ISCTANZ2026 presentation and poster
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AdAlta Limited (ASX:1AD) · ABN: 92 120 332 925 · www.adalta.com.au
Suite 1.01, 117 Camberwell Road, Hawthorn East VIC 3123, Australia
ASX Announcement | 20 July 2026
AdAlta Limited (ASX:1AD)
ISCT ANZ 2026 oral presentation and poster
Recognition of AdAlta’s unique ‘East to West’ model for bringing
groundbreaking cellular immunotherapies for cancer to patients worldwide
Investment highlights
• AdAlta’s abstract describing its ‘East to West’ business model was among the high-scoring
submissions selected for oral presentation at ISCT ANZ 2026.
• Selection recognises AdAlta’s differentiated, capital-efficient strategy for commercialising
ground breaking solid tumour CAR-T therapies.
Melbourne, Australia, 20 July 2026: AdAlta Limited (ASX:1AD) (“AdAlta” or “the Company”),
developer of next generation cellular immunotherapies for solid cancers, today releases its oral
presentation and poster describing its “East to West” business model being presented at the
International Society for Cell & Gene Therapy (ISCT) ANZ 2026 Regional Meeting in Melbourne (20-22
July 2026).
AdAlta’s presentation and poster describes how its “East to West” business model brings promising Asian
cell therapies to Western patients in a de-risked, capital efficient manner. They feature AdAlta’s collaboration
with Shanghai Cell Therapy Group on lead product BZDS1901 (now known by AdAlta product code
EW-001), a ground breaking CAR-T cell therapy that has demonstrated hard to achieve complete responses
in advanced mesothelioma, a deadly cancer asspciated with asbestos expsoure. It also describes
manufacturing collaborations with Cell Therapies Pty Ltd and Oribiotech that aim to deliver scalable, lower-
cost CAR-T manufacturing across the Asia-Pacific.
Next steps and strategic significance
Recognition on this stage raises AdAlta’s profile among scientists, clinicians, regulators and potential
partners central to executing its strategy, and reinforces the credibility of a replicable, capital-efficient model
designed to create value across multiple products. AdAlta continues to advance manufacturing transfer, US
FDA engagement and preparations for Australian Phase I development of EW-001 (BZDS1901).
To view a summary, and engage in discussion about this announcement, visit AdAlta’s InvestorHub here:
https://investorhub.adalta.com.au/link/PQRYGy
This ASX announcement has been authorised for release by the CEO of AdAlta Limited (ASX:1AD).
For further information, please contact:
AdAlta Limited (ASX:1AD)
Tim Oldham
CEO & Managing Director
P: +61 403 446 665
E: ir@adalta.com.au
2
About EW-001 (formerly BZDS1901)
EW-001 is a novel, first in class, CAR-T cell therapy designed to treat mesothelioma (a rare but rapidly fatal
cancer usually linked to asbestos exposure) and with possible application in more than ten other cancers.
CAR-T cell therapies are living drugs manufactured from a patient’s own immune cells that are engineered to
be able to find and kill cancer. They offer the potential to provide durable cancer control or cure from a single
treatment.
Patients diagnosed with mesothelioma today are typically treated with surgery if possible and then initial or
first line drug treatments are chemotherapy or immunotherapy. Once a patient has relapsed after initial
therapy, second line treatment options are even more limited and outcomes are much poorer. Current
treatments typically deliver: 1,2
• Tumour shrinkage (Overall Response) in only 40-44% of first line patients and 11-29% of second
and subsequent line patients
• Complete tumour clearance (Complete Response) is rare and seen in less than 3% of first line
patients and almost never in second line patients
• Median survival (at which point 50% of patients will have died) often only 14-18 months first line and
8-10 months second line, with tumours beginning to grow again typically after only half that time.
By contrast, EW-001 clinical studies in relapsed or advanced mesothelioma patients (second line and later)
in China have reported:
• Up to 50% Overall Response rate (tumour shrinkage)
• Up to 20% Complete Response rate (complete tumour clearance)
• Median overall survival has not yet been reached in the current study cohort, however an earlier
generation of EW-001 achieved more than 25 months median survival
These early results suggest EW-001 may offer an exciting potential new treatment option for patients with
few alternatives.
