ADALTA LIMITED — Capital/Financing Update 2024

Jan 21, 2024

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ASX Announcement | 22 January 2024 AdAlta Limited (ASX:1AD)

JPMorgan Week and Advanced Therapies Week partnering progress and presentation; AD-214 Phase I extension study update

AdAlta has advanced its AD-214 and i-CAR cell therapy partnering programs during events associated with the JPMorgan Healthcare Conference (8-11 January 2024, San Francisco, USA) and Advanced Therapies Week (16-19 January 2024, Miami, USA) including an Innovation Stage presentation at Advanced Therapies Week highlighting the Company’s capabilities to enable cell and gene therapies. The Company also reports that final participants have received their final dose in AD-214 Phase I extension study.

Investment highlights

• January partnering activity included Biotech Showcase™, BIOPartnering@JPM Week and Advanced Therapies Week

• 20 discussions relating to AD-214 licensing or asset financing, including a third top 20 pharma company requesting confidentiality agreement

• Final participants received final AD-214 dose in Phase I extension study; final results due end February to support partnering

• Significant interest in the potential of i-bodies to enable multifunctional advanced (cell and gene) therapies and the Company’s i-CAR-T strategy

• Innovation Stage presentation at Advanced Therapies Week highlighting i-body® capability in cell and gene therapy

AdAlta Limited (ASX:1AD) (“AdAlta” or “the Company”) is pleased to report positive progress on partnering initiatives at key January partnering conferences.

January partnering conferences important to advancing licensing and investment deals

AdAlta attended Biotech Showcase™ and BIOPartnering@JPM Week as part of JPMorgan Healthcare Week (8-11 January in San Francisco, USA), one of the most significant industry events for partnering and investment each year, followed by Advanced Therapies Week (16-19 January, Miami, USA) a key gathering of developers of, investors in and service providers to the cell and gene therapy industry.

The Company was advancing its three key partnering objectives:

1. Secure financing for Phase II clinical studies of its lead asset, AD-214, in Idiopathic Pulmonary Fibrosis by either out-licensing, or co-developing in a third party financed asset specific investment vehicle.

2. Establish new co-development collaborations to develop i-body-enabled i-CAR-T therapies

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AdAlta Limited (ASX:1AD) 15/2 Park Drive, Bundoora 3083 Victoria Australia ABN: 92 120 332 925 www.adalta.com.au

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1. Secure access to clinic ready technology that is complementary to the i-body® platform

AdAlta CEO and Managing Director, Tim Oldham said: " Our investors and shareholders are extremely interested in our partnering initiatives. While we cannot forecast the success or ultimate value of these, we continue to believe that they represent considerable upside potential for shareholders if successful. I am delighted with January’s progress towards our AD-214 partnering goals and the positive reception our i-CAR-T cell therapy strategy is receiving. "

New AD-214 partnering leads – three top 20 pharma companies under confidentiality agreement

Across the two weeks of partnering events, the Company participated in 20 meetings related to AD-214. With many partners already in AdAlta’s out-licensing pipeline waiting for the results of the ongoing Phase I extension study, the Company was pleased to field several new licensing enquiries. Of particular note were:

• A new confidentiality agreement request from a top 20 global pharmaceutical, the third such company actively progressing detailed evaluation of AD-214.

• Approximately half the discussions were new interest from investors exploring co-developing/asset financing of Phase II clinical trials of AD-214.

AD-214 Phase I extension study on track

A key milestone for AD-214 several partnering discussions is completion of the Phase I extension study testing the safety and tolerability of AD-214 at planned Phase II doses. All participants have now successfully received all doses, with final results on track for delivery by end of February 2024.

Based on the favourable interim results reported previously,[1] the Company is working to assemble a shortlist of partners to advance discussions as rapidly as possible once final results are available.

AdAlta’s role in next generation cell and gene therapies well received

AdAlta has identified the potential for the i-body® platform to become a key building block of advanced cell and gene therapy products, and particularly i-body® enabled Chimeric Antigen Receptor-T cell (i-CAR-T cell) therapies for solid tumours. Building on AdAlta’s i-CAR-T collaboration with Carina Biotech, a clear opportunity is emerging to use the i-body® platform as the smallest available tool to help direct these transformational therapies specifically to cancer and/or to enhance their function when they arrive. During Advanced Therapies Week, the Company was able to further test this strategy with potential co-development partners, investors, and owners of clinic ready assets that AdAlta could potentially license.

