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CLARITY PHARMACEUTICALS LTD AGM Information 2021

Nov 24, 2021

64721_rns_2021-11-24_c212aef9-c75a-4682-8441-b5e95c08c224.pdf

AGM Information

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Managing Director’s Presentation Annual General Meeting 25 November 2021

Dr Colin Biggin

Disclaimer

Introduction

This presentation has been prepared by Clarity Pharmaceuticals Ltd (ACN 143 005 341) ( Clarity or the Company ) and contains summary information about Clarity and the business conducted by it as at 25 November 2021. The information in this presentation is for general informational purposes only, does not purport to be complete or comprise all information which a shareholder or potential investor may require in order to determine whether to deal in Clarity shares. It should be read in conjunction with the Company’s IPO prospectus and other periodic and continuous disclosure announcements lodged with the ASX.

This presentation is not a prospectus, product disclosure statement or other disclosure document for the purposes of Chapter 6D or Part 7.9 of the Corporations Act 2001 (Cth) ( Act ) or other offer document under Australian law or the law of any other jurisdiction, including the United States.

Although reasonable care has been taken to ensure that the facts stated in this presentation are accurate and the opinions expressed are fair and reasonable, none of Clarity, nor its advisers ( Advisers ) nor their respective affiliates, related bodies corporate (as defined in the Act) or securityholders and their respective directors, officers, employees, partners, representatives, consultants, agents or advisers (each a Limited Party and together, the Limited Parties ) make any representation or warranty to, or takes responsibility for, the content of this presentation, and nothing contained in this document is, or may be relied upon as, a promise or representation, whether as to the past or future. To the maximum extent permitted by law, the Limited Parties disclaim all liability and responsibility (including without limitation any liability arising from fault or negligence) for any direct or indirect loss or damage which may arise or be suffered through use or reliance on anything contained in, or omitted from, this presentation.

Forward looking statements

The information contained in this presentation is given for illustrative purposes only and should not be relied upon as (and is not) an indication of Clarity’s views on future performance or condition. Past performance cannot be relied upon as an indicator of future performance. This presentation contains certain forward-looking statements. The words “forecast”, “estimate”, “like”, “anticipate”, “opinion”, “believe”, “expect”, “project”, “predict”, “intend”, “propose”, “should”, “could”, “may” and other similar expressions are intended to identify future earnings, financial position and performance of Clarity. You are cautioned not to place undue reliance on these statements. These forward-looking statements are based on estimates, projections and assumptions made by Clarity about circumstances and events that have not yet taken place. Although due care and attention has been used in the preparation of these statements, such forward-looking statements are based on numerous assumptions regarding Clarity’s present and future business strategies and the political, regulatory and economic environment in which Clarity will operate in the future, and are subject to change without notice. Statements about market and industry trends, which are based on interpretations of current market conditions, may not be reasonable, and are not guarantees or predictions of future performance. Actual results from any clinical trial may vary from any result that is anticipated. Under no circumstances will anything in this presentation create an implication that there has been no change in the affairs of the Company since the date of this presentation.

The actual results or performance of Clarity may be materially different from the results or performance expressed or implied by such forward-looking statements.

No representation, warranty or assurance (express or implied) is given or made in relation to any forwardlooking statement by any person (including any of the Limited Parties). In particular, no representation, warranty or assurance (express or implied) is given that the occurrence of the events expressed or implied in any forward-looking statement in this presentation will actually occur. Subject to any continuing obligations under applicable law, the Company expressly disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this presentation to reflect any change in expectations in relation to any forward-looking statement or any change in events, conditions or circumstances on which any statement is based.

Not an offer or financial product advice

The information contained in this presentation is for informational purposes only and should not be considered, and does not contain or purport to contain, an offer, invitation, solicitation or recommendation with respect the purchase or sale of any securities in Clarity ( Securities ) nor does it constitute legal, taxation, financial product or investment advice. The general information in this presentation has been prepared without taking into account the investment objectives, financial situation or particular needs of any particular person. This presentation does not constitute an advertisement for an offer or proposed offer of Securities. Investors must undertake their own independent investigations, consideration and evaluation. Neither this presentation nor any of its contents will form the basis of any contract or commitment and it is not intended to induce or solicit any person to engage in any transaction nor is it intended to be used as the basis for making an investment decision. This document does not constitute any part of any offer to sell, or the solicitation of an offer to buy, any securities in the United States or to, or for the account or benefit of, any “US person” as defined in Regulation S under the US Securities Act of 1993 ( Securities Act ).