About AdAlta
AdAlta (ASX: 1AD) is a clinical stage biotechnology business addressing the need for effective cellular
immunotherapies for the treatment of solid cancers.
Through its ‘East to West’ strategy, the Company is integrating Asia's prowess in T cell therapy development
with the efficiency and quality of Australia's clinical and manufacturing ecosystem to create a pathway
connecting ‘Eastern’ innovation in cellular immunotherapies with ‘Western’ regulated markets and patients.
AdAlta in-licenses products from Asian originators and invests to establish US FDA regulated manufacturing
and conduct Phase I clinical studies with potential to position each product for on-licensing to larger
biopharmaceutical companies for potential registrational studies and commercialization.
AdAlta implements a disciplined approach to asset selection focused on highly differentiated T cell therapy
products supported by clinical data in solid cancers. The company adopts a capital efficient business model
delivering a rapid return on investment in each project that is replicable and provides opportunities to scale
across multiple products.
Solid tumours account for 90% of cancers yet remain underserved by current cellular immunotherapies.
AdAlta aims to dominate this high-growth segment. The cellular immunotherapy market is projected to grow
at a compound annual growth rate of 34% to reach US$20.3 billion by 2028.
1 CHECKMATE-743 study (nivolumab + ipilimumab against chemotherapy): S Peters et al, Annals of Oncology, 2022 (33) 488;
https://doi.org/10.1016/j.annonc.2022.01.074
2 See for example CONFIRM study (nivolumab against placebo): DA Fennell et al, Lancet Oncol 2021 (22) 1530
3
AdAlta’s first in class fusion protein, AD-214, takes a whole new approach to fibrotic diseases of the lung and
kidney, such as the degenerative and fatal Idiopathic Pulmonary Fibrosis. Following demonstration of
efficacy in multiple animal models of disease and two successful Phase I clinical studies, AD-214 is available
for partnering.
To learn more, please visit: www.adalta.com.au
For more information
Join our InvestorHub
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AdAlta Ltd | ISCTANZ2026 Presentation | July 2026 | 1
“East to West”
Commercialising Asian cell therapy
innovation for Western markets
Tim Oldham, CEO & Managing Director, AdAlta Ltd
Bo Zhang, Vice President, Shanghai Cell Therapy Group Co Ltd
Bev Menner, CEO, Cell Therapies Pty Ltd
Jason Foster, CEO and Executive Director, Oribiotech Ltd
Angus Tester, VP Operations, AdAlta Ltd
ADALTA LIMITED (ASX:1AD) AND ADCELLA PTY LTD | ISCTANZ2026 PRESENTATION | JULY 2026
AdAlta Ltd | ISCTANZ2026 Presentation | July 2026 | 2
A repeatable arbitrage between Asia's innovation surplus and the West's access deficit - proven by a first asset in the clinic
Differentiated
• T cell only (CAR-T, TCR-T, TIL,
VST, etc) – most potent and easily
manufactured immune cell
• Solid-tumour only - away from
crowded blood-cancer and
autoimmune targets
• First-in-class armoured designs
with clinicalproof of concept
already in hand
Capital efficient
• ~US$15m all-in per asset to a
value-inflection exit
• 43.5% Australian R&D Tax
Incentive
• 25-50% cheaper than theUS
• 3-4 years fromin-license to exit
De-risked
• Assets in-licensed only with
existing human clinical data
• Australia-domiciled, US FDA
IND, ex-greater-China IP - a
compliant bridge
Scalable
• EW-001 proves the model;
multiple further assets
proceeding to option
• Reproducible Ori IRO + CTPL
manufacturing engine across
the pipeline
• Speed and cost efficient from
digitally/AI enabled
manufacturing and processes
(IRO, Oktopi, EMU)
Why it works
• Median autologous Phase 1 CAR-T licensing deal:
US$782m total / US$85m upfront.
