there? That's the first one. Just moving on to Viamet. You spoke about the contraindication in Viamet's approved drug. Can you just maybe give the background and status of that, please? Thank you.
Okay. Thanks, Colin. Yeah, sure. On Immunocore, I suppose we saw the positive momentum in the share price following the PIPE financing transaction that they completed during July. You know, as we said, we sold 380,000 shares. Really the aim of that is to de-risk the overall position by locking in a portion of the gain while maintaining a significant interest in the company. As we said in the prepared remarks on the call, we're very bullish on Immunocore's prospects in the future.
Locking in some of that realized gain, we're de-risking, you know, the position from some of the downside risks, some of which are out of Immunocore's control, such as, you know, a broader market dip like we saw earlier this year when Immunocore traded as low as $20 per share.
We saw that as a buying opportunity, and we saw the share price, you know, over the summer into the 50s, as being a good selling opportunity. That's really the rationale to just lock in that EUR 20 million, you know, at what we thought was a pretty good value.
Now look forward to holding that 4.5% interest and see what the company can deliver in terms of clinical data and KIMMTRAK traction over the coming months and possibly longer. In terms of Viamet and the contraindication. The contraindication dates back to an animal study and actually a rat study.
Ocular abnormalities were observed in a pre- and postnatal animal study in the offspring of rats that were administered oteseconazole, as it was then, from gestation day 6 through to lactation day 20. And that was done at doses about 3.5 times the recommended human dose. Further work will be required in animals to better understand the findings of that rat study.
It's important to note that all other tox work that was done in animals that was completed over the past decade was done without observing any troubling observations. I suppose probably more fundamentally is that this drug has been dosed in over 1,200 women to date over the various clinical studies before it was obviously approved.
Those studies have really established VIVJOA as a very safe drug and having a very safe safety profile alongside having best-in-class efficacy. It is just this rat pre- and post-natal study that the company's gonna have to work through and understand.
We're working with the company to understand what the impact of that contraindication is and the future strategies that they may pursue. I suppose we have an eye on the potential for and timing of the treatable patient population reverting to the wider group treated in the clinical studies. I think it's really a work in progress.
Okay, great. That's very helpful, Gerald. Thanks. I'll hand it over for anybody else who has questions and circle back if I can later on. Okay. Thank you.
As a reminder to ask a question, please press star followed by one on your telephone keypad now. As another reminder to ask a question, please press star followed by one on your telephone keypad. We have another question registered from Colin. Please go ahead, Colin.
Great. Yeah, just take the opportunity, Gerald. I hope that's okay. Just on another one in terms of the $6 billion of potential value that you mentioned. This is the total value that could come through to the company. Can you talk a little bit around. I'm just trying to get a sense of how to think about that in terms of the timing. What are the milestones? How should we think about the impact it could that Malin could actually see from that. How would that work out? Thanks.
Yeah. Thanks, Colin. So yeah, I suppose in any of these deals, some of the milestones and related contingent payments are easier achieved than others. The company have said that there's $110 million of milestones in addition to the $110 million upfront that are very near-term milestones.
I suppose the implication is that the company believe that that quantum of near-term milestones is pretty achievable. In terms of the other milestones are obviously curtailed from what we can say publicly, given Poseida is a public company as well. It's the typical milestones related across all of the programs.
The nature of the deal with Roche is that Roche has the option to essentially license several programs on the hematologic side of the Poseida cell therapy platform. You know, once they license them, then they are subject to development milestones as those programs progress through the clinic. At each stage, phase 1 to phase 2, etc., there will be payments due to Poseida.
Beyond that, assuming the drug does get approved, there will be sales related milestones and then dip into those double-digit sales royalties on drugs as well. I suppose the other thing is that Roche will be picking up the tab for development costs post phase 1.
That's obviously a major saving in terms of the cash burn. Also, I suppose the key thing around the collaboration is that we are bringing in, you know, one of the best oncology players in the world to help run these programs with Poseida. Poseida is obviously, you know, pretty small company in relative terms, so gaining that expertise from a development point of view, from a regulatory point of view, critically for cell therapy from a manufacturing point of view.
There are some of this probably softer but very important key benefits that we see from this Roche deal. Roche have obviously seen enough from what Poseida's technology offers to enter into this, you know, very broad collaboration.
From a Poseida point of view, it's obviously very important to get this deal done and you know, be able to move these programs on with a top quality partner.