Clarity recommends that potential investors consult their professional advisors as an investment in Clarity is subject to investment and other known and unknown risks, some of which are beyond the control of Clarity or its directors and therefore any investment is considered to be speculative in nature.

Market and industry data and other information

Certain market and industry data and other information used in this presentation may have been obtained from research, surveys or studies conducted by third parties, including industry or general publications. Neither the Company nor its representatives or its advisers have independently verified, or can assure investors as to the accuracy of, any market or industry data or other information provided by third parties or industry or general publications. Photographs and diagrams used in this presentation that do not have descriptions are for illustration only and should not be interpreted to mean that any person shown in them endorses this presentation or its contents or that the assets shown in them are owned by the Company. Diagrams used in this presentation are illustrative only and may not be drawn to scale.

General

Statements made in this presentation are made only as at the date of this presentation. The information in this presentation remains subject to change without notice. The Company may in its absolute discretion, but without being under any obligation to do so, update or supplement this presentation. Any further information will be provided subject to the terms and conditions contained in this Disclaimer.

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Clarity’s clinical development pipeline

Clarity’s products are progressing through Phase I and Phase II clinical trials with two open IND applications that received clearance to proceed to clinical trials from the FDA, two RPDDs and two ODDs from the FDA

Robust clinical trial strategy

  • Developing products for both rare and large indications with high unmet needs

  • Focus on high quality clinical sites and experienced investigators

  • Positioning products to maximise opportunity in current treatment paradigms

  • Targeting the lucrative US market for first product approvals

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*Note clinical development pipeline is indicative only, subject to review.

**All US studies are conducted under IND

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US prostate cancer in numbers

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1:8
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US men will develop
2 [nd] prostate cancer in
their lifetime
most common cancer in
US men
34,130
men will die annually of
>3.1M prostate cancer in the US
living with prostate cancer
today in US
248,530
new cases of
>200,000 prostate cancer in
the US in 2021 [1] ~45,000
Currently investigated in our Patients in the US
Patients in the US
diagnostic strategy in prostate cancer diagnosed with
diagnosed annually
localised/regional with mCRPC Currently investigated in our
disease annually [2] theranostic strategy in mCRPC
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(1) American Cancer Society. Cancer Facts & Figures 2021. Atlanta: American Cancer Society; 2021.

(2) Siegel DA, O’Neil ME, Richards TB, Dowling NF, Weir HK. Prostate Cancer Incidence and Survival, by Stage and Race/Ethnicity — United States, 2001–2017. MMWR Morb Mortal Wkly Rep 2020;69:1473–1480.

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SAR-bisPSMA: Pre-clinical data

SAR-bisPSMA has ideal product characteristics for a radiopharmaceutical

High uptake and retention in tumour

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120 Preclinical biodistribution
80 study demonstrating high
30 uptake and retention of
64Cu SAR-bisPSMA in
20
tumours with rapid
10 clearance from non-target
0 organs
Zia et al., 2019. Ang.Chem
1 hr 4 hr 24 hrs
BloodLungs Heart LiverKidneysMuscleSpleenTumour
% IA/g
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Significant anti-tumour effect

Preclinical efficacy study with increasing activity of [67] Cu SARbisPSMA (colours) demonstrating dose response

McInnes et al., 2020. JNM

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Rapid kidney clearance of non-bound activity

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1 hr 24 hr

Tumour targeting and superior retention over 24 hours

PET images showing [64] Cu SARbisPSMA targeting to tumours over time and rapid kidney clearance

‘Bis-PSMA’

The term Bis is used to denote the presence of two identical but separate complex groups in one molecule

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SAR-bisPSMA: Current clinical trials

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PROPELLER: PET Imaging of Participants With Confirmed Prostate Cancer (NCT04839367)

SECuRE: Systemic Copper theranostics in prostate cancer (NCT04868604)

A Phase I/IIa study of[64] Cu SAR-bisPSMA and[67] Cu SARbisPSMA for identification and treatment of PSMA-expressing metastatic castrate resistant prostate cancer (mCRPC)

  • Theranostic multi-centre, single arm, dose escalation study with a cohort expansion planned for up to 44 patients

  • Recruiting in the US under an open IND

  • The trial employs diagnostic PET imaging with[64] Cu SARbisPSMA for selection of patients suitable for therapy cycles with[67] Cu SAR-bisPSMA

A Phase I multi-centre, blinded review, dose ranging, non-randomised study in 30 patients across Australia