• AdAlta shares 50-60% of commercialisation proceeds per asset
with partner, a result neither could achieve alone, then recycles
capital into the next assets.
ADALTA’S UNIQUE“EAST TO WEST”BUSINESS MODEL BRINGS
“EASTERN”INNOVATION TO “WESTERN”PATIENTS
AdAlta Ltd | ISCTANZ2026 Presentation | July 2026 | 3
SOLID CANCER CAR-T IS THE NEXT FRONTIER
The unmet need is solid
cancers
• Solid tumours are ~90% of
all cancers, yet are
underserved by cellular
immunotherapy.
• Bringing CAR-T's blood-
cancer success to solid
tumours is the opportunity
AdAlta targets
• The cellular
immunotherapy market is
growing ~34% a year to
US$20.3bn by 2028
Sources: CAR-T mechanism adapted from US National Cancer Institute. Blood-cancer response ratesper Kymriah, Yescarta and Carvykti prescribing information (relapsed/refractory). Market: Grandview
Research, “T-cell Therapy Market Size, Share & Trends Analysis” Feb 2021; Polaris Market Research, “CAR-T Cell Therapy Market Share, Size, Trends, Industry Analysis Report”, June 2021; AdAlta analysis
T cell therapies are living drugs: a patient's own T cells, re-engineered to find and kill cancer - offering durable, potentially curative
responses from a single treatment
CAR T-Cell therapy: turbo charges the immune system to see and kill cancer
Living drug ⚫ Single Dose ⚫ Durable ⚫ Potentially Curative
Collect T cells Expand in lab
Engineer cells Infuse into patient Kill cancer
Blooddrawnfrom
patient
Millions of CAR Tcells
grown
Gene for CAR inserted
intoT cells
CAR T cellsreturned
to patient
CAR T cellsbind antigens
anddestroy tumours
T Cell Insert
gene
CAR T
cell
Chimeric Antigen
Receptor (CAR)
Proven where standard treatments failed:
Complete, durable responses in advanced blood cancers
83%
Up to
65% 78%
Complete response,
relapsed/ refractory
paediatric ALL
(leukaemia)
Complete response,
relapsed/ refractory
large B-cell
lymphoma
Response,
relapsed/refractory
multiple myeloma
First T cell therapies for solid
cancers recently approved
Amtagvi (TIL, Iovance) – US2024
Tecelra (TCR-T, Adaptimmune/US
WorldMeds) – US2024
Satri-cel (CAR-T, CARsgen) –
China 2026
AdAlta Ltd | ISCTANZ2026 Presentation | July 2026 | 4
970+
THE OPPORTUNITY: EASTERN INNOVATION SURPLUS THAT CAN'T
REACH WESTERN PATIENTS
China has a deep pool of clinical-stage cell therapies, but few have a credible, compliant path to access Western approval and
reimbursement
The innovation surplus (“East”)
Innovation is moving east. Western pharma increasingly sources
assets from China - but at high transaction and opportunity cost.
Cellular immunotherapy
clinical trials in China
350+
Cellular immunotherapy
developers in China
61%
Of global CAR-T clinical trials
run in Asia-Pacific
30%
Of big-pharma licensing deals
now involve a China biotech
The access deficit (barriers to the“West”)
This gap, proven innovation that cannot be Westernised
efficiently and compliant with multiple stakeholder needs, is
what AdAlta is built to close.
Limited clinical data - typically China-only,
not accepted as pivotal by the FDA
Manufacturing that lacks maturity and portability
across sites and platforms
Capital and trade barriers; rising geopolitical and
sovereign-risk scrutiny
High transaction and opportunity cost for Western
acquirers
Sources: GlobalData, Pharma Intelligence Centre, Clinical Trials Database (accessed 5 April 2024; Alliance for Regenerative Medicine, Developer Data Report Q3
2023 and H1 2025; https://www.biopharmadive.com/spons/is-2025-the-chinese-year-of-biopharma/738274/; AdAlta analysis
AdAlta Ltd | ISCTANZ2026 Presentation | July 2026 | 5
THE MODEL: IN-LICENSE CHEAPLY, WESTERNISE, EXIT, RECYCLE
In-license
(“East”)
• Acquire highly
differentiated,
clinically de-risked
assets from Asia at
low up-front cost.
