Slide 1: AD-214: progress and next steps
AD-214: progress and next steps Tim Oldham PhD, CEO and Managing Director Investor Webinar, 2 November 2022 at 3pm AEST
Slide 2: Disclaimer
AD-214 Program Update – NOVEMBER 2022 2 Disclaimer Investment in AdAlta is subject to This presentation may contain forward- There is no guarantee that the investment risk, including possible loss looking statements regarding the Company’s research and development of income and capital invested. AdA
Slide 3: AdAlta at a glance
AD-214 Program Update – NOVEMBER 2022 3 AdAlta at a glance AdAlta’s i-body platform is enabling a high-value product pipeline in two therapeutic areas of significant unmet medical need i-body platform enables A wholly owned fibrosis and A co-developed immuno- development of multiple, high inflammati
Slide 4: AD-214 – mid CY2021 status
AD-214 Program Update – NOVEMBER 2022 4 AD-214 – mid CY2021 status Pre-clinical ü Efficacy of injected AD-214 in lung fibrosis ü Efficacy of injected AD-114 (i-body only) in eye, kidney fibrosis ? Rapid clearance of IV AD-214 Clinical ü Phase I intravenous (IV) clinical study successfully completed1
Slide 5: AD-214 now – expanded options and value ahead of next clinical trial
AD-214 Program Update – NOVEMBER 2022 5 AD-214 now – expanded options and value ahead of next clinical trial Achievements since mid 2021 ü New pre-clinical data in kidney fibrosis – expands clinic ready indications ü Initiated preclinical studies (eye fibrosis) and partnership (cancer) – creates fur
Slide 6: Putting all the pieces together: prioritisation process
AD-214 Program Update – NOVEMBER 2022 6 Putting all the pieces together: prioritisation process Prioritisation considerations § Unmet need/market potential § Pipeline competition § Quality of preclinical data § Cost and time to return to clinic, to achieve preclinical proof of concept § Ability to u
Slide 7: Our preferred approach for AD-214 today
AD-214 Program Update – NOVEMBER 2022 7 Our preferred approach for AD-214 today Internal focus Progress through partnership Lung, kidney and eye fibrosis indications • Preclinical eye data, partnering discussions in next 6 months to further refine indication for next AdAlta sponsored clinical trial
Slide 8: Summary of newest data
Summary of newest data 8
Slide 9: Four indications offer best commercial potential, most favourable landscape
AD-214 Program Update – NOVEMBER 2022 9 Four indications offer best commercial potential, most favourable landscape § Compelling data from preclinical tissue and animal models show that AD-214 improves outcomes Lung Kidney across a range of fibrotic diseases and cancer IPF/ILD Lupus nephritis, FSGS
Slide 10: Recent preclinical data: inhalation feasibility for lung fibrosis
AD-214 Program Update – NOVEMBER 2022 10 Recent preclinical data: inhalation feasibility for lung fibrosis Status at mid-2021 Inhaled AD-214 is delivered throughout the lugs including to the margins of fibrotic lesions ü IV AD-214 efficacious in BLM Untreated sheep BLM treated sheep mouse model of l
Slide 11: Recent preclinical data: IV efficacy in kidney fibrosis
AD-214 Program Update – NOVEMBER 2022 11 Recent preclinical data: IV efficacy in kidney fibrosis Status at mid-2021 AD-214 prevents loss of kidney function in UUO model ü IV AD-114 efficacious in folic acid mouse model A 1. Control 2. UUO ü Phase I clinical study of AD- 214 supports IV Ph II 3. UUO
Slide 12: Preclinical eye fibrosis data
model, a standard animal disease This genes model picture usedoffor compared atonormal healthy theassessment the lasered eye with no this model, AD-114 laser treatment of the mouse eye 0.5 treatment. induc contract of drug IPF lung has been candidates for the treatment of pulmonary fibrosis. stained
Slide 13: Recent partnering progress: extending AD-214 (and other i-bodies) to cancer
AD-214 Program Update – NOVEMBER 2022 13 Recent partnering progress: extending AD-214 (and other i-bodies) to cancer Status at mid-2021 ? AD-214 and AD-114 studied in several in vitro models as monotherapy AdAlta-GPCR Therapeutics collaboration1 ü Marilyn Andersen, ONJCRI Cancer collaboration 23 dif
Slide 14: Recent manufacturing continuous improvement progress: yield enhancement
AD-214 Program Update – NOVEMBER 2022 14 Recent manufacturing continuous improvement progress: yield enhancement Status at mid-2021 ü cGMP production established ? Phase satisfactory yield; opportunities to improve Advances to date ü Causes of yield loss understood ü Cell line studies indicate poten
Slide 15: Recent formulation progress: IV improvement and inhaled development
AD-214 Program Update – NOVEMBER 2022 15 Recent formulation progress: IV improvement and inhaled development Status at mid-2021: IV Status at mid-2021: inhalation ü IV formulation well tolerated in ü Program initiated Phase I ? Rapid clearance from blood following IV administration – might limit dos
Slide 16: Near term milestones
Near term milestones 16
Slide 17: Expanding opportunities for AD-214: multiple indications and routes of administration progressing
AD-214 Program Update – NOVEMBER 2022 17 Expanding opportunities for AD-214: multiple indications and routes of administration progressing Preclinical Clinical Discovery in vitro in vivo Phase I Phase II Phase III Lung fibrosis IV Kidney fibrosis Oncology AD-214 IVT Eye fibrosis Inhaled Lung fibrosi
Slide 18: AD-214 | Milestones and next steps
AD-214 Program Update – NOVEMBER 2022 18 AD-214 | Milestones and next steps 1H CY2023 2H CY2023 • Manufacture extended dose toxicology • Manufacturing AD-214 for clinical studies batch to start in 2024 • Progress/accelerate existing partnering • Commence extended dose GLP toxicology discussions for
Slide 19: Corporate snapshot
AD-214 Program Update – NOVEMBER 2022 19 Corporate snapshot Key financial details (27 Oct 2022) Share price performance (last 12 months) 0.10 2.0 ASX code 1AD 0.09 1.8 Market capitalisation A$16.02m 0.08 1.6 Share price (12 month closing range) A$0.051 ($0.042 - 0.092) 0.07 1.4 Share price (A$) 12 m
Slide 20: Multiple assets in oncology and fibrosis, underpinned by AdAlta's i-body platform
AD-214 Program Update – NOVEMBER 2022 20 Multiple assets in oncology and fibrosis, underpinned by AdAlta’s i-body platform Co- developed Granzyme B i-body enabled PET imaging Precision engineered, i-body enabled CAR-T assets agents for use in immuno-oncology cells potentially providing new hope for
Slide 21: Investment proposition
AD-214 Program Update – NOVEMBER 2022 21 Investment proposition Fibrosis/inflammation Immuno-oncology Lead asset advancing to Phase II 2 x co-development collaborations to i-body platform to create value >$3b market potential in first indication1 leverage platform Multiple indication expansion initi
Slide 22: Contact: Tim Oldham, CEO and Managing Director
Contact: Tim Oldham, CEO and Managing Director enquiries@adalta.com.au www.adalta.com.au