  • Recruiting in early phase prostate cancer in participants with untreated, confirmed prostate cancer and planned for radical prostatectomy

  • Compare[64] Cu SAR-bisPSMA to[68] Ga PSMA-11, the Standard of Care for prostate cancer imaging in Australia

SECuRE study design

PROPELLER study design

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Dose Dose
Dosimetry escalation expansion
phase phase phase
(N=6) (N=~24) (N=14)
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Assignment to 64Cu SAR-
Screening +
68Ga PSMA-11 dosing cohorts bisPSMA
1-3 imaging
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SAR-bisPSMA mCRPC therapy

Preliminary imaging results from the dosimetry phase of the theranostic SECuRE clinical trial

PET scans in a patient with metastatic castrate-resistant prostate 64Cu SARcancer imaged over multiple timepoints between 1 and 72 hours post bisPSMA PET/CT administration of[64] Cu SAR-bisPSMA (Normalized Voxel Intensity)

Comparison of 1h[64] Cu SARbisPSMA PET with[99m] Tc-MDP Bone Scan

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12hr[64] Cu SAR1h[64] Cu SAR99mTc-MDP WB bisPSMA PET/CT bisPSMA PET Bone Scan Fused Sagittal

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SAR-Bombesin in prostate cancer

Detection of PSMA-negative prostate cancer (PC)

  • ~10% of prostate cancer patients do not express PSMA

  • PSMA negative prostate cancer patients will not respond to PSMA imaging or therapy

  • 75-100% of prostate cancer patients express GRPr

  • Diagnosis and treatment of these patients with TCTs targeting GRPr opens new possibilities

  • Significant clinical synergies with existing SAR-bisPSMA program for clinical and development and regulatory affairs

  • On-track to commence a US diagnostic study in 2022 under an IND

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68Ga PSMA-11 (top) images of a PSMA-negative 68Ga PSMA-11 (top) images of a PSMA-
patient with clinical signs of PC (a rising PSA score of
0.16 ng/mL) and [64] Cu SAR-Bombesin PET/CT images of
the same patient (bottom)
68Ga PSMA-11 68Ga PSMA-11
64Cu SAR- 64Cu SAR-
Bombesin Bombesin
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68Ga PSMA-11 (top) images of a PSMAnegative patient with history of PC (a rising PSA score of 25 ng/mL) and[64] Cu SAR-Bombesin PET/CT images of the same patient (bottom)

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68Ga PSMA-11
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SAR-Bombesin: A pan-cancer target

SAR-Bombesin is a highly targeted pan-cancer theranostic radiopharmaceutical being developed for identifying and selecting patients for subsequent treatment of their cancers that express gastrin releasing peptide receptor (GRPr)

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64Cu SAR-Bombesin in hormone positive metastatic breast cancer
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SAR-Bombesin

  • GRPr is a receptor that is overexpressed in a number of cancers including prostate, breast, colon, gastric, glioma, pancreatic, small cell lung and non-small cell lung cancer, as well as renal cell cancer

  • 75%-100% of prostate cancers express GRPr

  • 83% of estrogen receptor (ER) positive breast cancers express GRPr

  • 64Cu/67Cu SAR-Bombesin is under investigation as a theranostic pairing to treat breast and prostate cancer patients with tumours that express GRPr

Control group 67Cu-SAR-Bombesin treated group

Efficacy of[64] Cu SAR Bombesin in a mouse model of prostate cancer

  • 67Cu SAR-Bombesin has demonstrated an anti-tumour effect in preclinical models of prostate cancer, when compared to the control group

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SAR-Bombesin in metastatic breast cancer

C-BOBCAT: Recruitment closed

First-in-human pilot trial assessment of the diagnostic value of[64] Cu SAR-Bombesin PET/CT imaging for staging of hormone positive breast cancer patients with metastatic disease in comparison with standard of care imaging (CT, bone scan and[18] F FDG PET/CT)

  • Study Sponsor: St Vincent’s Hospital, Sydney

  • PI: Prof. Louise Emmett

  • Preliminary data from the C-BOBCAT trial shows that[64] Cu SAR-Bombesin is highly avid with a high tumour volume compared to 18F FDG in some patients

  • Preliminary results indicate[64] Cu SAR-Bombesin may have a role in imaging patients with hormone positive breast cancer

C-BOBCAT: One hour post[64] Cu-SAR-Bombesin administration in a breast cancer patient

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64Cu SAR-Bombesin 18F FDG
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PET/CT PET/CT
PET CT PET CT
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SARTATE™– next generation theranostic

