25 Nov

Managing Directors Presentation to Annual General Meeting

Managing Director’s Presentation Annual General Meeting 25 November 2021 Dr Colin Biggin 2 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. Disclaimer No representation, warranty or assurance (express or implied) is given or made in relation to any forward- looking 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. Clarity’s clinical development pipeline 3 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 *Note clinical development pipeline is indicative only, subject to review. **All US studies are conducted under IND 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 US prostate cancer in numbers 4 (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. 1:8 most common cancer in US men US men will develop prostate cancer in their lifetime 2 nd living with prostate cancer today in US men will die annually of prostate cancer in the US 34,130 248,530 new cases of prostate cancer in the US in 2021 1 Currently investigated in our theranostic strategy in mCRPC Currently investigated in our diagnostic strategy in prostate cancer >200,000 Patients in the US diagnosed with localised/regional disease annually 2 ~45,000 Patients in the US diagnosed annually with mCRPC >3.1M SAR-bisPSMA: Pre-clinical data 5 SAR-bisPSMA has ideal product characteristics for a radiopharmaceutical Blood Lungs Heart Liver Kidneys Muscle Spleen Tumour 0 10 20 30 80 120 % IA/g Tumour targeting and superior retention over 24 hours 1 hr 24 hr PET images showing 64 Cu SAR- bisPSMA targeting to tumours over time and rapid kidney clearance Preclinical biodistribution study demonstrating high uptake and retention of 64 Cu SAR-bisPSMA in tumours with rapid clearance from non-target organs Preclinical efficacy study with increasing activity of 67 Cu SAR- bisPSMA (colours) demonstrating dose response Significant anti-tumour effect High uptake and retention in tumour Rapid kidney clearance of non-bound activity Zia et al., 2019. Ang.Chem McInnes et al., 2020. JNM ‘Bis-PSMA’ The term Bis is used to denote the presence of two identical but separate complex groups in one molecule 1 hr 4 hr 24 hrs SAR-bisPSMA: Current clinical trials 6 SECuRE: Systemic Copper theranostics in prostate cancer (NCT04868604 ) A Phase I/IIa study of 64 Cu SAR-bisPSMA and 67 Cu SAR- bisPSMA 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 SAR- bisPSMA for selection of patients suitable for therapy cycles with 67 Cu SAR-bisPSMA PROPELLER: PET Imaging of Participants With Confirmed Prostate Cancer (NCT04839367 ) 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 Dosimetry phase (N=6) Dose escalation phase (N=~24) Dose expansion phase (N=14) SECuRE study design Screening + 68 Ga PSMA-11 Assignment to dosing cohorts 1-3 64 Cu SAR- bisPSMA imaging PROPELLER study design SAR-bisPSMA mCRPC therapy 7 1h 64 Cu SAR- bisPSMA PET Comparison of 1h 64 Cu SAR- bisPSMA PET with 99m Tc-MDP Bone Scan 64 Cu SAR- bisPSMA PET/CT 99m Tc-MDP WB Bone Scan PET scans in a patient with metastatic castrate-resistant prostate cancer imaged over multiple timepoints between 1 and 72 hours post administration of 64 Cu SAR-bisPSMA (Normalized Voxel Intensity) 12hr 64 Cu SAR- bisPSMA PET/CT Fused Sagittal Preliminary imaging results from the dosimetry phase of the theranostic SECuRE clinical trial SAR-Bombesin in prostate cancer 8 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 64 Cu SAR- Bombesin 68 Ga PSMA-11 (top) images of a PSMA-negative 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) 68 Ga PSMA-11 64 Cu SAR- Bombesin 68 Ga PSMA-11 68 Ga PSMA-11 (top) images of a PSMA- negative 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) 67 Cu-SAR-Bombesin treated group Control group • 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 • 64 Cu/ 67 Cu SAR-Bombesin is under investigation as a theranostic pairing to treat breast and prostate cancer patients with tumours that express GRPr SAR-Bombesin: A pan-cancer target 9 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) SAR-Bombesin 67 Cu SAR-Bombesin has demonstrated an anti-tumour effect in preclinical models of prostate cancer, when compared to the control group 64 Cu SAR-Bombesin in hormone positive metastatic breast cancer Efficacy of 64 Cu SAR Bombesin in a mouse model of prostate cancer SAR-Bombesin in metastatic breast cancer 10 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 18 F 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 PET PET CT CT PET/CT PET/CT 64 Cu SAR-Bombesin 18 F FDG SARTATE™ – next generation theranostic 11 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) • 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 • 64 Cu SARTATE TM for the management of neuroblastoma • 67 Cu SARTATE TM for the treatment of neuroblastoma • 64 Cu SARTATE TM for the management of NETs Future opportunities • Other SSTR2 positive diseases, including but not limited to pancreatic and gastrointestinal cancer, pulmonary NETs, and meningiomas. 64 Cu SARTATE TM PET screening 4 hours 67 Cu SARTATE TM SPECT scan 24 hours High Precision (in the same patient) High Accuracy 123 I MIBG Current Standard of Care SARTATE™: Clinical trials 12 SARTATE™ CL04: 67 Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk, Relapsed, Refractory Neuroblastoma (NCT 04023331 ) • 64 Cu/ 67 Cu SARTATE™ Phase I/IIa trial in high-risk neuroblastoma in the US with up to 34 patients • Multi-centre, dose-escalation, open label, non- randomised, theranostic clinical trial. 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 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 Clinical development pipeline - 12 month progress 13 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 *Note clinical development pipeline is indicative only, subject to review. **All US studies are conducted under IND Slide from Clarity AGM 2020 14 Clarity delivered on all our goals for 2021 from the last AGM Inflection points to Q4 2022 15 Q4 2021 Q1 2022 Q2 2022 Q3 2022 Q4 2022 Dosimetry complete PSMA Tx US manufacture expansion >50% recruitment PROPELLER 1st PSMA Tx >50% recruitment DISCO Open IND PSMA Dx Advance to Cohort 2: PSMA Tx Advance to Cohort 2: NB Tx Open IND BBN Dx Recruitment complete PROPELLER FPI PSMA Dx USA Advance to Cohort 3: PSMA Tx Recruitment complete DISCO >50% recruitment PSMA Dx USA FPFV BBN Dx US Open IND BBN Tx Advance to Cohort 4: PSMA Tx Recruitment complete PSMA Dx USA * Tx = therapy **Dx = diagnostic Contact details 16 Dr Alan Taylor Executive Chairman E: alan.taylor@claritypharm.com Dr Colin Biggin Managing Director E: colin.biggin@claritypharm.com 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. 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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