• Financing to the next
inflection point buys
AdAlta a share of the
asset at exit.
Add value
(“West”)
• Phase 1 in Australia
under a US FDA IND
and portable, low-
cost manufacturing
implemented.
• 30-50% cheaper
than the US plus a
43.5% R&D Tax
Incentive rebate.
Exit
(on-license)
• License the de-
risked, Western-data
enabled asset to a
global commercial-
isation partner.
• AdAlta and the Asian
partner share value
neither could
capture alone.
Recycle
• Retain regional rights
and a 50-60%
proceeds share.
• Redeploy capital into
the next assets to
compound the
platform.
Unit economics
per asset
~US$15m
All-in investment per asset to exit
3-4 yrs
Fromin-licenseto potential exit
US$782m
Median comparablePhase1
dealvalue
50-60%
AdAlta shareof
commercialisation proceeds
Funds recycle into future assets
AdAlta Ltd | ISCTANZ2026 Presentation | July 2026 | 6
EW-001: A STAND-OUT ARMOURED MSLN CAR-T FOR SOLID CANCERS
Optimised
target
• Mesothelin (MSLN) is highly expressed across
multiple poor-prognosis cancers
• Binding tuned to activate only at high MSLN
density, protecting healthy tissue
Armoured for
potency
• First MSLN CAR-T product to secrete PD1-
blocking molecules
• Overcomes tumour suppression of both CAR-T
and the patient's own T cells
Clinical
potential
• 36 patients across 3 investigator-initiated trials
• Responses exceed current 2nd-line standard of
care, including rare complete responses
(complete tumour clearance) in up to 20% of
patients
Faster, cheaper
to make
• Manufactured in under two days, with no
expensive viral vectors
• Transposase-based – no expensive viral
vectors; clear pathway to low commercial COGS
Lead indication: relapsed/
refractory mesothelioma -
a beachhead, not the
ceiling
~US$4.2B
Addressablemesothelioma
opportunity
10+
Additional MSLN-positive cancers
as labelled upside
Up to 20%
Of advanced patients had
complete tumour clearance
MSLN-targeted, anti-PD1nanobody-armoured autologous CAR-T. Developed as BZDS1901 by, and licensed from, Shanghai Cell
Therapy Group (SHcell); exclusive rights outside greater China (7 patent families).
AdAlta Ltd | ISCTANZ2026 Presentation | July 2026 | 7
COMPLETE RESPONSES: THE HIGHEST-VALUE EARLY SIGNAL IN
SOLID TUMOUR CAR-T
First-line therapy:
CHECKMATE-743 study1
Second-line therapy:
CONFIRM study2
Outcome
measure
Chemo-
therapy
Immuno-
therapy
Placebo
Immuno-
therapy
Complete
Response Rate
0% 2.6% 0% 0%
Overall
Response Rate
44.0% 39.6% 1% 11%*
Median Overall
Survival
14.1 mo 18.1 mo 6.9 mo 10.2 mo
1-year
survival rate
58% 68% ~30% ~45%
2-year
survival rate
27% 41% 18% 25%
1. CHECKMATE-743 study (nivolumab + ipilimumab against chemotherapy): S Peterset al, Annalsof Oncology, 2022 (33) 488; https://doi.org/10.1016/j.annonc.2022.01.074
2. CONFIRM study (nivolumab against placebo): DA Fennell etal, Lancet Oncol 2021 (22) 1530 * Overall response rates up to 29% have been reported in other studies
Mesothelioma remains a rapidly lethal disease:
standard of care outcomes
EW-001 (BZDS1901) has produced complete responses - complete tumour clearance - in advanced mesothelioma.
This is rare, and it is what changes the conversation with patients, regulators and acquirers.