The strategy and positioning were well received, increasing confidence in the potential to develop a robust and valuable clinical stage pipeline of assets after AD-214 and expanding the potential applications of i-bodies beyond CAR-T cell therapy to include gene and mRNA delivered therapies.

In an Innovation Stage presentation entitled “i-body next generation enabled advanced therapies” at 1:20am on Saturday 20 January AEST, CEO and Managing Director, Tim Oldham, summarized AdAlta’s capabilities in this transformational new field and the unique advantages of working with AdAlta in Australia. A copy of the presentation, directed to a technical audience, is attached.

For a video summary of this release and opportunity to engage in virtual discussion see: https://investorhub.adalta.com.au/link/GyVdgr

This ASX announcement has been authorised for release by the Board of AdAlta Limited (ASX:1AD).

For further information, please contact:

AdAlta Limited (ASX:1AD)

Media & Investor Enquiries

1 ASX Release 20 November 2023

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Tim Oldham The Capital Network CEO & Managing Director Julia Maguire P: +61 3 9479 5159 P: +61 2 8999 3699 E: t.oldham@adalta.com.au E: julia@thecapitalnetwork.com.au

About AdAlta Limited

AdAlta Limited is a clinical stage drug development company headquartered in Melbourne, Australia. The Company is using its proprietary i-body® technology platform to solve challenging drug targeting problems and generate a promising new class of single domain antibody enabled protein and cell therapeutics with the potential to treat some of today’s most challenging medical conditions.

The i-body® technology mimics the shape and stability of a unique and versatile antigen binding domain that was discovered initially in sharks and then developed as a human protein. The result is a range of unique proteins capable of interacting with high selectivity, specificity and affinity with previously difficult to access targets such as G-protein coupled receptors (GPCRs) that are implicated in many serious diseases. i-bodies are the first fully human single domain antibody scaffold and the first based on the shark motif to reach clinical trials.

AdAlta is extending Phase I clinical studies for its lead i-body candidate, AD-214, that is being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other human fibrotic diseases for which current therapies are sub-optimal and there is a high unmet medical need. Preparation for Phase II clinical studies is also underway.

The Company is also entering collaborative partnerships to advance the development of its i-body® platform. It has a collaboration with Carina Biotech to codevelop precision engineered, i-body enabled CAR-T cell therapies (i-CAR-T) to bring new hope to patients with cancer. It has an agreement with GE Healthcare to co-develop i-bodies as diagnostic imaging agents (i-PET imaging) against Granzyme B, a biomarker of response to immunooncology drugs, a program now in preclinical development.

AdAlta’s strategy is to maximise the products developed using its next generation i-body® platform by internally discovering and developing selected i-body enabled product candidates against GPCRs implicated in fibrosis, inflammation and cancer and partnering with other biopharmaceutical companies to develop product candidates against other classes of receptor, in other indications, and in other product formats.

For more information

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To learn more about AdAlta please click here: www.adalta.com.au

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i-body® enabled next generation advanced therapies

AdAlta Limited (ASX:1AD) Advanced Therapies Workshop Miami 19 January 2024

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Disclaimer

Investment in AdAlta is subject to investment risk, including possible loss of income and capital invested. AdAlta does not guarantee any particular rate of return or performance, nor do they guarantee the repayment of capital.

This presentation is not an offer or invitation for subscription or purchase of or a recommendation of securities. It does not take into account the investment objectives, financial situation and particular needs of the investor. Before making any investment in AdAlta, the investor or prospective investor should consider whether such an investment is appropriate to their particular investment needs, objectives and financial circumstances and consult an investment advisor if necessary.

This presentation may contain forward-looking statements regarding the potential of the Company’s projects and interests and the development and therapeutic potential of the company’s research and development. Any statement describing a goal, expectation, intention or belief of the company is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercialising drugs that are safe and effective for use as human therapeutics and the financing of such activities.

