AdAlta Limited (ASX:1AD)
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May 8, 2026, 4:10 PM AEST
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Investor Update

Jan 9, 2025

Tim Oldham
CEO and Managing Director, AdAlta Ltd

Hello, my name is Tim Oldham. I'm the CEO and Managing Director of AdAlta Limited, and I'm speaking to you today from San Francisco, where we're in final preparations for the J.P. Morgan Healthcare Week, one of the biggest partnering and investment conference events on the biotech calendar. We're very excited heading into 2025 about AdAlta's prospects and particularly about the potential for transactions to drive growth and value creation in our two core strategies, and I'm pleased today to present to you a quick summary of those strategies. Our purpose at AdAlta is developing next-generation cell and protein therapeutics for fatal diseases. Our company has two strategies to do this: our East-to-West cell therapy strategy to position the company for scalable growth in a rapidly growing cellular immunotherapy market, and our AD-214 novel approach to fibrotic diseases, which is now available for partnering and co-development.

Our company has an attractive valuation of AUD 11 million market capitalization, or about an AUD 8.5 million enterprise value, and this we believe represents a compelling investment proposition for investors to consider. What are our two strategies? Our East-to-West cellular immunotherapy strategy is about our future. It's how we're planning to drive growth and value creation beyond our first asset, AD-214. We're addressing the need for more effective cellular immunotherapies for solid cancers. We're focused on in-licensing first or best-in-class, highly differentiated assets originating from Asia and generating first FDA-regulated clinical data in return for a significant share of that asset ownership. In essence, we're operating as a force multiplier for our Asian partners to enable them to migrate their assets into a Western-regulated market and environment. Our second strategy is about transacting AD-214.

This is our first asset, which takes a whole new approach to fibrotic diseases, and our aim of that transaction is to unlock the value we've created in AdAlta to date. AD-214 addresses the need for improved therapies for fibrotic diseases, including idiopathic pulmonary fibrosis. It's a first-in-class molecule with extensive preclinical efficacy and mode of action data and demonstrated safety profile in phase 1 clinical studies. We're now seeking to out-license or co-invest or find co-investors to help us progress this asset into phase 2 clinical trials. Turning to our East-West cellular immunotherapy strategy in some more detail, the cellular immunotherapy market is large and growing. What do we mean by cell therapies? In the context of cancer, we're talking about modifying a patient's own immune system in the laboratory in order to help it find and kill cancer. We're focusing very much on the solid tumor marketplace.

90% of all cancers represent solid tumors, compared with the 10% where these cellular immunotherapies have achieved runaway successes to date. We're now starting to see the first FDA approvals for those T cell therapies in solid cancers, and this sets the stage for much more rapid growth in this sector in the near term. Importantly, Asia leads the field in innovation in this particular modality. More than 60% of all clinical trials in T cell therapies are currently conducted in Asia, the majority in China, providing a unique innovation pool, and AdAlta aims to dominate this high-growth segment with cutting-edge solutions originating in Asia. Our competitive advantage is built around five features. Firstly, our networks, integrating that rich innovation network and ecosystem that I talked about with the efficiency and quality of Australia's clinical trial and manufacturing ecosystem in cellular immunotherapy. We're very disciplined about strategic sourcing.

We're focused on highly differentiated assets with limited competition and existing clinical data in solid cancers in order to de-risk the next stage of development. We offer a unique partnering model. In essence, we're providing asset-specific financing for our partners, enabling us to be a force multiplier and enabling them to move towards a more valuable exit in the future. The business model is capital-efficient. A modest investment focused on a single clinical trial to deliver a major inflection point in a relatively short period of time ensures that not only are these assets already de-risked by existing clinical data, but they are already poised and ready to generate a return in a relatively short space of time. And importantly, this business model is scalable and replicable across multiple assets. We are closing in on our first assets.

We have an initial pipeline under term sheet that features high-value assets targeting lung, colorectal, and gastric cancers and other solid tumors, leveraging advanced multifunctional CAR T cell therapies. A couple of examples of the types of products that we're in negotiations with at the moment are listed on the slide here. Overall, our pipeline includes over 10 high-potential therapies targeting a range of solid cancers. This slide summarizes in graphic form our business model. We in-license leading assets from Asia, enabling us to access these assets at low acquisition cost. And by financing to the next inflection point, we acquire a share of the asset in advance of an exit. Our role is to build that value, build to that inflection point by establishing Western-regulated manufacturing and obtaining that first Western-regulated clinical data, which is a substantial inflection and de-risking point for big pharmaceutical companies.