Complete Response (CR)
• CR = no detectable
disease after treatment
• In advanced
mesothelioma, CR is
almost never achieved
with standard of care
• CR is the strongest
predictor of durable,
potentially curative
outcomes
• Delivered by a single
dose of a living drug
Up to 20% CR rate
CR’s very rare under current standard of care
25.6 mo
Earlier-generation median OS
~2 yrs
Longest current survivor, still in follow-up
CR rate underwrites premium,
high-value deals anchoring EW-001 value
CR rate differentiates EW-001
(BZDS1901)
Up to 50% OR rate
Improvement on second line therapies;
comparable with first line
AdAlta Ltd | ISCTANZ2026 Presentation | July 2026 | 8
EW-001 CAR-T RESULTS TO DATE POINT TO A BETTER OUTCOME
Outcome measure All patients (n=14) Higher doses (n=10)
Complete Response Rate 14% 20%
Overall Response Rate 43% 50%
Median Overall Survival Not yet reached Not yet reached
1-year survival rate
21% with 21% still alive
and not yet at one year
and 21% withdrawn
30% with 30% still alive
and not yet at one year
and 10% withdrawn
CR
PR
SD
PD
Low dose (0.5-0.6 x 10^6 CAR-T cells/kg)
Higher dose (0.8-1.0 x 10^6 CAR-T cells/kg)
Gen2 single plasmidproduct
Best
change
in
tumor
size
Patient number, type of mesothelioma
Good
Not
good
EW-001 (BZDS1901)’s CR rate supports accelerated / conditional approval pathways and anchors value in comparable-deal range
Patient #03
5cm tumours
cleared for more
than 2 years
CT imaging –
measures soft
tissue density
Target
Lesion
1
Target
Lesion
2
AdAlta Ltd | ISCTANZ2026 Presentation | July 2026 | 9
Clinical delivery
in Australia
• Globally recognised early stage research
• 55 institutions treating patients with cell &
gene therapies
• CAR-T penetration on par with the US, ~5x EU
• Six-strong KOL bench across five leading CAR-T centres
Manufacturing
and supply
• Cell Therapies Pty Ltd
• TGA- and PMDA-approved commercial CAR-T supply
• 20 years CAR-T manufacturing experience at all stages of
development
• Multiple successful technology transfers
Automation for
scale
Oribiotech’s IRO automated manufacturing platform being
deployed at CTPL and in China
• 10-50x higher throughput per m2
• 30-50% reduction in COGS
• 6-month reduction in tech transfer times (and cost)
• FDA Advanced Manufacturing Technology (AMT) designation
Oktopi and EMU AI solutions for R&D efficiency
AdAlta uses mature, FDA-recognised Australian clinical and manufacturing infrastructure that is materially cheaper than the US.
BUILT ECOSYSTEM: ADALTA’S CELL THERAPY ADVANTAGE
138
cell & gene therapytrials
delivered to date
4
commercial CAR-T products;
7 gene therapies
25% - 50%
cheaper clinical&
manufacturing vs theUS
25
sites approved forcommercial
CAR-T delivery
Australia’s national
competence
AdAlta Ltd | ISCTANZ2026 Presentation | July 2026 | 10
FOR MORE INFORMATION
PLEASE CONTACT:
TIM OLDHAM
CEO & MANAGING DIRECTOR
+61 403 446 665
T.OLDHAM@ADALTA.COM.AU
WWW.ADALTA.COM.AU
AdAlta Limited (ASX:1AD) | ISCT ANZ 2026| July 2026
AN EAST-TO-WEST BUSINESS MODEL FOR COMMERCIALISING SOLID
TUMOUR CAR-T THERAPIES: LEVERAGING CROSS-BORDER
PARTNERSHIPS, ADVANCED MANUFACTUIRNG AND CAPITAL
EFFICIENT DEVELOPMENT
Abstract #: 138
Tim Oldham,a Bo Zhang,b Bev Menner,c Jason Foster,d Angus Testera
a. AdAlta Ltd, Melbourne, Australia, www.adalta.com.au, t.oldham@adalta.com.au b. Shanghai Cell Therapy Group Co Ltd, Shanghai, China, www.shcell.com
c. Cell Therapies Pty Ltd, Melbourne, Australia, www.celltherapies.com d. Oribiotech Ltd, London, UK, www.oribiotech.com
Abstract
A. Despite rapid innovation in cellular immunotherapy across Asia, many promising cell therapies remain inaccessible to Western markets due to regulatory, manufacturing and commercialisation barriers. Autologous CAR-T therapies for solid tumours also face scalability challenges including
manufacturing complexity, high cost and limited portability between sites.