There is no guarantee that the Company’s research and development projects and interests (where applicable) will receive regulatory approvals or prove to be commercially successful in the future. Actual results of further research could differ from those projected or detailed in this presentation. As a result, you are cautioned not to rely on forward-looking statements. Consideration should be given to these and other risks concerning research and development programs referred to in this presentation.

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AdAlta (ASX:1AD): Progressing multiple transaction opportunities

Purpose: i-body® targeting for next generation therapeutics Going where antibodies can't to produce high-value, next generation protein and cell therapies for debilitating diseases

Discovery business

Product development business

i-body® “inventory” of high value product candidates for development or licensing

Product candidates progressing through value-adding development milestones for out-licensing or co-development

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Immuno-oncology
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Fibrosis/inflammation
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i-body® platform + in-house discovery team

Experienced leaders, in-house protein engineering + cost effective Australian location

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AdAlta’s portfolio: High value therapeutics addressing challenging diseases in fibrosis and immuno-oncology and a platform grow further

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Fibrosis: degenerative, progressive, fatal AdAlta’s AD-214 could meet a desperate need for new approaches for debilitating diseases of the lung (US$4.3b), kidney (US$10b) and eye (US$15b) – Phase I complete Comparator licensing transactions: >US$45m up front; US$320-1,000m milestones CAR-T cell therapy providing new hope… for blood cancer patients so far AdAlta and Carina’s i-CAR-T cells could offer the same hope for solid tumour patients (US$20b by end of decade) – discovery/ in vivo PoC stage Comparator licensing transactions: >US$10m up front; >US$300m milestones Immuno-oncology drugs revolutionising cancer treatment… for some AdAlta and GE Healthcare’s GZMB i-PET imaging agent could identify responders early (US$6b) – in vivo PoC Comparator product revenue potential: >US$400m pa Traditional antibodies can’t do everything! AdAlta’s i-bodies are a differentiated drug discovery platform partners can leverage for difficult diseases – building inventory

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i-bodies for advanced therapies

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Invention of i-body® technology: first fully human domain antibody system

hNCAM domain 1 scaffold + randomized synthetic shark VNAR-like binding loops

• 10% the size of Mab; 50% the size of scFv; CDR3 up to 24 AA

• • Capable of engaging unique receptor epitopes and inducing unique pharmacology

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CDR3
CDR1
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CDR3
CDR1
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Shark VNAR

hNCAM Domain 1

Ribbon overlay*

i-body® library

Basic research on unique shark immune system …

… led to discovery that the i-set family of human proteins have the same scaffold structure …

… leading to the choice of human NCAM domain 1 for the current scaffold …

… and invention and patenting of i-bodies by adding randomized synthetic VNAR-like binding loops to NCAM-1

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• Shark VNAR (red); human i-set immunoglobulins (yellow and blue)

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An immensely powerful drug discovery platform applicable to multiple therapeutic formats

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Current
examples Direct therapeutics
For challenging targets,
such as GCPRs
Future
examples
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AD-214
Targeting agents Bi-specifics and
multi-specifics
That deliver therapeutic
cargos more precisely To improve targeting
i-bodies
and selectivity
i-PET i-CAR-T
i-mRNA
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Manufacturing and delivery

• Delivery and expression ex vivo and in vivo using viral vectors or DNA/RNA

• Efficient i-body® expression in bacterial fermentation systems

• Mammalian fermentation systems for more complex formats eg i-body-Fcfusions

• Post synthesis chemical conjugation

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Vectorised antibodies
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Small payload for in
situ delivery
i-AAV
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i-bodies enable optimized, multifunctional advanced therapy products when combined with partner platforms

i-CAR-T example

TINY i-body® needs LESS room in inserted gene, enabling MORE engineered function

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i-body targeting domain
Tumor cell
Tumor Chimeric antigen receptor (CAR)
antigen
Cell killing
molecules Signaling
Immune cell
Secreted i-body
immune
checkpoint
inhibitors
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Results in superior, multifunctional advanced therapy products

v Targeting

• § Novel (tumor) antigens;

• § Dual and bi-specific CARs

v Persistence and performance

• § Overcome immune suppression “checkpoints”: armored CARs

• § Enhanced trafficking, reduced exhaustion

v Payload

• § Higher payload for vectorized antibody therapeutics (mRNA, etc)