Great. Thanks. Darragh, on the point of the $110 million, so there's 2 different amounts. There's an upfront one and then there's a near-term milestone. When does Poseida receive the upfront $110 million, do you know? And when in near term, I'm just trying to get a sense of what near term means for the other $110 million. Is that 12 months, 2 years? Any color on that?
I think in terms of the upfront amount, there was a competition clearance that was required before the deal could close. The company haven't announced that that has been done yet. That was the only barrier to it being done. I think they were looking at a pretty or typically a pretty short window for that clearance to come through. In terms of the EUR 110 million, again, they haven't said publicly what sort of timeframe that is, but I'd certainly understand it to be, you know, within the next year or so.
Okay.
It's not all one milestone. My understanding is that there's probably several milestones to be achieved to receive that EUR 110 million over that period.
Great. Thanks a million, Darragh.
We have a question from Dermot Farrelly from Herbert Street Capital. Please go ahead, Dermot.
Hello, Darragh. I just have a question in relation to your sale in Immunocore. As you say, it was opportunistic. You're left with 4.5%. Do you think your 4.5% holding would be considered by other investors in Immunocore as an overhang on the stock, and as an inhibitor for any further price increase, or has the company talked to you about that, talked about any sort of lockup on that remaining amount for a period of time or anything like that?
Yeah. Thanks, Dermot. We don't have any lockup on that. I suppose what we would say is that, you know, we did have a big position in the company. It is relative to our overall portfolio. It was obviously a big position for us. I certainly don't see us as an overhang on the stock. We were able to sell the 380,000 shares that we sold in, you know, over a period of a couple of weeks in August. We did that obviously in a careful way so as not to dump it on the stock. We are...
You know, we certainly see the significant upside potential in Immunocore now. You know, with further data this week and further data before the end of the year, we certainly want to participate in that. It was really just around taking some of the gain down and then waiting to see, you know, how the company or what the company delivers in terms of data over the next few months. We certainly don't see ourselves as an overhang on the stock.
We've been a shareholder in Immunocore for seven years. You know, they're now approaching a very exciting time where they've got multiple significant data updates coming. You know, we'd certainly be a holder until those data come out over the next year and beyond.
Okay. Fair enough. Thank you.
As another reminder to ask any questions, please press star followed by one on your telephone keypad now. We have a question come through from Paul Lep age from [ Software Limited]. Please go ahead, Paul. Paul, your line is open. Please ensure you are muted locally. Paul, we're unable to hear you. Please ensure your phone line is unmuted locally.
Apologies. Hi, Darragh. I've got a question relating to your valuation of Viamet. You carried it to December thirty-one, EUR 86.7 million. Then following the indication, you've marked it down to about EUR 80.3 million as of thirtieth of June.
Given that a large proportion of the treatable population has been excluded from the potential sales universe, why hasn't it been marked down further? Are there other things which have gone in the opposite direction, which have resulted in your valuation sort of not moving quite so much?
Hi, Paul. I suppose there's a number of factors at play. Obviously the drug was approved in April. There is a contraindication in there. I suppose we need to work through what that means both in terms of the patient population and you know whether we will be able to revert to a label that is essentially treating the full patient population that was treated in the clinical studies.
We're optimistic around that. This is a rare issue. We've treated over you know 1,200 patients. You know we obviously need to see how that plays out.
You know, I suppose what we have taken into account is the fact that this drug was always gonna take a long time to sort of reach commercial traction because, you know, it's gonna require a very big sales force. It's prescribed by, you know, OB/GYNs plus physicians, so it's a very big commercial efforts that's going to be required. In all our modeling over several years, we had assumed it would take, you know, a very long time for this to gain commercial traction.
What we have taken into account is that it's gonna take longer to reach that sort of level now because of this contraindication and that sort of does explain, you know, that has been taken into account in the valuation now.
I suppose the other thing is that we have gained from the strengthening of the US dollar on the other side, having taken into account that. There are different factors at play in terms of the valuation in coming to EUR 80 million. We obviously will need, you know, as we always do, we continue to look at the valuations over time based on the best available information we have and based on, you know, our views of what, you know, regulatory or other development milestones we see into the future.
Thank you.
We have no further questions registered, so I'll hand it back to Darragh for any closing remarks.
Sure. Thank you all for joining us this morning on the corporate update call. We'll meet many of you in the weeks ahead, and we look forward to continuing to communicate our progress with you in the months ahead. Good afternoon.