B. AdAlta Ltd has developed an “East-to-West”commercialisation model combining Asian innovation with Australia’s manufacturing, translational and regulatory ecosystem. AdAlta in-licenses clinically validated cellular immunotherapy assets from Asia, conducting manufacturing transfer and
US FDA-aligned Phase I development in Australia, and subsequent out-licensing to larger biopharmaceutical partners for registrational studies and commercialisation. The model aims to create substantial value inflection using a capital-efficient structure and Australia’s quality
manufacturing and clinical ecosystem. To support scalable, commercially viable manufacturing, AdAlta established collaborations with Ori Biotech and Cell Therapies Pty Ltd. These partnerships aim to deploy Ori’s IRO® automated manufacturing platform within Australia and Asia-Pacific to
improve throughput, reduce variability, accelerate technology transfer and lower CAR-T production costs. This demonstrates how partnerships between originators, technology providers, CDMOs and translational developers can de-risk development and improve partnerability of cell therapy
assets.
C. AdAlta's collaboration with Shanghai Cell Therapy Group (“SHcell”) is an exemplar of the model. EW-001 (BZDS1901) is a mesothelin-targeted, anti-PD1-armoured CAR-T therapy for mesothelioma and other solid tumours. Investigator-initiated studies in China demonstrated encouraging
activity, including multiple tumour responses and two difficult to achieve complete tumour clearances in advanced mesothelioma patients, supporting progression toward Western regulatory development. SHcell continues China-based development while AdAlta leads manufacturing
transfer, US FDA engagement and global Phase I development outside greater China.
D. This model demonstrates a scalable pathway for globalising innovative Asian cellular immunotherapies while strengthening advanced manufacturing capability within Australia and the Asia-Pacific region.
Solid cancer: the unmet
need
• Solid tumours are ~90% of all
cancers, yet are underserved by
cellular immunotherapy.
• Bringing CAR-T's blood-cancer
success to solid tumours is the
opportunity AdAlta targets
• The cellular immunotherapy market
is growing ~34% a year to
US$20.3bn by 20282
• First T cell therapies for solid
cancers approved – the next
frontier is here
Amtagvi (TIL, Iovance) – US 2024
Tecelra (TCR-T, Adaptimmune/US
World Meds) – US 2024
Satri-cel (CAR-T, CARsgen) – China
2026
CAR T-Cell therapy: turbo charges the immune system to kill cancer
Living drug ⚫ Single Dose ⚫ Durable ⚫ Potentially Curative
Collect T cells Expand in lab
Engineer Cells
Infuse into
patient Kill cancer
Blood
drawn from
patient
Millions of
CAR T cells
grown
Gene for CAR
inserted into T
cells
CAR T cells
returned
to patient
CAR T cells bind
antigens and
destroy tumours
T Cell Insert
gene
CAR T
cell
Chimeric Antigen
Receptor (CAR)
Proven where standard treatments failed:
Complete, durable responses in advanced blood cancers1
83% ~65% 78%
Complete response,
relapsed/ refractory
paediatric ALL
(leukaemia)
Complete response,
relapsed/ refractory
large B-cell
lymphoma
Response,
relapsed/refractory
multiple myeloma
970+
The opportunity: Asia Innovation surplus that can't reach Western patients
China has a deep pool of clinical-stage cell therapies, but few have a credible, compliant path to access Western approval and reimbursement
The innovation surplus (“East”)
Innovation is moving east. Western pharma increasingly
sources assets from China - but at high transaction and
opportunity cost.