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Co-developed advanced therapy programs: Case study #1: i-CAR-cell therapies

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The solution: Co-developed multi-specific i-CAR-T products in development with Carina Biotech (repeatable partnering model)

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Collaboration overview

• AdAlta discovers and supplies i-bodies against solid tumor associated antigens (targets)

i-body® platform cell therapy platform

• Carina engineer into i-CAR-T cells and demonstrate in vitro cytotoxicity (cell killing)

i-CAR-Ts for solid tumor patients

• Joint funding of in vivo proof of concept studies in relevant tumor models

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• Joint (50:50) ownership of resulting i-CAR-T products

Collaboration progress

• ü i-body® enabled CAR-T (i-CAR-T) cells have successfully demonstrated in vitro cancer cell line killing (lysis)

• ü 3 programs under way

• § Target A: progressed to in vivo proof of concept

• § Targets B and C in i-body® discovery

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i-body enabled CAR-T (i-CAR-T) cells demonstrate in vitro cell killing[1]

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UT
CNA4002
CNA4003
CNA4004
LOVO LIM-1215 U87
100 100 100
80 80 80
60 60 60
40 40 40
20 20 20
0 0 0
10:1 3:1 1:1 10:1 3:1 1:1 10:1 3:1 1:1
E:T E:T E:T
% Lysis % Lysis
% Lysis
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• § Cell lines: colorectal cancer (LOVO and LIM1215); glioblastoma (U87)

• § CAR-T constructs: CNA4002/CNA4003/CNA4004 incorporate an i-body against target “X” and variable linker lengths

§ Control: unmodified T cell (UT) that does not result in significant killing (lysis) of these cell lines

• § i-CAR-T cells manufactured with 97% transduction (i-body CAR insertion) efficiency

• § i-CAR-T cells included 60-70% CD4+ (helper) and 20-30% CD8+ (cytotoxic – killer) T cells

1ASX Release 29 November 2021.

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Co-developed advanced therapy programs: Case study #2: i-AAV in vivo production

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AdAlta VNARs delivered to brains of mice with functional effect using AAV-5 (DegenRx owned product)

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VNAR-DX001 detected in CA1 region following direct hippocampal or ICV injection of AAV-5 vector

AdAlta discovered VNARDX001 is highly specific to ab-oligomers

Improved cognition in rat AZD model (water maze test)

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Collaboration overview

• AdAlta discovered VNAR-DX001 with high selectivity for aboligomers only

• VNAR-DX001 assigned to CrossBeta Biosciences and DegenRx for development

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Source: Blits et al, AAV mediated gene therapy as local treatment modality directed against amyloid beta oligomers in the brain using a high affinity, high specificity antibody, Alzheimer’s Dement , 2020 16(9) DOI: 10.1002/alz.040920; WO 2018/084712A1; DegenRx

Partnering with AdAlta for Advanced Therapies

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Partnering with AdAlta brings Australian ecosystem advantages into play

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World class advanced therapies
clinical trial and translational
research
Geographic, time zone and
Experienced manufacturing and
economic connectivity with China
supply chain
and Rest of Asia
Australia's
Advanced
Therapies
ecosystem
AdAlta’s in house i-body®
Attractive R&D Tax Incentive
discovery capability
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Advanced therapies are key for AdAlta’s growth strategy

Near term partnering opportunities

AdAlta’s three core strategies

v Out-licensing; or v Co-development/asset financing

1. Realise the value of lead asset AD-214

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Advanced therapies partnering opportunities v Co-development collaborations in 2. Progress i-CAR and i-PET programs core i-body® application areas

v Sponsored research collaborations in non-core i-body® application areas 3. Invest in i-body® platform and pipeline v Complimentary IND ready technology and product in-licensing

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A modern targeting system for next generation drugs AdAlta Ltd (ASX:1AD) Presentation to Advanced Therapies Workshop January 2024

For more information please contact:

Tim Oldham

CEO & Managing Director +61 403 446 665 t.oldham@adalta.com.au

Investor Relations The Capital Network Julia Maguire +61 2 8999 3699 julia@thecapitalnetwork.com.au

www.adalta.com.au