We will then focus on establishing a global manufacturing network and on licensing the assets to commercialization partners, and we will share the increase in value with our Asian partners, so for them, they're getting access to that increased value from Western-regulated market exposure, and they can ride that increase in value rather than having to out-license the assets at the stage with only Chinese data available, so our competitive advantage I mentioned earlier is based on our strategic asset sourcing discipline combined with our unique partner value proposition that enables them to essentially provide and gain non-dilutive asset financing to grow their pipeline with our network and ecosystems and a capital-efficient and risk-managed business model. Importantly, this becomes highly scalable, so early successes enable us to drive substantial growth in the future. We've made significant progress since we launched the East-West cell therapy strategy in April 2024.

We're advancing a significant number of assets through due diligence. We've appointed our consultant chief medical officer and our manufacturing partner. And we're now poised to accelerate growth as we start to convert those in-licensing conversations and term sheets into definitive licensing agreements with our aim to secure the first asset in the first half of 2025 and have three assets secured by the end of 2025. Our ultimate goal is to be putting one new asset into clinical trials every year from 2026. Success will enable us to build a powerhouse in cellular immunotherapy. We're providing a pathway for Eastern innovation in cell therapies to reach Western-regulated markets. We're focused exclusively on T cell therapies for solid cancers. We're capitalizing hard on regional advantages. We have a robust and disciplined asset selection process.

We're positioned for a rapid return on investment and recycling of capital, and we have a very highly scalable business model. This really positions AdAlta's future growth strategy in a very, very exciting field. Turning to our history now, which is all about AD-214. This is a new approach to fibrotic diseases, and this molecule is now available for partnering or co-development financing. Fibrotic diseases, including idiopathic pulmonary fibrosis, have no good outcomes today. In IPF, this is a degenerative debilitating lung disease. It will kill the majority of patients within five years, and today, two marketed therapies generate sales in excess of $4 billion and do not work particularly well. They slow progression perhaps by a year. They have debilitating side effects, and in general, patients cannot tolerate them for more than about a year.

In addition to IPF, fibrosis affects almost every other organ system, with kidney fibrosis being our second indication, and it's a potential $10 billion market. AD-214 is AdAlta's lead product candidate to date, leveraging our i-body technology. We've built an incredible value proposition with a first-in-class molecule, a preclinical efficacy in multiple animal models of fibrotic disease to de-risk clinical studies and billion-dollar indications. Phase 1 studies, 2 of them successfully completed, and clinically viable dosing regimen established with a target of subcutaneous administration every week being the market-ready product. We have a strong intellectual property position giving protection out to 2036 and potentially beyond. We have Orphan Drug Designation from the U.S. FDA, and we will receive 10 to 12 years of market exclusivity in both the U.S. and the E.U.

Our product development goals are twofold: to develop clinical proof of concept or efficacy, which in this indication is unfortunately only doable in phase 2 clinical studies, and to develop a market-preferred formulation. We prefer the subcutaneous formulation, as do our pharma partners, over a two-weekly intravenous administration. This subcutaneous formulation will add enormous value in terms of patient convenience, in terms of market share, and reduction of cost of goods. We're seeking out licensing or third-party investments to unlock the next level of value in this asset. We have advisors engaged. We have a pipeline of active discussions and a number of term sheets continuing to be developed. The value of these assets is highlighted by recent transactions that happen regularly in this space. This is IPF alone. You can also see that there are a number of substantial pharmaceutical companies working in this space.

Our team now has global reach with the appointment of an international advisory board for AD-214, a U.S.-based consultant chief medical officer for AD-214 as well to complement our existing team. We have two new directors, Michelle Burke and Iain Ross, who joined the board in the last quarter, and they will be enormously valuable as we drive the transformation from a single asset company in AD-214 into a cellular immunotherapy powerhouse. So in summary, we have all the foundations in place for transaction-driven growth. Our East-to-West cellular immunotherapy is our growth strategy going forward. It's highly scalable and highly replicable. AD-214, our new approach to fibrotic disease, is ready for partnering, ready for transactions, and we are obviously working very, very hard at J.P. Morgan this week in order to progress those discussions. We have an experienced team and a global network.

We have an institutional and large shareholder register that's been incredibly supportive, and we believe we have a very attractive valuation at this point in time. So we look forward to providing further updates on those transactions through the first half of 2025. We're very, very excited about the opportunities in front of us this year, and we believe this is an incredible opportunity for our investors and shareholders to be considering.

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