Cellular
immunotherapy clinical
trials in China3
350+
Cellular
immunotherapy
developers in China4
61%
Of global CAR-T clinical
trials run in Asia-
Pacific3
30%
Of big-pharma licensing
deals now involve a China
biotech5
The access deficit (barriers to the“West”)
This gap, proven innovation that cannot be Westernised
efficiently and compliant with multiple stakeholder needs, is
what AdAlta is built to close.
Limited clinical data - typically China-only,
not accepted as pivotal by the FDA
Manufacturing that lacks maturity and portability
across sites and platforms
Capital and trade barriers; rising geopolitical and
sovereign-risk scrutiny
High transaction and opportunity cost for Western
acquirers
The model: in-license, westernise, exit, recycle
3
2
1
3
4
4 Unit economics
per asset
~US$15m
All-in investment per asset
to exit
3-4 yrs
From in-license to potential
exit
US$782m
Median comparable
Phase 1 deal value6
50-60%
AdAlta share of
commercialisation
proceeds
• Acquire highly
differentiated, clinically
de-risked assets at low
up-front cost.
• Financing to inflection
point buys AdAlta a
share of the asset.
• Ph 1 in Australia under
US FDA IND; portable,
low-cost manufacturing
implemented.
• 30-50% cheaper than
the US + 43.5% R&D Tax
Incentive rebate.
• License the Western-
data enabled asset to
global commercial-
isation partner.
• AdAlta and Asian
partner share value
neither captures alone.
• Retain regional rights
and a 50-60% proceeds
share.
• Redeploy capital into
new assets; compound
the platform.
3
2
1 4
The ecosystem AdAlta is building: China product development speed + Australian early stage clinical
+ manufacturing and automation
Clinical
delivery in
Australia
• Globally recognised early stage research
• 55 institutions treating patients with cell &
gene therapies
• CAR-T penetration on par with the US, ~5x EU
• Six-strong KOL bench across five leading CAR-T centres
Manufacturing
and supply
Cell Therapies Pty Ltd
• TGA- and PMDA-approved commercial CAR-T supply
• 20 years CAR-T manufacturing experience at all stages of
development
• Multiple successful technology transfers
Automation for
scale
Oribiotech’s IRO® automated manufacturing platform being
deployed at CTPL and in China
• Automates better biology, accelerates product development
• 10-50x higher throughput per m2
• 30-50% reduction in COGS
• 6-month reduction in tech transfer times (and cost)
• FDA Advanced Manufacturing Technology (AMT) designation
China
innovation
• Deep innovation pool; early clinical read via efficient IIT
system
• Rapid, low cost product development and optimisation
• Robust pipeline of assets in diligence
• Potential “two lane” model for Australian/Western assets
enabled by IRO®
138
cell & gene therapy trials
delivered to date
4
commercial CAR-T
products;
7 gene therapies
25% - 50%
cheaper clinical &
manufacturing vs the
US
25
sites approved for
commercial CAR-T
delivery
Australia’s
national
competence
Exemplar product: EW-001 (BZDS1901) – a groundbreaking solid cancer armoured CAR-T cell therapy
bringing new hope to patients with mesothelioma and up to 10 other cancers from Shanghai Cell
Therapy Group Co Ltd
EW-001 (BZDS1901): Next-gen CAR-T
• Modality: MSLN-targeted, anti-PD1 nanobody-armored
autologous CAR-T
• Target: Solid tumors (mesothelioma, gynaecological)
• Manufacturing: 30h, viral vector free
• Developer/licensor: Shanghai Cell Therapy Group Co
Ltd (SHcell), China as BZDS1901
• Development status: Clinical stage - 36 patients
treated in IIT’s to date
• IP Portfolio: 7 patent families in total
Development roadmap
• Manufacturing: establish
global reference site at Cell
Therapies (CTPL), Australia