SARTATE™is a highly targeted theranostic radiopharmaceutical which is being developed for diagnosing, staging and subsequently treating cancers that express somatostatin receptor 2 (SSTR2)

Target benefits

  • Targets tumours that express somatostatin receptor 2 (SSTR2)

High Accuracy High Precision

  • Well characterised and substantiated peptide

  • Octreotate, synthetic SSTR analogue, has been in many thousands of patients to date

  • Expectation of clinical benefit (efficacy) to patients

Current clinical development

  • 64Cu SARTATETM for the management of neuroblastoma

  • 67Cu SARTATETM for the treatment of neuroblastoma

  • 64Cu SARTATETM for the management of NETs

Future opportunities

  • Other SSTR2 positive diseases, including but not limited to pancreatic and gastrointestinal cancer, pulmonary NETs, and meningiomas.

67Cu SARTATETM

64Cu SARTATETM

123I MIBG

Current Standard PET screening SPECT scan of Care 4 hours 24 hours

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(in the same patient)

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SARTATE™: Clinical trials

SARTATE™CL04:[67] Cu-SARTATE™Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk, Relapsed, Refractory Neuroblastoma (NCT 04023331)

  • 64 67 Cu/ Cu SARTATE™Phase I/IIa trial in high-risk

  • neuroblastoma in the US with up to 34 patients

  • Multi-centre, dose-escalation, open label, nonrandomised, theranostic clinical trial.

Neuroblastoma is one of the most aggressive childhood cancers

  • 800 new cases each year in the US and the most common cancer in infants

  • Neuroblastoma accounts for approximately 13% of paediatric cancer mortalities

  • Approximately 84% of neuroblastomas express SSTR2

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DISCO: Diagnostic Imaging Study of Copper-64 SARTATE using PET on patients with known or suspected NETs (NCT 04438304)

  • Assessing the performance of imaging agent[64] Cu SARTATE[TM] in participants with known or suspected gastroenteropancreatic NETs as a potential new way to help diagnose and manage NETs

  • Phase II study recruiting in 63 patient trial at four sites in Australia with[64] Cu SARTATE[TM] manufactured centrally in Australia

  • Aims to capture and highlight the significant advantages of the longer half-life (12.7 hours) of copper-64, related to imaging and product supply which are relevant to Clarity’s entire pipeline of products in development

  • Comparing diagnostic performance of[64] Cu SARTATE[TM] at 4 and 20 hours to the current standard of care,[68] Ga DOTATATE, at one hour

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Clinical development pipeline - 12 month progress Clarity is rapidly progressing its pipeline of TCT products through clinical development as the Company anticipates the achievement of significant milestones in the next year

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*Note clinical development pipeline is indicative only, subject to review.

**All US studies are conducted under IND

13

Slide from Clarity AGM 2020

Clarity delivered on all our goals for 2021 from the last AGM

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Inflection points to Q4 2022

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50%
recruitment Recruitment FPFV BBN
US DISCO complete Dx US
manufacture PROPELLER
expansion
Advance Advance Advance
1st PSMA Tx to Cohort 2: to Cohort 3: to Cohort 4:
NB Tx PSMA Tx PSMA Tx
Q4 2021 Q1 2022 Q2 2022 Q3 2022 Q4 2022
Recruitment
Dosimetry complete Open IND PSMA Dx Open IND BBN Dx complete DISCO Open IND BBN Tx Recruitment
PSMA Tx
complete
PSMA
>50%
Advance Dx USA
recruitment FPI PSMA >50%
to Cohort 2:
PROPELLER Dx USA recruitment
PSMA Tx
PSMA Dx
USA
Tx = therapy
Dx = diagnostic 15
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Contact details

Dr Alan Taylor Executive Chairman E: [email protected]

Alan has been instrumental in the growth of Clarity over the last seven years, leading the Company from a start-up with no employees to where it is today, and heavily involved in all areas of the company. He has approximately 15 years of investment banking experience focused predominantly on the life sciences, with experience in capital raisings, mergers and acquisitions, and general corporate advisory, and has been involved in approximately $2 billion worth of transactions.

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Dr Colin Biggin Managing Director E: [email protected]

Colin has over 15 years of radiopharmaceutical development and commercialisation experience. He served with Algeta ASA from 2006-2015 during the development and commercialisation of Xofigo (radium-223) for metastatic prostate cancer and consulted to a range of biotech’s and large pharma companies developing radiopharmaceuticals prior to joining Clarity in 2017.

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