• Regulatory: Secure US FDA
IND
• Clinical – global: Ph 1 in
mesothelioma and other
solid cancers in Australia
• Clinical – China: SHcell
continue China development
Capital efficient
financing
• Budget: US$14-19M over 4
years to complete Ph 1; 3rd
party financing leverage
• The "AUS advantage”: US$8–
12M est RDTI rebate benefit;
cost-efficient, globally
recognized
• Governance: AdAlta SHcell
Joint Development C’tee
• The return: 60% of proceeds
of Ph 1 Commercialisation
Event to AdAlta
✓ Optimised for well established
target
Mesothelin (MSLN) is highly
expressed on multiple cancers
with poor prognosis; CAR-T
binding optimized to protect
healthy cells
✓ Armoured for success
First product to secrete PD1
molecules to overcome tumour
suppression of CAR-T cells and
endogenous T cells
✓ Proven promise in clinical
studies
IIT responses superior to
current 2nd line in r/r
mesothelioma – including
difficult to achieve complete
responses
✓ Faster, cheaper
manufacturing
Can be manufactured in less
than two days without
expensive viral vectors
EW-001 (BZDS1901): distinctive advantages
First-line therapy:
CHECKMATE-743 study7
Second-line therapy:
CONFIRM study8
Outcome measure Chemo-therapy
Immuno-
therapy
Placebo
Immuno-
therapy
Complete Response Rate 0% 2.6% 0% 0%
Overall Response Rate 44.0% 39.6% 1% 11%*
Median Overall Survival 14.1 mo 18.1 mo 6.9 mo 10.2 mo
1-year
survival rate
58% 68% ~30% ~45%
Mesothelioma remains a rapidly lethal disease:
standard of care (SoC) outcomes are poor
Up to 20% CR
CR’s very rare under SoC
25.6 mo mOS
Gen1 BZDS19019
CR rate differentiates
EW-001 (BZDS1901)
Up to 50% ORR
Improvement on second line;
comparable with first line
Outcome measure – Gen 2 BZDS1901 All patients (n=14) Higher doses (n=10)
Complete Response Rate 14% 20%
Overall Response Rate 43% 50%
Median Overall Survival Not yet reached Not yet reached
1-year survival rate
21% with 21% still alive and not yet at one
year and 21% withdrawn
30% with 30% still alive and not yet at one
year and 10% withdrawn
CR
PR
SD
PD
Low dose (0.5-0.6 x 10^6 CAR-T cells/kg)
Higher dose (0.8-1.0 x 10^6 CAR-T cells/kg)
Gen2 single plasmid product
Best
change
in
tumor
size
Patient number, type of mesothelioma
Good
Not
good
Patient #03
5cm tumours cleared for more than 2 years
CT imaging – measures soft tissue density
Target
Lesion
1
Target
Lesion
2
1. Kymriah, Yescarta and Carvytki prescribing information (US FDA)
2. Grandview Research,“T-cell Therapy Market Size, Share & Trends Analysis” Feb 2021; Polaris Market Research,“CAR-T Cell Therapy Market Share, Size, Trends, Industry Analysis
Report”, June 2021
3. GlobalData, Pharma Intelligence Centre, Clinical Trials Database (accessed 5 April 2024
4. Alliance for Regenerative Medicine, Developer Data Report Q3 2023 and H1 2025
5. https://www.biopharmadive.com/spons/is-2025-the-chinese-year-of-biopharma/738274/
6. Company press releases, GlobalData; Beacon Intelligence; Novotech “In vivo CAR-T therapies global research and development landscape” (2025)
7. CHECKMATE-743 study (nivolumab + ipilimumab against chemotherapy): S Peters et al, Annals of Oncology, 2022 (33) 488; https://doi.org/10.1016/j.annonc.2022.01.074
8. CONFIRM study (nivolumab against placebo): DA Fennell et al, Lancet Oncol 2021 (22) 1530 * Overall response rates up to 29% have been reported in other studies
9. Sun et al, Advanced Science, Oct 2025, DOI: 10.1002/advs.202508754
EW-001 (BZDS1901) results to date point the way to better outcomes
EW-001 (Gen 2 BZDS1901) results to date point the way to better outcomes
Best tumour response
(per RECIST v1.1)
A
B C
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